[House Report 116-646] [From the U.S. Government Publishing Office] 116th Congress } { Rept. 116-646 HOUSE OF REPRESENTATIVES 2d Session } { Part 1 ====================================================================== IMPROVING CHRONIC CARE MANAGEMENT ACT _______ December 15, 2020.--Ordered to be printed _______ Mr. Neal, from the Committee on Ways and Means, submitted the following R E P O R T together with DISSENTING VIEWS [To accompany H.R. 3436] [Including cost estimate of the Congressional Budget Office] The Committee on Ways and Means, to whom was referred the bill (H.R. 3436) to amend title XVIII of the Social Security Act to remove cost-sharing responsibilities for chronic care management services under the Medicare program, having considered the same, reports favorably thereon with an amendment and recommends that the bill as amended do pass. CONTENTS Page I. SUMMARY AND BACKGROUND...........................................3 A. Purpose and Summary................................. 3 B. Background and Need for Legislation................. 3 C. Legislative History................................. 4 II. EXPLANATION OF THE BILL..........................................5 A. The Improving Chronic Care Management Act of 2019... 5 III. VOTES OF THE COMMITTEE...........................................6 IV. BUDGET EFFECTS OF THE BILL.......................................7 A. Committee Estimate of Budgetary Effects............. 7 B. Statement Regarding New Budget Authority and Tax Expenditures Budget Authority...................... 7 C. Cost Estimate Prepared by the Congressional Budget Office............................................. 7 V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......9 A. Committee Oversight Findings and Recommendations.... 9 B. Statement of General Performance Goals and Objectives......................................... 9 C. Information Relating to Unfunded Mandates........... 10 D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff Benefits............................ 10 E. Duplication of Federal Programs..................... 10 F. Hearings............................................ 10 VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED...........10 VII. DISSENTING VIEWS...............................................145 The amendment is as follows: Strike all after the enacting clause and insert the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Improving Chronic Care Management Act''. SEC. 2. REMOVING COST-SHARING RESPONSIBILITIES FOR CHRONIC CARE MANAGEMENT SERVICES UNDER PART B OF THE MEDICARE PROGRAM. (a) In General.--Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended-- (1) in subsection (a)(1), by striking subparagraph (Z) and inserting the following: ``(Z) with respect to chronic care management services (as described in section 1848(b)(8)) furnished on or after January 1, 2021, the amount paid shall be an amount equal to 100 percent of the lesser of the actual charge for such services or the amount determined under section 1848,''; and (2) in subsection (b)-- (A) in paragraph (9), by striking ``and'' at the end; and (B) in paragraph (10), by striking the period at the end and inserting the following: ``, and (11) such deductible shall not apply with respect to chronic care management services (as described in section 1848(b)(8)) furnished on or after January 1, 2021.''. (b) Technical Amendments.-- (1) In general.--Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is amended-- (A) in paragraph (3)-- (i) in subparagraph (A)-- (I) by striking ``subparagraph (B)'' and inserting ``subparagraphs (B), (C), and (D)''; and (II) by striking ``or'' at the end; and (ii) by adding at the end the following new subparagraphs: ``(C) with respect to Federally qualified health center services (other than such services that are described in clause (i) or (ii) of subparagraph (D)) furnished on or after the implementation date of the prospective payment system under section 1834(o) for which payment is made under such section, the amounts paid shall be 80 percent of the lesser of the actual charge or the amount determined under such section; and ``(D) with respect to Federally qualified health center services and rural health clinic services that are-- ``(i) personalized prevention plan services (as described in paragraph (1)(X)) or preventive services (as described in paragraph (1)(Y)) furnished on or after January 1, 2011; or ``(ii) chronic care management services (as described in paragraph (1)(Z)) furnished on or after January 1, 2021; the amounts paid shall be equal to 100 percent of the lesser of the actual charge or the amount determined under subparagraph (A), section 1834(o), or section 1848, as applicable;''; and (B) by striking the matter following paragraph (9). (2) Conforming amendments.--Section 1834(o) of the Social Security Act (42 U.S.C. 1395m(o)) is amended-- (A) in paragraph (1)(A), by inserting ``(other than such services described in clause (i) or (ii) of section 1833(a)(3)(D))'' after ``Federally qualified health center services''; and (B) in paragraph (2)-- (i) in subparagraph (A), by inserting ``(other than such services described in clause (i) or (ii) of section 1833(a)(3)(D))'' after ``services''; and (ii) in subparagraph (B)(i)-- (I) by inserting ``(other than such services described in clause (i) or (ii) of section 1833(a)(3)(D))'' after ``Federally qualified health center services''; and (II) by striking ``section 1833(a)(1)(Z)'' and inserting ``subparagraphs (C) and (D) of section 1833(a)(3)''. I. SUMMARY AND BACKGROUND A. Purpose and Summary The bill, H.R. 3436, the ``Improving Chronic Care Management Act,'' as amended and ordered reported by the Committee on Ways and Means on June 26, 2019, modifies Section 1833 of the Social Security Act (SSA; 42 U.S.C. 1395l) to eliminate Medicare beneficiary cost-sharing for covered chronic care management (CCM) services provided under Part B beginning January 1, 2021. The modification would apply to both coinsurance and deductibles under Part B. B. Background and Need for Legislation Generally, beneficiaries are responsible for a coinsurance payment (20 percent in most cases) and an annual deductible ($185 in 2019) for covered Medicare Part B services. The notable exception is for preventive care services; Part B covers a number of clinical preventive services, including a one-time initial preventive physical examination, certain cancer screenings and immunizations, an annual wellness visit and health assessment, and other services. In 2015, Medicare began paying separately under the Physician Fee Schedule for CCM services furnished to beneficiaries with multiple chronic conditions. According to the Centers for Medicare and Medicaid Services (CMS), two out of three Medicare beneficiaries have multiple chronic conditions, making them eligible for CCM services.\1\ However, preliminary data suggest that although an estimated 35 million Medicare patients could have benefitted from CCM services, only 100,000 beneficiaries received care management under the CCM codes during 2015.\2\ The underutilization is due, in part, to the fact that CCM must be initiated during a face-to-face appointment, the services carry considerable documentation requirements for providers, and beneficiaries are responsible for 20 percent coinsurance. --------------------------------------------------------------------------- \1\Connected Care Toolkit: Chronic Care Management Resources for Health Care Professionals and Communities, CTRS. for Medicare & Medicaid Servs., at 2 https://www.cms.gov/About-CMS/Agency-Information/ OMH/Downloads/connected-hcptoolkit.pdf. \2\Susan Kreimer, CMS Coding Changes for Chronic Care Management Benefits Providers and Patients, Am. Assoc. for Physician Leadership (Aug. 16, 2017), https://www.physicianleaders.org/news/cms-coding- changes-for-chronic-care-management-benefits-providers-and-patients. --------------------------------------------------------------------------- The Committee believes that congressional action is necessary to help remove barriers to care management services. A broad swath of stakeholder organizations have registered their support for such action. For example, the American Academy of Family Physicians (AAFP) has noted, ``While we recognize that CMS made great strides to simplify the requirements of CCM services regarding consent and access to the care plan, we still see evidence that the cost-sharing requirement is an impediment to the broad utilization of this code.''\3\ In addition, the Federation of American Hospitals (FAH) states that, ``By removing the cost-sharing obligations from the [CCM] code, an additional number of chronically ill Medicare beneficiaries are likely to access the care management services they require.''\4\ This sentiment has been further echoed by fourteen provider and health organizations including the AMGA (formerly the American Medical Group Association), stating that ``[p]roviders and care managers report many positive outcomes for beneficiaries who receive CCM services, including improved patient satisfaction and adherence to recommended therapies, improved clinician efficiency, and decreased hospitalizations and emergency department visits.''\5\ --------------------------------------------------------------------------- \3\AAFP Letter Supporting Bill that Removes Medicare Beneficiary Cost-Sharing Responsibilities for the CCM, Am. Academy of Family Physicians (June 25, 2019), https://www.aafp.org/dam/AAFP/documents/ advocacy/payment/medicare/LT-WM-CCMCodes-062519.pdf. \4\FAH Support Letter to Ways and Means, Federation of Am. Hospitals (June 25, 2019), https://www.fah.org/fah-ee2-uploads/website/ documents/FAH_Support_Letter_-_Ways_and_ Means_Mark-Up_06.25.2019.pdf. \5\Joint Letter Supporting a Bill that Removes Medicare Beneficiary Cost-Sharing Responsibilities for the CCM, Am. Academy of Family Physicians (June 25, 2019), https://www.aafp.org/dam/AAFP/documents/ advocacy/payment/medicare/LT-SupportRemovalCCMCostSharing-062519.pdf. --------------------------------------------------------------------------- C. Legislative History Background H.R. 3436 was introduced on June 24, 2019, and was referred to the Committee on Ways and Means and additionally the Committee on Energy and Commerce. Committee Hearings On June 4, 2019, the Committee on Ways and Means held a full committee Member Day hearing to discuss the range of issues, concerns, and proposals among on-committee and off- committee members. During that hearing, Representative TJ Cox (D-CA) advocated for the Better Respiration Through Expanded Access to Tele-Health Act which proposes a demonstration project to help address the wholistic needs, including care management, of beneficiaries who suffer from Chronic obstructive pulmonary disease. Rep. Cox also championed Section 103 of H.R. 1301, the ``Mental Health Telemedicine Act,'' as a way to enhance telehealth services to help beneficiaries address and manage the ongoing burden of chronic conditions. On May 16, 2019, the Committee on Ways and Means held a full committee meeting to discuss, ``Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis.'' The Committee heard from a Member panel (Representatives Robin Kelly (D-IL) and Jamie Herrera-Beutler (R-WA); and a panel of witnesses representing the patient experience (Allyson Felix, US Track and Field Olympian); provider perspective (Dr. Patricia Harris, President-Elect of the American Medical Association, and Dr. Lisa Hollier, Immediate and Past President and interim CEO of the American College of Obstetricians and Gynecologists); state perspective (Dr. Loren Robinson, Deputy Secretary Pennsylvania Department of Health, and Melanie Rouse, PhD, Maternal Mortality Projects Coordinator for the Commonwealth of Virginia); and the academy (Dr. Michael Lu, Senior Associate Dean for Academic, Student, and Faculty Affairs at the Milken Institute School of Public Health at George Washington University). The hearing included significant discussion about social determinants of health being primary factors in poor health outcomes throughout the life cycle. Witnesses noted the role of weathering, a concept that refers to increased general health vulnerability and premature aging due to the collective impact of chronic, environmental stressors on people of color, and its role in disparities overall.\6\ Chronic care management (CCM) is considered to be one of the most important ways to mitigate disparities and poor health outcomes associated with social determinants of health. --------------------------------------------------------------------------- \6\Patrice Harris, Statement of the American Medical Association to the U.S. House of Representatives Committee on Ways and Means, Ways and Means Committee at 4 (May 16, 2019), https://docs.house.gov/meetings/ WM/WM00/20190516/109496/HHRG-116-WM00-Wstate-HarrisP-20190516.pdf; Loren Robinson, Testimony for Public Hearing on Overcoming Racial Disparities and Social Determinants in Maternal Mortality Crisis, Ways and Means Committee at 1 (May 16, 2019), https://docs.house.gov/ meetings/WM/WM00/20190516/109496/HHRG-116-WM00-Wstate-RobinsonL- 20190516.pdf; Michael Lu, Statement of Michael Lu Senior Associate Dean Milken Institute School of Public Health George Washington University, Ways and Means Committee at 6-7 (May 16, 2019), https://docs.house.gov/ meetings/WM/WM00/20190516/109496/HHRG-116-WM00-Wstate-LuM-20190516.pdf. --------------------------------------------------------------------------- Committee Action The Committee on Ways and Means marked up H.R. 3436, the ``Improving Chronic Care Management Act,'' on June 26, 2019, and ordered the bill as amended favorably reported by a roll call vote of 24 to 14 (with a quorum being present). II. EXPLANATION OF THE BILL A. The Improving Chronic Care Management Act of 2019 CURRENT LAW\7\ --------------------------------------------------------------------------- \7\All discussions of Current Law in this report refer to current law as of the date of the markup (i.e., June 26, 2019) and do not reflect subsequent law changes. --------------------------------------------------------------------------- Medicare beneficiaries are generally responsible for a coinsurance payment (20 percent in most cases) and an annual deductible ($185 in 2019) for covered Medicare Part B services. The notable exception is for preventive care services, with Part B covering a number of clinical preventive services. Under the Patient Protection and Affordable Care Act of 2010 (ACA; P.L. 111-148, as amended), Part B waives any cost-sharing for almost all covered preventive services, and authorizes the Secretary of Health and Human Services (HHS Secretary) to pay federally qualified health centers (FQHCs) for covered preventive services provided to Medicare beneficiaries. Some preventive services continue to require beneficiary cost- sharing, e.g., for diabetes self-management training or glaucoma tests. Medicare does not pay for preventive services that exceed the coverage limit, such as when a beneficiary receives more than one mammogram every 12 months. In 2015, CCM became eligible to be separately billed under the Medicare Physician Fee Schedule. Per calendar month, CCM services include at least 20 minutes of clinical staff time directed by a physician or other qualified health professional to address (1) multiple chronic conditions that are expected to last at least 12 months or until the patient dies; and (2) chronic conditions that place the patient at a significant risk of death, acute exacerbation or decompensation, or functional decline. CCM requires a comprehensive care plan, and beneficiaries with conditions requiring complex medical decision-making are eligible for up to 60 minutes of clinical staff time per calendar month. CCM service codes are general supervision services under Part B. Therefore, the billing practitioner's physical presence is not required in order to support claims for the services, nor is the beneficiary required to be present after initiating CCM services. The ``behind the curtain'' nature of CCM services leaves beneficiaries confused when they receive statements reflecting charges for CCM cost-sharing, when they have not had an actual office appointment within that time period. REASONS FOR CHANGE The Committee believes that legislative action is necessary to remove barriers to care management services. To improve access to and utilization of CCM services, this bill removes the cost-sharing requirement for beneficiaries to access CCM services, similar to current cost-sharing policies under Part B for preventive services. The provision would apply both to coinsurance and deductibles related to CCM services. EXPLANATION OF PROVISIONS Section 1. Short title The short title for this bill is the Improving Chronic Care Management Act. Section 2. Removing cost-sharing responsibilities for Chronic Care Management services under Part B of the Medicare program Section 2 removes the beneficiary cost-sharing requirement under Medicare Part B for CCM services. Effective January 1, 2021, the coinsurance cost-sharing requirement for chronic care management services for Medicare beneficiaries under Part B will go from 20 percent of payment to zero percent of payment. CCM services under Part B will also be exempt from any deductible requirements. CCM codes reflect services that are in addition to routine care coordination, behavioral health integration, or psychiatric collaborative care services that are already furnished by a Federally Qualified Health Center (FQHC) or Rural Health Center (RHC). EFFECTIVE DATE Certain named provision: Effective beginning on or after date January 1, 2021. III. VOTES OF THE COMMITTEE In compliance with clause 3(b) of rule XIII of the House of Representatives, the following statement is made concerning the vote of the Committee on Ways and Means during the markup consideration of H.R. 3436, ``The Improving Chronic Care Management Act.'' The Chairman's amendment in the nature of a substitute was adopted by a voice vote (with a quorum being present). H.R. 3436 was ordered favorably reported to the House of Representatives as amended by an amendment in the nature of a substitute offered by Chairman Neal by a roll call vote of 24 yeas to 14 nays. The vote was as follows: ---------------------------------------------------------------------------------------------------------------- Representative Yea Nay Present Representative Yea Nay Present ---------------------------------------------------------------------------------------------------------------- Mr. Neal...................... X ......... ......... Mr. Brady........ ........ X ......... Mr. Lewis..................... X ......... ......... Mr. Nunes........ ........ X ......... Mr. Doggett................... X ......... ......... Mr. Buchanan..... ........ X ......... Mr. Thompson.................. X ......... ......... Mr. Smith (NE)... ........ X ......... Mr. Larson.................... X ......... ......... Mr. Marchant..... ........ X ......... Mr. Blumenauer................ X ......... ......... Mr. Reed......... X ........ ......... Mr. Kind...................... ........ ......... ......... Mr. Kelly........ ........ X ......... Mr. Pascrell.................. X ......... ......... Mr. Holding...... ........ X ......... Mr. Davis..................... X ......... ......... Mr. Smith (MO)... ........ X ......... Ms. Sanchez................... X ......... ......... Mr. Rice......... ........ X ......... Mr. Higgins................... ........ ......... ......... Mr. Schweikert... ........ X ......... Ms. Sewell.................... X ......... ......... Ms. Walorski..... ........ ........ ......... Ms. DelBene................... X ......... ......... Mr. LaHood....... ........ X ......... Ms. Chu....................... X ......... ......... Mr. Wenstrup..... ........ X ......... Ms. Moore..................... X ......... ......... Mr. Arrington.... ........ ........ ......... Mr. Kildee.................... X ......... ......... Mr. Ferguson..... ........ X ......... Mr. Boyle..................... X ......... ......... Mr. Estes........ ........ X ......... Mr. Beyer..................... X Mr. Evans..................... X Mr. Schneider................. X Mr. Suozzi.................... X Mr. Panetta................... X Ms. Murphy.................... X Mr. Gomez..................... X Mr. Horsford.................. X ---------------------------------------------------------------------------------------------------------------- IV. BUDGET EFFECTS OF THE BILL A. Committee Estimate of Budgetary Effects In compliance with clause 3(d) of rule XIII of the Rules of the House of Representatives, the following statement is made concerning the effects on the budget of the bill, H.R. 3436, as reported. The Committee agrees with the estimate prepared by the Congressional Budget Office (CBO), which is included below. B. Statement Regarding New Budget Authority and Tax Expenditures Budget Authority In compliance with clause 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee states that the bill involves no new or increased budget authority. The Committee states further that the bill involves no new or increased tax expenditures. C. Cost Estimate Prepared by the Congressional Budget Office In compliance with clause 3(c)(3) of rule XIII of the Rules of the House of Representatives, requiring a cost estimate prepared by the CBO, the following statement by CBO is provided. U.S. Congress, Congressional Budget Office, Washington, DC, September 10, 2019. Hon. Richard Neal, Chairman, Committee on Ways and Means, House of Representatives, Washington, DC. Dear Mr. Chairman: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 3436, the Improving Chronic Care Management Act. If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Lori Housman. Sincerely, Phillip L. Swagel, Director. Enclosure. [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] The bill wouldEnd patient cost sharing for chronic care management (CCM) services under the Medicare fee-for- service program Estimated budgetary effects would primarily stem from Medicare's payment of the full amount for CCM services Areas of significant uncertainty include Projecting the number of Medicare beneficiaries who would use CCM services Bill summary: H.R. 3436 would end patients' cost-sharing responsibilities for chronic care management services under Medicare. Estimated Federal cost: The estimated budgetary effect of H.R. 3436 is shown in Table 1. The costs of the legislation fall within budget function 570 (Medicare). TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 3436 -------------------------------------------------------------------------------------------------------------------------------------------------------- By fiscal year, millions of dollars-- -------------------------------------------------------------------------------------------------- 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2019-2024 2019-2029 -------------------------------------------------------------------------------------------------------------------------------------------------------- Net Increase in the Deficit From Changes in Direct Spending Estimated Budget Authority........................... 0 25 70 75 80 85 90 90 90 95 90 335 790 Estimated Outlays.................................... 0 25 70 75 80 85 90 90 90 95 90 335 790 -------------------------------------------------------------------------------------------------------------------------------------------------------- Basis of estimate: For this estimate, CBO assumes that the bill will be enacted near the end of 2019. Direct spending: In 2015, Medicare began to pay for CCM services for beneficiaries who have two or more chronic conditions that are expected to last at least 12 months or until the death of the patient. CCM services are electronic and provided remotely. Examples of such services include developing comprehensive care plans and management, providing access to around-the-clock care and transitional care management, and coordinating home- and community-based care. Medicare patients must consent to receiving the services and acknowledge their cost-sharing responsibilities. Under its fee-for-service program, Medicare typically pays 80 percent of the physician fee schedule amount, and beneficiaries pay the remaining 20 percent. In 2018, about 4 million CCM services were provided to Medicare beneficiaries and, on average, patient's monthly cost sharing totaled about $11 per service. Beginning in 2020, H.R. 3436 would eliminate cost sharing for CCM services. CBO estimates that removing the cost sharing requirement would increase the number of CCM services provided to chronically ill individuals by about 200,000 (a five percent increase) in 2020, increasing to about I million additional services (a 25 percent increase) by 2029. Under H.R. 3436, Medicare would pay the full fee schedule amount, which would increase direct spending by $25 million in 2020 and by $790 million over the 2019-2029 period. Uncertainty: CBO cannot precisely estimate the number of Medicare beneficiaries who would use CCM services once cost sharing ends. Because coverage of CCM services is relatively new to the Medicare program, it is possible that the number of beneficiaries using CCM services could be higher or lower than CBO anticipated. Pay-As-You-Go considerations: The Statutory Pay-As-You-Go Act of 2010 establishes budget-reporting and enforcement procedures for legislation affecting direct spending or revenues. The net changes in outlays that are subject to those pay-as-you-go procedures are shown in Table 1. Increase in long-term deficits: CBO estimates that enacting H.R. 3436 would not increase on-budget deficits by more than $5 billion in any of the four consecutive 10-year periods beginning in 2030. Mandates: None. Estimate prepared by: Federal Costs: Lori Housman, Mandates: Andrew Laughlin. Estimate reviewed by: Tom Bradley, Chief, Health Systems and Medicare Cost Estimates Unit; Leo Lex, Deputy Assistant Director for Budget Analysis; Theresa Gullo, Assistant Director for Budget Analysis. V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE A. Committee Oversight Findings and Recommendations With respect to clause 3(c)(1) of rule XIII and clause 2(b)(1) of rule X of the Rules of the House of Representatives, the Committee made findings and recommendations that are reflected in this report. B. Statement of General Performance Goals and Objectives With respect to clause 3(c)(4) of rule XIII of the Rules of the House of Representatives, the Committee advises that the bill contains no measure that authorizes funding, so no statement of general performance goals and objectives for which any measure authorizes funding is required. C. Information Relating to Unfunded Mandates This information is provided in accordance with section 423 of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104- 94). The Committee has determined that the bill does not contain Federal mandates on the private sector. The Committee has determined that the bill does not impose a Federal intergovernmental mandate on State, local, or tribal governments. D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff Benefits With respect to clause 9 of rule XXI of the Rules of the House of Representatives, the Committee has carefully reviewed the provisions of the bill, and states that the provisions of the bill do not contain any congressional earmarks, limited tax benefits, or limited tariff benefits within the meaning of the rule. E. Duplication of Federal Programs In compliance with clause 3(c)(5) of rule XIII of the Rules of the House of Representatives, the Committee states that no provision of the bill establishes or reauthorizes: (1) a program of the Federal Government known to be duplicative of another Federal program; (2) a program included in any report to Congress pursuant to section 21 of Public Law 111-139; or (3) a program related to a program identified in the most recent Catalog of Federal Domestic Assistance, published pursuant to section 6104 of title 31, United States Code. F. Hearings In compliance with Sec. 103(i) of H. Res. 6 (116th Congress) the following hearings were used to develop or consider H.R. 3436: (1) On June 4, 2019, the Committee on Ways and Means held a full committee Member Day hearing to discuss the range of issues, concerns, and proposals among on-committee and off- committee members. (2) On May 16, 2019, the Committee on Ways and Means held a full committee hearing to discuss, ``Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis.'' VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED In compliance with clause 3(e)(1)(B) of rule XIII of the Rules of the House of Representatives, changes in existing law proposed by the bill, as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italics, existing law in which no change is proposed is shown in roman): Changes in Existing Law Made by the Bill, as Reported In compliance with clause 3(e) of rule XIII of the Rules of the House of Representatives, changes in existing law made by the bill, as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italics, and existing law in which no change is proposed is shown in roman): SOCIAL SECURITY ACT * * * * * * * TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED * * * * * * * Part B--Supplementary Medical Insurance Benefits for the Aged and Disabled * * * * * * * PAYMENT OF BENEFITS Sec. 1833. (a) Except as provided in section 1876, and subject to the succeeding provisions of this section, there shall be paid from the Federal Supplementary Medical Insurance Trust Fund, in the case of each individual who is covered under the insurance program established by this part and incurs expenses for services with respect to which benefits are payable under this part, amounts equal to--(1) in the case of services described in section 1832(a)(1)--80 percent of the reasonable charges for the services; except that (A) an organization which provides medical and other health services (or arranges for their availability) on a prepayment basis (and either is sponsored by a union or employer, or does not provide, or arrange for the provision of, any inpatient hospital services) may elect to be paid 80 percent of the reasonable cost of services for which payment may be made under this part on behalf of individuals enrolled in such organization in lieu of 80 percent of the reasonable charges for such services if the organization undertakes to charge such individuals no more than 20 percent of such reasonable cost plus any amounts payable by them as a result of subsection (b), (B) with respect to items and services described in section 1861(s)(10)(A), the amounts paid shall be 100 percent of the reasonable charges for such items and services, (C) with respect to expenses incurred for those physicians' services for which payment may be made under this part that are described in section 1862(a)(4), the amounts paid shall be subject to such limitations as may be prescribed by regulations, (D) with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule under subsection (h)(1) (for tests furnished before January 1, 2017) or section 1834(d)(1), the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis) of the lesser of the amount determined under such fee schedule, the limitation amount for that test determined under subsection (h)(4)(B), or the amount of the charges billed for the tests, or (II) undersection 1834A (for tests furnished on or after January1, 2017), the amount paid shall be equal to 80 percent(or 100 percent, in the case of such tests for whichpayment is made on an assignment-related basis) ofthe lesser of the amount determined under such sectionor the amount of the charges billed for the tests, or (ii) for tests furnished before January 1, 2017,on the basis of a negotiated rate established under subsection (h)(6), the amount paid shall be equal to 100 percent of such negotiated rate,,(E) with respect to services furnished to individuals who have been determined to have end stage renal disease, the amounts paid shall be determined subject to the provisions of section 1881,(F) with respect to clinical social worker services under section 1861(s)(2)(N), the amounts paid shall be 80 percent of the lesser of (i) the actual charge for the services or (ii) 75 percent of the amount determined for payment of a psychologist under clause (L), (G) with respect to facility services furnished in connection with a surgical procedure specified pursuant to subsection (i)(1)(A) and furnished to an individual in an ambulatory surgical center described in such subsection, for services furnished beginning with the implementation date of a revised payment system for such services in such facilities specified in subsection (i)(2)(D), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by the Secretary under such revised payment system, (H) with respect to services of a certified registered nurse anesthetist under section 1861(s)(11), the amounts paid shall be 80 percent of the least of the actual charge, the prevailing charge that would be recognized (or, for services furnished on or after January 1, 1992, the fee schedule amount provided under section 1848) if the services had been performed by an anesthesiologist, or the fee schedule for such services established by the Secretary in accordance with subsection (l), (I) with respect to covered items (described in section 1834(a)(13)), the amounts paid shall be the amounts described in section 1834(a)(1), and(J) with respect to expenses incurred for radiologist services (as defined in section 1834(b)(6)), subject to section 1848, the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount provided under the fee schedule established under section 1834(b), (K) with respect to certified nurse-midwife services under section 1861(s)(2)(L), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary for the purposes of this subparagraph (but in no event shall such fee schedule exceed 65 percent of the prevailing charge that would be allowed for the same service performed by a physician, or, for services furnished on or after January 1, 1992, 65 percent (or 100 percent for services furnished on or after January 1, 2011) of the fee schedule amount provided under section 1848 for the same service performed by a physician), (L) with respect to qualified psychologist services under section 1861(s)(2)(M), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary for the purposes of this subparagraph, (M) with respect to prosthetic devices and orthotics and prosthetics (as defined in section 1834(h)(4)), the amounts paid shall be the amounts described in section 1834(h)(1), (N) with respect to expenses incurred for physicians' services (as defined in section 1848(j)(3)) other than personalized prevention plan services (as defined in section 1861(hhh)(1)), the amounts paid shall be 80 percent of the payment basis determined under section 1848(a)(1), (O) with respect to services described in section 1861(s)(2)(K) (relating to services furnished by physician assistants, nurse practitioners, or clinic nurse specialists), the amounts paid shall be equal to 80 percent of (i) the lesser of the actual charge or 85 percent of the fee schedule amount provided under section 1848, or (ii) in the case of services as an assistant at surgery, the lesser of the actual charge or 85 percent of the amount that would otherwise be recognized if performed by a physician who is serving as an assistant at surgery, (P) with respect to surgical dressings, the amounts paid shall be the amounts determined under section 1834(i), (Q) with respect to items or services for which fee schedules are established pursuant to section 1842(s), the amounts paid shall be 80 percent of the lesser of the actual charge or the fee schedule established in such section, (R) with respect to ambulance services, (i) the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary under section 1834(l) and (ii) with respect to ambulance services described in section 1834(l)(8), the amounts paid shall be the amounts determined under section 1834(g) for outpatient critical access hospital services, (S) with respect to drugs and biologicals (including intravenous immune globulin (as defined in section 1861(zz))) not paid on a cost or prospective payment basis as otherwise provided in this part (other than items and services described in subparagraph (B)), the amounts paid shall be 80 percent of the lesser of the actual charge or the payment amount established in section 1842(o) (or, if applicable, under section 1847, 1847A, or 1847B), (T) with respect to medical nutrition therapy services (as defined in section 1861(vv)), the amount paid shall be 80 percent (or 100 percent if such services are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual) of the lesser of the actual charge for the services or 85 percent of the amount determined under the fee schedule established under section 1848(b) for the same services if furnished by a physician, (U) with respect to facility fees described in section 1834(m)(2)(B), the amounts paid shall be 80 percent of the lesser of the actual charge or the amounts specified in such section, (V) notwithstanding subparagraphs (I) (relating to durable medical equipment), (M) (relating to prosthetic devices and orthotics and prosthetics), and (Q) (relating to 1842(s) items), with respect to competitively priced items and services (described in section 1847(a)(2)) that are furnished in a competitive area, the amounts paid shall be the amounts described in section 1847(b)(5), (W) with respect to additional preventive services (as defined in section 1861(ddd)(1)), the amount paid shall be (i) in the case of such services which are clinical diagnostic laboratory tests, the amount determined under subparagraph (D) (if such subparagraph were applied, by substituting ``100 percent'' for ``80 percent''), and (ii) in the case of all other such services, 100 percent of the lesser of the actual charge for the service or the amount determined under a fee schedule established by the Secretary for purposes of this subparagraph, (X) with respect to personalized prevention plan services (as defined in section 1861(hhh)(1)), the amount paid shall be 100 percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848, (Y) with respect to preventive services described in subparagraphs (A) and (B) of section 1861(ddd)(3) that are appropriate for the individual and, in the case of such services described in subparagraph (A), are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population, the amount paid shall be 100 percent of (i) except as provided in clause (ii), the lesser of the actual charge for the services or the amount determined under the fee schedule that applies to such services under this part, and (ii) in the case of such services that are covered OPD services (as defined in subsection (t)(1)(B)), the amount determined under subsection (t), [(Z) with respect to Federally qualified health center services for which payment is made under section 1834(o), the amounts paid shall be 80 percent of the lesser of the actual charge or the amount determined under such section, ] (Z) with respect to chronic care management services (as described in section 1848(b)(8)) furnished on or after January 1, 2021, the amount paid shall be an amount equal to 100 percent of the lesser of the actual charge for such services or the amount determined under section 1848, (AA) with respect to an applicable disposable device (as defined in paragraph (2) of section 1834(s)) furnished to an individual pursuant to paragraph (1) of such section, the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under paragraph (3) of such section, (BB) with respect to home infusion therapy, the amount paid shall be an amount equal to 80 percent of the lesser of the actual charge for the services or the amount determined under section 1834(u), and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary; (2) in the case of services described in section 1832(a)(2) (except those services described in subparagraphs (C), (D), (E), (F), (G), (H), and (I) of such section and unless otherwise specified in section 1881)-- (A) with respect to home health services (other than a covered osteoporosis drug) (as defined in section 1861(kk)), the amount determined under the prospective payment system under section 1895; (B) with respect to other items and services (except those described in subparagraph (C), (D), or (E) of this paragraph and except as may be provided in section 1886 or section 1888(e)(9))-- (i) furnished before January 1, 1999, the lesser of-- (I) the reasonable cost of such services, as determined under section 1861(v), or (II) the customary charges with respect to such services,--less the amount a provider may charge as described in clause (ii) of section 1866(a)(2)(A), but in no case may the payment for such other services exceed 80 percent of such reasonable cost, or (ii) if such services are furnished before January 1, 1999, by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this clause), free of charge or at nominal charges to the public, 80 percent of the amount determined in accordance with section 1814(b)(2), or (iii) if such services are furnished on or after January 1, 1999, the amount determined under subsection (t), or (iv) if (and for so long as) the conditions described in section 1814(b)(3) are met, the amounts determined under the reimbursement system described in such section; (C) with respect to services described in the second sentence of section 1861(p), 80 percent of the reasonable charges for such services; (D) with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I)on the basis of a fee schedule determined under subsection(h)(1) (for tests furnished before January 1, 2017) or section 1834(d)(1), the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis or to a provider having an agreement under section 1866) of the lesser of the amount determined under such fee schedule, the limitation amount for that test determined under subsection (h)(4)(B), or the amount of the charges billed for the tests, or (II) under section 1834A (for tests furnished on or after January 1, 2017), the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis or to a provider having an agreement under section 1866) of the lesser of the amount determined under such section or the amount of the charges billed for the tests, or (ii) for tests furnished before January 1, 2017, on the basis of a negotiated rate established under subsection (h)(6), the amount paid shall be equal to 100 percent of such negotiated rate for such tests; (E) with respect to-- (i) outpatient hospital radiology services (including diagnostic and therapeutic radiology, nuclear medicine and CAT scan procedures, magnetic resonance imaging, and ultrasound and other imaging services, but excluding screening mammography and, for services furnished on or after January 1, 2005, diagnostic mammography), and (ii) effective for procedures performed on or after October 1, 1989, diagnostic procedures (as defined by the Secretary) described in section 1861(s)(3) (other than diagnostic x-ray tests and diagnostic laboratory tests), the amount determined under subsection (n) or, for services or procedures performed on or after January 1, 1999, subsection (t); (F) with respect to a covered osteoporosis drug (as defined in section 1861(kk)) furnished by a home health agency, 80 percent of the reasonable cost of such service, as determined under section 1861(v); (G) with respect to items and services described in section 1861(s)(10)(A), the lesser of-- (i) the reasonable cost of such services, as determined under section 1861(v), or (ii) the customary charges with respect to such services; and (H) with respect to personalized prevention plan services (as defined in section 1861(hhh)(1)) furnished by an outpatient department of a hospital, the amount determined under paragraph (1)(X), or, if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision), free of charge or at nominal charges to the public, the amount determined in accordance with section 1814(b)(2); (3) in the case of services described in section 1832(a)(2)(D)-- (A) except as provided in [subparagraph (B)] subparagraphs (B), (C), and (D), the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, including those authorized under section 1861(v)(1)(A), less the amount a provider may charge as described in clause (ii) of section 1866(a)(2)(A), but in no case may the payment for such services (other than for items and services described in section 1861(s)(10)(A)) exceed 80 percent of such costs; [or] (B) with respect to the services described in clause (ii) of section 1832(a)(2)(D) that are furnished to an individual enrolled with a MA plan under part C pursuant to a written agreement described in section 1853(a)(4), the amount (if any) by which-- (i) the amount of payment that would have otherwise been provided (I) under subparagraph (A) (calculated as if ``100 percent'' were substituted for ``80 percent'' in such subparagraph) for such services if the individual had not been so enrolled, or (II) in the case of such services furnished on or after the implementation date of the prospective payment system under section 1834(o), under such section (calculated as if ``100 percent'' were substituted for ``80 percent'' in such section) for such services if the individual had not been so enrolled; exceeds (ii) the amount of the payments received under such written agreement for such services (not including any financial incentives provided for in such agreement such as risk pool payments, bonuses, or withholds), less the amount the federally qualified health center may charge as described in section 1857(e)(3)(B); (C) with respect to Federally qualified health center services (other than such services that are described in clause (i) or (ii) of subparagraph (D)) furnished on or after the implementation date of the prospective payment system under section 1834(o) for which payment is made under such section, the amounts paid shall be 80 percent of the lesser of the actual charge or the amount determined under such section; and (D) with respect to Federally qualified health center services and rural health clinic services that are-- (i) personalized prevention plan services (as described in paragraph (1)(X)) or preventive services (as described in paragraph (1)(Y)) furnished on or after January 1, 2011; or (ii) chronic care management services (as described in paragraph (1)(Z)) furnished on or after January 1, 2021; the amounts paid shall be equal to 100 percent of the lesser of the actual charge or the amount determined under subparagraph (A), section 1834(o), or section 1848, as applicable; (4) in the case of facility services described in section 1832(a)(2)(F), and outpatient hospital facility services furnished in connection with surgical procedures specified by the Secretary pursuant to section 1833(i)(1)(A), the applicable amount as determined under paragraph (2) or (3) of subsection (i) or subsection (t); (5) in the case of covered items (described in section 1834(a)(13)) the amounts described in section 1834(a)(1); (6) in the case of outpatient critical access hospital services, the amounts described in section 1834(g); (7) in the case of prosthetic devices and orthotics and prosthetics (as described in section 1834(h)(4)), the amounts described in section 1834(h); (8) in the case of-- (A) outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished-- (i) by a rehabilitation agency, public health agency, clinic, comprehensive outpatient rehabilitation facility, or skilled nursing facility, (ii) by a home health agency to an individual who is not homebound, or (iii) by another entity under an arrangement with an entity described in clause (i) or (ii); and (B) outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished-- (i) by a hospital to an outpatient or to a hospital inpatient who is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness or is not so entitled to benefits under part A, or (ii) by another entity under an arrangement with a hospital described in clause (i), the amounts described in section 1834(k); and (9) in the case of services described in section 1832(a)(2)(E) that are not described in paragraph (8), the amounts described in section 1834(k). [Paragraph (3)(A) shall not apply to Federally qualified health center services furnished on or after the implementation date of the prospective payment system under section 1834(0).] (b) Before applying subsection (a) with respect to expenses incurred by an individual during any calendar year, the total amount of the expenses incurred by such individual during such year (which would, except for this subsection, constitute incurred expenses from which benefits payable under subsection (a) are determinable) shall be reduced by a deductible of $75 for calendar years before 1991, $100 for 1991 through 2004, $110 for 2005, and for a subsequent year the amount of such deductible for the previous year increased by the annual percentage increase in the monthly actuarial rate under section 1839(a)(1) ending with such subsequent year (rounded to the nearest $1); except that (1) such total amount shall not include expenses incurred for preventive services described in subparagraph (A) of section 1861(ddd)(3) that are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual., (2) such deductible shall not apply with respect to home health services (other than a covered osteoporosis drug (as defined in section 1861(kk))), (3) such deductible shall not apply with respect to clinical diagnostic laboratory tests for which payment is made under this part (A) under subsection (a)(1)(D)(i) or (a)(2)(D)(i) on an assignment- related basis, or to a provider having an agreement under section 1866, or (B) for tests furnished before January 1, 2017,on the basis of a negotiated rate determined under subsection (h)(6), (4) such deductible shall not apply to Federally qualified health center services, (5) such deductible shall not apply with respect to screening mammography (as described in section 1861(jj)), (6) such deductible shall not apply with respect to screening pap smear and screening pelvic exam (as described in section 1861(nn)), (7) such deductible shall not apply with respect to ultrasound screening for abdominal aortic aneurysm (as defined in section 1861(bbb)), (8) such deductible shall not apply with respect to colorectal cancer screening tests (as described in section 1861(pp)(1)), (9) such deductible shall not apply with respect to an initial preventive physical examination (as defined in section 1861(ww)), [and] (10) such deductible shall not apply with respect to personalized prevention plan services (as defined in section 1861(hhh)(1)). The total amount of the expenses incurred by an individual as determined under the preceding sentence shall, after the reduction specified in such sentence, be further reduced by an amount equal to the expenses incurred for the first three pints of whole blood (or equivalent quantities of packed red blood cells, as defined under regulations) furnished to the individual during the calendar year, except that such deductible for such blood shall in accordance with regulations be appropriately reduced to the extent that there has been a replacement of such blood (or equivalent quantities of packed red blood cells, as so defined); and for such purposes blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual shall be deemed replaced when the institution or other person furnishing such blood (or such equivalent quantities of packed red blood cells, as so defined) is given one pint of blood for each pint of blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual with respect to which a deduction is made under this sentence. The deductible under the previous sentence for blood or blood cells furnished an individual in a year shall be reduced to the extent that a deductible has been imposed under section 1813(a)(2) to blood or blood cells furnished the individual in the year. Paragraph (1) of the first sentence of this subsection shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test[.], and (11) such deductible shall not apply with respect to chronic care management services (as described in section 1848(b)(8)) furnished on or after January 1, 2021. (c)(1) Notwithstanding any other provision of this part, with respect to expenses incurred in a calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b)-- (A) for expenses incurred in years prior to 2010, only 62\1/2\ percent of such expenses; (B) for expenses incurred in 2010 or 2011, only 68\3/ 4\ percent of such expenses; (C) for expenses incurred in 2012, only 75 percent of such expenses; (D) for expenses incurred in 2013, only 81\1/4\ percent of such expenses; and (E) for expenses incurred in 2014 or any subsequent calendar year, 100 percent of such expenses. (2) For purposes of subparagraphs (A) through (D) of paragraph (1), the term ``treatment'' does not include brief office visits (as defined by the Secretary) for the sole purpose of monitoring or changing drug prescriptions used in the treatment of such disorders or partial hospitalization services that are not directly provided by a physician (d) No payment may be made under this part with respect to any services furnished an individual to the extent that such individual is entitled (or would be entitled except for section 1813) to have payment made with respect to such services under part A. (e) No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period. (f) In establishing limits under subsection (a) on payment for rural health clinic services provided by rural health clinics (other than such clinics in hospitals with less than 50 beds), the Secretary shall establish such limit, for services provided-- (1) in 1988, after March 31, at $46 per visit, and (2) in a subsequent year, at the limit established under this subsection for the previous year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) applicable to primary care services (as defined in section 1842(i)(4)) furnished as of the first day of that year. (g)(1)(A) Subject to paragraphs (4) and (5), in the case of physical therapy services of the type described in section 1861(p) and speech-language pathology services of the type described in such section through the application of section 1861(ll)(2), but (except as provided in paragraph (6)) not described in subsection (a)(8)(B), and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians' services, with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after December 31, 2017. (B) With respect to services furnished during 2018 or a subsequent year, in the case of physical therapy services of the type described in section 1861(p), speech-language pathology services of the type described in such section through the application of section 1861(ll)(2), and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians' services, with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met. (2) The amount specified in this paragraph-- (A) for 1999, 2000, and 2001, is $1,500, and (B) for a subsequent year is the amount specified in this paragraph for the preceding year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for such subsequent year; except that if an increase under subparagraph (B) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10. (3)(A) Subject to paragraphs (4) and (5), in the case of occupational therapy services (of the type that are described in section 1861(p) (but (except as provided in paragraph (6)) not described in subsection (a)(8)(B)) through the operation of section 1861(g) and of such type which are furnished by a physician or as incident to physicians' services), with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after December 31, 2017. (B) With respect to services furnished during 2018 or a subsequent year, in the case of occupational therapy services (of the type that are described in section 1861(p) through the operation of section 1861(g) and of such type which are furnished by a physician or as incident to physicians' services), with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met. (4) This subsection shall not apply to expenses incurred with respect to services furnished during 2000, 2001, 2002, 2004, and 2005. (5)(A) With respect to expenses incurred during the period beginning on January 1, 2006, and ending on December 31, 2017, for services, the Secretary shall implement a process under which an individual enrolled under this part may, upon request of the individual or a person on behalf of the individual, obtain an exception from the uniform dollar limitation specified in paragraph (2), for services described in paragraphs (1) and (3) if the provision of such services is determined to be medically necessary and if the requirement of subparagraph (B) is met. Under such process, if the Secretary does not make a decision on such a request for an exception within 10 business days of the date of the Secretary's receipt of the request made in accordance with such requirement, the Secretary shall be deemed to have found the services to be medically necessary. (B) In the case of outpatient therapy services for which an exception is requested under the first sentence of subparagraph (A), the claim for such services shall contain an appropriate modifier (such as the KX modifier used as of the date of the enactment of this subparagraph) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved. (C)(i) In applying this paragraph with respect to a request for an exception with respect to expenses that would be incurred for outpatient therapy services (including services described in subsection (a)(8)(B)) that would exceed the threshold described in clause (ii) for a year, the request for such an exception, for services furnished on or after October 1, 2012, shall be subject to a manual medical review process that, subject to subparagraph (E), is similar to the manual medical review process used for certain exceptions under this paragraph in 2006. (ii) The threshold under this clause for a year is $3,700. Such threshold shall be applied separately-- (I) for physical therapy services and speech-language pathology services; and (II) for occupational therapy services. (E)(i) In place of the manual medical review process under subparagraph (C)(i), the Secretary shall implement a process for medical review under this subparagraph under which the Secretary shall identify and conduct medical review for services described in subparagraph (C)(i) furnished by a provider of services or supplier (in this subparagraph referred to as a ``therapy provider'') using such factors as the Secretary determines to be appropriate. (ii) Such factors may include the following: (I) The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this title. (II) The therapy provider has a pattern of billing for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day. (III) The therapy provider is newly enrolled under this title or has not previously furnished therapy services under this part. (IV) The services are furnished to treat a type of medical condition. (V) The therapy provider is part of group that includes another therapy provider identified using the factors determined under this subparagraph. (iii) For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2015 and 2016, to remain available until expended. Such funds may not be used by a contractor under section 1893(h) for medical reviews under this subparagraph. (iv) The targeted review process under this subparagraph shall not apply to services for which expenses are incurred beyond the period for which the exceptions process under subparagraph (A) is implemented, except as such process is applied under paragraph (7)(B). (6)(A) In applying paragraphs (1) and (3) to services furnished during the period beginning not later than October 1, 2012, and ending on December 31, 2017, the exclusion of services described in subsection (a)(8)(B) from the uniform dollar limitation specified in paragraph (2) shall not apply to such services furnished during 2012 through 2017. (B)(i) With respect to outpatient therapy services furnished beginning on or after January 1, 2013, and before January 1, 2014, for which payment is made under section 1834(g), the Secretary shall count toward the uniform dollar limitations described in paragraphs (1) and (3) and the threshold described in paragraph (5)(C) the amount that would be payable under this part if such services were paid under section 1834(k)(1)(B) instead of being paid under section 1834(g). (ii) Nothing in clause (i) shall be construed as changing the method of payment for outpatient therapy services under section 1834(g). (7) For purposes of paragraphs (1)(B) and (3)(B), with respect to services described in such paragraphs, the requirements described in this paragraph are as follows: (A) Inclusion of appropriate modifier.--The claim for such services contains an appropriate modifier (such as the KX modifier described in paragraph (5)(B)) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved. (B) Targeted medical review for certain services above threshold.-- (i) In general.--In the case where expenses that would be incurred for such services would exceed the threshold described in clause (ii) for the year, such services shall be subject to the process for medical review implemented under paragraph (5)(E). (ii) Threshold.--The threshold under this clause for-- (I) a year before 2028, is $3,000; (II) 2028, is the amount specified in subclause (I) increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for 2028; and (III) a subsequent year, is the amount specified in this clause for the preceding year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for such subsequent year; except that if an increase under subclause (II) or (III) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10. (iii) Application.--The threshold under clause (ii) shall be applied separately-- (I) for physical therapy services and speech-language pathology services; and (II) for occupational therapy services. (iv) Funding.--For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $5,000,000 for each fiscal year beginning with fiscal year 2018, to remain available until expended. Such funds may not be used by a contractor under section 1893(h) for medical reviews under this subparagraph. (8) With respect to services furnished on or after January 1, 2013, where payment may not be made as a result of application of paragraphs (1) and (3), section 1879 shall apply in the same manner as such section applies to a denial that is made by reason of section 1862(a)(1). (h)(1)(A) Subject to section 1834(d)(1), the Secretary shall establish fee schedules for clinical diagnostic laboratory tests (including prostate cancer screening tests under section 1861(oo) consisting of prostate-specific antigen blood tests) for which payment is made under this part, other than such tests performed by a provider of services for an inpatient of such provider. (B) In the case of clinical diagnostic laboratory tests performed by a physician or by a laboratory (other than tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital), the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after July 1, 1984. (C) In the case of clinical diagnostic laboratory tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital, the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after July 1, 1984. (D) In this subsection, the term ``qualified hospital laboratory'' means a hospital laboratory, in a sole community hospital (as defined in section 1886(d)(5)(D)(iii)), which provides some clinical diagnostic laboratory tests 24 hours a day in order to serve a hospital emergency room which is available to provide services 24 hours a day and 7 days a week. (2)(A)(i) Except as provided in clause (v), subparagraph (B), and paragraph (4), the Secretary shall set the fee schedules at 60 percent (or, in the case of a test performed by a qualified hospital laboratory (as defined in paragraph (1)(D)) for outpatients of such hospital, 62 percent) of the prevailing charge level determined pursuant to the third and fourth sentences of section 1842(b)(3) for similar clinical diagnostic laboratory tests for the applicable region, State, or area for the 12-month period beginning July 1, 1984, adjusted annually (to become effective on January 1 of each year) by, subject to clause (iv), a percentage increase or decrease equal to the percentage increase or decrease in the Consumer Price Index for All Urban Consumers (United States city average) minus, for each of the years 2009 and 2010, 0.5 percentage points, and, for tests furnished before the dateof enactment of section 1834A, subject to such other adjustments as the Secretary determines are justified by technological changes. (ii) Notwithstanding clause (i)-- (I) any change in the fee schedules which would have become effective under this subsection for tests furnished on or after January 1, 1988, shall not be effective for tests furnished during the 3-month period beginning on January 1, 1988, (II) the Secretary shall not adjust the fee schedules under clause (i) to take into account any increase in the consumer price index for 1988, (III) the annual adjustment in the fee schedules determined under clause (i) for each of the years 1991, 1992, and 1993 shall be 2 percent, and (IV) the annual adjustment in the fee schedules determined under clause (i) for each of the years 1994 and 1995, 1998 through 2002, and 2004 through 2008 shall be 0 percent. (iii) In establishing fee schedules under clause (i) with respect to automated tests and tests (other than cytopathology tests) which before July 1, 1984, the Secretary made subject to a limit based on lowest charge levels under the sixth sentence of section 1842(b)(3) performed after March 31, 1988, the Secretary shall reduce by 8.3 percent the fee schedules otherwise established for 1988, and such reduced fee schedules shall serve as the base for 1989 and subsequent years. (iv) After determining the adjustment to the fee schedules under clause (i), the Secretary shall reduce such adjustment-- (I) for 2011 and each subsequent year, by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II); and (II) for each of 2011 through 2015, by 1.75 percentage points. Subclause (I) shall not apply in a year where the adjustment to the fee schedules determined under clause (i) is 0.0 or a percentage decrease for a year. The application of the productivity adjustment under subclause (I) shall not result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year. The application of subclause (II) may result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year, and may result in payment rates for a year being less than such payment rates for the preceding year. (v) The Secretary shall reduce by 2 percent the fee schedules otherwise determined under clause (i) for 2013, and such reduced fee schedules shall serve as the base for 2014 and subsequent years. (B) The Secretary may make further adjustments or exceptions to the fee schedules to assure adequate reimbursement of (i) emergency laboratory tests needed for the provision of bona fide emergency services, and (ii) certain low volume high-cost tests where highly sophisticated equipment or extremely skilled personnel are necessary to assure quality. (3) In addition to the amounts provided under the fee schedules (for tests furnished before January 1, 2017)or under section 1834A (for tests furnished on or afterJanuary 1, 2017), subject to subsection (b)(5) of such section, the Secretary shall provide for and establish (A) a nominal fee to cover the appropriate costs in collecting the sample on which a clinical diagnostic laboratory test was performed and for which payment is made under this part, except that not more than one such fee may be provided under this paragraph with respect to samples collected in the same encounter, and (B) a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect the sample, except that such a fee may be provided only with respect to an individual who is homebound or an inpatient in an inpatient facility (other than a hospital). In establishing a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect a sample, the Secretary shall provide a method for computing the fee based on the number of miles traveled and the personnel costs associated with the collection of each individual sample, but the Secretary shall only be required to apply such method in the case of tests furnished during the period beginning on April 1, 1989, and ending on December 31, 1990, by a laboratory that establishes to the satisfaction of the Secretary (based on data for the 12-month period ending June 30, 1988) that (i) the laboratory is dependent upon payments under this title for at least 80 percent of its collected revenues for clinical diagnostic laboratory tests, (ii) at least 85 percent of its gross revenues for such tests are attributable to tests performed with respect to individuals who are homebound or who are residents in a nursing facility, and (iii) the laboratory provided such tests for residents in nursing facilities representing at least 20 percent of the number of such facilities in the State in which the laboratory is located. (4)(A) In establishing any fee schedule under this subsection, the Secretary may provide for an adjustment to take into account, with respect to the portion of the expenses of clinical diagnostic laboratory tests attributable to wages, the relative difference between a region's or local area's wage rates and the wage rate presumed in the data on which the schedule is based. (B) For purposes of subsections (a)(1)(D)(i) and (a)(2)(D)(i), the limitation amount for a clinical diagnostic laboratory test performed-- (i) on or after July 1, 1986, and before April 1, 1988, is equal to 115 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1), (ii) after March 31, 1988, and before January 1, 1990, is equal to the median of all the fee schedules established for that test for that laboratory setting under paragraph (1), (iii) after December 31, 1989, and before January 1, 1991, is equal to 93 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1), (iv) after December 31, 1990, and before January 1, 1994, is equal to 88 percent of such median, (v) after December 31, 1993, and before January 1, 1995, is equal to 84 percent of such median, (vi) after December 31, 1994, and before January 1, 1996, is equal to 80 percent of such median, (vii) after December 31, 1995, and before January 1, 1998, is equal to 76 percent of such median, and (viii) after December 31, 1997, is equal to 74 percent of such median (or 100 percent of such median in the case of a clinical diagnostic laboratory test performed on or after January 1, 2001, that the Secretary determines is a new test for which no limitation amount has previously been established under this subparagraph). (5)(A) In the case of a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part on an assignment-related basis or under a provider agreement under section 1866, payment may be made only to the person or entity which performed or supervised the performance of such test; except that-- (i) if a physician performed or supervised the performance of such test, payment may be made to another physician with whom he shares his practice, (ii) in the case of a test performed at the request of a laboratory by another laboratory, payment may be made to the referring laboratory but only if-- (I) the referring laboratory is located in, or is part of, a rural hospital, (II) the referring laboratory is wholly owned by the entity performing such test, the referring laboratory wholly owns the entity performing such test, or both the referring laboratory and the entity performing such test are wholly-owned by a third entity, or (III) not more than 30 percent of the clinical diagnostic laboratory tests for which such referring laboratory (but not including a laboratory described in subclause (II)), receives requests for testing during the year in which the test is performed are performed by another laboratory, and (iii) in the case of a clinical diagnostic laboratory test provided under an arrangement (as defined in section 1861(w)(1)) made by a hospital, critical access hospital, or skilled nursing facility, payment shall be made to the hospital or skilled nursing facility. (B) In the case of such a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part, and which is not described in subparagraph (A), payment may be made to the beneficiary only on the basis of the itemized bill of the person or entity which performed or supervised the performance of the test. (C) Payment for a clinical diagnostic laboratory test, including a test performed in a physician's office but excluding a test performed by a rural health clinic may only be made on an assignment-related basis or to a provider of services with an agreement in effect under section 1866. (D) A person may not bill for a clinical diagnostic laboratory test, including a test performed in a physician's office but excluding a test performed by a rural health clinic, other than on an assignment-related basis. If a person knowingly and willfully and on a repeated basis bills for a clinical diagnostic laboratory test in violation of the previous sentence, the Secretary may apply sanctions against the person in the same manner as the Secretary may apply sanctions against a physician in accordance with paragraph (2) of section 1842(j) in the same manner such paragraphs apply with respect to a physician. Paragraph (4) of such section shall apply in this subparagraph in the same manner as such paragraph applies to such section. (6) For tests furnished before January 1, 2017, inthe case of any diagnostic laboratory test payment for which is not made on the basis of a fee schedule under paragraph (1), the Secretary may establish a payment rate which is acceptable to the person or entity performing the test and which would be considered the full charge for such tests. Such negotiated rate shall be limited to an amount not in excess of the total payment that would have been made for the services in the absence of such rate. (7) Notwithstanding paragraphs (1) and (4)and section 1834A, the Secretary shall establish a national minimum payment amount under this part for a diagnostic or screening pap smear laboratory test (including all cervical cancer screening technologies that have been approved by the Food and Drug Administration as a primary screening method for detection of cervical cancer) equal to $14.60 for tests furnished in 2000. For such tests furnished in subsequent years, such national minimum payment amount shall be adjusted annually as provided in paragraph (2). (8)(A) The Secretary shall establish by regulation procedures for determining the basis for, and amount of, payment under this subsection for any clinical diagnostic laboratory test with respect to which a new or substantially revised HCPCS code is assigned on or after January 1, 2005 (in this paragraph referred to as ``new tests''). (B) Determinations under subparagraph (A) shall be made only after the Secretary-- (i) makes available to the public (through an Internet website and other appropriate mechanisms) a list that includes any such test for which establishment of a payment amount under this subsection is being considered for a year; (ii) on the same day such list is made available, causes to have published in the Federal Register notice of a meeting to receive comments and recommendations (and data on which recommendations are based) from the public on the appropriate basis under this subsection for establishing payment amounts for the tests on such list; (iii) not less than 30 days after publication of such notice convenes a meeting, that includes representatives of officials of the Centers for Medicare & Medicaid Services involved in determining payment amounts, to receive such comments and recommendations (and data on which the recommendations are based); (iv) taking into account the comments and recommendations (and accompanying data) received at such meeting, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of proposed determinations with respect to the appropriate basis for establishing a payment amount under this subsection for each such code, together with an explanation of the reasons for each such determination, the data on which the determinations are based, and a request for public written comments on the proposed determination; and (v) taking into account the comments received during the public comment period, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of final determinations of the payment amounts for such tests under this subsection, together with the rationale for each such determination, the data on which the determinations are based, and responses to comments and suggestions received from the public. (C) Under the procedures established pursuant to subparagraph (A), the Secretary shall-- (i) set forth the criteria for making determinations under subparagraph (A); and (ii) make available to the public the data (other than proprietary data) considered in making such determinations. (D) The Secretary may convene such further public meetings to receive public comments on payment amounts for new tests under this subsection as the Secretary deems appropriate. (E) For purposes of this paragraph: (i) The term ``HCPCS'' refers to the Health Care Procedure Coding System. (ii) A code shall be considered to be ``substantially revised'' if there is a substantive change to the definition of the test or procedure to which the code applies (such as a new analyte or a new methodology for measuring an existing analyte-specific test). (9) Notwithstanding any other provision in this part, in the case of any diagnostic laboratory test for HbA1c that is labeled by the Food and Drug Administration for home use and is furnished on or after April 1, 2008, the payment rate for such test shall be the payment rate established under this part for a glycated hemoglobin test (identified as of October 1, 2007, by HCPCS code 83036 (and any succeeding codes)). (i)(1) The Secretary shall, in consultation with appropriate medical organizations-- (A) specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in an ambulatory surgical center (meeting the standards specified under section 1832(a)(2)(F)(i)), critical access hospital, or hospital outpatient department, and (B) specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in a physician's office. The lists of procedures established under subparagraphs (A) and (B) shall be reviewed and updated not less often than every 2 years, in consultation with appropriate trade and professional organizations. (2)(A) For services furnished prior to the implementation of the system described in subparagraph (D), subject to subparagraph (E), the amount of payment to be made for facility services furnished in connection with a surgical procedure specified pursuant to paragraph (1)(A) and furnished to an individual in an ambulatory surgical center described in such paragraph shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary's estimate of a fair fee which-- (i) takes into account the costs incurred by such centers, or classes of centers, generally in providing services furnished in connection with the performance of such procedure, as determined in accordance with a survey (based upon a representative sample of procedures and facilities) of the actual audited costs incurred by such centers in providing such services, (ii) takes such costs into account in such a manner as will assure that the performance of the procedure in such a center will result in substantially less amounts paid under this title than would have been paid if the procedure had been performed on an inpatient basis in a hospital, and (iii) in the case of insertion of an intraocular lens during or subsequent to cataract surgery includes payment which is reasonable and related to the cost of acquiring the class of lens involved. Each amount so established shall be reviewed and updated not later than July 1, 1987, and annually thereafter to take account of varying conditions in different areas. (B) The amount of payment to be made under this part for facility services furnished, in connection with a surgical procedure specified pursuant to paragraph (1)(B), in a physician's office shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary's estimate of a fair fee which-- (i) takes into account additional costs, not usually included in the professional fee, incurred by physicians in securing, maintaining, and staffing the facilities and ancillary services appropriate for the performance of such procedure in the physician's office, and (ii) takes such items into account in such a manner which will assure that the performance of such procedure in the physician's office will result in substantially less amounts paid under this title than would have been paid if the services had been furnished on an inpatient basis in a hospital. Each amount so established shall be reviewed and updated not later than July 1, 1987, and annually thereafter to take account of varying conditions in different areas. (C)(i) Notwithstanding the second sentence of each of subparagraphs (A) and (B), except as otherwise specified in clauses (ii), (iii), and (iv), if the Secretary has not updated amounts established under such subparagraphs or under subparagraph (D), with respect to facility services furnished during a fiscal year (beginning with fiscal year 1986 or a calendar year (beginning with 2006)), such amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. (ii) In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points. (iii) In fiscal year 2004, beginning with April 1, 2004, the increase under this subparagraph shall be the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with March 31, 2003, minus 3.0 percentage points. (iv) In fiscal year 2005, the last quarter of calendar year 2005, and each of calendar years 2006 through 2009, the increase under this subparagraph shall be 0 percent. (D)(i) Taking into account the recommendations in the report under section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary shall implement a revised payment system for payment of surgical services furnished in ambulatory surgical centers. (ii) In the year the system described in clause (i) is implemented, such system shall be designed to result in the same aggregate amount of expenditures for such services as would be made if this subparagraph did not apply, as estimated by the Secretary and taking into account reduced expenditures that would apply if subparagraph (E) were to continue to apply, as estimated by the Secretary. (iii) The Secretary shall implement the system described in clause (i) for periods in a manner so that it is first effective beginning on or after January 1, 2006, and not later than January 1, 2008. (iv) The Secretary may implement such system in a manner so as to provide for a reduction in any annual update for failure to report on quality measures in accordance with paragraph (7). (v) In implementing the system described in clause (i) for 2011 and each subsequent year, any annual update under such system for the year, after application of clause (iv), shall be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in such update being less than 0.0 for a year, and may result in payment rates under the system described in clause (i) for a year being less than such payment rates for the preceding year. (vi) There shall be no administrative or judicial review under section 1869, 1878, or otherwise, of the classification system, the relative weights, payment amounts, and the geographic adjustment factor, if any, under this subparagraph. (E) With respect to surgical procedures furnished on or after January 1, 2007, and before the effective date of the implementation of a revised payment system under subparagraph (D), if-- (i) the standard overhead amount under subparagraph (A) for a facility service for such procedure, without the application of any geographic adjustment, exceeds (ii) the Medicare OPD fee schedule amount established under the prospective payment system for hospital outpatient department services under paragraph (3)(D) of section 1833(t) for such service for such year, determined without regard to geographic adjustment under paragraph (2)(D) of such section, the Secretary shall substitute under subparagraph (A) the amount described in clause (ii) for the standard overhead amount for such service referred to in clause (i). (3)(A) The aggregate amount of the payments to be made under this part for outpatient hospital facility services or critical access hospital services furnished before January 1, 1999, in connection with surgical procedures specified under paragraph (1)(A) shall be equal to the lesser of-- (i) the amount determined with respect to such services under subsection (a)(2)(B); or (ii) the blend amount (described in subparagraph (B)). (B)(i) The blend amount for a cost reporting period is the sum of-- (I) the cost proportion (as defined in clause (ii)(I)) of the amount described in subparagraph (A)(i), and (II) the ASC proportion (as defined in clause (ii)(II)) of the standard overhead amount payable with respect to the same surgical procedure as if it were provided in an ambulatory surgical center in the same area, as determined under paragraph (2)(A), less the amount a provider may charge as described in clause (ii) of section 1866(a)(2)(A). (ii) Subject to paragraph (4), in this paragraph: (I) The term ``cost proportion'' means 75 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after October 1, 1988, and ending on or before December 31, 1990, and 42 percent for portions of cost reporting periods beginning on or after January 1, 1991. (II) The term ``ASC proportion'' means 25 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after October 1, 1988, and ending on or before December 31, 1990, and 58 percent for portions of cost reporting periods beginning on or after January 1, 1991. (4)(A) In the case of a hospital that-- (i) makes application to the Secretary and demonstrates that it specializes in eye services or eye and ear services (as determined by the Secretary), (ii) receives more than 30 percent of its total revenues from outpatient services, and (iii) on October 1, 1987-- (I) was an eye specialty hospital or an eye and ear specialty hospital, or (II) was operated as an eye or eye and ear unit (as defined in subparagraph (B)) of a general acute care hospital which, on the date of the application described in clause (i), operates less than 20 percent of the beds that the hospital operated on October 1, 1987, and has sold or otherwise disposed of a substantial portion of the hospital's other acute care operations, the cost proportion and ASC proportion in effect under subclauses (I) and (II) of paragraph (3)(B)(ii) for cost reporting periods beginning in fiscal year 1988 shall remain in effect for cost reporting periods beginning on or after October 1, 1988, and before January 1, 1995. (B) For purposes of this subparagraph (A)(iii)(II), the term ``eye or eye and ear unit'' means a physically separate or distinct unit containing separate surgical suites devoted solely to eye or eye and ear services. (5)(A) The Secretary is authorized to provide by regulations that in the case of a surgical procedure, specified by the Secretary pursuant to paragraph (1)(A), performed in an ambulatory surgical center described in such paragraph, there shall be paid (in lieu of any amounts otherwise payable under this part) with respect to the facility services furnished by such center and with respect to all related services (including physicians' services, laboratory, X-ray, and diagnostic services) a single all-inclusive fee established pursuant to subparagraph (B), if all parties furnishing all such services agree to accept such fee (to be divided among the parties involved in such manner as they shall have previously agreed upon) as full payment for the services furnished. (B) In implementing this paragraph, the Secretary shall establish with respect to each surgical procedure specified pursuant to paragraph (1)(A) the amount of the all-inclusive fee for such procedure, taking into account such factors as may be appropriate. The amount so established with respect to any surgical procedure shall be reviewed periodically and may be adjusted by the Secretary, when appropriate, to take account of varying conditions in different areas. (6) Any person, including a facility having an agreement under section 1832(a)(2)(F)(i), who knowingly and willfully presents, or causes to be presented, a bill or request for payment, for an intraocular lens inserted during or subsequent to cataract surgery for which payment may be made under paragraph (2)(A)(iii), is subject to a civil money penalty of not to exceed $2,000. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). (7)(A) For purposes of paragraph (2)(D)(iv), the Secretary may provide, in the case of an ambulatory surgical center that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to a year, any annual increase provided under the system established under paragraph (2)(D) for such year shall be reduced by 2.0 percentage points. A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing any annual increase factor for a subsequent year. (B) Except as the Secretary may otherwise provide, the provisions of subparagraphs (B), (C), (D), and (E) of paragraph (17) of section 1833(t) shall apply with respect to services of ambulatory surgical centers under this paragraph in a similar manner to the manner in which they apply under such paragraph and, for purposes of this subparagraph, any reference to a hospital, outpatient setting, or outpatient hospital services is deemed a reference to an ambulatory surgical center, the setting of such a center, or services of such a center, respectively. (8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary). (j) Whenever a final determination is made that the amount of payment made under this part either to a provider of services or to another person pursuant to an assignment under section 1842(b)(3)(B)(ii) was in excess of or less than the amount of payment that is due, and payment of such excess or deficit is not made (or effected by offset) within 30 days of the date of the determination, interest shall accrue on the balance of such excess or deficit not paid or offset (to the extent that the balance is owed by or owing to the provider) at a rate determined in accordance with the regulations of the Secretary of the Treasury applicable to charges for late payments. (k) With respect to services described in section 1861(s)(10)(B), the Secretary may provide, instead of the amount of payment otherwise provided under this part, for payment of such an amount or amounts as reasonably reflects the general cost of efficiently providing such services. (l)(1)(A) The Secretary shall establish a fee schedule for services of certified registered nurse anesthetists under section 1861(s)(11). (B) In establishing the fee schedule under this paragraph the Secretary may utilize a system of time units, a system of base and time units, or any appropriate methodology. (C) The provisions of this subsection shall not apply to certain services furnished in certain hospitals in rural areas under the provisions of section 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989. (2) Except as provided in paragraph (3), the fee schedule established under paragraph (1) shall be initially based on audited data from cost reporting periods ending in fiscal year 1985 and such other data as the Secretary determines necessary. (3)(A) In establishing the initial fee schedule for those services, the Secretary shall adjust the fee schedule to the extent necessary to ensure that the estimated total amount which will be paid under this title for those services plus applicable coinsurance in 1989 will equal the estimated total amount which would be paid under this title for those services in 1989 if the services were included as inpatient hospital services and payment for such services was made under part A in the same manner as payment was made in fiscal year 1987, adjusted to take into account changes in prices and technology relating to the administration of anesthesia. (B) The Secretary shall also reduce the prevailing charge of physicians for medical direction of a certified registered nurse anesthetist, or the fee schedule for services of certified registered nurse anesthetists, or both, to the extent necessary to ensure that the estimated total amount which will be paid under this title plus applicable coinsurance for such medical direction and such services in 1989 and 1990 will not exceed the estimated total amount which would have been paid plus applicable coinsurance but for the enactment of the amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986. A reduced prevailing charge under this subparagraph shall become the prevailing charge but for subsequent years for purposes of applying the economic index under the fourth sentence of section 1842(b)(3). (4)(A) Except as provided in subparagraphs (C) and (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after January 1, 1991, by a certified registered nurse anesthetist who is not medically directed-- (i) the conversion factor shall be-- (I) for services furnished in 1991, $15.50, (II) for services furnished in 1992, $15.75, (III) for services furnished in 1993, $16.00, (IV) for services furnished in 1994, $16.25, (V) for services furnished in 1995, $16.50, (VI) for services furnished in 1996, $16.75, and (VII) for services furnished in calendar years after 1996, the previous year's conversion factor increased by the update determined under section 1848(d) for physician anesthesia services for that year; (ii) the payment areas to be used shall be the fee schedule areas used under section 1848 (or, in the case of services furnished during 1991, the localities used under section 1842(b)) for purposes of computing payments for physicians' services that are anesthesia services; (iii) the geographic adjustment factors to be applied to the conversion factor under clause (i) for services in a fee schedule area or locality is-- (I) in the case of services furnished in 1991, the geographic work index value and the geographic practice cost index value specified in section 1842(q)(1)(B) for physicians' services that are anesthesia services furnished in the area or locality, and (II) in the case of services furnished after 1991, the geographic work index value, the geographic practice cost index value, and the geographic malpractice index value used for determining payments for physicians' services that are anesthesia services under section 1848, with 70 percent of the conversion factor treated as attributable to work and 30 percent as attributable to overhead for services furnished in 1991 (and the portions attributable to work, practice expenses, and malpractice expenses in 1992 and thereafter being the same as is applied under section 1848). (B)(i) Except as provided in clause (ii) and subparagraph (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after January 1, 1991, and before January 1, 1994, by a certified registered nurse anesthetist who is medically directed, the Secretary shall apply the same methodology specified in subparagraph (A). (ii) The conversion factor used under clause (i) shall be-- (I) for services furnished in 1991, $10.50, (II) for services furnished in 1992, $10.75, and (III) for services furnished in 1993, $11.00. (iii) In the case of services of a certified registered nurse anesthetist who is medically directed or medically supervised by a physician which are furnished on or after January 1, 1994, the fee schedule amount shall be one-half of the amount described in section 1848(a)(5)(B) with respect to the physician. (C) Notwithstanding subclauses (I) through (V) of subparagraph (A)(i)-- (i) in the case of a 1990 conversion factor that is greater than $16.50, the conversion factor for a calendar year after 1990 and before 1996 shall be the 1990 conversion factor reduced by the product of the last digit of the calendar year and one-fifth of the amount by which the 1990 conversion factor exceeds $16.50; and (ii) in the case of a 1990 conversion factor that is greater than $15.49 but less than $16.51, the conversion factor for a calendar year after 1990 and before 1996 shall be the greater of-- (I) the 1990 conversion factor, or (II) the conversion factor specified in subparagraph (A)(i) for the year involved. (D) Notwithstanding subparagraph (C), in no case may the conversion factor used to determine payment for services in a fee schedule area or locality under this subsection, as adjusted by the adjustment factors specified in subparagraphs (A)(iii), exceed the conversion factor used to determine the amount paid for physicians' services that are anesthesia services in the area or locality. (5)(A) Payment for the services of a certified registered nurse anesthetist (for which payment may otherwise be made under this part) may be made on the basis of a claim or request for payment presented by the certified registered nurse anesthetist furnishing such services, or by a hospital, critical access hospital, physician, group practice, or ambulatory surgical center with which the certified registered nurse anesthetist furnishing such services has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, critical access hospital, physician, group practice, or ambulatory surgical center. (B) No hospital or critical access hospital that presents a claim or request for payment for services of a certified nurse anesthetist under this part may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital or critical access hospital for purposes of this title. (6) If an adjustment under paragraph (3)(B) results in a reduction in the reasonable charge for a physicians' service and a nonparticipating physician furnishes the service to an individual entitled to benefits under this part after the effective date of the reduction, the physician's actual charge is subject to a limit under section 1842(j)(1)(D). (m)(1) In the case of physicians' services furnished in a year to an individual, who is covered under the insurance program established by this part and who incurs expenses for such services, in an area that is designated (under section 332(a)(1)(A) of the Public Health Service Act) as a health professional shortage area as identified by the Secretary prior to the beginning of such year, in addition to the amount otherwise paid under this part, there also shall be paid to the physician (or to an employer or facility in the cases described in clause (A) of section 1842(b)(6)) (on a monthly or quarterly basis) from the Federal Supplementary Medical Insurance Trust Fund an amount equal to 10 percent of the payment amount for the service under this part. (2) For each health professional shortage area identified in paragraph (1) that consists of an entire county, the Secretary shall provide for the additional payment under paragraph (1) without any requirement on the physician to identify the health professional shortage area involved. The Secretary may implement the previous sentence using the method specified in subsection (u)(4)(C). (3) The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a list of the health professional shortage areas identified in paragraph (1) that consist of a partial county to facilitate the additional payment under paragraph (1) in such areas. (4) There shall be no administrative or judicial review under section 1869, section 1878, or otherwise, respecting-- (A) the identification of a county or area; (B) the assignment of a specialty of any physician under this paragraph; (C) the assignment of a physician to a county under this subsection; or (D) the assignment of a postal ZIP Code to a county or other area under this subsection. (n)(1)(A) The aggregate amount of the payments to be made for all or part of a cost reporting period for services described in subsection (a)(2)(E)(i) furnished under this part on or after October 1, 1988, and before January 1, 1999, and for services described in subsection (a)(2)(E)(ii) furnished under this part on or after October 1, 1989, and before January 1, 1999, shall be equal to the lesser of-- (i) the amount determined with respect to such services under subsection (a)(2)(B), or (ii) the blend amount for radiology services and diagnostic procedures determined in accordance with subparagraph (B). (B)(i) The blend amount for radiology services and diagnostic procedures for a cost reporting period is the sum of-- (I) the cost proportion (as defined in clause (ii)) of the amount described in subparagraph (A)(i); and (II) the charge proportion (as defined in clause (ii)(II)) of 62 percent (for services described in subsection (a)(2)(E)(i)), or (for procedures described in subsection (a)(2)(E)(ii)), 42 percent or such other percent established by the Secretary (or carriers acting pursuant to guidelines issued by the Secretary) based on prevailing charges established with actual charge data, of the prevailing charge or (for services described in subsection (a)(2)(E)(i) furnished on or after January 1, 1989) the fee schedule amount established for participating physicians for the same services as if they were furnished in a physician's office in the same locality as determined under section 1842(b), less the amount a provider may charge as described in clause (ii) of section 1866(a)(2)(A). (ii) In this subparagraph: (I) The term ``cost proportion'' means 50 percent, except that such term means 65 percent in the case of outpatient radiology services for portions of cost reporting periods which occur in fiscal year 1989 and in the case of diagnostic procedures described in subsection (a)(2)(E)(ii) for portions of cost reporting periods which occur in fiscal year 1990, and such term means 42 percent in the case of outpatient radiology services for portions of cost reporting periods beginning on or after January 1, 1991. (II) The term ``charge proportion'' means 100 percent minus the cost proportion. (o)(1) In the case of shoes described in section 1861(s)(12)-- (A) no payment may be made under this part, with respect to any individual for any year, for the furnishing of-- (i) more than one pair of custom molded shoes (including inserts provided with such shoes) and 2 additional pairs of inserts for such shoes, or (ii) more than one pair of extra-depth shoes (not including inserts provided with such shoes) and 3 pairs of inserts for such shoes, and (B) with respect to expenses incurred in any calendar year, no more than the amount of payment applicable under paragraph (2) shall be considered as incurred expenses for purposes of subsections (a) and (b). Payment for shoes (or inserts) under this part shall be considered to include payment for any expenses for the fitting of such shoes (or inserts). (2)(A) Except as provided by the Secretary under subparagraphs (B) and (C), the amount of payment under this paragraph for custom molded shoes, extra-depth shoes, and inserts shall be the amount determined for such items by the Secretary under section 1834(h). (B) The Secretary may establish payment amounts for shoes and inserts that are lower than the amount established under section 1834(h) if the Secretary finds that shoes and inserts of an appropriate quality are readily available at or below the amount established under such section. (C) In accordance with procedures established by the Secretary, an individual entitled to benefits with respect to shoes described in section 1861(s)(12) may substitute modification of such shoes instead of obtaining one (or more, as specified by the Secretary) pair of inserts (other than the original pair of inserts with respect to such shoes). In such case, the Secretary shall substitute, for the payment amount established under section 1834(h), a payment amount that the Secretary estimates will assure that there is no net increase in expenditures under this subsection as a result of this subparagraph. (3) In this title, the term ``shoes'' includes, except for purposes of subparagraphs (A)(ii) and (B) of paragraph (2), inserts for extra-depth shoes. [(p) Striken.] (q)(1) Each request for payment, or bill submitted, for an item or service furnished by an entity for which payment may be made under this part and for which the entity knows or has reason to believe there has been a referral by a referring physician (within the meaning of section 1877) shall include the name and unique physician identification number for the referring physician. (2)(A) In the case of a request for payment for an item or service furnished by an entity under this part on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included, payment may be denied under this part. (B) In the case of a request for payment for an item or service furnished by an entity under this part not submitted on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included-- (i) if the entity knowingly and willfully fails to provide such information promptly upon request of the Secretary or a carrier, the entity may be subject to a civil money penalty in an amount not to exceed $2,000, and (ii) if the entity knowingly, willfully, and in repeated cases fails, after being notified by the Secretary of the obligations and requirements of this subsection to provide the information required under paragraph (1), the entity may be subject to exclusion from participation in the programs under this Act for a period not to exceed 5 years, in accordance with the procedures of subsections (c), (f), and (g) of section 1128. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to civil money penalties under clause (i) in the same manner as they apply to a penalty or proceeding under section 1128A(a). (r)(1) With respect to services described in section 1861(s)(2)(K)(ii) (relating to nurse practitioner or clinical nurse specialist services), payment may be made on the basis of a claim or request for payment presented by the nurse practitioner or clinical nurse specialist furnishing such services, or by a hospital, critical access hospital, skilled nursing facility or nursing facility (as defined in section 1919(a)), physician, group practice, or ambulatory surgical center with which the nurse practitioner or clinical nurse specialist has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, physician, group practice, or ambulatory surgical center. (2) No hospital or critical access hospital that presents a claim or request for payment under this part for services described in section 1861(s)(2)(K)(ii) may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital for purposes of this title. (s) The Secretary may not provide for payment under subsection (a)(1)(A) with respect to an organization unless the organization provides assurances satisfactory to the Secretary that the organization meets the requirement of section 1866(f) (relating to maintaining written policies and procedures respecting advance directives). (t) Prospective Payment System for Hospital Outpatient Department Services.-- (1) Amount of payment.-- (A) In general.--With respect to covered OPD services (as defined in subparagraph (B)) furnished during a year beginning with 1999, the amount of payment under this part shall be determined under a prospective payment system established by the Secretary in accordance with this subsection. (B) Definition of covered opd services.--For purposes of this subsection, the term ``covered OPD services''-- (i) means hospital outpatient services designated by the Secretary; (ii) subject to clause (iv), includes inpatient hospital services designated by the Secretary that are covered under this part and furnished to a hospital inpatient who (I) is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness, or (II) is not so entitled; (iii) includes implantable items described in paragraph (3), (6), or (8) of section 1861(s); (iv) does not include any therapy services described in subsection (a)(8) or ambulance services, for which payment is made under a fee schedule described in section 1834(k) or section 1834(l) and does not include screening mammography (as defined in section 1861(jj)), diagnostic mammography, or personalized prevention plan services (as defined in section 1861(hhh)(1)); and (v) does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after January 1, 2017, by an off-campus outpatient department of a provider (as defined in subparagraph (B) of such paragraph). (2) System requirements.--Under the payment system-- (A) the Secretary shall develop a classification system for covered OPD services; (B) the Secretary may establish groups of covered OPD services, within the classification system described in subparagraph (A), so that services classified within each group are comparable clinically and with respect to the use of resources and so that an implantable item is classified to the group that includes the service to which the item relates; (C) the Secretary shall, using data on claims from 1996 and using data from the most recent available cost reports, establish relative payment weights for covered OPD services (and any groups of such services described in subparagraph (B)) based on median (or, at the election of the Secretary, mean) hospital costs and shall determine projections of the frequency of utilization of each such service (or group of services) in 1999; (D) subject to paragraph (19), the Secretary shall determine a wage adjustment factor to adjust the portion of payment and coinsurance attributable to labor-related costs for relative differences in labor and labor-related costs across geographic regions in a budget neutral manner; (E) the Secretary shall establish, in a budget neutral manner, outlier adjustments under paragraph (5) and transitional pass- through payments under paragraph (6) and other adjustments as determined to be necessary to ensure equitable payments, such as adjustments for certain classes of hospitals; (F) the Secretary shall develop a method for controlling unnecessary increases in the volume of covered OPD services; (G) the Secretary shall create additional groups of covered OPD services that classify separately those procedures that utilize contrast agents from those that do not; and (H) with respect to devices of brachytherapy consisting of a seed or seeds (or radioactive source), the Secretary shall create additional groups of covered OPD services that classify such devices separately from the other services (or group of services) paid for under this subsection in a manner reflecting the number, isotope, and radioactive intensity of such devices furnished, including separate groups for palladium-103 and iodine-125 devices and for stranded and non-stranded devices furnished on or after July 1, 2007. For purposes of subparagraph (B), items and services within a group shall not be treated as ``comparable with respect to the use of resources'' if the highest median cost (or mean cost, if elected by the Secretary under subparagraph (C)) for an item or service within the group is more than 2 times greater than the lowest median cost (or mean cost, if so elected) for an item or service within the group; except that the Secretary may make exceptions in unusual cases, such as low volume items and services, but may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug and Cosmetic Act. (3) Calculation of base amounts.-- (A) Aggregate amounts that would be payable if deductibles were disregarded.--The Secretary shall estimate the sum of-- (i) the total amounts that would be payable from the Trust Fund under this part for covered OPD services in 1999, determined without regard to this subsection, as though the deductible under section 1833(b) did not apply, and (ii) the total amounts of copayments estimated to be paid under this subsection by beneficiaries to hospitals for covered OPD services in 1999, as though the deductible under section 1833(b) did not apply. (B) Unadjusted copayment amount.-- (i) In general.--For purposes of this subsection, subject to clause (ii), the ``unadjusted copayment amount'' applicable to a covered OPD service (or group of such services) is 20 percent of the national median of the charges for the service (or services within the group) furnished during 1996, updated to 1999 using the Secretary's estimate of charge growth during the period. (ii) Adjusted to be 20 percent when fully phased in.--If the pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year would be equal to or exceed 80 percent, then the unadjusted copayment amount shall be 20 percent of amount determined under subparagraph (D). (iii) Rules for new services.--The Secretary shall establish rules for establishment of an unadjusted copayment amount for a covered OPD service not furnished during 1996, based upon its classification within a group of such services. (C) Calculation of conversion factors.-- (i) For 1999.-- (I) In general.--The Secretary shall establish a 1999 conversion factor for determining the medicare OPD fee schedule amounts for each covered OPD service (or group of such services) furnished in 1999. Such conversion factor shall be established on the basis of the weights and frequencies described in paragraph (2)(C) and in such a manner that the sum for all services and groups of the products (described in subclause (II) for each such service or group) equals the total projected amount described in subparagraph (A). (II) Product described.--The Secretary shall determine for each service or group the product of the medicare OPD fee schedule amounts (taking into account appropriate adjustments described in paragraphs (2)(D) and (2)(E)) and the estimated frequencies for such service or group. (ii) Subsequent years.--Subject to paragraph (8)(B), the Secretary shall establish a conversion factor for covered OPD services furnished in subsequent years in an amount equal to the conversion factor established under this subparagraph and applicable to such services furnished in the previous year increased by the OPD fee schedule increase factor specified under clause (iv) for the year involved. (iii) Adjustment for service mix changes.--Insofar as the Secretary determines that the adjustments for service mix under paragraph (2) for a previous year (or estimates that such adjustments for a future year) did (or are likely to) result in a change in aggregate payments under this subsection during the year that are a result of changes in the coding or classification of covered OPD services that do not reflect real changes in service mix, the Secretary may adjust the conversion factor computed under this subparagraph for subsequent years so as to eliminate the effect of such coding or classification changes. (iv) OPD fee schedule increase factor.--For purposes of this subparagraph, subject to paragraph (17) and subparagraph (F) of this paragraph, the ``OPD fee schedule increase factor'' for services furnished in a year is equal to the market basket percentage increase applicable under section 1886(b)(3)(B)(iii) to hospital discharges occurring during the fiscal year ending in such year, reduced by 1 percentage point for such factor for services furnished in each of 2000 and 2002. In applying the previous sentence for years beginning with 2000, the Secretary may substitute for the market basket percentage increase an annual percentage increase that is computed and applied with respect to covered OPD services furnished in a year in the same manner as the market basket percentage increase is determined and applied to inpatient hospital services for discharges occurring in a fiscal year. (D) Calculation of medicare opd fee schedule amounts.--The Secretary shall compute a medicare OPD fee schedule amount for each covered OPD service (or group of such services) furnished in a year, in an amount equal to the product of-- (i) the conversion factor computed under subparagraph (C) for the year, and (ii) the relative payment weight (determined under paragraph (2)(C)) for the service or group. (E) Pre-deductible payment percentage.--The pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year is equal to the ratio of-- (i) the medicare OPD fee schedule amount established under subparagraph (D) for the year, minus the unadjusted copayment amount determined under subparagraph (B) for the service or group, to (ii) the medicare OPD fee schedule amount determined under subparagraph (D) for the year for such service or group. (F) Productivity and other adjustment.--After determining the OPD fee schedule increase factor under subparagraph (C)(iv), the Secretary shall reduce such increase factor-- (i) for 2012 and subsequent years, by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II); and (ii) for each of 2010 through 2019, by the adjustment described in subparagraph (G). The application of this subparagraph may result in the increase factor under subparagraph (C)(iv) being less than 0.0 for a year, and may result in payment rates under the payment system under this subsection for a year being less than such payment rates for the preceding year. (G) Other adjustment.--For purposes of subparagraph (F)(ii), the adjustment described in this subparagraph is-- (i) for each of 2010 and 2011, 0.25 percentage point; (ii) for each of 2012 and 2013, 0.1 percentage point; (iii) for 2014, 0.3 percentage point; (iv) for each of 2015 and 2016, 0.2 percentage point; and (v) for each of 2017, 2018, and 2019, 0.75 percentage point. (4) Medicare payment amount.--The amount of payment made from the Trust Fund under this part for a covered OPD service (and such services classified within a group) furnished in a year is determined, subject to paragraph (7), as follows: (A) Fee schedule adjustments.--The medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service or group and year is adjusted for relative differences in the cost of labor and other factors determined by the Secretary, as computed under paragraphs (2)(D) and (2)(E). (B) Subtract applicable deductible.--Reduce the adjusted amount determined under subparagraph (A) by the amount of the deductible under section 1833(b), to the extent applicable. (C) Apply payment proportion to remainder.-- The amount of payment is the amount so determined under subparagraph (B) multiplied by the pre-deductible payment percentage (as determined under paragraph (3)(E)) for the service or group and year involved, plus the amount of any reduction in the copayment amount attributable to paragraph (8)(C). (5) Outlier adjustment.-- (A) In general.--Subject to subparagraph (D), the Secretary shall provide for an additional payment for each covered OPD service (or group of services) for which a hospital's charges, adjusted to cost, exceed-- (i) a fixed multiple of the sum of-- (I) the applicable medicare OPD fee schedule amount determined under paragraph (3)(D), as adjusted under paragraph (4)(A) (other than for adjustments under this paragraph or paragraph (6)); and (II) any transitional pass- through payment under paragraph (6); and (ii) at the option of the Secretary, such fixed dollar amount as the Secretary may establish. (B) Amount of adjustment.--The amount of the additional payment under subparagraph (A) shall be determined by the Secretary and shall approximate the marginal cost of care beyond the applicable cutoff point under such subparagraph. (C) Limit on aggregate outlier adjustments.-- (i) In general.--The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year. (ii) Applicable percentage.--For purposes of clause (i), the term ``applicable percentage'' means a percentage specified by the Secretary up to (but not to exceed)-- (I) for a year (or portion of a year) before 2004, 2.5 percent; and (II) for 2004 and thereafter, 3.0 percent. (D) Transitional authority.--In applying subparagraph (A) for covered OPD services furnished before January 1, 2002, the Secretary may-- (i) apply such subparagraph to a bill for such services related to an outpatient encounter (rather than for a specific service or group of services) using OPD fee schedule amounts and transitional pass-through payments covered under the bill; and (ii) use an appropriate cost-to- charge ratio for the hospital involved (as determined by the Secretary), rather than for specific departments within the hospital. (E) Exclusion of separate drug and biological apcs from outlier payments.--No additional payment shall be made under subparagraph (A) in the case of ambulatory payment classification groups established separately for drugs or biologicals. (6) Transitional pass-through for additional costs of innovative medical devices, drugs, and biologicals.-- (A) In general.--The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services): (i) Current orphan drugs.--A drug or biological that is used for a rare disease or condition with respect to which the drug or biological has been designated as an orphan drug under section 526 of the Federal Food, Drug and Cosmetic Act if payment for the drug or biological as an outpatient hospital service under this part was being made on the first date that the system under this subsection is implemented. (ii) Current cancer therapy drugs and biologicals and brachytherapy.--A drug or biological that is used in cancer therapy, including (but not limited to) a chemotherapeutic agent, an antiemetic, a hematopoietic growth factor, a colony stimulating factor, a biological response modifier, a bisphosphonate, and a device of brachytherapy or temperature monitored cryoablation, if payment for such drug, biological, or device as an outpatient hospital service under this part was being made on such first date. (iii) Current radiopharmaceutical drugs and biological products.--A radiopharmaceutical drug or biological product used in diagnostic, monitoring, and therapeutic nuclear medicine procedures if payment for the drug or biological as an outpatient hospital service under this part was being made on such first date. (iv) New medical devices, drugs, and biologicals.--A medical device, drug, or biological not described in clause (i), (ii), or (iii) if-- (I) payment for the device, drug, or biological as an outpatient hospital service under this part was not being made as of December 31, 1996; and (II) the cost of the drug or biological or the average cost of the category of devices is not insignificant in relation to the OPD fee schedule amount (as calculated under paragraph (3)(D)) payable for the service (or group of services) involved. (B) Use of categories in determining eligibility of a device for pass-through payments.--The following provisions apply for purposes of determining whether a medical device qualifies for additional payments under clause (ii) or (iv) of subparagraph (A): (i) Establishment of initial categories.-- (I) In general.--The Secretary shall initially establish under this clause categories of medical devices based on type of device by April 1, 2001. Such categories shall be established in a manner such that each medical device that meets the requirements of clause (ii) or (iv) of subparagraph (A) as of January 1, 2001, is included in such a category and no such device is included in more than one category. For purposes of the preceding sentence, whether a medical device meets such requirements as of such date shall be determined on the basis of the program memoranda issued before such date. (II) Authorization of implementation other than through regulations.--The categories may be established under this clause by program memorandum or otherwise, after consultation with groups representing hospitals, manufacturers of medical devices, and other affected parties. (ii) Establishing criteria for additional categories.-- (I) In general.--The Secretary shall establish criteria that will be used for creation of additional categories (other than those established under clause (i)) through rulemaking (which may include use of an interim final rule with comment period). (II) Standard.--Such categories shall be established under this clause in a manner such that no medical device is described by more than one category. Such criteria shall include a test of whether the average cost of devices that would be included in a category and are in use at the time the category is established is not insignificant, as described in subparagraph (A)(iv)(II). (III) Deadline.--Criteria shall first be established under this clause by July 1, 2001. The Secretary may establish in compelling circumstances categories under this clause before the date such criteria are established. (IV) Adding categories.--The Secretary shall promptly establish a new category of medical devices under this clause for any medical device that meets the requirements of subparagraph (A)(iv) and for which none of the categories in effect (or that were previously in effect) is appropriate. (iii) Period for which category is in effect.--A category of medical devices established under clause (i) or (ii) shall be in effect for a period of at least 2 years, but not more than 3 years, that begins-- (I) in the case of a category established under clause (i), on the first date on which payment was made under this paragraph for any device described by such category (including payments made during the period before April 1, 2001); and (II) in the case of any other category, on the first date on which payment is made under this paragraph for any medical device that is described by such category. (iv) Requirements treated as met.--A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if-- (I) the device is described by a category established and in effect under clause (i); or (II) the device is described by a category established and in effect under clause (ii) and an application under section 515 of the Federal Food, Drug, and Cosmetic Act has been approved with respect to the device, or the device has been cleared for market under section 510(k) of such Act, or the device is exempt from the requirements of section 510(k) of such Act pursuant to subsection (l) or (m) of section 510 of such Act or section 520(g) of such Act. Nothing in this clause shall be construed as requiring an application or prior approval (other than that described in subclause (II)) in order for a covered device described by a category to qualify for payment under this paragraph. (C) Limited period of payment.-- (i) Drugs and biologicals.--Subject to subparagraph (G), the payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins-- (I) on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or (II) in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service. (ii) Medical devices.--Payment shall be made under this paragraph with respect to a medical device only if such device-- (I) is described by a category of medical devices established and in effect under subparagraph (B); and (II) is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph. (D) Amount of additional payment.--Subject to subparagraph (E)(iii), the amount of the payment under this paragraph with respect to a device, drug, or biological provided as part of a covered OPD service is-- (i) subject to subparagraph (H), in the case of a drug or biological, the amount by which the amount determined under section 1842(o) (or if the drug or biological is covered under a competitive acquisition contract under section 1847B, an amount determined by the Secretary equal to the average price for the drug or biological for all competitive acquisition areas and year established under such section as calculated and adjusted by the Secretary for purposes of this paragraph) for the drug or biological exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or (ii) in the case of a medical device, the amount by which the hospital's charges for the device, adjusted to cost, exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the device. (E) Limit on aggregate annual adjustment.-- (i) In general.--The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year. This clause shall not apply for 2018. (ii) Applicable percentage.--For purposes of clause (i), the term ``applicable percentage'' means-- (I) for a year (or portion of a year) before 2004, 2.5 percent; and (II) for 2004 and thereafter, a percentage specified by the Secretary up to (but not to exceed) 2.0 percent. (iii) Uniform prospective reduction if aggregate limit projected to be exceeded.--If the Secretary estimates before the beginning of a year that the amount of the additional payments under this paragraph for the year (or portion thereof) as determined under clause (i) without regard to this clause will exceed the limit established under such clause, the Secretary shall reduce pro rata the amount of each of the additional payments under this paragraph for that year (or portion thereof) in order to ensure that the aggregate additional payments under this paragraph (as so estimated) do not exceed such limit. (F) Limitation of application of functional equivalence standard.-- (i) In general.--The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph. (ii) Application.--Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after the date of enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 unless-- (I) such application was being made to such drug or biological prior to such date of enactment; and (II) the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this title. (iii) Rule of construction.--Nothing in this subparagraph shall be construed to effect the Secretary's authority to deem a particular drug to be identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs. (G) Pass-through extension for certain drugs and biologicals.--In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, such pass- through status shall be extended for a 2-year period beginning on October 1, 2018. (H) Temporary payment rule for certain drugs and biologicals.--In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, the payment amount for such drug or biological under this subsection that is furnished during the period beginning on October 1, 2018, and ending on March 31, 2019, shall be the greater of-- (i) the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or (ii) the payment amount that applied under such subparagraph (D)(i) for such drug or biological on December 31, 2017. (I) Special payment adjustment rules for last quarter of 2018.--In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment amount for a covered OPD service (or group of services) beginning January 1, 2018, the following rules shall apply with respect to payment amounts under this subsection for covered a OPD service (or group of services) furnished during the period beginning on October 1, 2018, and ending on December 31, 2018: (i) The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged. (ii) The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i). (7) Transitional adjustment to limit decline in payment.-- (A) Before 2002.--Subject to subparagraph (D), for covered OPD services furnished before January 1, 2002, for which the PPS amount (as defined in subparagraph (E)) is-- (i) at least 90 percent, but less than 100 percent, of the pre-BBA amount (as defined in subparagraph (F)), the amount of payment under this subsection shall be increased by 80 percent of the amount of such difference; (ii) at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.71 and the pre-BBA amount, exceeds (II) the product of 0.70 and the PPS amount; (iii) at least 70 percent, but less than 80 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.63 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or (iv) less than 70 percent of the pre- BBA amount, the amount of payment under this subsection shall be increased by 21 percent of the pre-BBA amount. (B) 2002.--Subject to subparagraph (D), for covered OPD services furnished during 2002, for which the PPS amount is-- (i) at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 70 percent of the amount of such difference; (ii) at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.61 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or (iii) less than 80 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 13 percent of the pre-BBA amount. (C) 2003.--Subject to subparagraph (D), for covered OPD services furnished during 2003, for which the PPS amount is-- (i) at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 60 percent of the amount of such difference; or (ii) less than 90 percent of the pre- BBA amount, the amount of payment under this subsection shall be increased by 6 percent of the pre-BBA amount. (D) Hold harmless provisions.-- (i) Temporary treatment for certain rural hospitals.--(I) In the case of a hospital located in a rural area and that has not more than 100 beds or a sole community hospital (as defined in section 1886(d)(5)(D)(iii)) located in a rural area, for covered OPD services furnished before January 1, 2006, for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount of such difference. (II) In the case of a hospital located in a rural area and that has not more than 100 beds and that is not a sole community hospital (as defined in section 1886(d)(5)(D)(iii)), for covered OPD services furnished on or after January 1, 2006, and before January 1, 2013, for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the applicable percentage of the amount of such difference. For purposes of the preceding sentence, the applicable percentage shall be 95 percent with respect to covered OPD services furnished in 2006, 90 percent with respect to such services furnished in 2007, and 85 percent with respect to such services furnished in 2008, 2009, 2010, 2011, or 2012. (III) In the case of a sole community hospital (as defined in section 1886(d)(5)(D)(iii)) that has not more than 100 beds, for covered OPD services furnished on or after January 1, 2009, and before January 1, 2013, for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by 85 percent of the amount of such difference. In the case of covered OPD services furnished on or after January 1, 2010, and before March 1, 2012, the preceding sentence shall be applied without regard to the 100-bed limitation. (ii) Permanent treatment for cancer hospitals and children's hospitals.--In the case of a hospital described in clause (iii) or (v) of section 1886(d)(1)(B), for covered OPD services for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount of such difference. (E) PPS amount defined.--In this paragraph, the term ``PPS amount'' means, with respect to covered OPD services, the amount payable under this title for such services (determined without regard to this paragraph), including amounts payable as copayment under paragraph (8), coinsurance under section 1866(a)(2)(A)(ii), and the deductible under section 1833(b). (F) Pre-BBA amount defined.-- (i) In general.--In this paragraph, the ``pre-BBA amount'' means, with respect to covered OPD services furnished by a hospital in a year, an amount equal to the product of the reasonable cost of the hospital for such services for the portions of the hospital's cost reporting period (or periods) occurring in the year and the base OPD payment-to-cost ratio for the hospital (as defined in clause (ii)). (ii) Base payment-to-cost-ratio defined.--For purposes of this subparagraph, the ``base payment-to- cost ratio'' for a hospital means the ratio of-- (I) the hospital's reimbursement under this part for covered OPD services furnished during the cost reporting period ending in 1996 (or in the case of a hospital that did not submit a cost report for such period, during the first subsequent cost reporting period ending before 2001 for which the hospital submitted a cost report), including any reimbursement for such services through cost- sharing described in subparagraph (E), to (II) the reasonable cost of such services for such period. The Secretary shall determine such ratios as if the amendments made by section 4521 of the Balanced Budget Act of 1997 were in effect in 1996. (G) Interim payments.--The Secretary shall make payments under this paragraph to hospitals on an interim basis, subject to retrospective adjustments based on settled cost reports. (H) No effect on copayments.--Nothing in this paragraph shall be construed to affect the unadjusted copayment amount described in paragraph (3)(B) or the copayment amount under paragraph (8). (I) Application without regard to budget neutrality.--The additional payments made under this paragraph-- (i) shall not be considered an adjustment under paragraph (2)(E); and (ii) shall not be implemented in a budget neutral manner. (8) Copayment amount.-- (A) In general.--Except as provided in subparagraphs (B) and (C), the copayment amount under this subsection is the amount by which the amount described in paragraph (4)(B) exceeds the amount of payment determined under paragraph (4)(C). (B) Election to offer reduced copayment amount.--The Secretary shall establish a procedure under which a hospital, before the beginning of a year (beginning with 1999), may elect to reduce the copayment amount otherwise established under subparagraph (A) for some or all covered OPD services to an amount that is not less than 20 percent of the medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service involved. Under such procedures, such reduced copayment amount may not be further reduced or increased during the year involved and the hospital may disseminate information on the reduction of copayment amount effected under this subparagraph. (C) Limitation on copayment amount.-- (i) To inpatient hospital deductible amount.--In no case shall the copayment amount for a procedure performed in a year exceed the amount of the inpatient hospital deductible established under section 1813(b) for that year. (ii) To specified percentage.--The Secretary shall reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed the following percentage: (I) For procedures performed in 2001, on or after April 1, 2001, 57 percent. (II) For procedures performed in 2002 or 2003, 55 percent. (III) For procedures performed in 2004, 50 percent. (IV) For procedures performed in 2005, 45 percent. (V) For procedures performed in 2006 and thereafter, 40 percent. (D) No impact on deductibles.--Nothing in this paragraph shall be construed as affecting a hospital's authority to waive the charging of a deductible under section 1833(b). (E) Computation ignoring outlier and pass- through adjustments.--The copayment amount shall be computed under subparagraph (A) as if the adjustments under paragraphs (5) and (6) (and any adjustment made under paragraph (2)(E) in relation to such adjustments) had not occurred. (9) Periodic review and adjustments components of prospective payment system.-- (A) Periodic review.--The Secretary shall review not less often than annually and revise the groups, the relative payment weights, and the wage and other adjustments described in paragraph (2) to take into account changes in medical practice, changes in technology, the addition of new services, new cost data, and other relevant information and factors. The Secretary shall consult with an expert outside advisory panel composed of an appropriate selection of representatives of providers to review (and advise the Secretary concerning) the clinical integrity of the groups and weights. Such panel may use data collected or developed by entities and organizations (other than the Department of Health and Human Services) in conducting such review. (B) Budget neutrality adjustment.--If the Secretary makes adjustments under subparagraph (A), then the adjustments for a year may not cause the estimated amount of expenditures under this part for the year to increase or decrease from the estimated amount of expenditures under this part that would have been made if the adjustments had not been made. In determining adjustments under the preceding sentence for 2004 and 2005, the Secretary shall not take into account under this subparagraph or paragraph (2)(E) any expenditures that would not have been made but for the application of paragraph (14). (C) Update factor.--If the Secretary determines under methodologies described in paragraph (2)(F) that the volume of services paid for under this subsection increased beyond amounts established through those methodologies, the Secretary may appropriately adjust the update to the conversion factor otherwise applicable in a subsequent year. (10) Special rule for ambulance services.--The Secretary shall pay for hospital outpatient services that are ambulance services on the basis described in section 1861(v)(1)(U), or, if applicable, the fee schedule established under section 1834(l). (11) Special rules for certain hospitals.--In the case of hospitals described in clause (iii) or (v) of section 1886(d)(1)(B)-- (A) the system under this subsection shall not apply to covered OPD services furnished before January 1, 2000; and (B) the Secretary may establish a separate conversion factor for such services in a manner that specifically takes into account the unique costs incurred by such hospitals by virtue of their patient population and service intensity. (12) Limitation on review.--There shall be no administrative or judicial review under section 1869, 1878, or otherwise of-- (A) the development of the classification system under paragraph (2), including the establishment of groups and relative payment weights for covered OPD services, of wage adjustment factors, other adjustments, and methods described in paragraph (2)(F); (B) the calculation of base amounts under paragraph (3); (C) periodic adjustments made under paragraph (6); (D) the establishment of a separate conversion factor under paragraph (8)(B); and (E) the determination of the fixed multiple, or a fixed dollar cutoff amount, the marginal cost of care, or applicable percentage under paragraph (5) or the determination of insignificance of cost, the duration of the additional payments, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6)), the portion of the medicare OPD fee schedule amount associated with particular devices, drugs, or biologicals, and the application of any pro rata reduction under paragraph (6). (13) Authorization of adjustment for rural hospitals.-- (A) Study.--The Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals located in rural areas by ambulatory payment classification groups (APCs) exceed those costs incurred by hospitals located in urban areas. (B) Authorization of adjustment.--Insofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals located in rural areas exceed those costs incurred by hospitals located in urban areas, the Secretary shall provide for an appropriate adjustment under paragraph (2)(E) to reflect those higher costs by January 1, 2006. (14) Drug apc payment rates.-- (A) In general.--The amount of payment under this subsection for a specified covered outpatient drug (defined in subparagraph (B)) that is furnished as part of a covered OPD service (or group of services)-- (i) in 2004, in the case of-- (I) a sole source drug shall in no case be less than 88 percent, or exceed 95 percent, of the reference average wholesale price for the drug; (II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or (III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; (ii) in 2005, in the case of-- (I) a sole source drug shall in no case be less than 83 percent, or exceed 95 percent, of the reference average wholesale price for the drug; (II) an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or (III) a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; or (iii) in a subsequent year, shall be equal, subject to subparagraph (E)-- (I) to the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under subparagraph (D); or (II) if hospital acquisition cost data are not available, the average price for the drug in the year established under section 1842(o), section 1847A, or section 1847B, as the case may be, as calculated and adjusted by the Secretary as necessary for purposes of this paragraph. (B) Specified covered outpatient drug defined.-- (i) In general.--In this paragraph, the term ``specified covered outpatient drug'' means, subject to clause (ii), a covered outpatient drug (as defined in section 1927(k)(2)) for which a separate ambulatory payment classification group (APC) has been established and that is-- (I) a radiopharmaceutical; or (II) a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before December 31, 2002. (ii) Exception.--Such term does not include-- (I) a drug or biological for which payment is first made on or after January 1, 2003, under paragraph (6); (II) a drug or biological for which a temporary HCPCS code has not been assigned; or (III) during 2004 and 2005, an orphan drug (as designated by the Secretary). (C) Payment for designated orphan drugs during 2004 and 2005.--The amount of payment under this subsection for an orphan drug designated by the Secretary under subparagraph (B)(ii)(III) that is furnished as part of a covered OPD service (or group of services) during 2004 and 2005 shall equal such amount as the Secretary may specify. (D) Acquisition cost survey for hospital outpatient drugs.-- (i) Annual gao surveys in 2004 and 2005.-- (I) In general.--The Comptroller General of the United States shall conduct a survey in each of 2004 and 2005 to determine the hospital acquisition cost for each specified covered outpatient drug. Not later than April 1, 2005, the Comptroller General shall furnish data from such surveys to the Secretary for use in setting the payment rates under subparagraph (A) for 2006. (II) Recommendations.--Upon the completion of such surveys, the Comptroller General shall recommend to the Secretary the frequency and methodology of subsequent surveys to be conducted by the Secretary under clause (ii). (ii) Subsequent secretarial surveys.--The Secretary, taking into account such recommendations, shall conduct periodic subsequent surveys to determine the hospital acquisition cost for each specified covered outpatient drug for use in setting the payment rates under subparagraph (A). (iii) Survey requirements.--The surveys conducted under clauses (i) and (ii) shall have a large sample of hospitals that is sufficient to generate a statistically significant estimate of the average hospital acquisition cost for each specified covered outpatient drug. With respect to the surveys conducted under clause (i), the Comptroller General shall report to Congress on the justification for the size of the sample used in order to assure the validity of such estimates. (iv) Differentiation in cost.--In conducting surveys under clause (i), the Comptroller General shall determine and report to Congress if there is (and the extent of any) variation in hospital acquisition costs for drugs among hospitals based on the volume of covered OPD services performed by such hospitals or other relevant characteristics of such hospitals (as defined by the Comptroller General). (v) Comment on proposed rates.--Not later than 30 days after the date the Secretary promulgated proposed rules setting forth the payment rates under subparagraph (A) for 2006, the Comptroller General shall evaluate such proposed rates and submit to Congress a report regarding the appropriateness of such rates based on the surveys the Comptroller General has conducted under clause (i). (E) Adjustment in payment rates for overhead costs.-- (i) Medpac report on drug apc design.--The Medicare Payment Advisory Commission shall submit to the Secretary, not later than July 1, 2005, a report on adjustment of payment for ambulatory payment classifications for specified covered outpatient drugs to take into account overhead and related expenses, such as pharmacy services and handling costs. Such report shall include-- (I) a description and analysis of the data available with regard to such expenses; (II) a recommendation as to whether such a payment adjustment should be made; and (III) if such adjustment should be made, a recommendation regarding the methodology for making such an adjustment. (ii) Adjustment authorized.--The Secretary may adjust the weights for ambulatory payment classifications for specified covered outpatient drugs to take into account the recommendations contained in the report submitted under clause (i). (F) Classes of drugs.--For purposes of this paragraph: (i) Sole source drugs.--The term ``sole source drug'' means-- (I) a biological product (as defined under section 1861(t)(1)); or (II) a single source drug (as defined in section 1927(k)(7)(A)(iv)). (ii) Innovator multiple source drugs.--The term ``innovator multiple source drug'' has the meaning given such term in section 1927(k)(7)(A)(ii). (iii) Noninnovator multiple source drugs.--The term ``noninnovator multiple source drug'' has the meaning given such term in section 1927(k)(7)(A)(iii). (G) Reference average wholesale price.--The term ``reference average wholesale price'' means, with respect to a specified covered outpatient drug, the average wholesale price for the drug as determined under section 1842(o) as of May 1, 2003. (H) Inapplicability of expenditures in determining conversion, weighting, and other adjustment factors.--Additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion, weighting, and other adjustment factors for 2004 and 2005 under paragraph (9), but shall be taken into account for subsequent years. (15) Payment for new drugs and biologicals until hcpcs code assigned.--With respect to payment under this part for an outpatient drug or biological that is covered under this part and is furnished as part of covered OPD services for which a HCPCS code has not been assigned, the amount provided for payment for such drug or biological under this part shall be equal to 95 percent of the average wholesale price for the drug or biological. (16) Miscellaneous provisions.-- (A) Application of reclassification of certain hospitals.--If a hospital is being treated as being located in a rural area under section 1886(d)(8)(E), that hospital shall be treated under this subsection as being located in that rural area. (B) Threshold for establishment of separate apcs for drugs.--The Secretary shall reduce the threshold for the establishment of separate ambulatory payment classification groups (APCs) with respect to drugs or biologicals to $50 per administration for drugs and biologicals furnished in 2005 and 2006. (C) Payment for devices of brachytherapy and therapeutic radiopharmaceuticals at charges adjusted to cost.--Notwithstanding the preceding provisions of this subsection, for a device of brachytherapy consisting of a seed or seeds (or radioactive source) furnished on or after January 1, 2004, and before January 1, 2010, and for therapeutic radiopharmaceuticals furnished on or after January 1, 2008, and before January 1, 2010, the payment basis for the device or therapeutic radiopharmaceutical under this subsection shall be equal to the hospital's charges for each device or therapeutic radiopharmaceutical furnished, adjusted to cost. Charges for such devices or therapeutic radiopharmaceuticals shall not be included in determining any outlier payment under this subsection. (D) Special payment rule.-- (i) In general.--In the case of covered OPD services furnished on or after April 1, 2013, in a hospital described in clause (ii), if-- (I) the payment rate that would otherwise apply under this subsection for stereotactic radiosurgery, complete course of treatment of cranial lesion(s) consisting of 1 session that is multi-source Cobalt 60 based (identified as of January 1, 2013, by HCPCS code 77371 (and any succeeding code) and reimbursed as of such date under APC 0127 (and any succeeding classification group)); exceeds (II) the payment rate that would otherwise apply under this subsection for linear accelerator based stereotactic radiosurgery, complete course of therapy in one session (identified as of January 1, 2013, by HCPCS code G0173 (and any succeeding code) and reimbursed as of such date under APC 0067 (and any succeeding classification group)), the payment rate for the service described in subclause (I) shall be reduced to an amount equal to the payment rate for the service described in subclause (II). (ii) Hospital described.--A hospital described in this clause is a hospital that is not-- (I) located in a rural area (as defined in section 1886(d)(2)(D)); (II) classified as a rural referral center under section 1886(d)(5)(C); or (III) a sole community hospital (as defined in section 1886(d)(5)(D)(iii)). (iii) Not budget neutral.--In making any budget neutrality adjustments under this subsection for 2013 (with respect to covered OPD services furnished on or after April 1, 2013, and before January 1, 2014) or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph. (E) Application of appropriate use criteria for certain imaging services.--For provisions relating to the application of appropriate use criteria for certain imaging services, see section 1834(q). (F) Payment incentive for the transition from traditional x-ray imaging to digital radiography.--Notwithstanding the previous provisions of this subsection: (i) Limitation on payment for film x- ray imaging services.--In the case of an imaging service that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 20 percent. (ii) Phased-in limitation on payment for computed radiography imaging services.--In the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in section 1848(b)(9)(C))-- (I) in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and (II) in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent. (iii) Application without regard to budget neutrality.--The reductions made under this subparagraph-- (I) shall not be considered an adjustment under paragraph (2)(E); and (II) shall not be implemented in a budget neutral manner. (iv) Implementation.--In order to implement this subparagraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers. (17) Quality reporting.-- (A) Reduction in update for failure to report.-- (i) In general.--For purposes of paragraph (3)(C)(iv) for 2009 and each subsequent year, in the case of a subsection (d) hospital (as defined in section 1886(d)(1)(B)) that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to such a year, the OPD fee schedule increase factor under paragraph (3)(C)(iv) for such year shall be reduced by 2.0 percentage points. (ii) Non-cumulative application.--A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing the OPD fee schedule increase factor for a subsequent year. (B) Form and manner of submission.--Each subsection (d) hospital shall submit data on measures selected under this paragraph to the Secretary in a form and manner, and at a time, specified by the Secretary for purposes of this paragraph. (C) Development of outpatient measures.-- (i) In general.--The Secretary shall develop measures that the Secretary determines to be appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in outpatient settings and that reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus building entities. (ii) Construction.--Nothing in this paragraph shall be construed as preventing the Secretary from selecting measures that are the same as (or a subset of) the measures for which data are required to be submitted under section 1886(b)(3)(B)(viii). (D) Replacement of measures.--For purposes of this paragraph, the Secretary may replace any measures or indicators in appropriate cases, such as where all hospitals are effectively in compliance or the measures or indicators have been subsequently shown not to represent the best clinical practice. (E) Availability of data.--The Secretary shall establish procedures for making data submitted under this paragraph available to the public. Such procedures shall ensure that a hospital has the opportunity to review the data that are to be made public with respect to the hospital prior to such data being made public. The Secretary shall report quality measures of process, structure, outcome, patients' perspectives on care, efficiency, and costs of care that relate to services furnished in outpatient settings in hospitals on the Internet website of the Centers for Medicare & Medicaid Services. (18) Authorization of adjustment for cancer hospitals.-- (A) Study.--The Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals described in section 1886(d)(1)(B)(v) with respect to ambulatory payment classification groups exceed those costs incurred by other hospitals furnishing services under this subsection (as determined appropriate by the Secretary). In conducting the study under this subparagraph, the Secretary shall take into consideration the cost of drugs and biologicals incurred by such hospitals. (B) Authorization of adjustment.--Insofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals described in section 1886(d)(1)(B)(v) exceed those costs incurred by other hospitals furnishing services under this subsection, the Secretary shall, subject to subparagraph (C), provide for an appropriate adjustment under paragraph (2)(E) to reflect those higher costs effective for services furnished on or after January 1, 2011. (C) Target pcr adjustment.--In applying section 419.43(i) of title 42 of the Code of Federal Regulations to implement the appropriate adjustment under this paragraph for services furnished on or after January 1, 2018, the Secretary shall use a target PCR that is 1.0 percentage points less than the target PCR that would otherwise apply. In addition to the percentage point reduction under the previous sentence, the Secretary may consider making an additional percentage point reduction to such target PCR that takes into account payment rates for applicable items and services described in paragraph (21)(C) other than for services furnished by hospitals described in section 1886(d)(1)(B)(v). In making any budget neutrality adjustments under this subsection for 2018 or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph. (19) Floor on area wage adjustment factor for hospital outpatient department services in frontier states.-- (A) In general.--Subject to subparagraph (B), with respect to covered OPD services furnished on or after January 1, 2011, the area wage adjustment factor applicable under the payment system established under this subsection to any hospital outpatient department which is located in a frontier State (as defined in section 1886(d)(3)(E)(iii)(II)) may not be less than 1.00. The preceding sentence shall not be applied in a budget neutral manner. (B) Limitation.--This paragraph shall not apply to any hospital outpatient department located in a State that receives a non-labor related share adjustment under section 1886(d)(5)(H). (20) Not budget neutral application of reduced expenditures resulting from quality incentives for computed tomography.--The Secretary shall not take into account the reduced expenditures that result from the application of section 1834(p) in making any budget neutrality adjustments this subsection. (21) Services furnished by an off-campus outpatient department of a provider.-- (A) Applicable items and services.--For purposes of paragraph (1)(B)(v) and this paragraph, the term ``applicable items and services'' means items and services other than items and services furnished by a dedicated emergency department (as defined in section 489.24(b) of title 42 of the Code of Federal Regulations). (B) Off-campus outpatient department of a provider.-- (i) In general.--For purposes of paragraph (1)(B)(v) and this paragraph, subject to the subsequent provisions of this subparagraph, the term ``off- campus outpatient department of a provider'' means a department of a provider (as defined in section 413.65(a)(2) of title 42 of the Code of Federal Regulations, as in effect as of the date of the enactment of this paragraph) that is not located-- (I) on the campus (as defined in such section 413.65(a)(2)) of such provider; or (II) within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section 413.65(a)(2)). (ii) Exception.--For purposes of paragraph (1)(B)(v) and this paragraph, the term ``off-campus outpatient department of a provider'' shall not include a department of a provider (as so defined) that was billing under this subsection with respect to covered OPD services furnished prior to the date of the enactment of this paragraph. (iii) Deemed treatment for 2017.--For purposes of applying clause (ii) with respect to applicable items and services furnished during 2017, a department of a provider (as so defined) not described in such clause is deemed to be billing under this subsection with respect to covered OPD services furnished prior to November 2, 2015, if the Secretary received from the provider prior to December 2, 2015, an attestation (pursuant to section 413.65(b)(3) of title 42 of the Code of Federal Regulations) that such department was a department of a provider (as so defined). (iv) Alternative exception beginning with 2018.--For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2018 or a subsequent year, the term ``off-campus outpatient department of a provider'' also shall not include a department of a provider (as so defined) that is not described in clause (ii) if-- (I) the Secretary receives from the provider an attestation (pursuant to such section 413.65(b)(3)) not later than December 31, 2016 (or, if later, 60 days after the date of the enactment of this clause), that such department met the requirements of a department of a provider specified in section 413.65 of title 42 of the Code of Federal Regulations; (II) the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under section 1866(j); and (III) the department met the mid-build requirement of clause (v) and the Secretary receives, not later than 60 days after the date of the enactment of this clause, from the chief executive officer or chief operating officer of the provider a written certification that the department met such requirement. (v) Mid-build requirement described.--The mid-build requirement of this clause is, with respect to a department of a provider, that before November 2, 2015, the provider had a binding written agreement with an outside unrelated party for the actual construction of such department. (vi) Exclusion for certain cancer hospitals.--For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2017 or a subsequent year, the term ``off-campus outpatient department of a provider'' also shall not include a department of a provider (as so defined) that is not described in clause (ii) if the provider is a hospital described in section 1886(d)(1)(B)(v) and-- (I) in the case of a department that met the requirements of section 413.65 of title 42 of the Code of Federal Regulations after November 1, 2015, and before the date of the enactment of this clause, the Secretary receives from the provider an attestation that such department met such requirements not later than 60 days after such date of enactment; or (II) in the case of a department that meets such requirements after such date of enactment, the Secretary receives from the provider an attestation that such department meets such requirements not later than 60 days after the date such requirements are first met with respect to such department. (vii) Audit.--Not later than December 31, 2018, the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department of a provider to which such clause applies. Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to compliance of a department of a provider with requirements referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department. If the Secretary finds as a result of an audit under this clause that the applicable requirements were not met with respect to such department, the department shall not be excluded from the term ``off-campus outpatient department of a provider'' under such clause. (viii) Implementation.--For purposes of implementing clauses (iii) through (vii): (I) Notwithstanding any other provision of law, the Secretary may implement such clauses by program instruction or otherwise. (II) Subchapter I of chapter 35 of title 44, United States Code, shall not apply. (III) For purposes of carrying out this subparagraph with respect to clauses (iii) and (iv) (and clause (vii) insofar as it relates to clause (iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to remain available until December 31, 2018. For purposes of carrying out this subparagraph with respect to clause (vi) (and clause (vii) insofar as it relates to such clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to remain available until expended. (C) Availability of payment under other payment systems.--Payments for applicable items and services furnished by an off-campus outpatient department of a provider that are described in paragraph (1)(B)(v) shall be made under the applicable payment system under this part (other than under this subsection) if the requirements for such payment are otherwise met. (D) Information needed for implementation.-- Each hospital shall provide to the Secretary such information as the Secretary determines appropriate to implement this paragraph and paragraph (1)(B)(v) (which may include reporting of information on a hospital claim using a code or modifier and reporting information about off-campus outpatient departments of a provider on the enrollment form described in section 1866(j)). (E) Limitations.--There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of the following: (i) The determination of the applicable items and services under subparagraph (A) and applicable payment systems under subparagraph (C). (ii) The determination of whether a department of a provider meets the term described in subparagraph (B). (iii) Any information that hospitals are required to report pursuant to subparagraph (D). (iv) The determination of an audit under subparagraph (B)(vii). (22) Review and revisions of payments for non-opioid alternative treatments.-- (A) In general.--With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary-- (i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management. (B) Priority.--In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management. (C) Revisions.--If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B). (D) Rules of construction.--Nothing in this paragraph shall be construed to preclude the Secretary-- (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management. (u) Incentive Payments for Physician Scarcity Areas.-- (1) In general.--In the case of physicians' services furnished on or after January 1, 2005, and before July 1, 2008-- (A) by a primary care physician in a primary care scarcity county (identified under paragraph (4)); or (B) by a physician who is not a primary care physician in a specialist care scarcity county (as so identified), in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid an amount equal to 5 percent of the payment amount for the service under this part. (2) Determination of ratios of physicians to medicare beneficiaries in area.--Based upon available data, the Secretary shall establish for each county or equivalent area in the United States, the following: (A) Number of physicians practicing in the area.--The number of physicians who furnish physicians' services in the active practice of medicine or osteopathy in that county or area, other than physicians whose practice is exclusively for the Federal Government, physicians who are retired, or physicians who only provide administrative services. Of such number, the number of such physicians who are-- (i) primary care physicians; or (ii) physicians who are not primary care physicians. (B) Number of medicare beneficiaries residing in the area.--The number of individuals who are residing in the county and are entitled to benefits under part A or enrolled under this part, or both (in this subsection referred to as ``individuals''). (C) Determination of ratios.-- (i) Primary care ratio.--The ratio (in this paragraph referred to as the ``primary care ratio'') of the number of primary care physicians (determined under subparagraph (A)(i)), to the number of individuals determined under subparagraph (B). (ii) Specialist care ratio.--The ratio (in this paragraph referred to as the ``specialist care ratio'') of the number of other physicians (determined under subparagraph (A)(ii)), to the number of individuals determined under subparagraph (B). (3) Ranking of counties.--The Secretary shall rank each such county or area based separately on its primary care ratio and its specialist care ratio. (4) Identification of counties.-- (A) In general.--The Secretary shall identify-- (i) those counties and areas (in this paragraph referred to as ``primary care scarcity counties'') with the lowest primary care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph; and (ii) those counties and areas (in this subsection referred to as ``specialist care scarcity counties'') with the lowest specialist care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph. (B) Periodic revisions.--The Secretary shall periodically revise the counties or areas identified in subparagraph (A) (but not less often than once every three years) unless the Secretary determines that there is no new data available on the number of physicians practicing in the county or area or the number of individuals residing in the county or area, as identified in paragraph (2). (C) Identification of counties where service is furnished.--For purposes of paying the additional amount specified in paragraph (1), if the Secretary uses the 5-digit postal ZIP Code where the service is furnished, the dominant county of the postal ZIP Code (as determined by the United States Postal Service, or otherwise) shall be used to determine whether the postal ZIP Code is in a scarcity county identified in subparagraph (A) or revised in subparagraph (B). (D) Special rule.--With respect to physicians' services furnished on or after January 1, 2008, and before July 1, 2008, for purposes of this subsection, the Secretary shall use the primary care scarcity counties and the specialty care scarcity counties (as identified under the preceding provisions of this paragraph) that the Secretary was using under this subsection with respect to physicians' services furnished on December 31, 2007. (E) Judicial review.--There shall be no administrative or judicial review under section 1869, 1878, or otherwise, respecting-- 116.(i) the identification of a county or area; (ii) the assignment of a specialty of any physician under this paragraph; (iii) the assignment of a physician to a county under paragraph (2); or (iv) the assignment of a postal ZIP Code to a county or other area under this subsection. (5) Rural census tracts.--To the extent feasible, the Secretary shall treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)), as an equivalent area for purposes of qualifying as a primary care scarcity county or specialist care scarcity county under this subsection. (6) Physician Defined.--For purposes of this paragraph, the term ``physician'' means a physician described in section 1861(r)(1) and the term ``primary care physician'' means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist. (7) Publication of list of counties; posting on website.--With respect to a year for which a county or area is identified or revised under paragraph (4), the Secretary shall identify such counties or areas as part of the proposed and final rule to implement the physician fee schedule under section 1848 for the applicable year. The Secretary shall post the list of counties identified or revised under paragraph (4) on the Internet website of the Centers for Medicare & Medicaid Services. (v) Increase of FQHC Payment Limits.--In the case of services furnished by Federally qualified health centers (as defined in section 1861(aa)(4)), the Secretary shall establish payment limits with respect to such services under this part for services furnished-- (1) in 2010, at the limits otherwise established under this part for such year increased by $5; and (2) in a subsequent year, at the limits established under this subsection for the previous year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for such subsequent year. (w) Methods of Payment.--The Secretary may develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies sponsored or supported by an agency of the Department of Health and Human Services, as determined by the Secretary, to those that would otherwise apply under this section, to the extent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where masking the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design. (x) Incentive Payments for Primary Care Services.-- (1) In general.--In the case of primary care services furnished on or after January 1, 2011, and before January 1, 2016, by a primary care practitioner, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part. (2) Definitions.--In this subsection: (A) Primary care practitioner.--The term ``primary care practitioner'' means an individual-- (i) who-- (I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or (II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)); and (ii) for whom primary care services accounted for at least 60 percent of the allowed charges under this part for such physician or practitioner in a prior period as determined appropriate by the Secretary. (B) Primary care services.--The term ``primary care services'' means services identified, as of January 1, 2009, by the following HCPCS codes (and as subsequently modified by the Secretary): (i) 99201 through 99215. (ii) 99304 through 99340. (iii) 99341 through 99350. (3) Coordination with other payments.--The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively. (4) Limitation on review.--There shall be no administrative or judicial review under section 1869, 1878, or otherwise, respecting the identification of primary care practitioners under this subsection. (y) Incentive Payments for Major Surgical Procedures Furnished in Health Professional Shortage Areas.-- (1) In general.--In the case of major surgical procedures furnished on or after January 1, 2011, and before January 1, 2016, by a general surgeon in an area that is designated (under section 332(a)(1)(A) of the Public Health Service Act) as a health professional shortage area as identified by the Secretary prior to the beginning of the year involved, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part. (2) Definitions.--In this subsection: (A) General surgeon.--In this subsection, the term ``general surgeon'' means a physician (as described in section 1861(r)(1)) who has designated CMS specialty code 02-General Surgery as their primary specialty code in the physician's enrollment under section 1866(j). (B) Major surgical procedures.--The term ``major surgical procedures'' means physicians' services which are surgical procedures for which a 10-day or 90-day global period is used for payment under the fee schedule under section 1848(b). (3) Coordination with other payments.--The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively. (4) Application.--The provisions of paragraph (2) and (4) of subsection (m) shall apply to the determination of additional payments under this subsection in the same manner as such provisions apply to the determination of additional payments under subsection (m). (z) Incentive Payments for Participation in Eligible Alternative Payment Models.-- (1) Payment incentive.-- (A) In general.--In the case of covered professional services furnished by an eligible professional during a year that is in the period beginning with 2019 and ending with 2024 and for which the professional is a qualifying APM participant with respect to such year, in addition to the amount of payment that would otherwise be made for such covered professional services under this part for such year, there also shall be paid to such professional an amount equal to 5 percent of the estimated aggregate payment amounts for such covered professional services under this part for the preceding year. For purposes of the previous sentence, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. The Secretary shall establish policies to implement this subparagraph in cases in which payment for covered professional services furnished by a qualifying APM participant in an alternative payment model-- (i) is made to an eligible alternative payment entity rather than directly to the qualifying APM participant; or (ii) is made on a basis other than a fee-for-service basis (such as payment on a capitated basis). (B) Form of payment.--Payments under this subsection shall be made in a lump sum, on an annual basis, as soon as practicable. (C) Treatment of payment incentive.--Payments under this subsection shall not be taken into account for purposes of determining actual expenditures under an alternative payment model and for purposes of determining or rebasing any benchmarks used under the alternative payment model. (D) Coordination.--The amount of the additional payment under this subsection or subsection (m) shall be determined without regard to any additional payment under subsection (m) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (x) shall be determined without regard to any additional payment under subsection (x) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (y) shall be determined without regard to any additional payment under subsection (y) and this subsection, respectively. (2) Qualifying apm participant.--For purposes of this subsection, the term ``qualifying APM participant'' means the following: (A) 2019 and 2020.--With respect to 2019 and 2020, an eligible professional for whom the Secretary determines that at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity. (B) 2021 and 2022.--With respect to 2021 and 2022, an eligible professional described in either of the following clauses: (i) Medicare payment threshold option.--An eligible professional for whom the Secretary determines that at least 50 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity. (ii) Combination all-payer and medicare payment threshold option.--An eligible professional-- (I) for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 50 percent of the sum of-- (aa) payments described in clause (i); and (bb) all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under title XIX in a State in which no medical home or alternative payment model is available under the State program under that title), meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb); (II) for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and (III) who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional. (iii) Requirement.--For purposes of clause (ii)(I)-- (I) the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and (II) the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which-- (aa) quality measures comparable to measures under the performance category described in section 1848(q)(2)(B)(i) apply; (bb) certified EHR technology is used; and (cc) the eligible professional participates in an entity that-- (AA) bears more than nominal financial risk if actual aggregate expenditures exceeds expected aggregate expenditures; or (BB) with respect to beneficiaries under title XIX, is a medical home that meets criteria comparable to medical homes expanded under section 1115A(c). (C) Beginning in 2023.--With respect to 2023 and each subsequent year, an eligible professional described in either of the following clauses: (i) Medicare payment threshold option.--An eligible professional for whom the Secretary determines that at least 75 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity. (ii) Combination all-payer and medicare payment threshold option.--An eligible professional-- (I) for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 75 percent of the sum of-- (aa) payments described in clause (i); and (bb) all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under title XIX in a State in which no medical home or alternative payment model is available under the State program under that title), meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb); (II) for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and (III) who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional. (iii) Requirement.--For purposes of clause (ii)(I)-- (I) the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and (II) the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which-- (aa) quality measures comparable to measures under the performance category described in section 1848(q)(2)(B)(i) apply; (bb) certified EHR technology is used; and (cc) the eligible professional participates in an entity that-- (AA) bears more than nominal financial risk if actual aggregate expenditures exceeds expected aggregate expenditures; or (BB) with respect to beneficiaries under title XIX, is a medical home that meets criteria comparable to medical homes expanded under section 1115A(c). (D) Use of patient approach.--The Secretary may base the determination of whether an eligible professional is a qualifying APM participant under this subsection and the determination of whether an eligible professional is a partial qualifying APM participant under section 1848(q)(1)(C)(iii) by using counts of patients in lieu of using payments and using the same or similar percentage criteria (as specified in this subsection and such section, respectively), as the Secretary determines appropriate. (3) Additional definitions.--In this subsection: (A) Covered professional services.--The term ``covered professional services'' has the meaning given that term in section 1848(k)(3)(A). (B) Eligible professional.--The term ``eligible professional'' has the meaning given that term in section 1848(k)(3)(B) and includes a group that includes such professionals. (C) Alternative payment model (apm).--The term ``alternative payment model'' means, other than for purposes of subparagraphs (B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph (2), any of the following: (i) A model under section 1115A (other than a health care innovation award). (ii) The shared savings program under section 1899. (iii) A demonstration under section 1866C. (iv) A demonstration required by Federal law. (D) Eligible alternative payment entity.--The term ``eligible alternative payment entity'' means, with respect to a year, an entity that-- (i) participates in an alternative payment model that-- (I) requires participants in such model to use certified EHR technology (as defined in subsection (o)(4)); and (II) provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1848(q)(2)(B)(i); and (ii)(I) bears financial risk for monetary losses under such alternative payment model that are in excess of a nominal amount; or (II) is a medical home expanded under section 1115A(c). (4) Limitation.--There shall be no administrative or judicial review under section 1869, 1878, or otherwise, of the following: (A) The determination that an eligible professional is a qualifying APM participant under paragraph (2) and the determination that an entity is an eligible alternative payment entity under paragraph (3)(D). (B) The determination of the amount of the 5 percent payment incentive under paragraph (1)(A), including any estimation as part of such determination. (aa) Medical Review of Spinal Subluxation Services.-- (1) In general.--The Secretary shall implement a process for the medical review (as described in paragraph (2)) of treatment by a chiropractor described in section 1861(r)(5) by means of manual manipulation of the spine to correct a subluxation (as described in such section) of an individual who is enrolled under this part and apply such process to such services furnished on or after January 1, 2017, focusing on services such as-- (A) services furnished by a such a chiropractor whose pattern of billing is aberrant compared to peers; and (B) services furnished by such a chiropractor who, in a prior period, has a services denial percentage in the 85th percentile or greater, taking into consideration the extent that service denials are overturned on appeal. (2) Medical review.-- (A) Prior authorization medical review.-- (i) In general.--Subject to clause (ii), the Secretary shall use prior authorization medical review for services described in paragraph (1) that are furnished to an individual by a chiropractor described in section 1861(r)(5) that are part of an episode of treatment that includes more than 12 services. For purposes of the preceding sentence, an episode of treatment shall be determined by the underlying cause that justifies the need for services, such as a diagnosis code. (ii) Ending application of prior authorization medical review.--The Secretary shall end the application of prior authorization medical review under clause (i) to services described in paragraph (1) by such a chiropractor if the Secretary determines that the chiropractor has a low denial rate under such prior authorization medical review. The Secretary may subsequently reapply prior authorization medical review to such chiropractor if the Secretary determines it to be appropriate and the chiropractor has, in the time period subsequent to the determination by the Secretary of a low denial rate with respect to the chiropractor, furnished such services described in paragraph (1). (iii) Early request for prior authorization review permitted.-- Nothing in this subsection shall be construed to prevent such a chiropractor from requesting prior authorization for services described in paragraph (1) that are to be furnished to an individual before the chiropractor furnishes the twelfth such service to such individual for an episode of treatment. (B) Type of review.--The Secretary may use pre-payment review or post-payment review of services described in section 1861(r)(5) that are not subject to prior authorization medical review under subparagraph (A). (C) Relationship to law enforcement activities.--The Secretary may determine that medical review under this subsection does not apply in the case where potential fraud may be involved. (3) No payment without prior authorization.--With respect to a service described in paragraph (1) for which prior authorization medical review under this subsection applies, the following shall apply: (A) Prior authorization determination.--The Secretary shall make a determination, prior to the service being furnished, of whether the service would or would not meet the applicable requirements of section 1862(a)(1)(A). (B) Denial of payment.--Subject to paragraph (5), no payment may be made under this part for the service unless the Secretary determines pursuant to subparagraph (A) that the service would meet the applicable requirements of such section 1862(a)(1)(A). (4) Submission of information.--A chiropractor described in section 1861(r)(5) may submit the information necessary for medical review by fax, by mail, or by electronic means. The Secretary shall make available the electronic means described in the preceding sentence as soon as practicable. (5) Timeliness.--If the Secretary does not make a prior authorization determination under paragraph (3)(A) within 14 business days of the date of the receipt of medical documentation needed to make such determination, paragraph (3)(B) shall not apply. (6) Application of limitation on beneficiary liability.--Where payment may not be made as a result of the application of paragraph (2)(B), section 1879 shall apply in the same manner as such section applies to a denial that is made by reason of section 1862(a)(1). (7) Review by contractors.--The medical review described in paragraph (2) may be conducted by medicare administrative contractors pursuant to section 1874A(a)(4)(G) or by any other contractor determined appropriate by the Secretary that is not a recovery audit contractor. (8) Multiple services.--The Secretary shall, where practicable, apply the medical review under this subsection in a manner so as to allow an individual described in paragraph (1) to obtain, at a single time rather than on a service-by-service basis, an authorization in accordance with paragraph (3)(A) for multiple services. (9) Construction.--With respect to a service described in paragraph (1) that has been affirmed by medical review under this subsection, nothing in this subsection shall be construed to preclude the subsequent denial of a claim for such service that does not meet other applicable requirements under this Act. (10) Implementation.-- (A) Authority.--The Secretary may implement the provisions of this subsection by interim final rule with comment period. (B) Administration.--Chapter 35 of title 44, United States Code, shall not apply to medical review under this subsection. (bb) Additional Payments for Certain Rural Health Clinics With Physicians or Practitioners Receiving DATA 2000 Waivers.-- (1) In general.--In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner. (2) Application.--In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic. (3) Requirements.--For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (4) Funding.--For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended. SPECIAL PAYMENT RULES FOR PARTICULAR ITEMS AND SERVICES Sec. 1834. (a) Payment for Durable Medical Equipment.-- (1) General rule for payment.-- (A) In general.--With respect to a covered item (as defined in paragraph (13)) for which payment is determined under this subsection, payment shall be made in the frequency specified in paragraphs (2) through (7) and in an amount equal to 80 percent of the payment basis described in subparagraph (B). (B) Payment basis.--Subject to subparagraph (F)(i), the payment basis described in this subparagraph is the lesser of-- (i) the actual charge for the item, or (ii) the payment amount recognized under paragraphs (2) through (7) of this subsection for the item; except that clause (i) shall not apply if the covered item is furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public. (C) Exclusive payment rule.--Subject to subparagraph (F)(ii), this subsection shall constitute the exclusive provision of this title for payment for covered items under this part or under part A to a home health agency. (D) Reduction in fee schedules for certain items.--With respect to a seat-lift chair or transcutaneous electrical nerve stimulator furnished on or after April 1, 1990, the Secretary shall reduce the payment amount applied under subparagraph (B)(ii) for such an item by 15 percent, and, in the case of a transcutaneous electrical nerve stimulator furnished on or after January 1, 1991, the Secretary shall further reduce such payment amount (as previously reduced) by 45 percent. (E) Clinical conditions for coverage.-- (i) In general.--The Secretary shall establish standards for clinical conditions for payment for covered items under this subsection. (ii) Requirements.--The standards established under clause (i) shall include the specification of types or classes of covered items that require, as a condition of payment under this subsection, a face-to-face examination of the individual by a physician (as defined in section 1861(r)), a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) and a prescription for the item. (iii) Priority of establishment of standards.--In establishing the standards under this subparagraph, the Secretary shall first establish standards for those covered items for which the Secretary determines there has been a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation to provide for payment of such covered items under this part. (iv) Standards for power wheelchairs.--Effective on the date of the enactment of this subparagraph, in the case of a covered item consisting of a motorized or power wheelchair for an individual, payment may not be made for such covered item unless a physician (as defined in section 1861(r)(1)), a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) has conducted a face-to-face examination of the individual and written a prescription for the item. (v) Limitation on payment for covered items.--Payment may not be made for a covered item under this subsection unless the item meets any standards established under this subparagraph for clinical condition of coverage. (F) Application of competitive acquisition; limitation of inherent reasonableness authority.--In the case of covered items furnished on or after January 1, 2011, subject to subparagraphs (G) and (H), that are included in a competitive acquisition program in a competitive acquisition area under section 1847(a)-- (i) the payment basis under this subsection for such items and services furnished in such area shall be the payment basis determined under such competitive acquisition program; (ii) the Secretary may (and, in the case of covered items furnished on or after January 1, 2016, subject to clause (iii), shall) use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under section 1847 and in the case of such adjustment, paragraph (10)(B) shall not be applied; and (iii) in the case of covered items furnished on or after January 1, 2016, the Secretary shall continue to make such adjustments described in clause (ii) as, under such competitive acquisition programs, additional covered items are phased in or information is updated as contracts under section 1847 are recompeted in accordance with section 1847(b)(3)(B). (G) Use of information on competitive bid rates.--The Secretary shall specify by regulation the methodology to be used in applying the provisions of subparagraph (F)(ii) and subsection (h)(1)(H)(ii). In promulgating such regulation, the Secretary shall consider the costs of items and services in areas in which such provisions would be applied compared to the payment rates for such items and services in competitive acquisition areas.In the case of items and services furnished on or after January 1, 2019, in making any adjustments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under section 1842(s)(3)(B), the Secretary shall-- (i) solicit and take into account stakeholder input; and (ii) take into account the highest amount bid by a winning supplier in a competitive acquisition area and a comparison of each of the following with respect to non-competitive acquisition areas and competitive acquisition areas: (I) The average travel distance and cost associated with furnishing items and services in the area. (II) The average volume of items and services furnished by suppliers in the area. (III) The number of suppliers in the area. (H) Diabetic supplies.-- (i) In general.--On or after the date described in clause (ii), the payment amount under this part for diabetic supplies, including testing strips, that are non-mail order items (as defined by the Secretary) shall be equal to the single payment amounts established under the national mail order competition for diabetic supplies under section 1847. (ii) Date described.--The date described in this clause is the date of the implementation of the single payment amounts under the national mail order competition for diabetic supplies under section 1847. (I) Treatment of vacuum erection systems.-- Effective for items and services furnished on and after July 1, 2015, vacuum erection systems described as prosthetic devices described in section 1861(s)(8) shall be treated in the same manner as erectile dysfunction drugs are treated for purposes of section 1860D- 2(e)(2)(A). (2) Payment for inexpensive and other routinely purchased durable medical equipment.-- (A) In general.--Payment for an item of durable medical equipment (as defined in paragraph (13))-- (i) the purchase price of which does not exceed $150, (ii) which the Secretary determines is acquired at least 75 percent of the time by purchase, (iii) which is an accessory used in conjunction with a nebulizer, aspirator, or a ventilator excluded under paragraph (3)(A), or (iv) in the case of devices furnished on or after October 1, 2015, which serves as a speech generating device or which is an accessory that is needed for the individual to effectively utilize such a device, shall be made on a rental basis or in a lump- sum amount for the purchase of the item. The payment amount recognized for purchase or rental of such equipment is the amount specified in subparagraph (B) for purchase or rental, except that the total amount of payments with respect to an item may not exceed the payment amount specified in subparagraph (B) with respect to the purchase of the item. (B) Payment amount.--For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to the purchase or rental of an item furnished in a carrier service area-- (i) in 1989 and in 1990 is the average reasonable charge in the area for the purchase or rental, respectively, of the item for the 12- month period ending on June 30, 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987; (ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991; (iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and (iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year (reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an individual with diabetes). (C) Computation of local payment amount and national limited payment amount.--For purposes of subparagraph (B)-- (i) the local payment amount for an item or device for a year is equal to-- (I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and (II) for 1992, 1993, and 1994 the amount determined under this clause for the preceding year increased by the covered item update for the year; and (ii) the national limited payment amount for an item or device for a year is equal to-- (I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item, (II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year, (III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and (IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year. (3) Payment for items requiring frequent and substantial servicing.-- (A) In general.--Payment for a covered item (such as IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or intermittent assist devices with continuous airway pressure devices) for which there must be frequent and substantial servicing in order to avoid risk to the patient's health shall be made on a monthly basis for the rental of the item and the amount recognized is the amount specified in subparagraph (B). (B) Payment amount.--For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to an item or device furnished in a carrier service area-- (i) in 1989 and in 1990 is the average reasonable charge in the area for the rental of the item or device for the 12-month period ending with June 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987; (ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991; (iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and (iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year. (C) Computation of local payment amount and national limited payment amount.--For purposes of subparagraph (B)-- (i) the local payment amount for an item or device for a year is equal to-- (I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and (II) for 1992, 1993, and 1994 the amount determined under this clause for the preceding year increased by the covered item update for the year; and (ii) the national limited payment amount for an item or device for a year is equal to-- (I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item, (II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year, (III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and (IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year. (4) Payment for certain customized items.--Payment with respect to a covered item that is uniquely constructed or substantially modified to meet the specific needs of an individual patient, and for that reason cannot be grouped with similar items for purposes of payment under this title, shall be made in a lump-sum amount (A) for the purchase of the item in a payment amount based upon the carrier's individual consideration for that item, and (B) for the reasonable and necessary maintenance and servicing for parts and labor not covered by the supplier's or manufacturer's warranty, when necessary during the period of medical need, and the amount recognized for such maintenance and servicing shall be paid on a lump-sum, as needed basis based upon the carrier's individual consideration for that item. In the case of a wheelchair furnished on or after January 1, 1992, the wheelchair shall be treated as a customized item for purposes of this paragraph if the wheelchair has been measured, fitted, or adapted in consideration of the patient's body size, disability, period of need, or intended use, and has been assembled by a supplier or ordered from a manufacturer who makes available customized features, modifications, or components for wheelchairs that are intended for an individual patient's use in accordance with instructions from the patient's physician. (5) Payment for oxygen and oxygen equipment.-- (A) In general.--Payment for oxygen and oxygen equipment shall be made on a monthly basis in the monthly payment amount recognized under paragraph (9) for oxygen and oxygen equipment (other than portable oxygen equipment), subject to subparagraphs (B), (C), (E), and (F). (B) Add-on for portable oxygen equipment.-- When portable oxygen equipment is used, but subject to subparagraph (D), the payment amount recognized under subparagraph (A) shall be increased by the monthly payment amount recognized under paragraph (9) for portable oxygen equipment. (C) Volume adjustment.--When the attending physician prescribes an oxygen flow rate-- (i) exceeding 4 liters per minute, the payment amount recognized under subparagraph (A), subject to subparagraph (D), shall be increased by 50 percent, or (ii) of less than 1 liter per minute, the payment amount recognized under subparagraph (A) shall be decreased by 50 percent. (D) Limit on adjustment.--When portable oxygen equipment is used and the attending physician prescribes an oxygen flow rate exceeding 4 liters per minute, there shall only be an increase under either subparagraph (B) or (C), whichever increase is larger, and not under both such subparagraphs. (E) Recertification for patients receiving home oxygen therapy.--In the case of a patient receiving home oxygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pressure of 56 or an arterial oxygen saturation at or above 89 percent (or such other values, pressures, or criteria as the Secretary may specify) no payment may be made under this part for such services after the expiration of the 90-day period that begins on the date the patient first receives such services unless the patient's attending physician certifies that, on the basis of a follow-up test of the patient's arterial blood gas value or arterial oxygen saturation conducted during the final 30 days of such 90- day period, there is a medical need for the patient to continue to receive such services. (F) Rental Cap.-- (i) In general.--Payment for oxygen equipment (including portable oxygen equipment) under this paragraph may not extend over a period of continuous use (as determined by the Secretary) of longer than 36 months. (ii) Payments and rules after rental cap.--After the 36th continuous month during which payment is made for the equipment under this paragraph-- (I) the supplier furnishing such equipment under this subsection shall continue to furnish the equipment during any period of medical need for the remainder of the reasonable useful lifetime of the equipment, as determined by the Secretary; (II) payments for oxygen shall continue to be made in the amount recognized for oxygen under paragraph (9) for the period of medical need; and (III) maintenance and servicing payments shall, if the Secretary determines such payments are reasonable and necessary, be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the equipment), and such payments shall be in an amount determined to be appropriate by the Secretary. (6) Payment for other covered items (other than durable medical equipment).--Payment for other covered items (other than durable medical equipment and other covered items described in paragraph (3), (4), or (5)) shall be made in a lump-sum amount for the purchase of the item in the amount of the purchase price recognized under paragraph (8). (7) Payment for other items of durable medical equipment.-- (A) Payment.--In the case of an item of durable medical equipment not described in paragraphs (2) through (6), the following rules shall apply: (i) Rental.-- (I) In general.--Except as provided in clause (iii), payment for the item shall be made on a monthly basis for the rental of the item during the period of medical need (but payments under this clause may not extend over a period of continuous use (as determined by the Secretary) of longer than 13 months). (II) Payment amount.--Subject to subclause (III) and subparagraph (B), the amount recognized for the item, for each of the first 3 months of such period, is 10 percent of the purchase price recognized under paragraph (8) with respect to the item, and, for each of the remaining months of such period, is 7.5 percent of such purchase price. (III) Special rule for power- driven wheelchairs.--For purposes of payment for power- driven wheelchairs, subclause (II) shall be applied by substituting ``15 percent'' and ``6 percent'' for ``10 percent'' and ``7.5 percent'', respectively. (ii) Ownership after rental.--On the first day that begins after the 13th continuous month during which payment is made for the rental of an item under clause (i), the supplier of the item shall transfer title to the item to the individual. (iii) Purchase agreement option for complex, rehabilitative power-driven wheelchairs.--In the case of a complex, rehabilitative power-driven wheelchair, at the time the supplier furnishes the item, the supplier shall offer the individual the option to purchase the item, and payment for such item shall be made on a lump-sum basis if the individual exercises such option. (iv) Maintenance and servicing.-- After the supplier transfers title to the item under clause (ii) or in the case of a power-driven wheelchair for which a purchase agreement has been entered into under clause (iii), maintenance and servicing payments shall, if the Secretary determines such payments are reasonable and necessary, be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the particular type of durable medical equipment), and such payments shall be in an amount determined to be appropriate by the Secretary. (B) Range for rental amounts.-- (i) For 1989.--For items furnished during 1989, the payment amount recognized under subparagraph (A)(i) shall not be more than 115 percent, and shall not be less than 85 percent, of the prevailing charge established for rental of the item in January 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987. (ii) For 1990.--For items furnished during 1990, clause (i) shall apply in the same manner as it applies to items furnished during 1989. (C) Replacement of items.-- (i) Establishment of reasonable useful lifetime.--In accordance with clause (iii), the Secretary shall determine and establish a reasonable useful lifetime for items of durable medical equipment for which payment may be made under this paragraph. (ii) Payment for replacement items.-- If the reasonable lifetime of such an item, as so established, has been reached during a continuous period of medical need, or the carrier determines that the item is lost or irreparably damaged, the patient may elect to have payment for an item serving as a replacement for such item made-- (I) on a monthly basis for the rental of the replacement item in accordance with subparagraph (A); or (II) in the case of an item for which a purchase agreement has been entered into under subparagraph (A)(iii), in a lump-sum amount for the purchase of the item. (iii) Length of reasonable useful lifetime.--The reasonable useful lifetime of an item of durable medical equipment under this subparagraph shall be equal to 5 years, except that, if the Secretary determines that, on the basis of prior experience in making payments for such an item under this title, a reasonable useful lifetime of 5 years is not appropriate with respect to a particular item, the Secretary shall establish an alternative reasonable lifetime for such item. (8) Purchase price recognized for miscellaneous devices and items.--For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for a covered item is the amount described in subparagraph (C) of this paragraph, determined as follows: (A) Computation of local purchase price.-- Each carrier under section 1842 shall compute a base local purchase price for the item as follows: (i) The carrier shall compute a base local purchase price, for each item described-- (I) in paragraph (6) equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987, or (II) in paragraph (7) equal to the average of the purchase prices on the claims submitted on an assignment-related basis for the unused item supplied during the 6-month period ending with December 1986. (ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item-- (I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6- month period ending with December 1987, (II) in 1991, equal to the local purchase price computed under this clause for the previous year, increased by the covered item update for 1991, and decreased by the percentage by which the average of the reasonable charges for claims paid for all items described in paragraph (7) is lower than the average of the purchase prices submitted for such items during the final 9 months of 1988; or (III) in 1992, 1993, and 1994 equal to the local purchase price computed under this clause for the previous year increased by the covered item update for the year. (B) Computation of national limited purchase price.--With respect to the furnishing of a particular item in a year, the Secretary shall compute a national limited purchase price-- (i) for 1991, equal to the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year; (ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year; (iii) for 1994, the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the median of all local purchase prices computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local purchase prices computed under such subparagraph for the item for the year; and (iv) for each subsequent year, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year. (C) Purchase price recognized.--For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for each item furnished-- (i) in 1989 or 1990, is 100 percent of the local purchase price computed under subparagraph (A)(ii)(I); (ii) in 1991, is the sum of (I) 67 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1991, and (II) 33 percent of the national limited purchase price computed under subparagraph (B) for 1991; (iii) in 1992, is the sum of (I) 33 percent of the local purchase price computed under subparagraph (A)(ii)(III) for 1992, and (II) 67 percent of the national limited purchase price computed under subparagraph (B) for 1992; and (iv) in 1993 or a subsequent year, is the national limited purchase price computed under subparagraph (B) for that year. (9) Monthly payment amount recognized with respect to oxygen and oxygen equipment.--For purposes of paragraph (5), the amount that is recognized under this paragraph for payment for oxygen and oxygen equipment is the monthly payment amount described in subparagraph (C) of this paragraph. Such amount shall be computed separately (i) for all items of oxygen and oxygen equipment (other than portable oxygen equipment) and (ii) for portable oxygen equipment (each such group referred to in this paragraph as an ``item''). (A) Computation of local monthly payment rate.--Each carrier under this section shall compute a base local payment rate for each item as follows: (i) The carrier shall compute a base local average monthly payment rate per beneficiary as an amount equal to (I) the total reasonable charges for the item during the 12-month period ending with December 1986, divided by (II) the total number of months for all beneficiaries receiving the item in the area during the 12-month period for which the carrier made payment for the item under this title. (ii) The carrier shall compute a local average monthly payment rate for the item applicable-- (I) to 1989 and 1990, equal to 95 percent of the base local average monthly payment rate computed under clause (i) for the item increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987, or (II) to 1991, 1992, 1993, and 1994 equal to the local average monthly payment rate computed under this clause for the item for the previous year increased by the covered item increase for the year. (B) Computation of national limited monthly payment rate.--With respect to the furnishing of an item in a year, the Secretary shall compute a national limited monthly payment rate equal to-- (i) for 1991, the local monthly payment rate computed under subparagraph (A)(ii)(II) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year; (ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year; (iii) for 1994, the local monthly payment rate computed under subparagraph (A)(ii) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year; (iv) for 1995, 1996, and 1997, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year; (v) for 1998, 75 percent of the amount determined under this subparagraph for 1997; and (vi) for 1999 and each subsequent year, 70 percent of the amount determined under this subparagraph for 1997. (C) Monthly payment amount recognized.--For purposes of paragraph (5), the amount that is recognized under this paragraph as the base monthly payment amount for each item furnished-- (i) in 1989 and in 1990, is 100 percent of the local average monthly payment rate computed under subparagraph (A)(ii) for the item; (ii) in 1991, is the sum of (I) 67 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1991, and (II) 33 percent of the national limited monthly payment rate computed under subparagraph (B)(i) for the item for 1991; (iii) in 1992, is the sum of (I) 33 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1992, and (II) 67 percent of the national limited monthly payment rate computed under subparagraph (B)(ii) for the item for 1992; and (iv) in a subsequent year, is the national limited monthly payment rate computed under subparagraph (B) for the item for that year. (10) Exceptions and adjustments.-- (A) Areas outside continental united states.--Exceptions to the amounts recognized under the previous provisions of this subsection shall be made to take into account the unique circumstances of covered items furnished in Alaska, Hawaii, or Puerto Rico. (B) Adjustment for inherent reasonableness.-- The Secretary is authorized to apply the provisions of paragraphs (8) and (9) of section 1842(b) to covered items and suppliers of such items and payments under this subsection in an area and with respect to covered items and services for which the Secretary does not make a payment amount adjustment under paragraph (1)(F). (C) Transcutaneous electrical nerve stimulator (tens).--In order to permit an attending physician time to determine whether the purchase of a transcutaneous electrical nerve stimulator is medically appropriate for a particular patient, the Secretary may determine an appropriate payment amount for the initial rental of such item for a period of not more than 2 months. If such item is subsequently purchased, the payment amount with respect to such purchase is the payment amount determined under paragraph (2). (11) Improper billing and requirement of physician order.-- (A) Improper billing for certain rental items.--Notwithstanding any other provision of this title, a supplier of a covered item for which payment is made under this subsection and which is furnished on a rental basis shall continue to supply the item without charge (other than a charge provided under this subsection for the maintenance and servicing of the item) after rental payments may no longer be made under this subsection. If a supplier knowingly and willfully violates the previous sentence, the Secretary may apply sanctions against the supplier under section 1842(j)(2) in the same manner such sanctions may apply with respect to a physician. (B) Requirement of physician order.-- (i) In general.--The Secretary is authorized to require, for specified covered items, that payment may be made under this subsection with respect to the item only if a physician enrolled under section 1866(j) or an eligible professional under section 1848(k)(3)(B) that is enrolled under section 1866(j) has communicated to the supplier, before delivery of the item, a written order for the item. (ii) Requirement for face to face encounter.--The Secretary shall require that such an order be written pursuant to a physician, a physician assistant, a nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) documenting such physician, physician assistant, practitioner, or specialist has had a face-to-face encounter (including through use of telehealth under subsection (m) and other than with respect to encounters that are incident to services involved) with the individual involved during the 6-month period preceding such written order, or other reasonable timeframe as determined by the Secretary. (12) Regional carriers.--The Secretary may designate, by regulation under section 1842, one carrier for one or more entire regions to process all claims within the region for covered items under this section. (13) Covered item.--In this subsection, the term ``covered item'' means durable medical equipment (as defined in section 1861(n)), including such equipment described in section 1861(m)(5), but not including implantable items for which payment may be made under section 1833(t). (14) Covered item update.--In this subsection, the term ``covered item update'' means, with respect to a year-- (A) for 1991 and 1992, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12- month period ending with June of the previous year reduced by 1 percentage point; (B) for 1993, 1994, 1995, 1996, and 1997, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year; (C) for each of the years 1998 through 2000, 0 percentage points; (D) for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000; (E) for 2002, 0 percentage points; (F) for 2003, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of 2002; (G) for 2004 through 2006-- (i) subject to clause (ii), in the case of class III medical devices described in section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(c)(1)(C)), the percentage increase described in subparagraph (B) for the year involved; and (ii) in the case of covered items not described in clause (i), 0 percentage points; (H) for 2007-- (i) subject to clause (ii), in the case of class III medical devices described in section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(c)(1)(C)), the percentage change determined by the Secretary to be appropriate taking into account recommendations contained in the report of the Comptroller General of the United States under section 302(c)(1)(B) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; and (ii) in the case of covered items not described in clause (i), 0 percentage points; (I) for 2008-- (i) subject to clause (ii), in the case of class III medical devices described in section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(c)(1)(C)), the percentage increase described in subparagraph (B) (as applied to the payment amount for 2007 determined after the application of the percentage change under subparagraph (H)(i)); and (ii) in the case of covered items not described in clause (i), 0 percentage points; (J) for 2009-- (i) in the case of items and services furnished in any geographic area, if such items or services were selected for competitive acquisition in any area under the competitive acquisition program under section 1847(a)(1)(B)(i)(I) before July 1, 2008, including related accessories but only if furnished with such items and services selected for such competition and diabetic supplies but only if furnished through mail order, - 9.5 percent; or (ii) in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2008; (K) for 2010, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year; and (L) for 2011 and each subsequent year-- (i) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year, reduced by-- (ii) the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of subparagraph (L)(ii) may result in the covered item update under this paragraph being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year. (15) Advance determinations of coverage for certain items.-- (A) Development of lists of items by secretary.--The Secretary may develop and periodically update a list of items for which payment may be made under this subsection that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization throughout a carrier's entire service area or a portion of such area. (B) Development of lists of suppliers by secretary.--The Secretary may develop and periodically update a list of suppliers of items for which payment may be made under this subsection with respect to whom-- (i) the Secretary has found that a substantial number of claims for payment under this part for items furnished by the supplier have been denied on the basis of the application of section 1862(a)(1); or (ii) the Secretary has identified a pattern of overutilization resulting from the business practice of the supplier. (C) Determinations of coverage in advance.--A carrier shall determine in advance of delivery of an item whether payment for the item may not be made because the item is not covered or because of the application of section 1862(a)(1) if-- (i) the item is included on the list developed by the Secretary under subparagraph (A); (ii) the item is furnished by a supplier included on the list developed by the Secretary under subparagraph (B); or (iii) the item is a customized item (other than inexpensive items specified by the Secretary) and the patient to whom the item is to be furnished or the supplier requests that such advance determination be made. (16) Disclosure of information and surety bond.--The Secretary shall not provide for the issuance (or renewal) of a provider number for a supplier of durable medical equipment, for purposes of payment under this part for durable medical equipment furnished by the supplier, unless the supplier provides the Secretary on a continuing basis-- (A) with-- (i) full and complete information as to the identity of each person with an ownership or control interest (as defined in section 1124(a)(3)) in the supplier or in any subcontractor (as defined by the Secretary in regulations) in which the supplier directly or indirectly has a 5 percent or more ownership interest; and (ii) to the extent determined to be feasible under regulations of the Secretary, the name of any disclosing entity (as defined in section 1124(a)(2)) with respect to which a person with such an ownership or control interest in the supplier is a person with such an ownership or control interest in the disclosing entity; and (B) with a surety bond in a form specified by the Secretary and in an amount that is not less than $50,000 that the Secretary determines is commensurate with the volume of the billing of the supplier. The Secretary may waive the requirement of a bond under subparagraph (B) in the case of a supplier that provides a comparable surety bond under State law. The Secretary, at the Secretary's discretion, may impose the requirements of the first sentence with respect to some or all providers of items or services under part A or some or all suppliers or other persons (other than physicians or other practitioners, as defined in section 1842(b)(18)(C)) who furnish items or services under this part. (17) Prohibition against unsolicited telephone contacts by suppliers.-- (A) In general.--A supplier of a covered item under this subsection may not contact an individual enrolled under this part by telephone regarding the furnishing of a covered item to the individual unless 1 of the following applies: (i) The individual has given written permission to the supplier to make contact by telephone regarding the furnishing of a covered item. (ii) The supplier has furnished a covered item to the individual and the supplier is contacting the individual only regarding the furnishing of such covered item. (iii) If the contact is regarding the furnishing of a covered item other than a covered item already furnished to the individual, the supplier has furnished at least 1 covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact. (B) Prohibiting payment for items furnished subsequent to unsolicited contacts.--If a supplier knowingly contacts an individual in violation of subparagraph (A), no payment may be made under this part for any item subsequently furnished to the individual by the supplier. (C) Exclusion from program for suppliers engaging in pattern of unsolicited contacts.-- If a supplier knowingly contacts individuals in violation of subparagraph (A) to such an extent that the supplier's conduct establishes a pattern of contacts in violation of such subparagraph, the Secretary shall exclude the supplier from participation in the programs under this Act, in accordance with the procedures set forth in subsections (c), (f), and (g) of section 1128. (18) Refund of amounts collected for certain disallowed items.-- (A) In general.--If a nonparticipating supplier furnishes to an individual enrolled under this part a covered item for which no payment may be made under this part by reason of paragraph (17)(B), the supplier shall refund on a timely basis to the patient (and shall be liable to the patient for) any amounts collected from the patient for the item, unless-- (i) the supplier establishes that the supplier did not know and could not reasonably have been expected to know that payment may not be made for the item by reason of paragraph (17)(B), or (ii) before the item was furnished, the patient was informed that payment under this part may not be made for that item and the patient has agreed to pay for that item. (B) Sanctions.--If a supplier knowingly and willfully fails to make refunds in violation of subparagraph (A), the Secretary may apply sanctions against the supplier in accordance with section 1842(j)(2). (C) Notice.--Each carrier with a contract in effect under this part with respect to suppliers of covered items shall send any notice of denial of payment for covered items by reason of paragraph (17)(B) and for which payment is not requested on an assignment- related basis to the supplier and the patient involved. (D) Timely basis defined.--A refund under subparagraph (A) is considered to be on a timely basis only if-- (i) in the case of a supplier who does not request reconsideration or seek appeal on a timely basis, the refund is made within 30 days after the date the supplier receives a denial notice under subparagraph (C), or (ii) in the case in which such a reconsideration or appeal is taken, the refund is made within 15 days after the date the supplier receives notice of an adverse determination on reconsideration or appeal. (19) Certain upgraded items.-- (A) Individual's right to choose upgraded item.--Notwithstanding any other provision of this title, the Secretary may issue regulations under which an individual may purchase or rent from a supplier an item of upgraded durable medical equipment for which payment would be made under this subsection if the item were a standard item. (B) Payments to supplier.--In the case of the purchase or rental of an upgraded item under subparagraph (A)-- (i) the supplier shall receive payment under this subsection with respect to such item as if such item were a standard item; and (ii) the individual purchasing or renting the item shall pay the supplier an amount equal to the difference between the supplier's charge and the amount under clause (i). In no event may the supplier's charge for an upgraded item exceed the applicable fee schedule amount (if any) for such item. (C) Consumer protection safeguards.--Any regulations under subparagraph (A) shall provide for consumer protection standards with respect to the furnishing of upgraded equipment under subparagraph (A). Such regulations shall provide for-- (i) determination of fair market prices with respect to an upgraded item; (ii) full disclosure of the availability and price of standard items and proof of receipt of such disclosure information by the beneficiary before the furnishing of the upgraded item; (iii) conditions of participation for suppliers in the billing arrangement; (iv) sanctions of suppliers who are determined to engage in coercive or abusive practices, including exclusion; and (v) such other safeguards as the Secretary determines are necessary. (20) Identification of quality standards.-- (A) In general.--Subject to subparagraph (C), the Secretary shall establish and implement quality standards for suppliers of items and services described in subparagraph (D) to be applied by recognized independent accreditation organizations (as designated under subparagraph (B)) and with which such suppliers shall be required to comply in order to-- (i) furnish any such item or service for which payment is made under this part; and (ii) receive or retain a provider or supplier number used to submit claims for reimbursement for any such item or service for which payment may be made under this title. (B) Designation of independent accreditation organizations.--Not later than the date that is 1 year after the date on which the Secretary implements the quality standards under subparagraph (A), notwithstanding section 1865(a), the Secretary shall designate and approve one or more independent accreditation organizations for purposes of such subparagraph. (C) Quality standards.--The quality standards described in subparagraph (A) may not be less stringent than the quality standards that would otherwise apply if this paragraph did not apply and shall include consumer services standards. (D) Items and services described.--The items and services described in this subparagraph are the following items and services, as the Secretary determines appropriate: (i) Covered items (as defined in paragraph (13)) for which payment may otherwise be made under this subsection. (ii) Prosthetic devices and orthotics and prosthetics described in section 1834(h)(4). (iii) Items and services described in section 1842(s)(2). (E) Implementation.--The Secretary may establish by program instruction or otherwise the quality standards under this paragraph, including subparagraph (F), after consultation with representatives of relevant parties. Such standards shall be applied prospectively and shall be published on the Internet website of the Centers for Medicare & Medicaid Services. (F) Application of accreditation requirement.--In implementing quality standards under this paragraph-- (i) subject to clause (ii) and subparagraph (G), the Secretary shall require suppliers furnishing items and services described in subparagraph (D) on or after October 1, 2009, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (B) as meeting applicable quality standards, except that the Secretary shall not require under this clause pharmacies to obtain such accreditation before January 1, 2010, except that the Secretary shall not require a pharmacy to have submitted to the Secretary such evidence of accreditation prior to January 1, 2011; and (ii) in applying such standards and the accreditation requirement of clause (i) with respect to eligible professionals (as defined in section 1848(k)(3)(B)), and including such other persons, such as orthotists and prosthetists, as specified by the Secretary, furnishing such items and services-- (I) such standards and accreditation requirement shall not apply to such professionals and persons unless the Secretary determines that the standards being applied are designed specifically to be applied to such professionals and persons; and (II) the Secretary may exempt such professionals and persons from such standards and requirement if the Secretary determines that licensing, accreditation, or other mandatory quality requirements apply to such professionals and persons with respect to the furnishing of such items and services. (G) Application of accreditation requirement to certain pharmacies.-- (i) In general.--With respect to items and services furnished on or after January 1, 2011, in implementing quality standards under this paragraph-- (I) subject to subclause (II), in applying such standards and the accreditation requirement of subparagraph (F)(i) with respect to pharmacies described in clause (ii) furnishing such items and services, such standards and accreditation requirement shall not apply to such pharmacies; and (II) the Secretary may apply to such pharmacies an alternative accreditation requirement established by the Secretary if the Secretary determines such alternative accreditation requirement is more appropriate for such pharmacies. (ii) Pharmacies described.--A pharmacy described in this clause is a pharmacy that meets each of the following criteria: (I) The total billings by the pharmacy for such items and services under this title are less than 5 percent of total pharmacy sales, as determined based on the average total pharmacy sales for the previous 3 calendar years, 3 fiscal years, or other yearly period specified by the Secretary. (II) The pharmacy has been enrolled under section 1866(j) as a supplier of durable medical equipment, prosthetics, orthotics, and supplies, has been issued (which may include the renewal of) a provider number for at least 5 years, and for which a final adverse action (as defined in section 424.57(a) of title 42, Code of Federal Regulations) has not been imposed in the past 5 years. (III) The pharmacy submits to the Secretary an attestation, in a form and manner, and at a time, specified by the Secretary, that the pharmacy meets the criteria described in subclauses (I) and (II). Such attestation shall be subject to section 1001 of title 18, United States Code. (IV) The pharmacy agrees to submit materials as requested by the Secretary, or during the course of an audit conducted on a random sample of pharmacies selected annually, to verify that the pharmacy meets the criteria described in subclauses (I) and (II). Materials submitted under the preceding sentence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods, as requested by the Secretary. (21) Special payment rule for specified items and supplies.-- (A) In general.--Notwithstanding the preceding provisions of this subsection, for specified items and supplies (described in subparagraph (B)) furnished during 2005, the payment amount otherwise determined under this subsection for such specified items and supplies shall be reduced by the percentage difference between-- (i) the amount of payment otherwise determined for the specified item or supply under this subsection for 2002, and (ii) the amount of payment for the specified item or supply under chapter 89 of title 5, United States Code, as identified in the column entitled ``Median FEHP Price'' in the table entitled ``SUMMARY OF MEDICARE PRICES COMPARED TO VA, MEDICAID, RETAIL, AND FEHP PRICES FOR 16 ITEMS'' included in the Testimony of the Inspector General before the Senate Committee on Appropriations, June 12, 2002, or any subsequent report by the Inspector General. (B) Specified item or supply described.--For purposes of subparagraph (A), a specified item or supply means oxygen and oxygen equipment, standard wheelchairs (including standard power wheelchairs), nebulizers, diabetic supplies consisting of lancets and testing strips, hospital beds, and air mattresses, but only if the HCPCS code for the item or supply is identified in a table referred to in subparagraph (A)(ii). (C) Application of update to special payment amount.--The covered item update under paragraph (14) for specified items and supplies for 2006 and each subsequent year shall be applied to the payment amount under subparagraph (A) unless payment is made for such items and supplies under section 1847. (22) Special payment rule for diabetic supplies.-- Notwithstanding the preceding provisions of this subsection, for purposes of determining the payment amount under this subsection for diabetic supplies furnished on or after the first day of the calendar quarter during 2013 that is at least 30 days after the date of the enactment of this paragraph and before the date described in paragraph (1)(H)(ii), the Secretary shall recalculate and apply the covered item update under paragraph (14) as if subparagraph (J)(i) of such paragraph was amended by striking ``but only if furnished through mail order''. (b) Fee Schedules for Radiologist Services.-- (1) Development.--The Secretary shall develop-- (A) a relative value scale to serve as the basis for the payment for radiologist services under this part, and (B) using such scale and appropriate conversion factors and subject to subsection (c)(1)(A), fee schedules (on a regional, statewide, locality, or carrier service area basis) for payment for radiologist services under this part, to be implemented for such services furnished during 1989. (2) Consultation.--In carrying out paragraph (1), the Secretary shall regularly consult closely with the Physician Payment Review Commission, the American College of Radiology, and other organizations representing physicians or suppliers who furnish radiologist services and shall share with them the data and data analysis being used to make the determinations under paragraph (1), including data on variations in current medicare payments by geographic area, and by service and physician specialty. (3) Considerations.--In developing the relative value scale and fee schedules under paragraph (1), the Secretary-- (A) shall take into consideration variations in the cost of furnishing such services among geographic areas and among different sites where services are furnished, and (B) may also take into consideration such other factors respecting the manner in which physicians in different specialties furnish such services as may be appropriate to assure that payment amounts are equitable and designed to promote effective and efficient provision of radiologist services by physicians in the different specialties. (4) Savings.-- (A) Budget neutral fee schedules.--The Secretary shall develop preliminary fee schedules for 1989, which are designed to result in the same amount of aggregate payments (net of any coinsurance and deductibles under sections 1833(a)(1)(J) and 1833(b)) for radiologist services furnished in 1989 as would have been made if this subsection had not been enacted. (B) Initial savings.--The fee schedules established for payment purposes under this subsection for services furnished in 1989 shall be 97 percent of the amounts permitted under these preliminary fee schedules developed under subparagraph (A). (C) 1990 fee schedules.--For radiologist services (other than portable X-ray services) furnished under this part during 1990, after March 31 of such year, the conversion factors used under this subsection shall be 96 percent of the conversion factors that applied under this subsection as of December 31, 1989. (D) 1991 fee schedules.--For radiologist services (other than portable X-ray services) furnished under this part during 1991, the conversion factors used in a locality under this subsection shall, subject to clause (vii), be reduced to the adjusted conversion factor for the locality determined as follows: (i) National weighted average conversion factor.--The Secretary shall estimate the national weighted average of the conversion factors used under this subsection for services furnished during 1990 beginning on April 1, using the best available data. (ii) Reduced national weighted average.--The national weighted average estimated under clause (i) shall be reduced by 13 percent. (iii) Computation of 1990 locality index relative to national average.-- The Secretary shall establish an index which reflects, for each locality, the ratio of the conversion factor used in the locality under this subsection to the national weighted average estimated under clause (i). (iv) Adjusted conversion factor.--The adjusted conversion factor for the professional or technical component of a service in a locality is the sum of \1/2\ of the locally-adjusted amount determined under clause (v) and \1/2\ of the GPCI-adjusted amount determined under clause (vi). (v) Locally-adjusted amount.--For purposes of clause (iv), the locally adjusted amount determined under this clause is the product of (I) the national weighted average conversion factor computed under clause (ii), and (II) the index value established under clause (iii) for the locality. (vi) GPCI-adjusted amount.--For purposes of clause (iv), the GPCI- adjusted amount determined under this clause is the sum of-- (I) the product of (a) the portion of the reduced national weighted average conversion factor computed under clause (ii) which is attributable to physician work and (b) the geographic work index value for the locality (specified in Addendum C to the Model Fee Schedule for Physician Services (published on September 4, 1990, 55 Federal Register pp. 36238-36243)); and (II) the product of (a) the remaining portion of the reduced national weighted average conversion factor computed under clause (ii), and (b) the geographic practice cost index value specified in section 1842(b)(14)(C)(iv) for the locality. In applying this clause with respect to the professional component of a service, 80 percent of the conversion factor shall be considered to be attributable to physician work and with respect to the technical component of the service, 0 percent shall be considered to be attributable to physician work. (vii) Limits on conversion factor.-- The conversion factor to be applied to a locality to the professional or technical component of a service shall not be reduced under this subparagraph by more than 9.5 percent below the conversion factor applied in the locality under subparagraph (C) to such component, but in no case shall the conversion factor be less than 60 percent of the national weighted average of the conversion factors (computed under clause (i)). (E) Rule for certain scanning services.--In the case of the technical components of magnetic resonance imaging (MRI) services and computer assisted tomography (CAT) services furnished after December 31, 1990, the amount otherwise payable shall be reduced by 10 percent. (F) Subsequent updating.--For radiologist services furnished in subsequent years, the fee schedules shall be the schedules for the previous year updated by the percentage increase in the MEI (as defined in section 1842(i)(3)) for the year. (G) Nonparticipating physicians and suppliers.--Each fee schedule so established shall provide that the payment rate recognized for nonparticipating physicians and suppliers is equal to the appropriate percent (as defined in section 1842(b)(4)(A)(iv)) of the payment rate recognized for participating physicians and suppliers. (5) Limiting charges of nonparticipating physicians and suppliers.-- (A) In general.--In the case of radiologist services furnished after January 1, 1989, for which payment is made under a fee schedule under this subsection, if a nonparticipating physician or supplier furnishes the service to an individual entitled to benefits under this part, the physician or supplier may not charge the individual more than the limiting charge (as defined in subparagraph (B)). (B) Limiting charge defined.--In subparagraph (A), the term ``limiting charge'' means, with respect to a service furnished-- (i) in 1989, 125 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1), (ii) in 1990, 120 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1), and (iii) after 1990, 115 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1). (C) Enforcement.--If a physician or supplier knowingly and willfully bills in violation of subparagraph (A), the Secretary may apply sanctions against such physician or supplier in accordance with section 1842(j)(2) in the same manner as such sanctions may apply to a physician. (6) Radiologist services defined.--For the purposes of this subsection and section 1833(a)(1)(J), the term ``radiologist services'' only includes radiology services performed by, or under the direction or supervision of, a physician-- (A) who is certified, or eligible to be certified, by the American Board of Radiology, or (B) for whom radiology services account for at least 50 percent of the total amount of charges made under this part. (c) Payment and Standards for Screening Mammography.-- (1) In general.--With respect to expenses incurred for screening mammography (as defined in section 1861(jj)), payment may be made only-- (A) for screening mammography conducted consistent with the frequency permitted under paragraph (2); and (B) if the screening mammography is conducted by a facility that has a certificate (or provisional certificate) issued under section 354 of the Public Health Service Act. (2) Frequency covered.-- (A) In general.--Subject to revision by the Secretary under subparagraph (B)-- (i) no payment may be made under this part for screening mammography performed on a woman under 35 years of age; (ii) payment may be made under this part for only one screening mammography performed on a woman over 34 years of age, but under 40 years of age; and (iii) in the case of a woman over 39 years of age, payment may not be made under this part for screening mammography performed within 11 months following the month in which a previous screening mammography was performed. (B) Revision of frequency.-- (i) Review.--The Secretary, in consultation with the Director of the National Cancer Institute, shall review periodically the appropriate frequency for performing screening mammography, based on age and such other factors as the Secretary believes to be pertinent. (ii) Revision of frequency.--The Secretary, taking into consideration the review made under clause (i), may revise from time to time the frequency with which screening mammography may be paid for under this subsection. (d) Frequency Limits and Payment for Colorectal Cancer Screening Tests.-- (1) Screening fecal-occult blood tests.-- (A) Payment amount.--The payment amount for colorectal cancer screening tests consisting of screening fecal-occult blood tests is equal to the payment amount established for diagnostic fecal-occult blood tests under section 1833(h). (B) Frequency limit.--No payment may be made under this part for a colorectal cancer screening test consisting of a screening fecal- occult blood test-- (i) if the individual is under 50 years of age; or (ii) if the test is performed within the 11 months after a previous screening fecal-occult blood test. (2) Screening flexible sigmoidoscopies.-- (A) Fee schedule.--With respect to colorectal cancer screening tests consisting of screening flexible sigmoidoscopies, payment under section 1848 shall be consistent with payment under such section for similar or related services. (B) Payment limit.--In the case of screening flexible sigmoidoscopy services, payment under this part shall not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic flexible sigmoidoscopy services. (C) Facility payment limit.-- (i) In general.--Notwithstanding subsections (i)(2)(A) and (t) of section 1833, in the case of screening flexible sigmoidoscopy services furnished on or after January 1, 1999, that-- (I) in accordance with regulations, may be performed in an ambulatory surgical center and for which the Secretary permits ambulatory surgical center payments under this part, and (II) are performed in an ambulatory surgical center or hospital outpatient department, payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area. (ii) Limitation on coinsurance.-- Notwithstanding any other provision of this title, in the case of a beneficiary who receives the services described in clause (i)-- (I) in computing the amount of any applicable copayment, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and (II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I). (D) Special rule for detected lesions.--If during the course of such screening flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening flexible sigmoidoscopy but shall be made for the procedure classified as a flexible sigmoidoscopy with such biopsy or removal. (E) Frequency limit.--No payment may be made under this part for a colorectal cancer screening test consisting of a screening flexible sigmoidoscopy-- (i) if the individual is under 50 years of age; or (ii) if the procedure is performed within the 47 months after a previous screening flexible sigmoidoscopy or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is performed within the 119 months after a previous screening colonoscopy. (3) Screening colonoscopy.-- (A) Fee schedule.--With respect to colorectal cancer screening test consisting of a screening colonoscopy, payment under section 1848 shall be consistent with payment amounts under such section for similar or related services. (B) Payment limit.--In the case of screening colonoscopy services, payment under this part shall not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic colonoscopy services. (C) Facility payment limit.-- (i) In general.--Notwithstanding subsections (i)(2)(A) and (t) of section 1833, in the case of screening colonoscopy services furnished on or after January 1, 1999, that are performed in an ambulatory surgical center or a hospital outpatient department, payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area. (ii) Limitation on coinsurance.-- Notwithstanding any other provision of this title, in the case of a beneficiary who receives the services described in clause (i)-- (I) in computing the amount of any applicable coinsurance, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and (II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I). (D) Special rule for detected lesions.--If during the course of such screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal. (E) Frequency limit.--No payment may be made under this part for a colorectal cancer screening test consisting of a screening colonoscopy for individuals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a previous screening flexible sigmoidoscopy. (e) Accreditation Requirement for Advanced Diagnostic Imaging Services.-- (1) In general.-- (A) In general.--Beginning with January 1, 2012, with respect to the technical component of advanced diagnostic imaging services for which payment is made under the fee schedule established under section 1848(b) and that are furnished by a supplier, payment may only be made if such supplier is accredited by an accreditation organization designated by the Secretary under paragraph (2)(B)(i). (B) Advanced diagnostic imaging services defined.--In this subsection, the term ``advanced diagnostic imaging services'' includes-- (i) diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and (ii) such other diagnostic imaging services, including services described in section 1848(b)(4)(B) (excluding X- ray, ultrasound, and fluoroscopy), as specified by the Secretary in consultation with physician specialty organizations and other stakeholders. (C) Supplier defined.--In this subsection, the term ``supplier'' has the meaning given such term in section 1861(d). (2) Accreditation organizations.-- (A) Factors for designation of accreditation organizations.--The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B)(i) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C): (i) The ability of the organization to conduct timely reviews of accreditation applications. (ii) Whether the organization has established a process for the timely integration of new advanced diagnostic imaging services into the organization's accreditation program. (iii) Whether the organization uses random site visits, site audits, or other strategies for ensuring accredited suppliers maintain adherence to the criteria described in paragraph (3). (iv) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D)). (v) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation. (vi) Such other factors as the Secretary determines appropriate. (B) Designation.--Not later than January 1, 2010, the Secretary shall designate organizations to accredit suppliers furnishing the technical component of advanced diagnostic imaging services. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C). (C) Review and modification of list of accreditation organizations.-- (i) In general.--The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B). (ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations.--In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect. (3) Criteria for accreditation.--The Secretary shall establish procedures to ensure that the criteria used by an accreditation organization designated under paragraph (2)(B) to evaluate a supplier that furnishes the technical component of advanced diagnostic imaging services for the purpose of accreditation of such supplier is specific to each imaging modality. Such criteria shall include-- (A) standards for qualifications of medical personnel who are not physicians and who furnish the technical component of advanced diagnostic imaging services; (B) standards for qualifications and responsibilities of medical directors and supervising physicians, including standards that recognize the considerations described in paragraph (4); (C) procedures to ensure that equipment used in furnishing the technical component of advanced diagnostic imaging services meets performance specifications; (D) standards that require the supplier have procedures in place to ensure the safety of persons who furnish the technical component of advanced diagnostic imaging services and individuals to whom such services are furnished; (E) standards that require the establishment and maintenance of a quality assurance and quality control program by the supplier that is adequate and appropriate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier; and (F) any other standards or procedures the Secretary determines appropriate. (4) Recognition in standards for the evaluation of medical directors and supervising physicians.--The standards described in paragraph (3)(B) shall recognize whether a medical director or supervising physician-- (A) in a particular specialty receives training in advanced diagnostic imaging services in a residency program; (B) has attained, through experience, the necessary expertise to be a medical director or a supervising physician; (C) has completed any continuing medical education courses relating to such services; or (D) has met such other standards as the Secretary determines appropriate. (5) Rule for accreditations made prior to designation.--In the case of a supplier that is accredited before January 1, 2010, by an accreditation organization designated by the Secretary under paragraph (2)(B) as of January 1, 2010, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2012, for the remaining period such accreditation is in effect. (f) Reduction in Payments for Physician Pathology Services During 1991.-- (1) In general.--For physician pathology services furnished under this part during 1991, the prevailing charges used in a locality under this part shall be 7 percent below the prevailing charges used in the locality under this part in 1990 after March 31. (2) Limitation.--The prevailing charge for the technical and professional components of an physician pathology service furnished by a physician through an independent laboratory shall not be reduced pursuant to paragraph (1) to the extent that such reduction would reduce such prevailing charge below 115 percent of the prevailing charge for the professional component of such service when furnished by a hospital-based physician in the same locality. For purposes of the preceding sentence, an independent laboratory is a laboratory that is independent of a hospital and separate from the attending or consulting physicians' office. (g) Payment for Outpatient Critical Access Hospital Services.-- (1) In general.--The amount of payment for outpatient critical access hospital services of a critical access hospital is equal to 101 percent of the reasonable costs of the hospital in providing such services, unless the hospital makes the election under paragraph (2). (2) Election of cost-based hospital outpatient service payment plus fee schedule for professional services.--A critical access hospital may elect to be paid for outpatient critical access hospital services amounts equal to the sum of the following, less the amount that such hospital may charge as described in section 1866(a)(2)(A): (A) Facility fee.--With respect to facility services, not including any services for which payment may be made under subparagraph (B), 101 percent of the reasonable costs of the critical access hospital in providing such services. (B) Fee schedule for professional services.-- With respect to professional services otherwise included within outpatient critical access hospital services, 115 percent of such amounts as would otherwise be paid under this part if such services were not included in outpatient critical access hospital services. Subsections (x) and (y) of section 1833 shall not be taken into account in determining the amounts that would otherwise be paid pursuant to the preceding sentence. The Secretary may not require, as a condition for applying subparagraph (B) with respect to a critical access hospital, that each physician or other practitioner providing professional services in the hospital must assign billing rights with respect to such services, except that such subparagraph shall not apply to those physicians and practitioners who have not assigned such billing rights. (3) Disregarding charges.--The payment amounts under this subsection shall be determined without regard to the amount of the customary or other charge. (4) Treatment of clinical diagnostic laboratory services.--No coinsurance, deductible, copayment, or other cost-sharing otherwise applicable under this part shall apply with respect to clinical diagnostic laboratory services furnished as an outpatient critical access hospital service. Nothing in this title shall be construed as providing for payment for clinical diagnostic laboratory services furnished as part of outpatient critical access hospital services, other than on the basis described in this subsection. For purposes of the preceding sentence and section 1861(mm)(3), clinical diagnostic laboratory services furnished by a critical access hospital shall be treated as being furnished as part of outpatient critical access services without regard to whether the individual with respect to whom such services are furnished is physically present in the critical access hospital, or in a skilled nursing facility or a clinic (including a rural health clinic) that is operated by a critical access hospital, at the time the specimen is collected. (5) Coverage of costs for certain emergency room on- call providers.--In determining the reasonable costs of outpatient critical access hospital services under paragraphs (1) and (2)(A), the Secretary shall recognize as allowable costs, amounts (as defined by the Secretary) for reasonable compensation and related costs for physicians, physician assistants, nurse practitioners, and clinical nurse specialists who are on-call (as defined by the Secretary) to provide emergency services but who are not present on the premises of the critical access hospital involved, and are not otherwise furnishing services covered under this title and are not on-call at any other provider or facility. (h) Payment for Prosthetic Devices and Orthotics and Prosthetics.-- (1) General rule for payment.-- (A) In general.--Payment under this subsection for prosthetic devices and orthotics and prosthetics shall be made in a lump-sum amount for the purchase of the item in an amount equal to 80 percent of the payment basis described in subparagraph (B). (B) Payment basis.--Except as provided in subparagraphs (C), (E), and (H)(i), the payment basis described in this subparagraph is the lesser of-- (i) the actual charge for the item; or (ii) the amount recognized under paragraph (2) as the purchase price for the item. (C) Exception for certain public home health agencies.--Subparagraph (B)(i) shall not apply to an item furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public. (D) Exclusive payment rule.--Subject to subparagraph (H)(ii), this subsection shall constitute the exclusive provision of this title for payment for prosthetic devices, orthotics, and prosthetics under this part or under part A to a home health agency. (E) Exception for certain items.--Payment for ostomy supplies, tracheostomy supplies, and urologicals shall be made in accordance with subparagraphs (B) and (C) of section 1834(a)(2). (F) Special payment rules for certain prosthetics and custom-fabricated orthotics.-- (i) In general.--No payment shall be made under this subsection for an item of custom-fabricated orthotics described in clause (ii) or for an item of prosthetics unless such item is-- (I) furnished by a qualified practitioner; and (II) fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate. (ii) Description of custom-fabricated item.-- (I) In general.--An item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experience to custom-fabricate and that is included in a list established by the Secretary in subclause (II). Such an item does not include shoes and shoe inserts. (II) List of items.--The Secretary, in consultation with appropriate experts in orthotics (including national organizations representing manufacturers of orthotics), shall establish and update as appropriate a list of items to which this subparagraph applies. No item may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient. (iii) Qualified practitioner defined.--In this subparagraph, the term ``qualified practitioner'' means a physician or other individual who-- (I) is a qualified physical therapist or a qualified occupational therapist; (II) in the case of a State that provides for the licensing of orthotics and prosthetics, is licensed in orthotics or prosthetics by the State in which the item is supplied; or (III) in the case of a State that does not provide for the licensing of orthotics and prosthetics, is specifically trained and educated to provide or manage the provision of prosthetics and custom-designed or -fabricated orthotics, and is certified by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/ Prosthetist Certification, or is credentialed and approved by a program that the Secretary determines, in consultation with appropriate experts in orthotics and prosthetics, has training and education standards that are necessary to provide such prosthetics and orthotics. (iv) Qualified supplier defined.--In this subparagraph, the term ``qualified supplier'' means any entity that is accredited by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or accredited and approved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board. (G) Replacement of prosthetic devices and parts.-- (i) In general.--Payment shall be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if an ordering physician determines that the provision of a replacement device, or a replacement part of such a device, is necessary because of any of the following: (I) A change in the physiological condition of the patient. (II) An irreparable change in the condition of the device, or in a part of the device. (III) The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced. (ii) Confirmation may be required if device or part being replaced is less than 3 years old.--If a physician determines that a replacement device, or a replacement part, is necessary pursuant to clause (i)-- (I) such determination shall be controlling; and (II) such replacement device or part shall be deemed to be reasonable and necessary for purposes of section 1862(a)(1)(A); except that if the device, or part, being replaced is less than 3 years old (calculated from the date on which the beneficiary began to use the device or part), the Secretary may also require confirmation of necessity of the replacement device or replacement part, as the case may be. (H) Application of competitive acquisition to orthotics; limitation of inherent reasonableness authority.--In the case of orthotics described in paragraph (2)(C) of section 1847(a) furnished on or after January 1, 2009, subject to subsection (a)(1)(G), that are included in a competitive acquisition program in a competitive acquisition area under such section-- (i) the payment basis under this subsection for such orthotics furnished in such area shall be the payment basis determined under such competitive acquisition program; and (ii) subject to subsection (a)(1)(G), the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under section 1847, and in the case of such adjustment, paragraphs (8) and (9) of section 1842(b) shall not be applied. (2) Purchase price recognized.--For purposes of paragraph (1), the amount that is recognized under this paragraph as the purchase price for prosthetic devices, orthotics, and prosthetics is the amount described in subparagraph (C) of this paragraph, determined as follows: (A) Computation of local purchase price.-- Each carrier under section 1842 shall compute a base local purchase price for the item as follows: (i) The carrier shall compute a base local purchase price for each item equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987. (ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item-- (I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 6-month period ending with December 1987, or (II) in 1991, 1992 or 1993, equal to the local purchase price computed under this clause for the previous year increased by the applicable percentage increase for the year. (B) Computation of regional purchase price.-- With respect to the furnishing of a particular item in each region (as defined by the Secretary), the Secretary shall compute a regional purchase price-- (i) for 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local purchase prices for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and (ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the applicable percentage increase for the year. (C) Purchase price recognized.--For purposes of paragraph (1) and subject to subparagraph (D), the amount that is recognized under this paragraph as the purchase price for each item furnished-- (i) in 1989, 1990, or 1991, is 100 percent of the local purchase price computed under subparagraph (A)(ii); (ii) in 1992, is the sum of (I) 75 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1992, and (II) 25 percent of the regional purchase price computed under subparagraph (B) for 1992; (iii) in 1993, is the sum of (I) 50 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1993, and (II) 50 percent of the regional purchase price computed under subparagraph (B) for 1993; and (iv) in 1994 or a subsequent year, is the regional purchase price computed under subparagraph (B) for that year. (D) Range on amount recognized.--The amount that is recognized under subparagraph (C) as the purchase price for an item furnished-- (i) in 1992, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year; and (ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year. (3) Applicability of certain provisions relating to durable medical equipment.--Paragraphs (12) and (17) and subparagraphs (A) and (B) of paragraph (10) and paragraph (11) of subsection (a) shall apply to prosthetic devices, orthotics, and prosthetics in the same manner as such provisions apply to covered items under such subsection. (4) Definitions.--In this subsection-- (A) the term ``applicable percentage increase'' means-- (i) for 1991, 0 percent; (ii) for 1992 and 1993, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; (iii) for 1994 and 1995, 0 percent; (iv) for 1996 and 1997, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; (v) for each of the years 1998 through 2000, 1 percent; (vi) for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000; (vii) for 2002, 1 percent; (viii) for 2003, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; (ix) for 2004, 2005, and 2006, 0 percent; (x) for for each of 2007 through 2010, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; and (xi) for 2011 and each subsequent year-- (I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year, reduced by-- (II) the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). (B) the term ``prosthetic devices'' has the meaning given such term in section 1861(s)(8), except that such term does not include parenteral and enteral nutrition nutrients, supplies, and equipment and does not include an implantable item for which payment may be made under section 1833(t); and (C) the term ``orthotics and prosthetics'' has the meaning given such term in section 1861(s)(9) (and includes shoes described in section 1861(s)(12)), but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a home health agency under section 1861(m)(5). The application of subparagraph (A)(xi)(II) may result in the applicable percentage increase under subparagraph (A) being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year. (5) Documentation created by orthotists and prosthetists.--For purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by eligible professionals described in section 1848(k)(3)(B). (i) Payment for Surgical Dressings.-- (1) In general.--Payment under this subsection for surgical dressings (described in section 1861(s)(5)) shall be made in a lump sum amount for the purchase of the item in an amount equal to 80 percent of the lesser of-- (A) the actual charge for the item; or (B) a payment amount determined in accordance with the methodology described in subparagraphs (B) and (C) of subsection (a)(2) (except that in applying such methodology, the national limited payment amount referred to in such subparagraphs shall be initially computed based on local payment amounts using average reasonable charges for the 12-month period ending December 31, 1992, increased by the covered item updates described in such subsection for 1993 and 1994). (2) Exceptions.--Paragraph (1) shall not apply to surgical dressings that are-- (A) furnished as an incident to a physician's professional service; or (B) furnished by a home health agency. (j) Requirements for Suppliers of Medical Equipment and Supplies.-- (1) Issuance and renewal of supplier number.-- (A) Payment.--Except as provided in subparagraph (C), no payment may be made under this part after the date of the enactment of the Social Security Act Amendments of 1994 for items furnished by a supplier of medical equipment and supplies unless such supplier obtains (and renews at such intervals as the Secretary may require) a supplier number. (B) Standards for possessing a supplier number.--A supplier may not obtain a supplier number unless-- (i) for medical equipment and supplies furnished on or after the date of the enactment of the Social Security Act Amendments of 1994 and before January 1, 1996, the supplier meets standards prescribed by the Secretary in regulations issued on June 18, 1992; and (ii) for medical equipment and supplies furnished on or after January 1, 1996, the supplier meets revised standards prescribed by the Secretary (in consultation with representatives of suppliers of medical equipment and supplies, carriers, and consumers) that shall include requirements that the supplier-- (I) comply with all applicable State and Federal licensure and regulatory requirements; (II) maintain a physical facility on an appropriate site; (III) have proof of appropriate liability insurance; and (IV) meet such other requirements as the Secretary may specify. (C) Exception for items furnished as incident to a physician's service.--Subparagraph (A) shall not apply with respect to medical equipment and supplies furnished incident to a physician's service. (D) Prohibition against multiple supplier numbers.--The Secretary may not issue more than one supplier number to any supplier of medical equipment and supplies unless the issuance of more than one number is appropriate to identify subsidiary or regional entities under the supplier's ownership or control. (E) Prohibition against delegation of supplier determinations.--The Secretary may not delegate (other than by contract under section 1842) the responsibility to determine whether suppliers meet the standards necessary to obtain a supplier number. (2) Certificates of medical necessity.-- (A) Limitation on information provided by suppliers on certificates of medical necessity.-- (i) In general.--Effective 60 days after the date of the enactment of the Social Security Act Amendments of 1994, a supplier of medical equipment and supplies may distribute to physicians, or to individuals entitled to benefits under this part, a certificate of medical necessity for commercial purposes which contains no more than the following information completed by the supplier: (I) An identification of the supplier and the beneficiary to whom such medical equipment and supplies are furnished. (II) A description of such medical equipment and supplies. (III) Any product code identifying such medical equipment and supplies. (IV) Any other administrative information (other than information relating to the beneficiary's medical condition) identified by the Secretary. (ii) Information on payment amount and charges.--If a supplier distributes a certificate of medical necessity containing any of the information permitted to be supplied under clause (i), the supplier shall also list on the certificate of medical necessity the fee schedule amount and the supplier's charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician. (iii) Penalty.--Any supplier of medical equipment and supplies who knowingly and willfully distributes a certificate of medical necessity in violation of clause (i) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such certificate of medical necessity so distributed. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to civil money penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under section 1128A(a). (B) Definition.--For purposes of this paragraph, the term ``certificate of medical necessity'' means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (3) Coverage and review criteria.--The Secretary shall annually review the coverage and utilization of items of medical equipment and supplies to determine whether such items should be made subject to coverage and utilization review criteria, and if appropriate, shall develop and apply such criteria to such items. (4) Limitation on patient liability.--If a supplier of medical equipment and supplies (as defined in paragraph (5))-- (A) furnishes an item or service to a beneficiary for which no payment may be made by reason of paragraph (1); (B) furnishes an item or service to a beneficiary for which payment is denied in advance under subsection (a)(15); or (C) furnishes an item or service to a beneficiary for which payment is denied under section 1862(a)(1); any expenses incurred for items and services furnished to an individual by such a supplier not on an assigned basis shall be the responsibility of such supplier. The individual shall have no financial responsibility for such expenses and the supplier shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items or services. The provisions of subsection (a)(18) shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection. (5) Definition.--The term ``medical equipment and supplies'' means-- (A) durable medical equipment (as defined in section 1861(n)); (B) prosthetic devices (as described in section 1861(s)(8)); (C) orthotics and prosthetics (as described in section 1861(s)(9)); (D) surgical dressings (as described in section 1861(s)(5)); (E) such other items as the Secretary may determine; and (F) for purposes of paragraphs (1) and (3)-- (i) home dialysis supplies and equipment (as described in section 1861(s)(2)(F)), (ii) immunosuppressive drugs (as described in section 1861(s)(2)(J)), (iii) therapeutic shoes for diabetics (as described in section 1861(s)(12)), (iv) oral drugs prescribed for use as an anticancer therapeutic agent (as described in section 1861(s)(2)(Q)), and (v) self-administered erythropoetin (as described in section 1861(s)(2)(P)). (k) Payment for Outpatient Therapy Services and Comprehensive Outpatient Rehabilitation Services.-- (1) In general.--With respect to services described in section 1833(a)(8) or 1833(a)(9) for which payment is determined under this subsection, the payment basis shall be-- (A) for services furnished during 1998, the amount determined under paragraph (2); or (B) for services furnished during a subsequent year, 80 percent of the lesser of-- (i) the actual charge for the services, or (ii) the applicable fee schedule amount (as defined in paragraph (3)) for the services. (2) Payment in 1998 based upon adjusted reasonable costs.--The amount under this paragraph for services is the lesser of-- (A) the charges imposed for the services, or (B) the adjusted reasonable costs (as defined in paragraph (4)) for the services, less 20 percent of the amount of the charges imposed for such services. (3) Applicable fee schedule amount.--In this subsection, the term ``applicable fee schedule amount'' means, with respect to services furnished in a year, the amount determined under the fee schedule established under section 1848 for such services furnished during the year or, if there is no such fee schedule established for such services, the amount determined under the fee schedule established for such comparable services as the Secretary specifies. (4) Adjusted reasonable costs.--In paragraph (2), the term ``adjusted reasonable costs'' means, with respect to any services, reasonable costs determined for such services, reduced by 10 percent. The 10-percent reduction shall not apply to services described in section 1833(a)(8)(B) (relating to services provided by hospitals). (5) Uniform coding.--For claims for services submitted on or after April 1, 1998, for which the amount of payment is determined under this subsection, the claim shall include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished. (6) Restraint on billing.--The provisions of subparagraphs (A) and (B) of section 1842(b)(18) shall apply to therapy services for which payment is made under this subsection in the same manner as they apply to services provided by a practitioner described in section 1842(b)(18)(C). (7) Adjustment in discount for certain multiple therapy services.--In the case of therapy services furnished on or after April 1, 2013, and for which payment is made under this subsection pursuant to the applicable fee schedule amount (as defined in paragraph (3)), instead of the 25 percent multiple procedure payment reduction specified in the final rule published by the Secretary in the Federal Register on November 29, 2010, the reduction percentage shall be 50 percent. (l) Establishment of Fee Schedule for Ambulance Services.-- (1) In general.--The Secretary shall establish a fee schedule for payment for ambulance services whether provided directly by a supplier or provider or under arrangement with a provider under this part through a negotiated rulemaking process described in title 5, United States Code, and in accordance with the requirements of this subsection. (2) Considerations.--In establishing such fee schedule, the Secretary shall-- (A) establish mechanisms to control increases in expenditures for ambulance services under this part; (B) establish definitions for ambulance services which link payments to the type of services provided; (C) consider appropriate regional and operational differences; (D) consider adjustments to payment rates to account for inflation and other relevant factors; and (E) phase in the application of the payment rates under the fee schedule in an efficient and fair manner consistent with paragraph (11), except that such phase-in shall provide for full payment of any national mileage rate for ambulance services provided by suppliers that are paid by carriers in any of the 50 States where payment by a carrier for such services for all such suppliers in such State did not, prior to the implementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is transported. (3) Savings.--In establishing such fee schedule, the Secretary shall-- (A) ensure that the aggregate amount of payments made for ambulance services under this part during 2000 does not exceed the aggregate amount of payments which would have been made for such services under this part during such year if the amendments made by section 4531(a) of the Balanced Budget Act of 1997 continued in effect, except that in making such determination the Secretary shall assume an update in such payments for 2002 equal to percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points; (B) set the payment amounts provided under the fee schedule for services furnished in 2001 and each subsequent year at amounts equal to the payment amounts under the fee schedule for services furnished during the previous year, increased, subject to subparagraph (C) and the succeeding sentence of this paragraph, by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points; and (C) for 2011 and each subsequent year, after determining the percentage increase under subparagraph (B) for the year, reduce such percentage increase by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of subparagraph (C) may result in the percentage increase under subparagraph (B) being less than 0.0 for a year, and may result in payment rates under the fee schedule under this subsection for a year being less than such payment rates for the preceding year. (4) Consultation.--In establishing the fee schedule for ambulance services under this subsection, the Secretary shall consult with various national organizations representing individuals and entities who furnish and regulate ambulance services and share with such organizations relevant data in establishing such schedule. (5) Limitation on review.--There shall be no administrative or judicial review under section 1869 or otherwise of the amounts established under the fee schedule for ambulance services under this subsection, including matters described in paragraph (2). (6) Restraint on billing.--The provisions of subparagraphs (A) and (B) of section 1842(b)(18) shall apply to ambulance services for which payment is made under this subsection in the same manner as they apply to services provided by a practitioner described in section 1842(b)(18)(C). (7) Coding system.--The Secretary may require the claim for any services for which the amount of payment is determined under this subsection to include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished. (8) Services furnished by critical access hospitals.--Notwithstanding any other provision of this subsection, the Secretary shall pay 101 percent of the reasonable costs incurred in furnishing ambulance services if such services are furnished-- (A) by a critical access hospital (as defined in section 1861(mm)(1)), or (B) by an entity that is owned and operated by a critical access hospital, but only if the critical access hospital or entity is the only provider or supplier of ambulance services that is located within a 35-mile drive of such critical access hospital. (9) Transitional assistance for rural providers.--In the case of ground ambulance services furnished on or after July 1, 2001, and before January 1, 2004, for which the transportation originates in a rural area (as defined in section 1886(d)(2)(D)) or in a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)), the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 17 miles, and up to 50 miles, the rate otherwise established shall be increased by not less than \1/2\ of the additional payment per mile established for the first 17 miles of such a trip originating in a rural area. (10) Phase-in providing floor using blend of fee schedule and regional fee schedules.--In carrying out the phase-in under paragraph (2)(E) for each level of ground service furnished in a year, the portion of the payment amount that is based on the fee schedule shall be the greater of the amount determined under such fee schedule (without regard to this paragraph) or the following blended rate of the fee schedule under paragraph (1) and of a regional fee schedule for the region involved: (A) For 2004 (for services furnished on or after July 1, 2004), the blended rate shall be based 20 percent on the fee schedule under paragraph (1) and 80 percent on the regional fee schedule. (B) For 2005, the blended rate shall be based 40 percent on the fee schedule under paragraph (1) and 60 percent on the regional fee schedule. (C) For 2006, the blended rate shall be based 60 percent on the fee schedule under paragraph (1) and 40 percent on the regional fee schedule. (D) For 2007, 2008, and 2009, the blended rate shall be based 80 percent on the fee schedule under paragraph (1) and 20 percent on the regional fee schedule. (E) For 2010 and each succeeding year, the blended rate shall be based 100 percent on the fee schedule under paragraph (1). For purposes of this paragraph, the Secretary shall establish a regional fee schedule for each of the nine census divisions (referred to in section 1886(d)(2)) using the methodology (used in establishing the fee schedule under paragraph (1)) to calculate a regional conversion factor and a regional mileage payment rate and using the same payment adjustments and the same relative value units as used in the fee schedule under such paragraph. (11) Adjustment in payment for certain long trips.-- In the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2009, regardless of where the transportation originates, the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 50 miles the per mile rate otherwise established shall be increased by \1/4\ of the payment per mile otherwise applicable to miles in excess of 50 miles in such trip. (12) Assistance for rural providers furnishing services in low population density areas.-- (A) In general.--In the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2023, for which the transportation originates in a qualified rural area (identified under subparagraph (B)(iii)), the Secretary shall provide for a percent increase in the base rate of the fee schedule for a trip established under this subsection. In establishing such percent increase, the Secretary shall estimate the average cost per trip for such services (not taking into account mileage) in the lowest quartile as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of all rural county populations. (B) Identification of qualified rural areas.-- (i) Determination of population density in area.--Based upon data from the United States decennial census for the year 2000, the Secretary shall determine, for each rural area, the population density for that area. (ii) Ranking of areas.--The Secretary shall rank each such area based on such population density. (iii) Identification of qualified rural areas.--The Secretary shall identify those areas (in subparagraph (A) referred to as ``qualified rural areas'') with the lowest population densities that represent, if each such area were weighted by the population of such area (as used in computing such population densities), an aggregate total of 25 percent of the total of the population of all such areas. (iv) Rural area.--For purposes of this paragraph, the term ``rural area'' has the meaning given such term in section 1886(d)(2)(D). If feasible, the Secretary shall treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725) as a rural area for purposes of this paragraph. (v) Judicial review.--There shall be no administrative or judicial review under section 1869, 1878, or otherwise, respecting the identification of an area under this subparagraph. (13) Temporary increase for ground ambulance services.-- (A) In general.--After computing the rates with respect to ground ambulance services under the other applicable provisions of this subsection, in the case of such services furnished on or after July 1, 2004, and before January 1, 2007, and for such services furnished on or after July 1, 2008, and before January 1, 2023, for which the transportation originates in-- (i) a rural area described in paragraph (9) or in a rural census tract described in such paragraph, the fee schedule established under this section shall provide that the rate for the service otherwise established, after the application of any increase under paragraphs (11) and (12), shall be increased by 2 percent (or 3 percent if such service is furnished on or after July 1, 2008, and before January 1, 2023); and (ii) an area not described in clause (i), the fee schedule established under this subsection shall provide that the rate for the service otherwise established, after the application of any increase under paragraph (11), shall be increased by 1 percent (or 2 percent if such service is furnished on or after July 1, 2008, and before January 1, 2023). (B) Application of increased payments after applicable period.--The increased payments under subparagraph (A) shall not be taken into account in calculating payments for services furnished after the applicable period specified in such subparagraph. (14) Providing appropriate coverage of rural air ambulance services.-- (A) In general.--The regulations described in section 1861(s)(7) shall provide, to the extent that any ambulance services (whether ground or air) may be covered under such section, that a rural air ambulance service (as defined in subparagraph (C)) is reimbursed under this subsection at the air ambulance rate if the air ambulance service-- (i) is reasonable and necessary based on the health condition of the individual being transported at or immediately prior to the time of the transport; and (ii) complies with equipment and crew requirements established by the Secretary. (B) Satisfaction of requirement of medically necessary.--The requirement of subparagraph (A)(i) is deemed to be met for a rural air ambulance service if-- (i) subject to subparagraph (D), such service is requested by a physician or other qualified medical personnel (as specified by the Secretary) who certifies or reasonably determines that the individual's condition is such that the time needed to transport the individual by land or the instability of transportation by land poses a threat to the individual's survival or seriously endangers the individual's health; or (ii) such service is furnished pursuant to a protocol that is established by a State or regional emergency medical service (EMS) agency and recognized or approved by the Secretary under which the use of an air ambulance is recommended, if such agency does not have an ownership interest in the entity furnishing such service. (C) Rural air ambulance service defined.--For purposes of this paragraph, the term ``rural air ambulance service'' means fixed wing and rotary wing air ambulance service in which the point of pick up of the individual occurs in a rural area (as defined in section 1886(d)(2)(D)) or in a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)). (D) Limitation.-- (i) In general.--Subparagraph (B)(i) shall not apply if there is a financial or employment relationship between the person requesting the rural air ambulance service and the entity furnishing the ambulance service, or an entity under common ownership with the entity furnishing the air ambulance service, or a financial relationship between an immediate family member of such requester and such an entity. (ii) Exception.--Where a hospital and the entity furnishing rural air ambulance services are under common ownership, clause (i) shall not apply to remuneration (through employment or other relationship) by the hospital of the requester or immediate family member if the remuneration is for provider-based physician services furnished in a hospital (as described in section 1887) which are reimbursed under part A and the amount of the remuneration is unrelated directly or indirectly to the provision of rural air ambulance services. (15) Payment adjustment for non-emergency ambulance transports for esrd beneficiaries.--The fee schedule amount otherwise applicable under the preceding provisions of this subsection shall be reduced by 10 percent for ambulance services furnished during the period beginning on October 1, 2013, and ending on September 30, 2018, and by 23 percent for such services furnished on or after October 1, 2018, consisting of non-emergency basic life support services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in section 1881(b)(14)(B)) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. (16) Prior authorization for repetitive scheduled non-emergent ambulance transports.-- (A) In general.--Beginning January 1, 2017, if the expansion to all States of the model of prior authorization described in paragraph (2) of section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015 meets the requirements described in paragraphs (1) through (3) of section 1115A(c), then the Secretary shall expand such model to all States. (B) Funding.--The Secretary shall use funds made available under section 1893(h)(10) to carry out this paragraph. (C) Clarification regarding budget neutrality.--Nothing in this paragraph may be construed to limit or modify the application of section 1115A(b)(3)(B) to models described in such section, including with respect to the model described in subparagraph (A) and expanded beginning on January 1, 2017, under such subparagraph. (17) Submission of cost and other information.-- (A) Development of data collection system.-- The Secretary shall develop a data collection system (which may include use of a cost survey) to collect cost, revenue, utilization, and other information determined appropriate by the Secretary with respect to providers of services (in this paragraph referred to as ``providers'') and suppliers of ground ambulance services. Such system shall be designed to collect information-- (i) needed to evaluate the extent to which reported costs relate to payment rates under this subsection; (ii) on the utilization of capital equipment and ambulance capacity, including information consistent with the type of information described in section 1121(a); and (iii) on different types of ground ambulance services furnished in different geographic locations, including rural areas and low population density areas described in paragraph (12). (B) Specification of data collection system.-- (i) In general.--The Secretary shall-- (I) not later than December 31, 2019, specify the data collection system under subparagraph (A); and (II) identify the providers and suppliers of ground ambulance services that would be required to submit information under such data collection system, including the representative sample described in clause (ii). (ii) Determination of representative sample.-- (I) In general.--Not later than December 31, 2019, with respect to the data collection for the first year under such system, and for each subsequent year through 2024, the Secretary shall determine a representative sample to submit information under the data collection system. (II) Requirements.--The sample under subclause (I) shall be representative of the different types of providers and suppliers of ground ambulance services (such as those providers and suppliers that are part of an emergency service or part of a government organization) and the geographic locations in which ground ambulance services are furnished (such as urban, rural, and low population density areas). (III) Limitation.--The Secretary shall not include an individual provider or supplier of ground ambulance services in the sample under subclause (I) in 2 consecutive years, to the extent practicable. (C) Reporting of cost information.--For each year, a provider or supplier of ground ambulance services identified by the Secretary under subparagraph (B)(i)(II) as being required to submit information under the data collection system with respect to a period for the year shall submit to the Secretary information specified under the system. Such information shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph. (D) Payment reduction for failure to report.-- (i) In general.--Beginning January 1, 2022, subject to clause (ii), a 10 percent reduction to payments under this subsection shall be made for the applicable period (as defined in clause (ii)) to a provider or supplier of ground ambulance services that-- (I) is required to submit information under the data collection system with respect to a period under subparagraph (C); and (II) does not sufficiently submit such information, as determined by the Secretary. (ii) Applicable period defined.--For purposes of clause (i), the term ``applicable period'' means, with respect to a provider or supplier of ground ambulance services, a year specified by the Secretary not more than 2 years after the end of the period with respect to which the Secretary has made a determination under clause (i)(II) that the provider or supplier of ground ambulance services failed to sufficiently submit information under the data collection system. (iii) Hardship exemption.--The Secretary may exempt a provider or supplier from the payment reduction under clause (i) with respect to an applicable period in the event of significant hardship, such as a natural disaster, bankruptcy, or other similar situation that the Secretary determines interfered with the ability of the provider or supplier of ground ambulance services to submit such information in a timely manner for the specified period. (iv) Informal review.--The Secretary shall establish a process under which a provider or supplier of ground ambulance services may seek an informal review of a determination that the provider or supplier is subject to the payment reduction under clause (i). (E) Ongoing data collection.-- (i) Revision of data collection system.--The Secretary may, as the Secretary determines appropriate and, if available, taking into consideration the report (or reports) under subparagraph (F), revise the data collection system under subparagraph (A). (ii) Subsequent data collection.--In order to continue to evaluate the extent to which reported costs relate to payment rates under this subsection and for other purposes the Secretary deems appropriate, the Secretary shall require providers and suppliers of ground ambulance services to submit information for years after 2024 as the Secretary determines appropriate, but in no case less often than once every 3 years. (F) Ground ambulance data collection system study.-- (i) In general.--Not later than March 15, 2023, and as determined necessary by the Medicare Payment Advisory Commission thereafter, such Commission shall assess, and submit to Congress a report on, information submitted by providers and suppliers of ground ambulance services through the data collection system under subparagraph (A), the adequacy of payments for ground ambulance services under this subsection, and geographic variations in the cost of furnishing such services. (ii) Contents.--A report under clause (i) shall contain the following: (I) An analysis of information submitted through the data collection system. (II) An analysis of any burden on providers and suppliers of ground ambulance services associated with the data collection system. (III) A recommendation as to whether information should continue to be submitted through such data collection system or if such system should be revised under subparagraph (E)(i). (IV) Other information determined appropriate by the Commission. (G) Public availability.--The Secretary shall post information on the results of the data collection under this paragraph on the Internet website of the Centers for Medicare & Medicaid Services, as determined appropriate by the Secretary. (H) Implementation.--The Secretary shall implement this paragraph through notice and comment rulemaking. (I) Administration.--Chapter 35 of title 44, United States Code, shall not apply to the collection of information required under this subsection. (J) Limitations on review.--There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of the data collection system or identification of respondents under this paragraph. (K) Funding for implementation.--For purposes of carrying out subparagraph (A), the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $15,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2018. Amounts transferred under this subparagraph shall remain available until expended. (m) Payment for Telehealth Services.-- (1) In general.--The Secretary shall pay for telehealth services that are furnished via a telecommunications system by a physician (as defined in section 1861(r)) or a practitioner (described in section 1842(b)(18)(C)) to an eligible telehealth individual enrolled under this part notwithstanding that the individual physician or practitioner providing the telehealth service is not at the same location as the beneficiary. For purposes of the preceding sentence, in the case of any Federal telemedicine demonstration program conducted in Alaska or Hawaii, the term ``telecommunications system'' includes store- and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats. (2) Payment amount.-- (A) Distant site.--The Secretary shall pay to a physician or practitioner located at a distant site that furnishes a telehealth service to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid under this title had such service been furnished without the use of a telecommunications system. (B) Facility fee for originating site.-- (i) In general.--Subject to clause (ii) and paragraph (6)(C), with respect to a telehealth service, subject to section 1833(a)(1)(U), there shall be paid to the originating site a facility fee equal to-- (I) for the period beginning on October 1, 2001, and ending on December 31, 2001, and for 2002, $20; and (II) for a subsequent year, the facility fee specified in subclause (I) or this subclause for the preceding year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for such subsequent year. (ii) No facility fee if originating site is the home.--No facility fee shall be paid under this subparagraph to an originating site described in paragraph (4)(C)(ii)(X). (C) Telepresenter not required.--Nothing in this subsection shall be construed as requiring an eligible telehealth individual to be presented by a physician or practitioner at the originating site for the furnishing of a service via a telecommunications system, unless it is medically necessary (as determined by the physician or practitioner at the distant site). (3) Limitation on beneficiary charges.-- (A) Physician and practitioner.--The provisions of section 1848(g) and subparagraphs (A) and (B) of section 1842(b)(18) shall apply to a physician or practitioner receiving payment under this subsection in the same manner as they apply to physicians or practitioners under such sections. (B) Originating site.--The provisions of section 1842(b)(18) shall apply to originating sites receiving a facility fee in the same manner as they apply to practitioners under such section. (4) Definitions.--For purposes of this subsection: (A) Distant site.--The term ``distant site'' means the site at which the physician or practitioner is located at the time the service is provided via a telecommunications system. (B) Eligible telehealth individual.--The term ``eligible telehealth individual'' means an individual enrolled under this part who receives a telehealth service furnished at an originating site. (C) Originating site.-- (i) In general.--Except as provided in paragraphs (5), (6), and (7), the term``originating site'' means only those sites described in clause (ii) at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system and only if such site is located-- (I) in an area that is designated as a rural health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)); (II) in a county that is not included in a Metropolitan Statistical Area; or (III) from an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. (ii) Sites described.--The sites referred to in clause (i) are the following sites: (I) The office of a physician or practitioner. (II) A critical access hospital (as defined in section 1861(mm)(1)). (III) A rural health clinic (as defined in section 1861(aa)(2)). (IV) A Federally qualified health center (as defined in section 1861(aa)(4)). (V) A hospital (as defined in section 1861(e)). (VI) A hospital-based or critical access hospital-based renal dialysis center (including satellites). (VII) A skilled nursing facility (as defined in section 1819(a)). (VIII) A community mental health center (as defined in section 1861(ff)(3)(B)). (IX) A renal dialysis facility, but only for purposes of section 1881(b)(3)(B). (X) The home of an individual, but only for purposes of section 1881(b)(3)(B) or telehealth services described in paragraph (7). (D) Physician.--The term ``physician'' has the meaning given that term in section 1861(r). (E) Practitioner.--The term ``practitioner'' has the meaning given that term in section 1842(b)(18)(C). (F) Telehealth service.-- (i) In general.--The term ``telehealth service'' means professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000, by HCPCS codes 99241-99275, 99201-99215, 90804-90809, and 90862 (and as subsequently modified by the Secretary)), and any additional service specified by the Secretary. (ii) Yearly update.--The Secretary shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as appropriate, to those specified in clause (i) for authorized payment under paragraph (1). (5) Treatment of home dialysis monthly esrd-related visit.--The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of section 1881(b)(3)(B), at an originating site described in subclause (VI), (IX), or (X) of paragraph (4)(C)(ii). (6) Treatment of stroke telehealth services.-- (A) Non-application of originating site requirements.--The requirements described in paragraph (4)(C) shall not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke, as determined by the Secretary. (B) Inclusion of certain sites.--With respect to telehealth services described in subparagraph (A), the term ``originating site'' shall include any hospital (as defined in section 1861(e)) or critical access hospital (as defined in section 1861(mm)(1)), any mobile stroke unit (as defined by the Secretary), or any other site determined appropriate by the Secretary, at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system. (C) No originating site facility fee for new sites.--No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (A) if the originating site does not otherwise meet the requirements for an originating site under paragraph (4)(C). (7) Treatment of substance use disorder services furnished through telehealth.--The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph). (n) Authority To Modify or Eliminate Coverage of Certain Preventive Services.--Notwithstanding any other provision of this title, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may-- (1) modify-- (A) the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force; and (B) the services included in the initial preventive physical examination described in subparagraph (B) of such section; and (2) provide that no payment shall be made under this title for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force. (o) Development and Implementation of Prospective Payment System.-- (1) Development.-- (A) In general.--The Secretary shall develop a prospective payment system for payment for Federally qualified health center services (other than such services described in clause (i) or (ii) of section 1833(a)(3)(D)) furnished by Federally qualified health centers under this title. Such system shall include a process for appropriately describing the services furnished by Federally qualified health centers and shall establish payment rates for specific payment codes based on such appropriate descriptions of services. Such system shall be established to take into account the type, intensity, and duration of services furnished by Federally qualified health centers. Such system may include adjustments, including geographic adjustments, determined appropriate by the Secretary. (B) Collection of data and evaluation.--By not later than January 1, 2011, the Secretary shall require Federally qualified health centers to submit to the Secretary such information as the Secretary may require in order to develop and implement the prospective payment system under this subsection, including the reporting of services using HCPCS codes. (2) Implementation.-- (A) In general.--Notwithstanding section 1833(a)(3)(A), the Secretary shall provide, for cost reporting periods beginning on or after October 1, 2014, for payments of prospective payment rates for Federally qualified health center services (other than such services described in clause (i) or (ii) of section 1833(a)(3)(D)) furnished by Federally qualified health centers under this title in accordance with the prospective payment system developed by the Secretary under paragraph (1). (B) Payments.-- (i) Initial payments.--The Secretary shall implement such prospective payment system so that the estimated aggregate amount of prospective payment rates (determined prior to the application of [section 1833(a)(1)(Z)] subparagraphs (C) and (D) of section 1833(a)(3)) under this title for Federally qualified health center services (other than such services described in clause (i) or (ii) of section 1833(a)(3)(D)) in the first year that such system is implemented is equal to 100 percent of the estimated amount of reasonable costs (determined without the application of a per visit payment limit or productivity screen and prior to the application of section 1866(a)(2)(A)(ii)) that would have occurred for such services under this title in such year if the system had not been implemented. (ii) Payments in subsequent years.-- Payment rates in years after the year of implementation of such system shall be the payment rates in the previous year increased-- (I) in the first year after implementation of such system, by the percentage increase in the MEI (as defined in section 1842(i)(3)) for the year involved; and (II) in subsequent years, by the percentage increase in a market basket of Federally qualified health center goods and services as promulgated through regulations, or if such an index is not available, by the percentage increase in the MEI (as defined in section 1842(i)(3)) for the year involved. (C) Preparation for pps implementation.-- Notwithstanding any other provision of law, the Secretary may establish and implement by program instruction or otherwise the payment codes to be used under the prospective payment system under this section. (3) Additional payments for certain fqhcs with physicians or other practitioners receiving data 2000 waivers.-- (A) In general.--In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C), the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner. (B) Application.--In order to receive a payment described in subparagraph (A), a Federally qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center. (C) Requirements.--For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (D) Funding.--For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. (p) Quality Incentives To Promote Patient Safety and Public Health in Computed Tomography.-- (1) Quality incentives.--In the case of an applicable computed tomography service (as defined in paragraph (2)) for which payment is made under an applicable payment system (as defined in paragraph (3)) and that is furnished on or after January 1, 2016, using equipment that is not consistent with the CT equipment standard (described in paragraph (4)), the payment amount for such service shall be reduced by the applicable percentage (as defined in paragraph (5)). (2) Applicable computed tomography services defined.--In this subsection, the term ``applicable computed tomography service'' means a service billed using diagnostic radiological imaging codes for computed tomography (identified as of January 1, 2014, by HCPCS codes 70450-70498, 71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-74178, 74261-74263, and 75571-75574 (and any succeeding codes). (3) Applicable payment system defined.--In this subsection, the term ``applicable payment system'' means the following: (A) The technical component and the technical component of the global fee under the fee schedule established under section 1848(b). (B) The prospective payment system for hospital outpatient department services under section 1833(t). (4) Consistency with ct equipment standard.--In this subsection, the term ``not consistent with the CT equipment standard'' means, with respect to an applicable computed tomography service, that the service was furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) Standard XR-29-2013, entitled ``Standard Attributes on CT Equipment Related to Dose Optimization and Management''. Through rulemaking, the Secretary may apply successor standards. (5) Applicable percentage defined.--In this subsection, the term ``applicable percentage'' means-- (A) for 2016, 5 percent; and (B) for 2017 and subsequent years, 15 percent. (6) Implementation.-- (A) Information.--The Secretary shall require that information be provided and attested to by a supplier and a hospital outpatient department that indicates whether an applicable computed tomography service was furnished that was not consistent with the CT equipment standard (described in paragraph (4)). Such information may be included on a claim and may be a modifier. Such information shall be verified, as appropriate, as part of the periodic accreditation of suppliers under section 1834(e) and hospitals under section 1865(a). (B) Administration.--Chapter 35 of title 44, United States Code, shall not apply to information described in subparagraph (A). (q) Recognizing Appropriate Use Criteria for Certain Imaging Services.-- (1) Program established.-- (A) In general.--The Secretary shall establish a program to promote the use of appropriate use criteria (as defined in subparagraph (B)) for applicable imaging services (as defined in subparagraph (C)) furnished in an applicable setting (as defined in subparagraph (D)) by ordering professionals and furnishing professionals (as defined in subparagraphs (E) and (F), respectively). (B) Appropriate use criteria defined.--In this subsection, the term ``appropriate use criteria'' means criteria, only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-based. (C) Applicable imaging service defined.--In this subsection, the term ``applicable imaging service'' means an advanced diagnostic imaging service (as defined in subsection (e)(1)(B)) for which the Secretary determines-- (i) one or more applicable appropriate use criteria specified under paragraph (2) apply; (ii) there are one or more qualified clinical decision support mechanisms listed under paragraph (3)(C); and (iii) one or more of such mechanisms is available free of charge. (D) Applicable setting defined.--In this subsection, the term ``applicable setting'' means a physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary. (E) Ordering professional defined.--In this subsection, the term ``ordering professional'' means a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who orders an applicable imaging service. (F) Furnishing professional defined.--In this subsection, the term ``furnishing professional'' means a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who furnishes an applicable imaging service. (2) Establishment of applicable appropriate use criteria.-- (A) In general.--Not later than November 15, 2015, the Secretary shall through rulemaking, and in consultation with physicians, practitioners, and other stakeholders, specify applicable appropriate use criteria for applicable imaging services only from among appropriate use criteria developed or endorsed by national professional medical specialty societies or other provider-led entities. (B) Considerations.--In specifying applicable appropriate use criteria under subparagraph (A), the Secretary shall take into account whether the criteria-- (i) have stakeholder consensus; (ii) are scientifically valid and evidence based; and (iii) are based on studies that are published and reviewable by stakeholders. (C) Revisions.--The Secretary shall review, on an annual basis, the specified applicable appropriate use criteria to determine if there is a need to update or revise (as appropriate) such specification of applicable appropriate use criteria and make such updates or revisions through rulemaking. (D) Treatment of multiple applicable appropriate use criteria.--In the case where the Secretary determines that more than one appropriate use criterion applies with respect to an applicable imaging service, the Secretary shall apply one or more applicable appropriate use criteria under this paragraph for the service. (3) Mechanisms for consultation with applicable appropriate use criteria.-- (A) Identification of mechanisms to consult with applicable appropriate use criteria.-- (i) In general.--The Secretary shall specify qualified clinical decision support mechanisms that could be used by ordering professionals to consult with applicable appropriate use criteria for applicable imaging services. (ii) Consultation.--The Secretary shall consult with physicians, practitioners, health care technology experts, and other stakeholders in specifying mechanisms under this paragraph. (iii) Inclusion of certain mechanisms.--Mechanisms specified under this paragraph may include any or all of the following that meet the requirements described in subparagraph (B)(ii): (I) Use of clinical decision support modules in certified EHR technology (as defined in section 1848(o)(4)). (II) Use of private sector clinical decision support mechanisms that are independent from certified EHR technology, which may include use of clinical decision support mechanisms available from medical specialty organizations. (III) Use of a clinical decision support mechanism established by the Secretary. (B) Qualified clinical decision support mechanisms.-- (i) In general.--For purposes of this subsection, a qualified clinical decision support mechanism is a mechanism that the Secretary determines meets the requirements described in clause (ii). (ii) Requirements.--The requirements described in this clause are the following: (I) The mechanism makes available to the ordering professional applicable appropriate use criteria specified under paragraph (2) and the supporting documentation for the applicable imaging service ordered. (II) In the case where there is more than one applicable appropriate use criterion specified under such paragraph for an applicable imaging service, the mechanism indicates the criteria that it uses for the service. (III) The mechanism determines the extent to which an applicable imaging service ordered is consistent with the applicable appropriate use criteria so specified. (IV) The mechanism generates and provides to the ordering professional a certification or documentation that documents that the qualified clinical decision support mechanism was consulted by the ordering professional. (V) The mechanism is updated on a timely basis to reflect revisions to the specification of applicable appropriate use criteria under such paragraph. (VI) The mechanism meets privacy and security standards under applicable provisions of law. (VII) The mechanism performs such other functions as specified by the Secretary, which may include a requirement to provide aggregate feedback to the ordering professional. (C) List of mechanisms for consultation with applicable appropriate use criteria.-- (i) Initial list.--Not later than April 1, 2016, the Secretary shall publish a list of mechanisms specified under this paragraph. (ii) Periodic updating of list.--The Secretary shall identify on an annual basis the list of qualified clinical decision support mechanisms specified under this paragraph. (4) Consultation with applicable appropriate use criteria.-- (A) Consultation by ordering professional.-- Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applicable imaging service ordered by an ordering professional that would be furnished in an applicable setting and paid for under an applicable payment system (as defined in subparagraph (D)), an ordering professional shall-- (i) consult with a qualified decision support mechanism listed under paragraph (3)(C); and (ii) provide to the furnishing professional the information described in clauses (i) through (iii) of subparagraph (B). (B) Reporting by furnishing professional.-- Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system (as defined in subparagraph (D)), payment for such service may only be made if the claim for the service includes the following: (i) Information about which qualified clinical decision support mechanism was consulted by the ordering professional for the service. (ii) Information regarding-- (I) whether the service ordered would adhere to the applicable appropriate use criteria specified under paragraph (2); (II) whether the service ordered would not adhere to such criteria; or (III) whether such criteria was not applicable to the service ordered. (iii) The national provider identifier of the ordering professional (if different from the furnishing professional). (C) Exceptions.--The provisions of subparagraphs (A) and (B) and paragraph (6)(A) shall not apply to the following: (i) Emergency services.--An applicable imaging service ordered for an individual with an emergency medical condition (as defined in section 1867(e)(1)). (ii) Inpatient services.--An applicable imaging service ordered for an inpatient and for which payment is made under part A. (iii) Significant hardship.--An applicable imaging service ordered by an ordering professional who the Secretary may, on a case-by-case basis, exempt from the application of such provisions if the Secretary determines, subject to annual renewal, that consultation with applicable appropriate use criteria would result in a significant hardship, such as in the case of a professional who practices in a rural area without sufficient Internet access. (D) Applicable payment system defined.--In this subsection, the term ``applicable payment system'' means the following: (i) The physician fee schedule established under section 1848(b). (ii) The prospective payment system for hospital outpatient department services under section 1833(t). (iii) The ambulatory surgical center payment systems under section 1833(i). (5) Identification of outlier ordering professionals.-- (A) In general.--With respect to applicable imaging services furnished beginning with 2017, the Secretary shall determine, on an annual basis, no more than five percent of the total number of ordering professionals who are outlier ordering professionals. (B) Outlier ordering professionals.--The determination of an outlier ordering professional shall-- (i) be based on low adherence to applicable appropriate use criteria specified under paragraph (2), which may be based on comparison to other ordering professionals; and (ii) include data for ordering professionals for whom prior authorization under paragraph (6)(A) applies. (C) Use of two years of data.--The Secretary shall use two years of data to identify outlier ordering professionals under this paragraph. (D) Process.--The Secretary shall establish a process for determining when an outlier ordering professional is no longer an outlier ordering professional. (E) Consultation with stakeholders.--The Secretary shall consult with physicians, practitioners and other stakeholders in developing methods to identify outlier ordering professionals under this paragraph. (6) Prior authorization for ordering professionals who are outliers.-- (A) In general.--Beginning January 1, 2020, subject to paragraph (4)(C), with respect to services furnished during a year, the Secretary shall, for a period determined appropriate by the Secretary, apply prior authorization for applicable imaging services that are ordered by an outlier ordering professional identified under paragraph (5). (B) Appropriate use criteria in prior authorization.--In applying prior authorization under subparagraph (A), the Secretary shall utilize only the applicable appropriate use criteria specified under this subsection. (C) Funding.--For purposes of carrying out this paragraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2019 through 2021. Amounts transferred under the preceding sentence shall remain available until expended. (7) Construction.--Nothing in this subsection shall be construed as granting the Secretary the authority to develop or initiate the development of clinical practice guidelines or appropriate use criteria. (r) Payment for Renal Dialysis Services for Individuals With Acute Kidney Injury.-- (1) Payment rate.--In the case of renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14)) furnished under this part by a renal dialysis facility or provider of services paid under such section during a year (beginning with 2017) to an individual with acute kidney injury (as defined in paragraph (2)), the amount of payment under this part for such services shall be the base rate for renal dialysis services determined for such year under such section, as adjusted by any applicable geographic adjustment factor applied under subparagraph (D)(iv)(II) of such section and may be adjusted by the Secretary (on a budget neutral basis for payments under this paragraph) by any other adjustment factor under subparagraph (D) of such section. (2) Individual with acute kidney injury defined.--In this subsection, the term ``individual with acute kidney injury'' means an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under section 1881(b)(14). (s) Payment for Applicable Disposable Devices.-- (1) Separate payment.--The Secretary shall make a payment (separate from the payments otherwise made under section 1895) in the amount established under paragraph (3) to a home health agency for an applicable disposable device (as defined in paragraph (2)) when furnished on or after January 1, 2017, to an individual who receives home health services for which payment is made under section 1895(b). (2) Applicable disposable device.--In this subsection, the term applicable disposable device means a disposable device that, as determined by the Secretary, is-- (A) a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and (B) a substitute for, and used in lieu of, a negative pressure wound therapy durable medical equipment item that is an integrated system of a negative pressure vacuum pump, a separate exudate collection canister, and dressings that would otherwise be covered for individuals for such wound therapy. (3) Payment amount.--The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to the amount of the payment that would be made under section 1833(t) (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device. (t) Site-of-Service Price Transparency.-- (1) In general.--In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title, the Secretary shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an appropriate number of such items and services-- (A) the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and (B) the estimated amount of beneficiary liability applicable to the item or service. (2) Calculation of estimated beneficiary liability.-- For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible. (3) Implementation.--In carrying out this subsection, the Secretary-- (A) shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and (B) may utilize mechanisms in existence on the date of enactment of this subsection, such as the portion of the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare Internet website), to make available such estimated amounts under such paragraph. (4) Funding.--For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2017, to remain available until expended. (u) Payment and Related Requirements for Home Infusion Therapy.-- (1) Payment.-- (A) Single payment.-- (i) In general.--Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement a payment system under which a single payment is made under this title to a qualified home infusion therapy supplier for items and services described in subparagraphs (A) and (B) of section 1861(iii)(2)) furnished by a qualified home infusion therapy supplier (as defined in section 1861(iii)(3)(D)) in coordination with the furnishing of home infusion drugs (as defined in section 1861(iii)(3)(C)) under this part. (ii) Unit of single payment.--A unit of single payment under the payment system implemented under this subparagraph is for each infusion drug administration calendar day in the individual's home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type. (iii) Limitation.--The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under section 1848 for infusion therapy services furnished in a calendar day if furnished in a physician office setting, except such single payment shall not reflect more than 5 hours of infusion for a particular therapy in a calendar day. (B) Required adjustments.--The Secretary shall adjust the single payment amount determined under subparagraph (A) for home infusion therapy services under section 1861(iii)(1) to reflect other factors such as-- (i) a geographic wage index and other costs that may vary by region; and (ii) patient acuity and complexity of drug administration. (C) Discretionary adjustments.-- (i) In general.--Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of subparagraph (B)) to reflect outlier situations and other factors as the Secretary determines appropriate. (ii) Requirement of budget neutrality.--Any adjustment under this subparagraph shall be made in a budget neutral manner. (2) Considerations.--In developing the payment system under this subsection, the Secretary may consider the costs of furnishing infusion therapy in the home, consult with home infusion therapy suppliers, consider payment amounts for similar items and services under this part and part A, and consider payment amounts established by Medicare Advantage plans under part C and in the private insurance market for home infusion therapy (including average per treatment day payment amounts by type of home infusion therapy). (3) Annual updates.-- (A) In general.--Subject to subparagraph (B), the Secretary shall update the single payment amount under this subsection from year to year beginning in 2022 by increasing the single payment amount from the prior year by the percentage increase in the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year. (B) Adjustment.--For each year, the Secretary shall reduce the percentage increase described in subparagraph (A) by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in a percentage being less than 0.0 for a year, and may result in payment being less than such payment rates for the preceding year. (4) Authority to apply prior authorization.--The Secretary may, as determined appropriate by the Secretary, apply prior authorization for home infusion therapy services under section 1861(iii)(1). (5) Accreditation of qualified home infusion therapy suppliers.-- (A) Factors for designation of accreditation organizations.--The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C): (i) The ability of the organization to conduct timely reviews of accreditation applications. (ii) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D)). (iii) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation. (iv) Such other factors as the Secretary determines appropriate. (B) Designation.--Not later than January 1, 2021, the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C). (C) Review and modification of list of accreditation organizations.-- (i) In general.--The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B). (ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations.--In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect. (D) Rule for accreditations made prior to designation.--In the case of a supplier that is accredited before January 1, 2021, by an accreditation organization designated by the Secretary under subparagraph (B) as of January 1, 2019, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2023, for the remaining period such accreditation is in effect. (6) Notification of infusion therapy options available prior to furnishing home infusion therapy.-- Prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan described in section 1861(iii)(1) for the individual shall provide notification (in a form, manner, and frequency determined appropriate by the Secretary) of the options available (such as home, physician's office, hospital outpatient department) for the furnishing of infusion therapy under this part. (7) Home infusion therapy services temporary transitional payment.-- (A) Temporary transitional payment.-- (i) In general.--The Secretary shall, in accordance with the payment methodology described in subparagraph (B) and subject to the provisions of this paragraph, provide a home infusion therapy services temporary transitional payment under this part to an eligible home infusion supplier (as defined in subparagraph (F)) for items and services described in subparagraphs (A) and (B) of section 1861(iii)(2)) furnished during the period specified in clause (ii) by such supplier in coordination with the furnishing of transitional home infusion drugs (as defined in clause (iii)). (ii) Period specified.--For purposes of clause (i), the period specified in this clause is the period beginning on January 1, 2019, and ending on the day before the date of the implementation of the payment system under paragraph (1)(A). (iii) Transitional home infusion drug defined.--For purposes of this paragraph, the term ``transitional home infusion drug'' has the meaning given to the term ``home infusion drug'' under section 1861(iii)(3)(C)), except that clause (ii) of such section shall not apply if a drug described in such clause is identified in clauses (i), (ii), (iii) or (iv) of subparagraph (C) as of the date of the enactment of this paragraph. (B) Payment methodology.--For purposes of this paragraph, the Secretary shall establish a payment methodology, with respect to items and services described in subparagraph (A)(i). Under such payment methodology the Secretary shall-- (i) create the three payment categories described in clauses (i), (ii), and (iii) of subparagraph (C); (ii) assign drugs to such categories, in accordance with such clauses; (iii) assign appropriate Healthcare Common Procedure Coding System (HCPCS) codes to each payment category; and (iv) establish a single payment amount for each such payment category, in accordance with subparagraph (D), for each infusion drug administration calendar day in the individual's home for drugs assigned to such category. (C) Payment categories.-- (i) Payment category 1.--The Secretary shall create a payment category 1 and assign to such category drugs which are covered under the Local Coverage Determination on External Infusion Pumps (LCD number L33794) and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J0133, J0285, J0287, J0288, J0289, J0895, J1170, J1250, J1265, J1325, J1455, J1457, J1570, J2175, J2260, J2270, J2274, J2278, J3010, or J3285. (ii) Payment category 2.--The Secretary shall create a payment category 2 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J1555 JB, J1559 JB, J1561 JB, J1562 JB, J1569 JB, or J1575 JB. (iii) Payment category 3.--The Secretary shall create a payment category 3 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J9000, J9039, J9040, J9065, J9100, J9190, J9200, J9360, or J9370. (iv) Infusion drugs not otherwise included.--With respect to drugs that are not included in payment category 1, 2, or 3 under clause (i), (ii), or (iii), respectively, the Secretary shall assign to the most appropriate of such categories, as determined by the Secretary, drugs which are-- (I) covered under such local coverage determination and billed under HCPCS codes J7799 or J7999 (as identified as of July 1, 2017, and as subsequently modified by the Secretary); or (II) billed under any code that is implemented after the date of the enactment of this paragraph and included in such local coverage determination or included in subregulatory guidance as a home infusion drug described in subparagraph (A)(i). (D) Payment amounts.-- (i) In general.--Under the payment methodology, the Secretary shall pay eligible home infusion suppliers, with respect to items and services described in subparagraph (A)(i) furnished during the period described in subparagraph (A)(ii) by such supplier to an individual, at amounts equal to the amounts determined under the physician fee schedule established under section 1848 for services furnished during the year for codes and units of such codes described in clauses (ii), (iii), and (iv) with respect to drugs included in the payment category under subparagraph (C) specified in the respective clause, determined without application of the geographic adjustment under subsection (e) of such section. (ii) Payment amount for category 1.-- For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 1 described in subparagraph (C)(i), are one unit of HCPCS code 96365 plus three units of HCPCS code 96366 (as identified as of January 1, 2018, and as subsequently modified by the Secretary). (iii) Payment amount for category 2.--For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 2 described in subparagraph (C)(i), are one unit of HCPCS code 96369 plus three units of HCPCS code 96370 (as identified as of January 1, 2018, and as subsequently modified by the Secretary). (iv) Payment amount for category 3.-- For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 3 described in subparagraph (C)(i), are one unit of HCPCS code 96413 plus three units of HCPCS code 96415 (as identified as of January 1, 2018, and as subsequently modified by the Secretary). (E) Clarifications.-- (i) Infusion drug administration day.--For purposes of this subsection, with respect to the furnishing of transitional home infusion drugs or home infusion drugs to an individual by an eligible home infusion supplier or a qualified home infusion therapy supplier, a reference to payment to such supplier for an infusion drug administration calendar day in the individual's home shall refer to payment only for the date on which professional services (as described in section 1861(iii)(2)(A)) were furnished to administer such drugs to such individual. For purposes of the previous sentence, an infusion drug administration calendar day shall include all such drugs administered to such individual on such day. (ii) Treatment of multiple drugs administered on same infusion drug administration day.--In the case that an eligible home infusion supplier, with respect to an infusion drug administration calendar day in an individual's home, furnishes to such individual transitional home infusion drugs which are not all assigned to the same payment category under subparagraph (C), payment to such supplier for such infusion drug administration calendar day in the individual's home shall be a single payment equal to the amount of payment under this paragraph for the drug, among all such drugs so furnished to such individual during such calendar day, for which the highest payment would be made under this paragraph. (F) Eligible home infusion suppliers.--In this paragraph, the term ``eligible home infusion supplier'' means a supplier that is enrolled under this part as a pharmacy that provides external infusion pumps and external infusion pump supplies and that maintains all pharmacy licensure requirements in the State in which the applicable infusion drugs are administered. (G) Implementation.--Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. (v) Payment for Outpatient Physical Therapy Services and Outpatient Occupational Therapy Services Furnished by a Therapy Assistant.-- (1) In general.--In the case of an outpatient physical therapy service or outpatient occupational therapy service furnished on or after January 1, 2022, for which payment is made under section 1848 or subsection (k), that is furnished in whole or in part by a therapy assistant (as defined by the Secretary), the amount of payment for such service shall be an amount equal to 85 percent of the amount of payment otherwise applicable for the service under this part. Nothing in the preceding sentence shall be construed to change applicable requirements with respect to such services. (2) Use of modifier.-- (A) Establishment.--Not later than January 1, 2019, the Secretary shall establish a modifier to indicate (in a form and manner specified by the Secretary), in the case of an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined), that the service was furnished by a therapy assistant. (B) Required use.--Each request for payment, or bill submitted, for an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined) on or after January 1, 2020, shall include the modifier established under subparagraph (A) for each such service. (3) Implementation.--The Secretary shall implement this subsection through notice and comment rulemaking. (w) Opioid Use Disorder Treatment Services.-- (1) In general.--The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program. (2) Considerations.--The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (3) Annual updates.--The Secretary shall provide an update each year to the bundled payment amounts under this subsection. * * * * * * * VII. DISSENTING VIEWS H.R. 3436, introduced by Representative DelBene (D-WA), amends Title XVIII of the Social Security Act to eliminate patient cost-sharing responsibilities for chronic care management (CCM) services under the Medicare program. The Medicare Hospital Insurance Trust Fund is expected to be exhausted in 2026. That means there will not be enough funds to cover senior's health care costs in only seven years' time, putting seniors' benefits and health care in jeopardy. A major contributing factor to high health care costs is that consumers have become increasingly insulated from the cost of health care services. For instance, at least 80% of Medicare beneficiaries have some type of supplemental coverage, which means the vast majority of Medicare beneficiaries currently pay little or nothing in cost sharing. This bill exacerbates that trend by eliminating cost- sharing for certain beneficiaries and shifting the cost of those services onto the already struggling Medicare program. To lower health care costs overall, Congress must advance policies that increase transparency about the price and incentivize consumers to properly utilize services--not paper over the price with more government spending. Under the CCM billing code, a clinician can bill each month for up to 20 minutes of non-face-to-face time for patients with two or more chronic conditions. This could include time spent talking to a lab regarding lab results or a pharmacist who calls the physician's office because the patient reported a rash using certain medication. It is a slippery slope for the government to use taxpayer dollars to not only pay for the natural communication and care coordination between health care providers, but take the next step and pay for all cost-sharing. This policy is consistent, however, with the Democrats' so- called ``Medicare for All'' proposals, where the government would pay the tab for everything, an unprecedented level of federal intervention. Under the CCM billing code, the patient must have two or more chronic conditions that: (1) are expected to last at least 12 months or until death, and (2) place the patient at significant risk of death, acute exacerbation or decompensation, or functional decline. Diagnoses that may be likely to qualify include diabetes, chronic obstructive pulmonary disease, cardiovascular disease, or atrial fibrillation. These are serious, costly conditions, but there are countless serious diseases that affect the daily lives of millions of Americans, and the government should not be picking winners and losers among disease groups and patient groups. Rather than expanding fee-for-service Medicare, we should be focused on paying for improved healthcare outcomes. Medicare is moving away from fee-for-service in order to pay for value rather than volume of services. Alternative payment models in Medicare focus on improving the coordination of care and improving the quality of care. Within the same vein, we should be focused on getting more seniors into plans that are designed around their needs. In Medicare Advantage, seniors with serious chronic conditions are able to enroll in a special needs plan tailored to their condition. These plans offer better benefits than traditional Medicare, and seniors are able to choose what type of care coordination they value the most. Moreover, these plans have the ability to reduce cost-sharing on services that will keep seniors with chronic conditions healthy. For example, a plan designed for diabetic patients would be able to offer coverage for foot and eye exams to make sure their patient is in good condition. Kevin Brady, Republican Leader, Committee on Ways and Means. [all]