[House Report 116-660]
[From the U.S. Government Publishing Office]
116th Congress } { Rept. 116-660
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
HELPING OUR SENIOR POPULATION IN COMFORT ENVIRONMENTS ACT
_______
December 17, 2020.--Ordered to be printed
_______
Mr. Neal, from the Committee on Ways and Means, submitted the following
R E P O R T
[To accompany H.R. 5821]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 5821) to amend title XVIII of the Social Security
Act to establish hospice program survey and enforcement
procedures under the Medicare program, and for other purposes,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND............................................5
A. Purpose and Summary............................................5
B. Background and Need for Legislation............................5
C. Legislative History............................................6
II. EXPLANATION OF THE BILL...........................................6
A. The HOSPICE Act................................................6
III.VOTES OF THE COMMITTEE...........................................13
IV. BUDGET EFFECTS OF THE BILL.......................................13
A. Committee Estimate of Budgetary Effects.......................13
B. Statement Regarding New Budget Authority and Tax Expenditures
Budget Authority.................................................13
C. Cost Estimate Prepared by the Congressional Budget Office.....13
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......17
A. Committee Oversight Findings and Recommendations..............17
B. Statement of General Performance Goals and Objectives.........17
C. Information Relating to Unfunded Mandates.....................17
D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits.........................................................17
E. Duplication of Federal Programs...............................17
F. Hearings......................................................17
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED............18
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 ``Helping Our Senior Population in
Comfort Environments Act'' or the ``HOSPICE Act''.
SEC. 2. ESTABLISHING HOSPICE PROGRAM SURVEY AND ENFORCEMENT PROCEDURES
UNDER THE MEDICARE PROGRAM.
(a) Survey and Enforcement Procedures.--
(1) In general.--Part A of title XVIII of the Social Security
Act (42 U.S.C. 1395c et seq.) is amended by adding at the end
the following new section:
``SEC. 1822. HOSPICE PROGRAM SURVEY AND ENFORCEMENT PROCEDURES.
``(a) Surveys.--
``(1) Frequency.--Any entity that is certified as a hospice
program shall be subject to a standard survey by an appropriate
State or local survey agency, or an approved accreditation
agency, as determined by the Secretary, not less frequently
than once every 36 months (and not less frequently than once
every 24 months beginning October 1, 2021).
``(2) Public transparency of survey and certification
information.--
``(A) Submission of information to the secretary.--
``(i) In general.--Each State, and each
national accreditation body with respect to
which the Secretary has made a finding under
section 1865(a) respecting the accreditation of
a hospice program by such body, shall submit,
in a form and manner, and at a time, specified
by the Secretary for purposes of this
subparagraph, information respecting any survey
or certification made with respect to a hospice
program by such State or body, as applicable.
Such information shall include any inspection
report made by such State or body with respect
to such survey or certification, any
enforcement actions taken as a result of such
survey or certification, and any other
information determined appropriate by the
Secretary.
``(ii) Required inclusion of specified
form.--With respect to a survey under this
subsection carried out by a national
accreditation body described in clause (i) on
or after October 1, 2021, information described
in such clause shall include Form 2567 (or a
successor form), along with such additional
information determined appropriate by such
body.
``(B) Public disclosure of information.--Beginning
not later than October 1, 2022, the Secretary shall
publish the information submitted under subparagraph
(A) on the public website of the Centers for Medicare &
Medicaid Services in a manner that is prominent, easily
accessible, readily understandable, and searchable. The
Secretary shall provide for the timely update of such
information so published.
``(3) Consistency of surveys.--Each State and the Secretary
shall implement programs to measure and reduce inconsistency in
the application of survey results among surveyors.
``(4) Survey teams.--
``(A) In general.--In the case of a survey conducted
under this subsection on or after October 1, 2021, by
more than 1 individual, such survey shall be conducted
by a multidisciplinary team of professionals (including
a registered professional nurse).
``(B) Prohibition of conflicts of interest.--
Beginning October 1, 2021, a State may not use as a
member of a survey team under this subsection an
individual who is serving (or has served within the
previous 2 years) as a member of the staff of, or as a
consultant to, the program surveyed respecting
compliance with the requirements of section 1861(dd) or
who has a personal or familial financial interest in
the program being surveyed.
``(C) Training.--The Secretary shall provide, not
later than October 1, 2021, for the comprehensive
training of State and Federal surveyors, and any
surveyor employed by a national accreditation body
described in paragraph (2)(A)(i), in the conduct of
surveys under this subsection, including training with
respect to the review of written plans for providing
hospice care (as described in section 1814(a)(7)(B)).
No individual shall serve as a member of a survey team
with respect to a survey conducted on or after such
date unless the individual has successfully completed a
training and testing program in survey and
certification techniques that has been approved by the
Secretary.
``(5) Funding.--The Secretary shall provide for the transfer,
from the Federal Hospital Insurance Trust Fund under section
1817 to the Centers for Medicare & Medicaid Program Management
Account, of $10,000,000 for each fiscal year (beginning with
fiscal year 2022) for purposes of carrying out surveys under
this subsection. Sums so transferred shall remain available
until expended. Any transfer pursuant to this paragraph shall
be in addition to any transfer pursuant to section 3(a)(2) of
the Improving Medicare Post-Acute Care Transformation Act of
2014.
``(b) Special Focus Program.--
``(1) In general.--The Secretary shall conduct a special
focus program for enforcement of requirements for hospice
programs that the Secretary has identified as having
substantially failed to meet applicable requirements of this
Act.
``(2) Periodic surveys.--Under such special focus program,
the Secretary shall conduct surveys of each hospice program in
the special focus program not less than once every 6 months.
``(c) Enforcement.--
``(1) Situations involving immediate jeopardy.--If the
Secretary determines on the basis of a standard survey or
otherwise that a hospice program that is certified for
participation under this title is no longer in compliance with
the requirements specified in section 1861(dd) and determines
that the deficiencies involved immediately jeopardize the
health and safety of the individuals to whom the program
furnishes items and services, the Secretary shall take
immediate action to remove the jeopardy and correct the
deficiencies through the remedy described in paragraph
(5)(B)(iii) or terminate the certification of the program, and
may provide, in addition, for 1 or more of the other remedies
described in paragraph (5)(B).
``(2) Situations not involving immediate jeopardy.--If the
Secretary determines on the basis of a standard survey or
otherwise that a hospice program that is certified for
participation under this title is no longer in compliance with
the requirements specified in section 1861(dd) and determines
that the deficiencies involved do not immediately jeopardize
the health and safety of the individuals to whom the program
furnishes items and services, the Secretary may (for a period
not to exceed 6 months) impose remedies developed pursuant to
paragraph (5)(A), in lieu of terminating the certification of
the program. If, after such a period of remedies, the program
is still no longer in compliance with such requirements, the
Secretary shall terminate the certification of the program.
``(3) Penalty for previous noncompliance.--If the Secretary
determines that a hospice program that is certified for
participation under this title is in compliance with the
requirements specified in section 1861(dd) but, as of a
previous period, did not meet such requirements, the Secretary
may provide for a civil monetary penalty under paragraph
(5)(B)(i) for the days in which the Secretary finds that the
program was not in compliance with such requirements.
``(4) Option to continue payments for noncompliant hospice
programs.--The Secretary may continue payments under this title
with respect to a hospice program not in compliance with the
requirements specified in section 1861(dd) over a period of not
longer than 6 months, if--
``(A) the State or local survey agency finds that it
is more appropriate to take alternative action to
assure compliance of the program with such requirements
than to terminate the certification of the program;
``(B) the program has submitted a plan and timetable
for corrective action to the Secretary for approval and
the Secretary approves the plan of corrective action;
and
``(C) the program agrees to repay to the Federal
Government payments received under this title during
such period if the corrective action is not taken in
accordance with the approved plan and timetable.
The Secretary shall establish guidelines for approval of
corrective actions requested by hospice programs under this
paragraph.
``(5) Remedies.--
``(A) Development.--
``(i) In general.--Not later than October 1,
2021, the Secretary shall develop and
implement--
``(I) a range of remedies to apply to
hospice programs under the conditions
described in paragraphs (1) through
(4); and
``(II) appropriate procedures for
appealing determinations relating to
the imposition of such remedies.
Remedies developed pursuant to the preceding
sentence shall include the remedies specified
in subparagraph (B).
``(ii) Conditions of imposition of
remedies.--Not later than October 1, 2021, the
Secretary shall develop and implement specific
procedures with respect to the conditions under
which each of the remedies developed under
clause (i) is to be applied, including the
amount of any fines and the severity of each of
these remedies. Such procedures shall be
designed so as to minimize the time between
identification of deficiencies and imposition
of these remedies and shall provide for the
imposition of incrementally more severe fines
for repeated or uncorrected deficiencies.
``(B) Specified remedies.--The remedies specified in
this subparagraph are the following:
``(i) Civil monetary penalties in an amount
not to exceed $10,000 for each day of
noncompliance by a hospice program with the
requirements specified in section 1861(dd).
``(ii) Suspension of all or part of the
payments to which a hospice program would
otherwise be entitled under this title with
respect to items and services furnished by a
hospice program on or after the date on which
the Secretary determines that remedies should
be imposed pursuant to paragraph (2).
``(iii) The appointment of temporary
management to oversee the operation of the
hospice program and to protect and assure the
health and safety of the individuals under the
care of the program while improvements are made
in order to bring the program into compliance
with all such requirements.
``(C) Procedures.--
``(i) Civil monetary penalties.--
``(I) In general.--Subject to
subclause (II), the provisions of
section 1128A (other than subsections
(a) and (b)) shall apply to a civil
monetary penalty under this subsection
in the same manner as such provisions
apply to a penalty or proceeding under
section 1128A(a).
``(II) Retention of amounts for
hospice program improvements.--The
Secretary may provide that any portion
of civil monetary penalties collected
under this subsection may be used to
support activities that benefit
individuals receiving hospice care,
including education and training
programs to ensure hospice program
compliance with the requirements of
section 1861(dd).
``(ii) Suspension of payment.--A finding to
suspend payment under subparagraph (B)(ii)
shall terminate when the Secretary finds that
the program is in substantial compliance with
all such requirements.
``(iii) Temporary management.--The temporary
management under subparagraph (B)(iii) shall
not be terminated until the Secretary has
determined that the program has the management
capability to ensure continued compliance with
all the requirements referred to in such
subparagraph.
``(D) Relationship to other remedies.--The remedies
developed under subparagraph (A) are in addition to
sanctions otherwise available under State or Federal
law and shall not be construed as limiting other
remedies, including any remedy available to an
individual at common law.''.
(2) Availability of hospice accreditation surveys.--Section
1865(b) of the Social Security Act (42 U.S.C. 1395bb(b)) is
amended by inserting ``or, beginning on the date of the
enactment of the HOSPICE Act, a hospice program'' after ``home
health agency''.
(3) State provision of hospice program information.--
(A) In general.--Section 1864(a) of the Social
Security Act (42 U.S.C. 1395aa(a)) is amended in the
sixth sentence--
(i) by inserting ``and hospice programs''
after ``information on home health agencies'';
(ii) by inserting ``or the hospice program''
after ``the home health agency'';
(iii) by inserting ``or the hospice program''
after ``with respect to the agency''; and
(iv) by inserting ``and hospice programs''
after ``with respect to home health agencies''.
(B) Effective date.--The amendments made by
subparagraph (A) shall apply with respect to agreements
entered into on or after, or in effect as of, the date
that is 1 year after the date of the enactment of this
Act.
(4) Conforming amendments.--
(A) Definition of a hospice program.--Section
1861(dd)(4) of the Social Security Act (42 U.S.C.
1395x(dd)(4)) is amended by striking subparagraph (C).
(B) Continuation of funding.--Section 3(a)(2) of the
Improving Medicare Post-Acute Care Transformation Act
of 2014 is amended by inserting ``and section
1822(a)(1) of such Act,'' after ``as added by paragraph
(1),''.
(b) Increasing Payment Reductions for Failure to Meet Quality Data
Reporting Requirements.--Section 1814(i)(5)(A)(i) of the Social
Security Act (42 U.S.C. 1395f(i)(5)(A)(i)) is amended by inserting
``(or, for fiscal year 2023 and each subsequent fiscal year, 4
percentage points)'' before the period.
(c) Report.--Not later than 36 months after the date of the enactment
of this Act, the Comptroller General of the United States shall submit
to the Committee on Ways and Means of the House of Representatives and
the Committee on Finance of the Senate a report containing an analysis
of the effects of the amendments made by subsection (a), including the
frequency of application of remedies specified in section 1822(c)(5)(B)
of the Social Security Act (as added by such subsection), on access to,
and quality of, care furnished by hospice programs under part A of
title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.).
I. Summary and Background
A. PURPOSE AND SUMMARY
H.R. 5821 the Helping Our Senior Population in Comfort
Environments (HOSPICE) Act, as amended and ordered reported by
the Committee on Ways and Means on February 12, 2020, amends
Title XVIII of the Social Security Act to provide additional
oversight and transparency of Medicare hospice providers, which
deliver care to patients nearing the end of life. H.R. 5821 was
introduced by Representatives Jimmy Panetta (D-CA-) and Tom
Reed (R-NY), on February 10, 2020.
B. BACKGROUND AND NEED FOR LEGISLATION
The Department of Health and Human Services (HHS) Office of
Inspector General (OIG) released two reports in July 2019 that
identified significant deficiencies in the quality of care
delivered to Medicare hospice enrollees.\1\\2\ According to the
OIG studies, 87 percent of hospices had at least one care
deficiency between 2012 and 2016. Twenty percent (903 out of
4,563 hospices surveyed) had at least one serious deficiency,
meaning the health and safety of a beneficiary were in jeopardy
or the hospice was limited in its capacity to deliver adequate
care. The OIG issued a series of recommendations for the
improvement of quality in hospice care, many of which are
addressed through H.R. 5821.
---------------------------------------------------------------------------
\1\Hospice Deficiencies Pose Risks to Medicare Beneficiaries, HHS
Office of Inspector General (July 3, 2019), https://oig.hhs.gov/oei/
reports/oei-02-17-00020.asp?utm_source=mmpage
&utm_medium=web&utm_campaign=OEI-02-17-00020.
\2\Safeguards Must Be Strengthened to Protect Medicare Hospice
Beneficiaries From Harm, HHS Office of Inspector General (July 3,
2019), https://oig.hhs.gov/oei/reports/oei-02-17-
00021.asp?utm_source=mmpage&utm_medium=web&utm_campaign=OEI-02-17-
00021.
---------------------------------------------------------------------------
Consistent with the OIG recommendations, H.R. 5821 provides
the HHS Secretary (the Secretary) with additional tools, which
align those that already exist for Medicare-certified skilled
nursing facilities and home health agencies, to oversee the
hospice program and provide support to help poor-performing
hospices improve. The legislation requires the Secretary to
develop a series of intermediate remedies--including corrective
action plans, suspension of payment, and civil monetary
penalties (CMPs)--in cases where the patient's health is at
risk. Some penalties paid under these additional oversight
standards may be reinvested back into the hospice program for
education of poor-performing providers. The HOSPICE Act
additionally requires state and federal surveyors to receive
comprehensive training to ensure consistent enforcement of the
Centers for Medicare & Medicaid Services (CMS) surveyor
guidance.
The HOSPICE Act also builds on improvements made in the
bipartisan Improving Medicare Post-Acute Care Transformation
Act of 2014\3\ by further increasing the frequency of surveys
of hospices from once every three years (as required under the
IMPACT Act) to once every two years. The bill requires
accreditation organizations who survey hospices to submit their
survey results to the Secretary and for CMS to publicly display
that information in an easily understandable format on the
agency's website.
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\3\Pub. L. No. 113-185.
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H.R. 5821 additionally creates a ``Special Focus Facility''
program that requires the Secretary to monitor and more
frequently survey poor-performing hospices, and the legislation
further requires states to maintain a toll-free hotline for
hospice patients and their families to report abuse and
neglect, similar to the one currently available for Medicare
beneficiaries using home health services. Finally, the bill
increases the penalty, from two percentage points to four, for
hospices that do not report quality data to the Secretary.
C. LEGISLATIVE HISTORY
Background
H.R. 5821 was introduced on February 10, 2020, and was
referred to the Committee on Ways and Means and additionally to
the Committee on Energy and Commerce.
Committee hearings
On November 13, 2019, the Committee on Ways and Mean held a
hearing entitled, ``Caring for Aging Americans.'' Among the
witnesses was Edo Banach, JD, President & Chief Executive
Officer of the National Hospice and Palliative Care
Organization, who discussed the challenges in the Medicare
hospice program, including the recent OIG report and the need
for increased oversight of the hospice program to protect
patients.
Committee action
The Committee on Ways and Means marked up H.R. 5821, the
HOSPICE Act, on February 12, 2020, and ordered the bill, as
amended, favorably reported by a voice vote (with a quorum
being present).
II. Explanation of the Bill
A. THE HOSPICE ACT
Current Law
The Medicare hospice benefit provides coverage for certain
services for Medicare beneficiaries with a life expectancy of
six months or less. The Medicare benefit covers a broad range
of services, including skilled nursing care; physician, home
health aide and homemaker services; and patient as well as
family bereavement counseling. Services are provided primarily
in the patient's home but may also be provided in institutional
settings, such as long-term care facilities.
Hospice services must be provided by a Medicare-certified
hospice agency. A certified hospice agency must be either a
public agency or private organization (or a subdivision of
either) that is primarily engaged in providing covered hospice
services and must make services available on a 24-hour basis.
To obtain and maintain federal certification, hospice agencies
must comply with federal regulatory requirements known as the
Conditions of Participation (CoPs). Medicare CoPs are distinct
from any state operational licensing requirements and
incorporate specific and general requirements set forth in
section 1861(dd) of the Social Security Act (SSA). The CoPs
include a broad array of requirements, such as the scope of
required services, patient rights (e.g., freedom from abuse),
and the organizational environment and structure of the
agency--including, but not limited to, staff qualifications and
the processes of clinical records management and/or infection
control.
There are two ways a hospice agency may be certified for
compliance of the CoPs. First, hospice agencies may choose to
use a private accrediting organization (AO) that is approved by
the Secretary. Second, if a hospice agency chooses not to be
accredited by an AO for certification, this agency is certified
for compliance by its respective local or state survey agency
(SA), in coordination with the Secretary. AOs and SAs ensure
the compliance of hospice agencies by, among other actions,
responding to any complaints made by beneficiaries, the public,
or representatives within the agency, and by performing
surveys, which generally are unannounced visits by a
professional or a team of professionals, known as a survey
team, to verify compliance with all regulatory requirements
(i.e., the CoPs). Survey teams can be deployed to conduct:
1. An initial Medicare certification survey to determine
compliance of all CoPs for a prospective agency,
2. Complaint investigations to assess the compliance of
specific CoPs, and/or
3. A standard survey, which occurs periodically to
comprehensively assess the compliance of all CoPs.
Surveys performed by SAs are subject to federal oversight,
which can include the auditing by federal surveyors.
Before the IMPACT Act, there was no statutory-required
frequency for which standard surveys of hospice agencies were
required to be completed. Additionally, aside from funding made
through general discretionary appropriations, there was no
mandatory spending specifically provided for surveying hospice
agencies. The IMPACT Act of 2014 amended Section 1861 of the
SSA to require that all hospice agencies be surveyed by an SA
or AO at least once every three years. The requirement started
six months after the October 6, 2014, enactment of the IMPACT
Act of 2014 and is set to end after Fiscal Year (FY) 2025
(September 30, 2025). For purposes of performing standard
surveys, the IMPACT Act of 2014 provided funding by directing
transfer from the Federal Hospital Insurance (HI) Trust Fund to
the CMS Program Management Account, in the amount of $25
million for each of FY 2015-2017 and $45 million for each of FY
2018-2025.
Although there currently are no statutory requirements for
the composition of survey teams, CMS provides guidance to all
surveyors as to the correct protocol for conducting a standard
survey as it relates to the relevant areas and items that must
be inspected or reviewed for each CoP. In addition to this
general guidance, CMS also details specific requirements that
are directed only at SAs. For example, CMS requires SAs to use
the CMS document entitled ``Principles of Documentation for the
Statement of Deficiencies'' (referred to as Form CMS 2567) to
document and report CoP deficiencies cited during a survey. AOs
have greater discretion, although their process could be
contingent upon approval of the organization by the Secretary
as to how deficiencies are documented and reported. Regardless
of the manner in which an AO constructs survey documentation,
Section 1865 of the SSA prohibits the Secretary from disclosing
the ``survey or information related to the survey,'' except to
the extent such survey and information is related to an
enforcement action taken by the Secretary.
To enforce compliance of federal requirements, the
Secretary has the authority to terminate the certification of a
hospice agency, which would remove the agency from the Medicare
program. The Secretary is not statutorily authorized to impose
certain remedies that are authorized for deficiencies found
during the surveys of other Medicare-certified organizations.
For example, the Secretary is authorized to impose fines (or
CMPs), for deficiencies found during the surveys of skilled
nursing facilities (SNFs) and Medicare home health agencies.
Currently, however, the Secretary is not authorized by law to
impose CMPs to hospice agencies for noncompliance.
Under Section 1814 of the SSA, the Secretary is required to
assess a financial penalty against hospice agencies that do not
report specified quality data to the Secretary. Currently,
hospice agencies that do not report quality data have their
Medicare hospice payments reduced by two percent.
Lastly, under Section 1864 of the SSA, SAs, in an agreement
with the Secretary, must maintain toll-free hotlines to collect
information pertaining to Medicare home health agencies.
Specifically, SAs must maintain hotlines that (1) collect,
maintain, and continually update information on home health
agencies, including significant deficiencies found with respect
to a survey conducted by an AO and any sanctions imposed, and
(2) receive complaints and answer questions with respect to
home health agencies. SAs are also required to maintain a unit
for investigating complaints that has enforcement authority and
access to survey reports of AOs and related medical records
(with consent of the individual or his or her legal
representative). Each investigative unit's enforcement
authority is limited to remedies authorized by law, although
states may develop remedial actions of their own.
Reasons for Change
Given the OIG's reports of patient safety concerns across
many hospices in the Medicare hospice program and the lack of
intermediary oversight and enforcement tools at the Secretary's
disposal, the Committee believes it is necessary to improve
hospice quality and ensure greater parity across Medicare's
post-acute and end-of-life settings of care. More specifically,
the provisions in H.R. 5821 require the Secretary to implement
a number of changes to the hospice program to align it with
both the SNF and home health settings and improve the quality
of care delivered to Medicare beneficiaries receiving hospice
services. Thus, the Committee anticipates CMS will implement
these statutory changes in a manner consistent with the
programs that already exist in other Medicare settings of care.
In developing this policy, consideration was given to the
inclusion of CMPs as an enforcement mechanism in the hospice
program, given concerns expressed by industry stakeholders
about the potential of such penalties to be punitive.
Ultimately, the policy recognizes CMPs are vital to ensuring
the Secretary will have at his or her disposal all of the same
similar mechanisms available in other settings of care to
ensure patient safety. The Secretary is encouraged to deploy
these new tools in a manner consistent with CMPs used in other
settings of care and in proportion to the severity of the
deficiency so that such penalties result in improved care for
hospice patients.
The bill also requires the Secretary to establish a
``Special Focus Program'' for hospice agencies that the
Secretary identifies as having substantially failed to meet
certification requirements, similar to the Special Focus
Program that current exists for SNFs. The Committee encourages
CMS to produce clear guidance for the program, including
defining ``substantially failed to meet,'' to ensure hospices,
SAs, and AOs have a clear understanding of the criteria the
Secretary intends to apply for entering and exiting the
program.
The policy additionally requires the Secretary to provide
``comprehensive training'' to all state and federal surveyors
of hospice agencies. The purpose of this provision is to ensure
greater uniformity across SAs and AOs as well as to increase
understanding of the unique aspects of the delivery of hospice
care. The comprehensive training would be required to include
training with respect to hospice written plans of care. The
Committee encourages CMS to include consideration for a
provider's electronic medical record in this plan-of-care
training. To ensure uniformity across hospice surveyors, the
Committee further encourages CMS to include training tailored
specific to hospice survey and certification techniques, as the
patient population has unique needs from other settings of
care. Such training could also include ways to better educate
hospice providers on emergency preparedness, including, but not
limited to, communication and risk assessment.
Explanation of Provisions
Section 1. Short Title.
The short title for this bill is the Helping Our Senior
Population in Comfort Environments (HOSPICE) Act.
Section 2. Establishing Hospice Program Survey and
Enforcement Procedures Under the Medicare Program.
(a) Survey and Enforcement Procedures
Subsection (a)(1) establishes a new section 1822 in Part A
of Title XVIII of the SSA. The following explanation of
provisions refers to the new section 1822 as created by H.R.
5821.
Survey Frequency and Funding
New paragraph 1822(a)(1) requires a SA or AO to perform a
standard survey of each Medicare hospice agency at a frequency
of no less than once every three years, until the end of
FY2021. Beginning FY2022, a SA or AO would be required to
perform a standard survey of each Medicare hospice agency at a
frequency of no less than once every two years.
New paragraph 1822(a)(2) requires that each state and
accreditation agency submit survey and certification
information to the Secretary. Such information shall be
publicly disclosed in an easy-to-understand format on CMS's
public website in a timely manner.
New paragraph 1822(a)(3) requires each state and the
Secretary to implement programs that measure and reduce the
inconsistency of the application of surveys across different
surveyors.
New paragraph 1822(a)(4) mandates that any standard survey
conducted by more than one surveyor shall be conducted by a
``multidisciplinary team of professionals,'' with at least one
registered nurse serving as a member of the survey team.
Additionally, states would be prohibited from surveying a
hospice agency with a survey team that includes an individual
who is serving, or has served within the previous two years, as
a staff member of or a consultant to the agency. This
prohibition applies to any person who ``has personal or
familial financial interest'' in the hospice agency being
surveyed. The paragraph also specifies that no later than
October 1, 2021, the Secretary must provide ``comprehensive
training'' to all state and federal surveyors of hospice
agencies.
New paragraph 1822(a)(5) provides funding, in the same
manner (from the HI Trust Fund), and in addition to the funding
provided by the IMPACT Act of 2014, to the CMS Program
Management Account in the amount of $10 million per FY,
beginning FY 2022. The funds would available for carrying out
standard surveys and would remain available until expended.
Special Focus Program
New subsection 1822(b) requires the Secretary to create a
Special Focus Program for poor-performing hospices, who will be
surveyed not less frequently than once every six months.
Enforcement
New subsection 1822(c) establishes two processes for the
enforcement of compliance when deficiencies are discovered
during a standard survey or otherwise. The main determinant of
which process would be used would be whether any discovered
deficiencies immediately jeopardize the health and safety of
the individuals receiving hospice care (which is referred to as
the presence of immediate jeopardy (IJ)).
1. If the presence of an IJ exists, the Secretary would be
required to take immediate action to either remove the IJ and
correct the deficiencies through the remedy of temporary
management or terminate the certification of the program and
may also impose aforementioned remedies.
2. If the presence of IJ does not exist, the Secretary
would be permitted, for a period of time that is not to exceed
six months, to impose aforementioned remedies in lieu of
terminating the certification of the agency. If after the
period of time the agency is still out of compliance with
federal requirements, the Secretary would be required to
terminate the agency's certification.
In either situation, the Secretary would be able to
continue Medicare payments to a hospice agency found out of
compliance for a period up to six months, if:
1. The SA finds that it is more appropriate to take
alternative action to assure compliance of the program with
such requirements than to terminate the agency's certification;
2. The agency has submitted a plan and timetable for
corrective action to the Secretary for approval and the
Secretary approves the plan of corrective action (under the
guidelines established by the Secretary); and
3. The agency agrees to repay to the federal government and
Medicare payments received during such period if the corrective
action is not taken in accordance with the approved plan and
timetable.
If the Secretary determines a hospice agency is currently
in compliance with CoPs but was previously noncompliant, the
Secretary would be permitted to assess the agency a CMP for
days in which the Secretary finds the agency was not in
compliance with the CoPs.
Subsection (c) also requires that the Secretary, no later
than the beginning of FY 2022, develop and implement remedies
that would be in addition to current federal and state
sanctions and would not be construed as limiting other existing
remedies. Specified remedies are to include:
1. CMPs, not to exceed $10,000 for each day of
noncompliance with the CoPs, to be applied using the processes
set forth under Section 1128A of the SSA, which provides
general authorities to the Secretary, and sets parameters, for
the imposition of CMPs.
2. The appointment of temporary management to oversee the
operation of a hospice agency. The temporary management would
remain until the Secretary has determined that the agency has
the management capability to ensure continued compliance of
certification requirements.
3. The suspension of all or part of Medicare payments,
which would terminate when the Secretary finds that the program
is in ``substantial compliance'' of all certification
requirements.
No later than the beginning of FY 2022, the Secretary would
be required to implement specific procedures for the conditions
under which the established remedies would be applied. Such
procedures would include the amount of any CMP and the severity
of each remedy. The procedures would be required to be designed
so as to minimize the time between identification of
deficiencies and the imposition of remedies, and to allow for
incrementally more severe fines for repeated or uncorrected
deficiencies. Additionally, the procedures would be required to
include a process for appealing determinations relating to the
imposition of the established remedies.
The Secretary would be able collect a portion of CMPs
collected from noncompliant hospice agencies and use those
funds to support activities that benefit individuals receiving
hospice care, including education and training programs to
ensure compliance with Medicare's hospice CoPs.
Additional Provisions
In addition to creating a new section 1822 in Part A of
Title XVIII of the SSA, subsection (a) of the bill also amends
SSA Section 1865 to allow the Secretary to disclose an AO's
hospice survey report, or information related to the survey,
regardless of whether or not the disclosure relates to an
enforcement action taken by the Secretary.
Subsection (a) also amends Section 1864 of the SSA to
include hospice agencies among the providers for which State or
local agencies must maintain a toll-free hotline for the
reporting of deficiencies and complaints, in addition to a unit
for processing such complaints. This would be effective one
year after the enactment of the proposed law.
(b) Increasing Payment Reductions for Failure to Meet
Quality Data Reporting Requirements
Subsection (b) increases the penalty for hospices not
reporting quality data to the Secretary from two to four
percentage points, beginning in FY 2021.
(c) Report
Subsection (c) requires the GAO to submit to the House
Committee on Ways and Means and the Senate Finance Committee,
no later than 36 months from enactment, a report that contains
an analysis of (1) the effects of the new requirements under
the new SSA Section 1822(a), (2) the frequency of application
of remedies specified by the proposed law, and (3) access to,
and quality of, hospice care provided by Medicare-certified
hospice agencies.
Effective Date
Section 2: Survey frequency updated to not less frequently
than once every 24 months, effective October 1, 2021.
Requirement that each national accreditation body complete
Form 2567, effective October 1, 2021.
Requirement that the Secretary publish survey information
on the CMS website, effective October 1, 2022.
Requirement that survey teams of more than one be conducted
by a multidisciplinary team of professionals, effective October
1, 2021.
Requirement that surveyors not have conflicts of interest,
effective October 1, 2021.
Requirement that the Secretary provide surveyor training,
no later than October 1, 2021.
Funding provided each FY, beginning with FY 2022.
Requirement that the Secretary develop a Special Focus
Program, effective on the date of enactment.
Requirement that the Secretary develop enforcement
penalties, no later than October 1, 2021.
Availability of accreditation surveys, effective on the
date of enactment.
Inclusion of hospices in each State's toll-free hotline,
effective one year after the date of enactment.
Increase in quality reporting payment reduction, starting
on FY 2023.
GAO report to Congress, no later than October 1, 2024.
III. Votes of the Committee
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the vote of the Committee on Ways and Means in its
consideration of H.R. 5821, the HOSPICE Act, on February 12,
2020.
The Chairman's amendment in the nature of a substitute was
adopted by a voice vote (with a quorum being present).
The bill, H.R. 5821 as amended, was ordered favorably
reported by voice vote (with a quorum being present).
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. 5821, 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, October 1, 2020.
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. 5821, the Helping
Our Senior Population in Comfort Environments Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Sarah
Sajewski, who can be reached at 226-9010.
Sincerely,
Phillip L. Swagel,
Director.
Enclosure.
H.R. 5821 would require hospice programs participating in
Medicare to undergo periodic surveys to ensure they comply with
federal standards. Under the bill, the Secretary of Health and
Human Services (HHS) could collect civil monetary penalties
from programs that fail to meet those standards. Under the
bill, hospice providers that fail to report certain data to the
Centers for Medicare & Medicaid Services (CMS) would be subject
to a reduction in federal payments that is larger than the
reduction applied under current law.
Provisions affecting direct spending: Overall, CBO
estimates that H.R. 5821 would reduce net direct spending by
$136 million over the 2021 2030 period (see Table 1).
Since 2014, hospice programs that do not report certain
quality data to CMS have been subject to a 2 percent reduction
in their annual payments. Using information on the share of
hospice programs that do not now report such data, CBO
estimates that over the 2021-2030 period, programs accounting
for about 15 percent of Medicare's payments to hospices will be
subject to the current-law reduction. Starting in 2023, H.R.
5821 would increase the reduction to 4 percent. CBO estimates
that under the bill, the number of hospices that do not report
would decline, and 10 percent of Medicare's payments to
hospices would be subject to the 4 percent reduction. CBO
estimates that the provision would decrease direct spending by
$277million over the 2021-2030 period.
Beginning in 2022, the bill would provide for a transfer of
$10 million annually from the Hospital Insurance (HI) Trust
Fund to CMS to fund surveys of hospice programs. The funds
would cover the cost of training surveyors and reviewing and
publishing survey results. CBO estimates that CMS would receive
$90 million in transfers from the HI trust fund over the 2021-
2030 period and that it would spend those amounts over the
period to implement the new requirements.
The bill would also give the Secretary authority to assess
penalties on hospice providers for failing to comply with
certain Medicare requirements. The Secretary would then be able
to spend amounts that are collected. CBO estimates that the new
authority would increase federal spending by $51 million over
the 2021 2030 period. The revenues collected under this
provision are discussed below.
Provision affecting direct spending and revenues: Under
current law, the Secretary of HHS cannot impose civil monetary
penalties when a hospice provider fails to comply with certain
Medicare requirements. H.R. 5821 would give the Secretary
authority to assess penalties of up to $10,000 for each day
that a provider is found not to be in compliance. Under the
bill, the Secretary of HHS could then spend revenues collected
in this manner on efforts to improve the Medicare program.
Using information on the number of hospice programs that have
received termination notices from CMS, CBO estimates that under
this provision, the federal government would collect $52million
in revenues over the 2021-2030 period.
Uncertainty: The key source of uncertainty in this estimate
is accurately assessing the number of hospices that do not
report quality data to CMS. Hospice providers vary greatly in
their size and business model, and it is difficult to
anticipate their decision making about whether to report data
under the increased payment reduction. Savings under the bill
could be larger or smaller than CBO estimates depending on the
number of hospice providers that report data.
The CBO staff contact for this estimate is Sarah Sajewski.
The estimate was reviewed by Paul Masi, Unit Chief for Health
Systems and Medicare, and Leo Lex, Deputy Director of Budget
Analysis.
TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 5821
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, millions of dollars--
-----------------------------------------------------------------------------------------------------------------------------------
2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2021-2025 2021-2030
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Net Increase or Decrease (-) in Direct Spending Outlays
Funding for Hospice Surveysa................................ 0 10 10 10 10 10 10 10 10 10 40 90
Increasing the Reduction in Payments for Hospices Not 0 0 -27 -29 -31 -33 -35 -38 -40 -44 -87 -277
Reporting Quality Dataa....................................
Spending From Authority to Apply a Civil Monetary Penalty:b
Budget Authority........................................ 0 5 5 6 6 6 6 6 6 6 22 52
Outlays................................................. 0 4 5 6 6 6 6 6 6 6 21 51
Total Changes in Direct Spending:
Estimated Budget Authority.......................... 0 15 -12 -13 -15 -17 -19 -22 -24 -28 -25 -135
Estimated Direct Spending........................... 0 14 -12 -13 -15 -17 -19 -22 -24 -28 -26 -136
Increases in Revenues
Revenues From Authority to Apply a Civil Monetary Penaltyb.. 0 5 5 6 6 6 6 6 6 6 22 52
Net Increase or Decrease (-) in the Deficit From Changes in Direct Spending and Revenues
Effect on the Deficit....................................... 0 9 -17 -19 -21 -23 -25 -28 -30 -34 -48 -188
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; estimates are relative to CBO's March 2020 Baseline.
a. Budget authority equals outlays.
b. Proposal would increase both direct spending and revenues, which are shown separately.
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-
4).
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 section 6104 of title 31, United States Code.
F. HEARINGS
In compliance with Sec.103(i) of H. Res. 6 (116th Congress)
(1) the following hearing was used to develop or consider
H.R. 5821:
On November 13, 2019, the Committee on Ways and Means held
a full-committee hearing entitled, ``Caring for Aging
Americans.''
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 italic, 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 A--Hospital Insurance Benefits for the Aged and Disabled
* * * * * * *
CONDITIONS OF AND LIMITATIONS ON PAYMENT FOR SERVICES
Requirement of Requests and Certifications
Sec. 1814. (a) Except as provided in subsections (d) and (g)
and in section 1876, payment for services furnished an
individual may be made only to providers of services which are
eligible therefor under section 1866 and only if--
(1) written request, signed by such individual,
except in cases in which the Secretary finds it
impracticable for the individual to do so, is filed for
such payment in such form, in such manner, and by such
person or persons as the Secretary may by regulation
prescribe, no later than the close of the period ending
1 calendar year after the date of service;
(2) a physician, or, in the case of services
described in subparagraph (B), a physician, or a nurse
practitioner, a clinical nurse specialist, or a
physician assistant (as those terms are defined in
section 1861(aa)(5)) who does not have a direct or
indirect employment relationship with the facility but
is working in collaboration with a physician,, or, in
the case of services described in subparagraph (C), a
physician enrolled under section 1866(j), certifies
(and recertifies, where such services are furnished
over a period of time, in such cases, with such
frequency, and accompanied by such supporting material,
appropriate to the case involved, as may be provided by
regulations, except that the first of such
recertifications shall be required in each case of
inpatient hospital services not later than the 20th day
of such period) that--
(A) in the case of inpatient psychiatric
hospital services, such services are or were
required to be given on an inpatient basis, by
or under the supervision of a physician, for
the psychiatric treatment of an individual; and
(i) such treatment can or could reasonably be
expected to improve the condition for which
such treatment is or was necessary or (ii)
inpatient diagnostic study is or was medically
required and such services are or were
necessary for such purposes;
(B) in the case of post-hospital extended
care services, such services are or were
required to be given because the individual
needs or needed on a daily basis skilled
nursing care (provided directly by or requiring
the supervision of skilled nursing personnel)
or other skilled rehabilitation services, which
as a practical matter can only be provided in a
skilled nursing facility on an inpatient basis,
for any of the conditions with respect to which
he was receiving inpatient hospital services
(or services which would constitute inpatient
hospital services if the institution met the
requirements of paragraphs (6) and (9) of
section 1861(e)) prior to transfer to the
skilled nursing facility or for a condition
requiring such extended care services which
arose after such transfer and while he was
still in the facility for treatment of the
condition or conditions for which he was
receiving such inpatient hospital services;
(C) in the case of home health services, such
services are or were required because the
individual is or was confined to his home
(except when receiving items and services
referred to in section 1861(m)(7)) and needs or
needed skilled nursing care (other than solely
venipuncture for the purpose of obtaining a
blood sample) on an intermittent basis or
physical or speech therapy or, in the case of
an individual who has been furnished home
health services based on such a need and who no
longer has such a need for such care or
therapy, continues or continued to need
occupational therapy; a plan for furnishing
such services to such individual has been
established and is periodically reviewed by a
physician; such services are or were furnished
while the individual was under the care of a
physician, and, in the case of a certification
made by a physician after January 1, 2010,
prior to making such certification the
physician must document that the physician
himself or herself, or a nurse practitioner or
clinical nurse specialist (as those terms are
defined in section 1861(aa)(5)) who is working
in collaboration with the physician in
accordance with State law, or a certified
nurse-midwife (as defined in section 1861(gg))
as authorized by State law, or a physician
assistant (as defined in section 1861(aa)(5))
under the supervision of the physician, has had
a face-to-face encounter (including through use
of telehealth, subject to the requirements in
section 1834(m), and other than with respect to
encounters that are incident to services
involved) with the individual within a
reasonable timeframe as determined by the
Secretary; or
(D) in the case of inpatient hospital
services in connection with the care,
treatment, filling, removal, or replacement of
teeth or structures directly supporting teeth,
the individual, because of his underlying
medical condition and clinical status or
because of the severity of the dental
procedure, requires hospitalization in
connection with the provision of such services;
(3) with respect to inpatient hospital services
(other than inpatient psychiatric hospital services)
which are furnished over a period of time, a physician
certifies that such services are required to be given
on an inpatient basis for such individual's medical
treatment, or that inpatient diagnostic study is
medically required and such services are necessary for
such purpose, except that (A) such certification shall
be furnished only in such cases, with such frequency,
and accompanied by such supporting material,
appropriate to the cases involved, as may be provided
by regulations, and (B) the first such certification
required in accordance with clause (A) shall be
furnished no later than the 20th day of such period;
(4) in the case of inpatient psychiatric hospital
services, the services are those which the records of
the hospital indicate were furnished to the individual
during periods when he was receiving (A) intensive
treatment services, (B) admission and related services
necessary for a diagnostic study, or (C) equivalent
services;
(5) with respect to inpatient hospital services
furnished such individual after the 20th day of a
continuous period of such services, there was not in
effect, at the time of admission of such individual to
the hospital, a decision under section 1866(d) (based
on a finding that utilization review of long-stay cases
is not being made in such hospital);
(6) with respect to inpatient hospital services or
post-hospital extended care services furnished such
individual during a continuous period, a finding has
not been made (by the physician members of the
committee or group, as described in section 1861(k)(4),
including any finding made in the course of a sample or
other review of admissions to the institution) pursuant
to the system of utilization review that further
inpatient hospital services or further post-hospital
extended care services, as the case may be, are not
medically necessary; except that, if such a finding has
been made, payment may be made for such services
furnished before the 4th day after the day on which the
hospital or skilled nursing facility, as the case may
be, received notice of such finding;
(7) in the case of hospice care provided an
individual--
(A)(i) in the first 90-day period--
(I) the individual's attending
physician (as defined in section
1861(dd)(3)(B)) (which for purposes of
this subparagraph does not include a
nurse practitioner or a physician
assistant), and
(II) the medical director (or
physician member of the
interdisciplinary group described in
section 1861(dd)(2)(B)) of the hospice
program providing (or arranging for)
the care,
each certify in writing at the beginning of the
period, that the individual is terminally ill
(as defined in section 1861(dd)(3)(A)) based on
the physician's or medical director's clinical
judgment regarding the normal course of the
individual's illness, and
(ii) in a subsequent 90- or 60-day period,
the medical director or physician described in
clause (i)(II) recertifies at the beginning of
the period that the individual is terminally
ill based on such clinical judgment;
(B) a written plan for providing hospice care
with respect to such individual has been
established (before such care is provided by,
or under arrangements made by, that hospice
program) and is periodically reviewed by the
individual's attending physician and by the
medical director (and the interdisciplinary
group described in section 1861(dd)(2)(B)) of
the hospice program;
(C) such care is being or was provided
pursuant to such plan of care;
(D) on and after January 1, 2011 (and, in the
case of clause (ii), before the date of
enactment of subparagraph (E))--
(i) a hospice physician or nurse
practitioner has a face-to-face
encounter with the individual to
determine continued eligibility of the
individual for hospice care prior to
the 180th-day recertification and each
subsequent recertification under
subparagraph (A)(ii) and attests that
such visit took place (in accordance
with procedures established by the
Secretary); and
(ii) in the case of hospice care
provided an individual for more than
180 days by a hospice program for which
the number of such cases for such
program comprises more than a percent
(specified by the Secretary) of the
total number of such cases for all
programs under this title, the hospice
care provided to such individual is
medically reviewed (in accordance with
procedures established by the
Secretary); and
(E) on and after the date of enactment of
this subparagraph, in the case of hospice care
provided an individual for more than 180 days
by a hospice program for which the number of
such cases for such program comprises more than
a percent (specified by the Secretary) of the
total number of all cases of individuals
provided hospice care by the program under this
title, the hospice care provided to such
individual is medically reviewed (in accordance
with procedures established by the Secretary);
and
(8) in the case of inpatient critical access hospital
services, a physician certifies that the individual may
reasonably be expected to be discharged or transferred
to a hospital within 96 hours after admission to the
critical access hospital.
To the extent provided by regulations, the certification and
recertification requirements of paragraph (2) shall be deemed
satisfied where, at a later date, a physician, nurse
practitioner, clinical nurse specialist, or physician assistant
(as the case may be) makes certification of the kind provided
in subparagraph (A), (B), (C), or (D) of paragraph (2)
(whichever would have applied), but only where such
certification is accompanied by such medical and other evidence
as may be required by such regulations. With respect to the
physician certification required by paragraph (2) for home
health services furnished to any individual by a home health
agency (other than an agency which is a governmental entity)
and with respect to the establishment and review of a plan for
such services, the Secretary shall prescribe regulations which
shall become effective no later than July 1, 1981, and which
prohibit a physician who has a significant ownership interest
in, or a significant financial or contractual relationship
with, such home health agency from performing such
certification and from establishing or reviewing such plan,
except that such prohibition shall not apply with respect to a
home health agency which is a sole community home health agency
(as determined by the Secretary). For purposes of the preceding
sentence, service by a physician as an uncompensated officer or
director of a home health agency shall not constitute having a
significant ownership interest in, or a significant financial
or contractual relationship with, such agency. For purposes of
documentation for physician certification and recertification
made under paragraph (2) on or after January 1, 2019, and made
with respect to home health services furnished by a home health
agency, in addition to using documentation in the medical
record of the physician who so certifies or the medical record
of the acute or post-acute care facility (in the case that home
health services were furnished to an individual who was
directly admitted to the home health agency from such a
facility), the Secretary may use documentation in the medical
record of the home health agency as supporting material, as
appropriate to the case involved. For purposes of paragraph
(2)(C), an individual shall be considered to be ``confined to
his home'' if the individual has a condition, due to an illness
or injury, that restricts the ability of the individual to
leave his or her home except with the assistance of another
individual or the aid of a supportive device (such as crutches,
a cane, a wheelchair, or a walker), or if the individual has a
condition such that leaving his or her home is medically
contraindicated. While an individual does not have to be
bedridden to be considered ``confined to his home'', the
condition of the individual should be such that there exists a
normal inability to leave home and that leaving home requires a
considerable and taxing effort by the individual. Any absence
of an individual from the home attributable to the need to
receive health care treatment, including regular absences for
the purpose of participating in therapeutic, psychosocial, or
medical treatment in an adult day-care program that is licensed
or certified by a State, or accredited, to furnish adult day-
care services in the State shall not disqualify an individual
from being considered to be ``confined to his home''. Any other
absence of an individual from the home shall not so disqualify
an individual if the absence is of infrequent or of relatively
short duration. For purposes of the preceding sentence, any
absence for the purpose of attending a religious service shall
be deemed to be an absence of infrequent or short duration. In
applying paragraph (1), the Secretary may specify exceptions to
the 1 calendar year period specified in such paragraph.
Amount Paid to Providers
(b) The amount paid to any provider of services (other than a
hospice program providing hospice care, other than a critical
access hospital providing inpatient critical access hospital
services, and other than a home health agency with respect to
durable medical equipment) with respect to services for which
payment may be made under this part shall, subject to the
provisions of sections 1813, 1886, and 1895, be--
(1) except as provided in paragraph (3), the lesser
of (A) the reasonable cost of such services, as
determined under section 1861(v) and as further limited
by section 1881(b)(2)(B), or (B) the customary charges
with respect to such services;
(2) 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
paragraph), free of charge or at nominal charges to the
public, the amount determined on the basis of those
items (specified in regulations prescribed by the
Secretary) included in the determination of such
reasonable cost which the Secretary finds will provide
fair compensation to such provider for such services;
or
(3) if some or all of the hospitals in a State have
been reimbursed for services (for which payment may be
made under this part) pursuant to a reimbursement
system approved as a demonstration project under
section 402 of the Social Security Amendments of 1967
or section 222 of the Social Security Amendments of
1972, if the rate of increase in such hospitals in
their costs per hospital inpatient admission of
individuals entitled to benefits under this part over
the duration of such project was equal to or less than
such rate of increase for admissions of such
individuals with respect to all hospitals in the United
States during such period, and if either the State has
legislative authority to operate such system and the
State elects to have reimbursement to such hospitals
made in accordance with this paragraph or the system is
operated through a voluntary agreement of hospitals and
such hospitals elect to have reimbursement to those
hospitals made in accordance with this paragraph, then,
subject to section 1886(d)(3)(B)(ix)(III), the
Secretary may provide for continuation of reimbursement
to such hospitals under such system until the Secretary
determines that--
(A) a third-party payor reimburses such a
hospital on a basis other than under such
system, or
(B) the aggregate rate of increase from
January 1, 1981, to the most recent date for
which annual data are available in such
hospitals in costs per hospital inpatient
admission of individuals entitled to benefits
under this part is greater than such rate of
increase for admissions of such individuals
with respect to all hospitals in the United
States for such period.
In the case of any State which has had such a demonstration
project reimbursement system in continuous operation since July
1, 1977, the Secretary shall provide under paragraph (3) for
continuation of reimbursement to hospitals in the State under
such system until the first day of the 37th month beginning
after the date the Secretary determines and notifies the
Governor of the State that either of the conditions described
in subparagraph (A) or (B) of such paragraph has occurred. If,
by the end of such 36-month period, the Secretary determines,
based on evidence submitted by the Governor of the State, that
neither of the conditions described in subparagraph (A) or (B)
of paragraph (3) continues to apply, the Secretary shall
continue without interruption payment to hospitals in the State
under the State's system. If, by the end of such 36-month
period, the Secretary determines, based on such evidence, that
either of the conditions described in subparagraph (A) or (B)
of such paragraph continues to apply, the Secretary shall (i)
collect any net excess reimbursement to hospitals in the State
during such 36-month period (basing such net excess
reimbursement on the net difference, if any, in the rate of
increase in costs per hospital inpatient admission under the
State system compared to the rate of increase in such costs
with respect to all hospitals in the United States over the 36-
month period, as measured by including the cumulative savings
under the State system based on the difference in the rate of
increase in costs per hospital inpatient admission under the
State system as compared to the rate of increase in such costs
with respect to all hospitals in the United States between
January 1, 1981, and the date of the Secretary's initial
notice), and (ii) provide a reasonable period, not to exceed 2
years, for transition from the State system to the national
payment system. For purposes of applying paragraph (3), there
shall be taken into account incentive payments, and payment
adjustments under subsection (b)(3)(B)(ix) or (n) of section
1886.
No Payments to Federal Providers of Services
(c) Subject to section 1880, no payment may be made under
this part (except under subsection (d) or subsection (h)) to
any Federal provider of services, except a provider of services
which the Secretary determines is providing services to the
public generally as a community institution or agency; and no
such payment may be made to any provider of services for any
item or service which such provider is obligated by a law of,
or a contract with, the United States to render at public
expense.
Payments for Emergency Hospital Services
(d)(1) Payments shall also be made to any hospital for
inpatient hospital services furnished in a calendar year, by
the hospital or under arrangements (as defined in section
1861(w)) with it, to an individual entitled to hospital
insurance benefits under section 226 even though such hospital
does not have an agreement in effect under this title if (A)
such services were emergency services, (B) the Secretary would
be required to make such payment if the hospital had such an
agreement in effect and otherwise met the conditions of payment
hereunder, and (C) such hospital has elected to claim payments
for all such inpatient emergency services and for the emergency
outpatient services referred to in section 1835(b) furnished
during such year. Such payments shall be made only in the
amounts provided under subsection (b) and then only if such
hospital agrees to comply, with respect to the emergency
services provided, with the provisions of section 1866(a).
(2) Payment may be made on the basis of an itemized bill to
an individual entitled to hospital insurance benefits under
section 226 for services described in paragraph (1) which are
emergency services if (A) payment cannot be made under
paragraph (1) solely because the hospital does not elect to
claim such payment, and (B) such individual files application
(submitted within such time and in such form and manner and by
such person, and containing and supported by such information
as the Secretary shall by regulations prescribe) for
reimbursement.
(3) The amounts payable under the preceding paragraph with
respect to services described therein shall, subject to the
provisions of section 1813, be equal to 60 percent of the
hospital's reasonable charges for routine services furnished in
the accommodations occupied by the individual or in semiprivate
accommodations (as defined in section 1861(v)(4)), whichever is
less, plus 80 percent of the hospital's reasonable charges for
ancillary services. If separate charges for routine and
ancillary services are not made by the hospital, reimbursement
may be based on two-thirds of the hospital's reasonable charges
for the services received but not to exceed the charges which
would have been made if the patient had occupied semiprivate
accommodations. For purposes of the preceding provisions of
this paragraph, the term ``routine services'' shall mean the
regular room, dietary, and nursing services, minor medical and
surgical supplies and the use of equipment and facilities for
which a separate charge is not customarily made; the term
``ancillary services'' shall mean those special services for
which charges are customarily made in addition to routine
services.
Payment for Inpatient Hospital Services Prior to Notification of
Noneligibility
(e) Notwithstanding that an individual is not entitled to
have payment made under this part for inpatient hospital
services furnished by any hospital, payment shall be made to
such hospital (unless it elects not to receive such payment or,
if payment has already been made by or on behalf of such
individual, fails to refund such payment within the time
specified by the Secretary) for such services which are
furnished to the individual prior to notification to such
hospital from the Secretary of his lack of entitlement, if such
payments are precluded only by reason of section 1812 and if
such hospital complies with the requirements of and regulations
under this title with respect to such payments, has acted in
good faith and without knowledge of such lack of entitlement,
and has acted reasonably in assuming entitlement existed.
Payment under the preceding sentence may not be made for
services furnished an individual pursuant to any admission
after the 6th elapsed day (not including as an elapsed day
Saturday, Sunday, or a legal holiday) after the day on which
such admission occurred.
Payment for Certain Inpatient Hospital Services Furnished Outside the
United States
(f)(1) Payment shall be made for inpatient hospital services
furnished to an individual entitled to hospital insurance
benefits under section 226 by a hospital located outside the
United States, or under arrangements (as defined in section
1861(w)) with it, if--
(A) such individual is a resident of the United
States, and
(B) such hospital was closer to, or substantially
more accessible from, the residence of such individual
than the nearest hospital within the United States
which was adequately equipped to deal with, and was
available for the treatment of, such individual's
illness or injury.
(2) Payment may also be made for emergency inpatient hospital
services furnished to an individual entitled to hospital
insurance benefits under section 226 by a hospital located
outside the United States if--
(A) such individual was physically present--
(i) in a place within the United States; or
(ii) at a place within Canada while traveling
without unreasonable delay by the most direct
route (as determined by the Secretary) between
Alaska and another State;
at the time the emergency which necessitated such
inpatient hospital services occurred, and
(B) such hospital was closer to, or substantially
more accessible from, such place than the nearest
hospital within the United States which was adequately
equipped to deal with, and was available for the
treatment of, such individual's illness or injury.
(3) Payment shall be made in the amount provided under
subsection (b) to any hospital for the inpatient hospital
services described in paragraph (1) or (2) furnished to an
individual by the hospital or under arrangements (as defined in
section 1861(w)) with it if (A) the Secretary would be required
to make such payment if the hospital had an agreement in effect
under this title and otherwise met the conditions of payment
hereunder, (B) such hospital elects to claim such payment, and
(C) such hospital agrees to comply, with respect to such
services, with the provisions of section 1866(a).
(4) Payment for the inpatient hospital services described in
paragraph (1) or (2) furnished to an individual entitled to
hospital insurance benefits under section 226 may be made on
the basis of an itemized bill to such individual if (A) payment
for such services cannot be made under paragraph (3) solely
because the hospital does not elect to claim such payment, and
(B) such individual files application (submitted within such
time and in such form and manner and by such person, and
continuing and supported by such information as the Secretary
shall by regulations prescribe) for reimbursement. The amount
payable with respect to such services shall, subject to the
provisions of section 1813, be equal to the amount which would
be payable under subsection (d)(3).
Payment for Services of a Physician Rendered in a Teaching Hospital
(g) For purposes of services for which the reasonable cost
thereof is determined under section 1861(v)(1)(D) (or would be
if section 1886 did not apply), payment under this part shall
be made to such fund as may be designated by the organized
medical staff of the hospital in which such services were
furnished or, if such services were furnished in such hospital
by the faculty of a medical school, to such fund as may be
designated by such faculty, but only if--
(1) such hospital has an agreement with the Secretary
under section 1866, and
(2) the Secretary has received written assurances
that (A) such payment will be used by such fund solely
for the improvement of care of hospital patients or for
educational or charitable purposes and (B) the
individuals who were furnished such services or any
other persons will not be charged for such services (or
if charged, provision will be made for return of any
moneys incorrectly collected).
Payment for Certain Hospital Services Provided in Department of
Veterans Affairs Hospitals
(h)(1) Payments shall also be made to any hospital operated
by the Department of Veterans Affairs for inpatient hospital
services furnished in a calendar year by the hospital, or under
arrangements (as defined in section 1861(w)) with it, to an
individual entitled to hospital benefits under section 226 even
though the hospital is a Federal provider of services if (A)
the individual was not entitled to have the services furnished
to him free of charge by the hospital, (B) the individual was
admitted to the hospital in the reasonable belief on the part
of the admitting authorities that the individual was a person
who was entitled to have the services furnished to him free of
charge, (C) the authorities of the hospital, in admitting the
individual, and the individual, acted in good faith, and (D)
the services were furnished during a period ending with the
close of the day on which the authorities operating the
hospital first became aware of the fact that the individual was
not entitled to have the services furnished to him by the
hospital free of charge, or (if later) ending with the first
day on which it was medically feasible to remove the individual
from the hospital by discharging him therefrom or transferring
him to a hospital which has in effect an agreement under this
title.
(2) Payment for services described in paragraph (1) shall be
in an amount equal to the charge imposed by the Secretary of
Veterans Affairs for such services, or (if less) the amount
that would be payable for such services under subsection (b)
and section 1886 (as estimated by the Secretary). Any such
payment shall be made to the entity to which payment for the
services involved would have been payable, if payment for such
services had been made by the individual receiving the services
involved (or by another private person acting on behalf of such
individual).
Payment for Hospice Care
(i)(1)(A) Subject to the limitation under paragraph (2) and
the provisions of section 1813(a)(4) and except as otherwise
provided in this paragraph, the amount paid to a hospice
program with respect to hospice care for which payment may be
made under this part shall be an amount equal to the costs
which are reasonable and related to the cost of providing
hospice care 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)),
except that no payment may be made for bereavement counseling
and no reimbursement may be made for other counseling services
(including nutritional and dietary counseling) as separate
services.
(B) Notwithstanding subparagraph (A), for hospice care
furnished on or after April 1, 1986, the daily rate of payment
per day for routine home care shall be $63.17 and the daily
rate of payment for other services included in hospice care
shall be the daily rate of payment recognized under
subparagraph (A) as of July 1, 1985, increased by $10.
(C)(i) With respect to routine home care and other services
included in hospice care furnished on or after January 1, 1990,
and on or before September 30, 1990, the payment rates for such
care and services shall be 120 percent of such rates in effect
as of September 30, 1989.
(ii) With respect to routine home care and other services
included in hospice care furnished during a subsequent fiscal
year (before the first fiscal year in which the payment
revisions described in paragraph (6)(D) are implemented), the
payment rates for such care and services shall be the payment
rates in effect under this subparagraph during the previous
fiscal year increased by--
(I) for a fiscal year ending on or before September
30, 1993, the market basket percentage increase (as
defined in section 1886(b)(3)(B)(iii)) for the fiscal
year;
(II) for fiscal year 1994, the market basket
percentage increase for the fiscal year minus 2.0
percentage points;
(III) for fiscal year 1995, the market basket
percentage increase for the fiscal year minus 1.5
percentage points;
(IV) for fiscal year 1996, the market basket
percentage increase for the fiscal year minus 1.5
percentage points;
(V) for fiscal year 1997, the market basket
percentage increase for the fiscal year minus 0.5
percentage point;
(VI) for each of fiscal years 1998 through 2002, the
market basket percentage increase for the fiscal year
involved minus 1.0 percentage points, plus, in the case
of fiscal year 2001, 5.0 percentage points; and
(VII) for a subsequent fiscal year (before the first
fiscal year in which the payment revisions described in
paragraph (6)(D) are implemented), subject to clauses
(iv) and (vi), the market basket percentage increase
for the fiscal year.
(iii) With respect to routine home care and other
services included in hospice care furnished during
fiscal years subsequent to the first fiscal year in
which payment revisions described in paragraph (6)(D)
are implemented, the payment rates for such care and
services shall be the payment rates in effect under
this clause during the preceding fiscal year increased
by, subject to clauses (iv) and (vi), the market basket
percentage increase (as defined in section
1886(b)(3)(B)(iii)) for the fiscal year.
(iv) Subject to clause (vi), after determining the market
basket percentage increase under clause (ii)(VII) or (iii), as
applicable, with respect to fiscal year 2013 and each
subsequent fiscal year, the Secretary shall reduce such
percentage--
(I) for 2013 and each subsequent fiscal year, by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II); and
(II) subject to clause (v), for each of fiscal years
2013 through 2019, by 0.3 percentage point.
The application of this clause may result in the market basket
percentage increase under clause (ii)(VII) or (iii), as
applicable, being less than 0.0 for a fiscal year, and may
result in payment rates under this subsection for a fiscal year
being less than such payment rates for the preceding fiscal
year.
(v) Clause (iv)(II) shall be applied with respect to any of
fiscal years 2014 through 2019 by substituting ``0.0 percentage
points'' for ``0.3 percentage point'', if for such fiscal
year--
(I) the excess (if any) of--
(aa) the total percentage of the non-elderly
insured population for the preceding fiscal
year (based on the most recent estimates
available from the Director of the
Congressional Budget Office before a vote in
either House on the Patient Protection and
Affordable Care Act that, if determined in the
affirmative, would clear such Act for
enrollment); over
(bb) the total percentage of the non-elderly
insured population for such preceding fiscal
year (as estimated by the Secretary); exceeds
(II) 5 percentage points.
(vi) For fiscal year 2018, the market basket percentage
increase under clause (ii)(VII) or (iii), as applicable, after
application of clause (iv), shall be 1 percent.
(2)(A) The amount of payment made under this part for hospice
care provided by (or under arrangements made by) a hospice
program for an accounting year may not exceed the ``cap
amount'' for the year (computed under subparagraph (B))
multiplied by the number of medicare beneficiaries in the
hospice program in that year (determined under subparagraph
(C)).
(B) (i) Except as provided in clause (ii), for purposes of
subparagraph (A), the ``cap amount'' for a year is $6,500,
increased or decreased, for accounting years that end after
October 1, 1984, by the same percentage as the percentage
increase or decrease, respectively, in the medical care
expenditure category of the Consumer Price Index for All Urban
Consumers (United States city average), published by the Bureau
of Labor Statistics, from March 1984 to the fifth month of the
accounting year.
(ii) For purposes of subparagraph (A) for accounting years
that end after September 30, 2016, and before October 1, 2025,
the ``cap amount'' is the cap amount under this subparagraph
for the preceding accounting year updated by the percentage
update to payment rates for hospice care under paragraph (1)(C)
for services furnished during the fiscal year beginning on the
October 1 preceding the beginning of the accounting year
(including the application of any productivity or other
adjustment under clause (iv) of that paragraph).
(iii) For accounting years that end after September 30, 2025,
the cap amount shall be computed under clause (i) as if clause
(ii) had never applied.
(C) For purposes of subparagraph (A), the ``number of
medicare beneficiaries'' in a hospice program in an accounting
year is equal to the number of individuals who have made an
election under subsection (d) with respect to the hospice
program and have been provided hospice care by (or under
arrangements made by) the hospice program under this part in
the accounting year, such number reduced to reflect the
proportion of hospice care that each such individual was
provided in a previous or subsequent accounting year or under a
plan of care established by another hospice program.
(D) A hospice program shall submit claims for payment for
hospice care furnished in an individual's home under this title
only on the basis of the geographic location at which the
service is furnished, as determined by the Secretary.
(3) Hospice programs providing hospice care for which payment
is made under this subsection shall submit to the Secretary
such data with respect to the costs for providing such care for
each fiscal year, beginning with fiscal year 1999, as the
Secretary determines necessary.
(4) The amount paid to a hospice program with respect to the
services under section 1812(a)(5) for which payment may be made
under this part shall be equal to an amount established for an
office or other outpatient visit for evaluation and management
associated with presenting problems of moderate severity and
requiring medical decisionmaking of low complexity under the
fee schedule established under section 1848(b), other than the
portion of such amount attributable to the practice expense
component.
(5) Quality reporting.--
(A) Reduction in update for failure to
report.--
(i) In general.--For purposes of
fiscal year 2014 and each subsequent
fiscal year, in the case of a hospice
program that does not submit data to
the Secretary in accordance with
subparagraph (C) with respect to such a
fiscal year, after determining the
market basket percentage increase under
paragraph (1)(C)(ii)(VII) or paragraph
(1)(C)(iii), as applicable, and after
application of clauses (iv) and (vi) of
paragraph (1)(C), with respect to the
fiscal year, the Secretary shall reduce
such market basket percentage increase
by 2 percentage points (or, for fiscal
year 2023 and each subsequent fiscal
year, 4 percentage points).
(ii) Special rule.--The application
of this subparagraph may result in the
market basket percentage increase under
paragraph (1)(C)(ii)(VII) or paragraph
(1)(C)(iii), as applicable, being less
than 0.0 for a fiscal year, and may
result in payment rates under this
subsection for a fiscal year being less
than such payment rates for the
preceding fiscal year.
(B) Noncumulative application.--Any reduction
under subparagraph (A) shall apply only with
respect to the fiscal year involved and the
Secretary shall not take into account such
reduction in computing the payment amount under
this subsection for a subsequent fiscal year.
(C) Submission of quality data.--For fiscal
year 2014 and each subsequent fiscal year, each
hospice program shall submit to the Secretary
data on quality measures specified under
subparagraph (D). Such data shall be submitted
in a form and manner, and at a time, specified
by the Secretary for purposes of this
subparagraph.
(D) Quality measures.--
(i) In general.--Subject to clause
(ii), any measure specified by the
Secretary under this subparagraph must
have been endorsed by the entity with a
contract under section 1890(a).
(ii) Exception.--In the case of a
specified area or medical topic
determined appropriate by the Secretary
for which a feasible and practical
measure has not been endorsed by the
entity with a contract under section
1890(a), the Secretary may specify a
measure that is not so endorsed as long
as due consideration is given to
measures that have been endorsed or
adopted by a consensus organization
identified by the Secretary.
(iii) Time frame.--Not later than
October 1, 2012, the Secretary shall
publish the measures selected under
this subparagraph that will be
applicable with respect to fiscal year
2014.
(E) Public availability of data submitted.--
The Secretary shall establish procedures for
making data submitted under subparagraph (C)
available to the public. Such procedures shall
ensure that a hospice program has the
opportunity to review the data that is to be
made public with respect to the hospice program
prior to such data being made public. The
Secretary shall report quality measures that
relate to hospice care provided by hospice
programs on the Internet website of the Centers
for Medicare & Medicaid Services.
(6)(A) The Secretary shall collect additional data
and information as the Secretary determines appropriate
to revise payments for hospice care under this
subsection pursuant to subparagraph (D) and for other
purposes as determined appropriate by the Secretary.
The Secretary shall begin to collect such data by not
later than January 1, 2011.
(B) The additional data and information to be
collected under subparagraph (A) may include data and
information on--
(i) charges and payments;
(ii) the number of days of hospice care which
are attributable to individuals who are
entitled to, or enrolled for, benefits under
part A; and
(iii) with respect to each type of service
included in hospice care--
(I) the number of days of hospice
care attributable to the type of
service;
(II) the cost of the type of service;
and
(III) the amount of payment for the
type of service;
(iv) charitable contributions and other
revenue of the hospice program;
(v) the number of hospice visits;
(vi) the type of practitioner providing the
visit; and
(vii) the length of the visit and other basic
information with respect to the visit.
(C) The Secretary may collect the additional data and
information under subparagraph (A) on cost reports,
claims, or other mechanisms as the Secretary determines
to be appropriate.
(D)(i) Notwithstanding the preceding paragraphs of
this subsection, not earlier than October 1, 2013, the
Secretary shall, by regulation, implement revisions to
the methodology for determining the payment rates for
routine home care and other services included in
hospice care under this part, as the Secretary
determines to be appropriate. Such revisions may be
based on an analysis of data and information collected
under subparagraph (A). Such revisions may include
adjustments to per diem payments that reflect changes
in resource intensity in providing such care and
services during the course of the entire episode of
hospice care.
(ii) Revisions in payment implemented pursuant to
clause (i) shall result in the same estimated amount of
aggregate expenditures under this title for hospice
care furnished in the fiscal year in which such
revisions in payment are implemented as would have been
made under this title for such care in such fiscal year
if such revisions had not been implemented.
(E) The Secretary shall consult with hospice programs
and the Medicare Payment Advisory Commission regarding
the additional data and information to be collected
under subparagraph (A) and the payment revisions under
subparagraph (D).
(7) In the case of hospice care provided by a hospice program
under arrangements under section 1861(dd)(5)(D) made by another
hospice program, the hospice program that made the arrangements
shall bill and be paid for the hospice care.
Elimination of Lesser-of-Cost-or-Charges Provision
(j)(1) The lesser-of-cost-or-charges provisions (described in
paragraph (2)) will not apply in the case of services provided
by a class of provider of services if the Secretary determines
and certifies to Congress that the failure of such provisions
to apply to the services provided by that class of providers
will not result in any increase in the amount of payments made
for those services under this title. Such change will take
effect with respect to services furnished, or cost reporting
periods of providers, on or after such date as the Secretary
shall provide in the certification. Such change for a class of
provider shall be discontinued if the Secretary determines and
notifies Congress that such change has resulted in an increase
in the amount of payments made under this title for services
provided by that class of provider.
(2) The lesser-of-cost-or-charges provisions referred to in
paragraph (1) are as follows:
(A) Clause (B) of paragraph (1) and paragraph (2) of
subsection (b).
(B) Section 1834(a)(1)(B).
(C) So much of subparagraph (A) of section 1833(a)(2)
as provides for payment other than of the reasonable
cost of such services, as determined under section
1861(v).
(D) Subclause (II) of clause (i) and clause (ii) of
section 1833(a)(2)(B).
Payments to Home Health Agencies for Durable Medical Equipment
(k) The amount paid to any home health agency with respect to
durable medical equipment for which payment may be made under
this part shall be the amount described in section 1834(a)(1).
Payment for Inpatient Critical Access Hospital Services
(l)(1) Except as provided in the subsequent paragraphs of
this subsection, the amount of payment under this part for
inpatient critical access hospital services is equal to 101
percent of the reasonable costs of the critical access hospital
in providing such services.
(2) In the case of a distinct part psychiatric or
rehabilitation unit of a critical access hospital described in
section 1820(c)(2)(E), the amount of payment for inpatient
critical access hospital services of such unit shall be equal
to the amount of the payment that would otherwise be made if
such services were inpatient hospital services of a distinct
part psychiatric or rehabilitation unit, respectively,
described in the matter following clause (v) of section
1886(d)(1)(B).
(3)(A) The following rules shall apply in determining payment
and reasonable costs under paragraph (1) for costs described in
subparagraph (C) for a critical access hospital that would be a
meaningful EHR user (as would be determined under paragraph (3)
of section 1886(n)) for an EHR reporting period for a cost
reporting period beginning during a payment year if such
critical access hospital was treated as an eligible hospital
under such section:
(i) The Secretary shall compute reasonable costs by
expensing such costs in a single payment year and not
depreciating such costs over a period of years (and
shall include as costs with respect to cost reporting
periods beginning during a payment year costs from
previous cost reporting periods to the extent they have
not been fully depreciated as of the period involved).
(ii) There shall be substituted for the Medicare
share that would otherwise be applied under paragraph
(1) a percent (not to exceed 100 percent) equal to the
sum of--
(I) the Medicare share (as would be specified
under paragraph (2)(D) of section 1886(n)) for
such critical access hospital if such critical
access hospital was treated as an eligible
hospital under such section; and
(II) 20 percentage points.
(B) The payment under this paragraph with respect to a
critical access hospital shall be paid through a prompt interim
payment (subject to reconciliation) after submission and review
of such information (as specified by the Secretary) necessary
to make such payment, including information necessary to apply
this paragraph. In no case may payment under this paragraph be
made with respect to a cost reporting period beginning during a
payment year after 2015 and in no case may a critical access
hospital receive payment under this paragraph with respect to
more than 4 consecutive payment years.
(C) The costs described in this subparagraph are costs for
the purchase of certified EHR technology to which purchase
depreciation (excluding interest) would apply if payment was
made under paragraph (1) and not under this paragraph.
(D) For purposes of this paragraph, paragraph (4), and
paragraph (5), the terms ``certified EHR technology'',
``eligible hospital'', ``EHR reporting period'', and ``payment
year'' have the meanings given such terms in sections 1886(n).
(4)(A) Subject to subparagraph (C), for cost reporting
periods beginning in fiscal year 2015 or a subsequent fiscal
year, in the case of a critical access hospital that is not a
meaningful EHR user (as would be determined under paragraph (3)
of section 1886(n) if such critical access hospital was treated
as an eligible hospital under such section) for an EHR
reporting period with respect to such fiscal year, paragraph
(1) shall be applied by substituting the applicable percent
under subparagraph (B) for the percent described in such
paragraph (1).
(B) The percent described in this subparagraph is--
(i) for fiscal year 2015, 100.66 percent;
(ii) for fiscal year 2016, 100.33 percent; and
(iii) for fiscal year 2017 and each subsequent fiscal
year, 100 percent.
(C) The provisions of subclause (II) of section
1886(b)(3)(B)(ix) shall apply with respect to subparagraph (A)
for a critical access hospital with respect to a cost reporting
period beginning in a fiscal year in the same manner as such
subclause applies with respect to subclause (I) of such section
for a subsection (d) hospital with respect to such fiscal year.
(5) There shall be no administrative or judicial review under
section 1869, section 1878, or otherwise, of--
(A) the methodology and standards for determining the
amount of payment and reasonable cost under paragraph
(3) and payment adjustments under paragraph (4),
including selection of periods under section 1886(n)(2)
for determining, and making estimates or using proxies
of, inpatient-bed-days, hospital charges, charity
charges, and Medicare share under subparagraph (D) of
section 1886(n)(2);
(B) the methodology and standards for determining a
meaningful EHR user under section 1886(n)(3) as would
apply if the hospital was treated as an eligible
hospital under section 1886(n), and the hardship
exception under paragraph (4)(C);
(C) the specification of EHR reporting periods under
section 1886(n)(6)(B) as applied under paragraphs (3)
and (4); and
(D) the identification of costs for purposes of
paragraph (3)(C).
* * * * * * *
SEC. 1822. HOSPICE PROGRAM SURVEY AND ENFORCEMENT PROCEDURES.
(a) Surveys.--
(1) Frequency.--Any entity that is certified as a
hospice program shall be subject to a standard survey
by an appropriate State or local survey agency, or an
approved accreditation agency, as determined by the
Secretary, not less frequently than once every 36
months (and not less frequently than once every 24
months beginning October 1, 2021).
(2) Public transparency of survey and certification
information.--
(A) Submission of information to the
secretary.--
(i) In general.--Each State, and each
national accreditation body with
respect to which the Secretary has made
a finding under section 1865(a)
respecting the accreditation of a
hospice program by such body, shall
submit, in a form and manner, and at a
time, specified by the Secretary for
purposes of this subparagraph,
information respecting any survey or
certification made with respect to a
hospice program by such State or body,
as applicable. Such information shall
include any inspection report made by
such State or body with respect to such
survey or certification, any
enforcement actions taken as a result
of such survey or certification, and
any other information determined
appropriate by the Secretary.
(ii) Required inclusion of specified
form.--With respect to a survey under
this subsection carried out by a
national accreditation body described
in clause (i) on or after October 1,
2021, information described in such
clause shall include Form 2567 (or a
successor form), along with such
additional information determined
appropriate by such body.
(B) Public disclosure of information.--
Beginning not later than October 1, 2022, the
Secretary shall publish the information
submitted under subparagraph (A) on the public
website of the Centers for Medicare & Medicaid
Services in a manner that is prominent, easily
accessible, readily understandable, and
searchable. The Secretary shall provide for the
timely update of such information so published.
(3) Consistency of surveys.--Each State and the
Secretary shall implement programs to measure and
reduce inconsistency in the application of survey
results among surveyors.
(4) Survey teams.--
(A) In general.--In the case of a survey
conducted under this subsection on or after
October 1, 2021, by more than 1 individual,
such survey shall be conducted by a
multidisciplinary team of professionals
(including a registered professional nurse).
(B) Prohibition of conflicts of interest.--
Beginning October 1, 2021, a State may not use
as a member of a survey team under this
subsection an individual who is serving (or has
served within the previous 2 years) as a member
of the staff of, or as a consultant to, the
program surveyed respecting compliance with the
requirements of section 1861(dd) or who has a
personal or familial financial interest in the
program being surveyed.
(C) Training.--The Secretary shall provide,
not later than October 1, 2021, for the
comprehensive training of State and Federal
surveyors, and any surveyor employed by a
national accreditation body described in
paragraph (2)(A)(i), in the conduct of surveys
under this subsection, including training with
respect to the review of written plans for
providing hospice care (as described in section
1814(a)(7)(B)). No individual shall serve as a
member of a survey team with respect to a
survey conducted on or after such date unless
the individual has successfully completed a
training and testing program in survey and
certification techniques that has been approved
by the Secretary.
(5) Funding.--The Secretary shall provide for the
transfer, from the Federal Hospital Insurance Trust
Fund under section 1817 to the Centers for Medicare &
Medicaid Program Management Account, of $10,000,000 for
each fiscal year (beginning with fiscal year 2022) for
purposes of carrying out surveys under this subsection.
Sums so transferred shall remain available until
expended. Any transfer pursuant to this paragraph shall
be in addition to any transfer pursuant to section
3(a)(2) of the Improving Medicare Post-Acute Care
Transformation Act of 2014.
(b) Special Focus Program.--
(1) In general.--The Secretary shall conduct a
special focus program for enforcement of requirements
for hospice programs that the Secretary has identified
as having substantially failed to meet applicable
requirements of this Act.
(2) Periodic surveys.--Under such special focus
program, the Secretary shall conduct surveys of each
hospice program in the special focus program not less
than once every 6 months.
(c) Enforcement.--
(1) Situations involving immediate jeopardy.--If the
Secretary determines on the basis of a standard survey
or otherwise that a hospice program that is certified
for participation under this title is no longer in
compliance with the requirements specified in section
1861(dd) and determines that the deficiencies involved
immediately jeopardize the health and safety of the
individuals to whom the program furnishes items and
services, the Secretary shall take immediate action to
remove the jeopardy and correct the deficiencies
through the remedy described in paragraph (5)(B)(iii)
or terminate the certification of the program, and may
provide, in addition, for 1 or more of the other
remedies described in paragraph (5)(B).
(2) Situations not involving immediate jeopardy.--If
the Secretary determines on the basis of a standard
survey or otherwise that a hospice program that is
certified for participation under this title is no
longer in compliance with the requirements specified in
section 1861(dd) and determines that the deficiencies
involved do not immediately jeopardize the health and
safety of the individuals to whom the program furnishes
items and services, the Secretary may (for a period not
to exceed 6 months) impose remedies developed pursuant
to paragraph (5)(A), in lieu of terminating the
certification of the program. If, after such a period
of remedies, the program is still no longer in
compliance with such requirements, the Secretary shall
terminate the certification of the program.
(3) Penalty for previous noncompliance.--If the
Secretary determines that a hospice program that is
certified for participation under this title is in
compliance with the requirements specified in section
1861(dd) but, as of a previous period, did not meet
such requirements, the Secretary may provide for a
civil monetary penalty under paragraph (5)(B)(i) for
the days in which the Secretary finds that the program
was not in compliance with such requirements.
(4) Option to continue payments for noncompliant
hospice programs.--The Secretary may continue payments
under this title with respect to a hospice program not
in compliance with the requirements specified in
section 1861(dd) over a period of not longer than 6
months, if--
(A) the State or local survey agency finds
that it is more appropriate to take alternative
action to assure compliance of the program with
such requirements than to terminate the
certification of the program;
(B) the program has submitted a plan and
timetable for corrective action to the
Secretary for approval and the Secretary
approves the plan of corrective action; and
(C) the program agrees to repay to the
Federal Government payments received under this
title during such period if the corrective
action is not taken in accordance with the
approved plan and timetable.
The Secretary shall establish guidelines for approval
of corrective actions requested by hospice programs
under this paragraph.
(5) Remedies.--
(A) Development.--
(i) In general.--Not later than
October 1, 2021, the Secretary shall
develop and implement--
(I) a range of remedies to
apply to hospice programs under
the conditions described in
paragraphs (1) through (4); and
(II) appropriate procedures
for appealing determinations
relating to the imposition of
such remedies.
Remedies developed pursuant to the
preceding sentence shall include the
remedies specified in subparagraph (B).
(ii) Conditions of imposition of
remedies.--Not later than October 1,
2021, the Secretary shall develop and
implement specific procedures with
respect to the conditions under which
each of the remedies developed under
clause (i) is to be applied, including
the amount of any fines and the
severity of each of these remedies.
Such procedures shall be designed so as
to minimize the time between
identification of deficiencies and
imposition of these remedies and shall
provide for the imposition of
incrementally more severe fines for
repeated or uncorrected deficiencies.
(B) Specified remedies.--The remedies
specified in this subparagraph are the
following:
(i) Civil monetary penalties in an
amount not to exceed $10,000 for each
day of noncompliance by a hospice
program with the requirements specified
in section 1861(dd).
(ii) Suspension of all or part of the
payments to which a hospice program
would otherwise be entitled under this
title with respect to items and
services furnished by a hospice program
on or after the date on which the
Secretary determines that remedies
should be imposed pursuant to paragraph
(2).
(iii) The appointment of temporary
management to oversee the operation of
the hospice program and to protect and
assure the health and safety of the
individuals under the care of the
program while improvements are made in
order to bring the program into
compliance with all such requirements.
(C) Procedures.--
(i) Civil monetary penalties.--
(I) In general.--Subject to
subclause (II), the provisions
of section 1128A (other than
subsections (a) and (b)) shall
apply to a civil monetary
penalty under this subsection
in the same manner as such
provisions apply to a penalty
or proceeding under section
1128A(a).
(II) Retention of amounts for
hospice program improvements.--
The Secretary may provide that
any portion of civil monetary
penalties collected under this
subsection may be used to
support activities that benefit
individuals receiving hospice
care, including education and
training programs to ensure
hospice program compliance with
the requirements of section
1861(dd).
(ii) Suspension of payment.--A
finding to suspend payment under
subparagraph (B)(ii) shall terminate
when the Secretary finds that the
program is in substantial compliance
with all such requirements.
(iii) Temporary management.--The
temporary management under subparagraph
(B)(iii) shall not be terminated until
the Secretary has determined that the
program has the management capability
to ensure continued compliance with all
the requirements referred to in such
subparagraph.
(D) Relationship to other remedies.--The
remedies developed under subparagraph (A) are
in addition to sanctions otherwise available
under State or Federal law and shall not be
construed as limiting other remedies, including
any remedy available to an individual at common
law.
* * * * * * *
Part E--Miscellaneous Provisions
definitions of services, institutions, etc.
Sec. 1861. For purposes of this title--
Spell of Illness
(a) The term ``spell of illness'' with respect to any
individual means a period of consecutive days--
(1) beginning with the first day (not included in a
previous spell of illness) (A) on which such individual
is furnished inpatient hospital services, inpatient
critical access hospital services or extended care
services, and (B) which occurs in a month for which he
is entitled to benefits under part A, and
(2) ending with the close of the first period of 60
consecutive days thereafter on each of which he is
neither an inpatient of a hospital or critical access
hospital nor an inpatient of a facility described in
section 1819(a)(1) or subsection (y)(1).
Inpatient Hospital Services
(b) The term ``inpatient hospital services'' means the
following items and services furnished to an inpatient of a
hospital and (except as provided in paragraph (3)) by the
hospital--
(1) bed and board;
(2) such nursing services and other related services,
such use of hospital facilities, and such medical
social services as are ordinarily furnished by the
hospital for the care and treatment of inpatients, and
such drugs, biologicals, supplies, appliances, and
equipment, for use in the hospital, as are ordinarily
furnished by such hospital for the care and treatment
of inpatients; and
(3) such other diagnostic or therapeutic items or
services, furnished by the hospital or by others under
arrangements with them made by the hospital, as are
ordinarily furnished to inpatients either by such
hospital or by others under such arrangements;
excluding, however--
(4) medical or surgical services provided by a
physician, resident, or intern, services described by
subsection (s)(2)(K), certified nurse-midwife services,
qualified psychologist services, and services of a
certified registered nurse anesthetist; and
(5) the services of a private-duty nurse or other
private-duty attendant.
Paragraph (4) shall not apply to services provided in a
hospital by--
(6) an intern or a resident-in-training under a
teaching program approved by the Council on Medical
Education of the American Medical Association or, in
the case of an osteopathic hospital, approved by the
Committee on Hospitals of the Bureau of Professional
Education of the American Osteopathic Association, or,
in the case of services in a hospital or osteopathic
hospital by an intern or resident-in-training in the
field of dentistry, approved by the Council on Dental
Education of the American Dental Association, or in the
case of services in a hospital or osteopathic hospital
by an intern or resident-in-training in the field of
podiatry, approved by the Council on Podiatric Medical
Education of the American Podiatric Medical
Association; or
(7) a physician where the hospital has a teaching
program approved as specified in paragraph (6), if (A)
the hospital elects to receive any payment due under
this title for reasonable costs of such services, and
(B) all physicians in such hospital agree not to bill
charges for professional services rendered in such
hospital to individuals covered under the insurance
program established by this title.
Inpatient Psychiatric Hospital Services
(c) The term ``inpatient psychiatric hospital services''
means inpatient hospital services furnished to an inpatient of
a psychiatric hospital.
Supplier
(d) The term ``supplier'' means, unless the context otherwise
requires, a physician or other practitioner, a facility, or
other entity (other than a provider of services) that furnishes
items or services under this title.
Hospital
(e) The term ``hospital'' (except for purposes of sections
1814(d), 1814(f), and 1835(b), subsection (a)(2) of this
section, paragraph (7) of this subsection, and subsection (i)
of this section) means an institution which--
(1) is primarily engaged in providing, by or under
the supervision of physicians, to inpatients (A)
diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured,
disabled, or sick persons, or (B) rehabilitation
services for the rehabilitation of injured, disabled,
or sick persons;
(2) maintains clinical records on all patients;
(3) has bylaws in effect with respect to its staff of
physicians;
(4) has a requirement that every patient with respect
to whom payment may be made under this title must be
under the care of a physician, except that a patient
receiving qualified psychologist services (as defined
in subsection (ii)) may be under the care of a clinical
psychologist with respect to such services to the
extent permitted under State law;
(5) provides 24-hour nursing service rendered or
supervised by a registered professional nurse, and has
a licensed practical nurse or registered professional
nurse on duty at all times; except that until January
1, 1979, the Secretary is authorized to waive the
requirement of this paragraph for any one-year period
with respect to any institution, insofar as such
requirement relates to the provision of twenty-four-
hour nursing service rendered or supervised by a
registered professional nurse (except that in any event
a registered professional nurse must be present on the
premises to render or supervise the nursing service
provided, during at least the regular daytime shift),
where immediately preceding such one-year period he
finds that--
(A) such institution is located in a rural
area and the supply of hospital services in
such area is not sufficient to meet the needs
of individuals residing therein,
(B) the failure of such institution to
qualify as a hospital would seriously reduce
the availability of such services to such
individuals, and
(C) such institution has made and continues
to make a good faith effort to comply with this
paragraph, but such compliance is impeded by
the lack of qualified nursing personnel in such
area;
(6)(A) has in effect a hospital utilization review
plan which meets the requirements of subsection (k) and
(B) has in place a discharge planning process that
meets the requirements of subsection (ee);
(7) in the case of an institution in any State in
which State or applicable local law provides for the
licensing of hospitals, (A) is licensed pursuant to
such law or (B) is approved, by the agency of such
State or locality responsible for licensing hospitals,
as meeting the standards established for such
licensing;
(8) has in effect an overall plan and budget that
meets the requirements of subsection (z); and
(9) meets such other requirements as the Secretary
finds necessary in the interest of the health and
safety of individuals who are furnished services in the
institution.
For purposes of subsection (a)(2), such term includes any
institution which meets the requirements of paragraph (1) of
this subsection. For purposes of sections 1814(d) and 1835(b)
(including determination of whether an individual received
inpatient hospital services or diagnostic services for purposes
of such sections), section 1814(f)(2), and subsection (i) of
this section, such term includes any institution which (i)
meets the requirements of paragraphs (5) and (7) of this
subsection, (ii) is not primarily engaged in providing the
services described in section 1861(j)(1)(A) and (iii) is
primarily engaged in providing, by or under the supervision of
individuals referred to in paragraph (1) of section 1861(r), to
inpatients diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured, disabled, or
sick persons, or rehabilitation services for the rehabilitation
of injured, disabled, or sick persons. For purposes of section
1814(f)(1), such term includes an institution which (i) is a
hospital for purposes of sections 1814(d), 1814(f)(2), and
1835(b) and (ii) is accredited by a national accreditation body
recognized by the Secretary under section 1865(a), or is
accredited by or approved by a program of the country in which
such institution is located if the Secretary finds the
accreditation or comparable approval standards of such program
to be essentially equivalent to those of such a national
accreditation body.. Notwithstanding the preceding provisions
of this subsection, such term shall not, except for purposes of
subsection (a)(2), include any institution which is primarily
for the care and treatment of mental diseases unless it is a
psychiatric hospital (as defined in subsection (f)). The term
``hospital'' also includes a religious nonmedical health care
institution (as defined in subsection (ss)(1)), but only with
respect to items and services ordinarily furnished by such
institution to inpatients, and payment may be made with respect
to services provided by or in such an institution only to such
extent and under such conditions, limitations, and requirements
(in addition to or in lieu of the conditions, limitations, and
requirements otherwise applicable) as may be provided in
regulations consistent with section 1821. For provisions
deeming certain requirements of this subsection to be met in
the case of accredited institutions, see section 1865. The term
``hospital'' also includes a facility of fifty beds or less
which is located in an area determined by the Secretary to meet
the definition relating to a rural area described in
subparagraph (A) of paragraph (5) of this subsection and which
meets the other requirements of this subsection, except that--
(A) with respect to the requirements for nursing
services applicable after December 31, 1978, such
requirements shall provide for temporary waiver of the
requirements, for such period as the Secretary deems
appropriate, where (i) the facility's failure to fully
comply with the requirements is attributable to a
temporary shortage of qualified nursing personnel in
the area in which the facility is located, (ii) a
registered professional nurse is present on the
premises to render or supervise the nursing service
provided during at least the regular daytime shift, and
(iii) the Secretary determines that the employment of
such nursing personnel as are available to the facility
during such temporary period will not adversely affect
the health and safety of patients;
(B) with respect to the health and safety
requirements promulgated under paragraph (9), such
requirements shall be applied by the Secretary to a
facility herein defined in such manner as to assure
that personnel requirements take into account the
availability of technical personnel and the educational
opportunities for technical personnel in the area in
which such facility is located, and the scope of
services rendered by such facility; and the Secretary,
by regulations, shall provide for the continued
participation of such a facility where such personnel
requirements are not fully met, for such period as the
Secretary determines that (i) the facility is making
good faith efforts to fully comply with the personnel
requirements, (ii) the employment by the facility of
such personnel as are available to the facility will
not adversely affect the health and safety of patients,
and (iii) if the Secretary has determined that because
of the facility's waiver under this subparagraph the
facility should limit its scope of services in order
not to adversely affect the health and safety of the
facility's patients, the facility is so limiting the
scope of services it provides; and
(C) with respect to the fire and safety requirements
promulgated under paragraph (9), the Secretary (i) may
waive, for such period as he deems appropriate,
specific provisions of such requirements which if
rigidly applied would result in unreasonable hardship
for such a facility and which, if not applied, would
not jeopardize the health and safety of patients, and
(ii) may accept a facility's compliance with all
applicable State codes relating to fire and safety in
lieu of compliance with the fire and safety
requirements promulgated under paragraph (9), if he
determines that such State has in effect fire and
safety codes, imposed by State law, which adequately
protect patients.
The term ``hospital'' does not include, unless the context
otherwise requires, a critical access hospital (as defined in
section 1861(mm)(1)).
Psychiatric Hospital
(f) The term ``psychiatric hospital'' means an institution
which--
(1) is primarily engaged in providing, by or under
the supervision of a physician, psychiatric services
for the diagnosis and treatment of mentally ill
persons;
(2) satisfies the requirements of paragraphs (3)
through (9) of subsection (e);
(3) maintains clinical records on all patients and
maintains such records as the Secretary finds to be
necessary to determine the degree and intensity of the
treatment provided to individuals entitled to hospital
insurance benefits under part A; and
(4) meets such staffing requirements as the Secretary
finds necessary for the institution to carry out an
active program of treatment for individuals who are
furnished services in the institution.
In the case of an institution which satisfies paragraphs (1)
and (2) of the preceding sentence and which contains a distinct
part which also satisfies paragraphs (3) and (4) of such
sentence, such distinct part shall be considered to be a
``psychiatric hospital''.
Outpatient Occupational Therapy Services
(g) The term ``outpatient occupational therapy services'' has
the meaning given the term ``outpatient physical therapy
services'' in subsection (p), except that ``occupational''
shall be substituted for ``physical'' each place it appears
therein.
Extended Care Services
(h) The term ``extended care services'' means the following
items and services furnished to an inpatient of a skilled
nursing facility and (except as provided in paragraphs (3), (6)
and (7)) by such skilled nursing facility--
(1) nursing care provided by or under the supervision
of a registered professional nurse;
(2) bed and board in connection with the furnishing
of such nursing care;
(3) physical or occupational therapy or speech-
language pathology services furnished by the skilled
nursing facility or by others under arrangements with
them made by the facility;
(4) medical social services;
(5) such drugs, biologicals, supplies, appliances,
and equipment, furnished for use in the skilled nursing
facility, as are ordinarily furnished by such facility
for the care and treatment of inpatients;
(6) medical services provided by an intern or
resident-in- training of a hospital with which the
facility has in effect a transfer agreement (meeting
the requirements of subsection (l)), under a teaching
program of such hospital approved as provided in the
last sentence of subsection (b), and other diagnostic
or therapeutic services provided by a hospital with
which the facility has such an agreement in effect; and
(7) such other services necessary to the health of
the patients as are generally provided by skilled
nursing facilities, or by others under arrangements
with them made by the facility;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital.
Post-Hospital Extended Care Services
(i) The term ``post-hospital extended care services'' means
extended care services furnished an individual after transfer
from a hospital in which he was an inpatient for not less than
3 consecutive days before his discharge from the hospital in
connection with such transfer. For purposes of the preceding
sentence, items and services shall be deemed to have been
furnished to an individual after transfer from a hospital, and
he shall be deemed to have been an inpatient in the hospital
immediately before transfer therefrom, if he is admitted to the
skilled nursing facility (A) within 30 days after discharge
from such hospital, or (B) within such time as it would be
medically appropriate to begin an active course of treatment,
in the case of an individual whose condition is such that
skilled nursing facility care would not be medically
appropriate within 30 days after discharge from a hospital; and
an individual shall be deemed not to have been discharged from
a skilled nursing facility if, within 30 days after discharge
therefrom, he is admitted to such facility or any other skilled
nursing facility.
Skilled Nursing Facility
(j) The term ``skilled nursing facility'' has the meaning
given such term in section 1819(a).
Utilization Review
(k) A utilization review plan of a hospital or skilled
nursing facility shall be considered sufficient if it is
applicable to services furnished by the institution to
individuals entitled to insurance benefits under this title and
if it provides--
(1) for the review, on a sample or other basis, of
admissions to the institution, the duration of stays
therein, and the professional services (including drugs
and biologicals) furnished, (A) with respect to the
medical necessity of the services, and (B) for the
purpose of promoting the most efficient use of
available health facilities and services;
(2) for such review to be made by either (A) a staff
committee of the institution composed of two or more
physicians (of which at least two must be physicians
described in subsection (r)(1) of this section), with
or without participation of other professional
personnel, or (B) a group outside the institution which
is similarly composed and (i) which is established by
the local medical society and some or all of the
hospitals and skilled nursing facilities in the
locality, or (ii) if (and for as long as) there has not
been established such a group which serves such
institution, which is established in such other manner
as may be approved by the Secretary;
(3) for such review, in each case of inpatient
hospital services or extended care services furnished
to such an individual during a continuous period of
extended duration, as of such days of such period
(which may differ for different classes of cases) as
may be specified in regulations, with such review to be
made as promptly as possible, after each day so
specified, and in no event later than one week
following such day; and
(4) for prompt notification to the institution, the
individual, and his attending physician of any finding
(made after opportunity for consultation to such
attending physician) by the physician members of such
committee or group that any further stay in the
institution is not medically necessary.
The review committee must be composed as provided in clause (B)
of paragraph (2) rather than as provided in clause (A) of such
paragraph in the case of any hospital or skilled nursing
facility where, because of the small size of the institution,
or (in the case of a skilled nursing facility) because of lack
of an organized medical staff, or for such other reason or
reasons as may be included in regulations, it is impracticable
for the institution to have a properly functioning staff
committee for the purposes of this subsection. If the Secretary
determines that the utilization review procedures established
pursuant to title XIX are superior in their effectiveness to
the procedures required under this section, he may, to the
extent that he deems it appropriate, require for purposes of
this title that the procedures established pursuant to title
XIX be utilized instead of the procedures required by this
section.
Agreements for Transfer Between Skilled Nursing Facilities and
Hospitals
(l) A hospital and a skilled nursing facility shall be
considered to have a transfer agreement in effect if, by reason
of a written agreement between them or (in case the two
institutions are under common control) by reason of a written
undertaking by the person or body which controls them, there is
reasonable assurance that--
(1) transfer of patients will be effected between the
hospital and the skilled nursing facility whenever such
transfer is medically appropriate as determined by the
attending physician; and
(2) there will be interchange of medical and other
information necessary or useful in the care and
treatment of individuals transferred between the
institutions, or in determining whether such
individuals can be adequately cared for otherwise than
in either of such institutions.
Any skilled nursing facility which does not have such an
agreement in effect, but which is found by a State agency (of
the State in which such facility is situated) with which an
agreement under section 1864 is in effect (or, in the case of a
State in which no such agency has an agreement under section
1864, by the Secretary) to have attempted in good faith to
enter into such an agreement with a hospital sufficiently close
to the facility to make feasible the transfer between them of
patients and the information referred to in paragraph (2),
shall be considered to have such an agreement in effect if and
for so long as such agency (or the Secretary, as the case may
be) finds that to do so is in the public interest and essential
to assuring extended care services for persons in the community
who are eligible for payments with respect to such services
under this title.
Home Health Services
(m) The term ``home health services'' means the following
items and services furnished to an individual, who is under the
care of a physician, by a home health agency or by others under
arrangements with them made by such agency, under a plan (for
furnishing such items and services to such individual)
established and periodically reviewed by a physician, which
items and services are, except as provided in paragraph (7),
provided on a visiting basis in a place of residence used as
such individual's home--
(1) part-time or intermittent nursing care provided
by or under the supervision of a registered
professional nurse;
(2) physical or occupational therapy or speech-
language pathology services;
(3) medical social services under the direction of a
physician;
(4) to the extent permitted in regulations, part-time
or intermittent services of a home health aide who has
successfully completed a training program approved by
the Secretary;
(5) medical supplies (including catheters, catheter
supplies, ostomy bags, and supplies related to ostomy
care, and a covered osteoporosis drug (as defined in
subsection (kk)), but excluding other drugs and
biologicals) and durable medical equipment and
applicable disposable devices (as defined in section
1834(s)(2)) while under such a plan;
(6) in the case of a home health agency which is
affiliated or under common control with a hospital,
medical services provided by an intern or resident-in-
training of such hospital, under a teaching program of
such hospital approved as provided in the last sentence
of subsection (b); and
(7) any of the foregoing items and services which are
provided on an outpatient basis, under arrangements
made by the home health agency, at a hospital or
skilled nursing facility, or at a rehabilitation center
which meets such standards as may be prescribed in
regulations, and--
(A) the furnishing of which involves the use
of equipment of such a nature that the items
and services cannot readily be made available
to the individual in such place of residence,
or
(B) which are furnished at such facility
while he is there to receive any such item or
service described in clause (A),
but not including transportation of the individual in
connection with any such item or service;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital and home infusion therapy (as defined in subsection
(iii)(i)). For purposes of paragraphs (1) and (4), the term
``part-time or intermittent services'' means skilled nursing
and home health aide services furnished any number of days per
week as long as they are furnished (combined) less than 8 hours
each day and 28 or fewer hours each week (or, subject to review
on a case-by-case basis as to the need for care, less than 8
hours each day and 35 or fewer hours per week). For purposes of
sections 1814(a)(2)(C) and 1835(a)(2)(A), ``intermittent''
means skilled nursing care that is either provided or needed on
fewer than 7 days each week, or less than 8 hours of each day
for periods of 21 days or less (with extensions in exceptional
circumstances when the need for additional care is finite and
predictable).
Durable Medical Equipment
(n) The term ``durable medical equipment'' includes iron
lungs, oxygen tents, hospital beds, and wheelchairs (which may
include a power-operated vehicle that may be appropriately used
as a wheelchair, but only where the use of such a vehicle is
determined to be necessary on the basis of the individual's
medical and physical condition and the vehicle meets such
safety requirements as the Secretary may prescribe) used in the
patient's home (including an institution used as his home other
than an institution that meets the requirements of subsection
(e)(1) of this section or section 1819(a)(1)), whether
furnished on a rental basis or purchased, and includes blood-
testing strips and blood glucose monitors for individuals with
diabetes without regard to whether the individual has Type I or
Type II diabetes or to the individual's use of insulin (as
determined under standards established by the Secretary in
consultation with the appropriate organizations) and eye
tracking and gaze interaction accessories for speech generating
devices furnished to individuals with a demonstrated medical
need for such accessories; except that such term does not
include such equipment furnished by a supplier who has used,
for the demonstration and use of specific equipment, an
individual who has not met such minimum training standards as
the Secretary may establish with respect to the demonstration
and use of such specific equipment. With respect to a seat-lift
chair, such term includes only the seat-lift mechanism and does
not include the chair.
Home Health Agency
(o) The term ``home health agency'' means a public agency or
private organization, or a subdivision of such an agency or
organization, which--
(1) is primarily engaged in providing skilled nursing
services and other therapeutic services;
(2) has policies, established by a group of
professional personnel (associated with the agency or
organization), including one or more physicians and one
or more registered professional nurses, to govern the
services (referred to in paragraph (1)) which it
provides, and provides for supervision of such services
by a physician or registered professional nurse;
(3) maintains clinical records on all patients;
(4) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, (A) is licensed pursuant to such law, or (B) is
approved, by the agency of such State or locality
responsible for licensing agencies or organizations of
this nature, as meeting the standards established for
such licensing;
(5) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(6) meets the conditions of participation specified
in section 1891(a) and such other conditions of
participation as the Secretary may find necessary in
the interest of the health and safety of individuals
who are furnished services by such agency or
organization;
(7) provides the Secretary with a surety bond--
(A) in a form specified by the Secretary and
in an amount that is not less than the minimum
of $50,000; and
(B) that the Secretary determines is
commensurate with the volume of payments to the
home health agency; and
(8) meets such additional requirements (including
conditions relating to bonding or establishing of
escrow accounts as the Secretary finds necessary for
the financial security of the program) as the Secretary
finds necessary for the effective and efficient
operation of the program;
except that for purposes of part A such term shall not include
any agency or organization which is primarily for the care and
treatment of mental diseases. The Secretary may waive the
requirement of a surety bond under paragraph (7) in the case of
an agency or organization that provides a comparable surety
bond under State law.
Outpatient Physical Therapy Services
(p) The term ``outpatient physical therapy services'' means
physical therapy services furnished by a provider of services,
a clinic, rehabilitation agency, or a public health agency, or
by others under an arrangement with, and under the supervision
of, such provider, clinic, rehabilitation agency, or public
health agency to an individual as an outpatient--
(1) who is under the care of a physician (as defined
in paragraph (1), (3), or (4) of section 1861(r)), and
(2) with respect to whom a plan prescribing the type,
amount, and duration of physical therapy services that
are to be furnished such individual has been
established by a physician (as so defined) or by a
qualified physical therapist and is periodically
reviewed by a physician (as so defined);
excluding, however--
(3) any item or service if it would not be included
under subsection (b) if furnished to an inpatient of a
hospital; and
(4) any such service--
(A) if furnished by a clinic or
rehabilitation agency, or by others under
arrangements with such clinic or agency, unless
such clinic or rehabilitation agency--
(i) provides an adequate program of
physical therapy services for
outpatients and has the facilities and
personnel required for such program or
required for the supervision of such a
program, in accordance with such
requirements as the Secretary may
specify,
(ii) has policies, established by a
group of professional personnel,
including one or more physicians
(associated with the clinic or
rehabilitation agency) and one or more
qualified physical therapists, to
govern the services (referred to in
clause (i)) it provides,
(iii) maintains clinical records on
all patients,
(iv) if such clinic or agency is
situated in a State in which State or
applicable local law provides for the
licensing of institutions of this
nature, (I) is licensed pursuant to
such law, or (II) is approved by the
agency of such State or locality
responsible for licensing institutions
of this nature, as meeting the
standards established for such
licensing; and
(v) meets such other conditions
relating to the health and safety of
individuals who are furnished services
by such clinic or agency on an
outpatient basis, as the Secretary may
find necessary, and provides the
Secretary on a continuing basis with a
surety bond in a form specified by the
Secretary and in an amount that is not
less than $50,000, or
(B) if furnished by a public health agency,
unless such agency meets such other conditions
relating to health and safety of individuals
who are furnished services by such agency on an
outpatient basis, as the Secretary may find
necessary.
The term ``outpatient physical therapy services'' also includes
physical therapy services furnished an individual by a physical
therapist (in his office or in such individual's home) who
meets licensing and other standards prescribed by the Secretary
in regulations, otherwise than under an arrangement with and
under the supervision of a provider of services, clinic,
rehabilitation agency, or public health agency, if the
furnishing of such services meets such conditions relating to
health and safety as the Secretary may find necessary. In
addition, such term includes physical therapy services which
meet the requirements of the first sentence of this subsection
except that they are furnished to an individual as an inpatient
of a hospital or extended care facility. Nothing in this
subsection shall be construed as requiring, with respect to
outpatients who are not entitled to benefits under this title,
a physical therapist to provide outpatient physical therapy
services only to outpatients who are under the care of a
physician or pursuant to a plan of care established by a
physician. The Secretary may waive the requirement of a surety
bond under paragraph (4)(A)(v) in the case of a clinic or
agency that provides a comparable surety bond under State law.
Physicians' Services
(q) The term ``physicians' services'' means professional
services performed by physicians, including surgery,
consultation, and home, office, and institutional calls (but
not including services described in subsection (b)(6)).
Physician
(r) The term ``physician'', when used in connection with the
performance of any function or action, means (1) a doctor of
medicine or osteopathy legally authorized to practice medicine
and surgery by the State in which he performs such function or
action (including a physician within the meaning of section
1101(a)(7)), (2) a doctor of dental surgery or of dental
medicine who is legally authorized to practice dentistry by the
State in which he performs such function and who is acting
within the scope of his license when he performs such
functions, (3) a doctor of podiatric medicine for the purposes
of subsections (k), (m), (p)(1), and (s) of this section and
sections 1814(a), 1832(a)(2)(F)(ii), and 1835 but only with
respect to functions which he is legally authorized to perform
as such by the State in which he performs them, (4) a doctor of
optometry, but only for purposes of subsection (p)(1) and with
respect to the provision of items or services described in
subsection (s) which he is legally authorized to perform as a
doctor of optometry by the State in which he performs them, or
(5) a chiropractor who is licensed as such by the State (or in
a State which does not license chiropractors as such, is
legally authorized to perform the services of a chiropractor in
the jurisdiction in which he performs such services), and who
meets uniform minimum standards promulgated by the Secretary,
but only for the purpose of sections 1861(s)(1) and
1861(s)(2)(A) and only with respect to treatment by means of
manual manipulation of the spine (to correct a subluxation)
which he is legally authorized to perform by the State or
jurisdiction in which such treatment is provided. For the
purposes of section 1862(a)(4) and subject to the limitations
and conditions provided in the previous sentence, such term
includes a doctor of one of the arts, specified in such
previous sentence, legally authorized to practice such art in
the country in which the inpatient hospital services (referred
to in such section 1862(a)(4)) are furnished.
Medical and Other Health Services
(s) The term ``medical and other health services'' means any
of the following items or services:
(1) physicians' services;
(2)(A) services and supplies (including drugs and
biologicals which are not usually self-administered by
the patient) furnished as an incident to a physician's
professional service, of kinds which are commonly
furnished in physicians' offices and are commonly
either rendered without charge or included in the
physicians' bills (or would have been so included but
for the application of section 1847B);
(B) hospital services (including drugs and
biologicals which are not usually self-administered by
the patient) incident to physicians' services rendered
to outpatients and partial hospitalization services
incident to such services;
(C) diagnostic services which are--
(i) furnished to an individual as an
outpatient by a hospital or by others under
arrangements with them made by a hospital, and
(ii) ordinarily furnished by such hospital
(or by others under such arrangements) to its
outpatients for the purpose of diagnostic
study;
(D) outpatient physical therapy services, outpatient
speech-language pathology services, and outpatient
occupational therapy services;
(E) rural health clinic services and Federally
qualified health center services;
(F) home dialysis supplies and equipment, self-care
home dialysis support services, and institutional
dialysis services and supplies, and, for items and
services furnished on or after January 1, 2011, renal
dialysis services (as defined in section
1881(b)(14)(B)), including such renal dialysis services
furnished on or after January 1, 2017, by a renal
dialysis facility or provider of services paid under
section 1881(b)(14) to an individual with acute kidney
injury (as defined in section 1834(r)(2));
(G) antigens (subject to quantity limitations
prescribed in regulations by the Secretary) prepared by
a physician, as defined in section 1861(r)(1), for a
particular patient, including antigens so prepared
which are forwarded to another qualified person
(including a rural health clinic) for administration to
such patient, from time to time, by or under the
supervision of another such physician;
(H)(i) services furnished pursuant to a contract
under section 1876 to a member of an eligible
organization by a physician assistant or by a nurse
practitioner (as defined in subsection (aa)(5)) and
such services and supplies furnished as an incident to
his service to such a member as would otherwise be
covered under this part if furnished by a physician or
as an incident to a physician's service; and
(ii) services furnished pursuant to a risk-sharing
contract under section 1876(g) to a member of an
eligible organization by a clinical psychologist (as
defined by the Secretary) or by a clinical social
worker (as defined in subsection (hh)(2)), and such
services and supplies furnished as an incident to such
clinical psychologist's services or clinical social
worker's services to such a member as would otherwise
be covered under this part if furnished by a physician
or as an incident to a physician's service;
(I) blood clotting factors, for hemophilia patients
competent to use such factors to control bleeding
without medical or other supervision, and items related
to the administration of such factors, subject to
utilization controls deemed necessary by the Secretary
for the efficient use of such factors;
(J) prescription drugs used in immunosuppressive
therapy furnished, to an individual who receives an
organ transplant for which payment is made under this
title;
(K)(i) services which would be physicians' services
and services described in subsections (ww)(1) and (hhh)
if furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a physician
assistant (as defined in subsection (aa)(5)) under the
supervision of a physician (as so defined) and which
the physician assistant is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services,
(ii) services which would be physicians' services and
services described in subsections (ww)(1) and (hhh) if
furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a nurse practitioner
or clinical nurse specialist (as defined in subsection
(aa)(5)) working in collaboration (as defined in
subsection (aa)(6)) with a physician (as defined in
subsection (r)(1)) which the nurse practitioner or
clinical nurse specialist is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
an incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services;
(L) certified nurse-midwife services;
(M) qualified psychologist services;
(N) clinical social worker services (as defined in
subsection (hh)(2));
(O) erythropoietin for dialysis patients competent to
use such drug without medical or other supervision with
respect to the administration of such drug, subject to
methods and standards established by the Secretary by
regulation for the safe and effective use of such drug,
and items related to the administration of such drug;
(P) prostate cancer screening tests (as defined in
subsection (oo));
(Q) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
anticancer chemotherapeutic agent for a given
indication, and containing an active ingredient (or
ingredients), which is the same indication and active
ingredient (or ingredients) as a drug which the carrier
determines would be covered pursuant to subparagraph
(A) or (B) if the drug could not be self-administered;
(R) colorectal cancer screening tests (as defined in
subsection (pp));
(S) diabetes outpatient self-management training
services (as defined in subsection (qq));
(T) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
acute anti-emetic used as part of an anticancer
chemotherapeutic regimen if the drug is administered by
a physician (or as prescribed by a physician)--
(i) for use immediately before, at, or within
48 hours after the time of the administration
of the anticancer chemotherapeutic agent; and
(ii) as a full replacement for the anti-
emetic therapy which would otherwise be
administered intravenously;
(U) screening for glaucoma (as defined in subsection
(uu)) for individuals determined to be at high risk for
glaucoma, individuals with a family history of glaucoma
and individuals with diabetes;
(V) medical nutrition therapy services (as defined in
subsection (vv)(1)) in the case of a beneficiary with
diabetes or a renal disease who--
(i) has not received diabetes outpatient
self-management training services within a time
period determined by the Secretary;
(ii) is not receiving maintenance dialysis
for which payment is made under section 1881;
and
(iii) meets such other criteria determined by
the Secretary after consideration of protocols
established by dietitian or nutrition
professional organizations;
(W) an initial preventive physical examination (as
defined in subsection (ww));
(X) cardiovascular screening blood tests (as defined
in subsection (xx)(1));
(Y) diabetes screening tests (as defined in
subsection (yy));
(Z) intravenous immune globulin for the treatment of
primary immune deficiency diseases in the home (as
defined in subsection (zz));
(AA) ultrasound screening for abdominal aortic
aneurysm (as defined in subsection (bbb)) for an
individual--
(i) who receives a referral for such an
ultrasound screening as a result of an initial
preventive physical examination (as defined in
section 1861(ww)(1));
(ii) who has not been previously furnished
such an ultrasound screening under this title;
and
(iii) who--
(I) has a family history of abdominal
aortic aneurysm; or
(II) manifests risk factors included
in a beneficiary category recommended
for screening by the United States
Preventive Services Task Force
regarding abdominal aortic aneurysms;
(BB) additional preventive services (described in
subsection (ddd)(1));
(CC) items and services furnished under a
cardiac rehabilitation program (as defined in
subsection (eee)(1)) or under a pulmonary
rehabilitation program (as defined in
subsection (fff)(1));
(DD) items and services furnished under an
intensive cardiac rehabilitation program (as
defined in subsection (eee)(4));
(EE) kidney disease education services (as defined in
subsection (ggg));
(FF) personalized prevention plan services (as
defined in subsection (hhh));
(GG) home infusion therapy (as defined in subsection
(iii)(1)); and
(HH) opioid use disorder treatment services (as
defined in subsection (jjj)).
(3) diagnostic X-ray tests (including tests under the
supervision of a physician, furnished in a place of
residence used as the patient's home, if the
performance of such tests meets such conditions
relating to health and safety as the Secretary may find
necessary and including diagnostic mammography if
conducted by a facility that has a certificate (or
provisional certificate) issued under section 354 of
the Public Health Service Act), diagnostic laboratory
tests, and other diagnostic tests;
(4) X-ray, radium, and radioactive isotope therapy,
including materials and services of technicians;
(5) surgical dressings, and splints, casts, and other
devices used for reduction of fractures and
dislocations;
(6) durable medical equipment;
(7) ambulance service where the use of other methods
of transportation is contraindicated by the
individual's condition, but, subject to section
1834(l)(14), only to the extent provided in
regulations;
(8) prosthetic devices (other than dental) which
replace all or part of an internal body organ
(including colostomy bags and supplies directly related
to colostomy care), including replacement of such
devices, and including one pair of conventional
eyeglasses or contact lenses furnished subsequent to
each cataract surgery with insertion of an intraocular
lens;
(9) leg, arm, back, and neck braces, and artificial
legs, arms, and eyes, including replacements if
required because of a change in the patient's physical
condition;
(10)(A) pneumococcal vaccine and its administration
and, subject to section 4071(b) of the Omnibus Budget
Reconciliation Act of 1987, influenza vaccine and its
administration; and
(B) hepatitis B vaccine and its administration,
furnished to an individual who is at high or
intermediate risk of contracting hepatitis B (as
determined by the Secretary under regulations);
(11) services of a certified registered nurse
anesthetist (as defined in subsection (bb));
(12) subject to section 4072(e) of the Omnibus Budget
Reconciliation Act of 1987, extra-depth shoes with
inserts or custom molded shoes with inserts for an
individual with diabetes, if--
(A) the physician who is managing the
individual's diabetic condition (i) documents
that the individual has peripheral neuropathy
with evidence of callus formation, a history of
pre-ulcerative calluses, a history of previous
ulceration, foot deformity, or previous
amputation, or poor circulation, and (ii)
certifies that the individual needs such shoes
under a comprehensive plan of care related to
the individual's diabetic condition;
(B) the particular type of shoes are
prescribed by a podiatrist or other qualified
physician (as established by the Secretary);
and
(C) the shoes are fitted and furnished by a
podiatrist or other qualified individual (such
as a pedorthist or orthotist, as established by
the Secretary) who is not the physician
described in subparagraph (A) (unless the
Secretary finds that the physician is the only
such qualified individual in the area);
(13) screening mammography (as defined in subsection
(jj));
(14) screening pap smear and screening pelvic exam;
and
(15) bone mass measurement (as defined in subsection
(rr)).
No diagnostic tests performed in any laboratory, including a
laboratory that is part of a rural health clinic, or a hospital
(which, for purposes of this sentence, means an institution
considered a hospital for purposes of section 1814(d)) shall be
included within paragraph (3) unless such laboratory--
(16) if situated in any State in which State or
applicable local law provides for licensing of
establishments of this nature, (A) is licensed pursuant
to such law, or (B) is approved, by the agency of such
State or locality responsible for licensing
establishments of this nature, as meeting the standards
established for such licensing; and
(17)(A) meets the certification requirements under
section 353 of the Public Health Service Act; and
(B) meets such other conditions relating to the
health and safety of individuals with respect to whom
such tests are performed as the Secretary may find
necessary.
There shall be excluded from the diagnostic services specified
in paragraph (2)(C) any item or service (except services
referred to in paragraph (1)) which would not be included under
subsection (b) if it were furnished to an inpatient of a
hospital. None of the items and services referred to in the
preceding paragraphs (other than paragraphs (1) and (2)(A)) of
this subsection which are furnished to a patient of an
institution which meets the definition of a hospital for
purposes of section 1814(d) shall be included unless such other
conditions are met as the Secretary may find necessary relating
to health and safety of individuals with respect to whom such
items and services are furnished.
Drugs and Biologicals
(t)(1) The term ``drugs'' and the term ``biologicals'',
except for purposes of subsection (m)(5) and paragraph (2),
include only such drugs (including contrast agents) and
biologicals, respectively, as are included (or approved for
inclusion) in the United States Pharmacopoeia, the National
Formulary, or the United States Homeopathic Pharmacopoeia, or
in New Drugs or Accepted Dental Remedies (except for any drugs
and biologicals unfavorably evaluated therein), or as are
approved by the pharmacy and drug therapeutics committee (or
equivalent committee) of the medical staff of the hospital
furnishing such drugs and biologicals for use in such hospital.
(2)(A) For purposes of paragraph (1), the term ``drugs'' also
includes any drugs or biologicals used in an anticancer
chemotherapeutic regimen for a medically accepted indication
(as described in subparagraph (B)).
(B) In subparagraph (A), the term ``medically accepted
indication'', with respect to the use of a drug, includes any
use which has been approved by the Food and Drug Administration
for the drug, and includes another use of the drug if--
(i) the drug has been approved by the Food and Drug
Administration; and
(ii)(I) such use is supported by one or more
citations which are included (or approved for
inclusion) in one or more of the following compendia:
the American Hospital Formulary Service-Drug
Information, the American Medical Association Drug
Evaluations, the United States Pharmacopoeia-Drug
Information (or its successor publications), and other
authoritative compendia as identified by the Secretary,
unless the Secretary has determined that the use is not
medically appropriate or the use is identified as not
indicated in one or more such compendia, or
(II) the carrier involved determines, based upon
guidance provided by the Secretary to carriers for
determining accepted uses of drugs, that such use is
medically accepted based on supportive clinical
evidence in peer reviewed medical literature appearing
in publications which have been identified for purposes
of this subclause by the Secretary.
The Secretary may revise the list of compendia in clause
(ii)(I) as is appropriate for identifying medically accepted
indications for drugs. On and after January 1, 2010, no
compendia may be included on the list of compendia under this
subparagraph unless the compendia has a publicly transparent
process for evaluating therapies and for identifying potential
conflicts of interests.
Provider of Services
(u) The term ``provider of services'' means a hospital,
critical access hospital, skilled nursing facility,
comprehensive outpatient rehabilitation facility, home health
agency, hospice program, or, for purposes of section 1814(g)
and section 1835(e), a fund.
Reasonable Cost
(v)(1)(A) The reasonable cost of any services shall be the
cost actually incurred, excluding therefrom any part of
incurred cost found to be unnecessary in the efficient delivery
of needed health services, and shall be determined in
accordance with regulations establishing the method or methods
to be used, and the items to be included, in determining such
costs for various types or classes of institutions, agencies,
and services; except that in any case to which paragraph (2) or
(3) applies, the amount of the payment determined under such
paragraph with respect to the services involved shall be
considered the reasonable cost of such services. In prescribing
the regulations referred to in the preceding sentence, the
Secretary shall consider, among other things, the principles
generally applied by national organizations or established
prepayment organizations (which have developed such principles)
in computing the amount of payment, to be made by persons other
than the recipients of services, to providers of services on
account of services furnished to such recipients by such
providers. Such regulations may provide for determination of
the costs of services on a per diem, per unit, per capita, or
other basis, may provide for using different methods in
different circumstances, may provide for the use of estimates
of costs of particular items or services, may provide for the
establishment of limits on the direct or indirect overall
incurred costs or incurred costs of specific items or services
or groups of items or services to be recognized as reasonable
based on estimates of the costs necessary in the efficient
delivery of needed health services to individuals covered by
the insurance programs established under this title, and may
provide for the use of charges or a percentage of charges where
this method reasonably reflects the costs. Such regulations
shall (i) take into account both direct and indirect costs of
providers of services (excluding therefrom any such costs,
including standby costs, which are determined in accordance
with regulations to be unnecessary in the efficient delivery of
services covered by the insurance programs established under
this title) in order that, under the methods of determining
costs, the necessary costs of efficiently delivering covered
services to individuals covered by the insurance programs
established by this title will not be borne by individuals not
so covered, and the costs with respect to individuals not so
covered will not be borne by such insurance programs, and (ii)
provide for the making of suitable retroactive corrective
adjustments where, for a provider of services for any fiscal
period, the aggregate reimbursement produced by the methods of
determining costs proves to be either inadequate or excessive.
(B) In the case of extended care services, the regulations
under subparagraph (A) shall not include provision for specific
recognition of a return on equity capital.
(C) Where a hospital has an arrangement with a medical school
under which the faculty of such school provides services at
such hospital, an amount not in excess of the reasonable cost
of such services to the medical school shall be included in
determining the reasonable cost to the hospital of furnishing
services--
(i) for which payment may be made under part A, but
only if--
(I) payment for such services as furnished
under such arrangement would be made under part
A to the hospital had such services been
furnished by the hospital, and
(II) such hospital pays to the medical school
at least the reasonable cost of such services
to the medical school, or
(ii) for which payment may be made under part B, but
only if such hospital pays to the medical school at
least the reasonable cost of such services to the
medical school.
(D) Where (i) physicians furnish services which are either
inpatient hospital services (including services in conjunction
with the teaching programs of such hospital) by reason of
paragraph (7) of subsection (b) or for which entitlement exists
by reason of clause (II) of section 1832(a)(2)(B)(i), and (ii)
such hospital (or medical school under arrangement with such
hospital) incurs no actual cost in the furnishing of such
services, the reasonable cost of such services shall (under
regulations of the Secretary) be deemed to be the cost such
hospital or medical school would have incurred had it paid a
salary to such physicians rendering such services approximately
equivalent to the average salary paid to all physicians
employed by such hospital (or if such employment does not
exist, or is minimal in such hospital, by similar hospitals in
a geographic area of sufficient size to assure reasonable
inclusion of sufficient physicians in development of such
average salary).
(E) Such regulations may, in the case of skilled nursing
facilities in any State, provide for the use of rates,
developed by the State in which such facilities are located,
for the payment of the cost of skilled nursing facility
services furnished under the State's plan approved under title
XIX (and such rates may be increased by the Secretary on a
class or size of institution or on a geographical basis by a
percentage factor not in excess of 10 percent to take into
account determinable items or services or other requirements
under this title not otherwise included in the computation of
such State rates), if the Secretary finds that such rates are
reasonably related to (but not necessarily limited to) analyses
undertaken by such State of costs of care in comparable
facilities in such State. Notwithstanding the previous
sentence, such regulations with respect to skilled nursing
facilities shall take into account (in a manner consistent with
subparagraph (A) and based on patient-days of services
furnished) the costs (including the costs of services required
to attain or maintain the highest practicable physical, mental,
and psychosocial well-being of each resident eligible for
benefits under this title) of such facilities complying with
the requirements of subsections (b), (c), and (d) of section
1819 (including the costs of conducting nurse aide training and
competency evaluation programs and competency evaluation
programs).
(F) Such regulations shall require each provider of services
(other than a fund) to make reports to the Secretary of
information described in section 1121(a) in accordance with the
uniform reporting system (established under such section) for
that type of provider.
(G)(i) In any case in which a hospital provides inpatient
services to an individual that would constitute post-hospital
extended care services if provided by a skilled nursing
facility and a quality improvement organization (or, in the
absence of such a qualified organization, the Secretary or such
agent as the Secretary may designate) determines that inpatient
hospital services for the individual are not medically
necessary but post-hospital extended care services for the
individual are medically necessary and such extended care
services are not otherwise available to the individual (as
determined in accordance with criteria established by the
Secretary) at the time of such determination, payment for such
services provided to the individual shall continue to be made
under this title at the payment rate described in clause (ii)
during the period in which--
(I) such post-hospital extended care services for the
individual are medically necessary and not otherwise
available to the individual (as so determined),
(II) inpatient hospital services for the individual
are not medically necessary, and
(III) the individual is entitled to have payment made
for post-hospital extended care services under this
title,
except that if the Secretary determines that there is not an
excess of hospital beds in such hospital and (subject to clause
(iv)) there is not an excess of hospital beds in the area of
such hospital, such payment shall be made (during such period)
on the basis of the amount otherwise payable under part A with
respect to inpatient hospital services.
(ii)(I) Except as provided in subclause (II), the payment
rate referred to in clause (i) is a rate equal to the estimated
adjusted State-wide average rate per patient-day paid for
services provided in skilled nursing facilities under the State
plan approved under title XIX for the State in which such
hospital is located, or, if the State in which the hospital is
located does not have a State plan approved under title XIX,
the estimated adjusted State-wide average allowable costs per
patient-day for extended care services under this title in that
State.
(II) If a hospital has a unit which is a skilled nursing
facility, the payment rate referred to in clause (i) for the
hospital is a rate equal to the lesser of the rate described in
subclause (I) or the allowable costs in effect under this title
for extended care services provided to patients of such unit.
(iii) Any day on which an individual receives inpatient
services for which payment is made under this subparagraph
shall, for purposes of this Act (other than this subparagraph),
be deemed to be a day on which the individual received
inpatient hospital services.
(iv) In determining under clause (i), in the case of a public
hospital, whether or not there is an excess of hospital beds in
the area of such hospital, such determination shall be made on
the basis of only the public hospitals (including the hospital)
which are in the area of the hospital and which are under
common ownership with that hospital.
(H) In determining such reasonable cost with respect to home
health agencies, the Secretary may not include--
(i) any costs incurred in connection with bonding or
establishing an escrow account by any such agency as a
result of the surety bond requirement described in
subsection (o)(7) and the financial security
requirement described in subsection (o)(8);
(ii) in the case of home health agencies to which the
surety bond requirement described in subsection (o)(7)
and the financial security requirement described in
subsection (o)(8) apply, any costs attributed to
interest charged such an agency in connection with
amounts borrowed by the agency to repay overpayments
made under this title to the agency, except that such
costs may be included in reasonable cost if the
Secretary determines that the agency was acting in good
faith in borrowing the amounts;
(iii) in the case of contracts entered into by a home
health agency after the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract
which is entered into for a period exceeding five
years; and
(iv) in the case of contracts entered into by a home
health agency before the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract,
which determines the amount payable by the home health
agency on the basis of a percentage of the agency's
reimbursement or claim for reimbursement for services
furnished by the agency, to the extent that such cost
exceeds the reasonable value of the services furnished
on behalf of such agency.
(I) In determining such reasonable cost, the Secretary may
not include any costs incurred by a provider with respect to
any services furnished in connection with matters for which
payment may be made under this title and furnished pursuant to
a contract between the provider and any of its subcontractors
which is entered into after the date of the enactment of this
subparagraph and the value or cost of which is $10,000 or more
over a twelve-month period unless the contract contains a
clause to the effect that--
(i) until the expiration of four years after the
furnishing of such services pursuant to such contract,
the subcontractor shall make available, upon written
request by the Secretary, or upon request by the
Comptroller General, or any of their duly authorized
representatives, the contract, and books, documents and
records of such subcontractor that are necessary to
certify the nature and extent of such costs, and
(ii) if the subcontractor carries out any of the
duties of the contract through a subcontract, with a
value or cost of $10,000 or more over a twelve-month
period, with a related organization, such subcontract
shall contain a clause to the effect that until the
expiration of four years after the furnishing of such
services pursuant to such subcontract, the related
organization shall make available, upon written request
by the Secretary, or upon request by the Comptroller
General, or any of their duly authorized
representatives, the subcontract, and books, documents
and records of such organization that are necessary to
verify the nature and extent of such costs.
The Secretary shall prescribe in regulation criteria and
procedures which the Secretary shall use in obtaining access to
books, documents, and records under clauses required in
contracts and subcontracts under this subparagraph.
(J) Such regulations may not provide for any inpatient
routine salary cost differential as a reimbursable cost for
hospitals and skilled nursing facilities.
(K)(i) The Secretary shall issue regulations that provide, to
the extent feasible, for the establishment of limitations on
the amount of any costs or charges that shall be considered
reasonable with respect to services provided on an outpatient
basis by hospitals (other than bona fide emergency services as
defined in clause (ii)) or clinics (other than rural health
clinics), which are reimbursed on a cost basis or on the basis
of cost related charges, and by physicians utilizing such
outpatient facilities. Such limitations shall be reasonably
related to the charges in the same area for similar services
provided in physicians' offices. Such regulations shall provide
for exceptions to such limitations in cases where similar
services are not generally available in physicians' offices in
the area to individuals entitled to benefits under this title.
(ii) For purposes of clause (i), the term ``bona fide
emergency services'' means services provided in a hospital
emergency room after the sudden onset of a medical condition
manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that the absence of immediate
medical attention could reasonably be expected to result in--
(I) placing the patient's health in serious jeopardy;
(II) serious impairment to bodily functions; or
(III) serious dysfunction of any bodily organ or
part.
(L)(i) The Secretary, in determining the amount of the
payments that may be made under this title with respect to
services furnished by home health agencies, may not recognize
as reasonable (in the efficient delivery of such services)
costs for the provision of such services by an agency to the
extent these costs exceed (on the aggregate for the agency) for
cost reporting periods beginning on or after--
(I) July 1, 1985, and before July 1, 1986, 120
percent of the mean of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
(II) July 1, 1986, and before July 1, 1987, 115
percent of such mean,
(III) July 1, 1987, and before October 1, 1997, 112
percent of such mean,
(IV) October 1, 1997, and before October 1, 1998, 105
percent of the median of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
or
(V) October 1, 1998, 106 percent of such median.
(ii) Effective for cost reporting periods beginning on or
after July 1, 1986, such limitations shall be applied on an
aggregate basis for the agency, rather than on a discipline
specific basis. The Secretary may provide for such exemptions
and exceptions to such limitation as he deems appropriate.
(iii) Not later than July 1, 1991, and annually thereafter
(but not for cost reporting periods beginning on or after July
1, 1994, and before July 1, 1996, or on or after July 1, 1997,
and before October 1, 1997), the Secretary shall establish
limits under this subparagraph for cost reporting periods
beginning on or after such date by utilizing the area wage
index applicable under section 1886(d)(3)(E) and determined
using the survey of the most recent available wages and wage-
related costs of hospitals located in the geographic area in
which the home health service is furnished (determined without
regard to whether such hospitals have been reclassified to a
new geographic area pursuant to section 1886(d)(8)(B), a
decision of the Medicare Geographic Classification Review Board
under section 1886(d)(10), or a decision of the Secretary).
(iv) In establishing limits under this subparagraph for cost
reporting periods beginning after September 30, 1997, the
Secretary shall not take into account any changes in the home
health market basket, as determined by the Secretary, with
respect to cost reporting periods which began on or after July
1, 1994, and before July 1, 1996.
(v) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997,
subject to clause (viii)(I), the Secretary shall provide for an
interim system of limits. Payment shall not exceed the costs
determined under the preceding provisions of this subparagraph
or, if lower, the product of--
(I) an agency-specific per beneficiary annual
limitation calculated based 75 percent on 98 percent of
the reasonable costs (including nonroutine medical
supplies) for the agency's 12-month cost reporting
period ending during fiscal year 1994, and based 25
percent on 98 percent of the standardized regional
average of such costs for the agency's census division,
as applied to such agency, for cost reporting periods
ending during fiscal year 1994, such costs updated by
the home health market basket index; and
(II) the agency's unduplicated census count of
patients (entitled to benefits under this title) for
the cost reporting period subject to the limitation.
(vi) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997, the
following rules apply:
(I) For new providers and those providers without a
12-month cost reporting period ending in fiscal year
1994 subject to clauses (viii)(II) and (viii)(III), the
per beneficiary limitation shall be equal to the median
of these limits (or the Secretary's best estimates
thereof) applied to other home health agencies as
determined by the Secretary. A home health agency that
has altered its corporate structure or name shall not
be considered a new provider for this purpose.
(II) For beneficiaries who use services furnished by
more than one home health agency, the per beneficiary
limitations shall be prorated among the agencies.
(vii)(I) Not later than January 1, 1998, the Secretary shall
establish per visit limits applicable for fiscal year 1998, and
not later than April 1, 1998, the Secretary shall establish per
beneficiary limits under clause (v)(I) for fiscal year 1998.
(II) Not later than August 1 of each year (beginning in 1998)
the Secretary shall establish the limits applicable under this
subparagraph for services furnished during the fiscal year
beginning October 1 of the year.
(viii)(I) In the case of a provider with a 12-month cost
reporting period ending in fiscal year 1994, if the limit
imposed under clause (v) (determined without regard to this
subclause) for a cost reporting period beginning during or
after fiscal year 1999 is less than the median described in
clause (vi)(I) (but determined as if any reference in clause
(v) to ``98 percent'' were a reference to ``100 percent''), the
limit otherwise imposed under clause (v) for such provider and
period shall be increased by \1/3\ of such difference.
(II) Subject to subclause (IV), for new providers and those
providers without a 12-month cost reporting period ending in
fiscal year 1994, but for which the first cost reporting period
begins before fiscal year 1999, for cost reporting periods
beginning during or after fiscal year 1999, the per beneficiary
limitation described in clause (vi)(I) shall be equal to the
median described in such clause (determined as if any reference
in clause (v) to ``98 percent'' were a reference to ``100
percent'').
(III) Subject to subclause (IV), in the case of a new
provider for which the first cost reporting period begins
during or after fiscal year 1999, the limitation applied under
clause (vi)(I) (but only with respect to such provider) shall
be equal to 75 percent of the median described in clause
(vi)(I).
(IV) In the case of a new provider or a provider without a
12-month cost reporting period ending in fiscal year 1994,
subclause (II) shall apply, instead of subclause (III), to a
home health agency which filed an application for home health
agency provider status under this title before September 15,
1998, or which was approved as a branch of its parent agency
before such date and becomes a subunit of the parent agency or
a separate agency on or after such date.
(V) Each of the amounts specified in subclauses (I) through
(III) are such amounts as adjusted under clause (iii) to
reflect variations in wages among different areas.
(ix) Notwithstanding the per beneficiary limit under clause
(viii), if the limit imposed under clause (v) (determined
without regard to this clause) for a cost reporting period
beginning during or after fiscal year 2000 is less than the
median described in clause (vi)(I) (but determined as if any
reference in clause (v) to ``98 percent'' were a reference to
``100 percent''), the limit otherwise imposed under clause (v)
for such provider and period shall be increased by 2 percent.
(x) Notwithstanding any other provision of this subparagraph,
in updating any limit under this subparagraph by a home health
market basket index for cost reporting periods beginning during
each of fiscal years 2000, 2002, and 2003, the update otherwise
provided shall be reduced by 1.1 percentage points. With
respect to cost reporting periods beginning during fiscal year
2001, the update to any limit under this subparagraph shall be
the home health market basket index.
(M) Such regulations shall provide that costs respecting care
provided by a provider of services, pursuant to an assurance
under title VI or XVI of the Public Health Service Act that the
provider will make available a reasonable volume of services to
persons unable to pay therefor, shall not be allowable as
reasonable costs.
(N) In determining such reasonable costs, costs incurred for
activities directly related to influencing employees respecting
unionization may not be included.
(O)(i) In establishing an appropriate allowance for
depreciation and for interest on capital indebtedness with
respect to an asset of a provider of services which has
undergone a change of ownership, such regulations shall
provide, except as provided in clause (iii), that the valuation
of the asset after such change of ownership shall be the
historical cost of the asset, as recognized under this title,
less depreciation allowed, to the owner of record as of the
date of enactment of the Balanced Budget Act of 1997 (or, in
the case of an asset not in existence as of that date, the
first owner of record of the asset after that date).
(ii) Such regulations shall not recognize, as reasonable in
the provision of health care services, costs (including legal
fees, accounting and administrative costs, travel costs, and
the costs of feasibility studies) attributable to the
negotiation or settlement of the sale or purchase of any
capital asset (by acquisition or merger) for which any payment
has previously been made under this title.
(iii) In the case of the transfer of a hospital from
ownership by a State to ownership by a nonprofit corporation
without monetary consideration, the basis for capital
allowances to the new owner shall be the book value of the
hospital to the State at the time of the transfer.
(P) If such regulations provide for the payment for a return
on equity capital (other than with respect to costs of
inpatient hospital services), the rate of return to be
recognized, for determining the reasonable cost of services
furnished in a cost reporting period, shall be equal to the
average of the rates of interest, for each of the months any
part of which is included in the period, on obligations issued
for purchase by the Federal Hospital Insurance Trust Fund.
(Q) Except as otherwise explicitly authorized, the Secretary
is not authorized to limit the rate of increase on allowable
costs of approved medical educational activities.
(R) In determining such reasonable cost, costs incurred by a
provider of services representing a beneficiary in an
unsuccessful appeal of a determination described in section
1869(b) shall not be allowable as reasonable costs.
(S)(i) Such regulations shall not include provision for
specific recognition of any return on equity capital with
respect to hospital outpatient departments.
(ii)(I) Such regulations shall provide that, in determining
the amount of the payments that may be made under this title
with respect to all the capital-related costs of outpatient
hospital services, the Secretary shall reduce the amounts of
such payments otherwise established under this title by 15
percent for payments attributable to portions of cost reporting
periods occurring during fiscal year 1990, by 15 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal year 1991, and by 10 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal years 1992 through 1999 and until the
first date that the prospective payment system under section
1833(t) is implemented.
(II) The Secretary shall reduce the reasonable cost of
outpatient hospital services (other than the capital-related
costs of such services) otherwise determined pursuant to
section 1833(a)(2)(B)(i)(I) by 5.8 percent for payments
attributable to portions of cost reporting periods occurring
during fiscal years 1991 through 1999 and until the first date
that the prospective payment system under section 1833(t) is
implemented.
(III) Subclauses (I) and (II) shall not apply to payments
with respect to the costs of hospital outpatient services
provided by any hospital that is a sole community hospital (as
defined in section 1886(d)(5)(D)(iii)) or a critical access
hospital (as defined in section 1861(mm)(1)).
(IV) In applying subclauses (I) and (II) to services for
which payment is made on the basis of a blend amount under
section 1833(i)(3)(A)(ii) or 1833(n)(1)(A)(ii), the costs
reflected in the amounts described in sections
1833(i)(3)(B)(i)(I) and 1833(n)(1)(B)(i)(I), respectively,
shall be reduced in accordance with such subclause.
(T) In determining such reasonable costs for hospitals, no
reduction in copayments under section 1833(t)(8)(B) shall be
treated as a bad debt and the amount of bad debts otherwise
treated as allowable costs which are attributable to the
deductibles and coinsurance amounts under this title shall be
reduced--
(i) for cost reporting periods beginning during
fiscal year 1998, by 25 percent of such amount
otherwise allowable,
(ii) for cost reporting periods beginning during
fiscal year 1999, by 40 percent of such amount
otherwise allowable,
(iii) for cost reporting periods beginning during
fiscal year 2000, by 45 percent of such amount
otherwise allowable,
(iv) for cost reporting periods beginning during
fiscal years 2001 through 2012, by 30 percent of such
amount otherwise allowable, and
(v) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(U) In determining the reasonable cost of ambulance services
(as described in subsection (s)(7)) provided during fiscal year
1998, during fiscal year 1999, and during so much of fiscal
year 2000 as precedes January 1, 2000, the Secretary shall not
recognize the costs per trip in excess of costs recognized as
reasonable for ambulance services provided on a per trip basis
during the previous fiscal year (after application of this
subparagraph), 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 fiscal year involved reduced by
1.0 percentage point. For ambulance services provided after
June 30, 1998, the Secretary may provide that claims for such
services must include a code (or codes) under a uniform coding
system specified by the Secretary that identifies the services
furnished.
(V) In determining such reasonable costs for skilled nursing
facilities and (beginning with respect to cost reporting
periods beginning during fiscal year 2013) for covered skilled
nursing services described in section 1888(e)(2)(A) furnished
by hospital providers of extended care services (as described
in section 1883), the amount of bad debts otherwise treated as
allowed costs which are attributable to the coinsurance amounts
under this title for individuals who are entitled to benefits
under part A and--
(i) are not described in section 1935(c)(6)(A)(ii)
shall be reduced by--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, 30
percent of such amount otherwise allowable; and
(II) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(ii) are described in such section--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, shall not
be reduced;
(II) for cost reporting periods beginning during
fiscal year 2013, shall be reduced by 12 percent of
such amount otherwise allowable;
(III) for cost reporting periods beginning during
fiscal year 2014, shall be reduced by 24 percent of
such amount otherwise allowable; and
(IV) for cost reporting periods beginning during a
subsequent fiscal year, shall be reduced by 35 percent
of such amount otherwise allowable.
(W)(i) In determining such reasonable costs for providers
described in clause (ii), the amount of bad debts otherwise
treated as allowable costs which are attributable to
deductibles and coinsurance amounts under this title shall be
reduced--
(I) for cost reporting periods beginning during
fiscal year 2013, by 12 percent of such amount
otherwise allowable;
(II) for cost reporting periods beginning during
fiscal year 2014, by 24 percent of such amount
otherwise allowable; and
(III) for cost reporting periods beginning during a
subsequent fiscal year, by 35 percent of such amount
otherwise allowable.
(ii) A provider described in this clause is a provider of
services not described in subparagraph (T) or (V), a supplier,
or any other type of entity that receives payment for bad debts
under the authority under subparagraph (A).
(2)(A) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations more
expensive than semi-private accommodations, the amount taken
into account for purposes of payment under this title with
respect to such services may not exceed the amount that would
be taken into account with respect to such services if
furnished in such semi-private accommodations unless the more
expensive accommodations were required for medical reasons.
(B) Where a provider of services which has an agreement in
effect under this title furnishes to an individual items or
services which are in excess of or more expensive than the
items or services with respect to which payment may be made
under part A or part B, as the case may be, the Secretary shall
take into account for purposes of payment to such provider of
services only the items or services with respect to which such
payment may be made.
(3) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations other
than, but not more expensive than, semi-private accommodations
and the use of such other accommodations rather than semi-
private accommodations was neither at the request of the
patient nor for a reason which the Secretary determines is
consistent with the purposes of this title, the amount of the
payment with respect to such bed and board under part A shall
be the amount otherwise payable under this title for such bed
and board furnished in semi-private accommodations minus the
difference between the charge customarily made by the hospital
or skilled nursing facility for bed and board in semi-private
accommodations and the charge customarily made by it for bed
and board in the accommodations furnished.
(4) If a provider of services furnishes items or services to
an individual which are in excess of or more expensive than the
items or services determined to be necessary in the efficient
delivery of needed health services and charges are imposed for
such more expensive items or services under the authority
granted in section 1866(a)(2)(B)(ii), the amount of payment
with respect to such items or services otherwise due such
provider in any fiscal period shall be reduced to the extent
that such payment plus such charges exceed the cost actually
incurred for such items or services in the fiscal period in
which such charges are imposed.
(5)(A) Where physical therapy services, occupational therapy
services, speech therapy services, or other therapy services or
services of other health-related personnel (other than
physicians) are furnished under an arrangement with a provider
of services or other organization, specified in the first
sentence of subsection (p) (including through the operation of
subsection (g)) the amount included in any payment to such
provider or other organization under this title as the
reasonable cost of such services (as furnished under such
arrangements) shall not exceed an amount equal to the salary
which would reasonably have been paid for such services
(together with any additional costs that would have been
incurred by the provider or other organization) to the person
performing them if they had been performed in an employment
relationship with such provider or other organization (rather
than under such arrangement) plus the cost of such other
expenses (including a reasonable allowance for traveltime and
other reasonable types of expense related to any differences in
acceptable methods of organization for the provision of such
therapy) incurred by such person, as the Secretary may in
regulations determine to be appropriate.
(B) Notwithstanding the provisions of subparagraph (A), if a
provider of services or other organization specified in the
first sentence of section 1861(p) requires the services of a
therapist on a limited part-time basis, or only to perform
intermittent services, the Secretary may make payment on the
basis of a reasonable rate per unit of service, even though
such rate is greater per unit of time than salary related
amounts, where he finds that such greater payment is, in the
aggregate, less than the amount that would have been paid if
such organization had employed a therapist on a full- or part-
time salary basis.
(6) For purposes of this subsection, the term ``semi-private
accommodations'' means two-bed, three-bed, or four-bed
accommodations.
(7)(A) For limitation on Federal participation for capital
expenditures which are out of conformity with a comprehensive
plan of a State or areawide planning agency, see section 1122.
(B) For further limitations on reasonable cost and
determination of payment amounts for operating costs of
inpatient hospital services and waivers for certain States, see
section 1886.
(C) For provisions restricting payment for provider-based
physicians' services and for payments under certain percentage
arrangements, see section 1887.
(D) For further limitations on reasonable cost and
determination of payment amounts for routine service costs of
skilled nursing facilities, see subsections (a) through (c) of
section 1888.
(8) Items unrelated to patient care.--Reasonable costs do not
include costs for the following--
(i) entertainment, including tickets to sporting and
other entertainment events;
(ii) gifts or donations;
(iii) personal use of motor vehicles;
(iv) costs for fines and penalties resulting from
violations of Federal, State, or local laws; and
(v) education expenses for spouses or other
dependents of providers of services, their employees or
contractors.
Arrangements for Certain Services
(w)(1) The term ``arrangements'' is limited to arrangements
under which receipt of payment by the hospital, critical access
hospital, skilled nursing facility, home health agency, or
hospice program (whether in its own right or as agent), with
respect to services for which an individual is entitled to have
payment made under this title, discharges the liability of such
individual or any other person to pay for the services.
(2) Utilization review activities conducted, in accordance
with the requirements of the program established under part B
of title XI of the Social Security Act with respect to services
furnished by a hospital or critical access hospital to patients
insured under part A of this title or entitled to have payment
made for such services under part B of this title or under a
State plan approved under title XIX, by a quality improvement
organization designated for the area in which such hospital or
critical access hospital is located shall be deemed to have
been conducted pursuant to arrangements between such hospital
or critical access hospital and such organization under which
such hospital or critical access hospital is obligated to pay
to such organization, as a condition of receiving payment for
hospital or critical access hospital services so furnished
under this part or under such a State plan, such amount as is
reasonably incurred and requested (as determined under
regulations of the Secretary) by such organization in
conducting such review activities with respect to services
furnished by such hospital or critical access hospital to such
patients.
State and United States
(x) The terms ``State'' and ``United States'' have the
meaning given to them by subsections (h) and (i), respectively,
of section 210.
Extended Care in Religious Nonmedical Health Care Institutions
(y)(1) The term ``skilled nursing facility'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only (except for purposes of
subsection (a)(2)) with respect to items and services
ordinarily furnished by such an institution to inpatients, and
payment may be made with respect to services provided by or in
such an institution only to such extent and under such
conditions, limitations, and requirements (in addition to or in
lieu of the conditions, limitations, and requirements otherwise
applicable) as may be provided in regulations consistent with
section 1821.
(2) Notwithstanding any other provision of this title,
payment under part A may not be made for services furnished an
individual in a skilled nursing facility to which paragraph (1)
applies unless such individual elects, in accordance with
regulations, for a spell of illness to have such services
treated as post-hospital extended care services for purposes of
such part; and payment under part A may not be made for post-
hospital extended care services--
(A) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) applies after--
(i) such services have been furnished to him
in such a facility for 30 days during such
spell, or
(ii) such services have been furnished to him
during such spell in a skilled nursing facility
to which such paragraph does not apply; or
(B) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) does not apply after such services have
been furnished to him during such spell in a skilled
nursing facility to which such paragraph applies.
(3) The amount payable under part A for post-hospital
extended care services furnished an individual during any spell
of illness in a skilled nursing facility to which paragraph (1)
applies shall be reduced by a coinsurance amount equal to one-
eighth of the inpatient hospital deductible for each day before
the 31st day on which he is furnished such services in such a
facility during such spell (and the reduction under this
paragraph shall be in lieu of any reduction under section
1813(a)(3)).
(4) For purposes of subsection (i), the determination of
whether services furnished by or in an institution described in
paragraph (1) constitute post-hospital extended care services
shall be made in accordance with and subject to such
conditions, limitations, and requirements as may be provided in
regulations.
Institutional Planning
(z) An overall plan and budget of a hospital, skilled nursing
facility, comprehensive outpatient rehabilitation facility, or
home health agency shall be considered sufficient if it--
(1) provides for an annual operating budget which
includes all anticipated income and expenses related to
items which would, under generally accepted accounting
principles, be considered income and expense items
(except that nothing in this paragraph shall require
that there be prepared, in connection with any budget,
an item-by-item identification of the components of
each type of anticipated expenditure or income);
(2)(A) provides for a capital expenditures plan for
at least a 3-year period (including the year to which
the operating budget described in paragraph (1) is
applicable) which includes and identifies in detail the
anticipated sources of financing for, and the
objectives of, each anticipated expenditure in excess
of $600,000 (or such lesser amount as may be
established by the State under section 1122(g)(1) in
which the hospital is located) related to the
acquisition of land, the improvement of land,
buildings, and equipment, and the replacement,
modernization, and expansion of the buildings and
equipment which would, under generally accepted
accounting principles, be considered capital items;
(B) provides that such plan is submitted to the
agency designated under section 1122(b), or if no such
agency is designated, to the appropriate health
planning agency in the State (but this subparagraph
shall not apply in the case of a facility exempt from
review under section 1122 by reason of section
1122(j));
(3) provides for review and updating at least
annually; and
(4) is prepared, under the direction of the governing
body of the institution or agency, by a committee
consisting of representatives of the governing body,
the administrative staff, and the medical staff (if
any) of the institution or agency.
Rural Health Clinic Services and Federally Qualified Health Center
Services
(aa)(1) The term ``rural health clinic services'' means --
(A) physicians' services and such services and
supplies as are covered under section 1861(s)(2)(A) if
furnished as an incident to a physician's professional
service and items and services described in section
1861(s)(10),
(B) such services furnished by a physician assistant
or a nurse practitioner (as defined in paragraph (5)),
by a clinical psychologist (as defined by the
Secretary) or by a clinical social worker (as defined
in subsection (hh)(1)), and such services and supplies
furnished as an incident to his service as would
otherwise be covered if furnished by a physician or as
an incident to a physician's service, and
(C) in the case of a rural health clinic located in
an area in which there exists a shortage of home health
agencies, part-time or intermittent nursing care and
related medical supplies (other than drugs and
biologicals) furnished by a registered professional
nurse or licensed practical nurse to a homebound
individual under a written plan of treatment (i)
established and periodically reviewed by a physician
described in paragraph (2)(B), or (ii) established by a
nurse practitioner or physician assistant and
periodically reviewed and approved by a physician
described in paragraph (2)(B),
when furnished to an individual as an outpatient of a rural
health clinic.
(2) The term ``rural health clinic'' means a facility which
--
(A) is primarily engaged in furnishing to outpatients
services described in subparagraphs (A) and (B) of
paragraph (1);
(B) in the case of a facility which is not a
physician-directed clinic, has an arrangement
(consistent with the provisions of State and local law
relative to the practice, performance, and delivery of
health services) with one or more physicians (as
defined in subsection (r)(1)) under which provision is
made for the periodic review by such physicians of
covered services furnished by physician assistants and
nurse practitioners, the supervision and guidance by
such physicians of physician assistants and nurse
practitioners, the preparation by such physicians of
such medical orders for care and treatment of clinic
patients as may be necessary, and the availability of
such physicians for such referral of and consultation
for patients as is necessary and for advice and
assistance in the management of medical emergencies;
and, in the case of a physician-directed clinic, has
one or more of its staff physicians perform the
activities accomplished through such an arrangement;
(C) maintains clinical records on all patients;
(D) has arrangements with one or more hospitals,
having agreements in effect under section 1866, for the
referral and admission of patients requiring inpatient
services or such diagnostic or other specialized
services as are not available at the clinic;
(E) has written policies, which are developed with
the advice of (and with provision for review of such
policies from time to time by) a group of professional
personnel, including one or more physicians and one or
more physician assistants or nurse practitioners, to
govern those services described in paragraph (1) which
it furnishes;
(F) has a physician, physician assistant, or nurse
practitioner responsible for the execution of policies
described in subparagraph (E) and relating to the
provision of the clinic's services;
(G) directly provides routine diagnostic services,
including clinical laboratory services, as prescribed
in regulations by the Secretary, and has prompt access
to additional diagnostic services from facilities
meeting requirements under this title;
(H) in compliance with State and Federal law, has
available for administering to patients of the clinic
at least such drugs and biologicals as are determined
by the Secretary to be necessary for the treatment of
emergency cases (as defined in regulations) and has
appropriate procedures or arrangements for storing,
administering, and dispensing any drugs and
biologicals;
(I) has a quality assessment and performance
improvement program, and appropriate procedures for
review of utilization of clinic services, as the
Secretary may specify;
(J) has a nurse practitioner, a physician assistant,
or a certified nurse-midwife (as defined in subsection
(gg)) available to furnish patient care services not
less than 50 percent of the time the clinic operates;
and
(K) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are furnished services by
the clinic.
For the purposes of this title, such term includes only a
facility which (i) is located in an area that is not an
urbanized area (as defined by the Bureau of the Census) and in
which there are insufficient numbers of needed health care
practitioners (as determined by the Secretary), and that,
within the previous 4-year period, has been designated by the
chief executive officer of the State and certified by the
Secretary as an area with a shortage of personal health
services or designated by the Secretary either (I) as an area
with a shortage of personal health services under section
330(b)(3) or 1302(7) of the Public Health Service Act, (II) as
a health professional shortage area described in section
332(a)(1)(A) of that Act because of its shortage of primary
medical care manpower, (III) as a high impact area described in
section 329(a)(5) of that Act, of (IV) as an area which
includes a population group which the Secretary determines has
a health manpower shortage under section 332(a)(1)(B) of that
Act, (ii) has filed an agreement with the Secretary by which it
agrees not to charge any individual or other person for items
or services for which such individual is entitled to have
payment made under this title, except for the amount of any
deductible or coinsurance amount imposed with respect to such
items or services (not in excess of the amount customarily
charged for such items and services by such clinic), pursuant
to subsections (a) and (b) of section 1833, (iii) employs a
physician assistant or nurse practitioner, and (iv) is not a
rehabilitation agency or a facility which is primarily for the
care and treatment of mental diseases. A facility that is in
operation and qualifies as a rural health clinic under this
title or title XIX and that subsequently fails to satisfy the
requirement of clause (i) shall be considered, for purposes of
this title and title XIX, as still satisfying the requirement
of such clause if it is determined, in accordance with criteria
established by the Secretary in regulations, to be essential to
the delivery of primary care services that would otherwise be
unavailable in the geographic area served by the clinic. If a
State agency has determined under section 1864(a) that a
facility is a rural health clinic and the facility has applied
to the Secretary for approval as such a clinic, the Secretary
shall notify the facility of the Secretary's approval or
disapproval not later than 60 days after the date of the State
agency determination or the application (whichever is later).
(3) The term ``Federally qualified health center services''
means--
(A) services of the type described in subparagraphs
(A) through (C) of paragraph (1) and preventive
services (as defined in section 1861(ddd)(3)); and
(B) preventive primary health services that a center
is required to provide under section 330 of the Public
Health Service Act,
when furnished to an individual as an outpatient of a Federally
qualified health center by the center or by a health care
professional under contract with the center and, for this
purpose, any reference to a rural health clinic or a physician
described in paragraph (2)(B) is deemed a reference to a
Federally qualified health center or a physician at the center,
respectively.
(4) The term ``Federally qualified health center'' means an
entity which--
(A)(i) is receiving a grant under section 330 of the
Public Health Service Act, or
(ii)(I) is receiving funding from such a grant under
a contract with the recipient of such a grant, and (II)
meets the requirements to receive a grant under section
330 of such Act;
(B) based on the recommendation of the Health
Resources and Services Administration within the Public
Health Service, is determined by the Secretary to meet
the requirements for receiving such a grant;
(C) was treated by the Secretary, for purposes of
part B, as a comprehensive Federally funded health
center as of January 1, 1990; or
(D) is an outpatient health program or facility
operated by a tribe or tribal organization under the
Indian Self-Determination Act or by an urban Indian
organization receiving funds under title V of the
Indian Health Care Improvement Act.
(5)(A) The term ``physician assistant'' and the term ``nurse
practitioner'' mean, for purposes of this title, a physician
assistant or nurse practitioner who performs such services as
such individual is legally authorized to perform (in the State
in which the individual performs such services) in accordance
with State law (or the State regulatory mechanism provided by
State law), and who meets such training, education, and
experience requirements (or any combination thereof) as the
Secretary may prescribe in regulations.
(B) The term ``clinical nurse specialist'' means, for
purposes of this title, an individual who--
(i) is a registered nurse and is licensed to practice
nursing in the State in which the clinical nurse
specialist services are performed; and
(ii) holds a master's degree in a defined clinical
area of nursing from an accredited educational
institution.
(6) The term ``collaboration'' means a process in which a
nurse practitioner works with a physician to deliver health
care services within the scope of the practitioner's
professional expertise, with medical direction and appropriate
supervision as provided for in jointly developed guidelines or
other mechanisms as defined by the law of the State in which
the services are performed.
(7)(A) The Secretary shall waive for a 1-year period the
requirements of paragraph (2) that a rural health clinic employ
a physician assistant, nurse practitioner or certified nurse
midwife or that such clinic require such providers to furnish
services at least 50 percent of the time that the clinic
operates for any facility that requests such waiver if the
facility demonstrates that the facility has been unable,
despite reasonable efforts, to hire a physician assistant,
nurse practitioner, or certified nurse-midwife in the previous
90-day period.
(B) The Secretary may not grant such a waiver under
subparagraph (A) to a facility if the request for the waiver is
made less than 6 months after the date of the expiration of any
previous such waiver for the facility, or if the facility has
not yet been determined to meet the requirements (including
subparagraph (J) of the first sentence of paragraph (2)) of a
rural health clinic.
(C) A waiver which is requested under this paragraph shall be
deemed granted unless such request is denied by the Secretary
within 60 days after the date such request is received.
Services of a Certified Registered Nurse Anesthetist
(bb)(1) The term ``services of a certified registered nurse
anesthetist'' means anesthesia services and related care
furnished by a certified registered nurse anesthetist (as
defined in paragraph (2)) which the nurse anesthetist is
legally authorized to perform as such by the State in which the
services are furnished.
(2) The term ``certified registered nurse anesthetist'' means
a certified registered nurse anesthetist licensed by the State
who meets such education, training, and other requirements
relating to anesthesia services and related care as the
Secretary may prescribe. In prescribing such requirements the
Secretary may use the same requirements as those established by
a national organization for the certification of nurse
anesthetists. Such term also includes, as prescribed by the
Secretary, an anesthesiologist assistant.
Comprehensive Outpatient Rehabilitation Facility Services
(cc)(1) The term ``comprehensive outpatient rehabilitation
facility services'' means the following items and services
furnished by a physician or other qualified professional
personnel (as defined in regulations by the Secretary) to an
individual who is an outpatient of a comprehensive outpatient
rehabilitation facility under a plan (for furnishing such items
and services to such individual) established and periodically
reviewed by a physician--
(A) physicians' services;
(B) physical therapy, occupational therapy, speech-
language pathology services, and respiratory therapy;
(C) prosthetic and orthotic devices, including
testing, fitting, or training in the use of prosthetic
and orthotic devices;
(D) social and psychological services;
(E) nursing care provided by or under the supervision
of a registered professional nurse;
(F) drugs and biologicals which cannot, as determined
in accordance with regulations, be self-administered;
(G) supplies and durable medical equipment; and
(H) such other items and services as are medically
necessary for the rehabilitation of the patient and are
ordinarily furnished by comprehensive outpatient
rehabilitation facilities,
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital. In the case of physical therapy, occupational
therapy, and speech pathology services, there shall be no
requirement that the item or service be furnished at any single
fixed location if the item or service is furnished pursuant to
such plan and payments are not otherwise made for the item or
service under this title.
(2) The term ``comprehensive outpatient rehabilitation
facility'' means a facility which--
(A) is primarily engaged in providing (by or under
the supervision of physicians) diagnostic, therapeutic,
and restorative services to outpatients for the
rehabilitation of injured, disabled, or sick persons;
(B) provides at least the following comprehensive
outpatient rehabilitation services: (i) physicians'
services (rendered by physicians, as defined in section
1861(r)(1), who are available at the facility on a
full- or part-time basis); (ii) physical therapy; and
(iii) social or psychological services;
(C) maintains clinical records on all patients;
(D) has policies established by a group of
professional personnel (associated with the facility),
including one or more physicians defined in subsection
(r)(1) to govern the comprehensive outpatient
rehabilitation services it furnishes, and provides for
the carrying out of such policies by a full- or part-
time physician referred to in subparagraph (B)(i);
(E) has a requirement that every patient must be
under the care of a physician;
(F) in the case of a facility in any State in which
State or applicable local law provides for the
licensing of facilities of this nature (i) is licensed
pursuant to such law, or (ii) is approved by the agency
of such State or locality, responsible for licensing
facilities of this nature, as meeting the standards
established for such licensing;
(G) has in effect a utilization review plan in
accordance with regulations prescribed by the
Secretary;
(H) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(I) provides the Secretary on a continuing basis with
a surety bond in a form specified by the Secretary and
in an amount that is not less than $50,000; and
(J) meets such other conditions of participation as
the Secretary may find necessary in the interest of the
health and safety of individuals who are furnished
services by such facility, including conditions
concerning qualifications of personnel in these
facilities.
The Secretary may waive the requirement of a surety bond under
subparagraph (I) in the case of a facility that provides a
comparable surety bond under State law.
Hospice Care; Hospice Program
(dd)(1) The term ``hospice care'' means the following items
and services provided to a terminally ill individual by, or by
others under arrangements made by, a hospice program under a
written plan (for providing such care to such individual)
established and periodically reviewed by the individual's
attending physician and by the medical director (and by the
interdisciplinary group described in paragraph (2)(B)) of the
program--
(A) nursing care provided by or under the supervision
of a registered professional nurse,
(B) physical or occupational therapy, or speech-
language pathology services,
(C) medical social services under the direction of a
physician,
(D)(i) services of a home health aide who has
successfully completed a training program approved by
the Secretary and (ii) homemaker services,
(E) medical supplies (including drugs and
biologicals) and the use of medical appliances, while
under such a plan,
(F) physicians' services,
(G) short-term inpatient care (including both respite
care and procedures necessary for pain control and
acute and chronic symptom management) in an inpatient
facility meeting such conditions as the Secretary
determines to be appropriate to provide such care, but
such respite care may be provided only on an
intermittent, nonroutine, and occasional basis and may
not be provided consecutively over longer than five
days,
(H) counseling (including dietary counseling) with
respect to care of the terminally ill individual and
adjustment to his death, and
(I) any other item or service which is specified in
the plan and for which payment may otherwise be made
under this title.
The care and services described in subparagraphs (A) and (D)
may be provided on a 24-hour, continuous basis only during
periods of crisis (meeting criteria established by the
Secretary) and only as necessary to maintain the terminally ill
individual at home.
(2) The term ``hospice program'' means a public agency or
private organization (or a subdivision thereof) which--
(A)(i) is primarily engaged in providing the care and
services described in paragraph (1) and makes such
services available (as needed) on a 24-hour basis and
which also provides bereavement counseling for the
immediate family of terminally ill individuals and
services described in section 1812(a)(5),
(ii) provides for such care and services in
individuals' homes, on an outpatient basis, and on a
short-term inpatient basis, directly or under
arrangements made by the agency or organization, except
that--
(I) the agency or organization must routinely
provide directly substantially all of each of
the services described in subparagraphs (A),
(C), and (H) of paragraph (1), except as
otherwise provided in paragraph (5), and
(II) in the case of other services described
in paragraph (1) which are not provided
directly by the agency or organization, the
agency or organization must maintain
professional management responsibility for all
such services furnished to an individual,
regardless of the location or facility in which
such services are furnished; and
(iii) provides assurances satisfactory to the
Secretary that the aggregate number of days of
inpatient care described in paragraph (1)(G) provided
in any 12-month period to individuals who have an
election in effect under section 1812(d) with respect
to that agency or organization does not exceed 20
percent of the aggregate number of days during that
period on which such elections for such individuals are
in effect;
(B) has an interdisciplinary group of personnel
which--
(i) includes at least--
(I) one physician (as defined in
subsection (r)(1)),
(II) one registered professional
nurse, and
(III) one social worker,
employed by or, in the case of a physician described in
subclause (I), under contract with the agency or
organization, and also includes at least one pastoral
or other counselor,
(ii) provides (or supervises the provision
of) the care and services described in
paragraph (1), and
(iii) establishes the policies governing the
provision of such care and services;
(C) maintains central clinical records on all
patients;
(D) does not discontinue the hospice care it provides
with respect to a patient because of the inability of
the patient to pay for such care;
(E)(i) utilizes volunteers in its provision of care
and services in accordance with standards set by the
Secretary, which standards shall ensure a continuing
level of effort to utilize such volunteers, and (ii)
maintains records on the use of these volunteers and
the cost savings and expansion of care and services
achieved through the use of these volunteers;
(F) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, is licensed pursuant to such law; and
(G) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are provided care and
services by such agency or organization.
(3)(A) An individual is considered to be ``terminally ill''
if the individual has a medical prognosis that the individual's
life expectancy is 6 months or less.
(B) The term ``attending physician'' means, with respect to
an individual, the physician (as defined in subsection (r)(1)),
the nurse practitioner (as defined in subsection (aa)(5)), or
the physician assistant (as defined in such subsection), who
may be employed by a hospice program, whom the individual
identifies as having the most significant role in the
determination and delivery of medical care to the individual at
the time the individual makes an election to receive hospice
care.
(4)(A) An entity which is certified as a provider of services
other than a hospice program shall be considered, for purposes
of certification as a hospice program, to have met any
requirements under paragraph (2) which are also the same
requirements for certification as such other type of provider.
The Secretary shall coordinate surveys for determining
certification under this title so as to provide, to the extent
feasible, for simultaneous surveys of an entity which seeks to
be certified as a hospice program and as a provider of services
of another type.
(B) Any entity which is certified as a hospice program and as
a provider of another type shall have separate provider
agreements under section 1866 and shall file separate cost
reports with respect to costs incurred in providing hospice
care and in providing other services and items under this
title.
[(C) Any entity that is certified as a hospice program shall
be subject to a standard survey by an appropriate State or
local survey agency, or an approved accreditation agency, as
determined by the Secretary, not less frequently than once
every 36 months beginning 6 months after the date of the
enactment of this subparagraph and ending September 30, 2025.]
(5)(A) The Secretary may waive the requirements of paragraph
(2)(A)(ii)(I) for an agency or organization with respect to all
or part of the nursing care described in paragraph (1)(A) if
such agency or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of the Census);
(ii) was in operation on or before January 1, 1983;
and
(iii) has demonstrated a good faith effort (as
determined by the Secretary) to hire a sufficient
number of nurses to provide such nursing care directly.
(B) Any waiver, which is in such form and containing such
information as the Secretary may require and which is requested
by an agency or organization under subparagraph (A) or (C),
shall be deemed to be granted unless such request is denied by
the Secretary within 60 days after the date such request is
received by the Secretary. The granting of a waiver under
subparagraph (A) or (C) shall not preclude the granting of any
subsequent waiver request should such a waiver again become
necessary.
(C) The Secretary may waive the requirements of paragraph
(2)(A)(i) and (2)(A)(ii) for an agency or organization with
respect to the services described in paragraph (1)(B) and, with
respect to dietary counseling, paragraph (1)(H), if such agency
or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of Census), and
(ii) demonstrates to the satisfaction of the
Secretary that the agency or organization has been
unable, despite diligent efforts, to recruit
appropriate personnel.
(D) In extraordinary, exigent, or other non-routine
circumstances, such as unanticipated periods of high patient
loads, staffing shortages due to illness or other events, or
temporary travel of a patient outside a hospice program's
service area, a hospice program may enter into arrangements
with another hospice program for the provision by that other
program of services described in paragraph (2)(A)(ii)(I). The
provisions of paragraph (2)(A)(ii)(II) shall apply with respect
to the services provided under such arrangements.
(E) A hospice program may provide services described in
paragraph (1)(A) other than directly by the program if the
services are highly specialized services of a registered
professional nurse and are provided non-routinely and so
infrequently so that the provision of such services directly
would be impracticable and prohibitively expensive.
Discharge Planning Process
(ee)(1) A discharge planning process of a hospital shall be
considered sufficient if it is applicable to services furnished
by the hospital to individuals entitled to benefits under this
title and if it meets the guidelines and standards established
by the Secretary under paragraph (2).
(2) The Secretary shall develop guidelines and standards for
the discharge planning process in order to ensure a timely and
smooth transition to the most appropriate type of and setting
for post-hospital or rehabilitative care. The guidelines and
standards shall include the following:
(A) The hospital must identify, at an early stage of
hospitalization, those patients who are likely to
suffer adverse health consequences upon discharge in
the absence of adequate discharge planning.
(B) Hospitals must provide a discharge planning
evaluation for patients identified under subparagraph
(A) and for other patients upon the request of the
patient, patient's representative, or patient's
physician.
(C) Any discharge planning evaluation must be made on
a timely basis to ensure that appropriate arrangements
for post-hospital care will be made before discharge
and to avoid unnecessary delays in discharge.
(D) A discharge planning evaluation must include an
evaluation of a patient's likely need for appropriate
post-hospital services, including hospice care and
post-hospital extended care services, and the
availability of those services, including the
availability of home health services through
individuals and entities that participate in the
program under this title and that serve the area in
which the patient resides and that request to be listed
by the hospital as available and, in the case of
individuals who are likely to need post-hospital
extended care services, the availability of such
services through facilities that participate in the
program under this title and that serve the area in
which the patient resides.
(E) The discharge planning evaluation must be
included in the patient's medical record for use in
establishing an appropriate discharge plan and the
results of the evaluation must be discussed with the
patient (or the patient's representative).
(F) Upon the request of a patient's physician, the
hospital must arrange for the development and initial
implementation of a discharge plan for the patient.
(G) Any discharge planning evaluation or discharge
plan required under this paragraph must be developed
by, or under the supervision of, a registered
professional nurse, social worker, or other
appropriately qualified personnel.
(H) Consistent with section 1802, the discharge plan
shall--
(i) not specify or otherwise limit the
qualified provider which may provide post-
hospital home health services, and
(ii) identify (in a form and manner specified
by the Secretary) any entity to whom the
individual is referred in which the hospital
has a disclosable financial interest (as
specified by the Secretary consistent with
section 1866(a)(1)(S)) or which has such an
interest in the hospital.
(3) With respect to a discharge plan for an individual who is
enrolled with a Medicare+Choice organization under a
Medicare+Choice plan and is furnished inpatient hospital
services by a hospital under a contract with the organization--
(A) the discharge planning evaluation under paragraph
(2)(D) is not required to include information on the
availability of home health services through
individuals and entities which do not have a contract
with the organization; and
(B) notwithstanding subparagraph (H)(i), the plan may
specify or limit the provider (or providers) of post-
hospital home health services or other post-hospital
services under the plan.
Partial Hospitalization Services
(ff)(1) The term ``partial hospitalization services'' means
the items and services described in paragraph (2) prescribed by
a physician and provided under a program described in paragraph
(3) under the supervision of a physician pursuant to an
individualized, written plan of treatment established and
periodically reviewed by a physician (in consultation with
appropriate staff participating in such program), which plan
sets forth the physician's diagnosis, the type, amount,
frequency, and duration of the items and services provided
under the plan, and the goals for treatment under the plan.
(2) The items and services described in this paragraph are--
(A) individual and group therapy with physicians or
psychologists (or other mental health professionals to
the extent authorized under State law),
(B) occupational therapy requiring the skills of a
qualified occupational therapist,
(C) services of social workers, trained psychiatric
nurses, and other staff trained to work with
psychiatric patients,
(D) drugs and biologicals furnished for therapeutic
purposes (which cannot, as determined in accordance
with regulations, be self-administered),
(E) individualized activity therapies that are not
primarily recreational or diversionary,
(F) family counseling (the primary purpose of which
is treatment of the individual's condition),
(G) patient training and education (to the extent
that training and educational activities are closely
and clearly related to individual's care and
treatment),
(H) diagnostic services, and
(I) such other items and services as the Secretary
may provide (but in no event to include meals and
transportation);
that are reasonable and necessary for the diagnosis or active
treatment of the individual's condition, reasonably expected to
improve or maintain the individual's condition and functional
level and to prevent relapse or hospitalization, and furnished
pursuant to such guidelines relating to frequency and duration
of services as the Secretary shall by regulation establish
(taking into account accepted norms of medical practice and the
reasonable expectation of patient improvement).
(3)(A) A program described in this paragraph is a program
which is furnished by a hospital to its outpatients or by a
community mental health center (as defined in subparagraph
(B)), and which is a distinct and organized intensive
ambulatory treatment service offering less than 24-hour-daily
care other than in an individual's home or in an inpatient or
residential setting.
(B) For purposes of subparagraph (A), the term ``community
mental health center'' means an entity that--
(i)(I) provides the mental health services described
in section 1913(c)(1) of the Public Health Service Act;
or
(II) in the case of an entity operating in a State
that by law precludes the entity from providing itself
the service described in subparagraph (E) of such
section, provides for such service by contract with an
approved organization or entity (as determined by the
Secretary);
(ii) meets applicable licensing or certification
requirements for community mental health centers in the
State in which it is located;
(iii) provides at least 40 percent of its services to
individuals who are not eligible for benefits under
this title; and
(iv) meets such additional conditions as the
Secretary shall specify to ensure (I) the health and
safety of individuals being furnished such services,
(II) the effective and efficient furnishing of such
services, and (III) the compliance of such entity with
the criteria described in section 1931(c)(1) of the
Public Health Service Act.
Certified Nurse-Midwife Services
(gg)(1) The term ``certified nurse-midwife services'' means
such services furnished by a certified nurse-midwife (as
defined in paragraph (2)) and such services and supplies
furnished as an incident to the nurse-midwife's service which
the certified nurse-midwife is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law) as would otherwise be covered if furnished by a
physician or as an incident to a physicians' service.
(2) The term ``certified nurse-midwife'' means a registered
nurse who has successfully completed a program of study and
clinical experience meeting guidelines prescribed by the
Secretary, or has been certified by an organization recognized
by the Secretary.
Clinical Social Worker; Clinical Social Worker Services
(hh)(1) The term ``clinical social worker'' means an
individual who--
(A) possesses a master's or doctor's degree in social
work;
(B) after obtaining such degree has performed at
least 2 years of supervised clinical social work; and
(C)(i) is licensed or certified as a clinical social
worker by the State in which the services are
performed, or
(ii) in the case of an individual in a State which
does not provide for licensure or certification--
(I) has completed at least 2 years or 3,000
hours of post-master's degree supervised
clinical social work practice under the
supervision of a master's level social worker
in an appropriate setting (as determined by the
Secretary), and
(II) meets such other criteria as the
Secretary establishes.
(2) The term ``clinical social worker services'' means
services performed by a clinical social worker (as defined in
paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital and other than services furnished to an inpatient of a
skilled nursing facility which the facility is required to
provide as a requirement for participation) which the clinical
social worker is legally authorized to perform under State law
(or the State regulatory mechanism provided by State law) of
the State in which such services are performed as would
otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.
Qualified Psychologist Services
(ii) The term ``qualified psychologist services'' means such
services and such services and supplies furnished as an
incident to his service furnished by a clinical psychologist
(as defined by the Secretary) which the psychologist is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) as would otherwise be covered
if furnished by a physician or as an incident to a physician's
service.
Screening Mammography
(jj) The term ``screening mammography'' means a radiologic
procedure provided to a woman for the purpose of early
detection of breast cancer and includes a physician's
interpretation of the results of the procedure.
Covered Osteoporosis Drug
(kk) The term ``covered osteoporosis drug'' means an
injectable drug approved for the treatment of post-menopausal
osteoporosis provided to an individual by a home health agency
if, in accordance with regulations promulgated by the
Secretary--
(1) the individual's attending physician certifies
that the individual has suffered a bone fracture
related to post-menopausal osteoporosis and that the
individual is unable to learn the skills needed to
self-administer such drug or is otherwise physically or
mentally incapable of self-administering such drug; and
(2) the individual is confined to the individual's
home (except when receiving items and services referred
to in subsection (m)(7)).
Speech-Language Pathology Services; Audiology Services
(ll)(1) The term ``speech-language pathology services'' means
such speech, language, and related function assessment and
rehabilitation services furnished by a qualified speech-
language pathologist as the speech-language pathologist is
legally authorized to perform under State law (or the State
regulatory mechanism provided by State law) as would otherwise
be covered if furnished by a physician.
(2) The term ``outpatient speech-language pathology
services'' has the meaning given the term ``outpatient physical
therapy services'' in subsection (p), except that in applying
such subsection--
(A) ``speech-language pathology'' shall be
substituted for ``physical therapy'' each place it
appears; and
(B) ``speech-language pathologist'' shall be
substituted for ``physical therapist'' each place it
appears.
(3) The term ``audiology services'' means such hearing and
balance assessment services furnished by a qualified
audiologist as the audiologist is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law), as would otherwise be covered if furnished by a
physician.
(4) In this subsection:
(A) The term ``qualified speech-language
pathologist'' means an individual with a master's or
doctoral degree in speech-language pathology who--
(i) is licensed as a speech-language
pathologist by the State in which the
individual furnishes such services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license speech-language pathologists, has
successfully completed 350 clock hours of
supervised clinical practicum (or is in the
process of accumulating such supervised
clinical experience), performed not less than 9
months of supervised full-time speech-language
pathology services after obtaining a master's
or doctoral degree in speech-language pathology
or a related field, and successfully completed
a national examination in speech-language
pathology approved by the Secretary.
(B) The term ``qualified audiologist'' means an
individual with a master's or doctoral degree in
audiology who--
(i) is licensed as an audiologist by the
State in which the individual furnishes such
services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license audiologists, has successfully
completed 350 clock hours of supervised
clinical practicum (or is in the process of
accumulating such supervised clinical
experience), performed not less than 9 months
of supervised full-time audiology services
after obtaining a master's or doctoral degree
in audiology or a related field, and
successfully completed a national examination
in audiology approved by the Secretary.
Critical Access Hospital; Critical Access Hospital Services
(mm)(1) The term ``critical access hospital'' means a
facility certified by the Secretary as a critical access
hospital under section 1820(e).
(2) The term ``inpatient critical access hospital services''
means items and services, furnished to an inpatient of a
critical access hospital by such facility, that would be
inpatient hospital services if furnished to an inpatient of a
hospital by a hospital.
(3) The term ``outpatient critical access hospital services''
means medical and other health services furnished by a critical
access hospital on an outpatient basis.
Screening Pap Smear; Screening Pelvic Exam
(nn)(1) The term ``screening pap smear'' means a diagnostic
laboratory test consisting of a routine exfoliative cytology
test (Papanicolaou test) provided to a woman for the purpose of
early detection of cervical or vaginal cancer and includes a
physician's interpretation of the results of the test, if the
individual involved has not had such a test during the
preceding 2 years, or during the preceding year in the case of
a woman described in paragraph (3).
(2) The term ``screening pelvic exam'' means a pelvic
examination provided to a woman if the woman involved has not
had such an examination during the preceding 2 years, or during
the preceding year in the case of a woman described in
paragraph (3), and includes a clinical breast examination.
(3) A woman described in this paragraph is a woman who--
(A) is of childbearing age and has had a test
described in this subsection during any of the
preceding 3 years that indicated the presence of
cervical or vaginal cancer or other abnormality; or
(B) is at high risk of developing cervical or vaginal
cancer (as determined pursuant to factors identified by
the Secretary).
Prostate Cancer Screening Tests
(oo)(1) The term ``prostate cancer screening test'' means a
test that consists of any (or all) of the procedures described
in paragraph (2) provided for the purpose of early detection of
prostate cancer to a man over 50 years of age who has not had
such a test during the preceding year.
(2) The procedures described in this paragraph are as
follows:
(A) A digital rectal examination.
(B) A prostate-specific antigen blood test.
(C) For years beginning after 2002, such other
procedures as the Secretary finds appropriate for the
purpose of early detection of prostate cancer, taking
into account changes in technology and standards of
medical practice, availability, effectiveness, costs,
and such other factors as the Secretary considers
appropriate.
Colorectal Cancer Screening Tests
(pp)(1) The term ``colorectal cancer screening test'' means
any of the following procedures furnished to an individual for
the purpose of early detection of colorectal cancer:
(A) Screening fecal-occult blood test.
(B) Screening flexible sigmoidoscopy.
(C) Screening colonoscopy.
(D) Such other tests or procedures, and modifications
to tests and procedures under this subsection, with
such frequency and payment limits, as the Secretary
determines appropriate, in consultation with
appropriate organizations.
(2) An ``individual at high risk for colorectal cancer'' is
an individual who, because of family history, prior experience
of cancer or precursor neoplastic polyps, a history of chronic
digestive disease condition (including inflammatory bowel
disease, Crohn's Disease, or ulcerative colitis), the presence
of any appropriate recognized gene markers for colorectal
cancer, or other predisposing factors, faces a high risk for
colorectal cancer.
Diabetes Outpatient Self-Management Training Services
(qq)(1) The term ``diabetes outpatient self-management
training services'' means educational and training services
furnished (at such times as the Secretary determines
appropriate) to an individual with diabetes by a certified
provider (as described in paragraph (2)(A)) in an outpatient
setting by an individual or entity who meets the quality
standards described in paragraph (2)(B), but only if the
physician who is managing the individual's diabetic condition
certifies that such services are needed under a comprehensive
plan of care related to the individual's diabetic condition to
ensure therapy compliance or to provide the individual with
necessary skills and knowledge (including skills related to the
self-administration of injectable drugs) to participate in the
management of the individual's condition.
(2) In paragraph (1)--
(A) a ``certified provider'' is a physician, or other
individual or entity designated by the Secretary, that,
in addition to providing diabetes outpatient self-
management training services, provides other items or
services for which payment may be made under this
title; and
(B) a physician, or such other individual or entity,
meets the quality standards described in this paragraph
if the physician, or individual or entity, meets
quality standards established by the Secretary, except
that the physician or other individual or entity shall
be deemed to have met such standards if the physician
or other individual or entity meets applicable
standards originally established by the National
Diabetes Advisory Board and subsequently revised by
organizations who participated in the establishment of
standards by such Board, or is recognized by an
organization that represents individuals (including
individuals under this title) with diabetes as meeting
standards for furnishing the services.
Bone Mass Measurement
(rr)(1) The term ``bone mass measurement'' means a radiologic
or radioisotopic procedure or other procedure approved by the
Food and Drug Administration performed on a qualified
individual (as defined in paragraph (2)) for the purpose of
identifying bone mass or detecting bone loss or determining
bone quality, and includes a physician's interpretation of the
results of the procedure.
(2) For purposes of this subsection, the term ``qualified
individual'' means an individual who is (in accordance with
regulations prescribed by the Secretary)--
(A) an estrogen-deficient woman at clinical risk for
osteoporosis;
(B) an individual with vertebral abnormalities;
(C) an individual receiving long-term glucocorticoid
steroid therapy;
(D) an individual with primary hyperparathyroidism;
or
(E) an individual being monitored to assess the
response to or efficacy of an approved osteoporosis
drug therapy.
(3) The Secretary shall establish such standards regarding
the frequency with which a qualified individual shall be
eligible to be provided benefits for bone mass measurement
under this title.
Religious Nonmedical Health Care Institution
(ss)(1) The term ``religious nonmedical health care
institution'' means an institution that--
(A) is described in subsection (c)(3) of
section 501 of the Internal Revenue Code of
1986 and is exempt from taxes under subsection
(a) of such section;
(B) is lawfully operated under all applicable
Federal, State, and local laws and regulations;
(C) provides only nonmedical nursing items
and services exclusively to patients who choose
to rely solely upon a religious method of
healing and for whom the acceptance of medical
health services would be inconsistent with
their religious beliefs;
(D) provides such nonmedical items and
services exclusively through nonmedical nursing
personnel who are experienced in caring for the
physical needs of such patients;
(E) provides such nonmedical items and
services to inpatients on a 24-hour basis;
(F) on the basis of its religious beliefs,
does not provide through its personnel or
otherwise medical items and services (including
any medical screening, examination, diagnosis,
prognosis, treatment, or the administration of
drugs) for its patients;
(G)(i) is not owned by, under common
ownership with, or has an ownership interest
in, a provider of medical treatment or
services;
(ii) is not affiliated with--
(I) a provider of medical treatment
or services, or
(II) an individual who has an
ownership interest in a provider of
medical treatment or services;
(H) has in effect a utilization review plan
which--
(i) provides for the review of
admissions to the institution, of the
duration of stays therein, of cases of
continuous extended duration, and of
the items and services furnished by the
institution,
(ii) requires that such reviews be
made by an appropriate committee of the
institution that includes the
individuals responsible for overall
administration and for supervision of
nursing personnel at the institution,
(iii) provides that records be
maintained of the meetings, decisions,
and actions of such committee, and
(iv) meets such other requirements as
the Secretary finds necessary to
establish an effective utilization
review plan;
(I) provides the Secretary with such
information as the Secretary may require to
implement section 1821, including information
relating to quality of care and coverage
determinations; and
(J) meets such other requirements as the
Secretary finds necessary in the interest of
the health and safety of individuals who are
furnished services in the institution.
(2) To the extent that the Secretary finds that the
accreditation of an institution by a State, regional, or
national agency or association provides reasonable assurances
that any or all of the requirements of paragraph (1) are met or
exceeded, the Secretary may treat such institution as meeting
the condition or conditions with respect to which the Secretary
made such finding.
(3)(A)(i) In administering this subsection and section 1821,
the Secretary shall not require any patient of a religious
nonmedical health care institution to undergo medical
screening, examination, diagnosis, prognosis, or treatment or
to accept any other medical health care service, if such
patient (or legal representative of the patient) objects
thereto on religious grounds.
(ii) Clause (i) shall not be construed as preventing the
Secretary from requiring under section 1821(a)(2) the provision
of sufficient information regarding an individual's condition
as a condition for receipt of benefits under part A for
services provided in such an institution.
(B)(i) In administering this subsection and section 1821, the
Secretary shall not subject a religious nonmedical health care
institution or its personnel to any medical supervision,
regulation, or control, insofar as such supervision,
regulation, or control would be contrary to the religious
beliefs observed by the institution or such personnel.
(ii) Clause (i) shall not be construed as preventing the
Secretary from reviewing items and services billed by the
institution to the extent the Secretary determines such review
to be necessary to determine whether such items and services
were not covered under part A, are excessive, or are
fraudulent.
(4)(A) For purposes of paragraph (1)(G)(i), an ownership
interest of less than 5 percent shall not be taken into
account.
(B) For purposes of paragraph (1)(G)(ii), none of the
following shall be considered to create an affiliation:
(i) An individual serving as an uncompensated
director, trustee, officer, or other member of the
governing body of a religious nonmedical health care
institution.
(ii) An individual who is a director, trustee,
officer, employee, or staff member of a religious
nonmedical health care institution having a family
relationship with an individual who is affiliated with
(or has an ownership interest in) a provider of medical
treatment or services.
(iii) An individual or entity furnishing goods or
services as a vendor to both providers of medical
treatment or services and religious nonmedical health
care institutions.
Post-Institutional Home Health Services; Home Health Spell of Illness
(tt)(1) The term ``post-institutional home health services''
means home health services furnished to an individual--
(A) after discharge from a hospital or critical
access hospital in which the individual was an
inpatient for not less than 3 consecutive days before
such discharge if such home health services were
initiated within 14 days after the date of such
discharge; or
(B) after discharge from a skilled nursing facility
in which the individual was provided post-hospital
extended care services if such home health services
were initiated within 14 days after the date of such
discharge.
(2) The term ``home health spell of illness'' with respect to
any individual means a period of consecutive days--
(A) beginning with the first day (not included in a
previous home health spell of illness) (i) on which
such individual is furnished post-institutional home
health services, and (ii) which occurs in a month for
which the individual is entitled to benefits under part
A, and
(B) ending with the close of the first period of 60
consecutive days thereafter on each of which the
individual is neither an inpatient of a hospital or
critical access hospital nor an inpatient of a facility
described in section 1819(a)(1) or subsection (y)(1)
nor provided home health services.
Screening for Glaucoma
(uu) The term ``screening for glaucoma'' means a dilated eye
examination with an intraocular pressure measurement, and a
direct ophthalmoscopy or a slit-lamp biomicroscopic examination
for the early detection of glaucoma which is furnished by or
under the direct supervision of an optometrist or
ophthalmologist who is legally authorized to furnish such
services under State law (or the State regulatory mechanism
provided by State law) of the State in which the services are
furnished, as would otherwise be covered if furnished by a
physician or as an incident to a physician's professional
service, if the individual involved has not had such an
examination in the preceding year.
Medical Nutrition Therapy Services; Registered Dietitian or Nutrition
Professional
(vv)(1) The term ``medical nutrition therapy services'' means
nutritional diagnostic, therapy, and counseling services for
the purpose of disease management which are furnished by a
registered dietitian or nutrition professional (as defined in
paragraph (2)) pursuant to a referral by a physician (as
defined in subsection (r)(1)).
(2) Subject to paragraph (3), the term ``registered dietitian
or nutrition professional'' means an individual who--
(A) holds a baccalaureate or higher degree granted by
a regionally accredited college or university in the
United States (or an equivalent foreign degree) with
completion of the academic requirements of a program in
nutrition or dietetics, as accredited by an appropriate
national accreditation organization recognized by the
Secretary for this purpose;
(B) has completed at least 900 hours of supervised
dietetics practice under the supervision of a
registered dietitian or nutrition professional; and
(C)(i) is licensed or certified as a dietitian or
nutrition professional by the State in which the
services are performed; or
(ii) in the case of an individual in a State that
does not provide for such licensure or certification,
meets such other criteria as the Secretary establishes.
(3) Subparagraphs (A) and (B) of paragraph (2) shall not
apply in the case of an individual who, as of the date of the
enactment of this subsection, is licensed or certified as a
dietitian or nutrition professional by the State in which
medical nutrition therapy services are performed.
Initial Preventive Physical Examination
(ww)(1) The term ``initial preventive physical examination''
means physicians' services consisting of a physical examination
(including measurement of height, weight body mass index,, and
blood pressure) with the goal of health promotion and disease
detection and includes education, counseling, and referral with
respect to screening and other preventive services described in
paragraph (2), end-of-life planning (as defined in paragraph
(3)) upon the agreement with the individual, and the furnishing
of a review of any current opioid prescriptions (as defined in
paragraph (4)), but does not include clinical laboratory tests.
(2) The screening and other preventive services described in
this paragraph include the following:
(A) Pneumococcal, influenza, and hepatitis B vaccine
and administration under subsection (s)(10).
(B) Screening mammography as defined in subsection
(jj).
(C) Screening pap smear and screening pelvic exam as
defined in subsection (nn).
(D) Prostate cancer screening tests as defined in
subsection (oo).
(E) Colorectal cancer screening tests as defined in
subsection (pp).
(F) Diabetes outpatient self-management training
services as defined in subsection (qq)(1).
(G) Bone mass measurement as defined in subsection
(rr).
(H) Screening for glaucoma as defined in subsection
(uu).
(I) Medical nutrition therapy services as defined in
subsection (vv).
(J) Cardiovascular screening blood tests as defined
in subsection (xx)(1).
(K) Diabetes screening tests as defined in subsection
(yy).
(L) Ultrasound screening for abdominal aortic
aneurysm as defined in section 1861(bbb).
(M) An electrocardiogram.
(N) Screening for potential substance use disorders.
(O) Additional preventive services (as defined in
subsection (ddd)(1)).
(3) For purposes of paragraph (1), the term ``end-of-life
planning'' means verbal or written information regarding--
(A) an individual's ability to prepare an advance
directive in the case that an injury or illness causes
the individual to be unable to make health care
decisions; and
(B) whether or not the physician is willing to follow
the individual's wishes as expressed in an advance
directive.
(4) For purposes of paragraph (1), the term ``a review of any
current opioid prescriptions'' means, with respect to an
individual determined to have a current prescription for
opioids--
(A) a review of the potential risk factors to the
individual for opioid use disorder;
(B) an evaluation of the individual's severity of
pain and current treatment plan;
(C) the provision of information on non-opioid
treatment options; and
(D) a referral to a specialist, as appropriate.
Cardiovascular Screening Blood Test
(xx)(1) The term ``cardiovascular screening blood test''
means a blood test for the early detection of cardiovascular
disease (or abnormalities associated with an elevated risk of
cardiovascular disease) that tests for the following:
(A) Cholesterol levels and other lipid or
triglyceride levels.
(B) Such other indications associated with the
presence of, or an elevated risk for, cardiovascular
disease as the Secretary may approve for all
individuals (or for some individuals determined by the
Secretary to be at risk for cardiovascular disease),
including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph
(B) for any individual unless a blood test for such is
recommended by the United States Preventive Services Task
Force.
(2) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency for
each type of cardiovascular screening blood tests, except that
such frequency may not be more often than once every 2 years.
Diabetes Screening Tests
(yy)(1) The term ``diabetes screening tests'' means testing
furnished to an individual at risk for diabetes (as defined in
paragraph (2)) for the purpose of early detection of diabetes,
including--
(A) a fasting plasma glucose test; and
(B) such other tests, and modifications to tests, as
the Secretary determines appropriate, in consultation
with appropriate organizations.
(2) For purposes of paragraph (1), the term ``individual at
risk for diabetes'' means an individual who has any of the
following risk factors for diabetes:
(A) Hypertension.
(B) Dyslipidemia.
(C) Obesity, defined as a body mass index greater
than or equal to 30 kg/m2.
(D) Previous identification of an elevated impaired
fasting glucose.
(E) Previous identification of impaired glucose
tolerance.
(F) A risk factor consisting of at least 2 of the
following characteristics:
(i) Overweight, defined as a body mass index
greater than 25, but less than 30, kg/
m2.
(ii) A family history of diabetes.
(iii) A history of gestational diabetes
mellitus or delivery of a baby weighing greater
than 9 pounds.
(iv) 65 years of age or older.
(3) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency of
diabetes screening tests, except that such frequency may not be
more often than twice within the 12-month period following the
date of the most recent diabetes screening test of that
individual.
Intravenous Immune Globulin
(zz) The term ``intravenous immune globulin'' means an
approved pooled plasma derivative for the treatment in the
patient's home of a patient with a diagnosed primary immune
deficiency disease, but not including items or services related
to the administration of the derivative, if a physician
determines administration of the derivative in the patient's
home is medically appropriate.
Extended Care in Religious Nonmedical Health Care Institutions
(aaa)(1) The term ``home health agency'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only with respect to items and
services ordinarily furnished by such an institution to
individuals in their homes, and that are comparable to items
and services furnished to individuals by a home health agency
that is not religious nonmedical health care institution.
(2)(A) Subject to subparagraphs (B), payment may be made with
respect to services provided by such an institution only to
such extent and under such conditions, limitations, and
requirements (in addition to or in lieu of the conditions,
limitations, and requirements otherwise applicable) as may be
provided in regulations consistent with section 1821.
(B) Notwithstanding any other provision of this title,
payment may not be made under subparagraph (A)--
(i) in a year insofar as such payments exceed
$700,000; and
(ii) after December 31, 2006.
Ultrasound Screening for Abdominal Aortic Aneurysm
(bbb) The term ``ultrasound screening for abdominal aortic
aneurysm'' means--
(1) a procedure using sound waves (or such other
procedures using alternative technologies, of
commensurate accuracy and cost, that the Secretary may
specify) provided for the early detection of abdominal
aortic aneurysm; and
(2) includes a physician's interpretation of the
results of the procedure.
Long-Term Care Hospital
(ccc) The term ``long-term care hospital'' means a hospital
which--
(1) is primarily engaged in providing inpatient
services, by or under the supervision of a physician,
to Medicare beneficiaries whose medically complex
conditions require a long hospital stay and programs of
care provided by a long-term care hospital;
(2) has an average inpatient length of stay (as
determined by the Secretary) of greater than 25 days,
or meets the requirements of clause (II) of section
1886(d)(1)(B)(iv);
(3) satisfies the requirements of subsection (e); and
(4) meets the following facility criteria:
(A) the institution has a patient review
process, documented in the patient medical
record, that screens patients prior to
admission for appropriateness of admission to a
long-term care hospital, validates within 48
hours of admission that patients meet admission
criteria for long-term care hospitals,
regularly evaluates patients throughout their
stay for continuation of care in a long-term
care hospital, and assesses the available
discharge options when patients no longer meet
such continued stay criteria;
(B) the institution has active physician
involvement with patients during their
treatment through an organized medical staff,
physician-directed treatment with physician on-
site availability on a daily basis to review
patient progress, and consulting physicians on
call and capable of being at the patient's side
within a moderate period of time, as determined
by the Secretary; and
(C) the institution has interdisciplinary
team treatment for patients, requiring
interdisciplinary teams of health care
professionals, including physicians, to prepare
and carry out an individualized treatment plan
for each patient.
Additional Preventive Services; Preventive Services
(ddd)(1) The term ``additional preventive services'' means
services not described in subparagraph (A) or (C) of paragraph
(3) that identify medical conditions or risk factors and that
the Secretary determines are--
(A) reasonable and necessary for the prevention or
early detection of an illness or disability;
(B) recommended with a grade of A or B by the United
States Preventive Services Task Force; and
(C) appropriate for individuals entitled to benefits
under part A or enrolled under part B.
(2) In making determinations under paragraph (1) regarding
the coverage of a new service, the Secretary shall use the
process for making national coverage determinations (as defined
in section 1869(f)(1)(B)) under this title. As part of the use
of such process, the Secretary may conduct an assessment of the
relation between predicted outcomes and the expenditures for
such service and may take into account the results of such
assessment in making such determination.
(3) The term ``preventive services'' means the following:
(A) The screening and preventive services described
in subsection (ww)(2) (other than the service described
in subparagraph (M) of such subsection).
(B) An initial preventive physical examination (as
defined in subsection (ww)).
(C) Personalized prevention plan services (as defined
in subsection (hhh)(1)).
Cardiac Rehabilitation Program; Intensive Cardiac Rehabilitation
Program
(eee)(1) The term ``cardiac rehabilitation program'' means a
program (as described in paragraph (2)) that furnishes the
items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5)).
(2) A program described in this paragraph is a program under
which--
(A) items and services under the program are
delivered--
(i) in a physician's office;
(ii) in a hospital on an outpatient basis; or
(iii) in other settings determined
appropriate by the Secretary;
(B) a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as those terms are defined in
subsection (aa)(5)) is immediately available and
accessible for medical consultation and medical
emergencies at all times items and services are being
furnished under the program, except that, in the case
of items and services furnished under such a program in
a hospital, such availability shall be presumed; and
(C) individualized treatment is furnished under a
written plan established, reviewed, and signed by a
physician every 30 days that describes--
(i) the individual's diagnosis;
(ii) the type, amount, frequency, and
duration of the items and services furnished
under the plan; and
(iii) the goals set for the individual under
the plan.
(3) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) cardiac risk factor modification, including
education, counseling, and behavioral intervention (to
the extent such education, counseling, and behavioral
intervention is closely related to the individual's
care and treatment and is tailored to the individual's
needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(4)(A) The term ``intensive cardiac rehabilitation program''
means a program (as described in paragraph (2)) that furnishes
the items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5))
and has shown, in peer-reviewed published research, that it
accomplished--
(i) one or more of the following:
(I) positively affected the progression of
coronary heart disease; or
(II) reduced the need for coronary bypass
surgery; or
(III) reduced the need for percutaneous
coronary interventions; and
(ii) a statistically significant reduction in 5 or
more of the following measures from their level before
receipt of cardiac rehabilitation services to their
level after receipt of such services:
(I) low density lipoprotein;
(II) triglycerides;
(III) body mass index;
(IV) systolic blood pressure;
(V) diastolic blood pressure; or
(VI) the need for cholesterol, blood
pressure, and diabetes medications.
(B) To be eligible for an intensive cardiac rehabilitation
program, an individual must have--
(i) had an acute myocardial infarction within the
preceding 12 months;
(ii) had coronary bypass surgery;
(iii) stable angina pectoris;
(iv) had heart valve repair or replacement;
(v) had percutaneous transluminal coronary
angioplasty (PTCA) or coronary stenting;
(vi) had a heart or heart-lung transplant;
(vii) stable, chronic heart failure (defined
as patients with left ventricular ejection
fraction of 35 percent or less and New York
Heart Association (NYHA) class II to IV
symptoms despite being on optimal heart failure
therapy for at least 6 weeks); or
(viii) any additional condition for which the
Secretary has determined that a cardiac
rehabilitation program shall be covered, unless
the Secretary determines, using the same
process used to determine that the condition is
covered for a cardiac rehabilitation program,
that such coverage is not supported by the
clinical evidence.
(C) An intensive cardiac rehabilitation program may be
provided in a series of 72 one-hour sessions (as defined in
section 1848(b)(5)), up to 6 sessions per day, over a period of
up to 18 weeks.
(5) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
cardiac pathophysiology who is licensed to practice medicine in
the State in which a cardiac rehabilitation program (or the
intensive cardiac rehabilitation program, as the case may be)
is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Pulmonary Rehabilitation Program
(fff)(1) The term ``pulmonary rehabilitation program'' means
a program (as described in subsection (eee)(2) with respect to
a program under this subsection) that furnishes the items and
services described in paragraph (2) under the supervision of a
physician (as defined in subsection (r)(1)) or a physician
assistant, nurse practitioner, or clinical nurse specialist (as
those terms are defined in subsection (aa)(5)).
(2) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) education or training (to the extent the
education or training is closely and clearly related to
the individual's care and treatment and is tailored to
such individual's needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(3) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
respiratory pathophysiology who is licensed to practice
medicine in the State in which a pulmonary rehabilitation
program is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Kidney Disease Education Services
(ggg)(1) The term ``kidney disease education services'' means
educational services that are--
(A) furnished to an individual with stage IV chronic
kidney disease who, according to accepted clinical
guidelines identified by the Secretary, will require
dialysis or a kidney transplant;
(B) furnished, upon the referral of the physician
managing the individual's kidney condition, by a
qualified person (as defined in paragraph (2)); and
(C) designed--
(i) to provide comprehensive information
(consistent with the standards set under
paragraph (3)) regarding--
(I) the management of comorbidities,
including for purposes of delaying the
need for dialysis;
(II) the prevention of uremic
complications; and
(III) each option for renal
replacement therapy (including
hemodialysis and peritoneal dialysis at
home and in-center as well as vascular
access options and transplantation);
(ii) to ensure that the individual has the
opportunity to actively participate in the
choice of therapy; and
(iii) to be tailored to meet the needs of the
individual involved.
(2)(A) The term ``qualified person'' means--
(i) a physician (as defined in section 1861(r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as defined in section 1861(aa)(5)),
who furnishes services for which payment may be made
under the fee schedule established under section 1848;
and
(ii) a provider of services located in a rural area
(as defined in section 1886(d)(2)(D)).
(B) Such term does not include a provider of services (other
than a provider of services described in subparagraph (A)(ii))
or a renal dialysis facility.
(3) The Secretary shall set standards for the content of such
information to be provided under paragraph (1)(C)(i) after
consulting with physicians, other health professionals, health
educators, professional organizations, accrediting
organizations, kidney patient organizations, dialysis
facilities, transplant centers, network organizations described
in section 1881(c)(2), and other knowledgeable persons. To the
extent possible the Secretary shall consult with persons or
entities described in the previous sentence, other than a
dialysis facility, that has not received industry funding from
a drug or biological manufacturer or dialysis facility.
(4) No individual shall be furnished more than 6 sessions of
kidney disease education services under this title.
Annual Wellness Visit
(hhh)(1) The term ``personalized prevention plan services''
means the creation of a plan for an individual--
(A) that includes a health risk assessment (that
meets the guidelines established by the Secretary under
paragraph (4)(A)) of the individual that is completed
prior to or as part of the same visit with a health
professional described in paragraph (3); and
(B) that--
(i) takes into account the results of the
health risk assessment; and
(ii) may contain the elements described in
paragraph (2).
(2) Subject to paragraph (4)(H), the elements described in
this paragraph are the following:
(A) The establishment of, or an update to, the
individual's medical and family history.
(B) A list of current providers and suppliers that
are regularly involved in providing medical care to the
individual (including a list of all prescribed
medications).
(C) A measurement of height, weight, body mass index
(or waist circumference, if appropriate), blood
pressure, and other routine measurements.
(D) Detection of any cognitive impairment.
(E) The establishment of, or an update to, the
following:
(i) A screening schedule for the next 5 to 10
years, as appropriate, based on recommendations
of the United States Preventive Services Task
Force and the Advisory Committee on
Immunization Practices, and the individual's
health status, screening history, and age-
appropriate preventive services covered under
this title.
(ii) A list of risk factors and conditions
for which primary, secondary, or tertiary
prevention interventions are recommended or are
underway, including any mental health
conditions or any such risk factors or
conditions that have been identified through an
initial preventive physical examination (as
described under subsection (ww)(1)), and a list
of treatment options and their associated risks
and benefits.
(F) The furnishing of personalized health advice and
a referral, as appropriate, to health education or
preventive counseling services or programs aimed at
reducing identified risk factors and improving self-
management, or community-based lifestyle interventions
to reduce health risks and promote self-management and
wellness, including weight loss, physical activity,
smoking cessation, fall prevention, and nutrition.
(G) Screening for potential substance use disorders
and referral for treatment as appropriate.
(H) The furnishing of a review of any current opioid
prescriptions (as defined in subsection (ww)(4)).
(I) Any other element determined appropriate by the
Secretary.
(3) A health professional described in this paragraph is--
(A) a physician;
(B) a practitioner described in clause (i) of section
1842(b)(18)(C); or
(C) a medical professional (including a health
educator, registered dietitian, or nutrition
professional) or a team of medical professionals, as
determined appropriate by the Secretary, under the
supervision of a physician.
(4)(A) For purposes of paragraph (1)(A), the Secretary, not
later than 1 year after the date of enactment of this
subsection, shall establish publicly available guidelines for
health risk assessments. Such guidelines shall be developed in
consultation with relevant groups and entities and shall
provide that a health risk assessment--
(i) identify chronic diseases, injury risks,
modifiable risk factors, and urgent health needs of the
individual; and
(ii) may be furnished--
(I) through an interactive telephonic or web-
based program that meets the standards
established under subparagraph (B);
(II) during an encounter with a health care
professional;
(III) through community-based prevention
programs; or
(IV) through any other means the Secretary
determines appropriate to maximize
accessibility and ease of use by beneficiaries,
while ensuring the privacy of such
beneficiaries.
(B) Not later than 1 year after the date of enactment of this
subsection, the Secretary shall establish standards for
interactive telephonic or web-based programs used to furnish
health risk assessments under subparagraph (A)(ii)(I). The
Secretary may utilize any health risk assessment developed
under section 4004(f) of the Patient Protection and Affordable
Care Act as part of the requirement to develop a personalized
prevention plan to comply with this subparagraph.
(C)(i) Not later than 18 months after the date of enactment
of this subsection, the Secretary shall develop and make
available to the public a health risk assessment model. Such
model shall meet the guidelines under subparagraph (A) and may
be used to meet the requirement under paragraph (1)(A).
(ii) Any health risk assessment that meets the guidelines
under subparagraph (A) and is approved by the Secretary may be
used to meet the requirement under paragraph (1)(A).
(D) The Secretary may coordinate with community-based
entities (including State Health Insurance Programs, Area
Agencies on Aging, Aging and Disability Resource Centers, and
the Administration on Aging) to--
(i) ensure that health risk assessments are
accessible to beneficiaries; and
(ii) provide appropriate support for the completion
of health risk assessments by beneficiaries.
(E) The Secretary shall establish procedures to make
beneficiaries and providers aware of the requirement that a
beneficiary complete a health risk assessment prior to or at
the same time as receiving personalized prevention plan
services.
(F) To the extent practicable, the Secretary shall encourage
the use of, integration with, and coordination of health
information technology (including use of technology that is
compatible with electronic medical records and personal health
records) and may experiment with the use of personalized
technology to aid in the development of self-management skills
and management of and adherence to provider recommendations in
order to improve the health status of beneficiaries.
(G) A beneficiary shall be eligible to receive only an
initial preventive physical examination (as defined under
subsection (ww)(1)) during the 12-month period after the date
that the beneficiary's coverage begins under part B and shall
be eligible to receive personalized prevention plan services
under this subsection each year thereafter provided that the
beneficiary has not received either an initial preventive
physical examination or personalized prevention plan services
within the preceding 12-month period.
(H) The Secretary shall issue guidance that--
(i) identifies elements under paragraph (2) that are
required to be provided to a beneficiary as part of
their first visit for personalized prevention plan
services; and
(ii) establishes a yearly schedule for appropriate
provision of such elements thereafter.
(iii) Home Infusion Therapy.--(1) The term ``home infusion
therapy'' means the items and services described in paragraph
(2) furnished by a qualified home infusion therapy supplier (as
defined in paragraph (3)(D)) which are furnished in the
individual's home (as defined in paragraph (3)(B)) to an
individual--
(A) who is under the care of an applicable provider
(as defined in paragraph (3)(A)); and
(B) with respect to whom a plan prescribing the type,
amount, and duration of infusion therapy services that
are to be furnished such individual has been
established by a physician (as defined in subsection
(r)(1)) and is periodically reviewed by a physician (as
so defined) in coordination with the furnishing of home
infusion drugs (as defined in paragraph (3)(C)) under
part B.
(2) The items and services described in this paragraph are
the following:
(A) Professional services, including nursing
services, furnished in accordance with the plan.
(B) Training and education (not otherwise paid for as
durable medical equipment (as defined in subsection
(n)), remote monitoring, and monitoring services for
the provision of home infusion therapy and home
infusion drugs furnished by a qualified home infusion
therapy supplier.
(3) For purposes of this subsection:
(A) The term ``applicable provider'' means--
(i) a physician;
(ii) a nurse practitioner; and
(iii) a physician assistant.
(B) The term ``home'' means a place of residence used
as the home of an individual (as defined for purposes
of subsection (n)).
(C) The term ``home infusion drug'' means a
parenteral drug or biological administered
intravenously, or subcutaneously for an administration
period of 15 minutes or more, in the home of an
individual through a pump that is an item of durable
medical equipment (as defined in subsection (n)). Such
term does not include the following:
(i) Insulin pump systems.
(ii) A self-administered drug or biological
on a self-administered drug exclusion list.
(D)(i) The term ``qualified home infusion therapy
supplier'' means a pharmacy, physician, or other
provider of services or supplier licensed by the State
in which the pharmacy, physician, or provider or
services or supplier furnishes items or services and
that--
(I) furnishes infusion therapy to individuals
with acute or chronic conditions requiring
administration of home infusion drugs;
(II) ensures the safe and effective provision
and administration of home infusion therapy on
a 7-day-a-week, 24-hour-a-day basis;
(III) is accredited by an organization
designated by the Secretary pursuant to section
1834(u)(5); and
(IV) meets such other requirements as the
Secretary determines appropriate, taking into
account the standards of care for home infusion
therapy established by Medicare Advantage plans
under part C and in the private sector.
(ii) A qualified home infusion therapy supplier may
subcontract with a pharmacy, physician, provider of
services, or supplier to meet the requirements of this
subparagraph.
(jjj) Opioid Use Disorder Treatment Services; Opioid
Treatment Program.--
(1) Opioid use disorder treatment services.--The term
``opioid use disorder treatment services'' means items
and services that are furnished by an opioid treatment
program for the treatment of opioid use disorder,
including--
(A) opioid agonist and antagonist treatment
medications (including oral, injected, or
implanted versions) that are approved by the
Food and Drug Administration under section 505
of the Federal Food, Drug, and Cosmetic Act for
use in the treatment of opioid use disorder;
(B) dispensing and administration of such
medications, if applicable;
(C) substance use counseling by a
professional to the extent authorized under
State law to furnish such services;
(D) individual and group therapy with a
physician or psychologist (or other mental
health professional to the extent authorized
under State law);
(E) toxicology testing, and
(F) other items and services that the
Secretary determines are appropriate (but in no
event to include meals or transportation).
(2) Opioid treatment program.--The term ``opioid
treatment program'' means an entity that is an opioid
treatment program (as defined in section 8.2 of title
42 of the Code of Federal Regulations, or any successor
regulation) that--
(A) is enrolled under section 1866(j);
(B) has in effect a certification by the
Substance Abuse and Mental Health Services
Administration for such a program;
(C) is accredited by an accrediting body
approved by the Substance Abuse and Mental
Health Services Administration; and
(D) meets such additional conditions as the
Secretary may find necessary to ensure--
(i) the health and safety of
individuals being furnished services
under such program; and
(ii) the effective and efficient
furnishing of such services.
* * * * * * *
use of state agencies to determine compliance by providers of services
with conditions of participation
Sec. 1864. (a) The Secretary shall make an agreement with any
State which is able and willing to do so under which the
services of the State health agency or other appropriate State
agency (or the appropriate local agencies) will be utilized by
him for the purpose of determining whether an institution
therein is a hospital or skilled nursing facility, or whether
an agency therein is a home health agency, or whether an agency
is a hospice program or whether a facility therein is a rural
health clinic as defined in section 1861(aa)(2), a critical
access hospital, as defined in section 1861(mm)(1), or a
comprehensive outpatient rehabilitation facility as defined in
section 1861(cc)(2), or whether a laboratory meets the
requirements of paragraphs (16) and (17) of section 1861(s) or
whether a clinic, rehabilitation agency or public health agency
meets the requirements of subparagraph (A) or (B), as the case
may be, of section 1861(p)(4), or whether an ambulatory
surgical center meets the standards specified under section
1832(a)(2)(F)(i). To the extent that the Secretary finds it
appropriate, an institution or agency which such a State (or
local) agency certifies is a hospital, skilled nursing
facility, rural health clinic, comprehensive outpatient
rehabilitation facility, home health agency, or hospice program
(as those terms are defined in section 1861) may be treated as
such by the Secretary. Any State agency which has such an
agreement may (subject to approval of the Secretary) furnish to
a skilled nursing facility, after proper request by such
facility, such specialized consultative services (which such
agency is able and willing to furnish in a manner satisfactory
to the Secretary) as such facility may need to meet one or more
of the conditions specified in section 1819(a). Any such
services furnished by a State agency shall be deemed to have
been furnished pursuant to such agreement. Within 90 days
following the completion of each survey of any health care
facility, ambulatory surgical center, rural health clinic,
comprehensive outpatient rehabilitation facility, laboratory,
clinic, agency, or organization by the appropriate State or
local agency described in the first sentence of this
subsection, the Secretary shall make public in readily
available form and place, and require (in the case of skilled
nursing facilities) the posting in a place readily accessible
to patients (and patients' representatives), the pertinent
findings of each such survey relating to the compliance of each
such health care facility, ambulatory surgical center, rural
health clinic, comprehensive outpatient rehabilitation
facility, laboratory, clinic, agency, or organization with (1)
the statutory conditions of participation imposed under this
title and (2) the major additional conditions which the
Secretary finds necessary in the interest of health and safety
of individuals who are furnished care or services by any such
health care facility, ambulatory surgical center, rural health
clinic, comprehensive outpatient rehabilitation facility,
laboratory, clinic, agency, or organization. Any agreement
under this subsection shall provide for the appropriate State
or local agency to maintain a toll-free hotline (1) to collect,
maintain, and continually update information on home health
agencies and hospice programs located in the State or locality
that are certified to participate in the program established
under this title (which information shall include any
significant deficiencies found with respect to patient care in
the most recent certification survey conducted by a State
agency or accreditation survey conducted by a private
accreditation agency under section 1865 with respect to the
home health agency or the hospice program, when that survey was
completed, whether corrective actions have been taken or are
planned, and the sanctions, if any, imposed under this title
with respect to the agency or the hospice program) and (2) to
receive complaints (and answer questions) with respect to home
health agencies and hospice programs in the State or locality.
Any such agreement shall provide for such State or local agency
to maintain a unit for investigating such complaints that
possesses enforcement authority and has access to survey and
certification reports, information gathered by any private
accreditation agency utilized by the Secretary under section
1865, and consumer medical records (but only with the consent
of the consumer or his or her legal representative).
(b) The Secretary shall pay any such State, in advance or by
way of reimbursement, as may be provided in the agreement with
it (and may make adjustments in such payments on account of
overpayments or underpayments previously made), for the
reasonable cost of performing the functions specified in
subsection (a), and for the Federal Hospital Insurance Trust
Fund's fair share of the costs attributable to the planning and
other efforts directed toward coordination of activities in
carrying out its agreement and other activities related to the
provision of services similar to those for which payment may be
made under part A, or related to the facilities and personnel
required for the provision of such services, or related to
improving the quality of such services.
(c) The Secretary is authorized to enter into an agreement
with any State under which the appropriate State or local
agency which performs the certification function described in
subsection (a) will survey, on a selective sample basis (or
where the Secretary finds that a survey is appropriate because
of substantial allegations of the existence of a significant
deficiency or deficiencies which would, if found to be present,
adversely affect health and safety of patients), provider
entities that, pursuant to section 1865(a)(1), are treated as
meeting the conditions or requirements of this title. The
Secretary shall pay for such services in the manner prescribed
in subsection (b).
(d) The Secretary may not enter an agreement under this
section with a State with respect to determining whether an
institution therein is a skilled nursing facility unless the
State meets the requirements specified in section 1819(e) and
section 1819(g) and the establishment of remedies under
sections 1819(h)(2)(B) and 1819(h)(2)(C) (relating to
establishment and application of remedies).
(e) Notwithstanding any other provision of law, the Secretary
may not impose, or require a State to impose, any fee on any
facility or entity subject to a determination under subsection
(a), or any renal dialysis facility subject to the requirements
of section 1881(b)(1), for any such determination or any survey
relating to determining the compliance of such facility or
entity with any requirement of this title (other than any fee
relating to section 353 of the Public Health Service Act).
effect of accreditation
Sec. 1865. (a)(1) If the Secretary finds that accreditation
of a provider entity (as defined in paragraph (4)) by the
American Osteopathic Association or any other national
accreditation body demonstrates that all of the applicable
conditions or requirements of this title (other than the
requirements of section 1834(j)) are met or exceeded--
(A) in the case of a provider entity not described in
paragraph (3)(B), the Secretary shall treat such entity
as meeting those conditions or requirements with
respect to which the Secretary made such finding; or
(B) in the case of a provider entity described in
paragraph (3)(B), the Secretary may treat such entity
as meeting those conditions or requirements with
respect to which the Secretary made such finding.
(2) In making such a finding, the Secretary shall consider,
among other factors with respect to a national accreditation
body, its requirements for accreditation, its survey
procedures, its ability to provide adequate resources for
conducting required surveys and supplying information for use
in enforcement activities, its monitoring procedures for
provider entities found out of compliance with the conditions
or requirements, and its ability to provide the Secretary with
necessary data for validation.
(3)(A) Except as provided in subparagraph (B), not later than
60 days after the date of receipt of a written request for a
finding under paragraph (1) (with any documentation necessary
to make a determination on the request), the Secretary shall
publish a notice identifying the national accreditation body
making the request, describing the nature of the request, and
providing a period of at least 30 days for the public to
comment on the request. The Secretary shall approve or deny a
request for such a finding, and shall publish notice of such
approval or denial, not later than 210 days after the date of
receipt of the request (with such documentation). Such an
approval shall be effective with respect to accreditation
determinations made on or after such effective date (which may
not be later than the date of publication of the approval) as
the Secretary specifies in the publication notice.
(B) The 210-day and 60-day deadlines specified in
subparagraph (A) shall not apply in the case of any request for
a finding with respect to accreditation of a provider entity to
which the conditions and requirements of sections 1819 and
1861(j) apply.
(4) For purposes of this section, the term ``provider
entity'' means a provider of services, supplier, facility
(including a renal dialysis facility), clinic, agency, or
laboratory.
(b) The Secretary may not disclose any accreditation survey
(other than a survey with respect to a home health agency or,
beginning on the date of the enactment of the HOSPICE Act, a
hospice program) made and released to the Secretary by the
American Osteopathic Association or any other national
accreditation body, of an entity accredited by such body,
except that the Secretary may disclose such a survey and
information related to such a survey to the extent such survey
and information relate to an enforcement action taken by the
Secretary.
(c) Notwithstanding any other provision of this title, if the
Secretary finds that a provider entity has significant
deficiencies (as defined in regulations pertaining to health
and safety), the entity shall, after the date of notice of such
finding to the entity and for such period as may be prescribed
in regulations, be deemed not to meet the conditions or
requirements the entity has been treated as meeting pursuant to
subsection (a)(1).
(d) For provisions relating to validation surveys of entities
that are treated as meeting applicable conditions or
requirements of this title pursuant to subsection (a)(1), see
section 1864(c).
(e) With respect to an accreditation body that has received
approval from the Secretary under subsection (a)(3)(A) for
accreditation of provider entities that are required to meet
the conditions and requirements under section 1881(b), in
addition to review and oversight authorities otherwise
applicable under this title, the Secretary shall (as the
Secretary determines appropriate) conduct, with respect to such
accreditation body and provider entities, any or all of the
following as frequently as is otherwise required to be
conducted under this title with respect to other accreditation
bodies or other provider entities:
(1) Validation surveys referred to in subsection (d).
(2) Accreditation program reviews (as defined in
section 488.8(c) of title 42 of the Code of Federal
Regulations, or a successor regulation).
(3) Performance reviews (as defined in section
488.8(a) of title 42 of the Code of Federal
Regulations, or a successor regulation).
* * * * * * *
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IMPROVING MEDICARE POST-ACUTE CARE TRANSFORMATION ACT OF 2014
* * * * * * *
SEC. 3. HOSPICE CARE.
(a) Hospice Survey Requirement.--
(1) In general.--Section 1861(dd)(4) of the Social
Security Act (42 U.S.C. 1395x(dd)(4)) is amended by
adding at the end the following new subparagraph:
``(C) Any entity that is certified as a hospice program shall
be subject to a standard survey by an appropriate State or
local survey agency, or an approved accreditation agency, as
determined by the Secretary, not less frequently than once
every 36 months beginning 6 months after the date of the
enactment of this subparagraph and ending September 30,
2025.''.
(2) Funding.--For purposes of carrying out
subparagraph (C) of section 1861(dd)(4) of the Social
Security Act (42 U.S.C. 1395x(dd)(4)), as added by
paragraph (1), and section 1822(a)(1) of such Act,
there shall be transferred from the Federal Hospital
Insurance Trust Fund under section 1817 of such Act (42
U.S.C. 1395i) to the Centers for Medicare & Medicaid
Services Program Management Account--
(A) $25,000,000 for fiscal years 2015 through
2017, to be made available for such purposes in
equal parts for each such fiscal year; and
(B) $45,000,000 for fiscal years 2018 through
2025, to be made available for such purposes in
equal parts for each such fiscal year.
(b) Hospice Program Eligibility Recertification Technical
Correction to Apply Limitation on Liability of Beneficiary
Rules.--Section 1879 of the Social Security Act (42 U.S.C.
1395pp) is amended by adding at the end the following new
subsection:
``(i) The provisions of this section shall apply with respect
to a denial of a payment under this title by reason of section
1814(a)(7)(E) in the same manner as such provisions apply with
respect to a denial of a payment under this title by reason of
section 1862(a)(1).''.
(c) Revision to Requirement for Medical Review of Certain
Hospice Care.--Section 1814(a)(7) of the Social Security Act
(42 U.S.C. 1395f(a)(7)) is amended--
(1) in subparagraph (C), by striking ``and'' at the
end;
(2) in subparagraph (D), in the matter preceding
clause (i), by inserting ``(and, in the case of clause
(ii), before the date of enactment of subparagraph
(E))'' after ``2011''; and
(3) by adding at the end the following new
subparagraph:
``(E) on and after the date of enactment of
this subparagraph, in the case of hospice care
provided an individual for more than 180 days
by a hospice program for which the number of
such cases for such program comprises more than
a percent (specified by the Secretary) of the
total number of all cases of individuals
provided hospice care by the program under this
title, the hospice care provided to such
individual is medically reviewed (in accordance
with procedures established by the Secretary);
and''.
(d) Update of Hospice Aggregate Payment Cap.--Section
1814(i)(2)(B) of the Social Security Act (42 U.S.C.
1395f(i)(2)(B)) is amended--
(1) by striking ``(B) For purposes'' and inserting
``(B)(i) Except as provided in clause (ii), for
purposes''; and
(2) by adding at the end the following:
``(ii) For purposes of subparagraph (A) for accounting years
that end after September 30, 2016, and before October 1, 2025,
the `cap amount' is the cap amount under this subparagraph for
the preceding accounting year updated by the percentage update
to payment rates for hospice care under paragraph (1)(C) for
services furnished during the fiscal year beginning on the
October 1 preceding the beginning of the accounting year
(including the application of any productivity or other
adjustment under clause (iv) of that paragraph).
``(iii) For accounting years that end after September 30,
2025, the cap amount shall be computed under clause (i) as if
clause (ii) had never applied.''.
(e) Medicare Improvement Fund.--Section 1898 of the Social
Security Act (42 U.S.C. 1395iii) is amended--
(1) by amending the heading to read as follows:
``medicare improvement fund'';
(2) by amending subsection (a) to read as follows:
``(a) Establishment.--The Secretary shall establish under
this title a Medicare Improvement Fund (in this section
referred to as the `Fund') which shall be available to the
Secretary to make improvements under the original Medicare fee-
for-service program under parts A and B for individuals
entitled to, or enrolled for, benefits under part or enrolled
under part B including adjustments to payments for items and
services furnished by providers of services and suppliers under
such original Medicare fee-for-service program.'';
(3) in subsection (b)(1), by striking ``during'' and
all that follows and inserting ``during and after
fiscal year 2020, $195,000,000.''; and
(4) in subsection (b)(2), by striking ``from the
Federal'' and all that follows and inserting ``from the
Federal Hospital Insurance Trust Fund and the Federal
Supplementary Medical Insurance Trust Fund in such
proportion as the Secretary determines appropriate.''.