[House Report 114-553]
[From the U.S. Government Publishing Office]
114th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 114-553
======================================================================
CO-PRESCRIBING TO REDUCE OVERDOSES ACT OF 2016
_______
May 10, 2016.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3680]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3680) to provide for the Secretary of Health and
Human Services to carry out a grant program for co-prescribing
opioid overdose reversal drugs, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Hearings......................................................... 4
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 4
Statement of General Performance Goals and Objectives............ 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 7
Duplication of Federal Programs.................................. 7
Disclosure of Directed Rule Makings.............................. 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
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 ``Co-Prescribing to Reduce Overdoses Act
of 2016''.
SEC. 2. OPIOID OVERDOSE REVERSAL DRUGS PRESCRIBING GRANT PROGRAM.
(a) Establishment.--
(1) In general.--Not later than six months after the date of
the enactment of this Act, the Secretary of Health and Human
Services may establish, in accordance with this section, a
five-year opioid overdose reversal drugs prescribing grant
program (in this Act referred to as the ``grant program'').
(2) Maximum grant amount.--A grant made under this section
may not be for more than $200,000 per grant year.
(3) Eligible entity.--For purposes of this section, the term
``eligible entity'' means a federally qualified health center
(as defined in section 1861(aa) of the Social Security Act (42
U.S.C. 1395x(aa)), an opioid treatment program under part 8 of
title 42, Code of Federal Regulations, any practitioner
dispensing narcotic drugs pursuant to section 303(g) of the
Controlled Substances Act (21 U.S.C. 823(g)), or any other
entity that the Secretary deems appropriate.
(4) Prescribing.--For purposes of this section and section 3,
the term ``prescribing'' means, with respect to an opioid
overdose reversal drug, such as naloxone, the practice of
prescribing such drug--
(A) in conjunction with an opioid prescription for
patients at an elevated risk of overdose;
(B) in conjunction with an opioid agonist approved
under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) for the treatment of
opioid abuse disorder;
(C) to the caregiver or a close relative of patients
at an elevated risk of overdose from opioids; or
(D) in other circumstances, as identified by the
Secretary, in which a provider identifies a patient is
at an elevated risk for an intentional or unintentional
drug overdose from heroin or prescription opioid
therapies.
(b) Application.--To be eligible to receive a grant under this
section, an eligible entity shall submit to the Secretary of Health and
Human Services, in such form and manner as specified by the Secretary,
an application that describes--
(1) the extent to which the area to which the entity will
furnish services through use of the grant is experiencing
significant morbidity and mortality caused by opioid abuse;
(2) the criteria that will be used to identify eligible
patients to participate in such program; and
(3) how such program will work to try to identify State,
local, or private funding to continue the program after
expiration of the grant.
(c) Use of Funds.--An eligible entity receiving a grant under this
section may use the grant for any of the following activities, but may
use not more than 20 percent of the grant funds for activities
described in paragraphs (4) and (5):
(1) To establish a program for prescribing opioid overdose
reversal drugs, such as naloxone.
(2) To train and provide resources for health care providers
and pharmacists on the prescribing of opioid overdose reversal
drugs, such as naloxone.
(3) To establish mechanisms and processes for tracking
patients participating in the program described in paragraph
(1) and the health outcomes of such patients.
(4) To purchase opioid overdose reversal drugs, such as
naloxone, for distribution under the program described in
paragraph (1).
(5) To offset the co-pays and other cost sharing associated
with opioid overdose reversal drugs, such as naloxone, to
ensure that cost is not a limiting factor for eligible
patients.
(6) To conduct community outreach, in conjunction with
community-based organizations, designed to raise awareness of
prescribing practices, and the availability of opioid overdose
reversal drugs, such as naloxone.
(7) To establish protocols to connect patients who have
experienced a drug overdose with appropriate treatment,
including medication assisted treatment and appropriate
counseling and behavioral therapies.
(d) Evaluations by Recipients.--As a condition of receipt of a grant
under this section, an eligible entity shall, for each year for which
the grant is received, submit to the Secretary of Health and Human
Services information on appropriate outcome measures specified by the
Secretary to assess the outcomes of the program funded by the grant,
including--
(1) the number of prescribers trained;
(2) the number of prescribers who have co-prescribed an
opioid overdose reversal drug, such as naloxone, to at least
one patient;
(3) the total number of prescriptions written for opioid
overdose reversal drugs, such as naloxone;
(4) the percentage of patients at elevated risk who received
a prescription for an opioid overdose reversal drug, such as
naloxone;
(5) the number of patients reporting use of an opioid
overdose reversal drug, such as naloxone; and
(6) any other outcome measures that the Secretary deems
appropriate.
(e) Reports by Secretary.--For each year of the grant program under
this section, the Secretary of Health and Human Services shall submit
to the appropriate committees of the House of Representatives and of
the Senate a report aggregating the information received from the grant
recipients for such year under subsection (d) and evaluating the
outcomes achieved by the programs funded by grants made under this
section.
SEC. 3. PROVIDING INFORMATION TO PRESCRIBERS IN CERTAIN FEDERAL HEALTH
CARE AND MEDICAL FACILITIES ON BEST PRACTICES FOR
PRESCRIBING OPIOID OVERDOSE REVERSAL DRUGS.
(a) In General.--Not later than 180 days after the date of enactment
of this Act, the Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') may, as appropriate, provide
information to prescribers within Federally qualified health centers
(as defined in paragraph (4) of section 1861(aa) of the Social Security
Act (42 U.S.C. 1395x(aa))), and the health care facilities of the
Indian Health Service, on best practices for prescribing opioid
overdose reversal drugs, such as naloxone, for patients receiving
chronic opioid therapy, patients being treated for opioid use
disorders, and other patients that a provider identifies as having an
elevated risk of overdose from heroin or prescription opioid therapies.
(b) Not Establishing a Medical Standard of Care.--The information on
best practices provided under this section shall not be construed as
constituting or establishing a medical standard of care for prescribing
opioid overdose reversal drugs, such as naloxone, for patients
described in subsection (a).
(c) No Authorization of Any Additional Appropriations.--The Secretary
shall carry out this section through funds otherwise appropriated and
nothing in this section shall be construed as authorizing the
appropriations of additional funds to carry out this section.
(d) Elevated Risk of Overdose Defined.--In this section, the term
``elevated risk of overdose'' has the meaning given such term by the
Secretary, which--
(1) may be based on the criteria provided in the Opioid
Overdose Toolkit published by the Substance Abuse and Mental
Health Services Administration (SAMHSA); and
(2) may include patients on a first course opioid treatment,
patients using extended-release and long-acting opioid
analgesics, and patients with a respiratory disease or other
co-morbidities.
SEC. 4. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out this Act
$5,000,000 for the period of fiscal years 2017 through 2021.
SEC. 5. CUT-GO COMPLIANCE.
Subsection (f) of section 319D of the Public Health Service Act (42
U.S.C. 247d-4) is amended by inserting before the period at the end the
following: ``(except such dollar amount shall be reduced by $5,000,000
for fiscal year 2018)''.
Purpose and Summary
H.R. 3680, the ``Co-Prescribing to Reduce Overdoses Act of
2016,'' was introduced by Rep. John Sarbanes (D-MD) on October
1, 2015. This legislation directs the Secretary of Health and
Human Services to carry out a grant program for co-prescribing
opioid overdose reversal drugs.
Background and Need for Legislation
In 1999, there were 6.1 overdose deaths per 100,000
Americans involving opioid analgesics and heroin. By 2014, that
number doubled to 14.7 overdose deaths. The rate of overdose
for individuals aged 24 to 34 nearly tripled going from 8.1
overdose deaths per 100,000 to 23.1 overdose deaths.\1\
Naloxone is an opioid antagonist that can prevent opioid
overdose deaths by binding to the opioid receptors in the body
and preventing the overdose. The World Health Organization
estimated that if naloxone was more widely available in the
United States, 20,000 overdose deaths could be prevented
annually.\2\ This legislation is a first step in promoting
wider access of naloxone or other opioid overdose reversal
drugs that may come to market.
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\1\http://www.cdc.gov/nchs/data/hus/hus15.pdf.
\2\http://www.reuters.com/article/us-health-who-naloxone-
idUSKBN0IO12420141104.
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Hearings
The Subcommittee on Health held a hearing on H.R. 3680 on
October 8, 2015. The Subcommittee received testimony from:
Mr. Michael Botticelli, Director, National
Drug Control Policy, Executive Office of the President;
Dr. Richard Frank, Assistant Secretary for
Planning and Evaluation, Department of Health and Human
Services;
Mr. Jack Riley, Deputy Administrator, Drug
Enforcement Administration;
Dr. Allen Anderson, President, American
Orthopaedic Society for Sports Medicine;
Dr. Paul Halverson, Dean, Indiana
University, Richard M. Fairbanks School of Public
Health;
Dr. Kenneth Katz, Lehigh Valley Health
Network, Department of Emergency Medicine, Section of
Medical Toxicology;
Dr. Chapman Sledge, Chief Medical Officer,
Cumberland Heights; and,
Dr. Robert Corey Waller, Chair, Legislative
Advocacy Committee, American Society of Addiction
Medicine.
Committee Consideration
On April 20, 2016, the Subcommittee on Health met in open
markup session and forwarded H.R. 3680, as amended, to the full
Committee by a voice vote. On April 26, 27, and 28, 2016, the
full Committee on Energy and Commerce met in open markup
session and ordered H.R. 3680 reported to the House, as
amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 3680 reported.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a hearing and made
findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The goal of this legislation is to provide grants to states
to encourage the co-prescribing of opioid overdose reversal
drugs for individuals identified as being at risk for overdose.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
3680 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 3680 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
H.R. 3680--Co-Prescribing To Reduce Overdoses Act of 2015
Summary: H.R. 3680 would authorize the Secretary of Health
and Human Services (MIS) to establish a grant program to
provide funds to eligible entities to develop guidelines and to
provide resources for prescribing drugs that reverse opioid
overdoses. The bill also would authorize the Secretary of MS to
provide information to prescribers and health care facilities
of the Indian Health Service on best practices for prescribing
certain drugs to patients with an elevated risk of opioid use
disorders. Additionally, H.R. 3680 would reduce amounts
authorized to be appropriated for certain existing activities
related to bioterrorism and public health emergencies by the
Centers for Disease Control and Prevention (CDC). Assuming
appropriation actions consistent with the bill, CB0 estimates
that implementing H.R. 3680 would reduce net discretionary
costs by $1 million over the 2017-2021 period.
Pay-as-you-go procedures do not apply because enacting H.R.
3680 would not affect direct spending or revenues. CB0
estimates that enacting H.R. 3680 would not increase net direct
spending or on-budget deficits in any of the four consecutive
10-year periods beginning in 2027.
H.R. 3680 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would not affect the budgets of state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary effect of H.R. 3680 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
---------------------------------------------
2017 2018 2019 2020 2021 2017-2021
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Health and Human Services:
Authorization Level........................................... 1 1 1 1 1 5
Estimated Outlays............................................. * 1 1 1 1 4
Centers for Disease Control and Prevention:
Authorization Level........................................... 0 -5 0 0 0 -5
Estimated Outlays............................................. 0 -2 -2 -1 * -5
Total Changes:
Authorization Level....................................... 1 -4 1 1 1 0
Estimated Outlays......................................... * -1 -1 * 1 -1
----------------------------------------------------------------------------------------------------------------
Notes: * = between -$500,000 and $500,000; details may not add to totals because of rounding.
Basis of estimate: For this estimate, CB0 assumes that H.R.
3680 will be enacted near the end of fiscal year 2016 and that
spending will follow historical patterns for similar programs.
Health and Human Services
The bill would require the Secretary of HHS to award grants
to states to develop guidelines for prescribing drugs that help
reverse opioid overdoses and to other eligible entities to
establish and support programs for prescribing such drugs. The
bill would authorize the appropriation of $5 million over the
2017-2021 period for those purposes. Assuming availability of
appropriated funds, CB0 estimates that implementing the grant
program would cost of $4 million over the 2017-2021 period.
Centers for Disease Control and Prevention
Under current law, an authorization of appropriation of
$138 million exists for 2018 for CDC activities related to
bioterrorism and public health emergencies. H.R. 3680 would
reduce the authorized amount by $5 million in 2018. Assuming
future appropriations are reduced accordingly, CBO estimates
that implementing this provision would result in $5 million
less in discretionary outlays for those activities over 2017-
2021 period.
Pay-As-You-Go considerations: None.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 3680 would not increase net direct
spending or on-budget deficits in any of the four consecutive
10-year periods beginning in 2027.
Intergovernmental and private-sector impact: H.R. 3680
contains no intergovernmental or private-sector mandates as
defined in UMRA. Any costs incurred by states or local
governments that apply for grants authorized by the bill would
be incurred voluntarily as a condition of federal assistance.
Estimate prepared by: Federal costs: Ellen Werble; Impact
on state, local, and tribal governments: Leo Lex; Impact on the
private sector: Amy Petz.
Estimate approved by: Holly Harvey; Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 3680 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 3680
specifically directs to be completed 0 rule makings within the
meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 states that the legislation may be cited as the
``Co-Prescribing to Reduce Overdoses Act of 2016.''
Section 2. Opioid overdose reversal drugs prescribing grant program
Section 2 directs the Secretary of Health and Human
Services to establish a five-year opioid overdose reversal
drugs prescribing grant program.
Rural health care clinics, federally qualified health
centers, eligible opioid treatment programs, or physicians who
dispense or prescribe certain drugs under DATA 2000, or any
other entity that the Secretary deems appropriate would be
eligible under the grant program.
Additionally, this section defines prescribing of an opioid
overdose reversal drug to mean in conjunction with an opioid
prescription for patients at increased risk for overdose, in
conjunction with an opioid agonist such as methadone used for
treatment of an opioid use disorder, to the caregiver or close
relative of someone at risk of overdose, or in circumstances as
defined by the Secretary.
To be eligible to receive a grant under this section, the
potential grantee must describe the following: the mortality
and morbidity in the area the grantee will be providing
services that is a result of opioid abuse, the criteria to
identify eligible patients for participation, and how the
program will work to identify other sources of funding to
continue the program after the grant expires.
Grants awarded by the Secretary under this section may be
used to establish a program for prescribing and training, to
provide resources for health care providers and pharmacists on
the prescribing of opioid overdose reversal drugs, to establish
ways to track patients' health outcomes in the program, to
purchase opioid overdose reversal drugs, to offset the copays
or cost sharing to these drugs, to conduct community outreach,
or to establish protocols to connect patients who have
experienced a drug overdose with appropriate treatment.
All grants awarded under this section will be evaluated on
six criteria: the number of prescribers trained, the number of
prescribers who have co-prescribed an opioid overdose reversal
drug, the total number of prescriptions written, the percentage
of patients at an elevated risk who received a prescription for
an overdose reversal drug, the number of patients reporting
using the drug, and any other outcome measures the Secretary
deems appropriate.
Finally, this section mandates a report from the Secretary
for each year of the grant program on the outcomes achieved by
the grants funded.
Section 3. Providing information to prescribers in certain federal
health care and medical facilities on best practices for
prescribing naloxone
This section authorizes the Secretary to provide
information to prescribers in federally qualified health
centers and Indian Health Service facilities on best practices
for prescribing naloxone. This section does not establish a
medical standard of care, and there is no additional
authorization of appropriation for this section to be carried
out.
This section also elucidates the term ``elevated risk of
overdose'' which meaning may be based on the Opioid Overdose
Toolkit published by the Substance Abuse and Mental Health
Services Administration and may include patients on a first
course opioid treatment, those using extended-release or long
acting opioids, or patients with respiratory disease or other
comorbidities.
Section 4. Authorization of appropriations
Section 4 authorizes an appropriation of $5,000,000 for the
period of fiscal years 2017 to 2021.
Section 5. Cut-Go compliance
Section 5 reduces the authorization of Section 319D of the
Public Health Service Act by $5,000,000 for fiscal year 2018 to
bring the legislation into compliance with Cut-Go. This
reduction in authorization is equal to the authorization of
appropriations in section 4.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
(a) Facilities; Capacities.--
(1) Findings.--Congress finds that the Centers for
Disease Control and Prevention has an essential role in
defending against and combatting public health threats
domestically and abroad and requires secure and modern
facilities, and expanded and improved capabilities
related to bioterrorism and other public health
emergencies, sufficient to enable such Centers to
conduct this important mission.
(2) Facilities.--
(A) In general.--The Director of the Centers
for Disease Control and Prevention may design,
construct, and equip new facilities, renovate
existing facilities (including laboratories,
laboratory support buildings, scientific
communication facilities, transshipment
complexes, secured and isolated parking
structures, office buildings, and other
facilities and infrastructure), and upgrade
security of such facilities, in order to better
conduct the capacities described in section
319A, and for supporting public health
activities.
(B) Multiyear contracting authority.--For any
project of designing, constructing, equipping,
or renovating any facility under subparagraph
(A), the Director of the Centers for Disease
Control and Prevention may enter into a single
contract or related contracts that collectively
include the full scope of the project, and the
solicitation and contract shall contain the
clause ``availability of funds'' found at
section 52.232-18 of title 48, Code of Federal
Regulations.
(3) Improving the capacities of the centers for
disease control and prevention.--The Secretary shall
expand, enhance, and improve the capabilities of the
Centers for Disease Control and Prevention relating to
preparedness for and responding effectively to
bioterrorism and other public health emergencies.
Activities that may be carried out under the preceding
sentence include--
(A) expanding or enhancing the training of
personnel;
(B) improving communications facilities and
networks, including delivery of necessary
information to rural areas;
(C) improving capabilities for public health
surveillance and reporting activities, taking
into account the integrated system or systems
of public health alert communications and
surveillance networks under subsection (b); and
(D) improving laboratory facilities related
to bioterrorism and other public health
emergencies, including increasing the security
of such facilities.
(b) National Communications and Surveillance Networks.--
(1) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements,
shall provide for the establishment of an integrated
system or systems of public health alert communications
and surveillance networks between and among--
(A) Federal, State, and local public health
officials;
(B) public and private health-related
laboratories, hospitals, poison control
centers, and other health care facilities; and
(C) any other entities determined appropriate
by the Secretary.
(2) Requirements.--The Secretary shall ensure that
networks under paragraph (1) allow for the timely
sharing and discussion, in a secure manner, of
essential information concerning bioterrorism or
another public health emergency, or recommended methods
for responding to such an attack or emergency, allowing
for coordination to maximize all-hazards medical and
public health preparedness and response and to minimize
duplication of effort.
(3) Standards.--Not later than one year after the
date of the enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, the
Secretary, in cooperation with health care providers
and State and local public health officials, shall
establish any additional technical and reporting
standards (including standards for interoperability)
for networks under paragraph (1) and update such
standards as necessary.
(c) Modernizing Public Health Situational Awareness and
Biosurveillance.--
(1) In general.--Not later than 2 years after the
date of enactment of the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013, the
Secretary, in collaboration with State, local, and
tribal public health officials, shall establish a near
real-time electronic nationwide public health
situational awareness capability through an
interoperable network of systems to share data and
information to enhance early detection of rapid
response to, and management of, potentially
catastrophic infectious disease outbreaks, novel
emerging threats, and other public health emergencies
that originate domestically or abroad. Such network
shall be built on existing State situational awareness
systems or enhanced systems that enable such
connectivity.
(2) Strategy and implementation plan.--Not later than
180 days after the date of enactment of the Pandemic
and All-Hazards Preparedness Reauthorization Act of
2013, the Secretary shall submit to the appropriate
committees of Congress a coordinated strategy and an
accompanying implementation plan that identifies and
demonstrates the measurable steps the Secretary will
carry out to--
(A) develop, implement, and evaluate the
network described in paragraph (1), utilizing
the elements described in paragraph (3);
(B) modernize and enhance biosurveillance
activities; and
(C) improve information sharing,
coordination, and communication among disparate
biosurveillance systems supported by the
Department of Health and Human Services.
(3) Elements.--The network described in paragraph (1)
shall include data and information transmitted in a
standardized format from--
(A) State, local, and tribal public health
entities, including public health laboratories;
(B) Federal health agencies;
(C) zoonotic disease monitoring systems;
(D) public and private sector health care
entities, hospitals, pharmacies, poison control
centers or professional organizations in the
field of poison control, community health
centers, health centers and clinical
laboratories, to the extent practicable and
provided that such data are voluntarily
provided simultaneously to the Secretary and
appropriate State, local, and tribal public
health agencies; and
(E) such other sources as the Secretary may
deem appropriate.
(4) Rule of construction.--Paragraph (3) shall not be
construed as requiring separate reporting of data and
information from each source listed.
(5) Required activities.--In establishing and
operating the network described in paragraph (1), the
Secretary shall--
(A) utilize applicable interoperability
standards as determined by the Secretary, and
in consultation with the Office of the National
Coordinator for Health Information Technology,
through a joint public and private sector
process;
(B) define minimal data elements for such
network;
(C) in collaboration with State, local, and
tribal public health officials, integrate and
build upon existing State, local, and tribal
capabilities, ensuring simultaneous sharing of
data, information, and analyses from the
network described in paragraph (1) with State,
local, and tribal public health agencies; and
(D) in collaboration with State, local, and
tribal public health officials, develop
procedures and standards for the collection,
analysis, and interpretation of data that
States, regions, or other entities collect and
report to the network described in paragraph
(1).
(6) Consultation with the national biodefense science
board.--In carrying out this section and consistent
with section 319M, the National Biodefense Science
Board shall provide expert advice and guidance,
including recommendations, regarding the measurable
steps the Secretary should take to modernize and
enhance biosurveillance activities pursuant to the
efforts of the Department of Health and Human Services
to ensure comprehensive, real-time, all-hazards
biosurveillance capabilities. In complying with the
preceding sentence, the National Biodefense Science
Board shall--
(A) identify the steps necessary to achieve a
national biosurveillance system for human
health, with international connectivity, where
appropriate, that is predicated on State,
regional, and community level capabilities and
creates a networked system to allow for two-way
information flow between and among Federal,
State, and local government public health
authorities and clinical health care providers;
(B) identify any duplicative surveillance
programs under the authority of the Secretary,
or changes that are necessary to existing
programs, in order to enhance and modernize
such activities, minimize duplication,
strengthen and streamline such activities under
the authority of the Secretary, and achieve
real-time and appropriate data that relate to
disease activity, both human and zoonotic; and
(C) coordinate with applicable existing
advisory committees of the Director of the
Centers for Disease Control and Prevention,
including such advisory committees consisting
of representatives from State, local, and
tribal public health authorities and
appropriate public and private sector health
care entities and academic institutions, in
order to provide guidance on public health
surveillance activities.
(d) State and Regional Systems To Enhance Situational
Awareness in Public Health Emergencies.--
(1) In general.--To implement the network described
in subsection (c), the Secretary may award grants to
States or consortia of States to enhance the ability of
such States or consortia of States to establish or
operate a coordinated public health situational
awareness system for regional or Statewide early
detection of, rapid response to, and management of
potentially catastrophic infectious disease outbreaks
and public health emergencies, in collaboration with
appropriate public health agencies, sentinel hospitals,
clinical laboratories, pharmacies, poison control
centers, other health care organizations, and animal
health organizations within such States.
(2) Eligibility.--To be eligible to receive a grant
under paragraph (1), the State or consortium of States
shall submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require, including an assurance
that the State or consortium of States will submit to
the Secretary--
(A) reports of such data, information, and
metrics as the Secretary may require;
(B) a report on the effectiveness of the
systems funded under the grant; and
(C) a description of the manner in which
grant funds will be used to enhance the
timelines and comprehensiveness of efforts to
detect, respond to, and manage potentially
catastrophic infectious disease outbreaks and
public health emergencies.
(3) Use of funds.--A State or consortium of States
that receives an award under this subsection--
(A) shall establish, enhance, or operate a
coordinated public health situational awareness
system for regional or Statewide early
detection of, rapid response to, and management
of potentially catastrophic infectious disease
outbreaks and public health emergencies;
(B) may award grants or contracts to entities
described in paragraph (1) within or serving
such State to assist such entities in improving
the operation of information technology
systems, facilitating the secure exchange of
data and information, and training personnel to
enhance the operation of the system described
in subparagraph (A); and
(C) may conduct a pilot program for the
development of multi-State telehealth network
test beds that build on, enhance, and securely
link existing State and local telehealth
programs to prepare for, monitor, respond to,
and manage the events of public health
emergencies, facilitate coordination and
communication among medical, public health, and
emergency response agencies, and provide
medical services through telehealth initiatives
within the States that are involved in such a
multi-State telehealth network test bed.
(4) Limitation.--Information technology systems
acquired or implemented using grants awarded under this
section must be compliant with--
(A) interoperability and other technological
standards, as determined by the Secretary; and
(B) data collection and reporting
requirements for the network described in
subsection (c).
(5) Independent evaluation.--Not later than 3 years
after the date of enactment of the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013, the
Government Accountability Office shall conduct an
independent evaluation, and submit to the Secretary and
the appropriate committees of Congress a report
concerning the activities conducted under this
subsection and subsection (c).
(e) Telehealth Enhancements for Emergency Response.--
(1) Evaluation.--The Secretary, in consultation with
the Federal Communications Commission and other
relevant Federal agencies, shall--
(A) conduct an inventory of telehealth
initiatives in existence on the date of
enactment of the Pandemic and All-Hazards
Preparedness Act, including--
(i) the specific location of network
components;
(ii) the medical, technological, and
communications capabilities of such
components;
(iii) the functionality of such
components; and
(iv) the capacity and ability of such
components to handle increased volume
during the response to a public health
emergency;
(B) identify methods to expand and
interconnect the regional health information
networks funded by the Secretary, the State and
regional broadband networks funded through the
rural health care support mechanism pilot
program funded by the Federal Communications
Commission, and other telehealth networks;
(C) evaluate ways to prepare for, monitor,
respond rapidly to, or manage the events of, a
public health emergency through the enhanced
use of telehealth technologies, including
mechanisms for payment or reimbursement for use
of such technologies and personnel during
public health emergencies;
(D) identify methods for reducing legal
barriers that deter health care professionals
from providing telemedicine services, such as
by utilizing State emergency health care
professional credentialing verification
systems, encouraging States to establish and
implement mechanisms to improve interstate
medical licensure cooperation, facilitating the
exchange of information among States regarding
investigations and adverse actions, and
encouraging States to waive the application of
licensing requirements during a public health
emergency;
(E) evaluate ways to integrate the practice
of telemedicine within the National Disaster
Medical System; and
(F) promote greater coordination among
existing Federal interagency telemedicine and
health information technology initiatives.
(2) Report.--Not later than 12 months after the date
of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall prepare and
submit a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives
regarding the findings and recommendations pursuant to
subparagraphs (A) through (F) of paragraph (1).
(f) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, $138,300,000 for
each of fiscal years 2014 through 2018 (except such dollar
amount shall be reduced by $5,000,000 for fiscal year 2018).
(g) Definition.--For purposes of this section the term
``biosurveillance'' means the process of gathering near real-
time biological data that relates to human and zoonotic disease
activity and threats to human or animal health, in order to
achieve early warning and identification of such health
threats, early detection and prompt ongoing tracking of health
events, and overall situational awareness of disease activity.
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