[Congressional Record Volume 162, Number 171 (Wednesday, November 30, 2016)]
[House]
[Pages H6894-H7006]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
TSUNAMI WARNING, EDUCATION, AND RESEARCH ACT OF 2015
Mr. UPTON. Mr. Speaker, pursuant to House Resolution 934, I call up
the bill (H.R. 34) to authorize and strengthen the tsunami detection,
forecast, warning, research, and mitigation program of the National
Oceanic and Atmospheric Administration, and for other purposes, with
the Senate amendment thereto, and ask for its immediate consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore. The Clerk will designate the Senate
amendment.
Senate amendment:
In lieu of the matter proposed to be inserted, add the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Tsunami Warning, Education,
and Research Act of 2015''.
SEC. 2. REFERENCES TO THE TSUNAMI WARNING AND EDUCATION ACT.
Except as otherwise expressly provided, whenever in this
Act an amendment or repeal is expressed in terms of an
amendment to, or repeal of, a section or other provision, the
reference shall be considered to be made to a section or
other provision of the Tsunami Warning and Education Act
(Public Law 109-424; 33 U.S.C. 3201 et seq.).
SEC. 3. EXPANSION OF PURPOSES OF TSUNAMI WARNING AND
EDUCATION ACT.
Section 3 (33 U.S.C. 3202) is amended--
(1) in paragraph (1), by inserting ``research,'' after
``warnings,'';
(2) by amending paragraph (2) to read as follows:
``(2) to enhance and modernize the existing United States
Tsunami Warning System to increase the accuracy of forecasts
and warnings, to ensure full coverage of tsunami threats to
the United States with a network of detection assets, and to
reduce false alarms;'';
(3) by amending paragraph (3) to read as follows:
``(3) to improve and develop standards and guidelines for
mapping, modeling, and assessment efforts to improve tsunami
detection, forecasting, warnings, notification, mitigation,
resiliency, response, outreach, and recovery;'';
(4) by redesignating paragraphs (4), (5), and (6) as
paragraphs (5), (6), and (8), respectively;
(5) by inserting after paragraph (3) the following:
``(4) to improve research efforts related to improving
tsunami detection, forecasting, warnings, notification,
mitigation, resiliency, response, outreach, and recovery;'';
(6) in paragraph (5), as redesignated--
(A) by striking ``and increase'' and inserting ``,
increase, and develop uniform standards and guidelines for'';
and
(B) by inserting ``, including the warning signs of locally
generated tsunami'' after ``approaching'';
(7) in paragraph (6), as redesignated, by striking ``,
including the Indian Ocean; and'' and inserting a semicolon;
and
(8) by inserting after paragraph (6), as redesignated, the
following:
``(7) to foster resilient communities in the face of
tsunami and other similar coastal hazards; and''.
SEC. 4. MODIFICATION OF TSUNAMI FORECASTING AND WARNING
PROGRAM.
(a) In General.--Subsection (a) of section 4 (33 U.S.C.
3203(a)) is amended by striking ``Atlantic Ocean, Caribbean
Sea, and Gulf of Mexico region'' and inserting ``Atlantic
Ocean region, including the Caribbean Sea and the Gulf of
Mexico''.
(b) Components.--Subsection (b) of section 4 (33 U.S.C.
3203(b)) is amended--
(1) in paragraph (1), by striking ``established'' and
inserting ``supported or maintained'';
(2) by redesignating paragraphs (7) through (9) as
paragraphs (8) through (10), respectively;
(3) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively;
(4) by inserting after paragraph (1) the following:
``(2) to the degree practicable, maintain not less than 80
percent of the Deep-ocean Assessment and Reporting of
Tsunamis buoy array at operational capacity to optimize data
reliability;''.
(5) by amending paragraph (5), as redesignated by paragraph
(3), to read as follows:
``(5) provide tsunami forecasting capability based on
models and measurements, including tsunami inundation models
and maps for use in increasing the preparedness of
communities and safeguarding port and harbor operations, that
incorporate inputs, including--
``(A) the United States and global ocean and coastal
observing system;
``(B) the global Earth observing system;
``(C) the global seismic network;
``(D) the Advanced National Seismic system;
``(E) tsunami model validation using historical and
paleotsunami data;
``(F) digital elevation models and bathymetry;
``(G) newly developing tsunami detection methodologies
using satellites and airborne remote sensing; and
``(H) any other data the Administrator determines is
necessary;'';
(6) by amending paragraph (7), as redesignated by paragraph
(3), to read as follows:
``(7) include a cooperative effort among the
Administration, the United States Geological Survey, and the
National Science Foundation under which the Director of the
United States Geological Survey and the Director of the
National Science Foundation shall--
``(A) provide rapid and reliable seismic information to the
Administrator from international and domestic seismic
networks; and
``(B) support seismic stations installed before the date of
the enactment of the Tsunami Warning, Education, and Research
Act of 2015 to supplement coverage in areas of sparse
instrumentation;'';
(7) in paragraph (8), as redesignated by paragraph (2)--
(A) by inserting ``, including graphical warning
products,'' after ``warnings'';
(B) by inserting ``, territories,'' after ``States''; and
(C) by inserting ``and Wireless Emergency Alerts'' after
``Hazards Program''; and
(8) in paragraph (9), as redesignated by paragraph (2)--
(A) by inserting ``provide and'' before ``allow''; and
(B) by inserting ``and commercial and Federal undersea
communications cables'' after ``observing technologies''.
(c) Tsunami Warning System.--Subsection (c) of section 4
(33 U.S.C. 3203(c)) is amended to read as follows:
``(c) Tsunami Warning System.--The program under this
section shall operate a tsunami warning system that--
``(1) is capable of forecasting tsunami, including
forecasting tsunami arrival time and inundation estimates,
anywhere in the Pacific and Arctic Ocean regions and
providing adequate warnings;
``(2) is capable of forecasting and providing adequate
warnings, including tsunami arrival time and inundation
models where applicable, in areas of the Atlantic Ocean,
including the Caribbean Sea and Gulf of Mexico, that are
determined--
``(A) to be geologically active, or to have significant
potential for geological activity; and
``(B) to pose significant risks of tsunami for States along
the coastal areas of the Atlantic Ocean, Caribbean Sea, or
Gulf of Mexico; and
``(3) supports other international tsunami forecasting and
warning efforts.''.
(d) Tsunami Warning Centers.--Subsection (d) of section 4
(33 U.S.C. 3203(d)) is amended to read as follows:
``(d) Tsunami Warning Centers.--
``(1) In general.--The Administrator shall support or
maintain centers to support the tsunami warning system
required by subsection (c). The Centers shall include--
[[Page H6895]]
``(A) the National Tsunami Warning Center, located in
Alaska, which is primarily responsible for Alaska and the
continental United States;
``(B) the Pacific Tsunami Warning Center, located in
Hawaii, which is primarily responsible for Hawaii, the
Caribbean, and other areas of the Pacific not covered by the
National Center; and
``(C) any additional forecast and warning centers
determined by the National Weather Service to be necessary.
``(2) Responsibilities.--The responsibilities of the
centers supported or maintained under paragraph (1) shall
include the following:
``(A) Continuously monitoring data from seismological, deep
ocean, coastal sea level, and tidal monitoring stations and
other data sources as may be developed and deployed.
``(B) Evaluating earthquakes, landslides, and volcanic
eruptions that have the potential to generate tsunami.
``(C) Evaluating deep ocean buoy data and tidal monitoring
stations for indications of tsunami resulting from
earthquakes and other sources.
``(D) To the extent practicable, utilizing a range of
models, including ensemble models, to predict tsunami,
including arrival times, flooding estimates, coastal and
harbor currents, and duration.
``(E) Using data from the Integrated Ocean Observing System
of the Administration in coordination with regional
associations to calculate new inundation estimates and
periodically update existing inundation estimates.
``(F) Disseminating forecasts and tsunami warning bulletins
to Federal, State, tribal, and local government officials and
the public.
``(G) Coordinating with the tsunami hazard mitigation
program conducted under section 5 to ensure ongoing sharing
of information between forecasters and emergency management
officials.
``(H) In coordination with the Coast Guard, evaluating and
recommending procedures for ports and harbors at risk of
tsunami inundation, including review of readiness, response,
and communication strategies, and data sharing policies.
``(I) Making data gathered under this Act and post-warning
analyses conducted by the National Weather Service or other
relevant Administration offices available to the public.
``(J) Integrating and modernizing the program operated
under this section with advances in tsunami science to
improve performance without compromising service.
``(3) Fail-safe warning capability.--The tsunami warning
centers supported or maintained under paragraph (1) shall
maintain a fail-safe warning capability and perform back-up
duties for each other.
``(4) Coordination with national weather service.--The
Administrator shall coordinate with the forecast offices of
the National Weather Service, the centers supported or
maintained under paragraph (1), and such program offices of
the Administration as the Administrator or the coordinating
committee, as established in section 5(d), consider
appropriate to ensure that regional and local forecast
offices--
``(A) have the technical knowledge and capability to
disseminate tsunami warnings for the communities they serve;
``(B) leverage connections with local emergency management
officials for optimally disseminating tsunami warnings and
forecasts; and
``(C) implement mass communication tools in effect on the
day before the date of the enactment of the Tsunami Warning,
Education, and Research Act of 2015 used by the National
Weather Service on such date and newer mass communication
technologies as they are developed as a part of the Weather-
Ready Nation program of the Administration, or otherwise, for
the purpose of timely and effective delivery of tsunami
warnings.
``(5) Uniform operating procedures.--The Administrator
shall--
``(A) develop uniform operational procedures for the
centers supported or maintained under paragraph (1),
including the use of software applications, checklists,
decision support tools, and tsunami warning products that
have been standardized across the program supported under
this section;
``(B) ensure that processes and products of the warning
system operated under subsection (c)--
``(i) reflect industry best practices when practicable;
``(ii) conform to the maximum extent practicable with
internationally recognized standards for information
technology; and
``(iii) conform to the maximum extent practicable with
other warning products and practices of the National Weather
Service;
``(C) ensure that future adjustments to operational
protocols, processes, and warning products--
``(i) are made consistently across the warning system
operated under subsection (c); and
``(ii) are applied in a uniform manner across such warning
system;
``(D) establish a systematic method for information
technology product development to improve long-term
technology planning efforts; and
``(E) disseminate guidelines and metrics for evaluating and
improving tsunami forecast models.
``(6) Available resources.--The Administrator, through the
National Weather Service, shall ensure that resources are
available to fulfill the obligations of this Act. This
includes ensuring supercomputing resources are available to
run, as rapidly as possible, such computer models as are
needed for purposes of the tsunami warning system operated
under subsection (c).''.
(e) Transfer of Technology; Maintenance and Upgrades.--
Subsection (e) of section 4 (33 U.S.C. 3203(e)) is amended to
read as follows:
``(e) Transfer of Technology; Maintenance and Upgrades.--In
carrying out this section, the Administrator shall--
``(1) develop requirements for the equipment used to
forecast tsunami, including--
``(A) provisions for multipurpose detection platforms;
``(B) reliability and performance metrics; and
``(C) to the maximum extent practicable, requirements for
the integration of equipment with other United States and
global ocean and coastal observation systems, the global
Earth observing system of systems, the global seismic
networks, and the Advanced National Seismic System;
``(2) develop and execute a plan for the transfer of
technology from ongoing research conducted as part of the
program supported or maintained under section 6 into the
program under this section; and
``(3) ensure that the Administration's operational tsunami
detection equipment is properly maintained.''.
(f) Federal Cooperation.--Subsection (f) of section 4 (33
U.S.C. 3203(f)) is amended to read as follows:
``(f) Federal Cooperation.--When deploying and maintaining
tsunami detection technologies under the program under this
section, the Administrator shall--
``(1) identify which assets of other Federal agencies are
necessary to support such program; and
``(2) work with each agency identified under paragraph
(1)--
``(A) to acquire the agency's assistance; and
``(B) to prioritize the necessary assets in support of the
tsunami forecast and warning program.''.
(g) Unnecessary Provisions.--Section 4 (33 U.S.C. 3203) is
further amended--
(1) by striking subsection (g);
(2) by striking subsections (i) through (k); and
(3) by redesignating subsection (h) as subsection (g).
(h) Congressional Notifications.--Subsection (g) of section
4 (33 U.S.C. 3203(g)), as redesignated by subsection (g)(3),
is amended--
(1) in the matter before paragraph (1), by striking ``30''
and inserting ``90'';
(2) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving such
subparagraphs 2 ems to the right;
(3) in the matter before subparagraph (A), as redesignated
by paragraph (2), by striking ``The Administrator'' and
inserting the following:
``(1) In general.--The Administrator'';
(4) in paragraph (1), as redesignated by paragraph (3)--
(A) in subparagraph (A), as redesignated by paragraph (2),
by striking ``and'' at the end;
(B) in subparagraph (B), as redesignated by paragraph (2),
by striking the period at the end and inserting ``; and'';
and
(C) by adding at the end the following:
``(C) the occurrence of a significant tsunami warning.'';
and
(5) by adding at the end the following:
``(2) Contents.--In a case in which notice is submitted
under paragraph (1) within 90 days of a significant tsunami
warning described in subparagraph (C) of such paragraph, such
notice shall include, as appropriate, brief information and
analysis of--
``(A) the accuracy of the tsunami model used;
``(B) the specific deep ocean or other monitoring equipment
that detected the incident, as well as the deep ocean or
other monitoring equipment that did not detect the incident
due to malfunction or other reasons;
``(C) the effectiveness of the warning communication,
including the dissemination of warnings with State,
territory, local, and tribal partners in the affected area
under the jurisdiction of the National Weather Service; and
``(D) such other findings as the Administrator considers
appropriate.''.
SEC. 5. MODIFICATION OF NATIONAL TSUNAMI HAZARD MITIGATION
PROGRAM.
(a) In General.--Section 5 (33 U.S.C. 3204) is amended by
striking subsections (a) through (d) and inserting the
following:
``(a) Program Required.--The Administrator, in coordination
with the Administrator of the Federal Emergency Management
Agency and the heads of such other agencies as the
Administrator considers relevant, shall conduct a community-
based tsunami hazard mitigation program to improve tsunami
preparedness and resiliency of at-risk areas in the United
States and the territories of the United States.
``(b) Program Components.--The Program conducted under
subsection (a) shall include the following:
``(1) Technical and financial assistance to coastal States,
territories, tribes, and local governments to develop and
implement activities under this section.
``(2) Integration of tsunami preparedness and mitigation
programs into ongoing State-based hazard warning, resilience
planning, and risk management activities, including
predisaster planning, emergency response, evacuation
planning, disaster recovery, hazard mitigation, and community
development and redevelopment planning programs in affected
areas.
``(3) Activities to promote the adoption of tsunami
resilience, preparedness, warning, and mitigation measures by
Federal, State, territorial, tribal, and local governments
and nongovernmental entities, including educational and risk
communication programs to discourage development in high-risk
areas.
``(4) Activities to support the development of regional
tsunami hazard and risk assessments. Such regional risk
assessments may include the following:
``(A) The sources, sizes, and other relevant historical
data of tsunami in the region, including paleotsunami data.
``(B) Inundation models and maps of critical infrastructure
and socioeconomic vulnerability in areas subject to tsunami
inundation.
[[Page H6896]]
``(C) Maps of evacuation areas and evacuation routes,
including, when appropriate, traffic studies that evaluate
the viability of evacuation routes.
``(D) Evaluations of the size of populations that will
require evacuation, including populations with special
evacuation needs.
``(E) Evaluations and technical assistance for vertical
evacuation structure planning for communities where models
indicate limited or no ability for timely evacuation,
especially in areas at risk of near shore generated tsunami.
``(F) Evaluation of at-risk ports and harbors.
``(G) Evaluation of the effect of tsunami currents on the
foundations of closely-spaced, coastal high-rise structures.
``(5) Activities to promote preparedness in at-risk ports
and harbors, including the following:
``(A) Evaluation and recommendation of procedures for ports
and harbors in the event of a distant or near-field tsunami.
``(B) A review of readiness, response, and communication
strategies to ensure coordination and data sharing with the
Coast Guard.
``(6) Activities to support the development of community-
based outreach and education programs to ensure community
readiness and resilience, including the following:
``(A) The development, implementation, and assessment of
technical training and public education programs, including
education programs that address unique characteristics of
distant and near-field tsunami.
``(B) The development of decision support tools.
``(C) The incorporation of social science research into
community readiness and resilience efforts.
``(D) The development of evidence-based education
guidelines.
``(7) Dissemination of guidelines and standards for
community planning, education, and training products,
programs, and tools, including--
``(A) standards for--
``(i) mapping products;
``(ii) inundation models; and
``(iii) effective emergency exercises; and
``(B) recommended guidance for at-risk port and harbor
tsunami warning, evacuation, and response procedures in
coordination with the Coast Guard.
``(c) Authorized Activities.--In addition to activities
conducted under subsection (b), the program conducted under
subsection (a) may include the following:
``(1) Multidisciplinary vulnerability assessment research,
education, and training to help integrate risk management and
resilience objectives with community development planning and
policies.
``(2) Risk management training for local officials and
community organizations to enhance understanding and
preparedness.
``(3) Interagency, Federal, State, tribal, and territorial
intergovernmental tsunami response exercise planning and
implementation in high risk areas.
``(4) Development of practical applications for existing or
emerging technologies, such as modeling, remote sensing,
geospatial technology, engineering, and observing systems,
including the integration of tsunami sensors into Federal and
commercial submarine telecommunication cables if practicable.
``(5) Risk management, risk assessment, and resilience data
and information services, including--
``(A) access to data and products derived from observing
and detection systems; and
``(B) development and maintenance of new integrated data
products to support risk management, risk assessment, and
resilience programs.
``(6) Risk notification systems that coordinate with and
build upon existing systems and actively engage
decisionmakers, State, local, tribal, and territorial
governments and agencies, business communities,
nongovernmental organizations, and the media.
``(d) Coordinating Committee.--
``(1) In general.--The Administrator shall maintain a
coordinating committee to assist the Administrator in the
conduct of the program required by subsection (a).
``(2) Composition.--The coordinating committee shall be
composed of members as follows:
``(A) Representatives from each of the States and
territories most at risk from tsunami, including Alaska,
Washington, Oregon, California, Hawaii, Puerto Rico, Guam,
American Samoa, and the Northern Marianas Islands.
``(B) Such other members as the Administrator considers
appropriate to represent Federal, State, tribal, territorial,
and local governments.
``(3) Subcommittees.--The Administrator may approve the
formation of subcommittees to address specific program
components or regional issues.
``(4) Responsibilities.--The coordinating committee shall--
``(A) provide feedback on how funds should be prioritized
to carry out the program required by subsection (a);
``(B) ensure that areas described in section 4(c) in the
United States and its territories have the opportunity to
participate in the program;
``(C) provide recommendations to the Administrator on how
to improve and continuously advance the TsunamiReady program
of the National Weather Service, particularly on ways to make
communities more tsunami resilient through the use of
inundation maps and models and other hazard mitigation
practices;
``(D) ensure that all components of the program required by
subsection (a) are integrated with ongoing State based hazard
warning, risk management, and resilience activities,
including--
``(i) integrating activities with emergency response plans,
disaster recovery, hazard mitigation, and community
development programs in affected areas; and
``(ii) integrating information to assist in tsunami
evacuation route planning.
``(5) Exemption from faca.--The provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall not apply to the
committee established and maintained under paragraph (1).
``(e) No Preemption With Respect to Designation of At-risk
Areas.--The establishment of national standards for
inundation models under this section shall not prevent
States, territories, tribes, and local governments from
designating additional areas as being at risk based on
knowledge of local conditions.
``(f) No New Regulatory Authority.--Nothing in this Act may
be construed as establishing new regulatory authority for any
Federal agency.''.
(b) Report on Accreditation of TsunamiReady Program.--Not
later than 180 days after the date of enactment of this Act,
the Administrator of the National Oceanic and Atmospheric
Administration shall submit to the Committee on Commerce,
Science, and Transportation of the Senate and the Committee
on Science, Space, and Technology of the House of
Representatives a report on which authorities and activities
would be needed to have the TsunamiReady program of the
National Weather Service accredited by the Emergency
Management Accreditation Program.
SEC. 6. MODIFICATION OF TSUNAMI RESEARCH PROGRAM.
Section 6 (33 U.S.C. 3205) is amended--
(1) in the matter before paragraph (1), by striking ``The
Administrator shall'' and all that follows through
``establish or maintain'' and inserting the following:
``(a) In General.--The Administrator shall, in consultation
with such other Federal agencies, State, tribal, and
territorial governments, and academic institutions as the
Administrator considers appropriate, the coordinating
committee under section 5(d), and the panel under section
8(a), support or maintain'';
(2) in subsection (a), as designated by paragraph (1), by
striking ``and assessment for tsunami tracking and numerical
forecast modeling. Such research program shall--'' and
inserting the following: ``assessment for tsunami tracking
and numerical forecast modeling, and standards development.
``(b) Responsibilities.--The research program supported or
maintained under subsection (a) shall--''; and
(3) in subsection (b), as designated by paragraph (2)--
(A) by amending paragraph (1) to read as follows:
``(1) consider other appropriate and cost effective
solutions to mitigate the impact of tsunami, including the
improvement of near-field and distant tsunami detection and
forecasting capabilities, which may include use of a new
generation of the Deep-ocean Assessment and Reporting of
Tsunamis array, integration of tsunami sensors into
commercial and Federal telecommunications cables, and other
real-time tsunami monitoring systems and supercomputer
capacity of the Administration to develop a rapid tsunami
forecast for all United States coastlines;'';
(B) in paragraph (3)--
(i) by striking ``include'' and inserting ``conduct''; and
(ii) by striking ``and'' at the end;
(C) by redesignating paragraph (4) as paragraph (5);
(D) by inserting after paragraph (3) the following:
``(4) develop the technical basis for validation of tsunami
maps, numerical tsunami models, digital elevation models, and
forecasts; and''; and
(E) in paragraph (5), as redesignated by subparagraph (C),
by striking ``to the scientific community'' and inserting
``to the public and the scientific community''.
SEC. 7. GLOBAL TSUNAMI WARNING AND MITIGATION NETWORK.
Section 7 (33 U.S.C. 3206) is amended--
(1) by amending subsection (a) to read as follows:
``(a) Support for Development of an International Tsunami
Warning System.--The Administrator shall, in coordination
with the Secretary of State and in consultation with such
other agencies as the Administrator considers relevant,
provide technical assistance, operational support, and
training to the Intergovernmental Oceanographic Commission of
the United Nations Educational, Scientific, and Cultural
Organization, the World Meteorological Organization of the
United Nations, and such other international entities as the
Administrator considers appropriate, as part of the
international efforts to develop a fully functional global
tsunami forecast and warning system comprised of regional
tsunami warning networks.'';
(2) in subsection (b), by striking ``shall'' each place it
appears and inserting ``may''; and
(3) in subsection (c)--
(A) in paragraph (1), by striking ``establishing'' and
inserting ``supporting''; and
(B) in paragraph (2)--
(i) by striking ``establish'' and inserting ``support'';
and
(ii) by striking ``establishing'' and inserting
``supporting''.
SEC. 8. TSUNAMI SCIENCE AND TECHNOLOGY ADVISORY PANEL.
(a) In General.--The Act is further amended--
(1) by redesignating section 8 (33 U.S.C. 3207) as section
9; and
(2) by inserting after section 7 (33 U.S.C. 3206) the
following:
``SEC. 8. TSUNAMI SCIENCE AND TECHNOLOGY ADVISORY PANEL.
``(a) Designation.--The Administrator shall designate an
existing working group within the Science Advisory Board of
the Administration to manage the Tsunami Science and
Technology Advisory Panel to provide advice to the
Administrator on matters regarding tsunami science,
technology, and regional preparedness.
[[Page H6897]]
``(b) Membership.--
``(1) Composition.--The Panel shall be composed of no fewer
than 7 members selected by the Administrator from among
individuals from academia or State agencies who have academic
or practical expertise in physical sciences, social sciences,
information technology, coastal resilience, emergency
management, or such other disciplines as the Administrator
considers appropriate.
``(2) Federal employment.--No member of the Panel may be a
Federal employee.
``(c) Responsibilities.--Not less frequently than once
every 4 years, the Panel shall--
``(1) review the activities of the Administration, and
other Federal activities as appropriate, relating to tsunami
research, detection, forecasting, warning, mitigation,
resiliency, and preparation; and
``(2) submit to the Administrator and such others as the
Administrator considers appropriate--
``(A) the findings of the working group with respect to the
most recent review conducted under paragraph (1); and
``(B) such recommendations for legislative or
administrative action as the working group considers
appropriate to improve Federal tsunami research, detection,
forecasting, warning, mitigation, resiliency, and
preparation.
``(d) Reports to Congress.--Not less frequently than once
every 4 years, the Administrator shall submit to the
Committee on Commerce, Science, and Transportation of the
Senate, and the Committee on Science, Space, and Technology
of the House of Representatives a report on the findings and
recommendations received by the Administrator under
subsection (c)(2).''.
SEC. 9. REPORTS.
(a) Report on Implementation of Tsunami Warning and
Education Act.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, the Administrator of the National
Oceanic and Atmospheric Administration shall submit to
Congress a report on the implementation of the Tsunami
Warning and Education Act (33 U.S.C. 3201 et seq.).
(2) Elements.--The report required by paragraph (1) shall
include the following:
(A) A detailed description of the progress made in
implementing sections 4(d)(6), 5(b)(6), and 6(b)(4) of the
Tsunami Warning and Education Act.
(B) A description of the ways that tsunami warnings and
warning products issued by the Tsunami Forecasting and
Warning Program established under section 4 of the Tsunami
Warning and Education Act (33 U.S.C. 3203) can be
standardized and streamlined with warnings and warning
products for hurricanes, coastal storms, and other coastal
flooding events.
(b) Report on National Efforts That Support Rapid Response
Following Near-shore Tsunami Events.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, the Administrator and the
Secretary of Homeland Security shall jointly, in coordination
with the Director of the United States Geological Survey,
Administrator of the Federal Emergency Management Agency, the
Chief of the National Guard Bureau, and the heads of such
other Federal agencies as the Administrator considers
appropriate, submit to the appropriate committees of Congress
a report on the national efforts in effect on the day before
the date of the enactment of this Act that support and
facilitate rapid emergency response following a domestic
near-shore tsunami event to better understand domestic
effects of earthquake derived tsunami on people,
infrastructure, and communities in the United States.
(2) Elements.--The report required by paragraph (1) shall
include the following:
(A) A description of scientific or other measurements
collected on the day before the date of the enactment of this
Act to quickly identify and quantify lost or degraded
infrastructure or terrestrial formations.
(B) A description of scientific or other measurements that
would be necessary to collect to quickly identify and
quantify lost or degraded infrastructure or terrestrial
formations.
(C) Identification and evaluation of Federal, State, local,
tribal, territorial, and military first responder and search
and rescue operation centers, bases, and other facilities as
well as other critical response assets and infrastructure,
including search and rescue aircraft, located within near-
shore and distant tsunami inundation areas on the day before
the date of the enactment of this Act.
(D) An evaluation of near-shore tsunami response plans in
areas described in subparagraph (C) in effect on the day
before the date of the enactment of this Act, and how those
response plans would be affected by the loss of search and
rescue and first responder infrastructure described in such
subparagraph.
(E) A description of redevelopment plans and reports in
effect on the day before the date of the enactment of this
Act for communities in areas that are at high-risk for near-
shore tsunami, as well identification of States or
communities that do not have redevelopment plans.
(F) Recommendations to enhance near-shore tsunami
preparedness and response plans, including recommended
responder exercises, predisaster planning, and mitigation
needs.
(G) Such other data and analysis information as the
Administrator and the Secretary of Homeland Security consider
appropriate.
(3) Appropriate committees of congress.--In this
subsection, the term ``appropriate committees of Congress''
means--
(A) the Committee on Commerce, Science, and Transportation
and the Committee on Homeland Security and Governmental
Affairs of the Senate; and
(B) the Committee on Science, Space, and Technology and the
Committee on Homeland Security of the House of
Representatives.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS.
Section 9 of the Act, as redesignated by section 8(a)(1) of
this Act, is amended--
(1) in paragraph (4)(B), by striking ``and'' at the end;
(2) in paragraph (5)(B), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(6) $27,000,000 for each of fiscal years 2016 through
2021, of which--
``(A) not less than 27 percent of the amount appropriated
for each fiscal year shall be for activities conducted at the
State level under the tsunami hazard mitigation program under
section 5; and
``(B) not less than 8 percent of the amount appropriated
shall be for the tsunami research program under section 6.''.
SEC. 11. OUTREACH RESPONSIBILITIES.
The Administrator of the National Oceanic and Atmospheric
Administration, in coordination with State and local
emergency managers, shall develop and carry out formal
outreach activities to improve tsunami education and
awareness and foster the development of resilient
communities. Outreach activities may include--
(1) the development of outreach plans to ensure the close
integration of tsunami warning centers supported or
maintained under section 4(d) of the Tsunami Warning and
Education Act (33 U.S.C. 3203(d)) with local Weather Forecast
Offices of the National Weather Service and emergency
managers;
(2) working with appropriate local Weather Forecast Offices
to ensure they have the technical knowledge and capability to
disseminate tsunami warnings to the communities they serve;
and
(3) evaluating the effectiveness of warnings and of
coordination with local Weather Forecast Offices after
significant tsunami events.
SEC. 12. MODIFICATION OF COASTAL OCEAN PROGRAM.
Section 201(c) of the National Oceanic and Atmospheric
Administration Authorization Act of 1992 (Public Law 102-567;
106 Stat. 4280) is amended--
(1) by inserting ``(1) In general.--'' before ``Of the
sums'' and indenting appropriately; and
(2) by adding at the end the following:
``(2) Regional coastal risk management coalitions.--The
Administrator of the National Oceanic and Atmospheric
Administration may form regional coastal risk management
coalitions comprised of representatives of Federal, State,
local, and tribal governments, community groups, academic
institutions, and nongovernmental groups to advance the goals
of this section for communities facing common coastal hazards
and risks. Such coalitions may enter into an agreement with
an organization described in section 501(c)(3) of the
Internal Revenue Code of 1986 to establish a nonprofit
foundation in order to accept gifts and donations to support
the goals of this subsection.''.
SEC. 13. REPEAL OF DUPLICATE PROVISIONS OF LAW.
(a) Repeal.--The Magnuson-Stevens Fishery Conservation and
Management Reauthorization Act of 2006 (Public Law 109-479)
is amended by striking title VIII (relating to tsunami
warning and education).
(b) Construction.--Nothing in this section shall be
construed to repeal, or affect in any way, Public Law 109-
424.
Motion Offered by Mr. Upton
Mr. UPTON. Mr. Speaker, I have a motion at the desk.
The SPEAKER pro tempore. The Clerk will designate the motion.
The text of the motion is as follows:
Mr. Upton moves that the House concur in the Senate
amendment to H.R. 34 with an amendment inserting the text of
Rules Committee Print 114-67, modified by the amendment
printed in part A of House Report 114-839, in lieu of the
matter proposed to be added by the Senate.
The text of the House amendment to the Senate amendment to the text
is as follows:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st
Century Cures Act''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
DIVISION A--21ST CENTURY CURES
Sec. 1000. Short title.
TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
Sec. 1001. NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.
TITLE II--DISCOVERY
Subtitle A--National Institutes of Health Reauthorization
Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.
Subtitle B--Advancing Precision Medicine
Sec. 2011. Precision Medicine Initiative.
Sec. 2012. Privacy protection for human research subjects.
Sec. 2013. Protection of identifiable and sensitive information.
Sec. 2014. Data sharing.
Subtitle C--Supporting Young Emerging Scientists
Sec. 2021. Investing in the next generation of researchers.
[[Page H6898]]
Sec. 2022. Improvement of loan repayment program.
Subtitle D--National Institutes of Health Planning and Administration
Sec. 2031. National Institutes of Health strategic plan.
Sec. 2032. Triennial reports.
Sec. 2033. Increasing accountability at the National Institutes of
Health.
Sec. 2034. Reducing administrative burden for researchers.
Sec. 2035. Exemption for the National Institutes of Health from the
Paperwork Reduction Act requirements.
Sec. 2036. High-risk, high-reward research.
Sec. 2037. National Center for Advancing Translational Sciences.
Sec. 2038. Collaboration and coordination to enhance research.
Sec. 2039. Enhancing the rigor and reproducibility of scientific
research.
Sec. 2040. Improving medical rehabilitation research at the National
Institutes of Health.
Sec. 2041. Task force on research specific to pregnant women and
lactating women.
Sec. 2042. Streamlining National Institutes of Health reporting
requirements.
Sec. 2043. Reimbursement for research substances and living organisms.
Sec. 2044. Sense of Congress on increased inclusion of underrepresented
populations in clinical trials.
Subtitle E--Advancement of the National Institutes of Health Research
and Data Access
Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.
Subtitle F--Facilitating Collaborative Research
Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research
purposes.
Subtitle G--Promoting Pediatric Research
Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
Sec. 3001. Patient experience data.
Sec. 3002. Patient-focused drug development guidance.
Sec. 3003. Streamlining patient input.
Sec. 3004. Report on patient experience drug development.
Subtitle B--Advancing New Drug Therapies
Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare
pediatric diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.
Subtitle C--Modern Trial Design and Evidence Development
Sec. 3021. Novel clinical trial designs.
Sec. 3022. Real world evidence.
Sec. 3023. Protection of human research subjects.
Sec. 3024. Informed consent waiver or alteration for clinical
investigations.
Subtitle D--Patient Access to Therapies and Information
Sec. 3031. Summary level review.
Sec. 3032. Expanded access policy.
Sec. 3033. Accelerated approval for regenerative advanced therapies.
Sec. 3034. Guidance regarding devices used in the recovery, isolation,
or delivery of regenerative advanced therapies.
Sec. 3035. Report on regenerative advanced therapies.
Sec. 3036. Standards for regenerative medicine and regenerative
advanced therapies.
Sec. 3037. Health care economic information.
Sec. 3038. Combination product innovation.
Subtitle E--Antimicrobial Innovation and Stewardship
Sec. 3041. Antimicrobial resistance monitoring.
Sec. 3042. Limited population pathway.
Sec. 3043. Prescribing authority.
Sec. 3044. Susceptibility test interpretive criteria for
microorganisms; antimicrobial susceptibility testing
devices.
Subtitle F--Medical Device Innovations
Sec. 3051. Breakthrough devices.
Sec. 3052. Humanitarian device exemption.
Sec. 3053. Recognition of standards.
Sec. 3054. Certain class I and class II devices.
Sec. 3055. Classification panels.
Sec. 3056. Institutional review board flexibility.
Sec. 3057. CLIA waiver improvements.
Sec. 3058. Least burdensome device review.
Sec. 3059. Cleaning instructions and validation data requirement.
Sec. 3060. Clarifying medical software regulation.
Subtitle G--Improving Scientific Expertise and Outreach at FDA
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical
Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional
personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter
Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug
Administration.
Subtitle H--Medical Countermeasures Innovation
Sec. 3081. Medical countermeasure guidelines.
Sec. 3082. Clarifying BARDA contracting authority.
Sec. 3083. Countermeasure budget plan.
Sec. 3084. Medical countermeasures innovation.
Sec. 3085. Streamlining Project BioShield procurement.
Sec. 3086. Encouraging treatments for agents that present a national
security threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health
emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use
authorization.
Subtitle I--Vaccine Access, Certainty, and Innovation
Sec. 3091. Predictable review timelines of vaccines by the Advisory
Committee on Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on
Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.
Subtitle J--Technical Corrections
Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.
TITLE IV--DELIVERY
Sec. 4001. Assisting doctors and hospitals in improving quality of care
for patients.
Sec. 4002. Transparent reporting on usability, security, and
functionality.
Sec. 4003. Interoperability.
Sec. 4004. Information blocking.
Sec. 4005. Leveraging electronic health records to improve patient
care.
Sec. 4006. Empowering patients and improving patient access to their
electronic health information.
Sec. 4007. GAO study on patient matching.
Sec. 4008. GAO study on patient access to health information.
Sec. 4009. Streamlining transfers used for educational purposes.
Sec. 4010. Improving Medicare local coverage determinations.
Sec. 4011. Medicare pharmaceutical and technology ombudsman.
Sec. 4012. Medicare site-of-service price transparency.
Sec. 4013. Telehealth services in Medicare.
TITLE V--SAVINGS
Sec. 5001. Savings in the Medicare Improvement Fund.
Sec. 5002. Medicaid reimbursement to States for durable medical
equipment.
Sec. 5003. Penalties for violations of grants, contracts, and other
agreements.
Sec. 5004. Reducing overpayments of infusion drugs.
Sec. 5005. Increasing oversight of termination of Medicaid providers.
Sec. 5006. Requiring publication of fee-for-service provider directory.
Sec. 5007. Fairness in Medicaid supplemental needs trusts.
Sec. 5008. Eliminating Federal financial participation with respect to
expenditures under Medicaid for agents used for cosmetic
purposes or hair growth.
Sec. 5009. Amendment to the Prevention and Public Health Fund.
Sec. 5010. Strategic Petroleum Reserve drawdown.
Sec. 5011. Rescission of portion of ACA territory funding.
Sec. 5012. Medicare coverage of home infusion therapy.
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
Sec. 6000. Short title.
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A--Leadership
Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and
Mental Health Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance
abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.
Subtitle B--Oversight and Accountability
Sec. 6021. Improving oversight of mental and substance use disorders
programs through the Assistant Secretary for Planning and
Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
Committee.
[[Page H6899]]
TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs
and practices.
Sec. 7003. Priority mental health needs of regional and national
significance.
Sec. 7004. Priority substance use disorder treatment needs of regional
and national significance.
Sec. 7005. Priority substance use disorder prevention needs of regional
and national significance.
TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse
prevention and treatment block grant and the community
mental health services block grant.
TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
CARE
Subtitle A--Helping Individuals and Families
Sec. 9001. Grants for treatment and recovery for homeless individuals.
Sec. 9002. Grants for jail diversion programs.
Sec. 9003. Promoting integration of primary and behavioral health care.
Sec. 9004. Projects for assistance in transition from homelessness.
Sec. 9005. National Suicide Prevention Lifeline Program.
Sec. 9006. Connecting individuals and families with care.
Sec. 9007. Strengthening community crisis response systems.
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
Sec. 9009. Adult suicide prevention.
Sec. 9010. Mental health awareness training grants.
Sec. 9011. Sense of Congress on prioritizing American Indians and
Alaska Native youth within suicide prevention programs.
Sec. 9012. Evidence-based practices for older adults.
Sec. 9013. National violent death reporting system.
Sec. 9014. Assisted outpatient treatment.
Sec. 9015. Assertive community treatment grant program.
Sec. 9016. Sober truth on preventing underage drinking reauthorization.
Sec. 9017. Center and program repeals.
Subtitle B--Strengthening the Health Care Workforce
Sec. 9021. Mental and behavioral health education and training grants.
Sec. 9022. Strengthening the mental and substance use disorders
workforce.
Sec. 9023. Clarification on current eligibility for loan repayment
programs.
Sec. 9024. Minority fellowship program.
Sec. 9025. Liability protections for health professional volunteers at
community health centers.
Sec. 9026. Reports.
Subtitle C--Mental Health on Campus Improvement
Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.
TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
CHILDREN AND ADOLESCENTS
Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention
services for children and adolescents.
Sec. 10004. Children's recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion,
intervention, and treatment.
TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of
protected health information.
Sec. 11004. Development and dissemination of model training programs.
TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
Sec. 12001. Rule of construction related to Medicaid coverage of mental
health services and primary care services furnished on
the same day.
Sec. 12002. Study and report related to Medicaid managed care
regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric
demonstration project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal
care services and home health care services under
Medicaid.
TITLE XIII--MENTAL HEALTH PARITY
Sec. 13001. Enhanced compliance with mental health and substance use
disorder coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and
substance use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health
and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use
disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.
TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A--Mental Health and Safe Communities
Sec. 14001. Law enforcement grants for crisis intervention teams,
mental health purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges
in drug courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
Sec. 14012. Co-occurring substance abuse and mental health challenges
in residential substance abuse treatment programs.
Sec. 14013. Mental health and drug treatment alternatives to
incarceration programs.
Sec. 14014. National criminal justice and mental health training and
technical assistance.
Sec. 14015. Improving Department of Justice data collection on mental
illness involved in crime.
Sec. 14016. Reports on the number of mentally ill offenders in prison.
Sec. 14017. Department of Veterans Affairs patients' rights.
Sec. 14018. Reauthorization of appropriations.
Subtitle B--Comprehensive Justice and Mental Health
Sec. 14021. Sequential intercept model.
Sec. 14022. Prison and jails.
Sec. 14023. Allowable uses.
Sec. 14024. Law enforcement training.
Sec. 14025. Federal law enforcement training.
Sec. 14026. GAO report.
Sec. 14027. Evidence based practices.
Sec. 14028. Transparency, program accountability, and enhancement of
local authority.
Sec. 14029. Grant accountability.
DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
AMERICANS
Sec. 15000. Short title.
TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for
similar hospital services.
Sec. 15002. Establishing beneficiary equity in the Medicare hospital
readmission program.
Sec. 15003. Five-year extension of the rural community hospital
demonstration program.
Sec. 15004. Regulatory relief for LTCHs.
Sec. 15005. Savings from IPPS MACRA pay-for through not applying
documentation and coding adjustments.
Sec. 15006. Extension of certain LTCH Medicare payment rules.
Sec. 15007. Application of rules on the calculation of hospital length
of stay to all LTCHs.
Sec. 15008. Change in Medicare classification for certain hospitals.
Sec. 15009. Temporary exception to the application of the Medicare LTCH
site neutral provisions for certain spinal cord specialty
hospitals.
Sec. 15010. Temporary extension to the application of the Medicare LTCH
site neutral provisions for certain discharges with
severe wounds.
TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
Sec. 16001. Continuing Medicare payment under HOPD prospective payment
system for services furnished by mid-build off-campus
outpatient departments of providers.
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient
department of a provider policy.
Sec. 16003. Treatment of eligible professionals in ambulatory surgical
centers for meaningful use and MIPS.
[[Page H6900]]
Sec. 16004. Continuing Access to Hospitals Act of 2016.
Sec. 16005. Delay of implementation of Medicare fee schedule
adjustments for wheelchair accessories and seating
systems when used in conjunction with complex
rehabilitation technology (CRT) wheelchairs.
Sec. 16006. Allowing physical therapists to utilize locum tenens
arrangements under Medicare.
Sec. 16007. Extension of the transition to new payment rates for
durable medical equipment under the Medicare program.
Sec. 16008. Requirements in determining adjustments using information
from competitive bidding programs.
TITLE XVII--OTHER MEDICARE PROVISIONS
Sec. 17001. Delay in authority to terminate contracts for Medicare
Advantage plans failing to achieve minimum quality
ratings.
Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly
enrolled providers or suppliers within a temporary
moratorium area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare
Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a
Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the
Medicare Shared Savings Program.
TITLE XVIII--OTHER PROVISIONS
Sec. 18001. Exception from group health plan requirements for qualified
small employer health reimbursement arrangements.
DIVISION D--CHILD AND FAMILY SERVICES AND SUPPORT
Sec. 19000. Short title.
TITLE XIX--INVESTING IN PREVENTION AND FAMILY SERVICES
Sec. 19001. Purpose.
Subtitle A--Prevention Activities Under Title IV-E
Sec. 19011. Foster care prevention services and programs.
Sec. 19012. Foster care maintenance payments for children with parents
in a licensed residential family-based treatment facility
for substance abuse.
Sec. 19013. Title IV-E payments for evidence-based kinship navigator
programs.
Subtitle B--Enhanced Support Under Title IV-B
Sec. 19021. Elimination of time limit for family reunification services
while in foster care and permitting time-limited family
reunification services when a child returns home from
foster care.
Sec. 19022. Reducing bureaucracy and unnecessary delays when placing
children in homes across State lines.
Sec. 19023. Enhancements to grants to improve well-being of families
affected by substance abuse.
Subtitle C--Miscellaneous
Sec. 19031. Reviewing and improving licensing standards for placement
in a relative foster family home.
Sec. 19032. Development of a statewide plan to prevent child abuse and
neglect fatalities.
Sec. 19033. Modernizing the title and purpose of title IV-E.
Sec. 19034. Effective dates.
TITLE XX--ENSURING THE NECESSITY OF A PLACEMENT THAT IS NOT IN A FOSTER
FAMILY HOME
Sec. 20001. Limitation on Federal financial participation for
placements that are not in foster family homes.
Sec. 20002. Assessment and documentation of the need for placement in a
qualified residential treatment program.
Sec. 20003. Protocols to prevent inappropriate diagnoses.
Sec. 20004. Additional data and reports regarding children placed in a
setting that is not a foster family home.
Sec. 20005. Effective dates; application to waivers.
TITLE XXI--CONTINUING SUPPORT FOR CHILD AND FAMILY SERVICES
Sec. 21001. Supporting and retaining foster families for children.
Sec. 21002. Extension of child and family services programs.
Sec. 21003. Improvements to the John H. Chafee foster care independence
program and related provisions.
TITLE XXII--CONTINUING INCENTIVES TO STATES TO PROMOTE ADOPTION AND
LEGAL GUARDIANSHIP
Sec. 22001. Reauthorizing adoption and legal guardianship incentive
programs.
TITLE XXIII--TECHNICAL CORRECTIONS
Sec. 23001. Technical corrections to data exchange standards to improve
program coordination.
Sec. 23002. Technical corrections to State requirement to address the
developmental needs of young children.
TITLE XXIV--ENSURING STATES REINVEST SAVINGS RESULTING FROM INCREASE IN
ADOPTION ASSISTANCE
Sec. 24001. Delay of adoption assistance phase-in.
Sec. 24002. GAO study and report on State reinvestment of savings
resulting from increase in adoption assistance.
TITLE XXV--SOCIAL IMPACT PARTNERSHIPS TO PAY FOR RESULTS
Sec. 25001. Short title.
Sec. 25002. Social Impact Partnerships to Pay for Results.
Sec. 25003. Extension of TANF program.
Sec. 25004. Strengthening welfare research and evaluation and
development of a What Works Clearinghouse.
Sec. 25005. Technical corrections to data exchange standards to improve
program coordination.
DIVISION A--21ST CENTURY CURES
SEC. 1000. SHORT TITLE.
This Division may be cited as the ``21st Century Cures
Act''.
TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE
SEC. 1001. NIH INNOVATION PROJECTS.
(a) In General.--The Director of the National Institutes of
Health (referred to in this section as the ``Director of
NIH'') shall use any funds appropriated pursuant to the
authorization of appropriations in subsection (b)(3) to carry
out the National Institutes of Health innovation projects
described in subsection (b)(4) (referred to in this section
as the ``NIH Innovation Projects'').
(b) National Institutes of Health Innovation Account.--
(1) Establishment of nih innovation account.--There is
established in the Treasury an account, to be known as the
``NIH Innovation Account'' (referred to in this subsection as
the ``Account''), for purposes of carrying out the NIH
Innovation Projects described in paragraph (4).
(2) Transfer of direct spending savings.--
(A) In general.--The following amounts shall be transferred
to the Account from the general fund of the Treasury:
(i) For fiscal year 2017, $352,000,000.
(ii) For fiscal year 2018, $496,000,000.
(iii) For fiscal year 2019, $711,000,000.
(iv) For fiscal year 2020, $492,000,000.
(v) For fiscal year 2021, $404,000,000.
(vi) For fiscal year 2022, $496,000,000.
(vii) For fiscal year 2023, $1,085,000,000.
(viii) For fiscal year 2024, $407,000,000.
(ix) For fiscal year 2025, $127,000,000.
(x) For fiscal year 2026, $226,000,000.
(B) Amounts deposited.--Any amounts transferred under
subparagraph (A) shall remain unavailable in the Account
until such amounts are appropriated pursuant to paragraph
(3).
(3) Appropriations.--
(A) Authorization of appropriations.--For each of the
fiscal years 2017 through 2026, there is authorized to be
appropriated from the Account to the Director of NIH, for the
purpose of carrying out the NIH Innovation Projects, an
amount not to exceed the total amount transferred to the
Account under paragraph (2)(A), to remain available until
expended.
(B) Offsetting future appropriations.--For any of fiscal
years 2017 through 2026, for any discretionary appropriation
under the heading ``NIH Innovation Account'' provided to the
Director of NIH pursuant to the authorization of
appropriations under subparagraph (A) for the purpose of
carrying out the NIH Innovation Projects, the total amount of
such appropriations for the applicable fiscal year (not to
exceed the total amount remaining in the Account) shall be
subtracted from the estimate of discretionary budget
authority and the resulting outlays for any estimate under
the Congressional Budget and Impoundment Control Act of 1974
or the Balanced Budget and Emergency Deficit Control Act of
1985, and the amount transferred to the Account shall be
reduced by the same amount.
(4) NIH innovation projects.--NIH Innovation Projects
authorized to be funded under this section shall consist of
the following and, of the total amounts authorized to be
appropriated under paragraph (3), there are authorized to be
appropriated to each such project a total amount not to
exceed the following, over the period of fiscal years 2017
through 2026:
(A) For the Precision Medicine Initiative, including for
the advancement of a cohort of individuals to support the
goals of the Precision Medicine Initiative, not to exceed a
total of $1,455,000,000, as follows:
(i) For fiscal year 2017, $40,000,000.
(ii) For fiscal year 2018, $100,000,000.
(iii) For fiscal year 2019, $186,000,000.
(iv) For fiscal year 2020, $149,000,000.
(v) For fiscal year 2021, $109,000,000.
(vi) For fiscal year 2022, $150,000,000.
(vii) For fiscal year 2023, $419,000,000.
(viii) For fiscal year 2024, $235,000,000.
(ix) For fiscal year 2025, $36,000,000.
(x) For fiscal year 2026, $31,000,000.
(B) For the Brain Research through Advancing Innovative
Neurotechnologies Initiative (known as the ``BRAIN
Initiative''), not to exceed a total of $1,511,000,000, as
follows:
(i) For fiscal year 2017, $10,000,000.
(ii) For fiscal year 2018, $86,000,000.
(iii) For fiscal year 2019, $115,000,000.
(iv) For fiscal year 2020, $140,000,000.
(v) For fiscal year 2021, $100,000,000.
(vi) For fiscal year 2022, $152,000,000.
(vii) For fiscal year 2023, $450,000,000.
(viii) For fiscal year 2024, $172,000,000.
(ix) For fiscal year 2025, $91,000,000.
(x) For fiscal year 2026, $195,000,000.
(C) To support cancer research, such as the development of
cancer vaccines, the development of more sensitive diagnostic
tests for cancer, immunotherapy and the development of
[[Page H6901]]
combination therapies, and research that has the potential to
transform the scientific field, that has inherently higher
risk, and that seeks to address major challenges related to
cancer, not to exceed a total of $1,800,000,000, as follows:
(i) For fiscal year 2017, $300,000,000.
(ii) For fiscal year 2018, $300,000,000.
(iii) For fiscal year 2019, $400,000,000.
(iv) For fiscal year 2020, $195,000,000.
(v) For fiscal year 2021, $195,000,000.
(vi) For fiscal year 2022, $194,000,000.
(vii) For fiscal year 2023, $216,000,000.
(D) For the National Institutes of Health, in coordination
with the Food and Drug Administration, to award grants and
contracts for clinical research to further the field of
regenerative medicine using adult stem cells, including
autologous stem cells, for which grants and contracts shall
be contingent upon the recipient making available non-Federal
contributions toward the costs of such research in an amount
not less than $1 for each $1 of Federal funds provided in the
award, not to exceed a total of $30,000,000, as follows:
(i) For fiscal year 2017, $2,000,000.
(ii) For each of fiscal years 2018 and 2019, $10,000,000.
(iii) For fiscal year 2020, $8,000,000.
(iv) For each of fiscal years 2021 through 2026, $0.
(c) Accountability and Oversight.--
(1) Work plan.--
(A) In general.--Not later than 180 days after the date of
enactment of this Act, the Director of NIH shall submit to
the Committee on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate and the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, a work plan
including the proposed allocation of funds authorized to be
appropriated pursuant to subsection (b)(3) for each of fiscal
years 2017 through 2026 for the NIH Innovation Projects and
the contents described in subparagraph (B).
(B) Contents.--The work plan submitted under subparagraph
(A) shall include--
(i) recommendations from the Advisory Committee described
in subparagraph (C);
(ii) the amount of money to be obligated or expended in
each fiscal year for each NIH Innovation Project;
(iii) a description and justification of each such project;
and
(iv) a description of how each such project supports the
strategic research priorities identified in the NIH Strategic
Plan under subsection (m) of section 402 of the Public Health
Service Act (42 U.S.C. 282), as added by section 2031.
(C) Recommendations.--Prior to submitting the work plan
under this paragraph, the Director of NIH shall seek
recommendations from the Advisory Committee to the Director
of NIH appointed under section 222 of the Public Health
Service Act (42 U.S.C. 217a) on--
(i) the allocations of funds appropriated pursuant to the
authorization of appropriations under subsection (b)(3) for
each of fiscal years 2017 through 2026; and
(ii) on the contents of the proposed work plan.
(2) Reports.--
(A) Annual reports.--Not later than October 1 of each of
fiscal years 2018 through 2027, the Director of NIH shall
submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, a report
including--
(i) the amount of money obligated or expended in the prior
fiscal year for each NIH Innovation Project;
(ii) a description of any such project using funds provided
pursuant to the authorization of appropriations under
subsection (b)(3); and
(iii) whether such projects are advancing the strategic
research priorities identified in the NIH Strategic Plan
under subsection (m) of section 402 of the Public Health
Service Act (42 U.S.C. 282), as added by section 2031.
(B) Additional reports.--At the request of the Committee on
Health, Education, Labor, and Pensions or the Committee on
Appropriations of the Senate, or the Committee on Energy and
Commerce or the Committee on Appropriations of the House of
Representatives, the Director of NIH shall provide an update
in the form of testimony and any additional reports to the
respective congressional committee regarding the allocation
of funding under this section or the description of the NIH
Innovation Projects.
(d) Limitations.--Notwithstanding any transfer authority
authorized by this Act or any appropriations Act, any funds
made available pursuant to the authorization of
appropriations under subsection (b)(3) may not be used for
any purpose other than a NIH Innovation Project.
(e) Sunset.--This section shall expire on September 30,
2026.
SEC. 1002. FDA INNOVATION PROJECTS.
(a) In General.--The Commissioner of Food and Drugs
(referred to in this section as the ``Commissioner'') shall
use any funds appropriated pursuant to the authorization of
appropriations under subsection (b)(3) to carry out the
activities described in subsection (b)(4).
(b) FDA Innovation Account.--
(1) Establishment of fda innovation account.--There is
established in the Treasury an account, to be known as the
``FDA Innovation Account'' (referred to in this subsection as
the ``Account''), for purposes of carrying out the activities
described in paragraph (4).
(2) Transfer of direct spending savings.--
(A) In general.--For each of fiscal years 2017 through
2025, the following amounts shall be transferred to the
Account from the general fund of the Treasury:
(i) For fiscal year 2017, $20,000,000.
(ii) For fiscal year 2018, $60,000,000.
(iii) For fiscal year 2019, $70,000,000.
(iv) For fiscal year 2020, $75,000,000.
(v) For fiscal year 2021, $70,000,000.
(vi) For fiscal year 2022, $50,000,000.
(vii) For fiscal year 2023, $50,000,000.
(viii) For fiscal year 2024, $50,000,000.
(ix) For fiscal year 2025, $55,000,000.
(B) Amounts deposited.--Any amounts transferred under
subparagraph (A) shall remain unavailable in the Account
until such amounts are appropriated pursuant to paragraph
(3).
(3) Appropriations.--
(A) Authorization of appropriations.--For each of the
fiscal years 2017 through 2025, there is authorized to be
appropriated from the Account to the Commissioner, for the
purpose of carrying out the activities described in paragraph
(5), an amount not to exceed the total amount transferred to
the Account under paragraph (2)(A), to remain available until
expended.
(B) Offsetting future appropriations.--For any of fiscal
years 2017 through 2025, for any discretionary appropriation
under the heading ``FDA Innovation Account'' provided to the
Commissioner pursuant to the authorization of appropriations
under subparagraph (A) for the purpose of carrying out the
projects activities described in paragraph (4), the total
amount of such appropriations in the applicable fiscal year
(not to exceed the total amount remaining in the Account)
shall be subtracted from the estimate of discretionary budget
authority and the resulting outlays for any estimate under
the Congressional Budget and Impoundment Control Act of 1974
or the Balanced Budget and Emergency Deficit Control Act of
1985, and the amount transferred to the Account shall be
reduced by the same amount.
(4) FDA activities.--The activities authorized to be funded
under this section are the activities under subtitles A
through F (including the amendments made by such subtitles)
of title III of this Act and section 1014 of the Federal
Food, Drug, and Cosmetic Act, as added by section 3073 of
this Act.
(c) Accountability and Oversight.--
(1) Work plan.--
(A) In general.--Not later than 180 days after the date of
enactment of this Act, the Commissioner shall submit to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives, a work plan including the
proposed allocation of funds appropriated pursuant to the
authorization of appropriations under subsection (b)(3) for
each of fiscal years 2017 through 2025 and the contents
described in subparagraph (B).
(B) Contents.--The work plan submitted under subparagraph
(A) shall include--
(i) recommendations from the Advisory Committee described
in subparagraph (C);
(ii) the amount of money to be obligated or expended in
each fiscal year for each activity described in subsection
(b)(4); and
(iii) a description and justification of each such project
activity.
(C) Recommendations.--Prior to submitting the work plan
under this paragraph, the Commissioner shall seek
recommendations from the Science Board to the Food and Drug
Administration, on the proposed allocation of funds
appropriated pursuant to the authorization of appropriations
under subsection (b)(3) for each of fiscal years 2017 through
2025 and on the contents of the proposed work plan.
(2) Reports.--
(A) Annual reports.--Not later than October 1 of each of
fiscal years 2018 through 2026, the Commissioner shall submit
to the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate and the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, a report
including--
(i) the amount of money obligated or expended in the prior
fiscal year for each activity described in subsection (b)(4);
(ii) a description of all such activities using funds
provided pursuant to the authorization of appropriations
under subsection (b)(3); and
(iii) how the activities are advancing public health.
(B) Additional reports.--At the request of the Committee on
Health, Education, Labor, and Pensions or the Committee on
Appropriations of the Senate, or the Committee on Energy and
Commerce or the Committee on Appropriations of the House of
Representatives, the Commissioner shall provide an update in
the form of testimony and any additional reports to the
respective congressional committee regarding the allocation
of funding under this section or the description of the
activities undertaken with such funding.
(d) Limitations.--Notwithstanding any transfer authority
authorized by this Act or any appropriations Act, any funds
made available pursuant to the authorization of
appropriations in subsection (b)(3) shall not be used for any
purpose other than an activity described in subsection
(b)(4).
(e) Sunset.--This section shall expire on September 30,
2025.
SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE
CRISIS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall use
any funds appropriated pursuant to the authorization of
appropriations under subsection (b) to carry out the grant
program described in subsection (c) for purposes of
addressing the opioid abuse crisis within the States.
(b) Account for the State Response to the Opioid Abuse
Crisis.--
(1) Establishment.--There is established in the Treasury an
account, to be known as the ``Account For the State Response
to the Opioid
[[Page H6902]]
Abuse Crisis'' (referred to in this subsection as the
``Account''), to carry out the opioid grant program described
in subsection (c).
(2) Transfer of direct spending savings.--
(A) In general.--The following amounts shall be transferred
to the Account from the general fund of the Treasury:
(i) For fiscal year 2017, $500,000,000.
(ii) For fiscal year 2018, $500,000,000.
(B) Amounts deposited.--Any amounts transferred under
subparagraph (A) shall remain unavailable in the Account
until such amounts are appropriated pursuant to paragraph
(3).
(3) Appropriations.--
(A) Authorization of appropriations.--In each of the fiscal
years 2017 and 2018, there is authorized to be appropriated
from the Account to the Secretary, for the grant program
described in subsection (c), an amount not to exceed the
total amount transferred to the Account under paragraph
(2)(A), to remain available until expended.
(B) Offsetting future appropriations.--In each of fiscal
years 2017 and 2018, for any discretionary appropriation
under the heading ``Account For the State Response to the
Opioid Abuse Crisis'' for the grant program described in
subsection (c), the total amount of such appropriations in
the applicable fiscal year (not to exceed the total amount
remaining in the Account) shall be subtracted from the
estimate of discretionary budget authority and the resulting
outlays for any estimate under the Congressional Budget and
Impoundment Control Act of 1974 or the Balanced Budget and
Emergency Deficit Control Act of 1985, and the amount
transferred to the Account shall be reduced by the same
amount.
(c) Opioid Grant Program.--
(1) State response to the opioid abuse crisis.--Subject to
the availability of appropriations, the Secretary shall award
grants to States for the purpose of addressing the opioid
abuse crisis within such States, in accordance with
subparagraph (B). In awarding such grants, the Secretary
shall give preference to States with an incidence or
prevalence of opioid use disorders that is substantially
higher relative to other States.
(2) Opioid grants.--Grants awarded to a State under this
subsection shall be used for carrying out activities that
supplement activities pertaining to opioids undertaken by the
State agency responsible for administering the substance
abuse prevention and treatment block grant under subpart II
of part B of title XIX of the Public Health Service Act (42
U.S.C. 300x-21 et seq.), which may include public health-
related activities such as the following:
(A) Improving State prescription drug monitoring programs.
(B) Implementing prevention activities, and evaluating such
activities to identify effective strategies to prevent opioid
abuse.
(C) Training for health care practitioners, such as best
practices for prescribing opioids, pain management,
recognizing potential cases of substance abuse, referral of
patients to treatment programs, and overdose prevention.
(D) Supporting access to health care services, including
those services provided by Federally certified opioid
treatment programs or other appropriate health care providers
to treat substance use disorders.
(E) Other public health-related activities, as the State
determines appropriate, related to addressing the opioid
abuse crisis within the State.
(d) Accountability and Oversight.--A State receiving a
grant under subsection (c) shall include in a report related
to substance abuse submitted to the Secretary pursuant to
section 1942 of the Public Health Service Act (42 U.S.C.
300x-52), a description of--
(1) the purposes for which the grant funds received by the
State under such subsection for the preceding fiscal year
were expended and a description of the activities of the
State under the program; and
(2) the ultimate recipients of amounts provided to the
State in the grant.
(e) Limitations.--Any funds made available pursuant to the
authorization of appropriations under subsection (b)--
(1) notwithstanding any transfer authority in any
appropriations Act, shall not be used for any purpose other
than the grant program in subsection (c); and
(2) shall be subject to the same requirements as substance
abuse prevention and treatment programs under titles V and
XIX of the Public Health Service Act (42 U.S.C. 290aa et
seq., 300w et seq.).
(f) Sunset.--This section shall expire on September 30,
2026.
SEC. 1004. BUDGETARY TREATMENT.
(a) Statutory Paygo Scorecards.--The budgetary effects of
division A of this Act shall not be entered on either PAYGO
scorecard maintained pursuant to section 4(d) of the
Statutory Pay-As-You-Go Act of 2010.
(b) Senate Paygo Scorecards.--The budgetary effects of
division A of this Act shall not be entered on any PAYGO
scorecard maintained for purposes of section 201 of S. Con.
Res. 21 (110th Congress).
(c) Reservation of Savings.--None of the funds in the NIH
Innovation Account, the FDA Innovation Account, or the
Account For the State Response to the Opioid Abuse Crisis
established by this title shall be made available except to
the extent provided in advance in appropriations Acts, and
legislation or an Act that rescinds or reduces amounts in
such accounts shall not be estimated as a reduction in direct
spending under the Congressional Budget and Impoundment
Control Act of 1974 or the Balanced Budget and Emergency
Deficit Control Act of 1985.
TITLE II--DISCOVERY
Subtitle A--National Institutes of Health Reauthorization
SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
Section 402A(a)(1) of the Public Health Service Act (42
U.S.C. 282a(a)(1)) is amended--
(1) in subparagraph (B), by striking ``and'' at the end;
(2) in subparagraph (C), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
``(D) $34,851,000,000 for fiscal year 2018;
``(E) $35,585,871,000 for fiscal year 2019; and
``(F) $36,472,442,775 for fiscal year 2020.''.
SEC. 2002. EUREKA PRIZE COMPETITIONS.
(a) In General.--Pursuant to the authorities and processes
established under section 24 of the Stevenson-Wydler
Technology Innovation Act of 1980 (15 U.S.C. 3719), the
Director of the National Institutes of Health shall support
prize competitions for one or both of the following goals:
(1) Identifying and funding areas of biomedical science
that could realize significant advancements through a prize
competition.
(2) Improving health outcomes, particularly with respect to
human diseases and conditions--
(A) for which public and private investment in research is
disproportionately small relative to Federal Government
expenditures on prevention and treatment activities with
respect to such diseases and conditions, such that Federal
expenditures on health programs would be reduced;
(B) that are serious and represent a significant disease
burden in the United States; or
(C) for which there is potential for significant return on
investment to the United States.
(b) Tracking; Reporting.--The Director of the National
Institutes of Health shall--
(1) collect information on--
(A) the effect of innovations funded through the prize
competitions under this section in advancing biomedical
science or improving health outcomes pursuant to subsection
(a); and
(B) the effect of the innovations on Federal expenditures;
and
(2) include the information collected under paragraph (1)
in the triennial report under section 403 of the Public
Health Service Act (42 U.S.C. 283) (as amended by section
2032).
Subtitle B--Advancing Precision Medicine
SEC. 2011. PRECISION MEDICINE INITIATIVE.
Part H of title IV of the Public Health Service Act (42
U.S.C. 289 et seq.) is amended by adding at the end the
following:
``SEC. 498E. PRECISION MEDICINE INITIATIVE.
``(a) In General.--The Secretary is encouraged to establish
and carry out an initiative, to be known as the `Precision
Medicine Initiative' (in this section referred to as the
`Initiative'), to augment efforts to address disease
prevention, diagnosis, and treatment.
``(b) Components.--The Initiative described under
subsection (a) may include--
``(1) developing a network of scientists to assist in
carrying out the purposes of the Initiative;
``(2) developing new approaches for addressing scientific,
medical, public health, and regulatory science issues;
``(3) applying genomic technologies, such as whole genomic
sequencing, to provide data on the molecular basis of
disease;
``(4) collecting information voluntarily provided by a
diverse cohort of individuals that can be used to better
understand health and disease; and
``(5) other activities to advance the goals of the
Initiative, as the Secretary determines appropriate.
``(c) Authority of the Secretary.--In carrying out this
section, the Secretary may--
``(1) coordinate with the Secretary of Energy, private
industry, and others, as the Secretary determines
appropriate, to identify and address the advanced
supercomputing and other advanced technology needs for the
Initiative;
``(2) develop and utilize public-private partnerships; and
``(3) leverage existing data sources.
``(d) Requirements.--In the implementation of the
Initiative under subsection (a), the Secretary shall--
``(1) ensure the collaboration of the National Institutes
of Health, the Food and Drug Administration, the Office of
the National Coordinator for Health Information Technology,
and the Office for Civil Rights of the Department of Health
and Human Services;
``(2) comply with existing laws and regulations for the
protection of human subjects involved in research, including
the protection of participant privacy;
``(3) implement policies and mechanisms for appropriate
secure data sharing across systems that include protections
for privacy and security of data;
``(4) consider the diversity of the cohort to ensure
inclusion of a broad range of participants, including
consideration of biological, social, and other determinants
of health that contribute to health disparities;
``(5) ensure that only authorized individuals may access
controlled or sensitive, identifiable biological material and
associated information collected or stored in connection with
the Initiative; and
``(6) on the appropriate Internet website of the Department
of Health and Human Services, identify any entities with
access to such information and provide information with
respect to the purpose of such access, a summary of the
research project for which such access is granted, as
applicable, and a description of the biological material and
associated information to which the entity has access.
``(e) Report.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
submit a report on the relevant data access policies and
procedures to the Committee on Health, Education, Labor, and
[[Page H6903]]
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives. Such report shall
include steps the Secretary has taken to consult with experts
or other heads of departments or agencies of the Federal
Government in the development of such policies.''.
SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.
(a) In General.--Subsection (d) of section 301 of the
Public Health Service Act (42 U.S.C. 241) is amended to read
as follows:
``(d)(1)(A) If a person is engaged in biomedical,
behavioral, clinical, or other research, in which
identifiable, sensitive information is collected (including
research on mental health and research on the use and effect
of alcohol and other psychoactive drugs), the Secretary, in
coordination with other agencies, as applicable--
``(i) shall issue to such person a certificate of
confidentiality to protect the privacy of individuals who are
the subjects of such research if the research is funded
wholly or in part by the Federal Government; and
``(ii) may, upon application by a person engaged in
research, issue to such person a certificate of
confidentiality to protect the privacy of such individuals if
the research is not so funded.
``(B) Except as provided in subparagraph (C), any person to
whom a certificate is issued under subparagraph (A) to
protect the privacy of individuals described in such
subparagraph shall not disclose or provide to any other
person not connected with the research the name of such an
individual or any information, document, or biospecimen that
contains identifiable, sensitive information about such an
individual and that was created or compiled for purposes of
the research.
``(C) The disclosure prohibition in subparagraph (B) shall
not apply to disclosure or use that is--
``(i) required by Federal, State, or local laws, excluding
instances described in subparagraph (D);
``(ii) necessary for the medical treatment of the
individual to whom the information, document, or biospecimen
pertains and made with the consent of such individual;
``(iii) made with the consent of the individual to whom the
information, document, or biospecimen pertains; or
``(iv) made for the purposes of other scientific research
that is in compliance with applicable Federal regulations
governing the protection of human subjects in research.
``(D) Any person to whom a certificate is issued under
subparagraph (A) to protect the privacy of an individual
described in such subparagraph shall not, in any Federal,
State, or local civil, criminal, administrative, legislative,
or other proceeding, disclose or provide the name of such
individual or any such information, document, or biospecimen
that contains identifiable, sensitive information about the
individual and that was created or compiled for purposes of
the research, except in the circumstance described in
subparagraph (C)(iii).
``(E) Identifiable, sensitive information protected under
subparagraph (A), and all copies thereof, shall be immune
from the legal process, and shall not, without the consent of
the individual to whom the information pertains, be
admissible as evidence or used for any purpose in any action,
suit, or other judicial, legislative, or administrative
proceeding.
``(F) Identifiable, sensitive information collected by a
person to whom a certificate has been issued under
subparagraph (A), and all copies thereof, shall be subject to
the protections afforded by this section for perpetuity.
``(G) The Secretary shall take steps to minimize the burden
to researchers, streamline the process, and reduce the time
it takes to comply with the requirements of this subsection.
``(2) The Secretary shall coordinate with the heads of
other applicable Federal agencies to ensure that such
departments have policies in place with respect to the
issuance of a certificate of confidentiality pursuant to
paragraph (1) and other requirements of this subsection.
``(3) Nothing in this subsection shall be construed to
limit the access of an individual who is a subject of
research to information about himself or herself collected
during such individual's participation in the research.
``(4) For purposes of this subsection, the term
`identifiable, sensitive information' means information that
is about an individual and that is gathered or used during
the course of research described in paragraph (1)(A) and--
``(A) through which an individual is identified; or
``(B) for which there is at least a very small risk, as
determined by current scientific practices or statistical
methods, that some combination of the information, a request
for the information, and other available data sources could
be used to deduce the identity of an individual.''.
(b) Applicability.--Beginning 180 days after the date of
enactment of this Act, all persons engaged in research and
authorized by the Secretary of Health and Human Services to
protect information under section 301(d) of the Public Health
Service Act (42 U.S.C. 241(d)) prior to the date of enactment
of this Act shall be subject to the requirements of such
section (as amended by this Act).
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE
INFORMATION.
Section 301 of the Public Health Service Act (42 U.S.C.
241) is amended by adding at the end the following:
``(f)(1) The Secretary may exempt from disclosure under
section 552(b)(3) of title 5, United States Code, biomedical
information that is about an individual and that is gathered
or used during the course of biomedical research if--
``(A) an individual is identified; or
``(B) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that
some combination of the information, the request, and other
available data sources could be used to deduce the identity
of an individual.
``(2)(A) Each determination of the Secretary under
paragraph (1) to exempt information from disclosure shall be
made in writing and accompanied by a statement of the basis
for the determination.
``(B) Each such determination and statement of basis shall
be available to the public, upon request, through the Office
of the Chief FOIA Officer of the Department of Health and
Human Services.
``(3) Nothing in this subsection shall be construed to
limit a research participant's access to information about
such participant collected during the participant's
participation in the research.''.
SEC. 2014. DATA SHARING.
(a) In General.--Section 402(b) of the Public Health
Service Act (42 U.S.C. 282(b)) is amended--
(1) in paragraph (23), by striking ``and'' at the end;
(2) in paragraph (24), by striking the period and inserting
``; and''; and
(3) by inserting after paragraph (24) the following:
``(25) may require recipients of National Institutes of
Health awards to share scientific data, to the extent
feasible, generated from such National Institutes of Health
awards in a manner that is consistent with all applicable
Federal laws and regulations, including such laws and
regulations for the protection of--
``(A) human research participants, including with respect
to privacy, security, informed consent, and protected health
information; and
``(B) proprietary interests, confidential commercial
information, and the intellectual property rights of the
funding recipient.''.
(b) Confidentiality.--Nothing in the amendments made by
subsection (a) authorizes the Secretary of Health and Human
Services to disclose any information that is a trade secret,
or other privileged or confidential information, described in
section 552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code, or be construed to
require recipients of grants or cooperative agreements
through the National Institutes of Health to share such
information.
Subtitle C--Supporting Young Emerging Scientists
SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.
(a) In General.--Part A of title IV of the Public Health
Service Act (42 U.S.C. 281 et seq.) is amended by adding at
the end the following:
``SEC. 404M. NEXT GENERATION OF RESEARCHERS.
``(a) Next Generation of Researchers Initiative.--There
shall be established within the Office of the Director of the
National Institutes of Health, the Next Generation of
Researchers Initiative (referred to in this section as the
`Initiative'), through which the Director shall coordinate
all policies and programs within the National Institutes of
Health that are focused on promoting and providing
opportunities for new researchers and earlier research
independence.
``(b) Activities.--The Director of the National Institutes
of Health, through the Initiative shall--
``(1) promote policies and programs within the National
Institutes of Health that are focused on improving
opportunities for new researchers and promoting earlier
research independence, including existing policies and
programs, as appropriate;
``(2) develop, modify, or prioritize policies, as needed,
within the National Institutes of Health to promote
opportunities for new researchers and earlier research
independence, such as policies to increase opportunities for
new researchers to receive funding, enhance training and
mentorship programs for researchers, and enhance workforce
diversity;
``(3) coordinate, as appropriate, with relevant agencies,
professional and academic associations, academic
institutions, and others, to improve and update existing
information on the biomedical research workforce in order to
inform programs related to the training, recruitment, and
retention of biomedical researchers; and
``(4) carry out other activities, including evaluation and
oversight of existing programs, as appropriate, to promote
the development of the next generation of researchers and
earlier research independence.''.
(b) Consideration of Recommendations.--In carrying out
activities under section 404M(b) of the Public Health Service
Act, the Director of the National Institutes of Health shall
take into consideration the recommendations made by the
National Academies of Sciences, Engineering, and Medicine as
part of the comprehensive study on policies affecting the
next generation of researchers under the Department of Health
and Human Services Appropriations Act, 2016 (Public Law 114-
113), and submit a report to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate, and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, with respect to any actions taken by the
National Institutes of Health based on the recommendations
not later than 2 years after the completion of the study
required pursuant to the Department of Health and Human
Services Appropriations Act, 2016.
SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.
(a) Intramural Loan Repayment Program.--Section 487A of the
Public Health Service Act (42 U.S.C. 288-1) is amended--
[[Page H6904]]
(1) by amending the section heading to read as follows:
``intramural loan repayment program'';
(2) in subsection (a)--
(A) by striking ``The Secretary shall carry out a program''
and inserting ``The Director of the National Institutes of
Health shall, as appropriate and based on workforce and
scientific priorities, carry out a program through the
subcategories listed in subsection (b)(1) (or modified
subcategories as provided for in subsection (b)(2))'';
(B) by striking ``conduct'' and inserting ``conduct
research'';
(C) by striking ``research with respect to acquired immune
deficiency syndrome''; and
(D) by striking ``$35,000'' and inserting ``$50,000'';
(3) by redesignating subsection (b) as subsection (d);
(4) by inserting after subsection (a), the following:
``(b) Subcategories of Research.--
``(1) In general.--In carrying out the program under
subsection (a), the Director of the National Institutes of
Health--
``(A) shall continue to focus on--
``(i) general research;
``(ii) research on acquired immune deficiency syndrome; and
``(iii) clinical research conducted by appropriately
qualified health professional who are from disadvantaged
backgrounds; and
``(B) may focus on an area of emerging scientific or
workforce need.
``(2) Elimination or establishment of subcategories.--The
Director of the National Institutes of Health may eliminate
one or more subcategories provided for in paragraph (1) due
to changes in workforce or scientific needs related to
biomedical research. The Director may establish other
subcategory areas based on workforce and scientific
priorities if the total number of subcategories does not
exceed the number of subcategories listed in paragraph (1).
``(c) Limitation.--The Director of the National Institutes
of Health may not enter into a contract with a health
professional pursuant to subsection (a) unless such
professional has a substantial amount of education loans
relative to income (as determined pursuant to guidelines
issued by the Director).''; and
(5) by adding at the end the following:
``(e) Availability of Appropriations.--Amounts available
for carrying out this section shall remain available until
the expiration of the second fiscal year beginning after the
fiscal year for which such amounts are made available.''.
(b) Extramural Loan Repayment Program.--Section 487B of the
Public Health Service Act (42 U.S.C. 288-2) is amended--
(1) by amending the section heading to read as follows:
``extramural loan repayment program'';
(2) in subsection (a)--
(A) by striking ``The Secretary, in consultation with the
Director of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, shall establish a
program'' and inserting ``In General.--The Director of the
National Institutes of Health shall, as appropriate and based
on workforce and scientific priorities, carry out a program
through the subcategories listed in subsection (b)(1) (or
modified subcategories as provided for in subsection
(b)(2)),'';
(B) by striking ``(including graduate students)'';
(C) by striking ``with respect to contraception, or with
respect to infertility,''; and
(D) by striking ``service, not more than $35,000'' and
inserting ``research, not more than $50,000'';
(3) by redesignating subsections (b) and (c) as subsections
(d) and (e), respectively;
(4) by inserting after subsection (a), the following:
``(b) Subcategories of Research.--
``(1) In general.--In carrying out the program under
subsection (a), the Director of the National Institutes of
Health--
``(A) shall continue to focus on--
``(i) contraception or infertility research;
``(ii) pediatric research, including pediatric
pharmacological research;
``(iii) minority health disparities research;
``(iv) clinical research; and
``(v) clinical research conducted by appropriately
qualified health professional who are from disadvantaged
backgrounds; and
``(B) may focus on an area of emerging scientific or
workforce need.
``(2) Elimination or establishment of subcategories.--The
Director of the National Institutes of Health may eliminate
one or more subcategories provided for in paragraph (1) due
to changes in workforce or scientific needs related to
biomedical research. The Director may establish other
subcategory areas based on workforce and scientific
priorities if the total number of subcategories does not
exceed the number of subcategories listed in paragraph (1).
``(c) Limitation.--The Director of the National Institutes
of Health may not enter into a contract with a health
professional pursuant to subsection (a) unless such
professional has a substantial amount of education loans
relative to income (as determined pursuant to guidelines
issued by the Director).'';
(5) in subsection (d) (as so redesignated), by striking
``The provisions'' and inserting ``Applicability of Certain
Provisions Regarding Obligated Service.--The provisions'';
and
(6) in subsection (e) (as so redesignated), by striking
``Amounts'' and inserting ``Availability of Appropriations.--
Amounts''.
(c) Technical and Conforming Amendments.--Title IV of the
Public Health Service Act is amended--
(1) by striking section 464z-5 (42 U.S.C. 285t-2);
(2) by striking section 487C (42 U.S.C. 288-3);
(3) by striking section 487E (42 U.S.C. 288-5);
(4) by striking section 487F (42 U.S.C. 288-5a), as added
by section 205 of Public Law 106-505, relating to loan
repayment for clinical researchers; and
(5) by striking section 487F (42 U.S.C. 288-6), as added by
section 1002(b) of Public Law 106-310 relating to pediatric
research loan repayment.
(d) GAO Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report on the efforts of
the National Institutes of Health to attract, retain, and
develop emerging scientists, including underrepresented
individuals in the sciences, such as women, racial and ethnic
minorities, and other groups. Such report shall include an
analysis of the impact of the additional authority provided
to the Secretary of Health and Human Services under this Act
to address workforce shortages and gaps in priority research
areas, including which centers and research areas offered
loan repayment program participants the increased award
amount.
Subtitle D--National Institutes of Health Planning and Administration
SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
(a) Strategic Plan.--Section 402 of the Public Health
Service Act (42 U.S.C. 282) is amended--
(1) in subsection (b)(5), by inserting before the semicolon
the following: ``, and through the development,
implementation, and updating of the strategic plan developed
under subsection (m)''; and
(2) by adding at the end the following:
``(m) National Institutes of Health Strategic Plan.--
``(1) In general.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, and at least every 6
years thereafter, the Director of the National Institutes of
Health shall develop and submit to the appropriate committees
of Congress and post on the Internet website of the National
Institutes of Health, a coordinated strategy (to be known as
the `National Institutes of Health Strategic Plan') to
provide direction to the biomedical research investments made
by the National Institutes of Health, to facilitate
collaboration across the institutes and centers, to leverage
scientific opportunity, and to advance biomedicine.
``(2) Requirements.--The strategy under paragraph (1)
shall--
``(A) identify strategic research priorities and objectives
across biomedical research, including--
``(i) an assessment of the state of biomedical and
behavioral research, including areas of opportunity with
respect to basic, clinical, and translational research;
``(ii) priorities and objectives to advance the treatment,
cure, and prevention of health conditions;
``(iii) emerging scientific opportunities, rising public
health challenges, and scientific knowledge gaps; and
``(iv) the identification of near-, mid-, and long-term
scientific needs;
``(B) consider, in carrying out subparagraph (A)--
``(i) disease burden in the United States and the potential
for return on investment to the United States;
``(ii) rare diseases and conditions;
``(iii) biological, social, and other determinants of
health that contribute to health disparities; and
``(iv) other factors the Director of National Institutes of
Health determines appropriate;
``(C) include multi-institute priorities, including
coordination of research among institutes and centers;
``(D) include strategic priorities for funding research
through the Common Fund, in accordance with section
402A(c)(1)(C);
``(E) address the National Institutes of Health's proposed
and ongoing activities related to training and the biomedical
workforce; and
``(F) describe opportunities for collaboration with other
agencies and departments, as appropriate.
``(3) Use of plans.--Strategic plans developed and updated
by the national research institutes and national centers of
the National Institutes of Health shall be prepared regularly
and in such a manner that such plans will be informed by the
strategic plans developed and updated under this subsection.
Such plans developed by and updated by the national research
institutes and national centers shall have a common template.
``(4) Consultation.--The Director of National Institutes of
Health shall develop the strategic plan under paragraph (1)
in consultation with the directors of the national research
institutes and national centers, researchers, patient
advocacy groups, and industry leaders.''.
(b) Conforming Amendment.--Section 402A(c)(1)(C) of the
Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is
amended by striking ``Not later than June 1, 2007, and every
2 years thereafter,'' and inserting ``As part of the National
Institutes of Health Strategic Plan required under section
402(m),''.
(c) Strategic Plan.--Section 492B(a) of the Public Health
Service Act (42 U.S.C. 289a-2(a)) is amended by adding at the
end the following:
``(3) Strategic planning.--
``(A) In general.--The directors of the national institutes
and national centers shall consult at least once annually
with the Director of the National Institute on Minority
Health and Health Disparities and the Director of the Office
of Research on Women's Health regarding objectives of the
national institutes and national centers to ensure that
future activities by such institutes and centers take into
account women
[[Page H6905]]
and minorities and are focused on reducing health
disparities.
``(B) Strategic plans.--Any strategic plan issued by a
national institute or national center shall include details
on the objectives described in subparagraph (A).''.
SEC. 2032. TRIENNIAL REPORTS.
Section 403 of the Public Health Service Act (42 U.S.C.
283) is amended--
(1) in the section heading, by striking ``biennial'' and
inserting ``triennial'' ; and
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``biennial'' and inserting ``triennial'';
(B) by amending paragraph (3) to read as follows:
``(3) A description of intra-National Institutes of Health
activities, including--
``(A) identification of the percentage of funds made
available by each national research institute and national
center with respect to each applicable fiscal year for
conducting or supporting research that involves collaboration
between the institute or center and 1 or more other national
research institutes or national centers; and
``(B) recommendations for promoting coordination of
information among the centers of excellence.'';
(C) in paragraph (4)--
(i) in subparagraph (B), by striking ``demographic
variables and other variables'' and inserting ``demographic
variables, including biological and social variables and
relevant age categories (such as pediatric subgroups), and
determinants of health,''; and
(ii) in subparagraph (C)(v)--
(I) by striking ``demographic variables and such'' and
inserting ``demographic variables, including relevant age
categories (such as pediatric subgroups), information
submitted by each national research institute and national
center to the Director of National Institutes of Health under
section 492B(f), and such''; and
(II) by striking ``(regarding inclusion of women and
minorities in clinical research)'' and inserting ``and other
applicable requirements regarding inclusion of demographic
groups''; and
(D) in paragraph (6)--
(i) in the matter preceding subparagraph (A), by striking
``the following:'' and inserting ``the following--'';
(ii) in subparagraph (A)--
(I) by striking ``An evaluation'' and inserting ``an
evaluation''; and
(II) by striking the period and inserting ``; and'';
(iii) by striking subparagraphs (B) and (D);
(iv) by redesignating subparagraph (C) as subparagraph (B);
and
(v) in subparagraph (B), as redesignated by clause (iv), by
striking ``Recommendations'' and inserting
``recommendations''.
SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL
INSTITUTES OF HEALTH.
(a) Appointment and Terms of Directors of National Research
Institutes and National Centers.--Subsection (a) of section
405 of the Public Health Service Act (42 U.S.C. 284) is
amended to read as follows:
``(a) Appointment.--
``(1) In general.--The Director of the National Cancer
Institute shall be appointed by the President, and the
Directors of the other national research institutes and
national centers shall be appointed by the Secretary, acting
through the Director of National Institutes of Health. Each
Director of a national research institute or national center
shall report directly to the Director of National Institutes
of Health.
``(2) Appointment.--
``(A) Term.--A Director of a national research institute or
national center who is appointed by the Secretary, acting
through the Director of National Institutes of Health, shall
be appointed for 5 years.
``(B) Reappointment.--At the end of the term of a Director
of a national research institute or national center, the
Director may be reappointed in accordance with standards
applicable to the relevant appointment mechanism. There shall
be no limit on the number of terms that a Director may serve.
``(C) Vacancies.--If the office of a Director of a national
research institute or national center becomes vacant before
the end of such Director's term, the Director appointed to
fill the vacancy shall be appointed for a 5-year term
starting on the date of such appointment.
``(D) Current directors.--Each Director of a national
research institute or national center who is serving on the
date of enactment of the 21st Century Cures Act shall be
deemed to be appointed for a 5-year term under this
subsection beginning on such date of enactment.
``(E) Rule of construction.--Nothing in this subsection
shall be construed to limit the authority of the Secretary or
the Director of National Institutes of Health to terminate
the appointment of a director referred to in subparagraph (A)
before the expiration of such director's 5-year term.
``(F) Nature of appointment.--Appointments and
reappointments under this subsection shall be made on the
basis of ability and experience as it relates to the mission
of the National Institutes of Health and its components,
including compliance with any legal requirement that the
Secretary or Director of National Institutes of Health
determines relevant.
``(3) Nonapplication of certain provision.--The
restrictions contained in section 202 of the Departments of
Labor, Health and Human Services, and Education, and Related
Agencies Appropriations Act, 1993 (Public Law 102-394; 42
U.S.C. 238f note) related to consultants and individual
scientists appointed for limited periods of time shall not
apply to Directors appointed under this subsection.''.
(b) Review of Certain Awards by Directors.--Section 405(b)
of the Public Health Service Act (42 U.S.C. 284(b)) is
amended by adding at the end the following:
``(3) Before an award is made by a national research
institute or by a national center for a grant for a research
program or project (commonly referred to as an `R-series
grant'), other than an award constituting a noncompetitive
renewal of such a grant, or a noncompetitive administrative
supplement to such a grant, the Director of such national
research institute or national center shall, consistent with
the peer review process--
``(A) review and make the final decision with respect to
making the award; and
``(B) take into consideration, as appropriate--
``(i) the mission of the national research institute or
national center and the scientific priorities identified in
the strategic plan under section 402(m);
``(ii) programs or projects funded by other agencies on
similar research topics; and
``(iii) advice by staff and the advisory council or board
of such national research institute or national center.''.
(c) Report on Duplication in Federal Biomedical Research.--
The Secretary of Health and Human Services (referred to in
this subsection as the ``Secretary''), shall, not later than
2 years after the date of enactment of this Act, submit a
report to Congress on efforts to prevent and eliminate
duplicative biomedical research that is not necessary for
scientific purposes. Such report shall--
(1) describe the procedures in place to identify such
duplicative research, including procedures for monitoring
research applications and funded research awards to prevent
unnecessary duplication;
(2) describe the steps taken to improve the procedures
described in paragraph (1), in response to relevant
recommendations made by the Comptroller General of the United
States;
(3) describe how the Secretary operationally distinguishes
necessary and appropriate scientific replication from
unnecessary duplication; and
(4) provide examples of instances where the Secretary has
identified unnecessarily duplicative research and the steps
taken to eliminate the unnecessary duplication.
SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS.
(a) Plan Preparation and Implementation of Measures To
Reduce Administrative Burdens.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall--
(A) lead a review by research funding agencies of all
regulations and policies related to the disclosure of
financial conflicts of interest, including the minimum
threshold for reporting financial conflicts of interest;
(B) make revisions, as appropriate, to harmonize existing
policies and reduce administrative burden on researchers
while maintaining the integrity and credibility of research
findings and protections of human participants; and
(C) confer with the Office of the Inspector General about
the activities of such office related to financial conflicts
of interest involving research funding agencies.
(2) Considerations.--In updating policies under paragraph
(1)(B), the Secretary shall consider--
(A) modifying the timelines for the reporting of financial
conflicts of interest to just-in-time information by
institutions receiving grant or cooperative agreement funding
from the National Institutes of Health;
(B) ensuring that financial interest disclosure reporting
requirements are appropriate for, and relevant to, awards
that will directly fund research, which may include
modification of the definition of the term ``investigator''
for purposes of the regulations and policies described in
subparagraphs (A) and (B) of paragraph (1); and
(C) updating any applicable training modules of the
National Institutes of Health related to Federal financial
interest disclosure.
(b) Monitoring of Subrecipients of Funding From the
National Institutes of Health.--The Director of the National
Institutes of Health (referred to in this section as the
``Director of National Institutes of Health'') shall
implement measures to reduce the administrative burdens
related to monitoring of subrecipients of grants by primary
awardees of funding from the National Institutes of Health,
which may incorporate findings and recommendations from
existing and ongoing activities. Such measures may include,
as appropriate--
(1) an exemption from subrecipient monitoring requirements,
upon request from the primary awardees, provided that--
(A) the subrecipient is subject to Federal audit
requirements pursuant to the Uniform Guidance of the Office
of Management and Budget;
(B) the primary awardee conducts, pursuant to guidance of
the National Institutes of Health, a pre-award evaluation of
each subrecipient's risk of noncompliance with Federal
statutes and regulations, the conditions of the subaward, and
any recurring audit findings; and
(C) such exemption does not absolve the primary awardee of
liability for misconduct by subrecipients; and
(2) the implementation of alternative grant structures that
obviate the need for subrecipient monitoring, which may
include collaborative grant models allowing for multiple
primary awardees.
(c) Reporting of Financial Expenditures.--The Secretary, in
consultation with the Director of National Institutes of
Health, shall evaluate financial expenditure reporting
procedures and requirements for recipients of funding from
the National Institutes of Health and take action, as
appropriate, to avoid duplication between department and
agency procedures and requirements and minimize burden to
funding recipients.
[[Page H6906]]
(d) Animal Care and Use in Research.--Not later than 2
years after the date of enactment of this Act, the Director
of National Institutes of Health, in collaboration with the
Secretary of Agriculture and the Commissioner of Food and
Drugs, shall complete a review of applicable regulations and
policies for the care and use of laboratory animals and make
revisions, as appropriate, to reduce administrative burden on
investigators while maintaining the integrity and credibility
of research findings and protection of research animals. In
carrying out this effort, the Director of the National
Institutes of Health shall seek the input of experts, as
appropriate. The Director of the National Institutes of
Health shall--
(1) identify ways to ensure such regulations and policies
are not inconsistent, overlapping, or unnecessarily
duplicative, including with respect to inspection and review
requirements by Federal agencies and accrediting
associations;
(2) take steps to eliminate or reduce identified
inconsistencies, overlap, or duplication among such
regulations and policies; and
(3) take other actions, as appropriate, to improve the
coordination of regulations and policies with respect to
research with laboratory animals.
(e) Documentation of Personnel Expenses.--The Secretary
shall clarify the applicability of the requirements under the
Office of Management and Budget Uniform Guidance for
management and certification systems adopted by entities
receiving Federal research grants through the Department of
Health and Human Services regarding documentation of
personnel expenses, including clarification of the extent to
which any flexibility to such requirements specified in such
Uniform Guidance applies to entities receiving grants through
the Department of Health and Human Services.
(f) Research Policy Board.--
(1) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Director of the Office of
Management and Budget shall establish an advisory committee,
to be known as the ``Research Policy Board'' (referred to in
this subsection as the ``Board''), to provide Federal
Government officials with information on the effects of
regulations related to Federal research requirements.
(2) Membership.--
(A) In general.--The Board shall include not more than 10
Federal members, including each of the following Federal
members or their designees:
(i) The Administrator of the Office of Information and
Regulatory Affairs of the Office of Management and Budget.
(ii) The Director of the Office of Science and Technology
Policy.
(iii) The Secretary of Health and Human Services.
(iv) The Director of the National Science Foundation.
(v) The secretaries and directors of other departments and
agencies that support or regulate scientific research, as
determined by the Director of the Office of Management and
Budget.
(B) Non-federal members.--The Board shall be comprised of
not less than 9 and not more than 12 representatives of
academic research institutions, other private, nonprofit
research institutions, or other nonprofit organizations with
relevant expertise. Such members shall be appointed by a
formal process, to be established by the Director of the
Office of Management and Budget, in consultation with the
Federal membership, and that incorporates--
(i) nomination by members of the nonprofit scientific
research community, including academic research institutions;
and
(ii) procedures to fill membership positions vacated before
the end of a member's term.
(3) Purpose and responsibilities.--The Board shall make
recommendations regarding the modification and harmonization
of regulations and policies having similar purposes across
research funding agencies to ensure that the administrative
burden of such research policy and regulation is minimized to
the greatest extent possible and consistent with maintaining
responsible oversight of federally funded research.
Activities of the Board may include--
(A) providing thorough and informed analysis of regulations
and policies;
(B) identifying negative or adverse consequences of
existing policies and making actionable recommendations
regarding possible improvement of such policies;
(C) making recommendations with respect to efforts within
the Federal Government to improve coordination of regulation
and policy related to research;
(D) creating a forum for the discussion of research policy
or regulatory gaps, challenges, clarification, or
harmonization of such policies or regulation, and best
practices; and
(E) conducting ongoing assessment and evaluation of
regulatory burden, including development of metrics, periodic
measurement, and identification of process improvements and
policy changes.
(4) Expert subcommittees.--The Board may form temporary
expert subcommittees, as appropriate, to develop timely
analysis on pressing issues and assist the Board in
anticipating future regulatory challenges, including
challenges emerging from new scientific advances.
(5) Reporting requirements.--Not later than 2 years after
the date of enactment of this Act, and once thereafter, the
Board shall submit a report to the Director of the Office of
Management and Budget, the Administrator of the Office of
Information and Regulatory Affairs of the Office of
Management and Budget, the Director of the Office of Science
and Technology Policy, the heads of relevant Federal
departments and agencies, the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on
Energy and Commerce of the House of Representatives
containing formal recommendations on the conceptualization,
development, harmonization, and reconsideration of scientific
research policy, including the regulatory benefits and
burdens.
(6) Sunset.--The Board shall terminate on September 30,
2021.
(7) GAO report.--Not later than 4 years after the date of
enactment of this Act, the Comptroller General of the United
States shall conduct an independent evaluation of the
activities carried out by the Board pursuant to this
subsection and submit to the appropriate committees of
Congress a report regarding the results of the independent
evaluation. Such report shall review and assess the Board's
activities with respect to the responsibilities described in
paragraph (3).
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH
FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS.
Section 301 of the Public Health Service Act (42 U.S.C.
241), as amended by section 2013, is further amended by
adding at the end the following:
``(g) Subchapter I of chapter 35 of title 44, United States
Code, shall not apply to the voluntary collection of
information during the conduct of research by the National
Institutes of Health.''.
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.
(a) In General.--Section 402 of the Public Health Service
Act (42 U.S.C. 282), as amended by section 2031, is further
amended by adding at the end the following:
``(n) Unique Research Initiatives.--
``(1) In general.--The Director of NIH may approve, after
consideration of a proposal under paragraph (2)(A), requests
by the national research institutes and centers, or program
officers within the Office of the Director to engage in
transactions other than a contract, grant, or cooperative
agreement with respect to projects that carry out--
``(A) the Precision Medicine Initiative under section 498E;
or
``(B) section 402(b)(7), except that not more than 50
percent of the funds available for a fiscal year through the
Common Fund under section 402A(c)(1) for purposes of carrying
out such section 402(b)(7) may be used to engage in such
other transactions.
``(2) Requirements.--The authority provided under this
subsection may be used to conduct or support high impact
cutting-edge research described in paragraph (1) using the
other transactions authority described in such paragraph if
the institute, center, or office--
``(A) submits a proposal to the Director of NIH for the use
of such authority before conducting or supporting the
research, including why the use of such authority is
essential to promoting the success of the project;
``(B) receives approval for the use of such authority from
the Director of NIH; and
``(C) for each year in which the institute, center, or
office has used such authority in accordance with this
subsection, submits a report to the Director of NIH on the
activities of the institute, center, or office relating to
such research.''.
(b) Report to Congress.--Not later than September 30, 2020,
the Secretary of Health and Human Services, acting through
the Director of the National Institutes of Health, shall
conduct an evaluation of the activities under subsection (n)
of section 402 of the Public Health Service Act (42 U.S.C.
282), as added by subsection (a), 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 on the results of such evaluation.
(c) Duties of Directors of Institutes.--Section 405(b)(1)
of the Public Health Service Act (42 U.S.C. 284(b)(1)) is
amended--
(1) by redesignating subparagraphs (C) through (L) as
subparagraphs (D) through (M), respectively; and
(2) by inserting after subparagraph (B), the following:
``(C) shall, as appropriate, conduct and support research
that has the potential to transform the scientific field, has
inherently higher risk, and that seeks to address major
current challenges;''.
SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL
SCIENCES.
(a) In General.--Section 479(b) of the Public Health
Service Act (42 U.S.C. 287(b)) is amended--
(1) in paragraph (1), by striking ``phase IIA'' and
inserting ``phase IIB''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A), by striking
``phase IIB'' and inserting ``phase III'';
(B) in subparagraph (A), by striking ``phase IIB'' and
inserting ``phase III'';
(C) in subparagraph (B), by striking ``phase IIA'' and
inserting ``phase IIB''; and
(D) in subparagraph (C), by striking ``phase IIB'' and
inserting ``phase III''.
(b) Increased Transparency.--Section 479 of the Public
Health Service Act (42 U.S.C. 287) is amended--
(1) in subsection (c)--
(A) in paragraph (4)(D), by striking ``and'' at the end;
(B) in paragraph (5), by striking the period and inserting
a semicolon; and
(C) by adding at the end the following:
``(6) the methods and tools, if any, that have been
developed since the last biennial report was prepared; and
``(7) the methods and tools, if any, that have been
developed and are being utilized by the Food and Drug
Administration to support medical product reviews.''; and
(2) by adding at the end the following:
``(d) Inclusion of List.--The first biennial report
submitted under this section after the
[[Page H6907]]
date of enactment of the 21st Century Cures Act shall include
a complete list of all of the methods and tools, if any,
which have been developed by research supported by the
Center.
``(e) Rule of Construction.--Nothing in this section shall
be construed as authorizing the Secretary to disclose any
information that is a trade secret, or other privileged or
confidential information subject to section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18,
United States Code.''.
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE
RESEARCH.
(a) Research Priorities; Collaborative Research Projects.--
Section 402(b) of the Public Health Service Act (42 U.S.C.
282(b)) is amended--
(1) by amending paragraph (4) to read as follows:
``(4) shall assemble accurate data to be used to assess
research priorities, including--
``(A) information to better evaluate scientific
opportunity, public health burdens, and progress in reducing
health disparities; and
``(B) data on study populations of clinical research,
funded by or conducted at each national research institute
and national center, which--
``(i) specifies the inclusion of--
``(I) women;
``(II) members of minority groups;
``(III) relevant age categories, including pediatric
subgroups; and
``(IV) other demographic variables as the Director of the
National Institutes of Health determines appropriate;
``(ii) is disaggregated by research area, condition, and
disease categories; and
``(iii) is to be made publicly available on the Internet
website of the National Institutes of Health;''; and
(2) in paragraph (8)--
(A) in subparagraph (A), by striking ``and'' at the end;
and
(B) by adding at the end the following:
``(C) foster collaboration between clinical research
projects funded by the respective national research
institutes and national centers that--
``(i) conduct research involving human subjects; and
``(ii) collect similar data; and
``(D) encourage the collaboration described in subparagraph
(C) to--
``(i) allow for an increase in the number of subjects
studied; and
``(ii) utilize diverse study populations, with special
consideration to biological, social, and other determinants
of health that contribute to health disparities;''.
(b) Reporting.--Section 492B(f) of the Public Health
Service Act (42 U.S.C. 289a-2(f)) is amended--
(1) by striking ``biennial'' each place such term appears
and inserting ``triennial'';
(2) by striking ``The advisory council'' and inserting the
following:
``(1) In general.--The advisory council''; and
(3) by adding at the end the following:
``(2) Contents.--Each triennial report prepared by an
advisory council of each national research institute as
described in paragraph (1) shall include each of the
following:
``(A) The number of women included as subjects, and the
proportion of subjects that are women, in any project of
clinical research conducted during the applicable reporting
period, disaggregated by categories of research area,
condition, or disease, and accounting for single-sex studies.
``(B) The number of members of minority groups included as
subjects, and the proportion of subjects that are members of
minority groups, in any project of clinical research
conducted during the applicable reporting period,
disaggregated by categories of research area, condition, or
disease and accounting for single-race and single-ethnicity
studies.
``(C) For the applicable reporting period, the number of
projects of clinical research that include women and members
of minority groups and that--
``(i) have been completed during such reporting period; and
``(ii) are being carried out during such reporting period
and have not been completed.
``(D) The number of studies completed during the applicable
reporting period for which reporting has been submitted in
accordance with subsection (c)(2)(A).''.
(c) Coordination.--Section 486(c)(2) of the Public Health
Service Act (42 U.S.C. 287d(c)(2)) is amended by striking
``designees'' and inserting ``senior-level staff designees''.
(d) In General.--Part A of title IV of the Public Health
Service Act (42 U.S.C. 281 et seq.), as amended by section
2021, is further amended by adding at the end the following:
``SEC. 404N. POPULATION FOCUSED RESEARCH.
``The Director of the National Institutes of Health shall,
as appropriate, encourage efforts to improve research related
to the health of sexual and gender minority populations,
including by--
``(1) facilitating increased participation of sexual and
gender minority populations in clinical research supported by
the National Institutes of Health, and reporting on such
participation, as applicable;
``(2) facilitating the development of valid and reliable
methods for research relevant to sexual and gender minority
populations; and
``(3) addressing methodological challenges.''.
(e) Reporting.--
(1) In general.--The Secretary, in collaboration with the
Director of the National Institutes of Health, shall as
appropriate--
(A) continue to support research for the development of
appropriate measures related to reporting health information
about sexual and gender minority populations; and
(B) not later than 2 years after the date of enactment of
this Act, disseminate and make public such measures.
(2) National academy of medicine recommendations.--In
developing the measures described in paragraph (1)(A), the
Secretary shall take into account recommendations made by the
National Academy of Medicine.
(f) Improving Coordination Related to Minority Health and
Health Disparities.--Section 464z-3 of the Public Health
Service Act (42 U.S.C. 285t) is amended--
(1) by redesignating subsection (h), relating to
interagency coordination, that follows subsection (j) as
subsection (k); and
(2) in subsection (k) (as so redesignated)--
(A) in the subsection heading, by striking ``Interagency''
and inserting ``Intra-National Institutes of Health'';
(B) by striking ``as the primary Federal officials'' and
inserting ``as the primary Federal official'';
(C) by inserting a comma after ``review'';
(D) by striking ``Institutes and Centers of the National
Institutes of Health'' and inserting ``national research
institutes and national centers''; and
(E) by adding at the end the following: ``The Director of
the Institute may foster partnerships between the national
research institutes and national centers and may encourage
the funding of collaborative research projects to achieve the
goals of the National Institutes of Health that are related
to minority health and health disparities.''.
(g) Basic Research.--
(1) Developing policies.--Not later than 2 years after the
date of enactment of this Act, the Director of the National
Institutes of Health (referred to in this section as the
``Director of the National Institutes of Health''), taking
into consideration the recommendations developed under
section 2039, shall develop policies for projects of basic
research funded by National Institutes of Health to assess--
(A) relevant biological variables including sex, as
appropriate; and
(B) how differences between male and female cells, tissues,
or animals may be examined and analyzed.
(2) Revising policies.--The Director of the National
Institutes of Health may update or revise the policies
developed under paragraph (1) as appropriate.
(3) Consultation and outreach.--In developing, updating, or
revising the policies under this section, the Director of the
National Institutes of Health shall--
(A) consult with--
(i) the Office of Research on Women's Health;
(ii) the Office of Laboratory Animal Welfare; and
(iii) appropriate members of the scientific and academic
communities; and
(B) conduct outreach to solicit feedback from members of
the scientific and academic communities on the influence of
sex as a variable in basic research, including feedback on
when it is appropriate for projects of basic research
involving cells, tissues, or animals to include both male and
female cells, tissues, or animals.
(4) Additional requirements.--The Director of the National
Institutes of Health shall--
(A) ensure that projects of basic research funded by the
National Institutes of Health are conducted in accordance
with the policies developed, updated, or revised under this
section, as applicable; and
(B) encourage that the results of such research, when
published or reported, be disaggregated as appropriate with
respect to the analysis of any sex differences.
(h) Clinical Research.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Director of the National
Institutes of Health, in consultation with the Director of
the Office of Research on Women's Health and the Director of
the National Institute on Minority Health and Health
Disparities, shall update the guidelines established under
section 492B(d) of Public Health Service Act (42 U.S.C. 289a-
2(d)) in accordance with paragraph (2).
(2) Requirements.--The updated guidelines described in
paragraph (1) shall--
(A) reflect the science regarding sex differences;
(B) improve adherence to the requirements under section
492B of the Public Health Service Act (42 U.S.C. 289a-2),
including the reporting requirements under subsection (f) of
such section; and
(C) clarify the circumstances under which studies should be
designed to support the conduct of analyses to detect
significant differences in the intervention effect due to
demographic factors related to section 492B of the Public
Health Service Act, including in the absence of prior studies
that demonstrate a difference in study outcomes on the basis
of such factors and considering the effects of the absence of
such analyses on the availability of data related to
demographic differences.
(i) Appropriate Age Groupings in Clinical Research.--
(1) Input from experts.--Not later than 180 days after the
date of enactment of this Act, the Director of the National
Institutes of Health shall convene a workshop of experts on
pediatric and older populations to provide input on--
(A) appropriate age groups to be included in research
studies involving human subjects; and
(B) acceptable justifications for excluding participants
from a range of age groups from human subjects research
studies.
(2) Policy updates.--Not later than 180 days after the
conclusion of the workshop under paragraph (1), the Director
of the National Institutes of Health shall make a
determination with respect to whether the policies of the
National Institutes of Health on the inclusion of relevant
age groups in clinical studies need to be updated, and shall
update such policies as appropriate. In making the
determination, the Director of the National Institutes of
Health shall take into consideration whether such policies--
[[Page H6908]]
(A) address the consideration of age as an inclusion
variable in research involving human subjects; and
(B) identify the criteria for justification for any age-
related exclusions in such research.
(3) Public availability of findings and conclusions.--The
Director of the National Institutes of Health shall--
(A) make the findings and conclusions resulting from the
workshop under paragraph (1) and updates to policies in
accordance with paragraph (2), as applicable, available to
the public on the Internet website of the National Institutes
of Health; and
(B) ensure that age-related data reported in the triennial
report under section 403 of the Public Health Service Act (42
U.S.C. 283) (as amended by section 2032) are made available
to the public on the Internet website of the National
Institutes of Health.
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF
SCIENTIFIC RESEARCH.
(a) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Director of the National
Institutes of Health, shall convene a working group under the
Advisory Committee to the Director of the National Institutes
of Health (referred to in this section as the ``Advisory
Committee''), appointed under section 222 of the Public
Health Service Act (42 U.S.C. 217a), to develop and issue
recommendations through the Advisory Committee for a formal
policy, which may incorporate or be informed by relevant
existing and ongoing activities, to enhance rigor and
reproducibility of scientific research funded by the National
Institutes of Health.
(b) Considerations.--In developing and issuing
recommendations through the Advisory Committee under
subsection (a), the working group established under such
subsection shall consider, as appropriate--
(1) preclinical experiment design, including analysis of
sex as a biological variable;
(2) clinical experiment design, including--
(A) the diversity of populations studied for clinical
research, with respect to biological, social, and other
determinants of health that contribute to health disparities;
(B) the circumstances under which summary information
regarding biological, social, and other factors that
contribute to health disparities should be reported; and
(C) the circumstances under which clinical studies,
including clinical trials, should conduct an analysis of the
data collected during the study on the basis of biological,
social, and other factors that contribute to health
disparities;
(3) applicable levels of rigor in statistical methods,
methodology, and analysis;
(4) data and information sharing in accordance with
applicable privacy laws and regulations; and
(5) any other matter the working group determines relevant.
(c) Policies.--Not later than 18 months after the date of
enactment of this Act, the Director of the National
Institutes of Health shall consider the recommendations
developed by the working group and issued by the Advisory
Committee under subsection (a) and develop or update policies
as appropriate.
(d) Report.--Not later than 2 years after the date of
enactment of this Act, the Director of the National
Institutes of Health shall issue a report to the Secretary of
Health and Human Services, the Committee on Health,
Education, Labor, and Pensions of the Senate, and the
Committee on Energy and Commerce of the House of
Representatives regarding recommendations developed under
subsection (a) and any subsequent policy changes implemented,
to enhance rigor and reproducibility in scientific research
funded by the National Institutes of Health.
(e) Confidentiality.--Nothing in this section authorizes
the Secretary of Health and Human Services to disclose any
information that is a trade secret, or other privileged or
confidential information, described in section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18,
United States Code.
SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE
NATIONAL INSTITUTES OF HEALTH.
(a) In General.--Section 452 of the Public Health Service
Act (42 U.S.C. 285g-4) is amended--
(1) in subsection (b), by striking ``conduct and support''
and inserting ``conduct, support, and coordination'';
(2) in subsection (c)(1)(C), by striking ``of the Center''
and inserting ``within the Center'';
(3) in subsection (d)--
(A) by striking ``(d)(1) In consultation'' and all that
follows through the end of paragraph (1) and inserting the
following:
``(d)(1) The Director of the Center, in consultation with
the Director of the Institute, the coordinating committee
established under subsection (e), and the advisory board
established under subsection (f), shall develop a
comprehensive plan (referred to in this section as the
`Research Plan') for the conduct, support, and coordination
of medical rehabilitation research.'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``; and'' and
inserting a semicolon;
(ii) in subparagraph (B), by striking the period and
inserting ``; and''; and
(iii) by adding at the end the following:
``(C) include goals and objectives for conducting,
supporting, and coordinating medical rehabilitation research,
consistent with the purpose described in subsection (b).'';
(C) by striking paragraph (4) and inserting the following:
``(4) The Director of the Center, in consultation with the
Director of the Institute, the coordinating committee
established under subsection (e), and the advisory board
established under subsection (f), shall revise and update the
Research Plan periodically, as appropriate, or not less than
every 5 years. Not later than 30 days after the Research Plan
is so revised and updated, the Director of the Center shall
transmit the revised and updated Research Plan to the
President, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives.''; and
(D) by adding at the end the following:
``(5) The Director of the Center, in consultation with the
Director of the Institute, shall, prior to revising and
updating the Research Plan, prepare a report for the
coordinating committee established under subsection (e) and
the advisory board established under subsection (f) that
describes and analyzes the progress during the preceding
fiscal year in achieving the goals and objectives described
in paragraph (2)(C) and includes expenditures for
rehabilitation research at the National Institutes of Health.
The report shall include recommendations for revising and
updating the Research Plan, and such initiatives as the
Director of the Center and the Director of the Institute
determine appropriate. In preparing the report, the Director
of the Center and the Director of the Institute shall consult
with the Director of the National Institutes of Health.'';
(4) in subsection (e)--
(A) in paragraph (2), by inserting ``periodically host a
scientific conference or workshop on medical rehabilitation
research and'' after ``The Coordinating Committee shall'';
and
(B) in paragraph (3), by inserting ``the Director of the
Division of Program Coordination, Planning, and Strategic
Initiatives within the Office of the Director of the National
Institutes of Health,'' after ``shall be composed of'';
(5) in subsection (f)(3)(B)--
(A) by redesignating clauses (ix) through (xi) as clauses
(x) through (xii), respectively; and
(B) by inserting after clause (viii) the following:
``(ix) The Director of the Division of Program
Coordination, Planning, and Strategic Initiatives.''; and
(6) by adding at the end the following:
``(g)(1) The Secretary and the heads of other Federal
agencies shall jointly review the programs carried out (or
proposed to be carried out) by each such official with
respect to medical rehabilitation research and, as
appropriate, enter into agreements preventing duplication
among such programs.
``(2) The Secretary shall, as appropriate, enter into
interagency agreements relating to the coordination of
medical rehabilitation research conducted by agencies of the
National Institutes of Health and other agencies of the
Federal Government.
``(h) For purposes of this section, the term `medical
rehabilitation research' means the science of mechanisms and
interventions that prevent, improve, restore, or replace
lost, underdeveloped, or deteriorating function.''.
(b) Conforming Amendment.--Section 3 of the National
Institutes of Health Amendments of 1990 (42 U.S.C. 285g-4
note) is amended--
(1) in subsection (a), by striking ``In General.--''; and
(2) by striking subsection (b).
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN
AND LACTATING WOMEN.
(a) Task Force on Research Specific to Pregnant Women and
Lactating Women.--
(1) Establishment.--Not later than 90 days after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall establish a task force, in accordance with the Federal
Advisory Committee Act (5 U.S.C. App.), to be known as the
``Task Force on Research Specific to Pregnant Women and
Lactating Women'' (in this section referred to as the ``Task
Force'').
(2) Duties.--The Task Force shall provide advice and
guidance to the Secretary regarding Federal activities
related to identifying and addressing gaps in knowledge and
research regarding safe and effective therapies for pregnant
women and lactating women, including the development of such
therapies and the collaboration on and coordination of such
activities.
(3) Membership.--
(A) Federal members.--The Task Force shall be composed of
each of the following Federal members, or the designees of
such members:
(i) The Director of the Centers for Disease Control and
Prevention.
(ii) The Director of the National Institutes of Health, the
Director of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, and the directors of such
other appropriate national research institutes.
(iii) The Commissioner of Food and Drugs.
(iv) The Director of the Office on Women's Health.
(v) The Director of the National Vaccine Program Office.
(vi) The head of any other research-related agency or
department not described in clauses (i) through (v) that the
Secretary determines appropriate, which may include the
Department of Veterans Affairs and the Department of Defense.
(B) Non-federal members.--The Task Force shall be composed
of each of the following non-Federal members, including--
(i) representatives from relevant medical societies with
subject matter expertise on pregnant women, lactating women,
or children;
(ii) nonprofit organizations with expertise related to the
health of women and children;
(iii) relevant industry representatives; and
(iv) other representatives, as appropriate.
(C) Limitations.--The non-Federal members described in
subparagraph (B) shall--
(i) compose not more than one-half, and not less than one-
third, of the total membership of the Task Force; and
[[Page H6909]]
(ii) be appointed by the Secretary.
(4) Termination.--
(A) In general.--Subject to subparagraph (B), the Task
Force shall terminate on the date that is 2 years after the
date on which the Task Force is established under paragraph
(1).
(B) Extension.--The Secretary may extend the operation of
the Task Force for one additional 2-year period following the
2-year period described in subparagraph (A), if the Secretary
determines that the extension is appropriate for carrying out
the purpose of this section.
(5) Meetings.--The Task Force shall meet not less than 2
times each year and shall convene public meetings, as
appropriate, to fulfill its duties under paragraph (2).
(6) Task force report to congress.--Not later than 18
months after the date on which the Task Force is established
under paragraph (1), the Task Force shall prepare and submit
to the Secretary, the Committee on Health, Education, Labor,
and Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives a report that
includes each of the following:
(A) A plan to identify and address gaps in knowledge and
research regarding safe and effective therapies for pregnant
women and lactating women, including the development of such
therapies.
(B) Ethical issues surrounding the inclusion of pregnant
women and lactating women in clinical research.
(C) Effective communication strategies with health care
providers and the public on information relevant to pregnant
women and lactating women.
(D) Identification of Federal activities, including--
(i) the state of research on pregnancy and lactation;
(ii) recommendations for the coordination of, and
collaboration on research related to pregnant women and
lactating women;
(iii) dissemination of research findings and information
relevant to pregnant women and lactating women to providers
and the public; and
(iv) existing Federal efforts and programs to improve the
scientific understanding of the health impacts on pregnant
women, lactating women, and related birth and pediatric
outcomes, including with respect to pharmacokinetics,
pharmacodynamics, and toxicities.
(E) Recommendations to improve the development of safe and
effective therapies for pregnant women and lactating women.
(b) Confidentiality.--Nothing in this section shall
authorize the Secretary of Health and Human Services to
disclose any information that is a trade secret, or other
privileged or confidential information, described in section
552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code.
(c) Updating Protections for Pregnant Women and Lactating
Women in Research.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary, considering any
recommendations of the Task Force available at such time and
in consultation with the heads of relevant agencies of the
Department of Health and Human Services, shall, as
appropriate, update regulations and guidance, as applicable,
regarding the inclusion of pregnant women and lactating women
in clinical research.
(2) Criteria for excluding pregnant or lactating women.--In
updating any regulations or guidance described in paragraph
(1), the Secretary shall consider any appropriate criteria to
be used by institutional review boards and individuals
reviewing grant proposals for excluding pregnant women or
lactating women as a study population requiring additional
protections from participating in human subject research.
SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH
REPORTING REQUIREMENTS.
(a) Trans-National Institutes of Health Research
Reporting.--Section 402A(c)(2) of the Public Health Service
Act (42 U.S.C. 282a(c)(2)) is amended--
(1) by amending subparagraph (B) to read as follows:
``(B) Reporting.--Not later than 2 years after the date of
enactment of 21st Century Cures Act, the head of each
national research institute or national center shall submit
to the Director of the National Institutes of Health a
report, to be included in the triennial report under section
403, on the amount made available by the institute or center
for conducting or supporting research that involves
collaboration between the institute or center and 1 or more
other national research institutes or national centers.'';
and
(2) in subparagraphs (D) and (E) by striking ``(B)(i)''
each place it appears and inserting ``(B)''.
(b) Fraud and Abuse Reporting.--Section 403B of the Public
Health Service Act (42 U.S.C. 283a-1) is amended--
(1) by striking subsection (b);
(2) by redesignating subsection (c) as subsection (b); and
(3) in subsection (b) (as so redesignated), by striking
``subsections (a) and (b)'' and inserting ``subsection (a)''.
(c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the
Public Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended
by striking ``(not including any leaves of absence)''.
(d) Vaccine Reporting.--Section 404B of the Public Health
Service Act (42 U.S.C. 283d) is amended--
(1) by striking subsection (b); and
(2) by striking ``(a) Development of New Vaccines.--The
Secretary'' and inserting ``The Secretary''.
(e) National Center for Advancing Translational Sciences.--
Section 479(c) of the Public Health Service Act (42 U.S.C.
287(c)) is amended--
(1) in the subsection heading, by striking ``Annual'' and
inserting ``Biennial''; and
(2) in the matter preceding paragraph (1), by striking ``an
annual report'' and inserting ``a report on a biennial
basis''.
(f) Review of Centers of Excellence.--
(1) Repeal.--Section 404H of the Public Health Service Act
(42 U.S.C. 283j) is repealed.
(2) Conforming amendment.--Section 399EE(c) of the Public
Health Service Act (42 U.S.C. 280-4(c)) is amended by
striking ``399CC, 404H,'' and inserting ``399CC''.
(g) Rapid HIV Test Report.--Section 502(a) of the Ryan
White CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is
amended--
(1) by striking paragraph (2); and
(2) by redesignating paragraph (3) as paragraph (2).
(h) National Institute of Nursing Research.--
(1) Repeal.--Section 464Y of the Public Health Service Act
(42 U.S.C. 285q-3) is repealed.
(2) Conforming amendment.--Section 464X(g) of the Public
Health Service Act (42 U.S.C. 285q-2(g)) is amended by
striking ``biennial report made under section 464Y,'' and
inserting ``triennial report made under section 403''.
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING
ORGANISMS.
Section 301 of the Public Health Service Act (42 U.S.C.
241), as amended by section 2035, is further amended--
(1) in the flush matter at the end of subsection (a)--
(A) by redesignating such matter as subsection (h)(1); and
(B) by moving such matter so as to appear at the end of
such section; and
(2) in subsection (h) (as so redesignated), by adding at
the end the following:
``(2) Where research substances and living organisms are
made available under paragraph (1) through contractors, the
Secretary may direct such contractors to collect payments on
behalf of the Secretary for the costs incurred to make
available such substances and organisms and to forward
amounts so collected to the Secretary, in the time and manner
specified by the Secretary.
``(3) Amounts collected under paragraph (2) shall be
credited to the appropriations accounts that incurred the
costs to make available the research substances and living
organisms involved, and shall remain available until expended
for carrying out activities under such accounts.''.
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF
UNDERREPRESENTED POPULATIONS IN CLINICAL
TRIALS.
It is the sense of Congress that the National Institute on
Minority Health and Health Disparities should include within
its strategic plan under section 402(m) of the Public Health
Service Act (42 U.S.C. 282(m)) ways to increase
representation of underrepresented populations in clinical
trials.
Subtitle E--Advancement of the National Institutes of Health Research
and Data Access
SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
Section 402(j)(2)(D) of the Public Health Service Act (42
U.S.C. 282(j)(2)(D)) is amended--
(1) in clause (ii)(I), by inserting before the semicolon
``, unless the responsible party affirmatively requests that
the Director of the National Institutes of Health publicly
post such clinical trial information for an applicable device
clinical trial prior to such date of clearance or approval'';
and
(2) by adding at the end the following:
``(iii) Option to make certain clinical trial information
available earlier.--The Director of the National Institutes
of Health shall inform responsible parties of the option to
request that clinical trial information for an applicable
device clinical trial be publicly posted prior to the date of
clearance or approval, in accordance with clause (ii)(I).
``(iv) Combination products.--An applicable clinical trial
for a product that is a combination of drug, device, or
biological product shall be considered--
``(I) an applicable drug clinical trial, if the Secretary
determines under section 503(g) of the Federal Food, Drug,
and Cosmetic Act that the primary mode of action of such
product is that of a drug or biological product; or
``(II) an applicable device clinical trial, if the
Secretary determines under such section that the primary mode
of action of such product is that of a device.''.
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
(a) Definitions.--In this section:
(1) Applicable clinical trial.--The term ``applicable
clinical trial'' has the meaning given the term in section
402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Report on Activities To Encourage Compliance.--Not
later than 2 years after the date of enactment of this Act,
the Secretary, acting through the Director of the National
Institutes of Health and in collaboration with the
Commissioner of Food and Drugs, shall submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives, a report that describes education and
outreach, guidance, enforcement, and other activities
undertaken to encourage compliance with section 402(j) of the
Public Health Service Act (42 U.S.C. 282(j)).
(c) Reports on Clinical Trials.--
(1) In general.--Not later than 2 years after the final
compliance date under the final rule implementing section
402(j) of the Public Health Service Act, and every 2 years
thereafter for the next 4 years, the Secretary, acting
through the Director of the National Institutes of Health
[[Page H6910]]
and in collaboration with the Commissioner of Food and Drugs,
shall submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a report
describing--
(A) the total number of applicable clinical trials with
complete data bank registration information registered during
the period for which the report is being prepared (broken
down by each year of such reporting period);
(B) the total number of applicable clinical trials
registered during the period for which the report is being
prepared for which results have been submitted to the data
bank (broken down by each year of such reporting period);
(C) the activities undertaken by the Secretary to educate
responsible persons about data bank registration and results
submission requirements, including through issuance of
guidance documents, informational meetings, and training
sessions; and
(D) the activities described in the report submitted under
subsection (b).
(2) Actions to enforce compliance.--After the Secretary has
undertaken the educational activities described in paragraph
(1)(C), the Secretary shall include in subsequent reports
submitted under paragraph (1) the number of actions taken by
the Secretary during the period for which the report is being
prepared to enforce compliance with data bank registration
and results submission requirements.
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.
Section 492B(c) of the Public Health Service Act (42 U.S.C.
289a-2(c)) is amended--
(1) by striking ``In the case'' and inserting the
following:
``(1) In general.--In the case''; and
(2) by adding at the end the following:
``(2) Reporting requirements.--For any new and competing
project of clinical research subject to the requirements
under this section that receives a grant award 1 year after
the date of enactment of the 21st Century Cures Act, or any
date thereafter, for which a valid analysis is provided under
paragraph (1)--
``(A) and which is an applicable clinical trial as defined
in section 402(j), the entity conducting such clinical
research shall submit the results of such valid analysis to
the clinical trial registry data bank expanded under section
402(j)(3), and the Director of the National Institutes of
Health shall, as appropriate, consider whether such entity
has complied with the reporting requirement described in this
subparagraph in awarding any future grant to such entity,
including pursuant to section 402(j)(5)(A)(ii) when
applicable; and
``(B) the Director of the National Institutes of Health
shall encourage the reporting of the results of such valid
analysis described in paragraph (1) through any additional
means determined appropriate by the Director.''.
SEC. 2054. CONSULTATION.
Not later than 90 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall consult
with relevant Federal agencies, including the Food and Drug
Administration, the Office of the National Coordinator for
Health Information Technology, and the National Institutes of
Health, as well as other stakeholders (including patients,
researchers, physicians, industry representatives, and
developers of health information technology) to receive
recommendations with respect to enhancements to the clinical
trial registry data bank under section 402(j) of the Public
Health Service Act (42 U.S.C. 282(j)), including with respect
to usability, functionality, and search capability.
Subtitle F--Facilitating Collaborative Research
SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE
SYSTEM.
Part P of title III of the Public Health Service Act (42
U.S.C. 280g et seq.) is amended by inserting after section
399S the following:
``SEC. 399S-1. SURVEILLANCE OF NEUROLOGICAL DISEASES.
``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention
and in coordination with other agencies as the Secretary
determines, shall, as appropriate--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases; and
``(2) incorporate information obtained through such
activities into an integrated surveillance system, which may
consist of or include a registry, to be known as the National
Neurological Conditions Surveillance System.
``(b) Research.--The Secretary shall ensure that the
National Neurological Conditions Surveillance System is
designed in a manner that facilitates further research on
neurological diseases.
``(c) Content.--In carrying out subsection (a), the
Secretary--
``(1) shall provide for the collection and storage of
information on the incidence and prevalence of neurological
diseases in the United States;
``(2) to the extent practicable, shall provide for the
collection and storage of other available information on
neurological diseases, including information related to
persons living with neurological diseases who choose to
participate, such as--
``(A) demographics, such as age, race, ethnicity, sex,
geographic location, family history, and other information,
as appropriate;
``(B) risk factors that may be associated with neurological
diseases, such as genetic and environmental risk factors and
other information, as appropriate; and
``(C) diagnosis and progression markers;
``(3) may provide for the collection and storage of
information relevant to analysis on neurological diseases,
such as information concerning--
``(A) the natural history of the diseases;
``(B) the prevention of the diseases;
``(C) the detection, management, and treatment approaches
for the diseases; and
``(D) the development of outcomes measures;
``(4) may address issues identified during the consultation
process under subsection (d); and
``(5) initially may address a limited number of
neurological diseases.
``(d) Consultation.--In carrying out this section, the
Secretary shall consult with individuals with appropriate
expertise, which may include--
``(1) epidemiologists with experience in disease
surveillance or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on neurological diseases; and
``(B) have demonstrated experience in research, care, or
patient services;
``(3) health information technology experts or other
information management specialists;
``(4) clinicians with expertise in neurological diseases;
and
``(5) research scientists with experience conducting
translational research or utilizing surveillance systems for
scientific research purposes.
``(e) Grants.--The Secretary may award grants to, or enter
into contracts or cooperative agreements with, public or
private nonprofit entities to carry out activities under this
section.
``(f) Coordination With Other Federal, State, and Local
Agencies.--Subject to subsection (h), the Secretary shall--
``(1) make information and analysis in the National
Neurological Conditions Surveillance System available, as
appropriate--
``(A) to Federal departments and agencies, such as the
National Institutes of Health and the Department of Veterans
Affairs; and
``(B) to State and local agencies; and
``(2) identify, build upon, leverage, and coordinate among
existing data and surveillance systems, surveys, registries,
and other Federal public health infrastructure, wherever
practicable.
``(g) Public Access.--Subject to subsection (h), the
Secretary shall ensure that information and analysis in the
National Neurological Conditions Surveillance System are
available, as appropriate, to the public, including
researchers.
``(h) Privacy.--The Secretary shall ensure that information
and analysis in the National Neurological Conditions
Surveillance System are made available only to the extent
permitted by applicable Federal and State law, and in a
manner that protects personal privacy, to the extent required
by applicable Federal and State privacy law, at a minimum.
``(i) Reports.--
``(1) Report on information and analyses.--Not later than 1
year after the date on which any system is established under
this section, the Secretary shall submit an interim 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 aggregate information
collected pursuant to this section and epidemiological
analyses, as appropriate. Such report shall be posted on the
Internet website of the Department of Health and Human
Services and shall be updated biennially.
``(2) Implementation report.--Not later than 4 years after
the date of the enactment of this section, the Secretary
shall submit a report to the Congress concerning the
implementation of this section. Such report shall include
information on--
``(A) the development and maintenance of the National
Neurological Conditions Surveillance System;
``(B) the type of information collected and stored in the
surveillance system;
``(C) the use and availability of such information,
including guidelines for such use; and
``(D) the use and coordination of databases that collect or
maintain information on neurological diseases.
``(j) Definition.--In this section, the term `national
voluntary health association' means a national nonprofit
organization with chapters, other affiliated organizations,
or networks in States throughout the United States with
experience serving the population of individuals with
neurological disease and have demonstrated experience in
neurological disease research, care, and patient services.
``(k) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $5,000,000
for each of fiscal years 2018 through 2022.''.
SEC. 2062. TICK-BORNE DISEASES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as ``the Secretary'') shall
continue to conduct or support epidemiological, basic,
translational, and clinical research related to vector-borne
diseases, including tick-borne diseases.
(b) Reports.--The Secretary shall ensure that each
triennial report under section 403 of the Public Health
Service Act (42 U.S.C. 283) (as amended by section 2032)
includes information on actions undertaken by the National
Institutes of Health to carry out subsection (a) with respect
to tick-borne diseases.
(c) Tick-borne Diseases Working Group.--
(1) Establishment.--The Secretary shall establish a working
group, to be known as the Tick-Borne Disease Working Group
(referred to in this section as the ``Working Group''),
comprised of representatives of appropriate Federal agencies
and other non-Federal entities, to provide expertise and to
review all efforts within the Department of Health and Human
Services related to all tick-borne diseases, to help ensure
interagency coordination and minimize overlap, and to examine
research priorities.
(2) Responsibilities.--The working group shall--
[[Page H6911]]
(A) not later than 2 years after the date of enactment of
this Act, develop or update a summary of--
(i) ongoing tick-borne disease research, including research
related to causes, prevention, treatment, surveillance,
diagnosis, diagnostics, duration of illness, and intervention
for individuals with tick-borne diseases;
(ii) advances made pursuant to such research;
(iii) Federal activities related to tick-borne diseases,
including--
(I) epidemiological activities related to tick-borne
diseases; and
(II) basic, clinical, and translational tick-borne disease
research related to the pathogenesis, prevention, diagnosis,
and treatment of tick-borne diseases;
(iv) gaps in tick-borne disease research described in
clause (iii)(II);
(v) the Working Group's meetings required under paragraph
(4); and
(vi) the comments received by the Working Group;
(B) make recommendations to the Secretary regarding any
appropriate changes or improvements to such activities and
research; and
(C) solicit input from States, localities, and
nongovernmental entities, including organizations
representing patients, health care providers, researchers,
and industry regarding scientific advances, research
questions, surveillance activities, and emerging strains in
species of pathogenic organisms.
(3) Membership.--The members of the working group shall
represent a diversity of scientific disciplines and views and
shall be composed of the following members:
(A) Federal members.--Seven Federal members, consisting of
one of more representatives of each of the following:
(i) The Office of the Assistant Secretary for Health.
(ii) The Food and Drug Administration.
(iii) The Centers for Disease Control and Prevention.
(iv) The National Institutes of Health.
(v) Such other agencies and offices of the Department of
Health and Human Services as the Secretary determines
appropriate.
(B) Non-Federal public members.--Seven non-Federal public
members, consisting of representatives of the following
categories:
(i) Physicians and other medical providers with experience
in diagnosing and treating tick-borne diseases.
(ii) Scientists or researchers with expertise.
(iii) Patients and their family members.
(iv) Nonprofit organizations that advocate for patients
with respect to tick-borne diseases.
(v) Other individuals whose expertise is determined by the
Secretary to be beneficial to the functioning of the Working
Group.
(4) Meetings.--The Working Group shall meet not less than
twice each year.
(5) Reporting.--Not later than 2 years after the date of
enactment of this Act, and every 2 years thereafter until
termination of the Working Group pursuant to paragraph (7),
the Working Group shall--
(A) submit a report on its activities under paragraph
(2)(A) and any recommendations under paragraph (2)(B) to the
Secretary, the Committee on Energy and Commerce of the House
of Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate; and
(B) make such report publicly available on the Internet
website of the Department of Health and Human Services.
(6) Applicability of faca.--The Working Group shall be
treated as an advisory committee subject to the Federal
Advisory Committee Act (5 U.S.C. App.).
(7) Sunset.--The Working Group under this section shall
terminate 6 years after the date of enactment of this Act.
SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR
RESEARCH PURPOSES.
(a) Guidance Related to Remote Access.--Not later than 1
year after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary'') shall issue guidance clarifying that
subparagraph (B) of section 164.512(i)(1)(ii) of part 164 of
the Rule (prohibiting the removal of protected health
information by a researcher) does not prohibit remote access
to health information by a researcher for such purposes as
described in section 164.512(i)(1)(ii) of part 164 of the
Rule so long as--
(1) at a minimum, security and privacy safeguards,
consistent with the requirements of the Rule, are maintained
by the covered entity and the researcher; and
(2) the protected health information is not copied or
otherwise retained by the researcher.
(b) Guidance Related to Streamlining Authorization.--Not
later than 1 year after the date of enactment of this Act,
the Secretary shall issue guidance on the following:
(1) Authorization for use and disclosure of health
information.--Clarification of the circumstances under which
the authorization for the use or disclosure of protected
health information, with respect to an individual, for future
research purposes contains a sufficient description of the
purpose of the use or disclosure, such as if the
authorization--
(A) sufficiently describes the purposes such that it would
be reasonable for the individual to expect that the protected
health information could be used or disclosed for such future
research;
(B) either--
(i) states that the authorization will expire on a
particular date or on the occurrence of a particular event;
or
(ii) states that the authorization will remain valid unless
and until it is revoked by the individual; and
(C) provides instruction to the individual on how to revoke
such authorization at any time.
(2) Reminder of the right to revoke.--Clarification of the
circumstances under which it is appropriate to provide an
individual with an annual notice or reminder that the
individual has the right to revoke such authorization.
(3) Revocation of authorization.--Clarification of
appropriate mechanisms by which an individual may revoke an
authorization for future research purposes, such as described
in paragraph (1)(C).
(c) Working Group on Protected Health Information for
Research.--
(1) Establishment.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall convene a working
group to study and report on the uses and disclosures of
protected health information for research purposes, under the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191).
(2) Members.--The working group shall include
representatives of--
(A) relevant Federal agencies, including the National
Institutes of Health, the Centers for Disease Control and
Prevention, the Food and Drug Administration, and the Office
for Civil Rights;
(B) the research community;
(C) patients;
(D) experts in civil rights, such as privacy rights;
(E) developers of health information technology;
(F) experts in data privacy and security;
(G) health care providers;
(H) bioethicists; and
(I) other experts and entities, as the Secretary determines
appropriate.
(3) Report.--Not later than 1 year after the date on which
the working group is convened under paragraph (1), the
working group shall conduct a review and submit a report to
the Secretary containing recommendations on whether the uses
and disclosures of protected health information for research
purposes should be modified to allow protected health
information to be available, as appropriate, for research
purposes, including studies to obtain generalizable
knowledge, while protecting individuals' privacy rights. In
conducting the review and making recommendations, the working
group shall--
(A) address, at a minimum--
(i) the appropriate manner and timing of authorization,
including whether additional notification to the individual
should be required when the individual's protected health
information will be used or disclosed for such research;
(ii) opportunities for individuals to set preferences on
the manner in which their protected health information is
used in research;
(iii) opportunities for patients to revoke authorization;
(iv) notification to individuals of a breach in privacy;
(v) existing gaps in statute, regulation, or policy related
to protecting the privacy of individuals, and
(vi) existing barriers to research related to the current
restrictions on the uses and disclosures of protected health
information; and
(B) consider, at a minimum--
(i) expectations and preferences on how an individual's
protected health information is shared and used;
(ii) issues related to specific subgroups of people, such
as children, incarcerated individuals, and individuals with a
cognitive or intellectual disability impacting capacity to
consent;
(iii) relevant Federal and State laws;
(iv) models of facilitating data access and levels of data
access, including data segmentation, where applicable;
(v) potential impacts of disclosure and non-disclosure of
protected health information on access to health care
services; and
(vi) the potential uses of such data.
(4) Report submission.--The Secretary shall submit the
report under paragraph (3) to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, and shall post such report on the
appropriate Internet website of the Department of Health and
Human Services.
(5) Termination.--The working group convened under
paragraph (1) shall terminate the day after the report under
paragraph (3) is submitted to Congress and made public in
accordance with paragraph (4).
(d) Definitions.--In this section:
(1) The rule.--References to ``the Rule'' refer to part 160
or part 164, as appropriate, of title 45, Code of Federal
Regulations (or any successor regulation).
(2) Part 164.--References to a specified section of ``part
164'', refer to such specified section of part 164 of title
45, Code of Federal Regulations (or any successor section).
Subtitle G--Promoting Pediatric Research
SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
Section 409D(d) of the Public Health Service Act (42 U.S.C.
284h(d)) is amended--
(1) in paragraph (1), by striking ``in consultation with
the Director of the Eunice Kennedy Shriver National Institute
of Child Health and Human Development and in collaboration
with other appropriate national research institutes and
national centers that carry out activities involving
pediatric research, may provide for the establishment of''
and inserting ``in collaboration with the national research
institutes and national centers that carry out activities
involving pediatric research, shall support''; and
(2) in paragraph (2)(A) and the first sentence of paragraph
(2)(E), by striking ``may'' each place such term appears and
inserting ``shall''.
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
It is the sense of Congress that--
(1) the National Institutes of Health should encourage a
global pediatric clinical study network by providing grants,
contracts, or cooperative agreements to support new and early
stage
[[Page H6912]]
investigators who participate in the global pediatric
clinical study network;
(2) the Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') should engage with
clinical investigators and appropriate authorities outside of
the United States, including authorities in the European
Union, during the formation of the global pediatric clinical
study network to encourage the participation of such
investigator and authorities; and
(3) once a global pediatric clinical study network is
established and becomes operational, the Secretary should
continue to encourage and facilitate the participation of
clinical investigators and appropriate authorities outside of
the United States, including in the European Union, to
participate in the network with the goal of enhancing the
global reach of the network.
TITLE III--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
SEC. 3001. PATIENT EXPERIENCE DATA.
Section 569C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-8c) is amended--
(1) in subsection (a)--
(A) in the subsection heading, by striking ``In General''
and inserting ``Patient Engagement in Drugs and Devices'';
(B) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving such
subparagraphs 2 ems to the right; and
(C) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary'';
(2) by redesignating subsections (b) through (e) as
paragraphs (2) through (5), respectively, and moving such
paragraphs 2 ems to the right; and
(3) by adding at the end the following:
``(b) Statement of Patient Experience.--
``(1) In general.--Following the approval of an application
that was submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act at least 180
days after the date of enactment of the 21st Century Cures
Act, the Secretary shall make public a brief statement
regarding the patient experience data and related
information, if any, submitted and reviewed as part of such
application.
``(2) Data and information.--The data and information
referred to in paragraph (1) are--
``(A) patient experience data;
``(B) information on patient-focused drug development
tools; and
``(C) other relevant information, as determined by the
Secretary.
``(c) Patient Experience Data.--For purposes of this
section, the term `patient experience data' includes data
that--
``(1) are collected by any persons (including patients,
family members and caregivers of patients, patient advocacy
organizations, disease research foundations, researchers, and
drug manufacturers); and
``(2) are intended to provide information about patients'
experiences with a disease or condition, including--
``(A) the impact of such disease or condition, or a related
therapy, on patients' lives; and
``(B) patient preferences with respect to treatment of such
disease or condition.''.
SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUIDANCE.
(a) Publication of Guidance Documents.--Not later than 180
days after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary''), acting through the Commissioner of Food
and Drugs, shall develop a plan to issue draft and final
versions of one or more guidance documents, over a period of
5 years, regarding the collection of patient experience data,
and the use of such data and related information in drug
development. Not later than 18 months after the date of
enactment of this Act, the Secretary shall issue a draft
version of at least one such guidance document. Not later
than 18 months after the public comment period on the draft
guidance ends, the Secretary shall issue a revised draft
guidance or final guidance.
(b) Patient Experience Data.--For purposes of this section,
the term ``patient experience data'' has the meaning given
such term in section 569C of the Federal Food, Drug, and
Cosmetic Act (as added by section 3001).
(c) Contents.--The guidance documents described in
subsection (a) shall address--
(1) methodological approaches that a person seeking to
collect patient experience data for submission to, and
proposed use by, the Secretary in regulatory decisionmaking
may use, that are relevant and objective and ensure that such
data are accurate and representative of the intended
population, including methods to collect meaningful patient
input throughout the drug development process and
methodological considerations for data collection, reporting,
management, and analysis;
(2) methodological approaches that may be used to develop
and identify what is most important to patients with respect
to burden of disease, burden of treatment, and the benefits
and risks in the management of the patient's disease;
(3) approaches to identifying and developing methods to
measure impacts to patients that will help facilitate
collection of patient experience data in clinical trials;
(4) methodologies, standards, and technologies to collect
and analyze clinical outcome assessments for purposes of
regulatory decisionmaking;
(5) how a person seeking to develop and submit proposed
draft guidance relating to patient experience data for
consideration by the Secretary may submit such proposed draft
guidance to the Secretary;
(6) the format and content required for submissions under
this section to the Secretary, including with respect to the
information described in paragraph (1);
(7) how the Secretary intends to respond to submissions of
information described in paragraph (1), if applicable,
including any timeframe for response when such submission is
not part of a regulatory application or other submission that
has an associated timeframe for response; and
(8) how the Secretary, if appropriate, anticipates using
relevant patient experience data and related information,
including with respect to the structured risk-benefit
assessment framework described in section 505(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to
inform regulatory decisionmaking.
SEC. 3003. STREAMLINING PATIENT INPUT.
Chapter 35 of title 44, United States Code, shall not apply
to the collection of information to which a response is
voluntary, that is initiated by the Secretary under section
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) (as amended by section 3001) or section 3002.
SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.
Not later than June 1 of 2021, 2026, and 2031, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall prepare and publish on
the Internet website of the Food and Drug Administration a
report assessing the use of patient experience data in
regulatory decisionmaking, in particular with respect to the
review of patient experience data and information on patient-
focused drug development tools as part of applications
approved under section 505(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a)).
Subtitle B--Advancing New Drug Therapies
SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506F the following new section:
``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
``(a) Process for Qualification.--
``(1) In general.--The Secretary shall establish a process
for the qualification of drug development tools for a
proposed context of use under which--
``(A)(i) a requestor initiates such process by submitting a
letter of intent to the Secretary; and
``(ii) the Secretary accepts or declines to accept such
letter of intent;
``(B)(i) if the Secretary accepts the letter of intent, a
requestor submits a qualification plan to the Secretary; and
``(ii) the Secretary accepts or declines to accept the
qualification plan; and
``(C)(i) if the Secretary accepts the qualification plan,
the requestor submits to the Secretary a full qualification
package;
``(ii) the Secretary determines whether to accept such
qualification package for review; and
``(iii) if the Secretary accepts such qualification package
for review, the Secretary conducts such review in accordance
with this section.
``(2) Acceptance and review of submissions.--
``(A) In general.--Subparagraphs (B), (C), and (D) shall
apply with respect to the treatment of a letter of intent, a
qualification plan, or a full qualification package submitted
under paragraph (1) (referred to in this paragraph as
`qualification submissions').
``(B) Acceptance factors; nonacceptance.--The Secretary
shall determine whether to accept a qualification submission
based on factors which may include the scientific merit of
the qualification submission. A determination not to accept a
submission under paragraph (1) shall not be construed as a
final determination by the Secretary under this section
regarding the qualification of a drug development tool for
its proposed context of use.
``(C) Prioritization of qualification review.--The
Secretary may prioritize the review of a full qualification
package submitted under paragraph (1) with respect to a drug
development tool, based on factors determined appropriate by
the Secretary, including--
``(i) as applicable, the severity, rarity, or prevalence of
the disease or condition targeted by the drug development
tool and the availability or lack of alternative treatments
for such disease or condition; and
``(ii) the identification, by the Secretary or by
biomedical research consortia and other expert stakeholders,
of such a drug development tool and its proposed context of
use as a public health priority.
``(D) Engagement of external experts.--The Secretary may,
for purposes of the review of qualification submissions,
through the use of cooperative agreements, grants, or other
appropriate mechanisms, consult with biomedical research
consortia and may consider the recommendations of such
consortia with respect to the review of any qualification
plan submitted under paragraph (1) or the review of any full
qualification package under paragraph (3).
``(3) Review of full qualification package.--The Secretary
shall--
``(A) conduct a comprehensive review of a full
qualification package accepted under paragraph (1)(C); and
``(B) determine whether the drug development tool at issue
is qualified for its proposed context of use.
``(4) Qualification.--The Secretary shall determine whether
a drug development tool is qualified for a proposed context
of use based on
[[Page H6913]]
the scientific merit of a full qualification package reviewed
under paragraph (3).
``(b) Effect of Qualification.--
``(1) In general.--A drug development tool determined to be
qualified under subsection (a)(4) for a proposed context of
use specified by the requestor may be used by any person in
such context of use for the purposes described in paragraph
(2).
``(2) Use of a drug development tool.--Subject to paragraph
(3), a drug development tool qualified under this section may
be used for--
``(A) supporting or obtaining approval or licensure (as
applicable) of a drug or biological product (including in
accordance with section 506(c)) under section 505 of this Act
or section 351 of the Public Health Service Act; or
``(B) supporting the investigational use of a drug or
biological product under section 505(i) of this Act or
section 351(a)(3) of the Public Health Service Act.
``(3) Rescission or modification.--
``(A) In general.--The Secretary may rescind or modify a
determination under this section to qualify a drug
development tool if the Secretary determines that the drug
development tool is not appropriate for the proposed context
of use specified by the requestor. Such a determination may
be based on new information that calls into question the
basis for such qualification.
``(B) Meeting for review.--If the Secretary rescinds or
modifies under subparagraph (A) a determination to qualify a
drug development tool, the requestor involved shall, on
request, be granted a meeting with the Secretary to discuss
the basis of the Secretary's decision to rescind or modify
the determination before the effective date of the rescission
or modification.
``(c) Transparency.--
``(1) In general.--Subject to paragraph (3), the Secretary
shall make publicly available, and update on at least a
biannual basis, on the Internet website of the Food and Drug
Administration the following:
``(A) Information with respect to each qualification
submission under the qualification process under subsection
(a), including--
``(i) the stage of the review process applicable to the
submission;
``(ii) the date of the most recent change in stage status;
``(iii) whether external scientific experts were utilized
in the development of a qualification plan or the review of a
full qualification package; and
``(iv) submissions from requestors under the qualification
process under subsection (a), including any data and evidence
contained in such submissions, and any updates to such
submissions.
``(B) The Secretary's formal written determinations in
response to such qualification submissions.
``(C) Any rescissions or modifications under subsection
(b)(3) of a determination to qualify a drug development tool.
``(D) Summary reviews that document conclusions and
recommendations for determinations to qualify drug
development tools under subsection (a).
``(E) A comprehensive list of--
``(i) all drug development tools qualified under subsection
(a); and
``(ii) all surrogate endpoints which were the basis of
approval or licensure (as applicable) of a drug or biological
product (including in accordance with section 506(c)) under
section 505 of this Act or section 351 of the Public Health
Service Act.
``(2) Relation to trade secrets act.--Information made
publicly available by the Secretary under paragraph (1) shall
be considered a disclosure authorized by law for purposes of
section 1905 of title 18, United States Code.
``(3) Applicability.--Nothing in this section shall be
construed as authorizing the Secretary to disclose any
information contained in an application submitted under
section 505 of this Act or section 351 of the Public Health
Service Act that is confidential commercial or trade secret
information subject to section 552(b)(4) of title 5, United
States Code, or section 1905 of title 18, United States Code.
``(d) Rule of Construction.--Nothing in this section shall
be construed--
``(1) to alter the standards of evidence under subsection
(c) or (d) of section 505, including the substantial evidence
standard in such subsection (d), or under section 351 of the
Public Health Service Act (as applicable); or
``(2) to limit the authority of the Secretary to approve or
license products under this Act or the Public Health Service
Act, as applicable (as in effect before the date of the
enactment of the 21st Century Cures Act).
``(e) Definitions.--In this section:
``(1) Biomarker.--The term `biomarker'--
``(A) means a characteristic (such as a physiologic,
pathologic, or anatomic characteristic or measurement) that
is objectively measured and evaluated as an indicator of
normal biologic processes, pathologic processes, or
biological responses to a therapeutic intervention; and
``(B) includes a surrogate endpoint.
``(2) Biomedical research consortia.--The term `biomedical
research consortia' means collaborative groups that may take
the form of public-private partnerships and may include
government agencies, institutions of higher education (as
defined in section 101(a) of the Higher Education Act of
1965), patient advocacy groups, industry representatives,
clinical and scientific experts, and other relevant entities
and individuals.
``(3) Clinical outcome assessment.--The term `clinical
outcome assessment' means--
``(A) a measurement of a patient's symptoms, overall mental
state, or the effects of a disease or condition on how the
patient functions; and
``(B) includes a patient-reported outcome.
``(4) Context of use.--The term `context of use' means,
with respect to a drug development tool, the circumstances
under which the drug development tool is to be used in drug
development and regulatory review.
``(5) Drug development tool.--The term `drug development
tool' includes--
``(A) a biomarker;
``(B) a clinical outcome assessment; and
``(C) any other method, material, or measure that the
Secretary determines aids drug development and regulatory
review for purposes of this section.
``(6) Patient-reported outcome.--The term `patient-reported
outcome' means a measurement based on a report from a patient
regarding the status of the patient's health condition
without amendment or interpretation of the patient's report
by a clinician or any other person.
``(7) Qualification.--The terms `qualification' and
`qualified' mean a determination by the Secretary that a drug
development tool and its proposed context of use can be
relied upon to have a specific interpretation and application
in drug development and regulatory review under this Act.
``(8) Requestor.--The term `requestor' means an entity or
entities, including a drug sponsor or a biomedical research
consortia, seeking to qualify a drug development tool for a
proposed context of use under this section.
``(9) Surrogate endpoint.--The term `surrogate endpoint'
means a marker, such as a laboratory measurement,
radiographic image, physical sign, or other measure, that is
not itself a direct measurement of clinical benefit, and--
``(A) is known to predict clinical benefit and could be
used to support traditional approval of a drug or biological
product; or
``(B) is reasonably likely to predict clinical benefit and
could be used to support the accelerated approval of a drug
or biological product in accordance with section 506(c).''.
(b) Guidance.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, in
consultation with biomedical research consortia (as defined
in subsection (e) of section 507 of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a)) and other
interested parties through a collaborative public process,
issue guidance to implement such section 507 that--
(A) provides a conceptual framework describing appropriate
standards and scientific approaches to support the
development of biomarkers delineated under the taxonomy
established under paragraph (3);
(B) with respect to the qualification process under such
section 507--
(i) describes the requirements that entities seeking to
qualify a drug development tool under such section shall
observe when engaging in such process;
(ii) outlines reasonable timeframes for the Secretary's
review of letters, qualification plans, or full qualification
packages submitted under such process; and
(iii) establishes a process by which such entities or the
Secretary may consult with biomedical research consortia and
other individuals and entities with expert knowledge and
insights that may assist the Secretary in the review of
qualification plans and full qualification submissions under
such section; and
(C) includes such other information as the Secretary
determines appropriate.
(2) Timing.--Not later than 3 years after the date of the
enactment of this Act, the Secretary shall issue draft
guidance under paragraph (1) on the implementation of section
507 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)). The Secretary shall issue final guidance on
the implementation of such section not later than 6 months
after the date on which the comment period for the draft
guidance closes.
(3) Taxonomy.--
(A) In general.--For purposes of informing guidance under
this subsection, the Secretary shall, in consultation with
biomedical research consortia and other interested parties
through a collaborative public process, establish a taxonomy
for the classification of biomarkers (and related scientific
concepts) for use in drug development.
(B) Public availability.--Not later than 2 years after the
date of the enactment of this Act, the Secretary shall make
such taxonomy publicly available in draft form for public
comment. The Secretary shall finalize the taxonomy not later
than 1 year after the close of the public comment period.
(c) Meeting and Report.--
(1) Meeting.--Not later than 2 years after the date of the
enactment of this Act, the Secretary shall convene a public
meeting to describe and solicit public input regarding the
qualification process under section 507 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a).
(2) Report.--Not later than 5 years after the date of the
enactment of this Act, the Secretary shall make publicly
available on the Internet website of the Food and Drug
Administration a report. Such report shall include, with
respect to the qualification process under section 507 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a), information on--
(A) the number of requests submitted, as a letter of
intent, for qualification of a drug development tool (as
defined in subsection (e) of such section 507);
(B) the number of such requests accepted and determined to
be eligible for submission of a qualification plan or full
qualification package (as such terms are defined in
subsection (e) of such section 507), respectively;
(C) the number of such requests for which external
scientific experts were utilized in the development of a
qualification plan or review of a full qualification package;
(D) the number of qualification plans and full
qualification packages, respectively, submitted to the
Secretary; and
[[Page H6914]]
(E) the drug development tools qualified through such
qualification process, specified by type of tool, such as a
biomarker or clinical outcome assessment (as such terms are
defined in subsection (e) of such section 507).
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.
Subchapter B of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by
inserting after section 529 the following:
``SEC. 529A. TARGETED DRUGS FOR RARE DISEASES.
``(a) Purpose.--The purpose of this section, through the
approach provided for in subsection (b), is to--
``(1) facilitate the development, review, and approval of
genetically targeted drugs and variant protein targeted drugs
to address an unmet medical need in one or more patient
subgroups, including subgroups of patients with different
mutations of a gene, with respect to rare diseases or
conditions that are serious or life-threatening; and
``(2) maximize the use of scientific tools or methods,
including surrogate endpoints and other biomarkers, for such
purposes.
``(b) Leveraging of Data From Previously Approved Drug
Application or Applications.--The Secretary may, consistent
with applicable standards for approval under this Act or
section 351(a) of the Public Health Service Act, allow the
sponsor of an application under section 505(b)(1) of this Act
or section 351(a) of the Public Health Service Act for a
genetically targeted drug or a variant protein targeted drug
to rely upon data and information--
``(1) previously developed by the same sponsor (or another
sponsor that has provided the sponsor with a contractual
right of reference to such data and information); and
``(2) submitted by a sponsor described in paragraph (1) in
support of one or more previously approved applications that
were submitted under section 505(b)(1) of this Act or section
351(a) of the Public Health Service Act,
for a drug that incorporates or utilizes the same or similar
genetically targeted technology as the drug or drugs that are
the subject of an application or applications described in
paragraph (2) or for a variant protein targeted drug that is
the same or incorporates or utilizes the same variant protein
targeted drug, as the drug or drugs that are the subject of
an application or applications described in paragraph (2).
``(c) Definitions.--For purposes of this section--
``(1) the term `genetically targeted drug' means a drug
that--
``(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act for the treatment of a rare disease or condition
(as such term is defined in section 526) that is serious or
life-threatening;
``(B) may result in the modulation (including suppression,
up-regulation, or activation) of the function of a gene or
its associated gene product; and
``(C) incorporates or utilizes a genetically targeted
technology;
``(2) the term `genetically targeted technology' means a
technology comprising non-replicating nucleic acid or
analogous compounds with a common or similar chemistry that
is intended to treat one or more patient subgroups, including
subgroups of patients with different mutations of a gene,
with the same disease or condition, including a disease or
condition due to other variants in the same gene; and
``(3) the term `variant protein targeted drug' means a drug
that--
``(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act for the treatment of a rare disease or condition
(as such term is defined in section 526) that is serious or
life-threatening;
``(B) modulates the function of a product of a mutated gene
where such mutation is responsible in whole or in part for a
given disease or condition; and
``(C) is intended to treat one or more patient subgroups,
including subgroups of patients with different mutations of a
gene, with the same disease or condition.
``(d) Rule of Construction.--Nothing in this section shall
be construed to--
``(1) alter the authority of the Secretary to approve drugs
pursuant to this Act or section 351 of the Public Health
Service Act (as authorized prior to the date of enactment of
the 21st Century Cures Act), including the standards of
evidence, and applicable conditions, for approval under such
applicable Act; or
``(2) confer any new rights, beyond those authorized under
this Act or the Public Health Service Act prior to enactment
of this section, with respect to the permissibility of a
sponsor referencing information contained in another
application submitted under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service Act.''.
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS
FOR RARE PEDIATRIC DISEASES.
(a) In General.--Section 529(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking
paragraph (5) and inserting the following:
``(5) Termination of authority.--The Secretary may not
award any priority review vouchers under paragraph (1) after
September 30, 2020, unless the rare pediatric disease product
application--
``(A) is for a drug that, not later than September 30,
2020, is designated under subsection (d) as a drug for a rare
pediatric disease; and
``(B) is, not later than September 30, 2022, approved under
section 505(b)(1) of this Act or section 351(a) of the Public
Health Service Act.''.
(b) Report.--The Advancing Hope Act of 2016 (Public Law
114-229) is amended by striking section 3.
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.
(a) Study.--The Comptroller General of the United States
(referred to in this section as the ``Comptroller General'')
shall conduct a study addressing the effectiveness and
overall impact of the following priority review voucher
programs, including any such programs amended or established
by this Act:
(1) The neglected tropical disease priority review voucher
program under section 524 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n).
(2) The rare pediatric disease priority review voucher
program under section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff).
(3) The medical countermeasure priority review voucher
program under section 565A of the Federal Food, Drug, and
Cosmetic Act, as added by section 3086.
(b) Issuance of Report.--Not later than January 31, 2020,
the Comptroller General shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report containing the results of the study
under subsection (a).
(c) Contents of Reports.--The report submitted under
subsection (b) shall address--
(1) for each drug for which a priority review voucher has
been awarded as of initiation of the study--
(A) the indications for which the drug is approved under
section 505(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(c)), pursuant to an application under section
505(b)(1) of such Act, or licensed under section 351(a) of
the Public Health Service Act (42 U.S.C. 262(a));
(B) whether, and to what extent, the voucher impacted the
sponsor's decision to develop the drug; and
(C) whether, and to what extent, the approval or licensure
of the drug, as applicable and appropriate--
(i) addressed a global unmet need related to the treatment
or prevention of a neglected tropical disease, including
whether the sponsor of a drug coordinated with international
development organizations;
(ii) addressed an unmet need related to the treatment of a
rare pediatric disease; or
(iii) affected the Nation's preparedness against a
chemical, biological, radiological, or nuclear threat,
including naturally occurring threats;
(2) for each drug for which a priority review voucher has
been used--
(A) the indications for which such drug is approved under
section 505(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(c)), pursuant to an application under section
505(b)(1) of such Act, or licensed under section 351(a) of
the Public Health Service Act (42 U.S.C. 262);
(B) the value of the voucher, if transferred; and
(C) the length of time between the date on which the
voucher was awarded and the date on which the voucher was
used; and
(3) an analysis of the priority review voucher programs
described in subsection (a), including--
(A) the resources used by the Food and Drug Administration
in reviewing drugs for which vouchers were used, including
the effect of the programs on the Food and Drug
Administration's review of drugs for which priority review
vouchers were not awarded or used;
(B) whether any improvements to such programs are necessary
to appropriately target incentives for the development of
drugs that would likely not otherwise be developed, or
developed in as timely a manner, and, as applicable and
appropriate--
(i) address global unmet needs related to the treatment or
prevention of neglected tropical diseases, including in
countries in which neglected tropical diseases are endemic;
or
(ii) address unmet needs related to the treatment of rare
pediatric diseases; and
(C) whether the sunset of the rare pediatric disease
program and medical countermeasure program has had an impact
on the program, including any potential unintended
consequences.
(d) Protection of National Security.--The Comptroller
General shall conduct the study and issue reports under this
section in a manner that does not compromise national
security.
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is
amended--
(1) in subsection (a), by striking paragraph (1) and
inserting the following: ``(1) defraying the costs of
developing drugs for rare diseases or conditions, including
qualified testing expenses,''; and
(2) in subsection (b)(1)--
(A) in subparagraph (A)(ii), by striking ``and'' after the
semicolon;
(B) in subparagraph (B), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(C) prospectively planned and designed observational
studies and other analyses conducted to assist in the
understanding of the natural history of a rare disease or
condition and in the development of a therapy, including
studies and analyses to--
``(i) develop or validate a drug development tool related
to a rare disease or condition; or
``(ii) understand the full spectrum of the disease
manifestations, including describing genotypic and phenotypic
variability and identifying and defining distinct
subpopulations affected by a rare disease or condition.''.
[[Page H6915]]
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING.
(a) In General.--The Secretary of Health and Human Services
may award grants to institutions of higher education and
nonprofit organizations for the purpose of studying and
recommending improvements to the process of continuous
manufacturing of drugs and biological products and similar
innovative monitoring and control techniques.
(b) Definitions.--In this section--
(1) the term ``drug'' has the meaning given such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(2) the term ``biological product'' has the meaning given
such term in section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)); and
(3) the term ``institution of higher education'' has the
meaning given such term in section 101(a) of the Higher
Education Act of 1965 (20 U.S.C. 1001(a)).
Subtitle C--Modern Trial Design and Evidence Development
SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS.
(a) Proposals for Use of Novel Clinical Trial Designs for
Drugs and Biological Products.--For purposes of assisting
sponsors in incorporating complex adaptive and other novel
trial designs into proposed clinical protocols and
applications for new drugs under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological
products under section 351 of the Public Health Service Act
(42 U.S.C. 262), the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
conduct a public meeting and issue guidance in accordance
with subsection (b).
(b) Guidance Addressing Use of Novel Clinical Trial
Designs.--
(1) In general.--The Secretary, acting through the
Commissioner of Food and Drugs, shall update or issue
guidance addressing the use of complex adaptive and other
novel trial design in the development and regulatory review
and approval or licensure for drugs and biological products.
(2) Contents.--The guidance under paragraph (1) shall
address--
(A) the use of complex adaptive and other novel trial
designs, including how such clinical trials proposed or
submitted help to satisfy the substantial evidence standard
under section 505(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(d));
(B) how sponsors may obtain feedback from the Secretary on
technical issues related to modeling and simulations prior
to--
(i) completion of such modeling or simulations; or
(ii) the submission of resulting information to the
Secretary;
(C) the types of quantitative and qualitative information
that should be submitted for review; and
(D) recommended analysis methodologies.
(3) Public meeting.--Prior to updating or issuing the
guidance required by paragraph (1), the Secretary shall
consult with stakeholders, including representatives of
regulated industry, academia, patient advocacy organizations,
consumer groups, and disease research foundations, through a
public meeting to be held not later than 18 months after the
date of enactment of this Act.
(4) Timing.--The Secretary shall update or issue a draft
version of the guidance required by paragraph (1) not later
than 18 months after the date of the public meeting required
by paragraph (3) and finalize such guidance not later than 1
year after the date on which the public comment period for
the draft guidance closes.
SEC. 3022. REAL WORLD EVIDENCE.
Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 505E (21 U.S.C. 355f) the
following:
``SEC. 505F. UTILIZING REAL WORLD EVIDENCE.
``(a) In General.--The Secretary shall establish a program
to evaluate the potential use of real world evidence--
``(1) to help to support the approval of a new indication
for a drug approved under section 505(c); and
``(2) to help to support or satisfy postapproval study
requirements.
``(b) Real World Evidence Defined.--In this section, the
term `real world evidence' means data regarding the usage, or
the potential benefits or risks, of a drug derived from
sources other than randomized clinical trials.
``(c) Program Framework.--
``(1) In general.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary shall
establish a draft framework for implementation of the program
under this section.
``(2) Contents of framework.--The framework shall include
information describing--
``(A) the sources of real world evidence, including ongoing
safety surveillance, observational studies, registries,
claims, and patient-centered outcomes research activities;
``(B) the gaps in data collection activities;
``(C) the standards and methodologies for collection and
analysis of real world evidence; and
``(D) the priority areas, remaining challenges, and
potential pilot opportunities that the program established
under this section will address.
``(3) Consultation.--
``(A) In general.--In developing the program framework
under this subsection, the Secretary shall consult with
regulated industry, academia, medical professional
organizations, representatives of patient advocacy
organizations, consumer organizations, disease research
foundations, and other interested parties.
``(B) Process.--The consultation under subparagraph (A) may
be carried out through approaches such as--
``(i) a public-private partnership with the entities
described in such subparagraph in which the Secretary may
participate;
``(ii) a contract, grant, or other arrangement, as the
Secretary determines appropriate, with such a partnership or
an independent research organization; or
``(iii) public workshops with the entities described in
such subparagraph.
``(d) Program Implementation.--The Secretary shall, not
later than 2 years after the date of enactment of the 21st
Century Cures Act and in accordance with the framework
established under subsection (c), implement the program to
evaluate the potential use of real world evidence.
``(e) Guidance for Industry.--The Secretary shall--
``(1) utilize the program established under subsection (a),
its activities, and any subsequent pilots or written reports,
to inform a guidance for industry on--
``(A) the circumstances under which sponsors of drugs and
the Secretary may rely on real world evidence for the
purposes described in paragraphs (1) and (2) of subsection
(a); and
``(B) the appropriate standards and methodologies for
collection and analysis of real world evidence submitted for
such purposes;
``(2) not later than 5 years after the date of enactment of
the 21st Century Cures Act, issue draft guidance for industry
as described in paragraph (1); and
``(3) not later than 18 months after the close of the
public comment period for the draft guidance described in
paragraph (2), issue revised draft guidance or final
guidance.
``(f) Rule of Construction.--
``(1) In general.--Subject to paragraph (2), nothing in
this section prohibits the Secretary from using real world
evidence for purposes not specified in this section, provided
the Secretary determines that sufficient basis exists for any
such nonspecified use.
``(2) Standards of evidence and secretary's authority.--
This section shall not be construed to alter--
``(A) the standards of evidence under--
``(i) subsection (c) or (d) of section 505, including the
substantial evidence standard in such subsection (d); or
``(ii) section 351(a) of the Public Health Service Act; or
``(B) the Secretary's authority to require postapproval
studies or clinical trials, or the standards of evidence
under which studies or trials are evaluated.''.
SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS.
(a) In General.--In order to simplify and facilitate
compliance by researchers with applicable regulations for the
protection of human subjects in research, the Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') shall, to the extent practicable and
consistent with other statutory provisions, harmonize
differences between the HHS Human Subject Regulations and the
FDA Human Subject Regulations in accordance with subsection
(b).
(b) Avoiding Regulatory Duplication and Unnecessary
Delays.--The Secretary shall, as appropriate--
(1) make such modifications to the provisions of the HHS
Human Subject Regulations, the FDA Human Subject Regulations,
and the vulnerable populations rules as may be necessary--
(A) to reduce regulatory duplication and unnecessary
delays;
(B) to modernize such provisions in the context of
multisite and cooperative research projects; and
(C) to protect vulnerable populations, incorporate local
considerations, and support community engagement through
mechanisms such as consultation with local researchers and
human research protection programs, in a manner consistent
with subparagraph (B); and
(2) ensure that human subject research that is subject to
the HHS Human Subject Regulations and to the FDA Human
Subject Regulations may--
(A) use joint or shared review;
(B) rely upon the review of--
(i) an independent institutional review board; or
(ii) an institutional review board of an entity other than
the sponsor of the research; or
(C) use similar arrangements to avoid duplication of
effort.
(c) Consultation.--In harmonizing or modifying regulations
or guidance under this section, the Secretary shall consult
with stakeholders (including researchers, academic
organizations, hospitals, institutional research boards,
pharmaceutical, biotechnology, and medical device developers,
clinical research organizations, patient groups, and others).
(d) Timing.--The Secretary shall complete the harmonization
described in subsection (a) not later than 3 years after the
date of enactment of this Act.
(e) Progress Report.--Not later than 2 years after the date
of enactment of this Act, the Secretary shall submit to
Congress a report on the progress made toward completing such
harmonization.
(f) Definitions.--
(1) Human subject regulations.--In this section:
(A) FDA human subject regulations.--The term ``FDA Human
Subject Regulations'' means the provisions of parts 50, 56,
312, and 812 of title 21, Code of Federal Regulations (or any
successor regulations).
(B) HHS human subject regulations.--The term ``HHS Human
Subject Regulations'' means the provisions of subpart A of
part 46 of title 45, Code of Federal Regulations (or any
successor regulations).
(C) Vulnerable population rules.--The term ``vulnerable
population rules'' means--
(i) except in the case of research described in clause
(ii), the provisions of subparts B through D of part 46, Code
of Federal Regulations (or any successor regulations); and
[[Page H6916]]
(ii) in the case of research that is subject to FDA Human
Subject Regulations, the provisions applicable to vulnerable
populations under part 56 of title 21, Code of Federal
Regulations (or any successor regulations) and subpart D of
part 50 of such title 21 (or any successor regulations).
(2) Institutional review board defined.--In this section,
the term ``institutional review board'' has the meaning that
applies to the term ``institutional review board'' under the
HHS Human Subject Regulations.
(B) Lead institutional review board.--The term ``lead
institutional review board'' means an institutional review
board that otherwise meets the requirements of the HHS Human
Subject Regulations and enters into a written agreement with
an institution, another institutional review board, a
sponsor, or a principal investigator to approve and oversee
human subject research that is conducted at multiple
locations. References to an institutional review board
include an institutional review board that serves a single
institution and a lead institutional review board.
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL
INVESTIGATIONS.
(a) Devices.--Section 520(g)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
(1) in subparagraph (D), by striking ``except where subject
to such conditions as the Secretary may prescribe, the
investigator'' and inserting the following: ``except where,
subject to such conditions as the Secretary may prescribe--
``(i) the proposed clinical testing poses no more than
minimal risk to the human subject and includes appropriate
safeguards to protect the rights, safety, and welfare of the
human subject; or
``(ii) the investigator''; and
(2) in the matter following subparagraph (D), by striking
``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
(b) Drugs.--Section 505(i)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking
``except where it is not feasible or it is contrary to the
best interests of such human beings'' and inserting ``except
where it is not feasible, it is contrary to the best
interests of such human beings, or the proposed clinical
testing poses no more than minimal risk to such human beings
and includes appropriate safeguards as prescribed to protect
the rights, safety, and welfare of such human beings''.
Subtitle D--Patient Access to Therapies and Information
SEC. 3031. SUMMARY LEVEL REVIEW.
(a) FFDCA.--Section 505(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the
end the following:
``(5)(A) The Secretary may rely upon qualified data
summaries to support the approval of a supplemental
application, with respect to a qualified indication for a
drug, submitted under subsection (b), if such supplemental
application complies with subparagraph (B).
``(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
``(i) there is existing data available and acceptable to
the Secretary demonstrating the safety of the drug; and
``(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
``(C) The Secretary shall post on the Internet website of
the Food and Drug Administration and update annually--
``(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
``(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
``(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section 351(a)(2)(E) of
the Public Health Service Act; and
``(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act for which the Secretary made use of full data
sets in addition to the qualified data summary.
``(D) In this paragraph--
``(i) the term `qualified indication' means an indication
for a drug that the Secretary determines to be appropriate
for summary level review under this paragraph; and
``(ii) the term `qualified data summary' means a summary of
clinical data that demonstrates the safety and effectiveness
of a drug with respect to a qualified indication.''.
(b) PHSA.--Section 351(a)(2) of the Public Health Service
Act (42 U.S.C. 262(a)(2)) is amended by adding at the end the
following:
``(E)(i) The Secretary may rely upon qualified data
summaries to support the approval of a supplemental
application, with respect to a qualified indication for a
drug, submitted under this subsection, if such supplemental
application complies with the requirements of subparagraph
(B) of section 505(c)(5) of the Federal Food, Drug, and
Cosmetic Act.
``(ii) In this subparagraph, the terms `qualified
indication' and `qualified data summary' have the meanings
given such terms in section 505(c)(5) of the Federal Food,
Drug, and Cosmetic Act.''.
SEC. 3032. EXPANDED ACCESS POLICY.
Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 561 (21 U.S.C. 360bbb) the
following:
``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR
INVESTIGATIONAL DRUGS.
``(a) In General.--The manufacturer or distributor of one
or more investigational drugs for the diagnosis, monitoring,
or treatment of one or more serious diseases or conditions
shall make available the policy of the manufacturer or
distributor on evaluating and responding to requests
submitted under section 561(b) for provision of such a drug.
``(b) Public Availability of Expanded Access Policy.--The
policies under subsection (a) shall be made public and
readily available, such as by posting such policies on a
publicly available Internet website. Such policies may be
generally applicable to all investigational drugs of such
manufacturer or distributor.
``(c) Content of Policy.--A policy described in subsection
(a) shall include--
``(1) contact information for the manufacturer or
distributor to facilitate communication about requests
described in subsection (a);
``(2) procedures for making such requests;
``(3) the general criteria the manufacturer or distributor
will use to evaluate such requests for individual patients,
and for responses to such requests;
``(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests; and
``(5) a hyperlink or other reference to the clinical trial
record containing information about the expanded access for
such drug that is required under section
402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act.
``(d) No Guarantee of Access.--The posting of policies by
manufacturers and distributors under subsection (a) shall not
serve as a guarantee of access to any specific
investigational drug by any individual patient.
``(e) Revised Policy.--Nothing in this section shall
prevent a manufacturer or distributor from revising a policy
required under this section at any time.
``(f) Application.--This section shall apply to a
manufacturer or distributor with respect to an
investigational drug beginning on the later of--
``(1) the date that is 60 calendar days after the date of
enactment of the 21st Century Cures Act; or
``(2) the first initiation of a phase 2 or phase 3 study
(as such terms are defined in section 312.21(b) and (c) of
title 21, Code of Federal Regulations (or any successor
regulations)) with respect to such investigational drug.''.
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
THERAPIES.
(a) In General.--Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended--
(1) by transferring subsection (e) (relating to
construction) so that it appears before subsection (f)
(relating to awareness efforts); and
(2) by adding at the end the following:
``(g) Regenerative Advanced Therapy.--
``(1) In general.--The Secretary, at the request of the
sponsor of a drug, shall facilitate an efficient development
program for, and expedite review of, such drug if the drug
qualifies as a regenerative advanced therapy under the
criteria described in paragraph (2).
``(2) Criteria.--A drug is eligible for designation as a
regenerative advanced therapy under this subsection if--
``(A) the drug is a regenerative medicine therapy (as
defined in paragraph (8));
``(B) the drug is intended to treat, modify, reverse, or
cure a serious or life-threatening disease or condition; and
``(C) preliminary clinical evidence indicates that the drug
has the potential to address unmet medical needs for such a
disease or condition.
``(3) Request for designation.--The sponsor of a drug may
request the Secretary to designate the drug as a regenerative
advanced therapy concurrently with, or at any time after,
submission of an application for the investigation of the
drug under section 505(i) of this Act or section 351(a)(3) of
the Public Health Service Act.
``(4) Designation.--Not later than 60 calendar days after
the receipt of a request under paragraph (3), the Secretary
shall determine whether the drug that is the subject of the
request meets the criteria described in paragraph (2). If the
Secretary determines that the drug meets the criteria, the
Secretary shall designate the drug as a regenerative advanced
therapy and shall take such actions as are appropriate under
paragraph (1). If the Secretary determines that a drug does
not meet the criteria for such designation, the Secretary
shall include with the determination a written description of
the rationale for such determination.
``(5) Actions.--The sponsor of a regenerative advanced
therapy shall be eligible for the actions to expedite
development and review of such therapy under subsection
(a)(3)(B), including early interactions to discuss any
potential surrogate or intermediate endpoint to be used to
support the accelerated approval of an application for the
product under subsection (c).
``(6) Access to expedited approval pathways.--An
application for a regenerative advanced therapy under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act may be--
``(A) eligible for priority review, as described in the
Manual of Policies and Procedures of the Food and Drug
Administration and goals identified in the letters described
in section 101(b) of the Prescription Drug User Fee
Amendments of 2012; and
``(B) eligible for accelerated approval under subsection
(c), as agreed upon pursuant to subsection (a)(3)(B),
through, as appropriate--
``(i) surrogate or intermediate endpoints reasonably likely
to predict long-term clinical benefit; or
``(ii) reliance upon data obtained from a meaningful number
of sites, including through expansion to additional sites, as
appropriate.
``(7) Postapproval requirements.--The sponsor of a
regenerative advanced therapy that is granted accelerated
approval and is subject to the postapproval requirements
under subsection
[[Page H6917]]
(c) may, as appropriate, fulfill such requirements, as the
Secretary may require, through--
``(A) the submission of clinical evidence, clinical
studies, patient registries, or other sources of real world
evidence, such as electronic health records;
``(B) the collection of larger confirmatory data sets, as
agreed upon pursuant to subsection (a)(3)(B); or
``(C) postapproval monitoring of all patients treated with
such therapy prior to approval of the therapy.
``(8) Definition.--For purposes of this section, the term
`regenerative medicine therapy' includes cell therapy,
therapeutic tissue engineering products, human cell and
tissue products, and combination products using any such
therapies or products, except for those regulated solely
under section 361 of the Public Health Service Act and part
1271 of title 21, Code of Federal Regulations.''.
(b) Rule of Construction.--Nothing in this section and the
amendments made by this section shall be construed to alter
the authority of the Secretary of Health and Human Services--
(1) to approve drugs pursuant to the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of
the Public Health Service Act (42 U.S.C. 262) as authorized
prior to the date of enactment of the 21st Century Cures Act,
including the standards of evidence, and applicable
conditions, for approval under such Acts; or
(2) to alter the authority of the Secretary to require
postapproval studies pursuant to such Acts, as authorized
prior to the date of enactment of the 21st Century Cures Act.
(c) Conforming Amendment.--Section 506(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended
by inserting ``and the 21st Century Cures Act'' after ``Food
and Drug Administration Safety and Innovation Act''.
SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY,
ISOLATION, OR DELIVERY OF REGENERATIVE ADVANCED
THERAPIES.
(a) Draft Guidance.--Not later than 1 year after the date
of enactment of the 21st Century Cures Act, the Secretary of
Health and Human Services, acting through the Commissioner of
Food and Drugs, shall issue draft guidance clarifying how, in
the context of regenerative advanced therapies, the Secretary
will evaluate devices used in the recovery, isolation, or
delivery of regenerative advanced therapies. In doing so, the
Secretary shall specifically address--
(1) how the Food and Drug Administration intends to
simplify and streamline regulatory requirements for
combination device and cell or tissue products;
(2) what, if any, intended uses or specific attributes
would result in a device used with a regenerative therapy
product to be classified as a class III device;
(3) when the Food and Drug Administration considers it is
necessary, if ever, for the intended use of a device to be
limited to a specific intended use with only one particular
type of cell; and
(4) application of the least burdensome approach to
demonstrate how a device may be used with more than one cell
type.
(b) Final Guidance.--Not later than 12 months after the
close of the period for public comment on the draft guidance
under subsection (a), the Secretary of Health and Human
Services shall finalize such guidance.
SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES.
(a) Report to Congress.--Before March 1 of each calendar
year, the Secretary of Health and Human Services shall, with
respect to the previous calendar year, 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 on--
(1) the number and type of applications for approval of
regenerative advanced therapies filed, approved or licensed
as applicable, withdrawn, or denied; and
(2) how many of such applications or therapies, as
applicable, were granted accelerated approval or priority
review.
(b) Regenerative Advanced Therapy.--In this section, the
term ``regenerative advanced therapy'' has the meaning given
such term in section 506(g) of the Federal Food, Drug, and
Cosmetic Act, as added by section 3033 of this Act.
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND
REGENERATIVE ADVANCED THERAPIES.
Subchapter A of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506F the following:
``SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND
REGENERATIVE ADVANCED THERAPIES.
``(a) In General.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary, in
consultation with the National Institute of Standards and
Technology and stakeholders (including regenerative medicine
and advanced therapies manufacturers and clinical trial
sponsors, contract manufacturers, academic institutions,
practicing clinicians, regenerative medicine and advanced
therapies industry organizations, and standard setting
organizations), shall facilitate an effort to coordinate and
prioritize the development of standards and consensus
definition of terms, through a public process, to support,
through regulatory predictability, the development,
evaluation, and review of regenerative medicine therapies and
regenerative advanced therapies, including with respect to
the manufacturing processes and controls of such products.
``(b) Activities.--
``(1) In general.--In carrying out this section, the
Secretary shall continue to--
``(A) identity opportunities to help advance the
development of regenerative medicine therapies and
regenerative advanced therapies;
``(B) identify opportunities for the development of
laboratory regulatory science research and documentary
standards that the Secretary determines would help support
the development, evaluation, and review of regenerative
medicine therapies and regenerative advanced therapies
through regulatory predictability; and
``(C) work with stakeholders, such as those described in
subsection (a), as appropriate, in the development of such
standards.
``(2) Regulations and guidance.--Not later than 1 year
after the development of standards as described in subsection
(a), the Secretary shall review relevant regulations and
guidance and, through a public process, update such
regulations and guidance as the Secretary determines
appropriate.
``(c) Definitions.--For purposes of this section, the terms
`regenerative medicine therapy' and `regenerative advanced
therapy' have the meanings given such terms in section
506(g).''.
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.
Section 502(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(a)) is amended--
(1) by striking ``(a) If its'' and inserting ``(a)(1) If
its'';
(2) by striking ``a formulary committee, or other similar
entity, in the course of the committee or the entity carrying
out its responsibilities for the selection of drugs for
managed care or other similar organizations'' and inserting
``a payor, formulary committee, or other similar entity with
knowledge and expertise in the area of health care economic
analysis, carrying out its responsibilities for the selection
of drugs for coverage or reimbursement'';
(3) by striking ``directly relates'' and inserting
``relates'';
(4) by striking ``and is based on competent and reliable
scientific evidence. The requirements set forth in section
505(a) or in section 351(a) of the Public Health Service Act
shall not apply to health care economic information provided
to such a committee or entity in accordance with this
paragraph'' and inserting ``, is based on competent and
reliable scientific evidence, and includes, where applicable,
a conspicuous and prominent statement describing any material
differences between the health care economic information and
the labeling approved for the drug under section 505 or under
section 351 of the Public Health Service Act. The
requirements set forth in section 505(a) or in subsections
(a) and (k) of section 351 of the Public Health Service Act
shall not apply to health care economic information provided
to such a payor, committee, or entity in accordance with this
paragraph''; and
(5) by striking ``In this paragraph, the term'' and all
that follows and inserting the following:
``(2)(A) For purposes of this paragraph, the term `health
care economic information' means any analysis (including the
clinical data, inputs, clinical or other assumptions,
methods, results, and other components underlying or
comprising the analysis) that identifies, measures, or
describes the economic consequences, which may be based on
the separate or aggregated clinical consequences of the
represented health outcomes, of the use of a drug. Such
analysis may be comparative to the use of another drug, to
another health care intervention, or to no intervention.
``(B) Such term does not include any analysis that relates
only to an indication that is not approved under section 505
or under section 351 of the Public Health Service Act for
such drug.''.
SEC. 3038. COMBINATION PRODUCT INNOVATION.
(a) In General.--Section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)) is amended--
(1) by striking paragraph (3);
(2) by redesignating paragraph (2) as paragraph (7);
(3) by redesignating paragraphs (4) and (5) as paragraphs
(8) and (9), respectively;
(4) by striking ``(g)(1)'' and all that follows through the
end of paragraph (1) and inserting the following:
``(g)(1)(A) The Secretary shall, in accordance with this
subsection, assign a primary agency center to regulate
products that constitute a combination of a drug, device, or
biological product.
``(B) The Secretary shall conduct the premarket review of
any combination product under a single application, whenever
appropriate.
``(C) For purposes of this subsection, the term `primary
mode of action' means the single mode of action of a
combination product expected to make the greatest
contribution to the overall intended therapeutic effects of
the combination product.
``(D) The Secretary shall determine the primary mode of
action of the combination product. If the Secretary
determines that the primary mode of action is that of--
``(i) a drug (other than a biological product), the agency
center charged with premarket review of drugs shall have
primary jurisdiction;
``(ii) a device, the agency center charged with premarket
review of devices shall have primary jurisdiction; or
``(iii) a biological product, the agency center charged
with premarket review of biological products shall have
primary jurisdiction.
``(E) In determining the primary mode of action of a
combination product, the Secretary shall not determine that
the primary mode of action is that of a drug or biological
product solely because the combination product has any
chemical action within or on the human body.
``(F) If a sponsor of a combination product disagrees with
the determination under subparagraph (D)--
``(i) such sponsor may request, and the Secretary shall
provide, a substantive rationale to
[[Page H6918]]
such sponsor that references scientific evidence provided by
the sponsor and any other scientific evidence relied upon by
the Secretary to support such determination; and
``(ii)(I) the sponsor of the combination product may
propose one or more studies (which may be nonclinical,
clinical, or both) to establish the relevance, if any, of the
chemical action in achieving the primary mode of action of
such product;
``(II) if the sponsor proposes any such studies, the
Secretary and the sponsor of such product shall collaborate
and seek to reach agreement, within a reasonable time of such
proposal, not to exceed 90 calendar days, on the design of
such studies; and
``(III) if an agreement is reached under subclause (II) and
the sponsor conducts one or more of such studies, the
Secretary shall consider the data resulting from any such
study when reevaluating the determination of the primary mode
of action of such product, and unless and until such
reevaluation has occurred and the Secretary issues a new
determination, the determination of the Secretary under
subparagraph (D) shall remain in effect.
``(2)(A)(i) To establish clarity and certainty for the
sponsor, the sponsor of a combination product may request a
meeting on such combination product. If the Secretary
concludes that a determination of the primary mode of action
pursuant to paragraph (1)(D) is necessary, the sponsor may
request such meeting only after the Secretary makes such
determination. If the sponsor submits a written meeting
request, the Secretary shall, not later than 75 calendar days
after receiving such request, meet with the sponsor of such
combination product.
``(ii) A meeting under clause (i) may--
``(I) address the standards and requirements for market
approval or clearance of the combination product;
``(II) address other issues relevant to such combination
product, such as requirements related to postmarket
modification of such combination product and good
manufacturing practices applicable to such combination
product; and
``(III) identify elements under subclauses (I) and (II)
that may be more appropriate for discussion and agreement
with the Secretary at a later date given that scientific or
other information is not available, or agreement is otherwise
not feasible regarding such elements, at the time a request
for such meeting is made.
``(iii) Any agreement under this subparagraph shall be in
writing and made part of the administrative record by the
Secretary.
``(iv) Any such agreement shall remain in effect, except--
``(I) upon the written agreement of the Secretary and the
sponsor or applicant; or
``(II) pursuant to a decision by the director of the
reviewing division of the primary agency center, or a person
more senior than such director, in consultation with
consulting centers and the Office, as appropriate, that an
issue essential to determining whether the standard for
market clearance or other applicable standard under this Act
or the Public Health Service Act applicable to the
combination product has been identified since the agreement
was reached, or that deviating from the agreement is
otherwise justifiable based on scientific evidence, for
public health reasons.
``(3) For purposes of conducting the premarket review of a
combination product that contains an approved constituent
part described in paragraph (4), the Secretary may require
that the sponsor of such combination product submit to the
Secretary only data or information that the Secretary
determines is necessary to meet the standard for clearance or
approval, as applicable, under this Act or the Public Health
Service Act, including any incremental risks and benefits
posed by such combination product, using a risk-based
approach and taking into account any prior finding of safety
and effectiveness or substantial equivalence for the approved
constituent part relied upon by the applicant in accordance
with paragraph (5).
``(4) For purposes of paragraph (3), an approved
constituent part is--
``(A) a drug constituent part of a combination product
being reviewed in a single application or request under
section 515, 510(k), or 513(f)(2) (submitted in accordance
with paragraph (5)), that is an approved drug, provided such
application or request complies with paragraph (5);
``(B) a device constituent part approved under section 515
that is referenced by the sponsor and that is available for
use by the Secretary under section 520(h)(4); or
``(C) any constituent part that was previously approved,
cleared, or classified under section 505, 510(k), 513(f)(2),
or 515 of this Act for which the sponsor has a right of
reference or any constituent part that is a nonprescription
drug, as defined in section 760(a)(2).
``(5)(A) If an application is submitted under section 515
or 510(k) or a request is submitted under section 513(f)(2),
consistent with any determination made under paragraph
(1)(D), for a combination product containing as a constituent
part an approved drug--
``(i) the application or request shall include the
certification or statement described in section 505(b)(2);
and
``(ii) the applicant or requester shall provide notice as
described in section 505(b)(3).
``(B) For purposes of this paragraph and paragraph (4), the
term `approved drug' means an active ingredient--
``(i) that was in an application previously approved under
section 505(c);
``(ii) where such application is relied upon by the
applicant submitting the application or request described in
subparagraph (A);
``(iii) for which full reports of investigations that have
been made to show whether such drug is safe for use and
whether such drug is effective in use were not conducted by
or for the applicant submitting the application or request
described in subparagraph (A); and
``(iv) for which the applicant submitting the application
or request described in subparagraph (A) has not obtained a
right of reference or use from the person by or for whom the
investigations described in clause (iii) were conducted.
``(C) The following provisions shall apply with respect to
an application or request described in subparagraph (A) to
the same extent and in the same manner as if such application
or request were an application described in section 505(b)(2)
that referenced the approved drug:
``(i) Subparagraphs (A), (B), (C), and (D) of section
505(c)(3).
``(ii) Clauses (ii), (iii), and (iv) of section
505(c)(3)(E).
``(iii) Subsections (b) and (c) of section 505A.
``(iv) Section 505E(a).
``(v) Section 527(a).
``(D) Notwithstanding any other provision of this
subsection, an application or request for classification for
a combination product described in subparagraph (A) shall be
considered an application submitted under section 505(b)(2)
for purposes of section 271(e)(2)(A) of title 35, United
States Code.
``(6) Nothing in this subsection shall be construed as
prohibiting a sponsor from submitting separate applications
for the constituent parts of a combination product, unless
the Secretary determines that a single application is
necessary.'';
(5) in paragraph (8) (as redesignated by paragraph (3))--
(A) in subparagraph (C)--
(i) by amending clause (i) to read as follows:
``(i) In carrying out this subsection, the Office shall
help to ensure timely and effective premarket review that
involves more than one agency center by coordinating such
reviews, overseeing the timeliness of such reviews, and
overseeing the alignment of feedback regarding such
reviews.'';
(ii) in clause (ii), by inserting ``and alignment'' after
``the timeliness'' each place it appears; and
(iii) by adding at the end the following new clauses:
``(iii) The Office shall ensure that, with respect to a
combination product, a designated person or persons in the
primary agency center is the primary point or points of
contact for the sponsor of such combination product. The
Office shall also coordinate communications to and from any
consulting center involved in such premarket review, if
requested by such primary agency center or any such
consulting center. Agency communications and commitments, to
the extent consistent with other provisions of law and the
requirements of all affected agency centers, from the primary
agency center shall be considered as communication from the
Secretary on behalf of all agency centers involved in the
review.
``(iv) The Office shall, with respect to the premarket
review of a combination product--
``(I) ensure that any meeting between the Secretary and the
sponsor of such product is attended by each agency center
involved in the review, as appropriate;
``(II) ensure that each consulting agency center has
completed its premarket review and provided the results of
such review to the primary agency center in a timely manner;
and
``(III) ensure that each consulting center follows the
guidance described in clause (vi) and advises, as
appropriate, on other relevant regulations, guidances, and
policies.
``(v) In seeking agency action with respect to a
combination product, the sponsor of such product--
``(I) shall identify the product as a combination product;
and
``(II) may request in writing the participation of
representatives of the Office in meetings related to such
combination product, or to have the Office otherwise engage
on such regulatory matters concerning the combination
product.
``(vi) Not later than 4 years after the date of enactment
of the 21st Century Cures Act, and after a public comment
period of not less than 60 calendar days, the Secretary shall
issue a final guidance that describes--
``(I) the structured process for managing pre-submission
interactions with sponsors developing combination products;
``(II) the best practices for ensuring that the feedback in
such pre-submission interactions represents the Agency's best
advice based on the information provided during such pre-
submission interactions;
``(III) the information that is required to be submitted
with a meeting request under paragraph (2), how such meetings
relate to other types of meetings in the Food and Drug
Administration, and the form and content of any agreement
reached through a meeting under such paragraph (2);''; and
(B) in subparagraph (G)--
(i) in the matter preceding clause (i), by inserting
``(except with respect to clause (iv), beginning not later
than one year after the date of the enactment of the 21st
Century Cures Act)'' after ``enactment of this paragraph'';
(ii) in clause (ii), by striking ``and'' at the end;
(iii) in clause (iii), by striking the period at the end
and inserting ``; and''; and
(iv) by adding at the end the following new clause:
``(iv) identifying the percentage of combination products
for which a dispute resolution, with respect to premarket
review, was requested by the combination product's
sponsor.''; and
(6) in paragraph (9) (as redesignated by paragraph (3))--
(A) in subparagraph (C)--
(i) in clause (i), by striking the comma at the end and
inserting a semicolon;
(ii) in clause (ii), by striking ``, and'' at the end and
inserting a semicolon;
[[Page H6919]]
(iii) in clause (iii), by striking the period at the end
and inserting ``; and''; and
(iv) by adding at the end the following:
``(iv) de novo classification under section 513(a)(1).'';
and
(B) by adding at the end the following:
``(D) The terms `premarket review' and `reviews' include
all activities of the Food and Drug Administration conducted
prior to approval or clearance of an application,
notification, or request for classification submitted under
section 505, 510(k), 513(f)(2), 515, or 520 of this Act or
under section 351 of the Public Health Service Act, including
with respect to investigational use of the product.''.
(b) Information for Approval of Combination Products.--
Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(h)(4)) is amended--
(1) in subparagraph (A), by striking ``Any information''
and inserting ``Subject to subparagraph (C), any
information''; and
(2) by adding at the end the following new subparagraph:
``(C) No information contained in an application for
premarket approval filed with the Secretary pursuant to
section 515(c) may be used to approve or clear any
application submitted under section 515 or 510(k) or to
classify a product under section 513(f)(2) for a combination
product containing as a constituent part an approved drug (as
defined in section 503(g)(5)(B)) unless--
``(i) the application includes the certification or
statement referenced in section 503(g)(5)(A);
``(ii) the applicant provides notice as described in
section 503(g)(5)(A); and
``(iii) the Secretary's approval of such application is
subject to the provisions in section 503(g)(5)(C).''.
(c) Variations From CGMP Streamlined Approach.--Not later
than 18 months after the date of enactment of this Act, the
Secretary of Health and Human Services (referred to in this
subsection as the ``Secretary'') shall identify types of
combination products and manufacturing processes with respect
to which the Secretary proposes that good manufacturing
processes may be adopted that vary from the requirements set
forth in section 4.4 of title 21, Code of Federal Regulations
(or any successor regulations) or that the Secretary proposes
can satisfy the requirements in section 4.4 through
alternative or streamlined mechanisms. The Secretary shall
identify such types, variations from such requirements, and
such mechanisms, in a proposed list published in the Federal
Register. After a public comment period regarding the
appropriate good manufacturing practices for such types, the
Secretary shall publish a final list in the Federal Register,
notwithstanding section 553 of title 5, United States Code.
The Secretary shall evaluate such types, variations, and
mechanisms using a risk-based approach. The Secretary shall
periodically review such final list.
Subtitle E--Antimicrobial Innovation and Stewardship
SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.
(a) In General.--Section 319E of the Public Health Service
Act (42 U.S.C. 247d-5) is amended--
(1) by redesignating subsections (f) and (g) as subsections
(l) and (m), respectively; and
(2) by inserting after subsection (e), the following:
``(f) Monitoring at Federal Health Care Facilities.--The
Secretary shall encourage reporting on aggregate
antimicrobial drug use and antimicrobial resistance to
antimicrobial drugs and the implementation of antimicrobial
stewardship programs by health care facilities of the
Department of Defense, the Department of Veterans Affairs,
and the Indian Health Service and shall provide technical
assistance to the Secretary of Defense and the Secretary of
Veterans Affairs, as appropriate and upon request.
``(g) Report on Antimicrobial Resistance in Humans and Use
of Antimicrobial Drugs.--Not later than 1 year after the date
of enactment of the 21st Century Cures Act, and annually
thereafter, the Secretary shall prepare and make publicly
available data and information concerning--
``(1) aggregate national and regional trends of
antimicrobial resistance in humans to antimicrobial drugs,
including such drugs approved under section 506(h) of the
Federal Food, Drug, and Cosmetic Act;
``(2) antimicrobial stewardship, which may include
summaries of State efforts to address antimicrobial
resistance in humans to antimicrobial drugs and antimicrobial
stewardship; and
``(3) coordination between the Director of the Centers for
Disease Control and Prevention and the Commissioner of Food
and Drugs with respect to the monitoring of--
``(A) any applicable resistance under paragraph (1); and
``(B) drugs approved under section 506(h) of the Federal
Food, Drug, and Cosmetic Act.
``(h) Information Related to Antimicrobial Stewardship
Programs.--The Secretary shall, as appropriate, disseminate
guidance, educational materials, or other appropriate
materials related to the development and implementation of
evidence-based antimicrobial stewardship programs or
practices at health care facilities, such as nursing homes
and other long-term care facilities, ambulatory surgical
centers, dialysis centers, outpatient clinics, and hospitals,
including community and rural hospitals.
``(i) Supporting State-Based Activities To Combat
Antimicrobial Resistance.--The Secretary shall continue to
work with State and local public health departments on
statewide or regional programs related to antimicrobial
resistance. Such efforts may include activities to related
to--
``(1) identifying patterns of bacterial and fungal
resistance in humans to antimicrobial drugs;
``(2) preventing the spread of bacterial and fungal
infections that are resistant to antimicrobial drugs; and
``(3) promoting antimicrobial stewardship.
``(j) Antimicrobial Resistance and Stewardship
Activities.--
``(1) In general.--For the purposes of supporting
stewardship activities, examining changes in antimicrobial
resistance, and evaluating the effectiveness of section
506(h) of the Federal Food, Drug, and Cosmetic Act, the
Secretary shall--
``(A) provide a mechanism for facilities to report data
related to their antimicrobial stewardship activities
(including analyzing the outcomes of such activities); and
``(B) evaluate--
``(i) antimicrobial resistance data using a standardized
approach; and
``(ii) trends in the utilization of drugs approved under
such section 506(h) with respect to patient populations.
``(2) Use of systems.--The Secretary shall use available
systems, including the National Healthcare Safety Network or
other systems identified by the Secretary, to fulfill the
requirements or conduct activities under this section.
``(k) Antimicrobial.--For purposes of subsections (f)
through (j), the term `antimicrobial' includes any
antibacterial or antifungal drugs, and may include drugs that
eliminate or inhibit the growth of other microorganisms, as
appropriate.''.
(b) Availability of Data.--The Secretary shall make the
data collected pursuant to this subsection public. Nothing in
this subsection shall be construed as authorizing the
Secretary to disclose any information that is a trade secret
or confidential information subject to section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18,
United States Code.
SEC. 3042. LIMITED POPULATION PATHWAY.
Section 506 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356), as amended by section 3033, is further amended
by adding at the end the following:
``(h) Limited Population Pathway for Antibacterial and
Antifungal Drugs.--
``(1) In general.--The Secretary may approve an
antibacterial or antifungal drug, alone or in combination
with one or more other drugs, as a limited population drug
pursuant to this subsection only if--
``(A) the drug is intended to treat a serious or life-
threatening infection in a limited population of patients
with unmet needs;
``(B) the standards for approval under section 505(c) and
(d), or the standards for licensure under section 351 of the
Public Health Service Act, as applicable, are met; and
``(C) the Secretary receives a written request from the
sponsor to approve the drug as a limited population drug
pursuant to this subsection.
``(2) Benefit-risk consideration.--The Secretary's
determination of safety and effectiveness of an antibacterial
or antifungal drug shall reflect the benefit-risk profile of
such drug in the intended limited population, taking into
account the severity, rarity, or prevalence of the infection
the drug is intended to treat and the availability or lack of
alternative treatment in such limited population. Such drug
may be approved under this subsection notwithstanding a lack
of evidence to fully establish a favorable benefit-risk
profile in a population that is broader than the intended
limited population.
``(3) Additional requirements.--A drug approved under this
subsection shall be subject to the following requirements, in
addition to any other applicable requirements of this Act:
``(A) Labeling.--To indicate that the safety and
effectiveness of a drug approved under this subsection has
been demonstrated only with respect to a limited population--
``(i) all labeling and advertising of an antibacterial or
antifungal drug approved under this subsection shall contain
the statement `Limited Population' in a prominent manner and
adjacent to, and not more prominent than--
``(I) the proprietary name of such drug, if any; or
``(II) if there is no proprietary name, the established
name of the drug, if any, as defined in section 503(e)(3),
or, in the case of a drug that is a biological product, the
proper name, as defined by regulation; and
``(ii) the prescribing information for the drug required by
section 201.57 of title 21, Code of Federal Regulations (or
any successor regulation) shall also include the following
statement: `This drug is indicated for use in a limited and
specific population of patients.'.
``(B) Promotional material.--The sponsor of an
antibacterial or antifungal drug subject to this subsection
shall submit to the Secretary copies of all promotional
materials related to such drug at least 30 calendar days
prior to dissemination of the materials.
``(4) Other programs.--A sponsor of a drug that seeks
approval of a drug under this subsection may also seek
designation or approval, as applicable, of such drug under
other applicable sections or subsections of this Act or the
Public Health Service Act.
``(5) Guidance.--Not later than 18 months after the date of
enactment of the 21st Century Cures Act, the Secretary shall
issue draft guidance describing criteria, processes, and
other general considerations for demonstrating the safety and
effectiveness of limited population antibacterial and
antifungal drugs. The Secretary shall publish final guidance
within 18 months of the close of the public comment period on
such draft guidance. The Secretary may approve antibacterial
and antifungal drugs under this subsection prior to issuing
guidance under this paragraph.
``(6) Advice.--The Secretary shall provide prompt advice to
the sponsor of a drug for
[[Page H6920]]
which the sponsor seeks approval under this subsection to
enable the sponsor to plan a development program to obtain
the necessary data for such approval, and to conduct any
additional studies that would be required to gain approval of
such drug for use in a broader population.
``(7) Termination of limitations.--If, after approval of a
drug under this subsection, the Secretary approves a broader
indication for such drug under section 505(b) or section
351(a) of the Public Health Service Act, the Secretary may
remove any postmarketing conditions, including requirements
with respect to labeling and review of promotional materials
under paragraph (3), applicable to the approval of the drug
under this subsection.
``(8) Rules of construction.--Nothing in this subsection
shall be construed to alter the authority of the Secretary to
approve drugs pursuant to this Act or section 351 of the
Public Health Service Act, including the standards of
evidence and applicable conditions for approval under such
Acts, the standards of approval of a drug under such Acts, or
to alter the authority of the Secretary to monitor drugs
pursuant to such Acts.
``(9) Reporting and accountability.--
``(A) Biennial reporting.--The Secretary shall report to
Congress not less often than once every 2 years on the number
of requests for approval, and the number of approvals, of an
antibacterial or antifungal drug under this subsection.
``(B) GAO report.--Not later than December 2021, the
Comptroller General of the United States shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor
and Pensions of the Senate a report on the coordination of
activities required under section 319E of the Public Health
Service Act. Such report shall include a review of such
activities, and the extent to which the use of the pathway
established under this subsection has streamlined premarket
approval for antibacterial or antifungal drugs for limited
populations, if such pathway has functioned as intended, if
such pathway has helped provide for safe and effective
treatment for patients, if such premarket approval would be
appropriate for other categories of drugs, and if the
authorities under this subsection have affected antibacterial
or antifungal resistance.''.
SEC. 3043. PRESCRIBING AUTHORITY.
Nothing in this subtitle, or an amendment made by this
subtitle, shall be construed to restrict the prescribing of
antimicrobial drugs or other products, including drugs
approved under subsection (h) of section 506 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as added by
section 3042), by health care professionals, or to limit the
practice of health care.
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY
TESTING DEVICES.
(a) In General.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
amended by inserting after section 511 the following:
``SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS.
``(a) Purpose; Identification of Criteria.--
``(1) Purpose.--The purpose of this section is to clarify
the Secretary's authority to--
``(A) efficiently update susceptibility test interpretive
criteria for antimicrobial drugs when necessary for public
health, due to, among other things, the constant evolution of
microorganisms that leads to the development of resistance to
drugs that have been effective in decreasing morbidity and
mortality for patients, which warrants unique management of
antimicrobial drugs that is inappropriate for most other
drugs in order to delay or prevent the development of further
resistance to existing therapies;
``(B) provide for public notice of the availability of
recognized interpretive criteria and interpretive criteria
standards; and
``(C) clear under section 510(k), classify under section
513(f)(2), or approve under section 515, antimicrobial
susceptibility testing devices utilizing updated, recognized
susceptibility test interpretive criteria to characterize the
in vitro susceptibility of particular bacteria, fungi, or
other microorganisms, as applicable, to antimicrobial drugs.
``(2) Identification of criteria.--The Secretary shall
identify appropriate susceptibility test interpretive
criteria with respect to antimicrobial drugs--
``(A) if such criteria are available on the date of
approval of the drug under section 505 of this Act or
licensure of the drug under section 351 of the Public Health
Service Act (as applicable), upon such approval or licensure;
or
``(B) if such criteria are unavailable on such date, on the
date on which such criteria are available for such drug.
``(3) Bases for initial identification.--The Secretary
shall identify appropriate susceptibility test interpretive
criteria under paragraph (2), based on the Secretary's review
of, to the extent available and relevant--
``(A) preclinical and clinical data, including
pharmacokinetic, pharmacodynamic, and epidemiological data;
``(B) the relationship of susceptibility test interpretive
criteria to morbidity and mortality associated with the
disease or condition for which such drug is used; and
``(C) such other evidence and information as the Secretary
considers appropriate.
``(b) Susceptibility Test Interpretive Criteria Website.--
``(1) In general.--Not later than 1 year after the date of
the enactment of the 21st Century Cures Act, the Secretary
shall establish, and maintain thereafter, on the website of
the Food and Drug Administration, a dedicated website that
contains a list of any appropriate new or updated
susceptibility test interpretive criteria standards and
interpretive criteria in accordance with paragraph (2)
(referred to in this section as the `Interpretive Criteria
Website').
``(2) Listing of susceptibility test interpretive criteria
standards and interpretive criteria.--
``(A) In general.--The list described in paragraph (1)
shall consist of any new or updated susceptibility test
interpretive criteria standards that are--
``(i) established by a nationally or internationally
recognized standard development organization that--
``(I) establishes and maintains procedures to address
potential conflicts of interest and ensure transparent
decisionmaking;
``(II) holds open meetings to ensure that there is an
opportunity for public input by interested parties, and
establishes and maintains processes to ensure that such input
is considered in decisionmaking; and
``(III) permits its standards to be made publicly
available, through the National Library of Medicine or
another similar source acceptable to the Secretary; and
``(ii) recognized in whole, or in part, by the Secretary
under subsection (c).
``(B) Other list.--The Interpretive Criteria Website shall,
in addition to the list described in subparagraph (A),
include a list of interpretive criteria, if any, that the
Secretary has determined to be appropriate with respect to
legally marketed antimicrobial drugs, where--
``(i) the Secretary does not recognize, in whole or in
part, an interpretive criteria standard described under
subparagraph (A) otherwise applicable to such a drug;
``(ii) the Secretary withdraws under subsection (c)(1)(A)
recognition of a standard, in whole or in part, otherwise
applicable to such a drug;
``(iii) the Secretary approves an application under section
505 of this Act or section 351 of the Public Health Service
Act, as applicable, with respect to marketing of such a drug
for which there are no relevant interpretive criteria
included in a standard recognized by the Secretary under
subsection (c); or
``(iv) because the characteristics of such a drug differ
from other drugs with the same active ingredient, the
interpretive criteria with respect to such drug--
``(I) differ from otherwise applicable interpretive
criteria included in a standard listed under subparagraph (A)
or interpretive criteria otherwise listed under this
subparagraph; and
``(II) are determined by the Secretary to be appropriate
for the drug.
``(C) Required statements.--The Interpretive Criteria
Website shall include statements conveying--
``(i) that the website provides information about the in
vitro susceptibility of bacteria, fungi, or other
microorganisms, as applicable to a certain drug (or drugs);
``(ii) that--
``(I) the safety and efficacy of such drugs in treating
clinical infections due to such bacteria, fungi, or other
microorganisms, as applicable, may or may not have been
established in adequate and well-controlled clinical trials
in order for the susceptibility information described in
clause (i) to be included on the website; and
``(II) the clinical significance of such susceptibility
information in such instances is unknown;
``(iii) that the approved product labeling for specific
drugs provides the uses for which the Secretary has approved
the product; and
``(iv) any other information that the Secretary determines
appropriate to adequately convey the meaning of the data
supporting the recognition or listing of susceptibility test
interpretive criteria standards or susceptibility test
interpretive criteria included on the website.
``(3) Notice.--Not later than the date on which the
Interpretive Criteria Website is established, the Secretary
shall publish a notice of that establishment in the Federal
Register.
``(4) Inapplicability of misbranding provision.--The
inclusion in the approved labeling of an antimicrobial drug
of a reference or hyperlink to the Interpretive Criteria
Website, in and of itself, shall not cause the drug to be
misbranded in violation of section 502.
``(5) Trade secrets and confidential information.--Nothing
in this section shall be construed as authorizing the
Secretary to disclose any information that is a trade secret
or confidential information subject to section 552(b)(4) of
title 5, United States Code.
``(c) Recognition of Susceptibility Test Interpretive
Criteria.--
``(1) Evaluation and publication.--
``(A) In general.--Beginning on the date of the
establishment of the Interpretive Criteria Website, and at
least every 6 months thereafter, the Secretary shall--
``(i) evaluate any appropriate new or updated
susceptibility test interpretive criteria standards
established by a nationally or internationally recognized
standard development organization described in subsection
(b)(2)(A)(i); and
``(ii) publish on the public website of the Food and Drug
Administration a notice--
``(I) withdrawing recognition of any different
susceptibility test interpretive criteria standard, in whole
or in part;
``(II) recognizing the new or updated standards;
``(III) recognizing one or more parts of the new or updated
interpretive criteria specified in such a standard and
declining to recognize the remainder of such standard; and
``(IV) making any necessary updates to the lists under
subsection (b)(2).
``(B) Upon approval of a drug.--Upon the approval of an
initial or supplemental application for an antimicrobial drug
under section 505 of this Act or section 351 of the Public
Health Service Act, as applicable, where such approval is
based on susceptibility test interpretive criteria which
differ from those contained in a standard recognized, or from
those otherwise
[[Page H6921]]
listed, by the Secretary pursuant to this subsection, or for
which there are no relevant interpretive criteria standards
recognized, or interpretive criteria otherwise listed, by the
Secretary pursuant to this subsection, the Secretary shall
update the lists under subparagraphs (A) and (B) of
subsection (b)(2) to include the susceptibility test
interpretive criteria upon which such approval was based.
``(2) Bases for updating interpretive criteria standards.--
In evaluating new or updated susceptibility test interpretive
criteria standards under paragraph (1)(A), the Secretary may
consider--
``(A) the Secretary's determination that such a standard is
not applicable to a particular drug because the
characteristics of the drug differ from other drugs with the
same active ingredient;
``(B) information provided by interested third parties,
including public comment on the annual compilation of notices
published under paragraph (3);
``(C) any bases used to identify susceptibility test
interpretive criteria under subsection (a)(2); and
``(D) such other information or factors as the Secretary
determines appropriate.
``(3) Annual compilation of notices.--Each year, the
Secretary shall compile the notices published under paragraph
(1)(A) and publish such compilation in the Federal Register
and provide for public comment. If the Secretary receives
comments, the Secretary shall review such comments and, if
the Secretary determines appropriate, update pursuant to this
subsection susceptibility test interpretive criteria
standards or criteria--
``(A) recognized by the Secretary under this subsection; or
``(B) otherwise listed on the Interpretive Criteria Website
under subsection (b)(2).
``(4) Relation to section 514(c).--Any susceptibility test
interpretive standard recognized under this subsection or any
criteria otherwise listed under subsection (b)(2)(B) shall be
deemed to be recognized as a standard by the Secretary under
section 514(c)(1).
``(5) Voluntary use of interpretive criteria.--Nothing in
this section prohibits a person from seeking approval or
clearance of a drug or device, or changes to the drug or the
device, on the basis of susceptibility test interpretive
criteria which differ from those contained in a standard
recognized, or from those otherwise listed, by the Secretary
pursuant to subsection (b)(2).
``(d) Antimicrobial Drug Labeling.--
``(1) Drugs marketed prior to establishment of interpretive
criteria website.--
``(A) In general.--With respect to an antimicrobial drug
lawfully introduced or delivered for introduction into
interstate commerce for commercial distribution before the
establishment of the Interpretive Criteria Website, a holder
of an approved application under section 505 of this Act or
section 351 of the Public Health Service Act, as applicable,
for each such drug, not later than 1 year after establishment
of the Interpretive Criteria Website described in subsection
(b)(1), shall remove susceptibility test interpretive
criteria, if any, and related information from the approved
drug labeling and replace it with a reference to the
Interpretive Criteria Website.
``(B) Labeling changes.--The labeling changes required by
this section shall be considered a minor change under section
314.70 of title 21, Code of Federal Regulations (or any
successor regulations) that may be implemented through
documentation in the next applicable annual report.
``(2) Drugs marketed subsequent to establishment of
interpretive criteria website.--With respect to antimicrobial
drugs approved on or after the date of the establishment of
the Interpretive Criteria Website described in subsection
(b)(1), the labeling for such a drug shall include, in lieu
of susceptibility test interpretive criteria and related
information, a reference to such Website.
``(e) Special Condition for Marketing of Antimicrobial
Susceptibility Testing Devices.--
``(1) In general.--Notwithstanding sections 501, 502, 505,
510, 513, and 515, if the conditions specified in paragraph
(2) are met (in addition to other applicable provisions under
this chapter) with respect to an antimicrobial susceptibility
testing device described in subsection (f)(1), the Secretary
may authorize the marketing of such device for a use
described in such subsection.
``(2) Conditions applicable to antimicrobial susceptibility
testing devices.--The conditions specified in this paragraph
are the following:
``(A) The device is used to make a determination of
susceptibility using susceptibility test interpretive
criteria that are--
``(i) included in a standard recognized by the Secretary
under subsection (c); or
``(ii) otherwise listed on the Interpretive Criteria
Website under subsection (b)(2).
``(B) The labeling of such device includes statements
conveying--
``(i) that the device provides information about the in
vitro susceptibility of bacteria, fungi, or other
microorganisms, as applicable to antimicrobial drugs;
``(ii) that--
``(I) the safety and efficacy of such drugs in treating
clinical infections due to such bacteria, fungi, or other
microorganisms, as applicable, may or may not have been
established in adequate and well-controlled clinical trials
in order for the device to report the susceptibility of such
bacteria, fungi, or other microorganisms, as applicable, to
such drugs; and
``(II) the clinical significance of such susceptibility
information in those instances is unknown;
``(iii) that the approved labeling for drugs tested using
such a device provides the uses for which the Secretary has
approved such drugs; and
``(iv) any other information the Secretary determines
appropriate to adequately convey the meaning of the data
supporting the recognition or listing of susceptibility test
interpretive criteria standards or susceptibility test
interpretive criteria described in subparagraph (A).
``(C) The antimicrobial susceptibility testing device meets
all other requirements to be cleared under section 510(k),
classified under section 513(f)(2), or approved under section
515.
``(f) Definitions.--In this section:
``(1) The term `antimicrobial susceptibility testing
device' means a device that utilizes susceptibility test
interpretive criteria to determine and report the in vitro
susceptibility of certain microorganisms to a drug (or
drugs).
``(2) The term `qualified infectious disease product' means
a qualified infectious disease product designated under
section 505E(d).
``(3) The term `susceptibility test interpretive criteria'
means--
``(A) one or more specific numerical values which
characterize the susceptibility of bacteria or other
microorganisms to the drug tested; and
``(B) related categorizations of such susceptibility,
including categorization of the drug as susceptible,
intermediate, resistant, or such other term as the Secretary
determines appropriate.
``(4)(A) The term `antimicrobial drug' means, subject to
subparagraph (B), a systemic antibacterial or antifungal drug
that--
``(i) is intended for human use in the treatment of a
disease or condition caused by a bacterium or fungus;
``(ii) may include a qualified infectious disease product
designated under section 505E(d); and
``(iii) is subject to section 503(b)(1).
``(B) If provided by the Secretary through regulations,
such term may include--
``(i) drugs other than systemic antibacterial and
antifungal drugs; and
``(ii) biological products (as such term is defined in
section 351 of the Public Health Service Act) to the extent
such products exhibit antimicrobial activity.
``(5) The term `interpretive criteria standard' means a
compilation of susceptibility test interpretive criteria
developed by a standard development organization that meets
the criteria set forth in subsection (b)(2)(A)(i).
``(g) Rule of Construction.--Nothing in this section shall
be construed to--
``(1) alter the standards of evidence under subsection (c)
or (d) of section 505 (including the substantial evidence
standard under section 505(d)) or under section 351 of the
Public Health Service Act (as applicable); or
``(2) with respect to clearing devices under section
510(k), classifying devices under section 513(f)(2), or
approving devices under section 515--
``(A) apply with respect to any drug, device, or biological
product, in any context other than an antimicrobial drug and
an antimicrobial susceptibility testing device that uses
susceptibility test interpretive criteria to characterize and
report the susceptibility of certain bacteria, fungi, or
other microorganisms, as applicable, to such drug to reflect
patient morbidity and mortality in accordance with this
section; or
``(B) unless specifically stated, have any effect on
authorities provided under other sections of this Act,
including any regulations issued under such sections.''.
(b) Conforming Amendments.--
(1) Repeal of prior related authority.--Section 1111 of the
Food and Drug Administration Amendments Act of 2007 (42
U.S.C. 247d-5a), relating to identification of clinically
susceptible concentrations of antimicrobials, is repealed.
(2) Addition to categories of misbranded drugs.--Section
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended by adding at the end the following:
``(dd) If it is an antimicrobial drug, as defined in
section 511A(f), and its labeling fails to conform with the
requirements under section 511A(d).''.
(3) Recognition of interpretive criteria standard as device
standard.--Section 514(c)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by
inserting after ``the Secretary shall, by publication in the
Federal Register'' the following: ``(or, with respect to a
susceptibility test interpretive criteria standard under
section 511A, by posting on the Interpretive Criteria Website
in accordance with such section)''.
(c) Report to Congress.--Not later than 2 years after the
date of enactment of this Act, the Secretary of Health and
Human Services shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report on the progress made in implementing
section 511A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360a), as added by subsection (a).
(d) Requests for Updates to Interpretive Criteria
Website.--Chapter 35 of title 44, United States Code, shall
not apply to the collection of information from interested
parties regarding updating the lists established under
section 511A(b) of the Federal Food, Drug, and Cosmetic Act
and posted on the Interpretive Criteria Website established
under section 511A(c) of such Act.
Subtitle F--Medical Device Innovations
SEC. 3051. BREAKTHROUGH DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 515B, as added by section 3034(b), the
following:
[[Page H6922]]
``SEC. 515C. BREAKTHROUGH DEVICES.
``(a) Purpose.--The purpose of this section is to encourage
the Secretary, and provide the Secretary with sufficient
authority, to apply efficient and flexible approaches to
expedite the development of, and prioritize the Food and Drug
Administration's review of, devices that represent
breakthrough technologies.
``(b) Establishment of Program.--The Secretary shall
establish a program to expedite the development of, and
provide for the priority review for, devices, as determined
by the Secretary--
``(1) that provide for more effective treatment or
diagnosis of life-threatening or irreversibly debilitating
human disease or conditions; and
``(2)(A) that represent breakthrough technologies;
``(B) for which no approved or cleared alternatives exist;
``(C) that offer significant advantages over existing
approved or cleared alternatives, including the potential,
compared to existing approved alternatives, to reduce or
eliminate the need for hospitalization, improve patient
quality of life, facilitate patients' ability to manage their
own care (such as through self-directed personal assistance),
or establish long-term clinical efficiencies; or
``(D) the availability of which is in the best interest of
patients.
``(c) Request for Designation.--A sponsor of a device may
request that the Secretary designate such device for
expedited development and priority review under this section.
Any such request for designation may be made at any time
prior to the submission of an application under section
515(c), a notification under section 510(k), or a petition
for classification under section 513(f)(2).
``(d) Designation Process.--
``(1) In general.--Not later than 60 calendar days after
the receipt of a request under subsection (c), the Secretary
shall determine whether the device that is the subject of the
request meets the criteria described in subsection (b). If
the Secretary determines that the device meets the criteria,
the Secretary shall designate the device for expedited
development and priority review.
``(2) Review.--Review of a request under subsection (c)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug
Administration.
``(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of the
criteria under subsection (b) no longer applying because of
the subsequent clearance or approval of another device that--
``(A) was designated under this section; or
``(B) was given priority review under section 515(d)(5), as
in effect prior to the date of enactment of the 21st Century
Cures Act.
``(e) Expedited Development and Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (d) the
Secretary shall--
``(A) assign a team of staff, including a team leader with
appropriate subject matter expertise and experience, for each
device for which a request is submitted under subsection (c);
``(B) provide for oversight of the team by senior agency
personnel to facilitate the efficient development of the
device and the efficient review of any submission described
in subsection (c) for the device;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive and timely communication with
the sponsor of the device during the development program and
review process;
``(E) expedite the Secretary's review of manufacturing and
quality systems compliance, as applicable;
``(F) disclose to the sponsor, not less than 5 business
days in advance, the topics of any consultation the Secretary
intends to undertake with external experts or an advisory
committee concerning the sponsor's device and provide the
sponsor the opportunity to recommend such external experts;
``(G) provide for advisory committee input, as the
Secretary determines appropriate (including in response to
the request of the sponsor) for applications submitted under
section 515(c); and
``(H) assign staff to be available within a reasonable time
to address questions by institutional review committees
concerning the conditions and clinical testing requirements
applicable to the investigational use of the device pursuant
to an exemption under section 520(g).
``(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting the
development and review of devices designated under subsection
(d), the Secretary, in collaboration with the device sponsor,
may, as appropriate--
``(A) coordinate with the sponsor regarding early agreement
on a data development plan;
``(B) take steps to ensure that the design of clinical
trials is as efficient and flexible as practicable, when
scientifically appropriate;
``(C) facilitate, when scientifically appropriate,
expedited and efficient development and review of the device
through utilization of timely postmarket data collection with
regard to application for approval under section 515(c); and
``(D) agree in writing to clinical protocols that the
Secretary will consider binding on the Secretary and the
sponsor, subject to--
``(i) changes to such protocols agreed to in writing by the
sponsor and the Secretary; or
``(ii) a decision, made by the director of the office
responsible for reviewing the device submission, that a
substantial scientific issue essential to determining the
safety or effectiveness of such device exists, provided that
such decision is in writing, and is made only after the
Secretary provides to the device sponsor or applicant an
opportunity for a meeting at which the director and the
sponsor or applicant are present and at which the director
documents the substantial scientific issue.
``(f) Priority Review Guidance.--
``(1) Content.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
issue guidance on the implementation of this section. Such
guidance shall--
``(A) set forth the process by which a person may seek a
designation under subsection (d);
``(B) provide a template for requests under subsection (c);
``(C) identify the criteria the Secretary will use in
evaluating a request for designation under this section; and
``(D) identify the criteria and processes the Secretary
will use to assign a team of staff, including team leaders,
to review devices designated for expedited development and
priority review, including any training required for such
personnel to ensure effective and efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment on a
proposed guidance.
``(g) Rule of Construction.--Nothing in this section shall
be construed to affect--
``(1) the criteria and standards for evaluating an
application pursuant to section 515(c), a report and request
for classification under section 513(f)(2), or a report under
section 510(k), including the recognition of valid scientific
evidence as described in section 513(a)(3)(B) and
consideration and application of the least burdensome means
of evaluating device effectiveness or demonstrating
substantial equivalence between devices with differing
technological characteristics, as applicable;
``(2) the authority of the Secretary with respect to
clinical holds under section 520(g)(8)(A);
``(3) the authority of the Secretary to act on an
application pursuant to section 515(d) before completion of
an establishment inspection, as the Secretary determines
appropriate; or
``(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and 522.''.
(b) Documentation and Review of Significant Decisions.--
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360g-1(a)(1)) is amended by inserting ``a
request for designation under section 515C,'' after
``application under section 515,''.
(c) Termination of Previous Program.--
(1) In general.--Section 515(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph (5).
(2) Conforming amendment.--Section 737(5) of the Federal
Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended
by striking ``515(d)(6)'' and inserting ``515(d)(5)''.
(d) Report.--On January 1, 2019, the Secretary of Health
and Human Services shall issue 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--
(1) on the program under section 515C of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), in
bringing safe and effective devices included in such program
to patients as soon as possible; and
(2) that includes recommendations, if any, to strengthen
the program to better meet patient device needs in a manner
as timely as possible.
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.
(a) In General.--Section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j) is amended--
(1) in paragraph (1) by striking ``fewer than 4,000'' and
inserting ``not more than 8,000'';
(2) in paragraph (2)(A) by striking ``fewer than 4,000''
and inserting ``not more than 8,000''; and
(3) in paragraph (6)(A)(ii), by striking ``4,000'' and
inserting ``8,000''.
(b) Guidance Document on Probable Benefit.--Not later than
18 months after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall publish a draft
guidance that defines the criteria for establishing
``probable benefit'' as that term is used in section
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(m)(2)(C)).
SEC. 3053. RECOGNITION OF STANDARDS.
(a) In General.--Section 514(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360d(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (B)
the following new subparagraphs:
``(C)(i) Any person may submit a request for recognition
under subparagraph (A) of all or part of an appropriate
standard established by a nationally or internationally
recognized standard organization.
``(ii) Not later than 60 calendar days after the Secretary
receives such a request, the Secretary shall--
``(I) make a determination to recognize all, part, or none
of the standard that is the subject of the request; and
``(II) issue to the person who submitted such request a
response in writing that states the Secretary's rationale for
that determination, including the scientific, technical,
regulatory, or other basis for such determination.
``(iii) The Secretary shall make a response issued under
clause (ii)(II) publicly available, in such a manner as the
Secretary determines appropriate.
``(iv) The Secretary shall take such actions as may be
necessary to implement all or part of a standard recognized
under clause (ii)(I), in accordance with subparagraph (A).
``(D) The Secretary shall make publicly available, in such
manner as the Secretary determines appropriate, the rationale
for recognition
[[Page H6923]]
under subparagraph (A) of all, part, or none of a standard,
including the scientific, technical, regulatory, or other
basis for the decision regarding such recognition.''; and
(2) by adding at the end the following:
``(4) The Secretary shall provide to all employees of the
Food and Drug Administration who review premarket submissions
for devices periodic training on the concept and use of
recognized standards for purposes of meeting a premarket
submission requirement or other applicable requirement under
this Act, including standards relevant to an employee's area
of device review.''.
(b) Guidance.--The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall
review and update, if necessary, previously published
guidance and standard operating procedures identifying the
principles for recognizing standards, and for withdrawing the
recognition of standards, under section 514(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into
account the experience with and reliance on a standard by
foreign regulatory authorities and the device industry, and
whether recognition of a standard will promote harmonization
among regulatory authorities in the regulation of devices.
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.
(a) Class I Devices.--Section 510(l) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended--
(1) by striking ``A report under subsection (k)'' and
inserting ``(1) A report under subsection (k)''; and
(2) by adding at the end the following new paragraph:
``(2) Not later than 120 calendar days after the date of
enactment of the 21st Century Cures Act and at least once
every 5 years thereafter, as the Secretary determines
appropriate, the Secretary shall identify, through
publication in the Federal Register, any type of class I
device that the Secretary determines no longer requires a
report under subsection (k) to provide reasonable assurance
of safety and effectiveness. Upon such publication--
``(A) each type of class I device so identified shall be
exempt from the requirement for a report under subsection
(k); and
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
(b) Class II Devices.--Section 510(m) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended--
(1) by striking ``(m)(1)'' and all that follows through
``by the Secretary.'' and inserting the following:
``(m)(1) The Secretary shall--
``(A) not later than 90 days after the date of enactment of
the 21st Century Cures Act and at least once every 5 years
thereafter, as the Secretary determines appropriate--
``(i) publish in the Federal Register a notice that
contains a list of each type of class II device that the
Secretary determines no longer requires a report under
subsection (k) to provide reasonable assurance of safety and
effectiveness; and
``(ii) provide for a period of not less than 60 calendar
days for public comment beginning on the date of the
publication of such notice; and
``(B) not later than 210 calendar days after the date of
enactment of the 21st Century Cures Act, publish in the
Federal Register a list representing the Secretary's final
determination with respect to the devices contained in the
list published under subparagraph (A).''; and
(2) in paragraph (2)--
(A) by striking ``1 day after the date of publication of a
list under this subsection,'' and inserting ``1 calendar day
after the date of publication of the final list under
paragraph (1)(B),''; and
(B) by striking ``30-day period'' and inserting ``60-
calendar-day period''; and
(C) by adding at the end the following new paragraph:
``(3) Upon the publication of the final list under
paragraph (1)(B)--
``(A) each type of class II device so listed shall be
exempt from the requirement for a report under subsection
(k); and
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
SEC. 3055. CLASSIFICATION PANELS.
(a) Classification Panels.--Paragraph (5) of section 513(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c(b)) is amended--
(1) by striking ``(5)'' and inserting ``(5)(A)''; and
(2) by adding at the end the following:
``(B) When a device is specifically the subject of review
by a classification panel, the Secretary shall--
``(i) ensure that adequate expertise is represented on the
classification panel to assess--
``(I) the disease or condition which the device is intended
to cure, treat, mitigate, prevent, or diagnose; and
``(II) the technology of the device; and
``(ii) provide an opportunity for the person whose device
is specifically the subject of panel review to provide
recommendations on the expertise needed among the voting
members of the panel.
``(C) For purposes of subparagraph (B)(i), the term
`adequate expertise' means that the membership of the
classification panel includes--
``(i) two or more voting members, with a specialty or other
expertise clinically relevant to the device under review; and
``(ii) at least one voting member who is knowledgeable
about the technology of the device.
``(D) The Secretary shall provide an annual opportunity for
patients, representatives of patients, and sponsors of
medical device submissions to provide recommendations for
individuals with appropriate expertise to fill voting member
positions on classification panels.''.
(b) Panel Review Process.--Section 513(b)(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is
amended--
(1) in subparagraph (A)(iii), by inserting before the
period at the end ``, including, subject to the discretion of
the panel chairperson, by designating a representative who
will be provided a time during the panel meeting to address
the panel for the purpose of correcting misstatements of fact
or providing clarifying information, and permitting the
person or representative to call on experts within the
person's organization to address such specific issues in the
time provided''; and
(2) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B)(i) Any meeting of a classification panel with respect
to the review of a device shall--
``(I) provide adequate time for initial presentations by
the person whose device is specifically the subject of such
review and by the Secretary; and
``(II) encourage free and open participation by all
interested persons.
``(ii) Following the initial presentations described in
clause (i), the panel may--
``(I) pose questions to a designated representative
described in subparagraph (A)(iii); and
``(II) consider the responses to such questions in the
panel's review of the device.''.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j) is amended--
(1) in subsection (g)(3)--
(A) in subparagraph (A)(i)--
(i) by striking ``local''; and
(ii) by striking ``which has been''; and
(B) in subparagraph (B), by striking ``a local
institutional'' and inserting ``an institutional''; and
(2) in subsection (m)(4)--
(A) by striking subparagraph (A) and inserting the
following:
``(A) in facilities in which clinical testing of devices is
supervised by an institutional review committee established
in accordance with the regulations of the Secretary; and'';
(B) in subparagraph (B), by striking ``a local
institutional'' and inserting ``an institutional''; and
(C) in the matter following subparagraph (B), by striking
``local''.
SEC. 3057. CLIA WAIVER IMPROVEMENTS.
(a) Draft Revised Guidance.--Not later than 1 year after
the date of the enactment of this Act, the Secretary of
Health and Human Services, acting through the Commissioner of
Food and Drugs, shall publish a draft guidance that--
(1) revises ``Section V. Demonstrating Insignificant Risk
of an Erroneous Result - Accuracy'' of the guidance entitled
``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices'' and dated
January 30, 2008; and
(2) includes the appropriate use of comparable performance
between a waived user and a moderately complex laboratory
user to demonstrate accuracy.
(b) Final Revised Guidance.--The Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall finalize the draft guidance published under
subsection (a) not later than 1 year after the comment period
for such draft guidance closes.
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.
(a) In General.--Section 513 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following:
``(j) Training and Oversight of Least Burdensome
Requirements.--
``(1) The Secretary shall--
``(A) ensure that each employee of the Food and Drug
Administration who is involved in the review of premarket
submissions, including supervisors, receives training
regarding the meaning and implementation of the least
burdensome requirements under subsections (a)(3)(D) and
(i)(1)(D) of this section and section 515(c)(5); and
``(B) periodically assess the implementation of the least
burdensome requirements, including the employee training
under subparagraph (A), to ensure that the least burdensome
requirements are fully and consistently applied.
``(2) Not later than 18 months after the date of enactment
of the 21st Century Cures Act, the ombudsman for any
organizational unit of the Food and Drug Administration
responsible for the premarket review of devices shall--
``(A) conduct an audit of the training described in
paragraph (1)(A), including the effectiveness of such
training in implementing the least burdensome requirements;
``(B) include in such audit interviews of persons who are
representatives of the device industry regarding their
experiences in the device premarket review process, including
with respect to the application of least burdensome concepts
to premarket review and decisionmaking;
``(C) include in such audit a list of the measurement tools
the Secretary uses to assess the implementation of the least
burdensome requirements, including under paragraph (1)(B) and
section 517A(a)(3), and may also provide feedback on the
effectiveness of such tools in the implementation of the
least burdensome requirements;
``(D) summarize the findings of such audit in a final audit
report; and
``(E) within 30 calendar days of completion of such final
audit report, make such final audit report available--
``(i) to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives; and
[[Page H6924]]
``(ii) on the Internet website of the Food and Drug
Administration.''.
(b) Premarket Applications.--Section 515(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended
by adding at the end the following:
``(5)(A) In requesting additional information with respect
to an application under this section, the Secretary shall
consider the least burdensome appropriate means necessary to
demonstrate a reasonable assurance of device safety and
effectiveness.
``(B) For purposes of subparagraph (A), the term
`necessary' means the minimum required information that would
support a determination by the Secretary that an application
provides a reasonable assurance of the safety and
effectiveness of the device.
``(C) For purposes of this paragraph, the Secretary shall
consider the role of postmarket information in determining
the least burdensome means of demonstrating a reasonable
assurance of device safety and effectiveness.
``(D) Nothing in this paragraph alters the standards for
premarket approval of a device.''.
(c) Rationale for Significant Decisions Regarding
Devices.--Section 517A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360g-1(a)) is amended by adding at
the end the following:
``(3) Application of least burdensome requirements.--The
substantive summary required under this subsection shall
include a brief statement regarding how the least burdensome
requirements were considered and applied consistent with
section 513(i)(1)(D), section 513(a)(3)(D), and section
515(c)(5), as applicable.''.
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA
REQUIREMENT.
(a) In General.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end
the following:
``(q) Reusable Medical Devices.--
``(1) In general.--Not later than 180 days after the date
of enactment of the 21st Century Cures Act, the Secretary
shall identify and publish a list of reusable device types
for which reports under subsection (k) are required to
include--
``(A) instructions for use, which have been validated in a
manner specified by the Secretary; and
``(B) validation data, the types of which shall be
specified by the Secretary;
regarding cleaning, disinfection, and sterilization, and for
which a substantial equivalence determination may be based.
``(2) Revision of list.--The Secretary shall revise the
list under paragraph (2), as the Secretary determines
appropriate, with notice in the Federal Register.
``(3) Content of reports.--Reports under subsection (k)
that are submitted after the publication of the list
described in paragraph (1), for devices or types of devices
included on such list, shall include such instructions for
use and validation data.''.
(b) Device Modifications.--The Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall issue final guidance regarding when a premarket
notification under section 510(k) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(k)) is required to be
submitted for a modification or change to a legally marketed
device. Such final guidance shall be issued not later than 1
year after the date on which the comment period closes for
the draft guidance on such subject.
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end
the following:
``(o) Regulation of Medical and Certain Decisions Support
Software.--
``(1) The term device, as defined in section 201(h), shall
not include a software function that is intended--
``(A) for administrative support of a health care facility,
including the processing and maintenance of financial
records, claims or billing information, appointment
schedules, business analytics, information about patient
populations, admissions, practice and inventory management,
analysis of historical claims data to predict future
utilization or cost-effectiveness, determination of health
benefit eligibility, population health management, and
laboratory workflow;
``(B) for maintaining or encouraging a healthy lifestyle
and is unrelated to the diagnosis, cure, mitigation,
prevention, or treatment of a disease or condition;
``(C) to serve as electronic patient records, including
patient-provided information, to the extent that such records
are intended to transfer, store, convert formats, or display
the equivalent of a paper medical chart, so long as--
``(i) such records were created, stored, transferred, or
reviewed by health care professionals, or by individuals
working under supervision of such professionals;
``(ii) such records are part of health information
technology that is certified under section 3001(c)(5) of the
Public Health Service Act; and
``(iii) such function is not intended to interpret or
analyze patient records, including medical image data, for
the purpose of the diagnosis, cure, mitigation, prevention,
or treatment of a disease or condition;
``(D) for transferring, storing, converting formats, or
displaying clinical laboratory test or other device data and
results, findings by a health care professional with respect
to such data and results, general information about such
findings, and general background information about such
laboratory test or other device, unless such function is
intended to interpret or analyze clinical laboratory test or
other device data, results, and findings; or
``(E) unless the function is intended to acquire, process,
or analyze a medical image or a signal from an in vitro
diagnostic device or a pattern or signal from a signal
acquisition system, for the purpose of--
``(i) displaying, analyzing, or printing medical
information about a patient or other medical information
(such as peer-reviewed clinical studies and clinical practice
guidelines);
``(ii) supporting or providing recommendations to a health
care professional about prevention, diagnosis, or treatment
of a disease or condition; and
``(iii) enabling such health care professional to
independently review the basis for such recommendations that
such software presents so that it is not the intent that such
health care professional rely primarily on any of such
recommendations to make a clinical diagnosis or treatment
decision regarding an individual patient.
``(2) In the case of a product with multiple functions that
contains--
``(A) at least one software function that meets the
criteria under paragraph (1) or that otherwise does not meet
the definition of device under section 201(h); and
``(B) at least one function that does not meet the criteria
under paragraph (1) and that otherwise meets the definition
of a device under section 201(h),
the Secretary shall not regulate the software function of
such product described in subparagraph (A) as a device.
Notwithstanding the preceding sentence, when assessing the
safety and effectiveness of the device function or functions
of such product described in subparagraph (B), the Secretary
may assess the impact that the software function or functions
described in subparagraph (A) have on such device function or
functions.
``(3)(A) Notwithstanding paragraph (1), a software function
described in subparagraph (C), (D), or (E) of paragraph (1)
shall not be excluded from the definition of device under
section 201(h) if--
``(i) the Secretary makes a finding that use of such
software function would be reasonably likely to have serious
adverse health consequences; and
``(ii) the software function has been identified in a final
order issued by the Secretary under subparagraph (B).
``(B) Subparagraph (A) shall apply only if the Secretary--
``(i) publishes a notification and proposed order in the
Federal Register;
``(ii) includes in such notification the Secretary's
finding, including the rationale and identification of the
evidence on which such finding was based, as described in
subparagraph (A)(i); and
``(iii) provides for a period of not less than 30 calendar
days for public comment before issuing a final order or
withdrawing such proposed order.
``(C) In making a finding under subparagraph (A)(i) with
respect to a software function, the Secretary shall
consider--
``(i) the likelihood and severity of patient harm if the
software function were to not perform as intended;
``(ii) the extent to which the software function is
intended to support the clinical judgment of a health care
professional;
``(iii) whether there is a reasonable opportunity for a
health care professional to review the basis of the
information or treatment recommendation provided by the
software function; and
``(iv) the intended user and user environment, such as
whether a health care professional will use a software
function of a type described in subparagraph (E) of paragraph
(1).
``(4) Nothing in this subsection shall be construed as
limiting the authority of the Secretary to--
``(A) exercise enforcement discretion as to any device
subject to regulation under this Act;
``(B) regulate software used in the manufacture and
transfusion of blood and blood components to assist in the
prevention of disease in humans; or
``(C) regulate software as a device under this Act if such
software meets the criteria under section 513(a)(1)(C).''.
(b) Reports.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary''), after
consultation with agencies and offices of the Department of
Health and Human Services involved in health information
technology, shall publish a report, not later than 2 years
after the date of enactment of this Act and every 2 years
thereafter, that--
(1) includes input from outside experts, such as
representatives of patients, consumers, health care
providers, startup companies, health plans or other third-
party payers, venture capital investors, information
technology vendors, health information technology vendors,
small businesses, purchasers, employers, and other
stakeholders with relevant expertise, as determined by the
Secretary;
(2) examines information available to the Secretary on any
risks and benefits to health associated with software
functions described in section 520(o)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j) (as amended by
subsection (a)); and
(3) summarizes findings regarding the impact of such
software functions on patient safety, including best
practices to promote safety, education, and competency
related to such functions.
(c) Classification of Accessories.--Section 513(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is
amended by adding at the end the following:
``(9) The Secretary shall classify an accessory under this
section based on the intended use of the accessory,
notwithstanding the classification of any other device with
which such accessory is intended to be used.''.
[[Page H6925]]
(d) Conforming Amendment.--Section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by
adding at the end the following: ``The term `device' does not
include software functions excluded pursuant to section
520(o).''.
Subtitle G--Improving Scientific Expertise and Outreach at FDA
SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND
BIOMEDICAL PRODUCT ASSESSMENT SERVICE.
(a) Hiring and Retention Authority.--Section 228 of the
Public Health Service Act (42 U.S.C. 237) is amended--
(1) in the section heading, by inserting ``and biomedical
product assessment'' after ``research'';
(2) in subsection (a)--
(A) in paragraph (1), by striking ``Silvio O. Conte Senior
Biomedical Research Service, not to exceed 500 members'' and
inserting ``Silvio O. Conte Senior Biomedical Research and
Biomedical Product Assessment Service (in this section
referred to as the `Service'), not to exceed 2,000 members,
the purpose of which is to recruit and retain outstanding and
qualified scientific and technical experts in the fields of
biomedical research, clinical research evaluation, and
biomedical product assessment'';
(B) by amending paragraph (2) to read as follows:
``(2) The authority established in paragraph (1) may not be
construed to require the Secretary to reduce the number of
employees serving under any other employment system in order
to offset the number of members serving in the Service.'';
and
(C) by adding at the end the following:
``(3) The Secretary shall assign experts under this section
to agencies within the Department of Health and Human
Services taking into account the need for the expertise of
such expert.'';
(3) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking ``or
clinical research evaluation'' and inserting ``, clinical
research evaluation, or biomedical product assessment''; and
(B) in paragraph (1), by inserting ``or a doctoral or
master's level degree in engineering, bioinformatics, or a
related or emerging field,'' after the comma;
(4) in subsection (d)(2), by striking ``and shall not
exceed the rate payable for level I of the Executive Schedule
unless approved by the President under section 5377(d)(2) of
title 5, United States Code'' and inserting ``and shall not
exceed the amount of annual compensation (excluding expenses)
specified in section 102 of title 3, United States Code'';
(5) by striking subsection (e); and
(6) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
(b) GAO Study.--
(1) In general.--The Comptroller General of the United
States shall conduct a study of the effectiveness of the
amendments to section 228 of the Public Health Service Act
(42 U.S.C. 237) made by subsection (a) and the impact of such
amendments, if any, on all agencies or departments of the
Department of Health and Human Services, and, not later than
4 years after the date of enactment of this Act, shall submit
a report based on such study to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives.
(2) Content of study and report.--The study and report
under paragraph (1) shall include an examination of the
extent to which recruitment and retention of outstanding and
qualified scientific, medical, or technical experts in the
fields of biomedical research, clinical research evaluation,
and biomedical product assessment have improved or otherwise
have been affected by the amendments to section 228 of the
Public Health Service Act (42 U.S.C. 237) made by subsection
(a), including by determining, during the period between the
date of enactment of this Act and the completion of the
study--
(A) the total number of members recruited and retained
under the Senior Biomedical Research and Biomedical Product
Assessment Service under such section 228, and the effect of
increasing the number of members eligible for such Service;
(B) the number of members of such Senior Biomedical
Research and Biomedical Product Assessment Service hired with
a doctoral level degree in biomedicine or a related field,
and the number of such members hired with a doctoral or
master's level degree in engineering, bioinformatics, or a
related or emerging field; and
(C) the number of Senior Biomedical Research and Biomedical
Product Assessment Service members that have been hired by
each agency or department of the Department of Health and
Human Services, and how such Department assigns such members
to each agency or department.
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
(a) In General.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 714 (21 U.S.C. 379d-3)
the following:
``SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
``(a) In General.--The Secretary may, notwithstanding title
5, United States Code, governing appointments in the
competitive service, appoint outstanding and qualified
candidates to scientific, technical, or professional
positions that support the development, review, and
regulation of medical products. Such positions shall be
within the competitive service.
``(b) Compensation.--
``(1) In general.--Notwithstanding any other provision of
law, including any requirement with respect to General
Schedule pay rates under subchapter III of chapter 53 of
title 5, United States Code, and consistent with the
requirements of paragraph (2), the Commissioner of Food and
Drugs may determine and set--
``(A) the annual rate of pay of any individual appointed
under subsection (a); and
``(B) for purposes of retaining qualified employees, the
annual rate of pay for any qualified scientific, technical,
or professional personnel appointed to a position described
in subsection (a) before the date of enactment of the 21st
Century Cures Act.
``(2) Limitation.--The annual rate of pay established
pursuant to paragraph (1) may not exceed the amount of annual
compensation (excluding expenses) specified in section 102 of
title 3, United States Code.
``(3) Public availability.--The annual rate of pay provided
to an individual in accordance with this section shall be
publicly available information.
``(c) Rule of Construction.--The authorities under this
section shall not be construed to affect the authority
provided under section 714.
``(d) Report on Workforce Planning.--
``(1) In general.--Not later than 18 months after the date
of enactment of the 21st Century Cures Act, the Secretary
shall submit a report on workforce planning to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives that examines the extent to which the Food
and Drug Administration has a critical need for qualified
individuals for scientific, technical, or professional
positions, including--
``(A) an analysis of the workforce needs at the Food and
Drug Administration and the Secretary's strategic plan for
addressing such needs, including through use of the authority
under this section; and
``(B) a recruitment and retention plan for hiring qualified
scientific, technical, and professional candidates, which may
include the use of--
``(i) recruitment through nongovernmental recruitment or
placement agencies;
``(ii) recruitment through academic institutions;
``(iii) recruitment or hiring bonuses, if applicable;
``(iv) recruitment using targeted direct hiring
authorities; and
``(v) retention of qualified scientific, technical, and
professional employees using the authority under this
section, or other applicable authorities of the Secretary.
``(2) Recommendations.--The report under paragraph (1) may
include the recommendations of the Commissioner of Food and
Drugs that would help the Food and Drug Administration to
better recruit and retain qualified individuals for
scientific, technical, or professional positions at the
agency.''.
(b) GAO Study and Report.--
(1) In general.--The Comptroller General of the United
States shall conduct a study of the ability of the Food and
Drug Administration to hire, train, and retain qualified
scientific, technical, and professional staff, not including
contractors, necessary to fulfill the mission of the Food and
Drug Administration to protect and promote public health. Not
later than January 1, 2022, the Comptroller General shall
submit a report on such study to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives.
(2) Contents of study.--The Comptroller General shall
include in the study and report under paragraph (1)--
(A) information about the progress of the Food and Drug
Administration in recruiting and retaining qualified
scientific, technical, and professional staff outstanding in
the field of biomedical research, clinical research
evaluation, and biomedical product assessment;
(B) the extent to which critical staffing needs exist at
the Food and Drug Administration, and barriers to hiring,
training, and retaining qualified staff, if any;
(C) an examination of the recruitment and retention
strategies of the Food and Drug Administration, including
examining any strategic workforce plan, focused on improving
scientific, technical, and professional staff recruitment and
retention; and
(D) recommendations for potential improvements that would
address staffing needs of the Food and Drug Administration.
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION
INTERCENTER INSTITUTES.
(a) In General.--Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at
the end the following:
``SEC. 1014. FOOD AND DRUG ADMINISTRATION INTERCENTER
INSTITUTES.
``(a) In General.--The Secretary shall establish one or
more Intercenter Institutes within the Food and Drug
Administration (referred to in this section as an
`Institute') for a major disease area or areas. With respect
to the major disease area of focus of an Institute, such
Institute shall develop and implement processes for
coordination of activities, as applicable to such major
disease area or areas, among the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health
(for the purposes of this section, referred to as the
`Centers'). Such activities may include--
``(1) coordination of staff from the Centers with diverse
product expertise in the diagnosis, cure, mitigation,
treatment, or prevention of the specific diseases relevant to
the major disease area of focus of the Institute;
``(2) streamlining, where appropriate, the review of
medical products to diagnose, cure, mitigate, treat, or
prevent the specific diseases relevant to the major disease
area of focus of the
[[Page H6926]]
Institute, applying relevant standards under sections 505,
510(k), 513(f)(2), and 515 of this Act and section 351 of the
Public Health Service Act, and other applicable authorities;
``(3) promotion of scientific programs within the Centers
related to the major disease area of focus of the Institute;
``(4) development of programs and enhancement of strategies
to recruit, train, and provide continuing education
opportunities for the personnel of the Centers with expertise
related to the major disease area of focus of the Institute;
``(5) enhancement of the interactions of the Centers with
patients, sponsors, and the external biomedical community
regarding the major disease area of focus of the Institute;
and
``(6) facilitation of the collaborative relationships of
the Centers with other agencies within the Department of
Health and Human Services regarding the major disease area of
focus of the Institute.
``(b) Public Process.--The Secretary shall provide a period
for public comment during the time that each Institute is
being implemented.
``(c) Timing.--The Secretary shall establish at least one
Institute under subsection (a) before the date that is 1 year
after the date of enactment of the 21st Century Cures Act.
``(d) Termination of Institutes.--The Secretary may
terminate any Institute established pursuant to this section
if the Secretary determines such Institute is no longer
benefitting the public health. Not less than 60 days prior to
so terminating an Institute, the Secretary shall provide
public notice, including the rationale for such
termination.''.
(b) Technical Amendments.--Chapter X of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
(1) by redesignating section 1012 as section 1013; and
(2) by redesignating the second section 1011 (with respect
to improving the training of State, local, territorial, and
tribal food safety officials), as added by section 209(a) of
the FDA Food Safety Modernization Act (Public Law 111-353),
as section 1012.
SEC. 3074. SCIENTIFIC ENGAGEMENT.
(a) In General.--Scientific meetings that are attended by
scientific or medical personnel, or other professionals, of
the Department of Health and Human Services for whom
attendance at such meeting is directly related to their
professional duties and the mission of the Department--
(1) shall not be considered conferences for the purposes of
complying with Federal reporting requirements contained in
annual appropriations Acts or in this section; and
(2) shall not be considered conferences for purposes of a
restriction contained in an annual appropriations Act, based
on Office of Management and Budget Memorandum M-12-12 or any
other regulation restricting travel to such meeting.
(b) Limitation.--Nothing in this section shall be construed
to exempt travel for scientific meetings from Federal
regulations relating to travel.
(c) Reports.--Not later than 90 days after the end of the
fiscal year, each operating division of the Department of
Health and Human Services shall prepare, and post on an
Internet website of the operating division, an annual report
on scientific meeting attendance and related travel spending
for each fiscal year. Such report shall include--
(1) general information concerning the scientific meeting
activities involved;
(2) information concerning the total amount expended for
such meetings;
(3) a description of all such meetings that were attended
by scientific or medical personnel, or other professionals,
of each such operating division where the total amount
expended by the operating division associated with each such
meeting were in excess of $30,000, including--
(A) the total amount of meeting expenses incurred by the
operating division for such meeting;
(B) the location of such meeting;
(C) the date of such meeting;
(D) a brief explanation on how such meeting advanced the
mission of the operating division; and
(E) the total number of individuals whose travel expenses
or other scientific meeting expenses were paid by the
operating division; and
(4) with respect to any such meeting where the total
expenses to the operating division exceeded $150,000, a
description of the exceptional circumstances that
necessitated the expenditure of such amounts.
SEC. 3075. DRUG SURVEILLANCE.
(a) New Drugs.--Section 505(k)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by
section 2074, is further amended--
(1) in subparagraph (A), by striking ``, bi-weekly
screening'' and inserting ``screenings'';
(2) in subparagraph (B), as redesignated by section
2074(1)(C), by striking the period at the end and inserting
``; and''; and
(3) by adding at the end the following:
``(C) make available on the Internet website of the Food
and Drug Administration--
``(i) guidelines, developed with input from experts
qualified by scientific training and experience to evaluate
the safety and effectiveness of drugs, that detail best
practices for drug safety surveillance using the Adverse
Event Reporting System; and
``(ii) criteria for public posting of adverse event
signals.''.
(b) FAERS Revision.--Section 505(r)(2)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is
amended by striking ``, by 18 months'' and all that follows
through the semicolon at the end of the subparagraph and
inserting ``and making publicly available on the Internet
website established under paragraph (1) best practices for
drug safety surveillance activities for drugs approved under
this section or section 351 of the Public Health Service
Act;''.
(c) Risk Evaluation and Mitigation Strategies.--Section
505-1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(f)(5)) is amended--
(1) in the matter preceding subparagraph (A), by inserting
``or other advisory committee'' after ``(or successor
committee)''; and
(2) in subparagraph (B), by striking ``at least annually,''
and inserting ``periodically''.
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) Board of Directors.--
(1) Composition and size.--Section 770(d)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(d)(1)(C)) is amended--
(A) by redesignating clause (ii) as clause (iii);
(B) by inserting after clause (i) the following:
``(ii) Additional members.--The Board, through amendments
to the bylaws of the Foundation, may provide that the number
of voting members of the Board shall be a number (to be
specified in such amendment) greater than 14. Any Board
positions that are established by any such amendment shall be
appointed (by majority vote) by the individuals who, as of
the date of such amendment, are voting members of the Board
and persons so appointed may represent any of the categories
specified in subclauses (I) through (V) of clause (i), so
long as no more than 30 percent of the total voting members
of the Board (including members whose positions are
established by such amendment) are representatives of the
general pharmaceutical, device, food, cosmetic, and
biotechnology industries.''; and
(C) in clause (iii)(I), as redesignated by subparagraph
(A), by striking ``The ex officio members shall ensure'' and
inserting ``The ex officio members, acting pursuant to clause
(i), and the Board, acting pursuant to clause (ii), shall
ensure''.
(2) Federal employees allowed to serve on board.--Clause
(iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated
by paragraph (1)(A), is amended by adding at the end the
following: ``For purposes of this section, the term `employee
of the Federal Government' does not include a special
Government employee, as that term is defined in section
202(a) of title 18, United States Code.''.
(3) Staggered terms.--Subparagraph (A) of section 770(d)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(d)(3)) is amended to read as follows:
``(A) Term.--The term of office of each member of the Board
appointed under paragraph (1)(C)(i), and the term of office
of any member of the Board whose position is established
pursuant to paragraph (1)(C)(ii), shall be 4 years, except
that--
``(i) the terms of offices for the members of the Board
initially appointed under paragraph (1)(C)(i) shall expire on
a staggered basis as determined by the ex officio members;
and
``(ii) the terms of office for the persons initially
appointed to positions established pursuant to paragraph
(1)(C)(ii) may be made to expire on a staggered basis, as
determined by the individuals who, as of the date of the
amendment establishing such positions, are members of the
Board.''.
(b) Executive Director Compensation.--Section 770(g)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(g)(2)) is amended by striking ``but shall not be
greater than the compensation of the Commissioner''.
(c) Separation of Funds.--Section 770(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended
by striking ``are held in separate accounts from funds
received from entities under subsection (i)'' and inserting
``are managed as individual programmatic funds under
subsection (i), according to best accounting practices''.
Subtitle H--Medical Countermeasures Innovation
SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.
Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--
(1) in subsection (a), by adding at the end the following:
``(3) Utilization guidelines.--The Secretary shall ensure
timely and accurate recommended utilization guidelines for
qualified countermeasures (as defined in section 319F-1),
qualified pandemic and epidemic products (as defined in
section 319F-3), and security countermeasures (as defined in
subsection (c)), including for such products in the
stockpile.''; and
(2) in subsection (g)--
(A) by amending paragraph (4) to read as follows:
``(4) Report on security countermeasure procurement.--Not
later than March 1 of each year in which the Secretary
determines that the amount of funds available for procurement
of security countermeasures is less than $1,500,000,000, the
Secretary shall submit to the Committee on Appropriations and
the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Appropriations and the
Committee on Energy and Commerce of the House of
Representatives a report detailing the amount of such funds
available for procurement and the impact such amount of
funding will have--
``(A) in meeting the security countermeasure needs
identified under this section; and
``(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation Plan
(pursuant to section 2811(d)).''.
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.
(a) In General.--Section 319F-2(g) of the Public Health
Service Act (42 U.S.C. 247d-6b(g)) is amended by adding at
the end the following:
``(5) Clarification on contracting authority.--The
Secretary, acting through the Director of the Biomedical
Advanced Research and
[[Page H6927]]
Development Authority, shall carry out the programs funded by
the special reserve fund (for the procurement of security
countermeasures under subsection (c) and for carrying out
section 319L), including the execution of procurement
contracts, grants, and cooperative agreements pursuant to
this section and section 319L.''.
(b) BARDA Contracting Authority.--Section 319L(c)(3) of the
Public Health Service Act (42 U.S.C. 247d-7c) is amended by
inserting ``, including the execution of procurement
contracts, grants, and cooperative agreements pursuant to
this section'' before the period.
SEC. 3083. COUNTERMEASURE BUDGET PLAN.
Section 2811(b)(7) of the Public Health Service Act (42
U.S.C. 300hh-10(b)(7)) is amended--
(1) in the matter preceding subparagraph (A), by striking
the first sentence and inserting ``Develop, and update not
later than March 1 of each year, a coordinated 5-year budget
plan based on the medical countermeasure priorities described
in subsection (d), including with respect to chemical,
biological, radiological, and nuclear agent or agents that
may present a threat to the Nation, including such agents
that are novel or emerging infectious diseases, and the
corresponding efforts to develop qualified countermeasures
(as defined in section 319F-1), security countermeasures (as
defined in section 319F-2), and qualified pandemic or
epidemic products (as defined in section 319F-3) for each
such threat.'';
(2) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(3) in subparagraph (D), by striking ``to the appropriate
committees of Congress upon request.'' and inserting ``, not
later than March 15 of each year, to the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on
Appropriations and the Committee on Energy and Commerce of
the House of Representatives; and''; and
(4) by adding at the end the following:
``(E) not later than March 15 of each year, be made
publicly available in a manner that does not compromise
national security.''.
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
Section 319L(c)(4) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(4)) is amended by adding at the end the
following:
``(E) Medical countermeasures innovation partner.--
``(i) In general.--To support the purposes described in
paragraph (2), the Secretary, acting through the Director of
BARDA, may enter into an agreement (including through the use
of grants, contracts, cooperative agreements, or other
transactions as described in paragraph (5)) with an
independent, nonprofit entity to--
``(I) foster and accelerate the development and innovation
of medical countermeasures and technologies that may assist
advanced research and the development of qualified
countermeasures and qualified pandemic or epidemic products,
including through the use of strategic venture capital
practices and methods;
``(II) promote the development of new and promising
technologies that address urgent medical countermeasure
needs, as identified by the Secretary;
``(III) address unmet public health needs that are directly
related to medical countermeasure requirements, such as novel
antimicrobials for multidrug resistant organisms and multiuse
platform technologies for diagnostics, prophylaxis, vaccines,
and therapeutics; and
``(IV) provide expert consultation and advice to foster
viable medical countermeasure innovators, including helping
qualified countermeasure innovators navigate unique industry
challenges with respect to developing chemical, biological,
radiological, and nuclear countermeasure products.
``(ii) Eligibility.--
``(I) In general.--To be eligible to enter into an
agreement under clause (i) an entity shall--
``(aa) be an independent, nonprofit entity;
``(bb) have a demonstrated record of being able to create
linkages between innovators and investors and leverage such
partnerships and resources for the purpose of addressing
identified strategic needs of the Federal Government;
``(cc) have experience in promoting novel technology
innovation;
``(dd) be problem-driven and solution-focused based on the
needs, requirements, and problems identified by the Secretary
under clause (iv);
``(ee) demonstrate the ability, or the potential ability,
to promote the development of medical countermeasure
products;
``(ff) demonstrate expertise, or the capacity to develop or
acquire expertise, related to technical and regulatory
considerations with respect to medical countermeasures; and
``(gg) not be within the Department of Health and Human
Services.
``(II) Partnering experience.--In selecting an entity with
which to enter into an agreement under clause (i), the
Secretary shall place a high value on the demonstrated
experience of the entity in partnering with the Federal
Government to meet identified strategic needs.
``(iii) Not agency.--An entity that enters into an
agreement under clause (i) shall not be deemed to be a
Federal agency for any purpose, including for any purpose
under title 5, United States Code.
``(iv) Direction.--Pursuant to an agreement entered into
under this subparagraph, the Secretary, acting through the
Director of BARDA, shall provide direction to the entity that
enters into an agreement under clause (i). As part of this
agreement the Director of BARDA shall--
``(I) communicate the medical countermeasure needs,
requirements, and problems to be addressed by the entity
under the agreement;
``(II) develop a description of work to be performed by the
entity under the agreement;
``(III) provide technical feedback and appropriate
oversight over work carried out by the entity under the
agreement, including subsequent development and partnerships
consistent with the needs and requirements set forth in this
subparagraph;
``(IV) ensure fair consideration of products developed
under the agreement in order to maintain competition to the
maximum practical extent, as applicable and appropriate under
applicable provisions of this section; and
``(V) ensure, as a condition of the agreement that the
entity--
``(aa) has in place a comprehensive set of policies that
demonstrate a commitment to transparency and accountability;
``(bb) protects against conflicts of interest through a
comprehensive set of policies that address potential
conflicts of interest, ethics, disclosure, and reporting
requirements;
``(cc) provides monthly accounting on the use of funds
provided under such agreement; and
``(dd) provides on a quarterly basis, reports regarding the
progress made toward meeting the identified needs set forth
in the agreement.
``(v) Supplement not supplant.--Activities carried out
under this subparagraph shall supplement, and not supplant,
other activities carried out under this section.
``(vi) No establishment of entity.--To prevent unnecessary
duplication and target resources effectively, nothing in this
subparagraph shall be construed to authorize the Secretary to
establish within the Department of Health and Human Services
an entity for the purposes of carrying out this subparagraph.
``(vii) Transparency and oversight.--Upon request, the
Secretary shall provide to Congress the information provided
to the Secretary under clause (iv)(V)(dd).
``(viii) Independent evaluation.--Not later than 4 years
after the date of enactment of the 21st Century Cures Act,
the Comptroller General of the United States shall conduct an
independent evaluation, and submit to the Secretary and the
appropriate committees of Congress a report, concerning the
activities conducted under this subparagraph. Such report
shall include recommendations with respect to any agreement
or activities carried out pursuant to this subparagraph.
``(ix) Sunset.--This subparagraph shall have no force or
effect after September 30, 2022.''.
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.
Section 319F-2(c) of the Public Health Service Act (42
U.S.C. 247d-6b(c)) is amended--
(1) in paragraph (4)(A)(ii), by striking ``make a
recommendation under paragraph (6) that the special reserve
fund as defined in subsection (h) be made available for the
procurement of such countermeasure'' and inserting ``and
subject to the availability of appropriations, make available
the special reserve fund as defined in subsection (h) for
procurement of such countermeasure, as applicable'';
(2) in paragraph (6)--
(A) by striking subparagraphs (A), (B), and (E);
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (A) and (B), respectively;
(C) by amending subparagraph (A), as so redesignated, to
read as follows:
``(A) Notice to appropriate congressional committees.--The
Secretary shall notify the Committee on Appropriations and
the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Appropriations and the
Committee on Energy and Commerce of the House of
Representatives of each decision to make available the
special reserve fund as defined in subsection (h) for
procurement of a security countermeasure, including, where
available, the number of, the nature of, and other
information concerning potential suppliers of such
countermeasure, and whether other potential suppliers of the
same or similar countermeasures were considered and rejected
for procurement under this section and the reasons for each
such rejection.''; and
(D) in the heading, by striking ``Recommendation for
president's approval'' and inserting ``Recommendations for
procurement''; and
(3) in paragraph (7)--
(A) by striking subparagraphs (A) and (B) and inserting the
following:
``(A) Payments from special reserve fund.--The special
reserve fund as defined in subsection (h) shall be available
for payments made by the Secretary to a vendor for
procurement of a security countermeasure in accordance with
the provisions of this paragraph.''; and
(B) by redesignating subparagraph (C) as subparagraph (B).
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A
NATIONAL SECURITY THREAT.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by
inserting after section 565 the following:
``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
AGENTS THAT PRESENT NATIONAL SECURITY THREATS.
``(a) Definitions.--In this section:
``(1) Human drug application.--The term `human drug
application' has the meaning given such term in section
735(1).
``(2) Priority review.--The term `priority review', with
respect to a human drug application, means review and action
by the Secretary on such application not later than 6 months
after receipt by the Secretary of such application, as
described in the Manual of Policies and Procedures in the
Food and Drug Administration and goals identified in the
letters described in section 101(b) of the Food and Drug
Administration Safety and Innovation Act.
``(3) Priority review voucher.--The term `priority review
voucher' means a voucher
[[Page H6928]]
issued by the Secretary to the sponsor of a material threat
medical countermeasure application that entitles the holder
of such voucher to priority review of a single human drug
application submitted under section 505(b)(1) or section
351(a) of the Public Health Service Act after the date of
approval of the material threat medical countermeasure
application.
``(4) Material threat medical countermeasure application.--
The term `material threat medical countermeasure application'
means an application that--
``(A) is a human drug application for a drug intended for
use--
``(i) to prevent, or treat harm from a biological,
chemical, radiological, or nuclear agent identified as a
material threat under section 319F-2(c)(2)(A)(ii) of the
Public Health Service Act; or
``(ii) to mitigate, prevent, or treat harm from a condition
that may result in adverse health consequences or death and
may be caused by administering a drug, or biological product
against such agent; and
``(B) the Secretary determines eligible for priority
review;
``(C) is approved after the date of enactment of the 21st
Century Cures Act; and
``(D) is for a human drug, no active ingredient (including
any ester or salt of the active ingredient) of which has been
approved in any other application under section 505(b)(1) or
section 351(a) of the Public Health Service Act.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a material threat medical
countermeasure application upon approval by the Secretary of
such material threat medical countermeasure application.
``(2) Transferability.--The sponsor of a material threat
medical countermeasure application that receives a priority
review voucher under this section may transfer (including by
sale) the entitlement to such voucher to a sponsor of a human
drug for which an application under section 505(b)(1) or
section 351(a) of the Public Health Service Act will be
submitted after the date of the approval of the material
threat medical countermeasure application. There is no limit
on the number of times a priority review voucher may be
transferred before such voucher is used.
``(3) Notification.--
``(A) In general.--The sponsor of a human drug application
shall notify the Secretary not later than 90 calendar days
prior to submission of the human drug application that is the
subject of a priority review voucher of an intent to submit
the human drug application, including the date on which the
sponsor intends to submit the application. Such notification
shall be a legally binding commitment to pay for the user fee
to be assessed in accordance with this section.
``(B) Transfer after notice.--The sponsor of a human drug
application that provides notification of the intent of such
sponsor to use the voucher for the human drug application
under subparagraph (A) may transfer the voucher after such
notification is provided, if such sponsor has not yet
submitted the human drug application described in the
notification.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application
that is the subject of a priority review voucher shall pay to
the Secretary a fee determined under paragraph (2). Such fee
shall be in addition to any fee required to be submitted by
the sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the
review of a human drug application subject to priority review
in the previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2016, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The priority review user fee required by
this subsection shall be due upon the submission of a human
drug application under section 505(b)(1) or section 351(a) of
the Public Health Service Act for which the priority review
voucher is used.
``(B) Complete application.--An application described under
subparagraph (A) for which the sponsor requests the use of a
priority review voucher shall be considered incomplete if the
fee required by this subsection and all other applicable user
fees are not paid in accordance with the Secretary's
procedures for paying such fees.
``(C) No waivers, exemptions, reductions, or refunds.--The
Secretary may not grant a waiver, exemption, reduction, or
refund of any fees due and payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to the
Food and Drug Administration; and
``(6) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.
``(d) Notice of Issuance of Voucher and Approval of
Products Under Voucher.--The Secretary shall publish a notice
in the Federal Register and on the Internet website of the
Food and Drug Administration not later than 30 calendar days
after the occurrence of each of the following:
``(1) The Secretary issues a priority review voucher under
this section.
``(2) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher
issued under this section.
``(e) Eligibility for Other Programs.--Nothing in this
section precludes a sponsor who seeks a priority review
voucher under this section from participating in any other
incentive program, including under this Act, except that no
sponsor of a material threat medical countermeasure
application may receive more than one priority review voucher
issued under any section of this Act with respect to such
drug.
``(f) Relation to Other Provisions.--The provisions of this
section shall supplement, not supplant, any other provisions
of this Act or the Public Health Service Act that encourage
the development of medical countermeasures.
``(g) Sunset.--The Secretary may not award any priority
review vouchers under subsection (b) after October 1,
2023.''.
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC
HEALTH EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following:
``(f) Determination With Respect to Paperwork Reduction Act
Waiver During a Public Health Emergency.--
``(1) Determination.--If the Secretary determines, after
consultation with such public health officials as may be
necessary, that--
``(A)(i) the criteria set forth for a public health
emergency under paragraph (1) or (2) of subsection (a) has
been met; or
``(ii) a disease or disorder, including a novel and
emerging public health threat, is significantly likely to
become a public health emergency; and
``(B) the circumstances of such public health emergency, or
potential for such significantly likely public health
emergency, including the specific preparation for and
response to such public health emergency or threat,
necessitate a waiver from the requirements of subchapter I of
chapter 35 of title 44, United States Code (commonly referred
to as the Paperwork Reduction Act),
then the requirements of such subchapter I with respect to
voluntary collection of information shall not be applicable
during the immediate investigation of, and response to, such
public health emergency during the period of such public
health emergency or the period of time necessary to determine
if a disease or disorder, including a novel and emerging
public health threat, will become a public health emergency
as provided for in this paragraph. The requirements of such
subchapter I with respect to voluntary collection of
information shall not be applicable during the immediate
postresponse review regarding such public health emergency if
such immediate postresponse review does not exceed a
reasonable length of time.
``(2) Transparency.--If the Secretary determines that a
waiver is necessary under paragraph (1), the Secretary shall
promptly post on the Internet website of the Department of
Health and Human Services a brief justification for such
waiver, the anticipated period of time such waiver will be in
effect, and the agencies and offices within the Department of
Health and Human Services to which such waiver shall apply,
and update such information posted on the Internet website of
the Department of Health and Human Services, as applicable.
``(3) Effectiveness of waiver.--Any waiver under this
subsection shall take effect on the date on which the
Secretary posts information on the Internet website as
provided for in this subsection.
``(4) Termination of waiver.--Upon determining that the
circumstances necessitating a waiver under paragraph (1) no
longer exist, the Secretary shall promptly update the
Internet website of the Department of Health and Human
Services to reflect the termination of such waiver.
``(5) Limitations.--
``(A) Period of waiver.--The period of a waiver under
paragraph (1) shall not exceed the period of time for the
related public health emergency, including a public health
emergency declared pursuant to subsection (a), and any
immediate postresponse review regarding the public health
emergency consistent with the requirements of this
subsection.
``(B) Subsequent compliance.--An initiative subject to a
waiver under paragraph (1) that is ongoing after the date on
which the waiver expires, shall be subject to the
requirements of subchapter I of chapter 35 of title 44,
United States Code, and the Secretary shall ensure that
compliance with such requirements occurs in as timely a
manner as possible based on the applicable circumstances, but
not to exceed 30 calendar days after the expiration of the
applicable waiver.''.
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY
USE AUTHORIZATION.
(a) Authorization for Medical Products for Use in
Emergencies.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
(1) in subsection (a)(2)--
(A) in subparagraph (A)--
(i) by striking ``or 515'' and inserting ``512, or 515'';
and
(ii) by inserting ``or conditionally approved under section
571 of this Act'' after ``Public Health Service Act''; and
(B) in subparagraph (B), by inserting ``conditionally
approved under section 571,'' after ``approved,'' each place
the term appears;
(2) in subsection (b)(4), by striking the second comma
after ``determination'';
(3) in subsection (e)(3)(B), by striking ``section 503(b)''
and inserting ``subsection (b) or (f) of section 503 or under
section 504'';
(4) in subsection (f)(2)--
(A) by inserting ``, or an animal to which,'' after ``to a
patient to whom''; and
[[Page H6929]]
(B) by inserting ``or by the veterinarian caring for such
animal, as applicable'' after ``attending physician'';
(5) in subsection (g)(1), by inserting ``conditional
approval under section 571,'' after ``approval,'';
(6) in subsection (h)(1), by striking ``or section
520(g)''and inserting ``512(j), or 520(g)''; and
(7) in subsection (k), by striking ``section 520(g),''and
inserting ``512(j), or 520(g)''.
(b) New Animal Drugs.--Section 512(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is
amended--
(1) in subparagraph (B), by striking ``or'' at the end;
(2) in subparagraph (C), by striking the period and
inserting ``; or''; and
(3) by inserting after subparagraph (C) the following:
``(D) there is in effect an authorization pursuant to
section 564 with respect to such use or intended use of such
drug, and such drug, its labeling, and such use conform to
any conditions of such authorization.''.
(c) Emergency Use of Medical Products.--Section 564A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is
amended--
(1) in subsection (a)(1)(A), by inserting ``, conditionally
approved under section 571,'' after ``chapter''; and
(2) in subsection (d), by striking ``sections 503(b) and
520(e)'' and inserting ``subsections (b) and (f) of section
503, section 504, and section 520(e)''.
(d) Products Held for Emergency Use.--Section 564B(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
3b(2)) is amended--
(1) in subparagraph (A)--
(A) by inserting ``or conditionally approved under section
571 of this Act'' after ``Public Health Service Act''; and
(B) by striking ``or 515'' and inserting ``512, or 515'';
and
(2) in subparagraph (B), by striking ``or 520'' and
inserting ``512, or 520''.
Subtitle I--Vaccine Access, Certainty, and Innovation
SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.
(a) Consideration of New Vaccines.--Upon the licensure of
any vaccine or any new indication for a vaccine, the Advisory
Committee on Immunization Practices (in this section referred
to as the ``Advisory Committee'') shall, as appropriate,
consider the use of the vaccine at its next regularly
scheduled meeting.
(b) Additional Information.--If the Advisory Committee does
not make a recommendation with respect to the use of a
vaccine at the Advisory Committee's first regularly scheduled
meeting after the licensure of the vaccine or any new
indication for the vaccine, the Advisory Committee shall
provide an update on the status of such committee's review.
(c) Consideration for Breakthrough Therapies and for
Potential Use During Public Health Emergency.--The Advisory
Committee shall make recommendations with respect to the use
of certain vaccines in a timely manner, as appropriate,
including vaccines that--
(1) are designated as a breakthrough therapy under section
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356) and licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262); or
(2) could be used in a public health emergency.
(d) Definition.--In this section, the terms ``Advisory
Committee on Immunization Practices'' and ``Advisory
Committee'' mean the Advisory Committee on Immunization
Practices established by the Secretary pursuant to section
222 of the Public Health Service Act (42 U.S.C. 217a), acting
through the Director of the Centers for Disease Control and
Prevention.''.
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY
COMMITTEE ON IMMUNIZATION PRACTICES
RECOMMENDATIONS.
(a) Review.--The Director of the Centers for Disease
Control and Prevention shall conduct a review of the
processes used by the Advisory Committee on Immunization
Practices in formulating and issuing recommendations
pertaining to vaccines, including with respect to
consistency.
(b) Considerations.--The review under subsection (a) shall
include an assessment of--
(1) the criteria used to evaluate new and existing
vaccines, including the identification of any areas for which
flexibility in evaluating such criteria is necessary and the
reason for such flexibility;
(2) the Grading of Recommendations, Assessment,
Development, and Evaluation (GRADE) approach to the review
and analysis of scientific and economic data, including the
scientific basis for such approach; and
(3) the extent to which the processes used by the work
groups of the Advisory Committee on Immunization Practices
are consistent among such groups, including the
identification of reasons for any variation.
(c) Stakeholders.--In carrying out the review under
subsection (a), the Director of the Centers for Disease
Control and Prevention shall solicit input from vaccine
stakeholders.
(d) Report.--Not later than 18 months after the date of
enactment of this Act, the Director of the Centers for
Disease Control and Prevention shall submit to the
appropriate committees of the Congress, and make publicly
available, a report on the results of the review under
subsection (a), including any recommendations on improving
the consistency of the processes described in such
subsection.
(e) Definition.--In this section, the term ``Advisory
Committee on Immunization Practices'' means the Advisory
Committee on Immunization Practices established by the
Secretary of Health and Human Services pursuant to section
222 of the Public Health Service Act (42 U.S.C. 217a), acting
through the Director of the Centers for Disease Control and
Prevention.
SEC. 3093. ENCOURAGING VACCINE INNOVATION.
(a) Vaccine Meetings.--The Director of the Centers for
Disease Control and Prevention shall ensure that appropriate
staff within the relevant centers and divisions of the Office
of Infectious Diseases, and others, as appropriate,
coordinate with respect to the public health needs,
epidemiology, and program planning and implementation
considerations related to immunization, including with regard
to meetings with stakeholders related to such topics.
(b) Report on Vaccine Innovation.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
in collaboration with appropriate agencies or offices within
the Department of Health and Human Services, including the
National Institutes of Health, the Centers for Disease
Control and Prevention, the Food and Drug Administration, and
the Biomedical Advanced Research and Development Authority,
shall submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, and post publicly
on the Internet website of the Department of Health and Human
Services, a report on ways to promote innovation in the
development of vaccines that minimize the burden of
infectious disease.
(2) Contents.--The report described in paragraph (1) shall
review the current status of vaccine development and, as
appropriate--
(A) consider the optimal process to determine which
vaccines would be beneficial to public health and how
information on such vaccines is disseminated to key
stakeholders;
(B) examine and identify whether obstacles exist that
inhibit the development of beneficial vaccines; and
(C) make recommendations about how best to remove any
obstacles identified under subparagraph (B) in order to
promote and incentivize vaccine innovation and development.
(3) Consultation.--In preparing the report under this
subsection, the Secretary may consult with--
(A) representatives of relevant Federal agencies and
departments, including the Department of Defense and the
Department of Veterans Affairs;
(B) academic researchers;
(C) developers and manufacturers of vaccines;
(D) medical and public health practitioners;
(E) representatives of patient, policy, and advocacy
organizations; and
(F) representatives of other entities, as the Secretary
determines appropriate.
(c) Updates Related to Maternal Immunization.--
(1) Additional vaccines.--Section 2114(e) of the Public
Health Service Act (42 U.S.C. 300aa-14(e)) is amended by
adding at the end the following:
``(3) Vaccines recommended for use in pregnant women.--The
Secretary shall revise the Vaccine Injury Table included in
subsection (a), through the process described in subsection
(c), to include vaccines recommended by the Centers for
Disease Control and Prevention for routine administration in
pregnant women and the information described in subparagraphs
(B) and (C) of paragraph (2) with respect to such
vaccines.''.
(2) Petition content.--Section 2111 of the Public Health
Service Act (42 U.S.C. 300aa-11) is amended by adding at the
end the following:
``(f) Maternal Immunization.--
``(1) In general.--Notwithstanding any other provision of
law, for purposes of this subtitle, both a woman who received
a covered vaccine while pregnant and any child who was in
utero at the time such woman received the vaccine shall be
considered persons to whom the covered vaccine was
administered and persons who received the covered vaccine.
``(2) Definition.--As used in this subsection, the term
`child' shall have the meaning given that term by subsections
(a) and (b) of section 8 of title 1, United States Code,
except that, for purposes of this subsection, such section 8
shall be applied as if the term `include' in subsection (a)
of such section were replaced with the term `mean'.''.
(3) Petitioners.--Section 2111(b)(2) of the Public Health
Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding
``A covered vaccine administered to a pregnant woman shall
constitute more than one administration, one to the mother
and one to each child (as such term is defined in subsection
(f)(2)) who was in utero at the time such woman was
administered the vaccine.'' at the end.
Subtitle J--Technical Corrections
SEC. 3101. TECHNICAL CORRECTIONS.
(a) FFDCA.--
(1) References.--Except as otherwise expressly provided,
whenever in this subsection an amendment is expressed in
terms of an amendment to a section or other provision, the
reference shall be considered to be made to that section or
other provision of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.).
(2) Amendments.--
(A) Prohibited acts.--Section 301(r) (21 U.S.C. 331(r)) is
amended by inserting ``, drug,'' after ``device'' each place
the term appears.
(B) New drugs.--Section 505 (21 U.S.C. 355) is amended--
(i) in subsection (d), in the last sentence, by striking
``premarket approval'' and inserting ``marketing approval'';
and
(ii) in subsection (q)(5)(A), by striking ``subsection
(b)(2) or (j) of the Act or 351(k)'' and inserting
``subsection (b)(2) or (j) of this section or section
351(k)''.
[[Page H6930]]
(C) Risk evaluation and mitigation strategies.--Section
505-1(h)(21 U.S.C. 355-1(h)) is amended--
(i) in paragraph (2)(A)(iii)--
(I) in the clause heading, by striking ``label'' and
inserting ``labeling'';
(II) by striking ``label'' each place the term appears and
inserting ``labeling''; and
(III) by striking ``sponsor'' and inserting ``responsible
person''; and
(ii) in paragraph (8), by striking ``and (7).'' and
inserting ``and (7)''.
(D) Pediatric study plans.--Section 505B (21 U.S.C. 355c)
is amended--
(i) in subsection (e)--
(I) in paragraph (2)--
(aa) in subparagraph (A), by inserting ``study'' after
``initial pediatric'' each place the term appears; and
(bb) in subparagraph (B), in the subparagraph heading, by
striking ``initial plan'' and inserting ``initial pediatric
study plan'';
(II) in paragraph (5), in the paragraph heading, by
inserting ``agreed initial pediatric study'' before ``plan'';
and
(III) in paragraph (6), by striking ``agreed initial
pediatric plan'' and inserting ``agreed initial pediatric
study plan''; and
(ii) in subsection (f)(1), by inserting ``and any
significant amendments to such plans,'' after ``agreed
initial pediatric study plans,''.
(E) Discontinuance or interruption in the production of
live-saving drugs.--Section 506C (21 U.S.C. 356c) is
amended--
(i) in subsection (c), by striking ``discontinuation'' and
inserting ``discontinuance''; and
(ii) in subsection (g)(1), by striking ``section 505(j)
that could help'' and inserting ``section 505(j), that could
help''.
(F) Annual reporting on drug shortages.--Section 506C-1(a)
(21 U.S.C. 331(a)) is amended, in the matter before paragraph
(1)--
(i) by striking ``Not later than the end of calendar year
2013, and not later than the end of each calendar year
thereafter,'' and inserting ``Not later than March 31 of each
calendar year,''; and
(ii) by inserting ``, with respect to the preceding
calendar year,'' after ``a report''.
(G) Drug shortage list.--Section 506E(b)(3)(E) (21 U.S.C.
356e(b)(3)(E)) is amended by striking ``discontinuation'' and
inserting ``discontinuance''.
(H) Inspections of establishments.--Section 510(h) (21
U.S.C. 360(h)) is amended--
(i) in paragraph (4), in the matter preceding subparagraph
(A), by striking ``establishing the risk-based scheduled''
and inserting ``establishing a risk-based schedule''; and
(ii) in paragraph (6)--
(I) in subparagraph (A), by striking ``fiscal'' and
inserting ``calendar'' each place the term appears; and
(II) in subparagraph (B), by striking ``an active
ingredient of a drug, a finished drug product, or an
excipient of a drug'' and inserting ``an active ingredient of
a drug or a finished drug product''.
(I) Classification of devices intended for human use.--
Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is amended--
(i) in clause (i), by striking ``within 30 days''; and
(ii) in clause (iv), by striking ``low-moderate'' and
inserting ``low to moderate''.
(J) Premarket approval.--Section 515(a)(1) (21 U.S.C.
360e(a)(1)) is amended by striking ``subject to a an order''
and inserting ``subject to an order''.
(K) Program to improve the device recall system.--Section
518A (21 U.S.C. 360h-1) is amended--
(i) by striking subsection (c); and
(ii) by redesignating subsection (d) as subsection (c).
(L) Unique device identifier.--Section 519(f) (21 U.S.C.
360i(f)) is amended by striking ``and life sustaining'' and
inserting ``or life sustaining''.
(M) Priority review to encourage treatments for tropical
diseases.--Section 524(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) is amended by
striking ``Services Act'' and inserting ``Service Act''.
(N) Priority review for qualified infectious disease
products.--Section 524A (21 U.S.C. 360n-1) is amended--
(i) by striking ``If the Secretary'' and inserting the
following:
``(a) In General.--If the Secretary'';
(ii) by striking ``any'' and inserting ``the first''; and
(iii) by adding at the end the following:
``(b) Construction.--Nothing in this section shall prohibit
the Secretary from giving priority review to a human drug
application or efficacy supplement submitted for approval
under section 505(b) that otherwise meets the criteria for
the Secretary to grant priority review.''.
(O) Consultation with external experts on rare diseases,
targeted therapies, and genetic targeting of treatments.--
Section 569(a)(2)(A) (21 U.S.C. 360bbb-8(a)(2)(A)) is
amended, in the first sentence, by striking ``subsection
(c)'' and inserting ``subsection (b)''.
(P) Optimizing global clinical trials.--Section 569A(c) (21
U.S.C. 360bbb-8a(c)) is amended by inserting ``or under the
Public Health Service Act'' after ``this Act''.
(Q) Use of clinical investigation data from outside the
united states.--Section 569B (21 U.S.C. 360bbb-8b) is amended
by striking ``drug or device'' and inserting ``drug,
biological product, or device'' each place the term appears.
(R) Medical gases definitions.--Section 575(1)(H) (21
U.S.C. 360ddd(1)(H)) is amended--
(i) by inserting ``for a new drug'' after ``any period of
exclusivity''; and
(ii) by inserting ``or any period of exclusivity for a new
animal drug under section 512(c)(2)(F),'' after ``section
505A,''.
(S) Regulation of medical gases.--Section 576(a) (21 U.S.C.
360ddd-1(a)) is amended--
(i) in the matter preceding subparagraph (A) of paragraph
(1), by inserting ``who seeks to initially introduce or
deliver for introduction a designated medical gas into
interstate commerce'' after ``any person''; and
(ii) in paragraph (3)--
(I) in subparagraph (A)--
(aa) in clause (i)(VIII), by inserting ``for a new drug''
after ``any period of exclusivity''; and
(bb) in clause (ii), in the matter preceding subclause (I),
by inserting ``the'' before ``final use''; and
(II) in subparagraph (B)--
(aa) in clause (i), by inserting ``for a new drug'' after
``any period of exclusivity''; and
(bb) in clause (ii), by inserting a comma after ``drug
product''.
(T) Inapplicability of drug fees to designated medical
gases.--Section 577 (21 U.S.C. 360ddd-2) is amended by
inserting ``or 740(a)'' after ``section 736(a)''.
(U) Conflicts of interest.--Section 712(e)(1)(B) (21 U.S.C.
379d-1(e)(1)(B)) is amended by striking ``services'' and
inserting ``service''.
(V) Authority to assess and use biosimilar biological
product fees.--Section 744H(a) (21 U.S.C. 379j-52(a)) is
amended--
(i) in paragraph (1)(A)(v), by striking ``Biosimilars User
Fee Act of 2012'' and inserting ``Biosimilar User Fee Act of
2012''; and
(ii) in paragraph (2)(B), by striking ``Biosimilars User
Fee Act of 2012'' and inserting ``Biosimilar User Fee Act of
2012''.
(W) Registration of commercial importers.--
(i) Amendment.--Section 801(s)(2) (21 U.S.C. 381(s)(2)) is
amended by adding at the end the following:
``(D) Effective date.--In establishing the effective date
of the regulations under subparagraph (A), the Secretary
shall, in consultation with the Secretary of Homeland
Security acting through U.S. Customs and Border Protection,
as determined appropriate by the Secretary of Health and
Human Services, provide a reasonable period of time for an
importer of a drug to comply with good importer practices,
taking into account differences among importers and types of
imports, including based on the level of risk posed by the
imported product.''.
(ii) Conforming amendment.--Section 714 of the Food and
Drug Administration Safety and Innovation Act (Public Law
112-144; 126 Stat. 1074) is amended by striking subsection
(d).
(X) Recognition of foreign government inspections.--Section
809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking
``conduction'' and inserting ``conducting''.
(b) FDASIA.--
(1) Findings relating to drug approval.--Section
901(a)(1)(A) of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is
amended by striking ``serious and life-threatening diseases''
and inserting ``serious or life-threatening diseases''.
(2) Reporting of inclusion of demographic subgroups.--
Section 907 of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is
amended--
(A) in the section heading, by striking ``biologics'' in
the heading and inserting ``biological products''; and
(B) in subsection (a)(2)(B), by striking ``applications for
new drug applications'' and inserting ``new drug
applications''.
(3) Combating prescription drug abuse.--Section 1122 of the
Food and Drug Administration Safety and Innovation Act
(Public Law 112-144; 126 Stat. 1112, 1113) is amended--
(A) in subsection (a)(2), by striking ``dependance'' and
inserting ``dependence''; and
(B) in subsection (c), by striking ``promulgate'' and
inserting ``issue''.
SEC. 3102. COMPLETED STUDIES.
The Federal Food, Drug, and Cosmetic Act is amended--
(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
(A) in subparagraph (A), by inserting ``and'' after the
semicolon;
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as subparagraph (B);
(2) in section 505A (21 U.S.C. 355a), by striking
subsection (p);
(3) in section 505B (21 U.S.C. 355c)--
(A) by striking subsection (l); and
(B) by redesignating subsection (m) as subsection (l); and
(4) in section 523 (21 U.S.C. 360m), by striking subsection
(d).
TITLE IV--DELIVERY
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING
QUALITY OF CARE FOR PATIENTS.
(a) In General.--The Health Information Technology for
Economic and Clinical Health Act (title XIII of division A of
Public Law 111-5) is amended--
(1) by adding at the end of part 1 of subtitle A the
following:
``SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING
QUALITY OF CARE FOR PATIENTS.
``(a) Reduction in Burdens Goal.--The Secretary of Health
and Human Services (referred to in this section as the
`Secretary'), in consultation with providers of health
services, health care suppliers of services, health care
payers, health professional societies, health information
technology developers, health care quality organizations,
health care accreditation organizations, public health
entities, States, and other appropriate entities, shall, in
accordance with subsection (b)--
``(1) establish a goal with respect to the reduction of
regulatory or administrative burdens
[[Page H6931]]
(such as documentation requirements) relating to the use of
electronic health records;
``(2) develop a strategy for meeting the goal established
under paragraph (1); and
``(3) develop recommendations for meeting the goal
established under paragraph (1).
``(b) Strategy and Recommendations.--
``(1) In general.--To achieve the goal established under
subsection (a)(1), the Secretary, in consultation with the
entities described in such subsection, shall, not later than
1 year after the date of enactment of the 21st Century Cures
Act, develop a strategy and recommendations to meet the goal
in accordance with this subsection.
``(2) Strategy.--The strategy developed under paragraph (1)
shall address the regulatory and administrative burdens (such
as documentation requirements) relating to the use of
electronic health records. Such strategy shall include broad
public comment and shall prioritize--
``(A)(i) incentives for meaningful use of certified EHR
technology for eligible professionals and hospitals under
sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of
the Social Security Act (42 U.S.C. 1395w-4(a)(7),
1395ww(b)(3)(B)(ix));
``(ii) the program for making payments under section
1903(a)(3)(F) of the Social Security Act (42 U.S.C.
1396b(a)(3)(F)) to encourage the adoption and use of
certified EHR technology by Medicaid providers;
``(iii) the Merit-based Incentive Payment System under
section 1848(q) of the Social Security Act (42 U.S.C. 1395w-
4(q));
``(iv) alternative payment models (as defined in section
1833(z)(3)(C) of the Social Security Act (42 U.S.C.
1395l(z)(3)(C));
``(v) the Hospital Value-Based Purchasing Program under
section 1886(o) of the Social Security Act (42 U.S.C.
1395ww(o)); and
``(vi) other value-based payment programs, as the Secretary
determines appropriate;
``(B) health information technology certification;
``(C) standards and implementation specifications, as
appropriate;
``(D) activities that provide individuals access to their
electronic health information;
``(E) activities related to protecting the privacy of
electronic health information;
``(F) activities related to protecting the security of
electronic health information;
``(G) activities related to facilitating health and
clinical research;
``(H) activities related to public health;
``(I) activities related to aligning and simplifying
quality measures across Federal programs and other payers;
``(J) activities related to reporting clinical data for
administrative purposes; and
``(K) other areas, as the Secretary determines appropriate.
``(3) Recommendations.--The recommendations developed under
paragraph (1) shall address--
``(A) actions that improve the clinical documentation
experience;
``(B) actions that improve patient care;
``(C) actions to be taken by the Secretary and by other
entities; and
``(D) other areas, as the Secretary determines appropriate,
to reduce the reporting burden required of health care
providers.
``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the development of the goal,
strategies, or recommendations described in this section.
``(c) Application of Certain Regulatory Requirements.--A
physician (as defined in section 1861(r)(1) of the Social
Security Act), to the extent consistent with applicable State
law, may delegate electronic medical record documentation
requirements specified in regulations promulgated by the
Centers for Medicare & Medicaid Services to a person
performing a scribe function who is not such physician if
such physician has signed and verified the documentation.'';
and
(2) in the table of contents in section 13001(b), by
inserting after the item relating to section 13102 the
following:
``13103. Assisting doctors and hospitals in improving the quality and
care for patients.''.
(b) Certification of Health Information Technology for
Medical Specialties and Sites of Service.--Section 3001(c)(5)
of the Public Health Service Act (42 U.S.C. 300jj-11(c)(5))
is amended by adding at the end the following:
``(C) Health information technology for medical specialties
and sites of service.--
``(i) In general.--The National Coordinator shall
encourage, keep, or recognize, through existing authorities,
the voluntary certification of health information technology
under the program developed under subparagraph (A) for use in
medical specialties and sites of service for which no such
technology is available or where more technological
advancement or integration is needed.
``(ii) Specific medical specialties.--The Secretary shall
accept public comment on specific medical specialties and
sites of service, in addition to those described in clause
(i), for the purpose of selecting additional specialties and
sites of service as necessary.
``(iii) Health information technology for pediatrics.--Not
later than 18 months after the date of enactment of the 21st
Century Cures Act, the Secretary, in consultation with
relevant stakeholders, shall make recommendations for the
voluntary certification of health information technology for
use by pediatric health providers to support the health care
of children. Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary shall
adopt certification criteria under section 3004 to support
the voluntary certification of health information technology
for use by pediatric health providers to support the health
care of children.''.
(c) Meaningful Use Statistics.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the HIT Advisory Committee of the
Office of the National Coordinator for Health Information
Technology, a report concerning attestation statistics for
the Medicare and Medicaid EHR Meaningful Use Incentive
programs to assist in informing standards adoption and
related practices. Such statistics shall include attestation
information delineated by State, including, to the extent
practicable, the number of providers who did not meet the
minimum criteria necessary to attest for the Medicare and
Medicaid EHR Meaningful Use Incentive programs for a calendar
year, and shall be made publicly available on the Internet
website of the Secretary on at least a quarterly basis.
(2) Authority to alter format.--The Secretary of Health and
Human Services may alter the format of the reports on the
attestation of eligible health care professionals following
the first performance year of the Merit-based Incentive
Payment System to account for changes arising from the
implementation of such payment system.
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND
FUNCTIONALITY.
(a) Enhancements to Certification.--Section 3001(c)(5) of
the Public Health Service Act (42 U.S.C. 300jj-11), as
amended by section 4001(b), is further amended by adding at
the end the following:
``(D) Conditions of certification.--Not later than 1 year
after the date of enactment of the 21st Century Cures Act,
the Secretary, through notice and comment rulemaking, shall
require, as a condition of certification and maintenance of
certification for programs maintained or recognized under
this paragraph, consistent with other conditions and
requirements under this title, that the health information
technology developer or entity--
``(i) does not take any action that constitutes information
blocking as defined in section 3022(a);
``(ii) provides assurances satisfactory to the Secretary
that such developer or entity, unless for legitimate purposes
specified by the Secretary, will not take any action
described in clause (i) or any other action that may inhibit
the appropriate exchange, access, and use of electronic
health information;
``(iii) does not prohibit or restrict communication
regarding--
``(I) the usability of the health information technology;
``(II) the interoperability of the health information
technology;
``(III) the security of the health information technology;
``(IV) relevant information regarding users' experiences
when using the health information technology;
``(V) the business practices of developers of health
information technology related to exchanging electronic
health information; and
``(VI) the manner in which a user of the health information
technology has used such technology;
``(iv) has published application programming interfaces and
allows health information from such technology to be
accessed, exchanged, and used without special effort through
the use of application programming interfaces or successor
technology or standards, as provided for under applicable
law, including providing access to all data elements of a
patient's electronic health record to the extent permissible
under applicable privacy laws;
``(v) has successfully tested the real world use of the
technology for interoperability (as defined in section 3000)
in the type of setting in which such technology would be
marketed;
``(vi) provides to the Secretary an attestation that the
developer or entity--
``(I) has not engaged in any of the conduct described in
clause (i);
``(II) has provided assurances satisfactory to the
Secretary in accordance with clause (ii);
``(III) does not prohibit or restrict communication as
described in clause (iii);
``(IV) has published information in accordance with clause
(iv);
``(V) ensures that its technology allows for health
information to be exchanged, accessed, and used, in the
manner described in clause (iv); and
``(VI) has undertaken real world testing as described in
clause (v); and
``(vii) submits reporting criteria in accordance with
section 3009A(b).''.
``(E) Compliance with conditions of certification.--The
Secretary may encourage compliance with the conditions of
certification described in subparagraph (D) and take action
to discourage noncompliance, as appropriate.''.
(b) EHR Significant Hardship Exception.--
(1) Application to eligible professionals.--
(A) In case of decertification.--Section 1848(a)(7)(B) of
the Social Security Act (42 U.S.C. 1395w-4(a)(7)(B)) is
amended by inserting after the first sentence the following
new sentence: ``The Secretary shall exempt an eligible
professional from the application of the payment adjustment
under subparagraph (A) with respect to a year, subject to
annual renewal, if the Secretary determines that compliance
with the requirement for being a meaningful EHR user is not
possible because the certified EHR technology used by such
professional has been decertified under a program kept or
recognized pursuant to section 3001(c)(5) of the Public
Health Service Act.''.
(B) Continued application under mips.--Section
1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w-
4(o)(2)(D)) is amended by adding at the end the following new
sentence: ``The
[[Page H6932]]
provisions of subparagraphs (B) and (D) of subsection (a)(7),
shall apply to assessments of MIPS eligible professionals
under subsection (q) with respect to the performance category
described in subsection (q)(2)(A)(iv) in an appropriate
manner which may be similar to the manner in which such
provisions apply with respect to payment adjustments made
under subsection (a)(7)(A).''.
(2) Application to eligible hospitals.--Section
1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the
first sentence the following new sentence: ``The Secretary
shall exempt an eligible hospital from the application of the
payment adjustment under subclause (I) with respect to a
fiscal year, subject to annual renewal, if the Secretary
determines that compliance with the requirement for being a
meaningful EHR user is not possible because the certified EHR
technology used by such hospital is decertified under a
program kept or recognized pursuant to section 3001(c)(5) of
the Public Health Service Act.''.
(c) Electronic Health Record Reporting Program.--Subtitle A
of title XXX of the Public Health Service Act (42 U.S.C.
300jj-11 et seq.) is amended by adding at the end the
following:
``SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM.
``(a) Reporting Criteria.--
``(1) Convening of stakeholders.--Not later than 1 year
after the date of enactment of the 21st Century Cures Act,
the Secretary shall convene stakeholders, as described in
paragraph (2), for the purpose of developing the reporting
criteria in accordance with paragraph (3).
``(2) Development of reporting criteria.--The reporting
criteria under this subsection shall be developed through a
public, transparent process that reflects input from relevant
stakeholders, including--
``(A) health care providers, including primary care and
specialty care health care professionals;
``(B) hospitals and hospital systems;
``(C) health information technology developers;
``(D) patients, consumers, and their advocates;
``(E) data sharing networks, such as health information
exchanges;
``(F) authorized certification bodies and testing
laboratories;
``(G) security experts;
``(H) relevant manufacturers of medical devices;
``(I) experts in health information technology market
economics;
``(J) public and private entities engaged in the evaluation
of health information technology performance;
``(K) quality organizations, including the consensus based
entity described in section 1890 of the Social Security Act;
``(L) experts in human factors engineering and the
measurement of user-centered design; and
``(M) other entities or individuals, as the Secretary
determines appropriate.
``(3) Considerations for reporting criteria.--The reporting
criteria developed under this subsection--
``(A) shall include measures that reflect categories
including--
``(i) security;
``(ii) usability and user-centered design;
``(iii) interoperability;
``(iv) conformance to certification testing; and
``(v) other categories, as appropriate to measure the
performance of electronic health record technology;
``(B) may include categories such as--
``(i) enabling the user to order and view the results of
laboratory tests, imaging tests, and other diagnostic tests;
``(ii) submitting, editing, and retrieving data from
registries such as clinician-led clinical data registries;
``(iii) accessing and exchanging information and data from
and through health information exchanges;
``(iv) accessing and exchanging information and data from
medical devices;
``(v) accessing and exchanging information and data held by
Federal, State, and local agencies and other applicable
entities useful to a health care provider or other applicable
user in the furtherance of patient care;
``(vi) accessing and exchanging information from other
health care providers or applicable users;
``(vii) accessing and exchanging patient generated
information;
``(viii) providing the patient or an authorized designee
with a complete copy of their health information from an
electronic record in a computable format;
``(ix) providing accurate patient information for the
correct patient, including exchanging such information, and
avoiding the duplication of patients records; and
``(x) other categories regarding performance,
accessibility, as the Secretary determines appropriate; and
``(C) shall be designed to ensure that small and startup
health information technology developers are not unduly
disadvantaged by the reporting criteria.
``(4) Modifications.--After the reporting criteria have
been developed under paragraph (3), the Secretary may convene
stakeholders and conduct a public comment period for the
purpose of modifying the reporting criteria developed under
such paragraph.
``(b) Participation.--As a condition of maintaining
certification under section 3001(c)(5)(D), a developer of
certified electronic health records shall submit to an
appropriate recipient of a grant, contract, or agreement
under subsection (c)(1) responses to the criteria developed
under subsection (a), with respect to all certified
technology offered by such developer.
``(c) Reporting Program.--
``(1) In general.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
award grants, contracts, or agreements to independent
entities on a competitive basis to support the convening of
stakeholders as described in subsection (a)(2), collect the
information required to be reported in accordance with the
criteria established as described subsection (a)(3), and
develop and implement a process in accordance with paragraph
(5) and report such information to the Secretary.
``(2) Applications.--An independent entity that seeks a
grant, contract, or agreement under this subsection shall
submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
reasonably require, including a description of--
``(A) the proposed method for reviewing and summarizing
information gathered based on reporting criteria established
under subsection (a);
``(B) if applicable, the intended focus on a specific
subset of certified electronic health record technology
users, such as health care providers, including primary care,
specialty care, and care provided in rural settings;
hospitals and hospital systems; and patients, consumers, and
patients and consumer advocates;
``(C) the plan for widely distributing reports described in
paragraph (6);
``(D) the period for which the grant, contract, or
agreement is requested, which may be up to 2 years; and
``(E) the budget for reporting program participation, and
whether the eligible independent entity intends to continue
participation after the period of the grant, contract, or
agreement.
``(3) Considerations for independent entities.--In awarding
grants, contracts, and agreements under paragraph (1), the
Secretary shall give priority to independent entities with
appropriate expertise in health information technology
usability, interoperability, and security (especially
entities with such expertise in electronic health records)
with respect to--
``(A) health care providers, including primary care,
specialty care, and care provided in rural settings;
``(B) hospitals and hospital systems; and
``(C) patients, consumers, and patient and consumer
advocates.
``(4) Limitations.--
``(A) Assessment and redetermination.--Not later than 4
years after the date of enactment of the 21st Century Cures
Act and every 2 years thereafter, the Secretary, in
consultation with stakeholders, shall--
``(i) assess performance of the recipients of the grants,
contracts, and agreements under paragraph (1) based on
quality and usability of reports described in paragraph (6);
and
``(ii) re-determine grants, contracts, and agreements as
necessary.
``(B) Prohibitions on participation.--The Secretary may not
award a grant, contract, or cooperative agreement under
paragraph (1) to--
``(i) a proprietor of certified health information
technology or a business affiliate of such a proprietor;
``(ii) a developer of certified health information
technology; or
``(iii) a State or local government agency.
``(5) Feedback.--Based on reporting criteria established
under subsection (a), the recipients of grants, contracts,
and agreements under paragraph (1) shall develop and
implement a process to collect and verify confidential
feedback on such criteria from--
``(A) health care providers, patients, and other users of
certified electronic health record technology; and
``(B) developers of certified electronic health record
technology.
``(6) Reports.--
``(A) Development of reports.--Each recipient of a grant,
contract, or agreement under paragraph (1) shall report on
the information reported to such recipient pursuant to
subsection (a) and the user feedback collected under
paragraph (5) by preparing summary reports and detailed
reports of such information.
``(B) Distribution of reports.--Each recipient of a grant,
contract, or agreement under paragraph (1) shall submit the
reports prepared under subparagraph (A) to the Secretary for
public distribution in accordance with subsection (d).
``(d) Publication.--The Secretary shall distribute widely,
as appropriate, and publish, on the Internet website of the
Office of the National Coordinator--
``(1) the reporting criteria developed under subsection
(a); and
``(2) the summary and detailed reports under subsection
(c)(6).
``(e) Review.--Each recipient of a grant, contract, or
agreement under paragraph (1) shall develop and implement a
process through which participating electronic health record
technology developers may review and recommend changes to the
reports created under subsection (c)(6) for products
developed by such developer prior to the publication of such
report under subsection (d).
``(f) Additional Resources.--The Secretary may provide
additional resources on the Internet website of the Office of
the National Coordinator to better inform consumers of health
information technology. Such reports may be carried out
through partnerships with private organizations with
appropriate expertise.''.
(d) Authorization of Appropriations.--There is authorized
to be appropriated $15,000,000 for purposes of carrying out
subparagraph (D) of section 3001(c)(5) of the Public Health
Service Act (42 U.S.C. 300jj-11) (as added by subsection (a))
and section 3009A of the Public Health Service Act (as added
by subsection (b)), including for purposes of administering
any contracts, grants, or agreements, to remain available
until expended.
[[Page H6933]]
SEC. 4003. INTEROPERABILITY.
(a) Definition.--Section 3000 of the Public Health Service
Act (42 U.S.C. 300jj) is amended--
(1) by redesignating paragraphs (10) through (14), as
paragraphs (11) through (15), respectively; and
(2) by inserting after paragraph (9) the following:
``(10) Interoperability.--The term `interoperability', with
respect to health information technology, means such health
information technology that--
``(A) enables the secure exchange of electronic health
information with, and use of electronic health information
from, other health information technology without special
effort on the part of the user;
``(B) allows for complete access, exchange, and use of all
electronically accessible health information for authorized
use under applicable State or Federal law; and
``(C) does not constitute information blocking as defined
in section 3022(a).''.
(b) Support for Interoperable Network Exchange.--Section
3001(c) of the Public Health Service Act (42 U.S.C. 300jj-
11(c)) is amended by adding at the end the following:
``(9) Support for interoperable networks exchange.--
``(A) In general.--The National Coordinator shall, in
collaboration with the National Institute of Standards and
Technology and other relevant agencies within the Department
of Health and Human Services, for the purpose of ensuring
full network-to-network exchange of health information,
convene public-private and public-public partnerships to
build consensus and develop or support a trusted exchange
framework, including a common agreement among health
information networks nationally. Such convention may occur at
a frequency determined appropriate by the Secretary.
``(B) Establishing a trusted exchange framework.--
``(i) In general.--Not later than 6 months after the date
of enactment of the 21st Century Cures Act, the National
Coordinator shall convene appropriate public and private
stakeholders to develop or support a trusted exchange
framework for trust policies and practices and for a common
agreement for exchange between health information networks.
The common agreement may include--
``(I) a common method for authenticating trusted health
information network participants;
``(II) a common set of rules for trusted exchange;
``(III) organizational and operational policies to enable
the exchange of health information among networks, including
minimum conditions for such exchange to occur; and
``(IV) a process for filing and adjudicating noncompliance
with the terms of the common agreement.
``(ii) Technical assistance.--The National Coordinator, in
collaboration with the National Institute of Standards and
Technology, shall provide technical assistance on how to
implement the trusted exchange framework and common agreement
under this paragraph.
``(iii) Pilot testing.--The National Coordinator, in
consultation with the National Institute of Standards and
Technology, shall provide for the pilot testing of the
trusted exchange framework and common agreement established
or supported under this subsection (as authorized under
section 13201 of the Health Information Technology for
Economic and Clinical Health Act). The National Coordinator,
in consultation with the National Institute of Standards and
Technology, may delegate pilot testing activities under this
clause to independent entities with appropriate expertise.
``(C) Publication of a trusted exchange framework and
common agreement.--Not later than 1 year after convening
stakeholders under subparagraph (A), the National Coordinator
shall publish on its public Internet website, and in the
Federal register, the trusted exchange framework and common
agreement developed or supported under subparagraph (B). Such
trusted exchange framework and common agreement shall be
published in a manner that protects proprietary and security
information, including trade secrets and any other protected
intellectual property.
``(D) Directory of participating health information
networks.--
``(i) In general.--Not later than 2 years after convening
stakeholders under subparagraph (A), and annually thereafter,
the National Coordinator shall publish on its public Internet
website a list of the health information networks that have
adopted the common agreement and are capable of trusted
exchange pursuant to the common agreement developed or
supported under paragraph (B).
``(ii) Process.--The Secretary shall, through notice and
comment rulemaking, establish a process for health
information networks that voluntarily elect to adopt the
trusted exchange framework and common agreement to attest to
such adoption of the framework and agreement.
``(E) Application of the trusted exchange framework and
common agreement.--As appropriate, Federal agencies
contracting or entering into agreements with health
information exchange networks may require that as each such
network upgrades health information technology or trust and
operational practices, such network may adopt, where
available, the trusted exchange framework and common
agreement published under subparagraph (C).
``(F) Rule of construction.--
``(i) General adoption.--Nothing in this paragraph shall be
construed to require a health information network to adopt
the trusted exchange framework or common agreement.
``(ii) Adoption when exchange of information is within
network.--Nothing in this paragraph shall be construed to
require a health information network to adopt the trusted
exchange framework or common agreement for the exchange of
electronic health information between participants of the
same network.
``(iii) Existing frameworks and agreements.--The trusted
exchange framework and common agreement published under
subparagraph (C) shall take into account existing trusted
exchange frameworks and agreements used by health information
networks to avoid the disruption of existing exchanges
between participants of health information networks.
``(iv) Application by federal agencies.--Notwithstanding
clauses (i), (ii), and (iii), Federal agencies may require
the adoption of the trusted exchange framework and common
agreement published under subparagraph (C) for health
information exchanges contracting with or entering into
agreements pursuant to subparagraph (E).
``(v) Consideration of ongoing work.--In carrying out this
paragraph, the Secretary shall ensure the consideration of
activities carried out by public and private organizations
related to exchange between health information exchanges to
avoid duplication of efforts.''.
(c) Provider Digital Contact Information Index.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the
``Secretary'') shall, directly or through a partnership with
a private entity, establish a provider digital contact
information index to provide digital contact information for
health professionals and health facilities.
(2) Use of existing index.--In establishing the initial
index under paragraph (1), the Secretary may utilize an
existing provider directory to make such digital contact
information available.
(3) Contact information.--An index established under this
subsection shall ensure that contact information is available
at the individual health care provider level and at the
health facility or practice level.
(4) Rule of construction.--
(A) In general.--The purpose of this subsection is to
encourage the exchange of electronic health information by
providing the most useful, reliable, and comprehensive index
of providers possible. In furthering such purpose, the
Secretary shall include all health professionals and health
facilities applicable to provide a useful, reliable, and
comprehensive index for use in the exchange of health
information.
(B) Limitation.--In no case shall exclusion from the index
of providers be used as a measure to achieve objectives other
the objectives described in subparagraph (A).
(d) Standards Development Organizations.--Section 3004 of
the Public Health Service Act (42 U.S.C. 300jj-14) is amended
by adding at the end the following:
``(c) Deference to Standards Development Organizations.--In
adopting and implementing standards under this section, the
Secretary shall give deference to standards published by
standards development organizations and voluntary consensus-
based standards bodies.''.
(e) Health Information Technology Advisory Committee.--
(1) In general.--Title XXX of the Public Health Service Act
(42 U.S.C. 300jj et seq.) is amended by striking sections
3002 (42 U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and
inserting the following:
``SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY
COMMITTEE.
``(a) Establishment.--There is established a Health
Information Technology Advisory Committee (referred to in
this section as the `HIT Advisory Committee') to recommend to
the National Coordinator, consistent with the implementation
of the strategic plan described in section 3001(c)(3),
policies, and, for purposes of adoption under section 3004,
standards, implementation specifications, and certification
criteria, relating to the implementation of a health
information technology infrastructure, nationally and
locally, that advances the electronic access, exchange, and
use of health information. Such Committee shall serve to
unify the roles of, and replace, the HIT Policy Committee and
the HIT Standards Committee, as in existence before the date
of the enactment of the 21st Century Cures Act.
``(b) Duties.--
``(1) Recommendations on policy framework to advance an
interoperable health information technology infrastructure.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator a policy framework for
adoption by the Secretary consistent with the strategic plan
under section 3001(c)(3) for advancing the target areas
described in this subsection. Such policy framework shall
seek to prioritize achieving advancements in the target areas
specified in subparagraph (B) of paragraph (2) and may, to
the extent consistent with this section, incorporate policy
recommendations made by the HIT Policy Committee, as in
existence before the date of the enactment of the 21st
Century Cures Act.
``(B) Updates.--The HIT Advisory Committee shall propose
updates to such recommendations to the policy framework and
make new recommendations, as appropriate.
``(2) General duties and target areas.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator for purposes of
adoption under section 3004, standards, implementation
specifications, and certification criteria and an order of
priority for the development, harmonization, and recognition
of such standards, specifications, and certification
criteria. Such recommendations shall include recommended
standards, architectures, and software schemes for access to
electronic individually identifiable health information
across disparate systems including user
[[Page H6934]]
vetting, authentication, privilege management, and access
control.
``(B) Priority target areas.--For purposes of this section,
the HIT Advisory Committee shall make recommendations under
subparagraph (A) with respect to at least each of the
following target areas:
``(i) Achieving a health information technology
infrastructure, nationally and locally, that allows for the
electronic access, exchange, and use of health information,
including through technology that provides accurate patient
information for the correct patient, including exchanging
such information, and avoids the duplication of patient
records.
``(ii) The promotion and protection of privacy and security
of health information in health information technology,
including technologies that allow for an accounting of
disclosures and protections against disclosures of
individually identifiable health information made by a
covered entity for purposes of treatment, payment, and health
care operations (as such terms are defined for purposes of
the regulation promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996),
including for the segmentation and protection from disclosure
of specific and sensitive individually identifiable health
information with the goal of minimizing the reluctance of
patients to seek care.
``(iii) The facilitation of secure access by an individual
to such individual's protected health information and access
to such information by a family member, caregiver, or
guardian acting on behalf of a patient, including due to age-
related and other disability, cognitive impairment, or
dementia.
``(iv) Subject to subparagraph (D), any other target area
that the HIT Advisory Committee identifies as an appropriate
target area to be considered under this subparagraph.
``(C) Additional target areas.--For purposes of this
section, the HIT Advisory Committee may make recommendations
under subparagraph (A), in addition to areas described in
subparagraph (B), with respect to any of the following areas:
``(i) The use of health information technology to improve
the quality of health care, such as by promoting the
coordination of health care and improving continuity of
health care among health care providers, reducing medical
errors, improving population health, reducing chronic
disease, and advancing research and education.
``(ii) The use of technologies that address the needs of
children and other vulnerable populations.
``(iii) The use of electronic systems to ensure the
comprehensive collection of patient demographic data,
including at a minimum, race, ethnicity, primary language,
and gender information.
``(iv) The use of self-service, telemedicine, home health
care, and remote monitoring technologies.
``(v) The use of technologies that meet the needs of
diverse populations.
``(vi) The use of technologies that support--
``(I) data for use in quality and public reporting
programs;
``(II) public health; or
``(III) drug safety.
``(vii) The use of technologies that allow individually
identifiable health information to be rendered unusable,
unreadable, or indecipherable to unauthorized individuals
when such information is transmitted in a health information
network or transported outside of the secure facilities or
systems where the disclosing covered entity is responsible
for security conditions.
``(viii) The use of a certified health information
technology for each individual in the United States.
``(D) Authority for temporary additional priority target
areas.--For purposes of subparagraph (B)(iv), the HIT
Advisory Committee may identify an area to be considered for
purposes of recommendations under this subsection as a target
area described in subparagraph (B) if--
``(i) the area is so identified for purposes of responding
to new circumstances that have arisen in the health
information technology community that affect the
interoperability, privacy, or security of health information,
or affect patient safety; and
``(ii) at least 30 days prior to treating such area as if
it were a target area described in subparagraph (B), the
National Coordinator provides adequate notice to Congress of
the intent to treat such area as so described.
``(E) Focus of committee work.--It is the sense of Congress
that the HIT Advisory Committee shall focus its work on the
priority areas described in subparagraph (B) before
proceeding to other work under subparagraph (C).
``(3) Rules relating to recommendations for standards,
implementation specifications, and certification criteria.--
``(A) In general.--The HIT Advisory Committee shall
recommend to the National Coordinator standards,
implementation specifications, and certification criteria
described in subsection (a), which may include standards,
implementation specifications, and certification criteria
that have been developed, harmonized, or recognized by the
HIT Advisory Committee or predecessor committee. The HIT
Advisory Committee shall update such recommendations and make
new recommendations as appropriate, including in response to
a notification sent under section 3004(a)(2)(B). Such
recommendations shall be consistent with the latest
recommendations made by the Committee.
``(B) Harmonization.--The HIT Advisory Committee may
recognize harmonized or updated standards from an entity or
entities for the purpose of harmonizing or updating standards
and implementation specifications in order to achieve uniform
and consistent implementation of the standards and
implementation specification.
``(C) Pilot testing of standards and implementation
specifications.--In the development, harmonization, or
recognition of standards and implementation specifications,
the HIT Advisory Committee for purposes of recommendations
under paragraph (2)(B), shall, as appropriate, provide for
the testing of such standards and specifications by the
National Institute for Standards and Technology under section
13201(a) of the Health Information Technology for Economic
and Clinical Health Act.
``(D) Consistency.--The standards, implementation
specifications, and certification criteria recommended under
paragraph (2)(B) shall be consistent with the standards for
information transactions and data elements adopted pursuant
to section 1173 of the Social Security Act.
``(E) Special rule related to interoperability.--Any
recommendation made by the HIT Advisory Committee after the
date of the enactment of this subparagraph with respect to
interoperability of health information technology shall be
consistent with interoperability as described in section
3000.
``(4) Forum.--The HIT Advisory Committee shall serve as a
forum for the participation of a broad range of stakeholders
with specific expertise in policies, including technical
expertise, relating to the matters described in paragraphs
(1), (2), and (3) to provide input on the development,
harmonization, and recognition of standards, implementation
specifications, and certification criteria necessary for the
development and adoption of health information technology
infrastructure nationally and locally that allows for the
electronic access, exchange, and use of health information.
``(5) Schedule.--Not later than 30 days after the date on
which the HIT Advisory Committee first meets, such HIT
Advisory Committee shall develop a schedule for the
assessment of policy recommendations developed under
paragraph (1). The HIT Advisory Committee shall update such
schedule annually. The Secretary shall publish such schedule
in the Federal Register.
``(6) Public input.--The HIT Advisory Committee shall
conduct open public meetings and develop a process to allow
for public comment on the schedule described in paragraph (5)
and recommendations described in this subsection. Under such
process comments shall be submitted in a timely manner after
the date of publication of a recommendation under this
subsection.
``(c) Measured Progress in Advancing Priority Areas.--
``(1) In general.--For purposes of this section, the
National Coordinator, in collaboration with the Secretary,
shall establish, and update as appropriate, objectives and
benchmarks for advancing and measuring the advancement of the
priority target areas described in subsection (b)(2)(B).
``(2) Annual progress reports on advancing
interoperability.--
``(A) In general.--The HIT Advisory Committee, in
consultation with the National Coordinator, shall annually
submit to the Secretary and Congress a report on the progress
made during the preceding fiscal year in--
``(i) achieving a health information technology
infrastructure, nationally and locally, that allows for the
electronic access, exchange, and use of health information;
and
``(ii) meeting the objectives and benchmarks described in
paragraph (1).
``(B) Content.--Each such report shall include, for a
fiscal year--
``(i) a description of the work conducted by the HIT
Advisory Committee during the preceding fiscal year with
respect to the areas described in subsection (b)(2)(B);
``(ii) an assessment of the status of the infrastructure
described in subparagraph (A), including the extent to which
electronic health information is appropriately and readily
available to enhance the access, exchange, and the use of
electronic health information between users and across
technology offered by different developers;
``(iii) the extent to which advancements have been achieved
with respect to areas described in subsection (b)(2)(B);
``(iv) an analysis identifying existing gaps in policies
and resources for--
``(I) achieving the objectives and benchmarks established
under paragraph (1); and
``(II) furthering interoperability throughout the health
information technology infrastructure;
``(v) recommendations for addressing the gaps identified in
clause (iii); and
``(vi) a description of additional initiatives as the HIT
Advisory Committee and National Coordinator determine
appropriate.
``(3) Significant advancement determination.--The Secretary
shall periodically, based on the reports submitted under this
subsection, review the target areas described in subsection
(b)(2)(B), and, based on the objectives and benchmarks
established under paragraph (1), the Secretary shall
determine if significant advancement has been achieved with
respect to such an area. Such determination shall be taken
into consideration by the HIT Advisory Committee when
determining to what extent the Committee makes
recommendations for an area other than an area described in
subsection (b)(2)(B).
``(d) Membership and Operations.--
``(1) In general.--The National Coordinator shall take a
leading position in the establishment and operations of the
HIT Advisory Committee.
``(2) Membership.--The membership of the HIT Advisory
Committee shall--
``(A) include at least 25 members, of which--
``(i) no fewer than 2 members are advocates for patients or
consumers of health information technology;
``(ii) 3 members are appointed by the Secretary, 1 of whom
shall be appointed to represent the Department of Health and
Human
[[Page H6935]]
Services and 1 of whom shall be a public health official;
``(iii) 2 members are appointed by the majority leader of
the Senate;
``(iv) 2 members are appointed by the minority leader of
the Senate;
``(v) 2 members are appointed by the Speaker of the House
of Representatives;
``(vi) 2 members are appointed by the minority leader of
the House of Representatives; and
``(vii) such other members are appointed by the Comptroller
General of the United States; and
``(B) at least reflect providers, ancillary health care
workers, consumers, purchasers, health plans, health
information technology developers, researchers, patients,
relevant Federal agencies, and individuals with technical
expertise on health care quality, system functions, privacy,
security, and on the electronic exchange and use of health
information, including the use standards for such activity.
``(3) Participation.--The members of the HIT Advisory
Committee shall represent a balance among various sectors of
the health care system so that no single sector unduly
influences the recommendations of the Committee.
``(4) Terms.--
``(A) In general.--The terms of the members of the HIT
Advisory Committee shall be for 3 years, except that the
Secretary shall designate staggered terms of the members
first appointed.
``(B) Vacancies.--Any member appointed to fill a vacancy in
the membership of the HIT Advisory Committee that occurs
prior to the expiration of the term for which the member's
predecessor was appointed shall be appointed only for the
remainder of that term. A member may serve after the
expiration of that member's term until a successor has been
appointed. A vacancy in the HIT Advisory Committee shall be
filled in the manner in which the original appointment was
made.
``(C) Limits.--Members of the HIT Advisory Committee shall
be limited to two 3-year terms, for a total of not to exceed
6 years of service on the Committee.
``(5) Outside involvement.--The HIT Advisory Committee
shall ensure an opportunity for the participation in
activities of the Committee of outside advisors, including
individuals with expertise in the development of policies and
standards for the electronic exchange and use of health
information, including in the areas of health information
privacy and security.
``(6) Quorum.--A majority of the members of the HIT
Advisory Committee shall constitute a quorum for purposes of
voting, but a lesser number of members may meet and hold
hearings.
``(7) Consideration.--The National Coordinator shall ensure
that the relevant and available recommendations and comments
from the National Committee on Vital and Health Statistics
are considered in the development of policies.
``(8) Assistance.--For the purposes of carrying out this
section, the Secretary may provide or ensure that financial
assistance is provided by the HIT Advisory Committee to
defray in whole or in part any membership fees or dues
charged by such Committee to those consumer advocacy groups
and not-for-profit entities that work in the public interest
as a party of their mission.
``(e) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.), other than section 14 of such Act, shall
apply to the HIT Advisory Committee.
``(f) Publication.--The Secretary shall provide for
publication in the Federal Register and the posting on the
Internet website of the Office of the National Coordinator
for Health Information Technology of all policy
recommendations made by the HIT Advisory Committee under this
section.''.
(2) Technical and conforming amendments.--Title XXX of the
Public Health Service Act (42 U.S.C. 300jj et seq.) is
amended--
(A) by striking--
(i) ``HIT Policy Committee'' and ``HIT Standards
Committee'' each place that such terms appear (other than
within the term ``HIT Policy Committee and the HIT Standards
Committee'' or within the term ``HIT Policy Committee or the
HIT Standards Committee'') and inserting ``HIT Advisory
Committee'';
(ii) ``HIT Policy Committee and the HIT Standards
Committee'' each place that such term appears and inserting
``HIT Advisory Committee''; and
(iii) ``HIT Policy Committee or the HIT Standards
Committee'' each place that such term appears and inserting
``HIT Advisory Committee'';
(B) in section 3000 (42 U.S.C. 300jj)--
(i) by striking paragraphs (7) and (8) and redesignating
paragraphs (9) through (14) as paragraphs (8) through (13),
respectively; and
(ii) by inserting after paragraph (6) the following
paragraph:
``(7) Hit advisory committee.--The term `HIT Advisory
Committee' means such Committee established under section
3002(a).'';
(C) in section 3001(c) (42 U.S.C. 300jj-11(c))--
(i) in paragraph (1)(A), by striking ``under section 3003''
and inserting ``under section 3002'';
(ii) in paragraph (2), by striking subparagraph (B) and
inserting the following:
``(B) Hit advisory committee.--The National Coordinator
shall be a leading member in the establishment and operations
of the HIT Advisory Committee and shall serve as a liaison
between that Committee and the Federal Government.'';
(D) in section 3004(b)(3) (42 U.S.C. 300jj-14(b)(3)), by
striking ``3003(b)(2)'' and inserting ``3002(b)(4)'';
(E) in section 3007(b) (42 U.S.C. 300jj-17(b)), by striking
``3003(a)'' and inserting ``3002(a)(2)''; and
(F) in section 3008 (42 U.S.C. 300jj-18)--
(i) in subsection (b), by striking ``or 3003''; and
(ii) in subsection (c), by striking ``3003(b)(1)(A)'' and
inserting ``3002(b)(2)''.
(3) Transition to the hit advisory committee.--The
Secretary of Health and Human Services shall provide for an
orderly and timely transition to the HIT Advisory Committee
established under amendments made by this section.
(f) Priorities for Adoption of Standards, Implementation
Specifications, and Certification Criteria.--Title XXX of the
Public Health Service Act (42 U.S.C. 300jj et seq.), as
amended by subsection (e), is further amended by inserting
after section 3002 the following:
``SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION.
``(a) Identifying Priorities.--
``(1) In general.--Not later than 6 months after the date
on which the HIT Advisory Committee first meets, the National
Coordinator shall periodically convene the HIT Advisory
Committee to--
``(A) identify priority uses of health information
technology, focusing on priorities--
``(i) arising from the implementation of the incentive
programs for the meaningful use of certified EHR technology,
the Merit-based Incentive Payment System, Alternative Payment
Models, the Hospital Value-Based Purchasing Program, and any
other value-based payment program determined appropriate by
the Secretary;
``(ii) related to the quality of patient care;
``(iii) related to public health;
``(iv) related to clinical research;
``(v) related to the privacy and security of electronic
health information;
``(vi) related to innovation in the field of health
information technology;
``(vii) related to patient safety;
``(viii) related to the usability of health information
technology;
``(ix) related to individuals' access to electronic health
information; and
``(x) other priorities determined appropriate by the
Secretary;
``(B) identify existing standards and implementation
specifications that support the use and exchange of
electronic health information needed to meet the priorities
identified in subparagraph (A); and
``(C) publish a report summarizing the findings of the
analysis conducted under subparagraphs (A) and (B) and make
appropriate recommendations.
``(2) Prioritization.--In identifying such standards and
implementation specifications under paragraph (1)(B), the HIT
Advisory Committee shall prioritize standards and
implementation specifications developed by consensus-based
standards development organizations.
``(3) Guidelines for review of existing standards and
specifications.--In consultation with the consensus-based
entity described in section 1890 of the Social Security Act
and other appropriate Federal agencies, the analysis of
existing standards under paragraph (1)(B) shall include an
evaluation of the need for a core set of common data elements
and associated value sets to enhance the ability of certified
health information technology to capture, use, and exchange
structured electronic health information.
``(b) Review of Adopted Standards.--
``(1) In general.--Beginning 5 years after the date of
enactment of the 21st Century Cures Act and every 3 years
thereafter, the National Coordinator shall convene
stakeholders to review the existing set of adopted standards
and implementation specifications and make recommendations
with respect to whether to--
``(A) maintain the use of such standards and implementation
specifications; or
``(B) phase out such standards and implementation
specifications.
``(2) Priorities.--The HIT Advisory Committee, in
collaboration with the National Institute for Standards and
Technology, shall annually and through the use of public
input, review and publish priorities for the use of health
information technology, standards, and implementation
specifications to support those priorities.
``(c) Rule of Construction.--Nothing in this section shall
be construed to prevent the use or adoption of novel
standards that improve upon the existing health information
technology infrastructure and facilitate the secure exchange
of health information.''.
SEC. 4004. INFORMATION BLOCKING.
Subtitle C of title XXX of the Public Health Service Act
(42 U.S.C. 300jj-51 et seq.) is amended by adding at the end
the following:
``SEC. 3022. INFORMATION BLOCKING.
``(a) Definition.--
``(1) In general.--In this section, the term `information
blocking' means a practice that--
``(A) except as required by law or specified by the
Secretary pursuant to rulemaking under paragraph (3), is
likely to interfere with, prevent, or materially discourage
access, exchange, or use of electronic health information;
and
``(B)(i) if conducted by a health information technology
developer, exchange, or network, such developer, exchange, or
network knows, or should know, that such practice is likely
to interfere with, prevent, or materially discourage the
access, exchange, or use of electronic health information; or
``(ii) if conducted by a health care provider, such
provider knows that such practice is unreasonable and is
likely to interfere with, prevent, or materially discourage
access, exchange, or use of electronic health information.
``(2) Practices described.--The information blocking
practices described in paragraph (1) may include--
``(A) practices that restrict authorized access, exchange,
or use under applicable State or Federal law of such
information for treatment and other permitted purposes under
such applicable law, including transitions between certified
health information technologies;
``(B) implementing health information technology in
nonstandard ways that are likely to
[[Page H6936]]
substantially increase the complexity or burden of accessing,
exchanging, or using electronic health information; and
``(C) implementing health information technology in ways
that are likely to--
``(i) restrict the access, exchange, or use of electronic
health information with respect to exporting complete
information sets or in transitioning between health
information technology systems; or
``(ii) lead to fraud, waste, or abuse, or impede
innovations and advancements in health information access,
exchange, and use, including care delivery enabled by health
information technology.
``(3) Rulemaking.--The Secretary, through rulemaking, shall
identify reasonable and necessary activities that do not
constitute information blocking for purposes of paragraph
(1).
``(4) No enforcement before exception identified.--The term
`information blocking' does not include any practice or
conduct occurring prior to the date that is 30 days after the
date of enactment of the 21st Century Cures Act.
``(5) Consultation.--The Secretary may consult with the
Federal Trade Commission in promulgating regulations under
this subsection, to the extent that such regulations define
practices that are necessary to promote competition and
consumer welfare.
``(6) Application.--The term `information blocking', with
respect to an individual or entity, shall not include an act
or practice other than an act or practice committed by such
individual or entity.
``(7) Clarification.--In carrying out this section, the
Secretary shall ensure that health care providers are not
penalized for the failure of developers of health information
technology or other entities offering health information
technology to such providers to ensure that such technology
meets the requirements to be certified under this title.
``(b) Inspector General Authority.--
``(1) In general.--The inspector general of the Department
of Health and Human Services (referred to in this section as
the `Inspector General') may investigate any claim that--
``(A) a health information technology developer of
certified health information technology or other entity
offering certified health information technology--
``(i) submitted a false attestation under section
3001(c)(5)(D)(vii); or
``(ii) engaged in information blocking;
``(B) a health care provider engaged in information
blocking; or
``(C) a health information exchange or network engaged in
information blocking.
``(2) Penalties.--
``(A) Developers, networks, and exchanges.--Any individual
or entity described in subparagraph (A) or (C) of paragraph
(1) that the Inspector General, following an investigation
conducted under this subsection, determines to have committed
information blocking shall be subject to a civil monetary
penalty determined by the Secretary for all such violations
identified through such investigation, which may not exceed
$1,000,000 per violation. Such determination shall take into
account factors such as the nature and extent of the
information blocking and harm resulting from such information
blocking, including, where applicable, the number of patients
affected, the number of providers affected, and the number of
days the information blocking persisted.
``(B) Providers.--Any individual or entity described in
subparagraph (B) of paragraph (1) determined by the Inspector
General to have committed information blocking shall be
referred to the appropriate agency to be subject to
appropriate disincentives using authorities under applicable
Federal law, as the Secretary sets forth through notice and
comment rulemaking.
``(C) Procedure.--The provisions of section 1128A of the
Social Security Act (other than subsections (a) and (b) of
such section) shall apply to a civil money penalty applied
under this paragraph in the same manner as such provisions
apply to a civil money penalty or proceeding under such
section 1128A(a).
``(D) Recovered penalty funds.--The amounts recovered under
this paragraph shall be allocated as follows:
``(i) Annual operating expenses.--Each year following the
establishment of the authority under this subsection, the
Office of the Inspector General shall provide to the
Secretary an estimate of the costs to carry out
investigations under this section. Such estimate may include
reasonable reserves to account for variance in annual amounts
recovered under this paragraph. There is authorized to be
appropriated for purposes of carrying out this section an
amount equal to the amount specified in such estimate for the
fiscal year.
``(ii) Application to other programs.--The amounts
recovered under this paragraph and remaining after amounts
are made available under clause (i) shall be transferred to
the Federal Hospital Insurance Trust Fund under section 1817
of the Social Security Act and the Federal Supplementary
Medical Insurance Trust Fund under section 1841 of such Act,
in such proportion as the Secretary determines appropriate.
``(E) Authorization of appropriations.--There is authorized
to be appropriated to the Office of the Inspector General to
carry out this section $10,000,000, to remain available until
expended.
``(3) Resolution of claims.--
``(A) In general.--The Office of the Inspector General, if
such Office determines that a consultation regarding the
health privacy and security rules promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d-2 note) will resolve an
information blocking claim, may refer such instances of
information blocking to the Office for Civil Rights of the
Department of Health and Human Services for resolution.
``(B) Limitation on liability.--If a health care provider
or health information technology developer makes information
available based on a good faith reliance on consultations
with the Office for Civil Rights of the Department of Health
and Human Services pursuant to a referral under subparagraph
(A), with respect to such information, the health care
provider or developer shall not be liable for such disclosure
or disclosures made pursuant to subparagraph (A).
``(c) Identifying Barriers To Exchange of Certified Health
Information Technology.--
``(1) Trusted exchange defined.--In this section, the term
`trusted exchange' with respect to certified electronic
health records means that the certified electronic health
record technology has the technical capability to enable
secure health information exchange between users and multiple
certified electronic health record technology systems.
``(2) Guidance.--The National Coordinator, in consultation
with the Office for Civil Rights of the Department of Health
and Human Services, shall issue guidance on common legal,
governance, and security barriers that prevent the trusted
exchange of electronic health information.
``(3) Referral.--The National Coordinator and the Office
for Civil Rights of the Department of Health and Human
Services may refer to the Inspector General instances or
patterns of refusal to exchange health information with an
individual or entity using certified electronic health record
technology that is technically capable of trusted exchange
and under conditions when exchange is legally permissible.
``(d) Additional Provisions.--
``(1) Information sharing provisions.--The National
Coordinator may serve as a technical consultant to the
Inspector General and the Federal Trade Commission for
purposes of carrying out this section. The National
Coordinator may, notwithstanding any other provision of law,
share information related to claims or investigations under
subsection (b) with the Federal Trade Commission for purposes
of such investigations and shall share information with the
Inspector General, as required by law.
``(2) Protection from disclosure of information.--Any
information that is received by the National Coordinator in
connection with a claim or suggestion of possible information
blocking and that could reasonably be expected to facilitate
identification of the source of the information--
``(A) shall not be disclosed by the National Coordinator
except as may be necessary to carry out the purpose of this
section;
``(B) shall be exempt from mandatory disclosure under
section 552 of title 5, United States Code, as provided by
subsection (b)(3) of such section; and
``(C) may be used by the Inspector General or Federal Trade
Commission for reporting purposes to the extent that such
information could not reasonably be expected to facilitate
identification of the source of such information.
``(3) Standardized process.--
``(A) In general.--The National Coordinator shall implement
a standardized process for the public to submit reports on
claims of--
``(i) health information technology products or developers
of such products (or other entities offering such products to
health care providers) not being interoperable or resulting
in information blocking;
``(ii) actions described in subsection (b)(1) that result
in information blocking as described in subsection (a); and
``(iii) any other act described in subsection (a).
``(B) Collection of information.--The standardized process
implemented under subparagraph (A) shall provide for the
collection of such information as the originating
institution, location, type of transaction, system and
version, timestamp, terminating institution, locations,
system and version, failure notice, and other related
information.
``(4) Nonduplication of penalty structures.--In carrying
out this subsection, the Secretary shall, to the extent
possible, ensure that penalties do not duplicate penalty
structures that would otherwise apply with respect to
information blocking and the type of individual or entity
involved as of the day before the date of the enactment of
this section.''.
SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE
PATIENT CARE.
(a) Requirement Relating to Registries.--
(1) In general.--To be certified in accordance with title
XXX of the Public Health Service Act (42 U.S.C. 300jj et
seq.), electronic health records shall be capable of
transmitting to, and where applicable, receiving and
accepting data from, registries in accordance with standards
recognized by the Office of the National Coordinator for
Health Information Technology, including clinician-led
clinical data registries, that are also certified to be
technically capable of receiving and accepting from, and
where applicable, transmitting data to certified electronic
health record technology in accordance with such standards.
(2) Rule of construction.--Nothing in this subsection shall
be construed to require the certification of registries
beyond the technical capability to exchange data in
accordance with applicable recognized standards.
(b) Definition.--For purposes of this Act, the term
``clinician-led clinical data registry'' means a clinical
data repository--
(1) that is established and operated by a clinician-led or
controlled, tax-exempt (pursuant to section 501(c) of the
Internal Revenue Code of 1986), professional society or other
similar clinician-led or -controlled organization, or such
organization's controlled affiliate, devoted to the
[[Page H6937]]
care of a population defined by a particular disease,
condition, exposure or therapy;
(2) that is designed to collect detailed, standardized data
on an ongoing basis for medical procedures, services, or
therapies for particular diseases, conditions, or exposures;
(3) that provides feedback to participants who submit
reports to the repository;
(4) that meets standards for data quality including--
(A) systematically collecting clinical and other health
care data, using standardized data elements and having
procedures in place to verify the completeness and validity
of those data; and
(B) being subject to regular data checks or audits to
verify completeness and validity; and
(5) that provides ongoing participant training and support.
(c) Treatment of Health Information Technology Developers
With Respect to Patient Safety Organizations.--
(1) In general.--In applying part C of title IX of the
Public Health Service Act (42 U.S.C. 299b-21 et seq.), a
health information technology developer shall be treated as a
provider (as defined in section 921 of such Act) for purposes
of reporting and conducting patient safety activities
concerning improving clinical care through the use of health
information technology that could result in improved patient
safety, health care quality, or health care outcomes.
(2) Report.--Not later than 4 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
concerning best practices and current trends voluntarily
provided, without identifying individual providers or
disclosing or using protected health information or
individually identifiable information, by patient safety
organizations to improve the integration of health
information technology into clinical practice.
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS
TO THEIR ELECTRONIC HEALTH INFORMATION.
(a) Use of Health Information Exchanges for Patient
Access.--Section 3009 of the Public Health Service Act (42
U.S.C. 300jj-19) is amended by adding at the end the
following:
``(c) Promoting Patient Access to Electronic Health
Information Through Health Information Exchanges .--
``(1) In general.--The Secretary shall use existing
authorities to encourage partnerships between health
information exchange organizations and networks and health
care providers, health plans, and other appropriate entities
with the goal of offering patients access to their electronic
health information in a single, longitudinal format that is
easy to understand, secure, and may be updated automatically.
``(2) Education of providers.--The Secretary, in
coordination with the Office for Civil Rights of the
Department of Health and Human Services, shall--
``(A) educate health care providers on ways of leveraging
the capabilities of health information exchanges (or other
relevant platforms) to provide patients with access to their
electronic health information;
``(B) clarify misunderstandings by health care providers
about using health information exchanges (or other relevant
platforms) for patient access to electronic health
information; and
``(C) to the extent practicable, educate providers about
health information exchanges (or other relevant platforms)
that employ some or all of the capabilities described in
paragraph (1).
``(3) Requirements.--In carrying out paragraph (1), the
Secretary, in coordination with the Office for Civil Rights,
shall issue guidance to health information exchanges related
to best practices to ensure that the electronic health
information provided to patients is--
``(A) private and secure;
``(B) accurate;
``(C) verifiable; and
``(D) where a patient's authorization to exchange
information is required by law, easily exchanged pursuant to
such authorization.
``(4) Rule of construction.--Nothing in this subsection
shall be construed to preempt State laws applicable to
patient consent for the access of information through a
health information exchange (or other relevant platform) that
provide protections to patients that are greater than the
protections otherwise provided for under applicable Federal
law.
``(d) Efforts To Promote Access to Health Information.--The
National Coordinator and the Office for Civil Rights of the
Department of Health and Human Services shall jointly promote
patient access to health information in a manner that would
ensure that such information is available in a form
convenient for the patient, in a reasonable manner, without
burdening the health care provider involved.
``(e) Accessibility of Patient Records.--
``(1) Accessibility and updating of information.--
``(A) In general.--The Secretary, in consultation with the
National Coordinator, shall promote policies that ensure that
a patient's electronic health information is accessible to
that patient and the patient's designees, in a manner that
facilitates communication with the patient's health care
providers and other individuals, including researchers,
consistent with such patient's consent.
``(B) Updating education on accessing and exchanging
personal health information.--To promote awareness that an
individual has a right of access to inspect, obtain a copy
of, and transmit to a third party a copy of such individual's
protected health information pursuant to the Health
Information Portability and Accountability Act, Privacy Rule
(subpart E of part 164 of title 45, Code of Federal
Regulations), the Director of the Office for Civil Rights, in
consultation with the National Coordinator, shall assist
individuals and health care providers in understanding a
patient's rights to access and protect personal health
information under the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191), including
providing best practices for requesting personal health
information in a computable format, including using patient
portals or third-party applications and common cases when a
provider is permitted to exchange and provide access to
health information.''.
``(2) Certifying usability for patients.--In carrying out
certification programs under section 3001(c)(5), the National
Coordinator may require that--
``(A) the certification criteria support--
``(i) patient access to their electronic health
information, including in a single longitudinal format that
is easy to understand, secure, and may be updated
automatically;
``(ii) the patient's ability to electronically communicate
patient-reported information (such as family history and
medical history); and
``(iii) patient access to their personal electronic health
information for research at the option of the patient; and
``(B) the HIT Advisory Committee develop and prioritize
standards, implementation specifications, and certification
criteria required to help support patient access to
electronic health information, patient usability, and support
for technologies that offer patients access to their
electronic health information in a single, longitudinal
format that is easy to understand, secure, and may be updated
automatically.''.
(b) Access to Information in an Electronic Format.--Section
13405(e) of the Health Information Technology for Economic
and Clinical Health Act (42 U.S.C. 17935) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) by redesignating paragraph (2) as paragraph (3); and
(3) by inserting after paragraph (1), the following:
``(2) if the individual makes a request to a business
associate for access to, or a copy of, protected health
information about the individual, or if an individual makes a
request to a business associate to grant such access to, or
transmit such copy directly to, a person or entity designated
by the individual, a business associate may provide the
individual with such access or copy, which may be in an
electronic form, or grant or transmit such access or copy to
such person or entity designated by the individual; and''.
SEC. 4007. GAO STUDY ON PATIENT MATCHING.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United
States shall conduct a study to--
(1) review the policies and activities of the Office of the
National Coordinator for Health Information Technology and
other relevant stakeholders, which may include standards
development organizations, experts in the technical aspects
of health information technology, health information
technology developers, providers of health services, health
care suppliers, health care payers, health care quality
organizations, States, health information technology policy
experts, and other appropriate entities, to ensure
appropriate patient matching to protect patient privacy and
security with respect to electronic health records and the
exchange of electronic health information; and
(2) survey ongoing efforts related to the policies and
activities described in paragraph (1) and the effectiveness
of such efforts occurring in the private sector.
(b) Areas of Concentration.--In conducting the study under
subsection (a), the Comptroller General shall--
(1) evaluate current methods used in certified electronic
health records for patient matching based on performance
related to factors such as--
(A) the privacy of patient information;
(B) the security of patient information;
(C) improving matching rates;
(D) reducing matching errors; and
(E) reducing duplicate records; and
(2) determine whether the Office of the National
Coordinator for Health Information Technology could improve
patient matching by taking steps including--
(A) defining additional data elements to assist in patient
data matching;
(B) agreeing on a required minimum set of elements that
need to be collected and exchanged;
(C) requiring electronic health records to have the ability
to make certain fields required and use specific standards;
and
(D) other options recommended by the relevant stakeholders
consulted pursuant to subsection (a).
(c) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General shall submit
to the appropriate committees of Congress a report concerning
the findings of the study conducted under subsection (a).
SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (referred to in this section as the ``Comptroller
General'') shall build on prior Government Accountability
Office studies and other literature review and conduct a
study to review patient access to their own protected health
information, including barriers to such patient access and
complications or difficulties providers experience in
providing access to patients. In conducting such study, the
Comptroller General shall consider the increase in adoption
of health information technology and the increasing
prevalence of protected health information that is maintained
electronically.
[[Page H6938]]
(2) Areas of concentration.--In conducting the review under
paragraph (1), the Comptroller General shall consider--
(A) instances when covered entities charge individuals,
including patients, third parties, and health care providers,
for record requests, including records that are requested in
an electronic format;
(B) examples of the amounts and types of fees charged to
individuals for record requests, including instances when the
record is requested to be transmitted to a third party;
(C) the extent to which covered entities are unable to
provide the access requested by individuals in the form and
format requested by the individual, including examples of
such instances;
(D) instances in which third parties may request protected
health information through patients' individual right of
access, including instances where such requests may be used
to circumvent appropriate fees that may be charged to third
parties;
(E) opportunities that permit covered entities to charge
appropriate fees to third parties for patient records while
providing patients with access to their protected health
information at low or no cost;
(F) the ability of providers to distinguish between
requests originating from an individual that require
limitation to a cost-based fee and requests originating from
third parties that may not be limited to cost-based fees; and
(G) other circumstances that may inhibit the ability of
providers to provide patients with access to their records,
and the ability of patients to gain access to their records.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General shall submit a
report to Congress on the findings of the study conducted
under subsection (a).
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
(a) In General.--Section 1862(l)(5) of the Social Security
Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end
the following new subparagraph:
``(D) Local coverage determinations.--The Secretary shall
require each Medicare administrative contractor that develops
a local coverage determination to make available on the
Internet website of such contractor and on the Medicare
Internet website, at least 45 days before the effective date
of such determination, the following information:
``(i) Such determination in its entirety.
``(ii) Where and when the proposed determination was first
made public.
``(iii) Hyperlinks to the proposed determination and a
response to comments submitted to the contractor with respect
to such proposed determination.
``(iv) A summary of evidence that was considered by the
contractor during the development of such determination and a
list of the sources of such evidence.
``(v) An explanation of the rationale that supports such
determination.''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply with respect to local coverage determinations
that are proposed or revised on or after the date that is 180
days after the date of enactment of this Act.
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
Section 1808 of the Social Security Act (42 U.S.C. 1395b-9)
is amended by adding at the end the following new subsection:
``(d) Pharmaceutical and Technology Ombudsman.--
``(1) In general.--Not later than 12 months after the date
of enactment of this paragraph, the Secretary shall provide
for a pharmaceutical and technology ombudsman within the
Centers for Medicare & Medicaid Services who shall receive
and respond to complaints, grievances, and requests that--
``(A) are from entities that manufacture pharmaceutical,
biotechnology, medical device, or diagnostic products that
are covered or for which coverage is being sought under this
title; and
``(B) are with respect to coverage, coding, or payment
under this title for such products.
``(2) Application.--The second sentence of subsection
(c)(2) shall apply to the ombudsman under subparagraph (A) in
the same manner as such sentence applies to the Medicare
Beneficiary Ombudsman under subsection (c).''.
SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
Section 1834 of the Social Security Act (42 U.S.C. 1395m)
is amended by adding at the end the following new subsection:
``(t) Site-of-Service Price Transparency.--
``(1) In general.--In order to facilitate price
transparency with respect to items and services for which
payment may be made either to a hospital outpatient
department or to an ambulatory surgical center under this
title, the Secretary shall, for 2018 and each year
thereafter, make available to the public via a searchable
Internet website, with respect to an appropriate number of
such items and services--
``(A) the estimated payment amount for the item or service
under the outpatient department fee schedule under subsection
(t) of section 1833 and the ambulatory surgical center
payment system under subsection (i) of such section; and
``(B) the estimated amount of beneficiary liability
applicable to the item or service.
``(2) Calculation of estimated beneficiary liability.--For
purposes of paragraph (1)(B), the estimated amount of
beneficiary liability, with respect to an item or service, is
the amount for such item or service for which an individual
who does not have coverage under a Medicare supplemental
policy certified under section 1882 or any other supplemental
insurance coverage is responsible.
``(3) Implementation.--In carrying out this subsection, the
Secretary--
``(A) shall include in the notice described in section
1804(a) a notification of the availability of the estimated
amounts made available under paragraph (1); and
``(B) may utilize mechanisms in existence on the date of
enactment of this subsection, such as the portion of the
Internet website of the Centers for Medicare & Medicaid
Services on which information comparing physician performance
is posted (commonly referred to as the Physician Compare
Internet website), to make available such estimated amounts
under such paragraph.
``(4) Funding.--For purposes of implementing this
subsection, the Secretary shall provide for the transfer,
from the Federal Supplementary Medical Insurance Trust Fund
under section 1841 to the Centers for Medicare & Medicaid
Services Program Management Account, of $6,000,000 for fiscal
year 2017, to remain available until expended.''.
SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.
(a) Provision of Information by Centers for Medicare &
Medicaid Services.--Not later than 1 year after the date of
enactment of this Act, the Administrator of the Centers for
Medicare & Medicaid Services shall provide to the committees
of jurisdiction of the House of Representatives and the
Senate information on the following:
(1) The populations of Medicare beneficiaries, such as
those who are dually eligible for the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) and the Medicaid program under title XIX of such Act
(42 U.S.C. 1396 et seq.) and those with chronic conditions,
whose care may be improved most in terms of quality and
efficiency by the expansion, in a manner that meets or
exceeds the existing in-person standard of care under the
Medicare program under such title XVIII, of telehealth
services under section 1834(m)(4) of such Act (42 U.S.C.
1395m(m)(4)).
(2) Activities by the Center for Medicare and Medicaid
Innovation which examine the use of telehealth services in
models, projects, or initiatives funded through section 1115A
of such Act (42 U.S.C. 1315a).
(3) The types of high-volume services (and related
diagnoses) under such title XVIII which might be suitable to
be furnished using telehealth.
(4) Barriers that might prevent the expansion of telehealth
services under section 1834(m)(4) of the Social Security Act
(42 U.S.C. 1395m(m)(4)) beyond such services that are in
effect as of the date of enactment of this Act.
(b) Provision of Information by MedPAC.--Not later than
March 15, 2018, the Medicare Payment Advisory Commission
established under section 1805 of the Social Security Act (42
U.S.C. 1395b-6) shall, using quantitative and qualitative
research methods, provide information to the committees of
jurisdiction of the House of Representatives and the Senate
that identifies--
(1) the telehealth services for which payment can be made,
as of the date of enactment of this Act, under the fee-for-
service program under parts A and B of title XVIII of such
Act;
(2) the telehealth services for which payment can be made,
as of such date, under private health insurance plans; and
(3) with respect to services identified under paragraph (2)
but not under paragraph (1), ways in which payment for such
services might be incorporated into such fee-for-service
program (including any recommendations for ways to accomplish
this incorporation).
(c) Sense of Congress.--It is the sense of Congress that--
(1) eligible originating sites should be expanded beyond
those originating sites described in section 1834(m)(4)(C) of
the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
(2) any expansion of telehealth services under the Medicare
program under title XVIII of such Act should--
(A) recognize that telemedicine is the delivery of safe,
effective, quality health care services, by a health care
provider, using technology as the mode of care delivery;
(B) meet or exceed the conditions of coverage and payment
with respect to the Medicare program if the service was
furnished in person, including standards of care, unless
specifically addressed in subsequent legislation; and
(C) involve clinically appropriate means to furnish such
services.
TITLE V--SAVINGS
SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)), as amended by section 704(h) of the
Comprehensive Addiction and Recovery Act of 2016, is amended
by striking ``$140,000,000'' and inserting ``$270,000,000''.
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE
MEDICAL EQUIPMENT.
Section 1903(i)(27) of the Social Security Act (42 U.S.C.
1396b(i)(27)) is amended by striking ``January 1, 2019'' and
inserting ``January 1, 2018''.
SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND
OTHER AGREEMENTS.
(a) In General.--Section 1128A of the Social Security Act
(42 U.S.C. 1320a-7a) is amended by adding at the end the
following new subsections:
``(o) Any person (including an organization, agency, or
other entity, but excluding a program beneficiary, as defined
in subsection (q)(4)) that, with respect to a grant,
contract, or other agreement for which the Secretary provides
funding--
``(1) knowingly presents or causes to be presented a
specified claim (as defined in subsection (r)) under such
grant, contract, or other agreement that the person knows or
should know is false or fraudulent;
``(2) knowingly makes, uses, or causes to be made or used
any false statement, omission, or
[[Page H6939]]
misrepresentation of a material fact in any application,
proposal, bid, progress report, or other document that is
required to be submitted in order to directly or indirectly
receive or retain funds provided in whole or in part by such
Secretary pursuant to such grant, contract, or other
agreement;
``(3) knowingly makes, uses, or causes to be made or used,
a false record or statement material to a false or fraudulent
specified claim under such grant, contract, or other
agreement;
``(4) knowingly makes, uses, or causes to be made or used,
a false record or statement material to an obligation (as
defined in subsection (s)) to pay or transmit funds or
property to such Secretary with respect to such grant,
contract, or other agreement, or knowingly conceals or
knowingly and improperly avoids or decreases an obligation to
pay or transmit funds or property to such Secretary with
respect to such grant, contract, or other agreement; or
``(5) fails to grant timely access, upon reasonable request
(as defined by such Secretary in regulations), to the
Inspector General of the Department, for the purpose of
audits, investigations, evaluations, or other statutory
functions of such Inspector General in matters involving such
grants, contracts, or other agreements;
shall be subject, in addition to any other penalties that may
be prescribed by law, to a civil money penalty in cases under
paragraph (1), of not more than $10,000 for each specified
claim; in cases under paragraph (2), not more than $50,000
for each false statement, omission, or misrepresentation of a
material fact; in cases under paragraph (3), not more than
$50,000 for each false record or statement; in cases under
paragraph (4), not more than $50,000 for each false record or
statement or $10,000 for each day that the person knowingly
conceals or knowingly and improperly avoids or decreases an
obligation to pay; or in cases under paragraph (5), not more
than $15,000 for each day of the failure described in such
paragraph. In addition, in cases under paragraphs (1) and
(3), such a person shall be subject to an assessment of not
more than 3 times the amount claimed in the specified claim
described in such paragraph in lieu of damages sustained by
the United States or a specified State agency because of such
specified claim, and in cases under paragraphs (2) and (4),
such a person shall be subject to an assessment of not more
than 3 times the total amount of the funds described in
paragraph (2) or (4), respectively (or, in the case of an
obligation to transmit property to the Secretary described in
paragraph (4), of the value of the property described in such
paragraph) in lieu of damages sustained by the United States
or a specified State agency because of such case. In
addition, the Secretary may make a determination in the same
proceeding to exclude the person from participation in the
Federal health care programs (as defined in section
1128B(f)(1)) and to direct the appropriate State agency to
exclude the person from participation in any State health
care program.
``(p) The provisions of subsections (c), (d), (g), and (h)
shall apply to a civil money penalty or assessment under
subsection (o) in the same manner as such provisions apply to
a penalty, assessment, or proceeding under subsection (a). In
applying subsection (d), each reference to a claim under such
subsection shall be treated as including a reference to a
specified claim (as defined in subsection (r)).
``(q) For purposes of this subsection and subsections (o)
and (p):
``(1) The term `Department' means the Department of Health
and Human Services.
``(2) The term `material' means having a natural tendency
to influence, or be capable of influencing, the payment or
receipt of money or property.
``(3) The term `other agreement' includes a cooperative
agreement, scholarship, fellowship, loan, subsidy, payment
for a specified use, donation agreement, award, or subaward
(regardless of whether one or more of the persons entering
into the agreement is a contractor or subcontractor).
``(4) The term `program beneficiary' means, in the case of
a grant, contract, or other agreement designed to accomplish
the objective of awarding or otherwise furnishing benefits or
assistance to individuals and for which the Secretary
provides funding, an individual who applies for, or who
receives, such benefits or assistance from such grant,
contract, or other agreement. Such term does not include,
with respect to such grant, contract, or other agreement, an
officer, employee, or agent of a person or entity that
receives such grant or that enters into such contract or
other agreement.
``(5) The term `recipient' includes a subrecipient or
subcontractor.
``(6) The term `specified State agency' means an agency of
a State government established or designated to administer or
supervise the administration of a grant, contract, or other
agreement funded in whole or in part by the Secretary.
``(r) For purposes of this section, the term `specified
claim' means any application, request, or demand under a
grant, contract, or other agreement for money or property,
whether or not the United States or a specified State agency
has title to the money or property, that is not a claim (as
defined in subsection (i)(2)) and that--
``(1) is presented or caused to be presented to an officer,
employee, or agent of the Department or agency thereof, or of
any specified State agency; or
``(2) is made to a contractor, grantee, or any other
recipient if the money or property is to be spent or used on
the Department's behalf or to advance a Department program or
interest, and if the Department--
``(A) provides or has provided any portion of the money or
property requested or demanded; or
``(B) will reimburse such contractor, grantee, or other
recipient for any portion of the money or property which is
requested or demanded.
``(s) For purposes of subsection (o), the term `obligation'
means an established duty, whether or not fixed, arising from
an express or implied contractual, grantor-grantee, or
licensor-licensee relationship, for a fee-based or similar
relationship, from statute or regulation, or from the
retention of any overpayment.''.
(b) Conforming Amendments.--Section 1128A of the Social
Security Act (42 U.S.C. 1320a-7a) is amended--
(1) in subsection (e), by inserting ``or specified claim''
after ``claim'' in the first sentence; and
(2) in subsection (f)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``or specified claim (as defined in
subsection (r))'' after ``district where the claim''; and
(ii) by inserting ``(or, with respect to a person described
in subsection (o), the person)'' after ``claimant''; and
(B) in the matter following paragraph (4), by inserting
``(or, in the case of a penalty or assessment under
subsection (o), by a specified State agency (as defined in
subsection (q)(6)),'' after ``or a State agency''.
SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
(a) Treatment of Infusion Drugs Furnished Through Durable
Medical Equipment.--Section 1842(o)(1) of the Social Security
Act (42 U.S.C. 1395u(o)(1)) is amended--
(1) in subparagraph (C), by inserting ``(and including a
drug or biological described in subparagraph (D)(i) furnished
on or after January 1, 2017)'' after ``2005''; and
(2) in subparagraph (D)--
(A) by striking ``infusion drugs'' and inserting ``infusion
drugs or biologicals'' each place it appears; and
(B) in clause (i)--
(i) by striking ``2004'' and inserting ``2004, and before
January 1, 2017''; and
(ii) by striking ``for such drug''.
(b) Noninclusion of DME Infusion Drugs Under DME
Competitive Acquisition Programs.--
(1) In general.--Section 1847(a)(2)(A) of the Social
Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
(A) by striking ``and excluding'' and inserting ``,
excluding''; and
(B) by inserting before the period at the end the
following: ``, and excluding drugs and biologicals described
in section 1842(o)(1)(D)''.
(2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the
Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended
by striking ``2007'' and inserting ``2007, and before the
date of the enactment of the 21st Century Cures Act.''.
SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID
PROVIDERS.
(a) Increased Oversight and Reporting.--
(1) State reporting requirements.--Section 1902(kk) of the
Social Security Act (42 U.S.C. 1396a(kk)) is amended--
(A) by redesignating paragraph (8) as paragraph (9); and
(B) by inserting after paragraph (7) the following new
paragraph:
``(8) Provider terminations.--
``(A) In general.--Beginning on July 1, 2018, in the case
of a notification under subsection (a)(41) with respect to a
termination for a reason specified in section 455.101 of
title 42, Code of Federal Regulations (as in effect on
November 1, 2015) or for any other reason specified by the
Secretary, of the participation of a provider of services or
any other person under the State plan (or under a waiver of
the plan), the State, not later than 30 days after the
effective date of such termination submits to the Secretary
with respect to any such provider or person, as appropriate--
``(i) the name of such provider or person;
``(ii) the provider type of such provider or person;
``(iii) the specialty of such provider's or person's
practice;
``(iv) the date of birth, Social Security number, national
provider identifier (if applicable), Federal taxpayer
identification number, and the State license or certification
number of such provider or person (if applicable);
``(v) the reason for the termination;
``(vi) a copy of the notice of termination sent to the
provider or person;
``(vii) the date on which such termination is effective, as
specified in the notice; and
``(viii) any other information required by the Secretary.
``(B) Effective date defined.--For purposes of this
paragraph, the term `effective date' means, with respect to a
termination described in subparagraph (A), the later of--
``(i) the date on which such termination is effective, as
specified in the notice of such termination; or
``(ii) the date on which all appeal rights applicable to
such termination have been exhausted or the timeline for any
such appeal has expired.''.
(2) Contract requirement for managed care entities.--
Section 1932(d) of the Social Security Act (42 U.S.C. 1396u-
2(d)) is amended by adding at the end the following new
paragraph:
``(5) Contract requirement for managed care entities.--With
respect to any contract with a managed care entity under
section 1903(m) or 1905(t)(3) (as applicable), no later than
July 1, 2018, such contract shall include a provision that
providers of services or persons terminated (as described in
section 1902(kk)(8)) from participation under this title,
title XVIII, or title XXI shall be terminated from
participating under this title as a provider in any network
of such entity that serves individuals eligible to receive
medical assistance under this title.''.
(3) Termination notification database.--Section 1902 of the
Social Security Act (42 U.S.C.
[[Page H6940]]
1396a) is amended by adding at the end the following new
subsection:
``(ll) Termination Notification Database.--In the case of a
provider of services or any other person whose participation
under this title or title XXI is terminated (as described in
subsection (kk)(8)), the Secretary shall, not later than 30
days after the date on which the Secretary is notified of
such termination under subsection (a)(41) (as applicable),
review such termination and, if the Secretary determines
appropriate, include such termination in any database or
similar system developed pursuant to section 6401(b)(2) of
the Patient Protection and Affordable Care Act (42 U.S.C.
1395cc note; Public Law 111-148).''.
(4) No federal funds for items and services furnished by
terminated providers.--Section 1903 of the Social Security
Act (42 U.S.C. 1396b) is amended--
(A) in subsection (i)(2)--
(i) in subparagraph (A), by striking the comma at the end
and inserting a semicolon;
(ii) in subparagraph (B), by striking ``or'' at the end;
and
(iii) by adding at the end the following new subparagraph:
``(D) beginning on July 1, 2018, under the plan by any
provider of services or person whose participation in the
State plan is terminated (as described in section
1902(kk)(8)) after the date that is 60 days after the date on
which such termination is included in the database or other
system under section 1902(ll); or''; and
(B) in subsection (m), by inserting after paragraph (2) the
following new paragraph:
``(3) No payment shall be made under this title to a State
with respect to expenditures incurred by the State for
payment for services provided by a managed care entity (as
defined under section 1932(a)(1)) under the State plan under
this title (or under a waiver of the plan) unless the State--
``(A) beginning on July 1, 2018, has a contract with such
entity that complies with the requirement specified in
section 1932(d)(5); and
``(B) beginning on January 1, 2018, complies with the
requirement specified in section 1932(d)(6)(A).''.
(5) Development of uniform terminology for reasons for
provider termination.--Not later than July 1, 2017, the
Secretary of Health and Human Services shall, in consultation
with the heads of State agencies administering State Medicaid
plans (or waivers of such plans), issue regulations
establishing uniform terminology to be used with respect to
specifying reasons under subparagraph (A)(v) of paragraph (8)
of section 1902(kk) of the Social Security Act (42 U.S.C.
1396a(kk)), as added by paragraph (1), for the termination
(as described in such paragraph (8)) of the participation of
certain providers in the Medicaid program under title XIX of
such Act or the Children's Health Insurance Program under
title XXI of such Act.
(6) Conforming amendment.--Section 1902(a)(41) of the
Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by
striking ``provide that whenever'' and inserting ``provide,
in accordance with subsection (kk)(8) (as applicable), that
whenever''.
(b) Increasing Availability of Medicaid Provider
Information.--
(1) FFS provider enrollment.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)) is amended by inserting
after paragraph (77) the following new paragraph:
``(78) provide that, not later than January 1, 2017, in the
case of a State that pursuant to its State plan or waiver of
the plan for medical assistance pays for medical assistance
on a fee-for-service basis, the State shall require each
provider furnishing items and services to, or ordering,
prescribing, referring, or certifying eligibility for,
services for individuals eligible to receive medical
assistance under such plan to enroll with the State agency
and provide to the State agency the provider's identifying
information, including the name, specialty, date of birth,
Social Security number, national provider identifier (if
applicable), Federal taxpayer identification number, and the
State license or certification number of the provider (if
applicable);''.
(2) Managed care provider enrollment.--Section 1932(d) of
the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by
subsection (a)(2), is amended by adding at the end the
following new paragraph:
``(6) Enrollment of participating providers.--
``(A) In general.--Beginning not later than January 1,
2018, a State shall require that, in order to participate as
a provider in the network of a managed care entity that
provides services to, or orders, prescribes, refers, or
certifies eligibility for services for, individuals who are
eligible for medical assistance under the State plan under
this title (or under a waiver of the plan) and who are
enrolled with the entity, the provider is enrolled consistent
with section 1902(kk) with the State agency administering the
State plan under this title. Such enrollment shall include
providing to the State agency the provider's identifying
information, including the name, specialty, date of birth,
Social Security number, national provider identifier, Federal
taxpayer identification number, and the State license or
certification number of the provider.
``(B) Rule of construction.--Nothing in subparagraph (A)
shall be construed as requiring a provider described in such
subparagraph to provide services to individuals who are not
enrolled with a managed care entity under this title.''.
(c) Coordination With CHIP.--
(1) In general.--Section 2107(e)(1) of the Social Security
Act (42 U.S.C. 1397gg(e)(1)) is amended--
(A) by redesignating subparagraphs (B), (C), (D), (E), (F),
(G), (H), (I), (J), (K), (L), (M), (N), and (O) as
subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M),
(N), (O), (P), (Q), and (R), respectively;
(B) by inserting after subparagraph (A) the following new
subparagraphs:
``(B) Section 1902(a)(39) (relating to termination of
participation of certain providers).
``(C) Section 1902(a)(78) (relating to enrollment of
providers participating in State plans providing medical
assistance on a fee-for-service basis).'';
(C) by inserting after subparagraph (K) (as redesignated by
subparagraph (A)) the following new subparagraph:
``(L) Section 1903(m)(3) (relating to limitation on payment
with respect to managed care).''; and
(D) in subparagraph (P) (as redesignated by subparagraph
(A)), by striking ``(a)(2)(C) and (h)'' and inserting
``(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating
to contract requirement for managed care entities), (d)(6)
(relating to enrollment of providers participating with a
managed care entity), and (h) (relating to special rules with
respect to Indian enrollees, Indian health care providers,
and Indian managed care entities)''.
(2) Excluding from medicaid providers excluded from chip.--
Section 1902(a)(39) of the Social Security Act (42 U.S.C.
1396a(a)(39)) is amended by striking ``title XVIII or any
other State plan under this title'' and inserting ``title
XVIII, any other State plan under this title (or waiver of
the plan), or any State child health plan under title XXI (or
waiver of the plan) and such termination is included by the
Secretary in any database or similar system developed
pursuant to section 6401(b)(2) of the Patient Protection and
Affordable Care Act''.
(d) Rule of Construction.--Nothing in this section shall be
construed as changing or limiting the appeal rights of
providers or the process for appeals of States under the
Social Security Act.
(e) OIG Report.--Not later than March 31, 2020, the
Inspector General of the Department of Health and Human
Services shall submit to Congress a report on the
implementation of the amendments made by this section. Such
report shall include the following:
(1) An assessment of the extent to which providers who are
included under subsection (ll) of section 1902 of the Social
Security Act (42 U.S.C. 1396a) (as added by subsection
(a)(3)) in the database or similar system referred to in such
subsection are terminated (as described in paragraph (8) of
subsection (kk) of such section, as added by subsection
(a)(1)) from participation in all State plans under title XIX
of such Act (or waivers of such plans).
(2) Information on the amount of Federal financial
participation paid to States under section 1903 of such Act
in violation of the limitation on such payment specified in
subparagraph (D) of subsection (i)(2) of such section and
paragraph (3) of subsection (m) of such section, as added by
subsection (a)(4).
(3) An assessment of the extent to which contracts with
managed care entities under title XIX of such Act comply with
the requirement specified in paragraph (5) of section 1932(d)
of such Act, as added by subsection (a)(2).
(4) An assessment of the extent to which providers have
been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of
such Act (42 U.S.C. 1396a(a)(78), 1396u-2(d)(6)(A)) with
State agencies administering State plans under title XIX of
such Act (or waivers of such plans).
SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER
DIRECTORY.
(a) In General.--Section 1902(a) of the Social Security Act
(42 U.S.C. 1396a(a)) is amended--
(1) in paragraph (81), by striking ``and'' at the end;
(2) in paragraph (82), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (82) the following new
paragraph:
``(83) provide that, not later than January 1, 2017, in the
case of a State plan (or waiver of the plan) that provides
medical assistance on a fee-for-service basis or through a
primary care case-management system described in section
1915(b)(1) (other than a primary care case management entity
(as defined by the Secretary)), the State shall publish (and
update on at least an annual basis) on the public website of
the State agency administering the State plan, a directory of
the physicians described in subsection (mm) and, at State
option, other providers described in such subsection that--
``(A) includes--
``(i) with respect to each such physician or provider--
``(I) the name of the physician or provider;
``(II) the specialty of the physician or provider;
``(III) the address at which the physician or provider
provides services; and
``(IV) the telephone number of the physician or provider;
and
``(ii) with respect to any such physician or provider
participating in such a primary care case-management system,
information regarding--
``(I) whether the physician or provider is accepting as new
patients individuals who receive medical assistance under
this title; and
``(II) the physician's or provider's cultural and
linguistic capabilities, including the languages spoken by
the physician or provider or by the skilled medical
interpreter providing interpretation services at the
physician's or provider's office; and
``(B) may include, at State option, with respect to each
such physician or provider--
``(i) the Internet website of such physician or provider;
or
``(ii) whether the physician or provider is accepting as
new patients individuals who receive medical assistance under
this title.''.
(b) Directory Physician or Provider Described.--Section
1902 of the Social Security Act (42 U.S.C. 1396a), as amended
by section
[[Page H6941]]
5005(a)(3), is further amended by adding at the end the
following new subsection:
``(mm) Directory Physician or Provider Described.--A
physician or provider described in this subsection is--
``(1) in the case of a physician or provider of a provider
type for which the State agency, as a condition on receiving
payment for items and services furnished by the physician or
provider to individuals eligible to receive medical
assistance under the State plan, requires the enrollment of
the physician or provider with the State agency, a physician
or a provider that--
``(A) is enrolled with the agency as of the date on which
the directory is published or updated (as applicable) under
subsection (a)(83); and
``(B) received payment under the State plan in the 12-month
period preceding such date; and
``(2) in the case of a physician or provider of a provider
type for which the State agency does not require such
enrollment, a physician or provider that received payment
under the State plan (or a waiver of the plan) in the 12-
month period preceding the date on which the directory is
published or updated (as applicable) under subsection
(a)(83).''.
(c) Rule of Construction.--
(1) In general.--The amendment made by subsection (a) shall
not be construed to apply in the case of a State (as defined
for purposes of title XIX of the Social Security Act) in
which all the individuals enrolled in the State plan under
such title (or under a waiver of such plan), other than
individuals described in paragraph (2), are enrolled with a
medicaid managed care organization (as defined in section
1903(m)(1)(A) of such Act (42 U.S.C. 1396b(m)(1)(A))),
including prepaid inpatient health plans and prepaid
ambulatory health plans (as defined by the Secretary of
Health and Human Services).
(2) Individuals described.--An individual described in this
paragraph is an individual who is an Indian (as defined in
section 4 of the Indian Health Care Improvement Act (25
U.S.C. 1603)) or an Alaska Native.
(d) Exception for State Legislation.--In the case of a
State plan under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.), which the Secretary of Health and Human
Services determines requires State legislation in order for
the respective plan to meet one or more additional
requirements imposed by amendments made by this section, the
respective plan shall not be regarded as failing to comply
with the requirements of such title solely on the basis of
its failure to meet such an additional requirement before the
first day of the first calendar quarter beginning after the
close of the first regular session of the State legislature
that begins after the date of enactment of this Act. For
purposes of the previous sentence, in the case of a State
that has a 2-year legislative session, each year of the
session shall be considered to be a separate regular session
of the State legislature.
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.
(a) In General.--Section 1917(d)(4)(A) of the Social
Security Act (42 U.S.C. 1396p(d)(4)(A)) is amended by
inserting ``the individual,'' after ``for the benefit of such
individual by''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply to trusts established on or after the date of the
enactment of this Act.
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH
RESPECT TO EXPENDITURES UNDER MEDICAID FOR
AGENTS USED FOR COSMETIC PURPOSES OR HAIR
GROWTH.
(a) In General.--Section 1903(i)(21) of the Social Security
Act (42 U.S.C. 1396b(i)(21)) is amended by inserting
``section 1927(d)(2)(C) (relating to drugs when used for
cosmetic purposes or hair growth), except where medically
necessary, and'' after ``drugs described in''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply with respect to calendar quarters beginning on or
after the date of the enactment of this Act.
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH
FUND.
Section 4002(b) of the Patient Protection and Affordable
Care Act (42 U.S.C. 300u-11(b)) is amended--
(1) in paragraph (3), by striking ``$1,250,000,000'' and
inserting ``$900,000,000'';
(2) in paragraph (4), by striking ``$1,500,000,000'' and
inserting ``$1,000,000,000''; and
(3) by striking paragraph (5) and inserting the following:
``(5) for fiscal year 2022, $1,500,000,000;
``(6) for fiscal year 2023, $1,000,000,000;
``(7) for fiscal year 2024, $1,700,000,000; and
``(8) for fiscal year 2025 and each fiscal year thereafter,
$2,000,000,000.''.
SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.
(a) Drawdown and Sale.--
(1) In general.--Notwithstanding section 161 of the Energy
Policy and Conservation Act (42 U.S.C. 6241), except as
provided in subsections (b) and (c), the Secretary of Energy
shall drawdown and sell from the Strategic Petroleum
Reserve--
(A) 10,000,000 barrels of crude oil during fiscal year
2017;
(B) 9,000,000 barrels of crude oil during fiscal year 2018;
and
(C) 6,000,000 barrels of crude oil during fiscal year 2019.
(2) Deposit of amounts received from sale.--Amounts
received from a sale under paragraph (1) shall be deposited
in the general fund of the Treasury during the fiscal year in
which the sale occurs.
(b) Emergency Protection.--The Secretary shall not draw
down and sell crude oil under this section in quantities that
would limit the authority to sell petroleum products under
section 161(h) of the Energy Policy and Conservation Act (42
U.S.C. 6241(h)) in the full quantity authorized by that
subsection.
(c) Strategic Petroleum Drawdown Limitations.--
Subparagraphs (C) and (D) of section 161(h)(2) of the Energy
Policy and Conservation Act (42 U.S.C. 6241(h)(2)(C) and (D))
are both amended by striking ``500,000,000'' and inserting
``450,000,000''.
SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.
Of the unobligated amounts available under section
1323(c)(1) of the Patient Protection and Affordable Care Act
(42 U.S.C. 18043(c)(1)), $464,000,000 is rescinded
immediately upon the date of the enactment of this Act.
SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
(a) In General.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x) is amended--
(1) in subsection (s)(2)--
(A) by striking ``and'' at the end of subparagraph (EE);
(B) by inserting ``and'' at the end of subparagraph (FF);
and
(C) by inserting at the end the following new subparagraph:
``(GG) home infusion therapy (as defined in subsection
(iii)(1));''; and
(2) by adding at the end the following new subsection:
``(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.''.
(b) Payment and Related Requirements for Home Infusion
Therapy.--Section 1834 of the Social Security Act (42 U.S.C.
1395m), as amended by section 4011, is further amended by
adding at the end the following new subsection:
``(u) Payment and Related Requirements for Home Infusion
Therapy.--
``(1) Payment.--
``(A) Single payment.--
``(i) In general.--Subject to clause (iii) and
subparagraphs (B) and (C), the Secretary shall implement a
payment system under which a single payment is made under
this title to a qualified home infusion therapy supplier for
items and services described in subparagraphs (A) and (B) of
section 1861(iii)(2)) furnished by a qualified home infusion
therapy supplier (as defined in section 1861(iii)(3)(D)) in
coordination with the furnishing of home infusion drugs (as
defined in section 1861(iii)(3)(C)) under this part.
``(ii) Unit of single payment.--A unit of single payment
under the payment system implemented under this subparagraph
is for each infusion drug administration calendar day in the
individual's home. The Secretary shall, as appropriate,
establish single payment amounts for types of infusion
therapy, including to take into account variation in
utilization of nursing services by therapy type.
``(iii) Limitation.--The single payment amount determined
under this subparagraph
[[Page H6942]]
after application of subparagraph (B) and paragraph (3) shall
not exceed the amount determined under the fee schedule under
section 1848 for infusion therapy services furnished in a
calendar day if furnished in a physician office setting,
except such single payment shall not reflect more than 5
hours of infusion for a particular therapy in a calendar day.
``(B) Required adjustments.--The Secretary shall adjust the
single payment amount determined under subparagraph (A) for
home infusion therapy services under section 1861(iii)(1) to
reflect other factors such as--
``(i) a geographic wage index and other costs that may vary
by region; and
``(ii) patient acuity and complexity of drug
administration.
``(C) Discretionary adjustments.--
``(i) In general.--Subject to clause (ii), the Secretary
may adjust the single payment amount determined under
subparagraph (A) (after application of subparagraph (B)) to
reflect outlier situations and other factors as the Secretary
determines appropriate.
``(ii) Requirement of budget neutrality.--Any adjustment
under this subparagraph shall be made in a budget neutral
manner.
``(2) Considerations.--In developing the payment system
under this subsection, the Secretary may consider the costs
of furnishing infusion therapy in the home, consult with home
infusion therapy suppliers, consider payment amounts for
similar items and services under this part and part A, and
consider payment amounts established by Medicare Advantage
plans under part C and in the private insurance market for
home infusion therapy (including average per treatment day
payment amounts by type of home infusion therapy).
``(3) Annual updates.--
``(A) In general.--Subject to subparagraph (B), the
Secretary shall update the single payment amount under this
subsection from year to year beginning in 2022 by increasing
the single payment amount from the prior year by the
percentage increase in the Consumer Price Index for all urban
consumers (United States city average) for the 12-month
period ending with June of the preceding year.
``(B) Adjustment.--For each year, the Secretary shall
reduce the percentage increase described in subparagraph (A)
by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the preceding
sentence may result in a percentage being less than 0.0 for a
year, and may result in payment being less than such payment
rates for the preceding year.
``(4) Authority to apply prior authorization.--The
Secretary may, as determined appropriate by the Secretary,
apply prior authorization for home infusion therapy services
under section 1861(iii)(1).
``(5) Accreditation of qualified home infusion therapy
suppliers.--
``(A) Factors for designation of accreditation
organizations.--The Secretary shall consider the following
factors in designating accreditation organizations under
subparagraph (B) and in reviewing and modifying the list of
accreditation organizations designated pursuant to
subparagraph (C):
``(i) The ability of the organization to conduct timely
reviews of accreditation applications.
``(ii) The ability of the organization to take into account
the capacities of suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
``(iii) Whether the organization has established reasonable
fees to be charged to suppliers applying for accreditation.
``(iv) Such other factors as the Secretary determines
appropriate.
``(B) Designation.--Not later than January 1, 2021, the
Secretary shall designate organizations to accredit suppliers
furnishing home infusion therapy. The list of accreditation
organizations so designated may be modified pursuant to
subparagraph (C).
``(C) Review and modification of list of accreditation
organizations.--
``(i) In general.--The Secretary shall review the list of
accreditation organizations designated under subparagraph (B)
taking into account the factors under subparagraph (A).
Taking into account the results of such review, the Secretary
may, by regulation, modify the list of accreditation
organizations designated under subparagraph (B).
``(ii) Special rule for accreditations done prior to
removal from list of designated accreditation
organizations.--In the case where the Secretary removes an
organization from the list of accreditation organizations
designated under subparagraph (B), any supplier that is
accredited by the organization during the period beginning on
the date on which the organization is designated as an
accreditation organization under subparagraph (B) and ending
on the date on which the organization is removed from such
list shall be considered to have been accredited by an
organization designated by the Secretary under subparagraph
(B) for the remaining period such accreditation is in effect.
``(D) Rule for accreditations made prior to designation.--
In the case of a supplier that is accredited before January
1, 2021, by an accreditation organization designated by the
Secretary under subparagraph (B) as of January 1, 2019, such
supplier shall be considered to have been accredited by an
organization designated by the Secretary under such paragraph
as of January 1, 2023, for the remaining period such
accreditation is in effect.
``(6) Notification of infusion therapy options available
prior to furnishing home infusion therapy.--Prior to the
furnishing of home infusion therapy to an individual, the
physician who establishes the plan described in section
1861(iii)(1) for the individual shall provide notification
(in a form, manner, and frequency determined appropriate by
the Secretary) of the options available (such as home,
physician's office, hospital outpatient department) for the
furnishing of infusion therapy under this part.''.
(c) Conforming Amendments.--
(1) Payment reference.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and'' before ``(AA)''; and
(B) by inserting before the semicolon at the end the
following: ``, and (BB) with respect to home infusion
therapy, the amount paid shall be an amount equal to 80
percent of the lesser of the actual charge for the services
or the amount determined under section 1834(u)''.
(2) Direct payment.--The first sentence of section
1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6))
is amended--
(A) by striking ``and'' before ``(H)''; and
(B) by inserting before the period at the end the
following: ``, and (I) in the case of home infusion therapy,
payment shall be made to the qualified home infusion therapy
supplier''.
(3) Exclusion from home health services.--Section 1861(m)
of the Social Security Act (42 U.S.C. 1395x(m)) is amended,
in the first sentence, by inserting the following before the
period at the end: ``and home infusion therapy (as defined in
subsection (iii)(i))''.
(d) Effective Date.--The amendments made by this section
shall apply to items and services furnished on or after
January 1, 2021.
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
SEC. 6000. SHORT TITLE.
This division may be cited as the ``Helping Families in
Mental Health Crisis Reform Act of 2016''.
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A--Leadership
SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND
SUBSTANCE USE.
(a) Assistant Secretary.--Section 501(c) of the Public
Health Service Act (42 U.S.C. 290aa(c)) is amended to read as
follows:
``(c) Assistant Secretary and Deputy Assistant Secretary.--
``(1) Assistant secretary.--The Administration shall be
headed by an official to be known as the Assistant Secretary
for Mental Health and Substance Use (hereinafter in this
title referred to as the `Assistant Secretary') who shall be
appointed by the President, by and with the advice and
consent of the Senate.
``(2) Deputy assistant secretary.--The Assistant Secretary,
with the approval of the Secretary, may appoint a Deputy
Assistant Secretary and may employ and prescribe the
functions of such officers and employees, including
attorneys, as are necessary to administer the activities to
be carried out through the Administration.''.
(b) Transfer of Authorities.--The Secretary of Health and
Human Services shall delegate to the Assistant Secretary for
Mental Health and Substance Use all duties and authorities
that--
(1) as of the day before the date of enactment of this Act,
were vested in the Administrator of the Substance Abuse and
Mental Health Services Administration; and
(2) are not terminated by this Act.
(c) Conforming Amendments.--Title V of the Public Health
Service Act (42 U.S.C. 290aa et seq.), as amended by the
previous provisions of this section, is further amended--
(1) by striking ``Administrator of the Substance Abuse and
Mental Health Services Administration'' each place it appears
and inserting ``Assistant Secretary for Mental Health and
Substance Use''; and
(2) by striking ``Administrator'' or ``Administrator'' each
place it appears (including in any headings) and inserting
``Assistant Secretary'' or ``Assistant Secretary'',
respectively, except where the term ``Administrator''
appears--
(A) in each of subsections (e) and (f) of section 501 of
such Act (42 U.S.C. 290aa), including the headings of such
subsections, within the term ``Associate Administrator'';
(B) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ``Administrator of the Health
Resources and Services Administration'';
(C) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ``Administrator of the Centers
for Medicare & Medicaid Services'';
(D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 290bb-
25b(c)(1)(B)), within the term ``Administrator of the
National Highway Traffic Safety Administration''; or
(E) in each of sections 519B(c)(1)(B), 520C(a), and 520D(a)
of such Act (42 U.S.C. 290bb-25b(c)(1)(B), 290bb-34(a),
290bb-35(a)), within the term ``Administrator of the Office
of Juvenile Justice and Delinquency Prevention''.
(d) References.--After executing subsections (a), (b), and
(c), any reference in statute, regulation, or guidance to the
Administrator of the Substance Abuse and Mental Health
Services Administration shall be construed to be a reference
to the Assistant Secretary for Mental Health and Substance
Use.
SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE
ABUSE AND MENTAL HEALTH SERVICES
ADMINISTRATION.
Section 501 of the Public Health Service Act (42 U.S.C.
290aa), as amended by section 6001, is further amended--
(1) in subsection (b)--
(A) in the subsection heading, by striking ``Agencies'' and
inserting ``Centers''; and
[[Page H6943]]
(B) in the matter preceding paragraph (1), by striking
``entities'' and inserting ``Centers'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) by striking ``agencies'' each place the term appears
and inserting ``Centers''; and
(ii) by striking ``such agency'' and inserting ``such
Center'';
(B) in paragraph (2)--
(i) by striking ``agencies'' and inserting ``Centers'';
(ii) by striking ``with respect to substance abuse'' and
inserting ``with respect to substance use disorders''; and
(iii) by striking ``and individuals who are substance
abusers'' and inserting ``and individuals with substance use
disorders'';
(C) in paragraph (5), by striking ``substance abuse'' and
inserting ``substance use disorder'';
(D) in paragraph (6)--
(i) by striking ``the Centers for Disease Control'' and
inserting ``the Centers for Disease Control and
Prevention,'';
(ii) by striking ``Administration develop'' and inserting
``Administration, develop'';
(iii) by striking ``HIV or tuberculosis among substance
abusers and individuals with mental illness'' and inserting
``HIV, hepatitis, tuberculosis, and other communicable
diseases among individuals with mental or substance use
disorders,''; and
(iv) by striking ``illnesses'' at the end and inserting
``diseases or disorders'';
(E) in paragraph (7), by striking ``abuse utilizing anti-
addiction medications, including methadone'' and inserting
``use disorders, including services that utilize drugs or
devices approved or cleared by the Food and Drug
Administration for the treatment of substance use
disorders'';
(F) in paragraph (8)--
(i) by striking ``Agency for Health Care Policy Research''
and inserting ``Agency for Healthcare Research and Quality'';
and
(ii) by striking ``treatment and prevention'' and inserting
``prevention and treatment'';
(G) in paragraph (9)--
(i) by inserting ``and maintenance'' after ``development'';
(ii) by striking ``Agency for Health Care Policy Research''
and inserting ``Agency for Healthcare Research and Quality'';
and
(iii) by striking ``treatment and prevention services'' and
inserting ``prevention, treatment, and recovery support
services and are appropriately incorporated into programs
carried out by the Administration'';
(H) in paragraph (10), by striking ``abuse'' and inserting
``use disorder'';
(I) by striking paragraph (11) and inserting the following:
``(11) work with relevant agencies of the Department of
Health and Human Services on integrating mental health
promotion and substance use disorder prevention with general
health promotion and disease prevention and integrating
mental and substance use disorders treatment services with
physical health treatment services;'';
(J) in paragraph (13)--
(i) in the matter preceding subparagraph (A), by striking
``this title, assure that'' and inserting ``this title or
part B of title XIX, or grant programs otherwise funded by
the Administration'';
(ii) in subparagraph (A)--
(I) by inserting ``require that'' before ``all grants'';
and
(II) by striking ``and'' at the end;
(iii) by redesignating subparagraph (B) as subparagraph
(C);
(iv) by inserting after subparagraph (A) the following:
``(B) ensure that the director of each Center of the
Administration consistently documents the application of
criteria when awarding grants and the ongoing oversight of
grantees after such grants are awarded;'';
(v) in subparagraph (C), as so redesignated--
(I) by inserting ``require that'' before ``all grants'';
and
(II) in clause (ii), by inserting ``and'' after the
semicolon at the end; and
(vi) by adding at the end the following:
``(D) inform a State when any funds are awarded through
such a grant to any entity within such State;'';
(K) in paragraph (16), by striking ``abuse and mental
health information'' and inserting ``use disorder
information, including evidence-based and promising best
practices for prevention, treatment, and recovery support
services for individuals with mental and substance use
disorders,'';
(L) in paragraph (17)--
(i) by striking ``substance abuse'' and inserting
``substance use disorder''; and
(ii) by striking ``and'' at the end;
(M) in paragraph (18), by striking the period and inserting
a semicolon; and
(N) by adding at the end the following:
``(19) consult with State, local, and tribal governments,
nongovernmental entities, and individuals with mental
illness, particularly adults with a serious mental illness,
children with a serious emotional disturbance, and the family
members of such adults and children, with respect to
improving community-based and other mental health services;
``(20) collaborate with the Secretary of Defense and the
Secretary of Veterans Affairs to improve the provision of
mental and substance use disorder services provided by the
Department of Defense and the Department of Veterans Affairs
to members of the Armed Forces, veterans, and the family
members of such members and veterans, including through the
provision of services using the telehealth capabilities of
the Department of Defense and the Department of Veterans
Affairs;
``(21) collaborate with the heads of relevant Federal
agencies and departments, States, communities, and
nongovernmental experts to improve mental and substance use
disorders services for chronically homeless individuals,
including by designing strategies to provide such services in
supportive housing;
``(22) work with States and other stakeholders to develop
and support activities to recruit and retain a workforce
addressing mental and substance use disorders;
``(23) collaborate with the Attorney General and
representatives of the criminal justice system to improve
mental and substance use disorders services for individuals
who have been arrested or incarcerated;
``(24) after providing an opportunity for public input, set
standards for grant programs under this title for mental and
substance use disorders services and prevention programs,
which standards may address--
``(A) the capacity of the grantee to implement the award;
``(B) requirements for the description of the program
implementation approach;
``(C) the extent to which the grant plan submitted by the
grantee as part of its application must explain how the
grantee will reach the population of focus and provide a
statement of need, which may include information on how the
grantee will increase access to services and a description of
measurable objectives for improving outcomes;
``(D) the extent to which the grantee must collect and
report on required performance measures; and
``(E) the extent to which the grantee is proposing to use
evidence-based practices; and
``(25) advance, through existing programs, the use of
performance metrics, including those based on the
recommendations on performance metrics from the Assistant
Secretary for Planning and Evaluation under section 6021(d)
of the Helping Families in Mental Health Crisis Reform Act of
2016.''; and
(3) in subsection (m), by adding at the end the following:
``(4) Emergency response.--Amounts made available for
carrying out this subsection shall remain available through
the end of the fiscal year following the fiscal year for
which such amounts are appropriated.''.
SEC. 6003. CHIEF MEDICAL OFFICER.
Section 501 of the Public Health Service Act (42 U.S.C.
290aa), as amended by sections 6001 and 6002, is further
amended--
(1) by redesignating subsections (g) through (j) and
subsections (k) through (o) as subsections (h) through (k)
and subsections (m) through (q), respectively;
(2) in subsection (e)(3)(C), by striking ``subsection (k)''
and inserting ``subsection (m)'';
(3) in subsection (f)(2)(C)(iii), by striking ``subsection
(k)'' and inserting ``subsection (m)''; and
(4) by inserting after subsection (f) the following:
``(g) Chief Medical Officer.--
``(1) In general.--The Assistant Secretary, with the
approval of the Secretary, shall appoint a Chief Medical
Officer to serve within the Administration.
``(2) Eligible candidates.--The Assistant Secretary shall
select the Chief Medical Officer from among individuals who--
``(A) have a doctoral degree in medicine or osteopathic
medicine;
``(B) have experience in the provision of mental or
substance use disorder services;
``(C) have experience working with mental or substance use
disorder programs;
``(D) have an understanding of biological, psychosocial,
and pharmaceutical treatments of mental or substance use
disorders; and
``(E) are licensed to practice medicine in one or more
States.
``(3) Duties.--The Chief Medical Officer shall--
``(A) serve as a liaison between the Administration and
providers of mental and substance use disorders prevention,
treatment, and recovery services;
``(B) assist the Assistant Secretary in the evaluation,
organization, integration, and coordination of programs
operated by the Administration;
``(C) promote evidence-based and promising best practices,
including culturally and linguistically appropriate
practices, as appropriate, for the prevention and treatment
of, and recovery from, mental and substance use disorders,
including serious mental illness and serious emotional
disturbances;
``(D) participate in regular strategic planning with the
Administration;
``(E) coordinate with the Assistant Secretary for Planning
and Evaluation to assess the use of performance metrics to
evaluate activities within the Administration related to
mental and substance use disorders; and
``(F) coordinate with the Assistant Secretary to ensure
mental and substance use disorders grant programs within the
Administration consistently utilize appropriate performance
metrics and evaluation designs.''.
SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH
PROGRAMS.
Section 505 of the Public Health Service Act (42 U.S.C.
290aa-4), as amended by section 6001(c), is amended--
(1) by striking the section designation and heading and
inserting the following:
``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND
QUALITY.'';
(2) by redesignating subsections (a) through (d) as
subsections (b) through (e), respectively;
(3) before subsection (b), as redesignated by paragraph
(2), by inserting the following:
``(a) In General.--The Assistant Secretary shall maintain
within the Administration a Center for Behavioral Health
Statistics and Quality (in this section referred to as the
`Center'). The Center shall be headed by a Director (in this
section referred to as the `Director') appointed
[[Page H6944]]
by the Secretary from among individuals with extensive
experience and academic qualifications in research and
analysis in behavioral health care or related fields.'';
(4) in subsection (b), as redesignated by paragraph (2)--
(A) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(B) by striking ``The Secretary, acting'' and all that
follows through ``year on--'' and inserting ``The Director
shall--
``(1) coordinate the Administration's integrated data
strategy, including by collecting data each year on--'';
(C) in the subparagraph (B), as redesignated by
subparagraph (A), by striking ``Assistant Secretary'' and
inserting ``Director''; and
(D) by adding at the end the following new paragraphs:
``(2) provide statistical and analytical support for
activities of the Administration;
``(3) recommend a core set of performance metrics to
evaluate activities supported by the Administration; and
``(4) coordinate with the Assistant Secretary, the
Assistant Secretary for Planning and Evaluation, and the
Chief Medical Officer appointed under section 501(g), as
appropriate, to improve the quality of services provided by
programs of the Administration and the evaluation of
activities carried out by the Administration.''.
(5) in subsection (c), as so redesignated--
(A) by striking ``With respect to the activities'' and
inserting ``Mental Health.--With respect to the activities'';
(B) by striking ``Assistant Secretary'' each place it
appears and inserting ``Director''; and
(C) by striking ``subsection (a)'' and inserting
``subsection (b)(1)'';
(6) in subsection (d), as so redesignated--
(A) by striking the subsection designation and all that
follows through ``With respect to the activities'' and
inserting the following:
``(d) Substance Abuse.--
``(1) In general.--With respect to the activities'';
(B) in paragraph (1)--
(i) in the matter before subparagraph (A)--
(I) by striking ``subsection (a)'' and inserting
``subsection (b)(1)''; and
(II) by striking ``Assistant Secretary'' each place it
appears and inserting ``Director''; and
(ii) in subparagraph (B), by inserting ``in coordination
with the Centers for Disease Control and Prevention'' before
the semicolon at the end; and
(C) in paragraph (2), by striking ``Annual surveys'' and
inserting ``Annual surveys; public availability of data.--
Annual surveys''; and
(7) in subsection (e), as so redesignated--
(A) by striking ``After consultation'' and inserting
``Consultation.--After consultation''; and
(B) by striking ``Assistant Secretary shall develop'' and
inserting ``Assistant Secretary shall use existing standards
and best practices to develop''.
SEC. 6005. STRATEGIC PLAN.
Section 501 of the Public Health Service Act (42 U.S.C.
290aa), as amended by sections 6001 through 6003, is further
amended by inserting after subsection (k), as redesignated by
section 6003, the following:
``(l) Strategic Plan.--
``(1) In general.--Not later than September 30, 2018, and
every 4 years thereafter, the Assistant Secretary shall
develop and carry out a strategic plan in accordance with
this subsection for the planning and operation of activities
carried out by the Administration, including evidence-based
programs.
``(2) Coordination.--In developing and carrying out the
strategic plan under this subsection, the Assistant Secretary
shall take into consideration the findings and
recommendations of the Assistant Secretary for Planning and
Evaluation under section 6021(d) of the Helping Families in
Mental Health Crisis Reform Act of 2016 and the report of the
Interdepartmental Serious Mental Illness Coordinating
Committee under section 6031 of such Act.
``(3) Publication of plan.--Not later than September 30,
2018, and every 4 years thereafter, the Assistant Secretary
shall--
``(A) submit the strategic plan developed under paragraph
(1) to the Committee on Energy and Commerce and the Committee
on Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate; and
``(B) post such plan on the Internet website of the
Administration.
``(4) Contents.--The strategic plan developed under
paragraph (1) shall--
``(A) identify strategic priorities, goals, and measurable
objectives for mental and substance use disorders activities
and programs operated and supported by the Administration,
including priorities to prevent or eliminate the burden of
mental and substance use disorders;
``(B) identify ways to improve the quality of services for
individuals with mental and substance use disorders, and to
reduce homelessness, arrest, incarceration, violence,
including self-directed violence, and unnecessary
hospitalization of individuals with a mental or substance use
disorder, including adults with a serious mental illness or
children with a serious emotional disturbance;
``(C) ensure that programs provide, as appropriate, access
to effective and evidence-based prevention, diagnosis,
intervention, treatment, and recovery services, including
culturally and linguistically appropriate services, as
appropriate, for individuals with a mental or substance use
disorder;
``(D) identify opportunities to collaborate with the Health
Resources and Services Administration to develop or improve--
``(i) initiatives to encourage individuals to pursue
careers (especially in rural and underserved areas and with
rural and underserved populations) as psychiatrists,
including child and adolescent psychiatrists, psychologists,
psychiatric nurse practitioners, physician assistants,
clinical social workers, certified peer support specialists,
licensed professional counselors, or other licensed or
certified mental health or substance use disorder
professionals, including such professionals specializing in
the diagnosis, evaluation, or treatment of adults with a
serious mental illness or children with a serious emotional
disturbance; and
``(ii) a strategy to improve the recruitment, training, and
retention of a workforce for the treatment of individuals
with mental or substance use disorders, or co-occurring
disorders;
``(E) identify opportunities to improve collaboration with
States, local governments, communities, and Indian tribes and
tribal organizations (as such terms are defined in section 4
of the Indian Self-Determination and Education Assistance
Act); and
``(F) specify a strategy to disseminate evidence-based and
promising best practices related to prevention, diagnosis,
early intervention, treatment, and recovery services related
to mental illness, particularly for adults with a serious
mental illness and children with a serious emotional
disturbance, and for individuals with a substance use
disorder.''.
SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND
PROGRESS.
(a) In General.--Section 501 of the Public Health Service
Act (42 U.S.C. 290aa), as so amended, is further amended by
amending subsection (m), as redesignated by section 6003, to
read as follows:
``(m) Biennial Report Concerning Activities and Progress.--
Not later than September 30, 2020, and every 2 years
thereafter, the Assistant Secretary shall prepare and submit
to the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate, and post on the
Internet website of the Administration, a report containing
at a minimum--
``(1) a review of activities conducted or supported by the
Administration, including progress toward strategic
priorities, goals, and objectives identified in the strategic
plan developed under subsection (l);
``(2) an assessment of programs and activities carried out
by the Assistant Secretary, including the extent to which
programs and activities under this title and part B of title
XIX meet identified goals and performance measures developed
for the respective programs and activities;
``(3) a description of the progress made in addressing gaps
in mental and substance use disorders prevention, treatment,
and recovery services and improving outcomes by the
Administration, including with respect to serious mental
illnesses, serious emotional disturbances, and co-occurring
disorders;
``(4) a description of the manner in which the
Administration coordinates and partners with other Federal
agencies and departments related to mental and substance use
disorders, including activities related to--
``(A) the implementation and dissemination of research
findings into improved programs, including with respect to
how advances in serious mental illness and serious emotional
disturbance research have been incorporated into programs;
``(B) the recruitment, training, and retention of a mental
and substance use disorders workforce;
``(C) the integration of mental disorder services,
substance use disorder services, and physical health
services;
``(D) homelessness; and
``(E) veterans;
``(5) a description of the manner in which the
Administration promotes coordination by grantees under this
title, and part B of title XIX, with State or local agencies;
and
``(6) a description of the activities carried out under
section 501A(e), with respect to mental and substance use
disorders, including--
``(A) the number and a description of grants awarded;
``(B) the total amount of funding for grants awarded;
``(C) a description of the activities supported through
such grants, including outcomes of programs supported; and
``(D) information on how the National Mental Health and
Substance Use Policy Laboratory is consulting with the
Assistant Secretary for Planning and Evaluation and
collaborating with the Center for Substance Abuse Treatment,
the Center for Substance Abuse Prevention, the Center for
Behavioral Health Statistics and Quality, and the Center for
Mental Health Services to carry out such activities; and
``(7) recommendations made by the Assistant Secretary for
Planning and Evaluation under section 6021 of the Helping
Families in Mental Health Crisis Reform Act of 2016 to
improve programs within the Administration, and actions taken
in response to such recommendations to improve programs
within the Administration.
The Assistant Secretary may meet reporting requirements
established under this title by providing the contents of
such reports as an addendum to the biennial report
established under this subsection, notwithstanding the
timeline of other reporting requirements in this title.
Nothing in this subsection shall be construed to alter the
content requirements of such reports or authorize the
Assistant Secretary to alter the timeline of any such reports
to be less frequent than biennially, unless as specified in
this title.''.
(b) Conforming Amendment.--Section 508(p) of the Public
Health Service Act (42 U.S.C. 290bb-1(p)) is amended by
striking ``section 501(k)'' and inserting ``section 501(m)''.
[[Page H6945]]
SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES,
SUBSTANCE ABUSE PREVENTION, AND SUBSTANCE ABUSE
TREATMENT.
(a) Center for Mental Health Services.--Section 520(b) of
the Public Health Service Act (42 U.S.C. 290bb-31(b)) is
amended--
(1) by redesignating paragraphs (3) through (15) as
paragraphs (4) through (16), respectively;
(2) by inserting after paragraph (2) the following:
``(3) collaborate with the Director of the National
Institute of Mental Health and the Chief Medical Officer,
appointed under section 501(g), to ensure that, as
appropriate, programs related to the prevention and treatment
of mental illness and the promotion of mental health and
recovery support are carried out in a manner that reflects
the best available science and evidence-based practices,
including culturally and linguistically appropriate services,
as appropriate;'';
(3) in paragraph (5), as so redesignated, by inserting ``,
including through programs that reduce risk and promote
resiliency'' before the semicolon;
(4) in paragraph (6), as so redesignated, by inserting ``in
collaboration with the Director of the National Institute of
Mental Health,'' before ``develop'';
(5) in paragraph (8), as so redesignated, by inserting ``,
increase meaningful participation of individuals with mental
illness in programs and activities of the Administration,''
before ``and protect the legal'';
(6) in paragraph (10), as so redesignated, by striking
``professional and paraprofessional personnel pursuant to
section 303'' and inserting ``health paraprofessional
personnel and health professionals'';
(7) in paragraph (11), as so redesignated, by inserting
``and tele-mental health'' after ``rural mental health'';
(8) in paragraph (12), as so redesignated, by striking
``establish a clearinghouse for mental health information to
assure the widespread dissemination of such information'' and
inserting ``disseminate mental health information, including
evidence-based practices,'';
(9) in paragraph (15), as so redesignated, by striking
``and'' at the end;
(10) in paragraph (16), as so redesignated, by striking the
period and inserting ``; and''; and
(11) by adding at the end the following:
``(17) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded.''.
(b) Director of the Center for Substance Abuse
Prevention.--Section 515 of the Public Health Service Act (42
U.S.C. 290bb-21) is amended--
(1) in the section heading, by striking ``office'' and
inserting ``center'';
(2) in subsection (a)--
(A) by striking ``an Office'' and inserting ``a Center'';
and
(B) by striking ``The Office'' and inserting ``The
Prevention Center''; and
(3) in subsection (b)--
(A) in paragraph (1), by inserting ``through the reduction
of risk and the promotion of resiliency'' before the
semicolon;
(B) by redesignating paragraphs (3) through (11) as
paragraphs (4) through (12), respectively;
(C) by inserting after paragraph (2) the following:
``(3) collaborate with the Director of the National
Institute on Drug Abuse, the Director of the National
Institute on Alcohol Abuse and Alcoholism, and States to
promote the study of substance abuse prevention and the
dissemination and implementation of research findings that
will improve the delivery and effectiveness of substance
abuse prevention activities;'';
(D) in paragraph (4), as so redesignated, by striking
``literature on the adverse effects of cocaine free base
(known as crack)'' and inserting ``educational information on
the effects of drugs abused by individuals, including drugs
that are emerging as abused drugs'';
(E) in paragraph (6), as so redesignated--
(i) by striking ``substance abuse counselors'' and
inserting ``health professionals who provide substance use
and misuse prevention and treatment services''; and
(ii) by striking ``drug abuse education, prevention,'' and
inserting ``illicit drug use education and prevention'';
(F) by amending paragraph (7), as so redesignated, to read
as follows:
``(7) in cooperation with the Director of the Centers for
Disease Control and Prevention, develop and disseminate
educational materials to increase awareness for individuals
at greatest risk for substance use disorders to prevent the
transmission of communicable diseases, such as HIV,
hepatitis, tuberculosis, and other communicable diseases;'';
(G) in paragraph (9), as so redesignated--
(i) by striking ``to discourage'' and inserting ``that
reduce the risk of''; and
(ii) by inserting before the semicolon ``and promote
resiliency'';
(H) in paragraph (11), as so redesignated, by striking
``and'' after the semicolon;
(I) in paragraph (12), as so redesignated, by striking the
period and inserting a semicolon; and
(J) by adding at the end the following:
``(13) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded; and
``(14) assist and support States in preventing illicit drug
use, including emerging illicit drug use issues.''.
(c) Director of the Center for Substance Abuse Treatment.--
Section 507 of the Public Health Service Act (42 U.S.C.
290bb) is amended--
(1) in subsection (a)--
(A) by striking ``treatment of substance abuse'' and
inserting ``treatment of substance use disorders''; and
(B) by striking ``abuse treatment systems'' and inserting
``use disorder treatment systems''; and
(2) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and inserting
``use disorder'';
(B) in paragraph (3), by striking ``abuse'' and inserting
``use disorder'';
(C) in paragraph (4), by striking ``individuals who abuse
drugs'' and inserting ``individuals who illicitly use
drugs'';
(D) in paragraph (9), by striking ``carried out by the
Director'';
(E) by striking paragraph (10);
(F) by redesignating paragraphs (11) through (14) as
paragraphs (10) through (13), respectively;
(G) in paragraph (12), as so redesignated, by striking ``;
and'' and inserting a semicolon; and
(H) by striking paragraph (13), as so redesignated, and
inserting the following:
``(13) ensure the consistent documentation of the
application of criteria when awarding grants and the ongoing
oversight of grantees after such grants are awarded; and
``(14) work with States, providers, and individuals in
recovery, and their families, to promote the expansion of
recovery support services and systems of care oriented toward
recovery.''.
SEC. 6008. ADVISORY COUNCILS.
Section 502(b) of the Public Health Service Act (42 U.S.C.
290aa-1(b)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (E), by striking ``and'' after the
semicolon;
(B) by redesignating subparagraph (F) as subparagraph (J);
and
(C) by inserting after subparagraph (E), the following:
``(F) the Chief Medical Officer, appointed under section
501(g);
``(G) the Director of the National Institute of Mental
Health for the advisory councils appointed under subsections
(a)(1)(A) and (a)(1)(D);
``(H) the Director of the National Institute on Drug Abuse
for the advisory councils appointed under subsections
(a)(1)(A), (a)(1)(B), and (a)(1)(C);
``(I) the Director of the National Institute on Alcohol
Abuse and Alcoholism for the advisory councils appointed
under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and'';
and
(2) in paragraph (3), by adding at the end the following:
``(C) Not less than half of the members of the advisory
council appointed under subsection (a)(1)(D)--
``(i) shall--
``(I) have a medical degree;
``(II) have a doctoral degree in psychology; or
``(III) have an advanced degree in nursing or social work
from an accredited graduate school or be a certified
physician assistant; and
``(ii) shall specialize in the mental health field.
``(D) Not less than half of the members of the advisory
councils appointed under subsections (a)(1)(B) and
(a)(1)(C)--
``(i) shall--
``(I) have a medical degree;
``(II) have a doctoral degree; or
``(III) have an advanced degree in nursing, public health,
behavioral or social sciences, or social work from an
accredited graduate school or be a certified physician
assistant; and
``(ii) shall have experience in the provision of substance
use disorder services or the development and implementation
of programs to prevent substance misuse.''.
SEC. 6009. PEER REVIEW.
Section 504(b) of the Public Health Service Act (42 U.S.C.
290aa-3(b)) is amended by adding at the end the following:
``In the case of any such peer review group that is reviewing
a grant, cooperative agreement, or contract related to mental
illness treatment, not less than half of the members of such
peer review group shall be licensed and experienced
professionals in the prevention, diagnosis, or treatment of,
or recovery from, mental illness or co-occurring mental
illness and substance use disorders and have a medical
degree, a doctoral degree in psychology, or an advanced
degree in nursing or social work from an accredited program,
and the Secretary, in consultation with the Assistant
Secretary, shall, to the extent possible, ensure such peer
review groups include broad geographic representation,
including both urban and rural representatives.''.
Subtitle B--Oversight and Accountability
SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE
DISORDERS PROGRAMS THROUGH THE ASSISTANT
SECRETARY FOR PLANNING AND EVALUATION.
(a) In General.--The Secretary of Health and Human
Services, acting through the Assistant Secretary for Planning
and Evaluation, shall ensure efficient and effective planning
and evaluation of mental and substance use disorders
prevention and treatment programs and related activities.
(b) Evaluation Strategy.--In carrying out subsection (a),
the Assistant Secretary for Planning and Evaluation shall,
not later than 180 days after the date of enactment of this
Act, develop a strategy for conducting ongoing evaluations
that identifies priority programs to be evaluated by the
Assistant Secretary for Planning and Evaluation and priority
programs to be evaluated by other relevant offices and
agencies within the Department of Health and Human Services.
The strategy shall--
(1) include a plan for evaluating programs related to
mental and substance use disorders, including co-occurring
disorders, across agencies, as appropriate, including
programs related to--
[[Page H6946]]
(A) prevention, intervention, treatment, and recovery
support services, including such services for adults with a
serious mental illness or children with a serious emotional
disturbance;
(B) the reduction of homelessness and incarceration among
individuals with a mental or substance use disorder; and
(C) public health and health services; and
(2) include a plan for assessing the use of performance
metrics to evaluate activities carried out by entities
receiving grants, contracts, or cooperative agreements
related to mental and substance use disorders prevention and
treatment services under title V or title XIX of the Public
Health Service Act (42 U.S.C. 290aa et seq.; 42 U.S.C. 300w
et seq.).
(c) Consultation.--In carrying out this section, the
Assistant Secretary for Planning and Evaluation shall
consult, as appropriate, with the Assistant Secretary for
Mental Health and Substance Use, the Chief Medical Officer of
the Substance Abuse and Mental Health Services Administration
appointed under section 501(g) of the Public Health Service
Act (42 U.S.C. 290aa(g)), as amended by section 6003, the
Behavioral Health Coordinating Council of the Department of
Health and Human Services, other agencies within the
Department of Health and Human Services, and other relevant
Federal departments and agencies.
(d) Recommendations.--In carrying out this section, the
Assistant Secretary for Planning and Evaluation shall provide
recommendations to the Secretary of Health and Human
Services, the Assistant Secretary for Mental Health and
Substance Use, and the Congress on improving the quality of
prevention and treatment programs and activities related to
mental and substance use disorders, including recommendations
for the use of performance metrics. The Assistant Secretary
for Mental Health and Substance Use shall include such
recommendations in the biennial report required by subsection
501(m) of the Public Health Service Act, as redesignated by
section 6003 of this Act.
SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY
ORGANIZATIONS.
(a) Public Availability of Reports.--Section 105(a)(7) of
the Protection and Advocacy for Individuals with Mental
Illness Act (42 U.S.C. 10805(a)(7)) is amended by striking
``is located a report'' and inserting ``is located, and make
publicly available, a report''.
(b) Detailed Accounting.--Section 114(a) of the Protection
and Advocacy for Individuals with Mental Illness Act (42
U.S.C. 10824(a)) is amended--
(1) in paragraph (3), by striking ``and'' at the end;
(2) in paragraph (4), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(5) using data from the existing required annual program
progress reports submitted by each system funded under this
title, a detailed accounting for each such system of how
funds are spent, disaggregated according to whether the funds
were received from the Federal Government, the State
government, a local government, or a private entity.''.
SEC. 6023. GAO STUDY.
(a) In General.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United
States, in consultation with the Secretary of Health and
Human Services and the Assistant Secretary for Mental Health
and Substance Use, shall conduct an independent evaluation,
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, on programs
funded by allotments made under title I of the Protection and
Advocacy for Individuals with Mental Illness Act (42 U.S.C.
10801 et seq.).
(b) Contents.--The report and evaluation required under
subsection (a) shall include--
(1) a review of the programs described in such subsection
that are carried out by State agencies and such programs that
are carried out by private, nonprofit organizations; and
(2) a review of the compliance of the programs described in
subsection (a) with statutory and regulatory
responsibilities, such as--
(A) responsibilities relating to family engagement;
(B) responsibilities relating to the grievance procedure
for clients or prospective clients of the system to assure
that individuals with mental illness have full access to the
services of the system, for individuals who have received or
are receiving mental health services, and for family members
of such individuals with mental illness, or representatives
of such individuals or family members, to assure that the
eligible system is operating in compliance with the
provisions of the Protection and Advocacy for Individuals
with Mental Illness Act, as required to be established by
section 105(a)(9) of such Act (42 U.S.C. 10805(a)(9));
(C) investigation of alleged abuse and neglect of persons
with mental illness;
(D) availability of adequate medical and behavioral health
treatment;
(E) denial of rights for persons with mental illness; and
(F) compliance with the Federal prohibition on lobbying.
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS
COORDINATING COMMITTEE.
(a) Establishment.--
(1) In general.--Not later than 3 months after the date of
enactment of this Act, the Secretary of Health and Human
Services, or the designee of the Secretary, shall establish a
committee to be known as the Interdepartmental Serious Mental
Illness Coordinating Committee (in this section referred to
as the ``Committee'').
(2) Federal advisory committee act.--Except as provided in
this section, the provisions of the Federal Advisory
Committee Act (5 U.S.C. App.) shall apply to the Committee.
(b) Meetings.--The Committee shall meet not fewer than 2
times each year.
(c) Responsibilities.--Not later than 1 year after the date
of enactment of this Act, and 5 years after such date of
enactment, the Committee shall submit to Congress and any
other relevant Federal department or agency a report
including--
(1) a summary of advances in serious mental illness and
serious emotional disturbance research related to the
prevention of, diagnosis of, intervention in, and treatment
and recovery of serious mental illnesses, serious emotional
disturbances, and advances in access to services and support
for adults with a serious mental illness or children with a
serious emotional disturbance;
(2) an evaluation of the effect Federal programs related to
serious mental illness have on public health, including
public health outcomes such as--
(A) rates of suicide, suicide attempts, incidence and
prevalence of serious mental illnesses, serious emotional
disturbances, and substance use disorders, overdose, overdose
deaths, emergency hospitalizations, emergency room boarding,
preventable emergency room visits, interaction with the
criminal justice system, homelessness, and unemployment;
(B) increased rates of employment and enrollment in
educational and vocational programs;
(C) quality of mental and substance use disorders treatment
services; or
(D) any other criteria as may be determined by the
Secretary; and
(3) specific recommendations for actions that agencies can
take to better coordinate the administration of mental health
services for adults with a serious mental illness or children
with a serious emotional disturbance.
(d) Committee Extension.--Upon the submission of the second
report under subsection (c), the Secretary shall submit a
recommendation to Congress on whether to extend the operation
of the Committee.
(e) Membership.--
(1) Federal members.--The Committee shall be composed of
the following Federal representatives, or the designees of
such representatives--
(A) the Secretary of Health and Human Services, who shall
serve as the Chair of the Committee;
(B) the Assistant Secretary for Mental Health and Substance
Use;
(C) the Attorney General;
(D) the Secretary of Veterans Affairs;
(E) the Secretary of Defense;
(F) the Secretary of Housing and Urban Development;
(G) the Secretary of Education;
(H) the Secretary of Labor;
(I) the Administrator of the Centers for Medicare &
Medicaid Services; and
(J) the Commissioner of Social Security.
(2) Non-federal members.--The Committee shall also include
not less than 14 non-Federal public members appointed by the
Secretary of Health and Human Services, of which--
(A) at least 2 members shall be an individual who has
received treatment for a diagnosis of a serious mental
illness;
(B) at least 1 member shall be a parent or legal guardian
of an adult with a history of a serious mental illness or a
child with a history of a serious emotional disturbance;
(C) at least 1 member shall be a representative of a
leading research, advocacy, or service organization for
adults with a serious mental illness;
(D) at least 2 members shall be--
(i) a licensed psychiatrist with experience in treating
serious mental illnesses;
(ii) a licensed psychologist with experience in treating
serious mental illnesses or serious emotional disturbances;
(iii) a licensed clinical social worker with experience
treating serious mental illnesses or serious emotional
disturbances; or
(iv) a licensed psychiatric nurse, nurse practitioner, or
physician assistant with experience in treating serious
mental illnesses or serious emotional disturbances;
(E) at least 1 member shall be a licensed mental health
professional with a specialty in treating children and
adolescents with a serious emotional disturbance;
(F) at least 1 member shall be a mental health professional
who has research or clinical mental health experience in
working with minorities;
(G) at least 1 member shall be a mental health professional
who has research or clinical mental health experience in
working with medically underserved populations;
(H) at least 1 member shall be a State certified mental
health peer support specialist;
(I) at least 1 member shall be a judge with experience in
adjudicating cases related to criminal justice or serious
mental illness;
(J) at least 1 member shall be a law enforcement officer or
corrections officer with extensive experience in interfacing
with adults with a serious mental illness, children with a
serious emotional disturbance, or individuals in a mental
health crisis; and
(K) at least 1 member shall have experience providing
services for homeless individuals and working with adults
with a serious mental illness, children with a serious
emotional disturbance, or individuals in a mental health
crisis.
(3) Terms.--A member of the Committee appointed under
subsection (e)(2) shall serve for a term of 3 years, and may
be reappointed for 1 or more additional 3-year terms. Any
member appointed to fill a vacancy for an unexpired term
shall be appointed for the remainder of such term. A member
may serve after the expiration of the member's term until a
successor has been appointed.
(f) Working Groups.--In carrying out its functions, the
Committee may establish working
[[Page H6947]]
groups. Such working groups shall be composed of Committee
members, or their designees, and may hold such meetings as
are necessary.
(g) Sunset.--The Committee shall terminate on the date that
is 6 years after the date on which the Committee is
established under subsection (a)(1).
TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION,
TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED
PROGRAMS.
Title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by inserting after section 501 (42 U.S.C.
290aa) the following:
``SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY
LABORATORY.
``(a) In General.--There shall be established within the
Administration a National Mental Health and Substance Use
Policy Laboratory (referred to in this section as the
`Laboratory').
``(b) Responsibilities.--The Laboratory shall--
``(1) continue to carry out the authorities and activities
that were in effect for the Office of Policy, Planning, and
Innovation as such Office existed prior to the date of
enactment of the Helping Families in Mental Health Crisis
Reform Act of 2016;
``(2) identify, coordinate, and facilitate the
implementation of policy changes likely to have a significant
effect on mental health, mental illness, recovery supports,
and the prevention and treatment of substance use disorder
services;
``(3) work with the Center for Behavioral Health Statistics
and Quality to collect, as appropriate, information from
grantees under programs operated by the Administration in
order to evaluate and disseminate information on evidence-
based practices, including culturally and linguistically
appropriate services, as appropriate, and service delivery
models;
``(4) provide leadership in identifying and coordinating
policies and programs, including evidence-based programs,
related to mental and substance use disorders;
``(5) periodically review programs and activities operated
by the Administration relating to the diagnosis or prevention
of, treatment for, and recovery from, mental and substance
use disorders to--
``(A) identify any such programs or activities that are
duplicative;
``(B) identify any such programs or activities that are not
evidence-based, effective, or efficient; and
``(C) formulate recommendations for coordinating,
eliminating, or improving programs or activities identified
under subparagraph (A) or (B) and merging such programs or
activities into other successful programs or activities; and
``(6) carry out other activities as deemed necessary to
continue to encourage innovation and disseminate evidence-
based programs and practices.
``(c) Evidence-Based Practices and Service Delivery
Models.--
``(1) In general.--In carrying out subsection (b)(3), the
Laboratory--
``(A) may give preference to models that improve--
``(i) the coordination between mental health and physical
health providers;
``(ii) the coordination among such providers and the
justice and corrections system; and
``(iii) the cost effectiveness, quality, effectiveness, and
efficiency of health care services furnished to adults with a
serious mental illness, children with a serious emotional
disturbance, or individuals in a mental health crisis; and
``(B) may include clinical protocols and practices that
address the needs of individuals with early serious mental
illness.
``(2) Consultation.--In carrying out this section, the
Laboratory shall consult with--
``(A) the Chief Medical Officer appointed under section
501(g);
``(B) representatives of the National Institute of Mental
Health, the National Institute on Drug Abuse, and the
National Institute on Alcohol Abuse and Alcoholism, on an
ongoing basis;
``(C) other appropriate Federal agencies;
``(D) clinical and analytical experts with expertise in
psychiatric medical care and clinical psychological care,
health care management, education, corrections health care,
and mental health court systems, as appropriate; and
``(E) other individuals and agencies as determined
appropriate by the Assistant Secretary.
``(d) Deadline for Beginning Implementation.--The
Laboratory shall begin implementation of this section not
later than January 1, 2018.
``(e) Promoting Innovation.--
``(1) In general.--The Assistant Secretary, in coordination
with the Laboratory, may award grants to States, local
governments, Indian tribes or tribal organizations (as such
terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act), educational
institutions, and nonprofit organizations to develop
evidence-based interventions, including culturally and
linguistically appropriate services, as appropriate, for--
``(A) evaluating a model that has been scientifically
demonstrated to show promise, but would benefit from further
applied development, for--
``(i) enhancing the prevention, diagnosis, intervention,
and treatment of, and recovery from, mental illness, serious
emotional disturbances, substance use disorders, and co-
occurring illness or disorders; or
``(ii) integrating or coordinating physical health services
and mental and substance use disorders services; and
``(B) expanding, replicating, or scaling evidence-based
programs across a wider area to enhance effective screening,
early diagnosis, intervention, and treatment with respect to
mental illness, serious mental illness, serious emotional
disturbances, and substance use disorders, primarily by--
``(i) applying such evidence-based programs to the delivery
of care, including by training staff in effective evidence-
based treatments; or
``(ii) integrating such evidence-based programs into models
of care across specialties and jurisdictions.
``(2) Consultation.--In awarding grants under this
subsection, the Assistant Secretary shall, as appropriate,
consult with the Chief Medical Officer, appointed under
section 501(g), the advisory councils described in section
502, the National Institute of Mental Health, the National
Institute on Drug Abuse, and the National Institute on
Alcohol Abuse and Alcoholism, as appropriate.
``(3) Authorization of appropriations.--There are
authorized to be appropriated--
``(A) to carry out paragraph (1)(A), $7,000,000 for the
period of fiscal years 2018 through 2020; and
``(B) to carry out paragraph (1)(B), $7,000,000 for the
period of fiscal years 2018 through 2020.''.
SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED
PROGRAMS AND PRACTICES.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.) is amended by inserting after section
543 of such Act (42 U.S.C. 290dd-2) the following:
``SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-
BASED PROGRAMS AND PRACTICES.
``(a) In General.--The Assistant Secretary shall, as
appropriate, improve access to reliable and valid information
on evidence-based programs and practices, including
information on the strength of evidence associated with such
programs and practices, related to mental and substance use
disorders for States, local communities, nonprofit entities,
and other stakeholders, by posting on the Internet website of
the Administration information on evidence-based programs and
practices that have been reviewed by the Assistant Secretary
in accordance with the requirements of this section.
``(b) Applications.--
``(1) Application period.--In carrying out subsection (a),
the Assistant Secretary may establish a period for the
submission of applications for evidence-based programs and
practices to be posted publicly in accordance with subsection
(a).
``(2) Notice.--In establishing the application period under
paragraph (1), the Assistant Secretary shall provide for the
public notice of such application period in the Federal
Register. Such notice may solicit applications for evidence-
based programs and practices to address gaps in information
identified by the Assistant Secretary, the National Mental
Health and Substance Use Policy Laboratory established under
section 501A, or the Assistant Secretary for Planning and
Evaluation, including pursuant to the evaluation and
recommendations under section 6021 of the Helping Families in
Mental Health Crisis Reform Act of 2016 or priorities
identified in the strategic plan under section 501(l).
``(c) Requirements.--The Assistant Secretary may establish
minimum requirements for the applications submitted under
subsection (b), including applications related to the
submission of research and evaluation.
``(d) Review and Rating.--
``(1) In general.--The Assistant Secretary shall review
applications prior to public posting in accordance with
subsection (a), and may prioritize the review of applications
for evidence-based programs and practices that are related to
topics included in the notice provided under subsection
(b)(2).
``(2) System.--In carrying out paragraph (1), the Assistant
Secretary may utilize a rating and review system, which may
include information on the strength of evidence associated
with the evidence-based programs and practices and a rating
of the methodological rigor of the research supporting the
applications.
``(3) Public access to metrics and rating.--The Assistant
Secretary shall make the metrics used to evaluate
applications under this section, and any resulting ratings of
such applications, publicly available.''.
SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND
NATIONAL SIGNIFICANCE.
Section 520A of the Public Health Service Act (42 U.S.C.
290bb-32) is amended--
(1) in subsection (a)--
(A) in paragraph (4), by inserting before the period ``,
which may include technical assistance centers''; and
(B) in the flush sentence following paragraph (4)--
(i) by inserting ``, contracts,'' before ``or cooperative
agreements''; and
(ii) by striking ``Indian tribes and tribal organizations''
and inserting ``Indian tribes or tribal organizations (as
such terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act), health
facilities, or programs operated by or in accordance with a
contract or grant with the Indian Health Service, or''; and
(2) by amending subsection (f) to read as follows:
``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$394,550,000 for each of fiscal years 2018 through 2022.''.
SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
Section 509 of the Public Health Service Act (42 U.S.C.
290bb-2) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``abuse'' and inserting ``use disorder'';
[[Page H6948]]
(B) in paragraph (3), by inserting before the period ``that
permit States, local governments, communities, and Indian
tribes and tribal organizations (as the terms `Indian tribes'
and `tribal organizations' are defined in section 4 of the
Indian Self-Determination and Education Assistance Act) to
focus on emerging trends in substance abuse and co-occurrence
of substance use disorders with mental illness or other
conditions''; and
(C) in the flush sentence following paragraph (3)--
(i) by inserting ``, contracts,'' before ``or cooperative
agreements''; and
(ii) by striking ``Indian tribes and tribal
organizations,'' and inserting ``Indian tribes or tribal
organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act),
health facilities, or programs operated by or in accordance
with a contract or grant with the Indian Health Service,
or'';
(2) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and inserting
``use disorder''; and
(B) in paragraph (2), by striking ``abuse'' and inserting
``use disorder'';
(3) in subsection (e), by striking ``abuse'' and inserting
``use disorder''; and
(4) in subsection (f), by striking ``$300,000,000'' and all
that follows through the period and inserting ``$333,806,000
for each of fiscal years 2018 through 2022.''.
SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS
OF REGIONAL AND NATIONAL SIGNIFICANCE.
Section 516 of the Public Health Service Act (42 U.S.C.
290bb-22) is amended--
(1) in the section heading, by striking ``abuse'' and
inserting ``use disorder'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``abuse'' and inserting ``use disorder'';
(B) in paragraph (3), by inserting before the period ``,
including such programs that focus on emerging drug abuse
issues''; and
(C) in the flush sentence following paragraph (3)--
(i) by inserting ``, contracts,'' before ``or cooperative
agreements''; and
(ii) by striking ``Indian tribes and tribal
organizations,'' and inserting ``Indian tribes or tribal
organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act),
health facilities, or programs operated by or in accordance
with a contract or grant with the Indian Health Service,'';
(3) in subsection (b)--
(A) in paragraph (1), by striking ``abuse'' and inserting
``use disorder''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``; and'' at the end
and inserting ``;'';
(ii) in subparagraph (B)--
(I) by striking ``abuse'' and inserting ``use disorder'';
and
(II) by striking the period and inserting ``; and''; and
(iii) by adding at the end the following:
``(C) substance use disorder prevention among high-risk
groups.'';
(4) in subsection (e), by striking ``abuse'' and inserting
``use disorder''; and
(5) in subsection (f), by striking ``$300,000,000'' and all
that follows through the period and inserting ``$211,148,000
for each of fiscal years 2018 through 2022.''.
TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO
MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
(a) Formula Grants.--Section 1911(b) of the Public Health
Service Act (42 U.S.C. 300x(b)) is amended--
(1) by redesignating paragraphs (1) through (3) as
paragraphs (2) through (4), respectively; and
(2) by inserting before paragraph (2) (as so redesignated)
the following:
``(1) providing community mental health services for adults
with a serious mental illness and children with a serious
emotional disturbance as defined in accordance with section
1912(c);''.
(b) State Plan.--Section 1912(b) of the Public Health
Service Act (42 U.S.C. 300x-1(b)) is amended--
(1) in paragraph (3), by redesignating subparagraphs (A)
through (C) as clauses (i) through (iii), respectively, and
realigning the margins accordingly;
(2) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively, and realigning
the margins accordingly;
(3) in the matter preceding subparagraph (A) (as so
redesignated), by striking ``With respect to'' and all that
follows through ``are as follows:'' and inserting ``In
accordance with subsection (a), a State shall submit to the
Secretary a plan every two years that, at a minimum, includes
each of the following:'';
(4) by inserting before subparagraph (A) (as so
redesignated) the following:
``(1) System of care.--A description of the State's system
of care that contains the following:'';
(5) by striking subparagraph (A) (as so redesignated) and
inserting the following:
``(A) Comprehensive community-based health systems.--The
plan shall--
``(i) identify the single State agency to be responsible
for the administration of the program under the grant,
including any third party who administers mental health
services and is responsible for complying with the
requirements of this part with respect to the grant;
``(ii) provide for an organized community-based system of
care for individuals with mental illness, and describe
available services and resources in a comprehensive system of
care, including services for individuals with co-occurring
disorders;
``(iii) include a description of the manner in which the
State and local entities will coordinate services to maximize
the efficiency, effectiveness, quality, and cost-
effectiveness of services and programs to produce the best
possible outcomes (including health services, rehabilitation
services, employment services, housing services, educational
services, substance use disorder services, legal services,
law enforcement services, social services, child welfare
services, medical and dental care services, and other support
services to be provided with Federal, State, and local public
and private resources) with other agencies to enable
individuals receiving services to function outside of
inpatient or residential institutions, to the maximum extent
of their capabilities, including services to be provided by
local school systems under the Individuals with Disabilities
Education Act;
``(iv) include a description of how the State promotes
evidence-based practices, including those evidence-based
programs that address the needs of individuals with early
serious mental illness regardless of the age of the
individual at onset, provide comprehensive individualized
treatment, or integrate mental and physical health services;
``(v) include a description of case management services;
``(vi) include a description of activities that seek to
engage adults with a serious mental illness or children with
a serious emotional disturbance and their caregivers where
appropriate in making health care decisions, including
activities that enhance communication among individuals,
families, caregivers, and treatment providers; and
``(vii) as appropriate to, and reflective of, the uses the
State proposes for the block grant funds, include--
``(I) a description of the activities intended to reduce
hospitalizations and hospital stays using the block grant
funds;
``(II) a description of the activities intended to reduce
incidents of suicide using the block grant funds;
``(III) a description of how the State integrates mental
health and primary care using the block grant funds, which
may include providing, in the case of individuals with co-
occurring mental and substance use disorders, both mental and
substance use disorders services in primary care settings or
arrangements to provide primary and specialty care services
in community-based mental and substance use disorders
settings; and
``(IV) a description of recovery and recovery support
services for adults with a serious mental illness and
children with a serious emotional disturbance.'';
(6) in subparagraph (B) (as so redesignated)--
(A) by striking ``The plan contains'' and inserting ``The
plan shall contain''; and
(B) by striking ``presents quantitative targets to be
achieved in the implementation of the system described in
paragraph (1)'' and inserting ``present quantitative targets
and outcome measures for programs and services provided under
this subpart'';
(7) in subparagraph (C) (as so redesignated)--
(A) by striking ``serious emotional disturbance'' in the
matter preceding clause (i) (as so redesignated) and all that
follows through ``substance abuse services'' in clause (i)
(as so redesignated) and inserting the following: ``a serious
emotional disturbance (as defined pursuant to subsection
(c)), the plan shall provide for a system of integrated
social services, educational services, child welfare
services, juvenile justice services, law enforcement
services, and substance use disorder services'';
(B) by striking ``Education Act);'' and inserting
``Education Act).''; and
(C) by striking clauses (ii) and (iii) (as so
redesignated);
(8) in subparagraph (D) (as so redesignated), by striking
``plan describes'' and inserting ``plan shall describe'';
(9) in subparagraph (E) (as so redesignated)--
(A) in the subparagraph heading by striking ``systems'' and
inserting ``services'';
(B) in the first sentence, by striking ``plan describes''
and all that follows through ``and provides for'' and
inserting ``plan shall describe the financial resources
available, the existing mental health workforce, and the
workforce trained in treating individuals with co-occurring
mental and substance use disorders, and shall provide for'';
and
(C) in the second sentence--
(i) by striking ``further describes'' and inserting ``shall
further describe''; and
(ii) by striking ``involved.'' and inserting ``involved,
and the manner in which the State intends to comply with each
of the funding agreements in this subpart and subpart III.'';
(10) by striking the flush matter at the end; and
(11) by adding at the end the following:
``(2) Goals and objectives.--The establishment of goals and
objectives for the period of the plan, including targets and
milestones that are intended to be met, and the activities
that will be undertaken to achieve those targets.''.
(c) Early Serious Mental Illness.--Section 1920 of the
Public Health Service Act (42 U.S.C. 300x-9) is amended by
adding at the end the following:
``(c) Early Serious Mental Illness.--
``(1) In general.--Except as provided in paragraph (2), a
State shall expend not less than 10 percent of the amount the
State receives for carrying out this section for each fiscal
year to support evidence-based programs that address the
needs of individuals with early serious mental illness,
including psychotic disorders, regardless of the age of the
individual at onset.
``(2) State flexibility.--In lieu of expending 10 percent
of the amount the State receives
[[Page H6949]]
under this section for a fiscal year as required under
paragraph (1), a State may elect to expend not less than 20
percent of such amount by the end of such succeeding fiscal
year.''.
(d) Additional Provisions.--Section 1915(b) of the Public
Health Service Act (42 U.S.C. 300x-4(b)) is amended--
(1) in paragraph (3)--
(A) by striking ``The Secretary'' and inserting the
following:
``(A) In general.--The Secretary'';
(B) by striking ``paragraph (1) if'' and inserting
``paragraph (1) in whole or in part if'';
(C) by striking ``State justify the waiver.'' and inserting
``State in the fiscal year involved or in the previous fiscal
year justify the waiver''; and
(D) by adding at the end the following:
``(B) Date certain for action upon request.--The Secretary
shall approve or deny a request for a waiver under this
paragraph not later than 120 days after the date on which the
request is made.
``(C) Applicability of waiver.--A waiver provided by the
Secretary under this paragraph shall be applicable only to
the fiscal year involved.''; and
(2) in paragraph (4)--
(A) in subparagraph (A)--
(i) by inserting after the subparagraph designation the
following: ``In general.--'';
(ii) by striking ``In making a grant'' and inserting the
following:
``(i) Determination.--In making a grant''; and
(iii) by inserting at the end the following:
``(ii) Alternative.--A State that has failed to comply with
paragraph (1) and would otherwise be subject to a reduction
in the State's allotment under section 1911 may, upon request
by the State, in lieu of having the amount of the allotment
under section 1911 for the State reduced for the fiscal year
of the grant, agree to comply with a negotiated agreement
that is approved by the Secretary and carried out in
accordance with guidelines issued by the Secretary. If a
State fails to enter into or comply with a negotiated
agreement, the Secretary may take action under this paragraph
or the terms of the negotiated agreement.''; and
(B) in subparagraph (B)--
(i) by inserting after the subparagraph designation the
following: ``Submission of information to the secretary.--'';
and
(ii) by striking ``subparagraph (A)'' and inserting
``subparagraph (A)(i)''.
(e) Application for Grant.--Section 1917(a) of the Public
Health Service Act (42 U.S.C. 300x-6(a)) is amended--
(1) in paragraph (1), by striking ``1941'' and inserting
``1942(a)''; and
(2) in paragraph (5), by striking ``1915(b)(3)(B)'' and
inserting ``1915(b)''.
(f) Funding.--Section 1920 of the Public Health Service Act
(42 U.S.C. 300x-9) is amended--
(1) in subsection (a)--
(A) by striking ``section 505'' and inserting ``section
505(c)''; and
(B) by striking ``$450,000,000'' and all that follows
through the period and inserting ``$532,571,000 for each of
fiscal years 2018 through 2022.''; and
(2) in subsection (b)(2) by striking ``sections 505 and''
and inserting ``sections 505(c) and''.
SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK
GRANT.
(a) Formula Grants.--Section 1921(b) of the Public Health
Service Act (42 U.S.C. 300x-21(b)) is amended--
(1) by inserting ``carrying out the plan developed in
accordance with section 1932(b) and for'' after ``for the
purpose of''; and
(2) by striking ``abuse'' and inserting ``use disorders''.
(b) Outreach to Persons Who Inject Drugs.--Section 1923(b)
of the Public Health Service Act (42 U.S.C. 300x-23(b)) is
amended--
(1) in the subsection heading, by striking ``Regarding
Intravenous Substance Abuse'' and inserting ``to Persons Who
Inject Drugs''; and
(2) by striking ``for intravenous drug abuse'' and
inserting ``for persons who inject drugs''.
(c) Requirements Regarding Tuberculosis and Human
Immunodeficiency Virus.--Section 1924 of the Public Health
Service Act (42 U.S.C. 300x-24) is amended--
(1) in subsection (a)(1)--
(A) in the matter preceding subparagraph (A), by striking
``substance abuse'' and inserting ``substance use
disorders''; and
(B) in subparagraph (A), by striking ``such abuse'' and
inserting ``such disorders'';
(2) in subsection (b)--
(A) in paragraph (1)(A), by striking ``substance abuse''
and inserting ``substance use disorders'';
(B) in paragraph (2), by inserting ``and Prevention'' after
``Disease Control'';
(C) in paragraph (3)--
(i) in the paragraph heading, by striking ``abuse'' and
inserting ``use disorders''; and
(ii) by striking ``substance abuse'' and inserting
``substance use disorders''; and
(D) in paragraph (6)(B), by striking ``substance abuse''
and inserting ``substance use disorders'';
(3) by striking subsection (d); and
(4) by redesignating subsection (e) as subsection (d).
(d) Group Homes.--Section 1925 of the Public Health Service
Act (42 U.S.C. 300x-25) is amended--
(1) in the section heading, by striking ``recovering
substance abusers'' and inserting ``persons in recovery from
substance use disorders''; and
(2) in subsection (a), in the matter preceding paragraph
(1), by striking ``recovering substance abusers'' and
inserting ``persons in recovery from substance use
disorders''.
(e) Additional Agreements.--Section 1928 of the Public
Health Service Act (42 U.S.C. 300x-28) is amended--
(1) in subsection (a), by striking ``(relative to fiscal
year 1992)'';
(2) by striking subsection (b) and inserting the following:
``(b) Professional Development.--A funding agreement for a
grant under section 1921 is that the State involved will
ensure that prevention, treatment, and recovery personnel
operating in the State's substance use disorder prevention,
treatment, and recovery systems have an opportunity to
receive training, on an ongoing basis, concerning--
``(1) recent trends in substance use disorders in the
State;
``(2) improved methods and evidence-based practices for
providing substance use disorder prevention and treatment
services;
``(3) performance-based accountability;
``(4) data collection and reporting requirements; and
``(5) any other matters that would serve to further improve
the delivery of substance use disorder prevention and
treatment services within the State.''; and
(3) in subsection (d)(1), by striking ``substance abuse''
and inserting ``substance use disorders''.
(f) Repeal.--Section 1929 of the Public Health Service Act
(42 U.S.C. 300x-29) is repealed.
(g) Maintenance of Effort.--Section 1930 of the Public
Health Service Act (42 U.S.C. 300x-30) is amended--
(1) in subsection (c)(1), by striking ``in the State
justify the waiver'' and inserting ``exist in the State, or
any part of the State, to justify the waiver''; and
(2) in subsection (d), by inserting at the end the
following:
``(3) Alternative.--A State that has failed to comply with
this section and would otherwise be subject to a reduction in
the State's allotment under section 1921, may, upon request
by the State, in lieu of having the State's allotment under
section 1921 reduced, agree to comply with a negotiated
agreement that is approved by the Secretary and carried out
in accordance with guidelines issued by the Secretary. If a
State fails to enter into or comply with a negotiated
agreement, the Secretary may take action under this paragraph
or the terms of the negotiated agreement.''.
(h) Restrictions on Expenditures.--Section 1931(b)(1) of
the Public Health Service Act (42 U.S.C. 300x-31(b)(1)) is
amended by striking ``substance abuse'' and inserting
``substance use disorders''.
(i) Application.--Section 1932 of the Public Health Service
Act (42 U.S.C. 300x-32) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``subsections (c) and (d)(2)'' and inserting ``subsection
(c)''; and
(B) in paragraph (5), by striking ``the information
required in section 1929, the information required in section
1930(c)(2), and'';
(2) in subsection (b)--
(A) by striking paragraph (1) and inserting the following:
``(1) In general.--In order for a State to be in compliance
with subsection (a)(6), the State shall submit to the
Secretary a plan that, at a minimum, includes the following:
``(A) A description of the State's system of care that--
``(i) identifies the single State agency responsible for
the administration of the program, including any third party
who administers substance use disorder services and is
responsible for complying with the requirements of the grant;
``(ii) provides information on the need for substance use
disorder prevention and treatment services in the State,
including estimates on the number of individuals who need
treatment, who are pregnant women, women with dependent
children, individuals with a co-occurring mental health and
substance use disorder, persons who inject drugs, and persons
who are experiencing homelessness;
``(iii) provides aggregate information on the number of
individuals in treatment within the State, including the
number of such individuals who are pregnant women, women with
dependent children, individuals with a co-occurring mental
health and substance use disorder, persons who inject drugs,
and persons who are experiencing homelessness;
``(iv) provides a description of the system that is
available to provide services by modality, including the
provision of recovery support services;
``(v) provides a description of the State's comprehensive
statewide prevention efforts, including the number of
individuals being served in the system, target populations,
and priority needs, and provides a description of the amount
of funds from the prevention set-aside expended on primary
prevention;
``(vi) provides a description of the financial resources
available;
``(vii) describes the existing substance use disorders
workforce and workforce trained in treating co-occurring
substance use and mental disorders;
``(viii) includes a description of how the State promotes
evidence-based practices; and
``(ix) describes how the State integrates substance use
disorder services and primary health care, which in the case
of those individuals with co-occurring mental health and
substance use disorders may include providing both mental
health and substance use disorder services in primary care
settings or providing primary and specialty care services in
community-based mental health and substance use disorder
service settings.
``(B) The establishment of goals and objectives for the
period of the plan, including targets and milestones that are
intended to be met, and the activities that will be
undertaken to achieve those targets.
[[Page H6950]]
``(C) A description of how the State will comply with each
funding agreement for a grant under section 1921 that is
applicable to the State, including a description of the
manner in which the State intends to expend grant funds.'';
and
(B) in paragraph (2)--
(i) in the paragraph heading, by striking ``authority of
secretary regarding modifications'' and inserting
``modifications'';
(ii) by striking ``As a condition'' and inserting the
following:
``(A) Authority of secretary.--As a condition;''; and
(iii) by adding at the end the following:
``(B) State request for modification.--If the State
determines that a modification to such plan is necessary, the
State may request the Secretary to approve the modification.
Any such modification shall be in accordance with paragraph
(1) and section 1941.''; and
(C) in paragraph (3), by inserting, ``, including any
modification under paragraph (2)'' after ``subsection
(a)(6)''; and
(3) in subsection (e)(2), by striking ``section 1922(c)''
and inserting ``section 1922(b)''.
(j) Definitions.--Section 1934 of the Public Health Service
Act (42 U.S.C. 300x-34) is amended--
(1) in paragraph (3), by striking ``substance abuse'' and
inserting ``substance use disorders''; and
(2) in paragraph (7), by striking ``substance abuse'' and
inserting ``substance use disorders''.
(k) Funding.--Section 1935 of the Public Health Service Act
(42 U.S.C. 300x-35) is amended--
(1) in subsection (a)--
(A) by striking ``section 505'' and inserting ``section
505(d)''; and
(B) by striking ``$2,000,000,000 for fiscal year 2001, and
such sums as may be necessary for each of the fiscal years
2002 and 2003'' and inserting ``$1,858,079,000 for each of
fiscal years 2018 through 2022.''; and
(2) in subsection (b)(1)(B) by striking ``sections 505
and'' and inserting ``sections 505(d) and''.
SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
Subpart III of part B of title XIX of the Public Health
Service Act (42 U.S.C. 300x-51 et seq.) is amended--
(1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by
striking ``section 505'' and inserting ``subsections (c) and
(d) of section 505'';
(2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking
``substance abuse'' and inserting ``substance use disorder'';
and
(3) by adding at the end the following:
``SEC. 1957. PUBLIC HEALTH EMERGENCIES.
``In the case of a public health emergency (as determined
under section 319), the Secretary, on a State by State basis,
may, as the circumstances of the emergency reasonably require
and for the period of the emergency, grant an extension, or
waive application deadlines or compliance with any other
requirement, of a grant authorized under section 521, 1911,
or 1921 or an allotment authorized under Public Law 99-319
(42 U.S.C. 10801 et seq.).
``SEC. 1958. JOINT APPLICATIONS.
``The Secretary, acting through the Assistant Secretary for
Mental Health and Substance Use, shall permit a joint
application to be submitted for grants under subpart I and
subpart II upon the request of a State. Such application may
be jointly reviewed and approved by the Secretary with
respect to such subparts, consistent with the purposes and
authorized activities of each such grant program. A State
submitting such a joint application shall otherwise meet the
requirements with respect to each such subpart.''.
SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE
ABUSE PREVENTION AND TREATMENT BLOCK GRANT AND
THE COMMUNITY MENTAL HEALTH SERVICES BLOCK
GRANT.
(a) In General.--The Secretary of Health and Human
Services, acting through the Assistant Secretary for Mental
Health and Substance Use, shall through a grant or contract,
or through an agreement with a third party, conduct a study
on the formulas for distribution of funds under the substance
abuse prevention and treatment block grant, and the community
mental health services block grant, under part B of title XIX
of the Public Health Service Act (42 U.S.C. 300x et seq.) and
recommend changes if necessary. Such study shall include--
(1) an analysis of whether the distributions under such
block grants accurately reflect the need for the services
under the grants in the States;
(2) an examination of whether the indices used under the
formulas for distribution of funds under such block grants
are appropriate, and if not, alternatives recommended by the
Secretary;
(3) where recommendations are included under paragraph (2)
for the use of different indices, a description of the
variables and data sources that should be used to determine
the indices;
(4) an evaluation of the variables and data sources that
are being used for each of the indices involved, and whether
such variables and data sources accurately represent the need
for services, the cost of providing services, and the ability
of the States to pay for such services;
(5) the effect that the minimum allotment requirements for
each such block grant have on each State's final allotment
and the effect of such requirements, if any, on each State's
formula-based allotment;
(6) recommendations for modifications to the minimum
allotment provisions to ensure an appropriate distribution of
funds; and
(7) any other information that the Secretary determines
appropriate.
(b) Report.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
containing the findings and recommendations of the study
conducted under subsection (a) and the study conducted under
section 9004(g).
TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
CARE
Subtitle A--Helping Individuals and Families
SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
INDIVIDUALS.
Section 506 of the Public Health Service Act (42 U.S.C.
290aa-5) is amended--
(1) in subsection (a), by striking ``substance abuse'' and
inserting ``substance use disorder'';
(2) in subsection (b)--
(A) in paragraphs (1) and (3), by striking ``substance
abuse'' each place the term appears and inserting ``substance
use disorder''; and
(B) in paragraph (4), by striking ``substance abuse'' and
inserting ``a substance use disorder'';
(3) in subsection (c)--
(A) in paragraph (1), by striking ``substance abuse
disorder'' and inserting ``substance use disorder''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``substance abuse''
and inserting ``a substance use disorder''; and
(ii) in subparagraph (B), by striking ``substance abuse''
and inserting ``substance use disorder''; and
(4) in subsection (e), by striking ``, $50,000,000 for
fiscal year 2001, and such sums as may be necessary for each
of the fiscal years 2002 and 2003'' and inserting
``$41,304,000 for each of fiscal years 2018 through 2022''.
SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
Section 520G of the Public Health Service Act (42 U.S.C.
290bb-38) is amended--
(1) by striking ``substance abuse'' each place such term
appears and inserting ``substance use disorder'';
(2) in subsection (a)--
(A) by striking ``Indian tribes, and tribal organizations''
and inserting ``and Indian tribes and tribal organizations
(as the terms `Indian tribes' and `tribal organizations' are
defined in section 4 of the Indian Self-Determination and
Education Assistance Act)''; and
(B) by inserting ``or a health facility or program operated
by or in accordance with a contract or grant with the Indian
Health Service,'' after ``entities,'';
(3) in subsection (c)(2)(A)(i), by striking ``the best
known'' and inserting ``evidence-based'';
(4) by redesignating subsections (d) through (i) as
subsections (e) through (j), respectively;
(5) by inserting after subsection (c) the following:
``(d) Special Consideration Regarding Veterans.--In
awarding grants under subsection (a), the Secretary shall, as
appropriate, give special consideration to entities proposing
to use grant funding to support jail diversion services for
veterans.'';
(6) in subsection (e), as so redesignated--
(A) in paragraph (3), by striking ``; and'' and inserting a
semicolon;
(B) in paragraph (4), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(5) develop programs to divert individuals prior to
booking or arrest.''; and
(7) in subsection (j), as so redesignated, by striking
``$10,000,000 for fiscal year 2001, and such sums as may be
necessary for fiscal years 2002 through 2003'' and inserting
``$4,269,000 for each of fiscal years 2018 through 2022''.
SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL
HEALTH CARE.
Section 520K of the Public Health Service Act (42 U.S.C.
290bb-42) is amended to read as follows:
``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
AGREEMENTS.
``(a) Definitions.--In this section:
``(1) Eligible entity.--The term `eligible entity' means a
State, or other appropriate State agency, in collaboration
with 1 or more qualified community programs as described in
section 1913(b)(1) or 1 or more community health centers as
described in section 330.
``(2) Integrated care.--The term `integrated care' means
collaborative models or practices offering mental and
physical health services, which may include practices that
share the same space in the same facility.
``(3) Special population.--The term `special population'
means--
``(A) adults with a mental illness who have co-occurring
physical health conditions or chronic diseases;
``(B) adults with a serious mental illness who have co-
occurring physical health conditions or chronic diseases;
``(C) children and adolescents with a serious emotional
disturbance with co-occurring physical health conditions or
chronic diseases; or
``(D) individuals with a substance use disorder.
``(b) Grants and Cooperative Agreements.--
``(1) In general.--The Secretary may award grants and
cooperative agreements to eligible entities to support the
improvement of integrated care for primary care and
behavioral health care in accordance with paragraph (2).
``(2) Purposes.--A grant or cooperative agreement awarded
under this section shall be designed to--
[[Page H6951]]
``(A) promote full integration and collaboration in
clinical practices between primary and behavioral health
care;
``(B) support the improvement of integrated care models for
primary care and behavioral health care to improve the
overall wellness and physical health status of adults with a
serious mental illness or children with a serious emotional
disturbance; and
``(C) promote integrated care services related to
screening, diagnosis, prevention, and treatment of mental and
substance use disorders, and co-occurring physical health
conditions and chronic diseases.
``(c) Applications.--
``(1) In general.--An eligible entity seeking a grant or
cooperative agreement under this section shall submit an
application to the Secretary at such time, in such manner,
and accompanied by such information as the Secretary may
require, including the contents described in paragraph (2).
``(2) Contents.--The contents described in this paragraph
are--
``(A) a description of a plan to achieve fully
collaborative agreements to provide services to special
populations;
``(B) a document that summarizes the policies, if any, that
serve as barriers to the provision of integrated care, and
the specific steps, if applicable, that will be taken to
address such barriers;
``(C) a description of partnerships or other arrangements
with local health care providers to provide services to
special populations;
``(D) an agreement and plan to report to the Secretary
performance measures necessary to evaluate patient outcomes
and facilitate evaluations across participating projects; and
``(E) a plan for sustainability beyond the grant or
cooperative agreement period under subsection (e).
``(d) Grant and Cooperative Agreement Amounts.--
``(1) Target amount.--The target amount that an eligible
entity may receive for a year through a grant or cooperative
agreement under this section shall be $2,000,000.
``(2) Adjustment permitted.--The Secretary, taking into
consideration the quality of the application and the number
of eligible entities that received grants under this section
prior to the date of enactment of the Helping Families in
Mental Health Crisis Reform Act of 2016, may adjust the
target amount that an eligible entity may receive for a year
through a grant or cooperative agreement under this section.
``(3) Limitation.--An eligible entity receiving funding
under this section may not allocate more than 10 percent of
funds awarded under this section to administrative functions,
and the remaining amounts shall be allocated to health
facilities that provide integrated care.
``(e) Duration.--A grant or cooperative agreement under
this section shall be for a period not to exceed 5 years.
``(f) Report on Program Outcomes.--An eligible entity
receiving a grant or cooperative agreement under this section
shall submit an annual report to the Secretary that
includes--
``(1) the progress made to reduce barriers to integrated
care as described in the entity's application under
subsection (c); and
``(2) a description of functional outcomes of special
populations, including--
``(A) with respect to adults with a serious mental illness,
participation in supportive housing or independent living
programs, attendance in social and rehabilitative programs,
participation in job training opportunities, satisfactory
performance in work settings, attendance at scheduled medical
and mental health appointments, and compliance with
prescribed medication regimes;
``(B) with respect to individuals with co-occurring mental
illness and physical health conditions and chronic diseases,
attendance at scheduled medical and mental health
appointments, compliance with prescribed medication regimes,
and participation in learning opportunities related to
improved health and lifestyle practices; and
``(C) with respect to children and adolescents with a
serious emotional disturbance who have co-occurring physical
health conditions and chronic diseases, attendance at
scheduled medical and mental health appointments, compliance
with prescribed medication regimes, and participation in
learning opportunities at school and extracurricular
activities.
``(g) Technical Assistance for Primary-Behavioral Health
Care Integration.--
``(1) In general.--The Secretary may provide appropriate
information, training, and technical assistance to eligible
entities that receive a grant or cooperative agreement under
this section, in order to help such entities meet the
requirements of this section, including assistance with--
``(A) development and selection of integrated care models;
``(B) dissemination of evidence-based interventions in
integrated care;
``(C) establishment of organizational practices to support
operational and administrative success; and
``(D) other activities, as the Secretary determines
appropriate.
``(2) Additional dissemination of technical information.--
The information and resources provided by the Secretary under
paragraph (1) shall, as appropriate, be made available to
States, political subdivisions of States, Indian tribes or
tribal organizations (as defined in section 4 of the Indian
Self-Determination and Education Assistance Act), outpatient
mental health and addiction treatment centers, community
mental health centers that meet the criteria under section
1913(c), certified community behavioral health clinics
described in section 223 of the Protecting Access to Medicare
Act of 2014, primary care organizations such as Federally
qualified health centers or rural health clinics as defined
in section 1861(aa) of the Social Security Act, other
community-based organizations, or other entities engaging in
integrated care activities, as the Secretary determines
appropriate.
``(h) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $51,878,000
for each of fiscal years 2018 through 2022.''.
SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM
HOMELESSNESS.
(a) Formula Grants to States.--Section 521 of the Public
Health Service Act (42 U.S.C. 290cc-21) is amended by
striking ``1991 through 1994'' and inserting ``2018 through
2022''.
(b) Purpose of Grants.--Section 522 of the Public Health
Service Act (42 U.S.C. 290cc-22) is amended--
(1) in subsection (a)(1)(B), by striking ``substance
abuse'' and inserting ``a substance use disorder'';
(2) in subsection (b)(6), by striking ``substance abuse''
and inserting ``substance use disorder'';
(3) in subsection (c), by striking ``substance abuse'' and
inserting ``a substance use disorder'';
(4) in subsection (e)--
(A) in paragraph (1), by striking ``substance abuse'' and
inserting ``a substance use disorder''; and
(B) in paragraph (2), by striking ``substance abuse'' and
inserting ``substance use disorder'';
(5) by striking subsection (g) and redesignating
subsections (h) and (i) as (g) and (h), accordingly; and
(6) in subsection (g), as redesignated by paragraph (5), by
striking ``substance abuse'' each place such term appears and
inserting ``substance use disorder''.
(c) Description of Intended Expenditures of Grant.--Section
527 of the Public Health Service Act (42 U.S.C. 290cc-27) is
amended by striking ``substance abuse'' each place such term
appears and inserting ``substance use disorder''.
(d) Technical Assistance.--Section 530 of the Public Health
Service Act (42 U.S.C. 290cc-30) is amended by striking
``through the National Institute of Mental Health, the
National Institute of Alcohol Abuse and Alcoholism, and the
National Institute on Drug Abuse'' and inserting ``acting
through the Assistant Secretary''.
(e) Definitions.--Section 534(4) of the Public Health
Service Act (42 U.S.C. 290cc-34(4)) is amended to read as
follows:
``(4) Substance use disorder services.--The term `substance
use disorder services' has the meaning given the term
`substance abuse services' in section 330(h)(5)(C).''.
(f) Funding.--Section 535(a) of the Public Health Service
Act (42 U.S.C. 290cc-35(a)) is amended by striking
``$75,000,000 for each of the fiscal years 2001 through
2003'' and inserting ``$64,635,000 for each of fiscal years
2018 through 2022''.
(g) Study Concerning Formula.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Assistant Secretary for Mental
Health and Substance Use (referred to in this section as the
``Assistant Secretary'') shall conduct a study concerning the
formula used under section 524 of the Public Health Service
Act (42 U.S.C. 290cc-24) for making allotments to States
under section 521 of such Act (42 U.S.C. 290cc-21). Such
study shall include an evaluation of quality indicators of
need for purposes of revising the formula for determining the
amount of each allotment for the fiscal years following the
submission of the study.
(2) Report.--In accordance with section 8004(b), the
Assistant Secretary shall submit to the committees of
Congress described in such section a report concerning the
results of the study conducted under paragraph (1).
SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb-31 et seq.) is amended by inserting
after section 520E-2 (42 U.S.C. 290bb-36b) the following:
``SEC. 520E-3. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
``(a) In General.--The Secretary, acting through the
Assistant Secretary, shall maintain the National Suicide
Prevention Lifeline program (referred to in this section as
the `program'), authorized under section 520A and in effect
prior to the date of enactment of the Helping Families in
Mental Health Crisis Reform Act of 2016.
``(b) Activities.--In maintaining the program, the
activities of the Secretary shall include--
``(1) coordinating a network of crisis centers across the
United States for providing suicide prevention and crisis
intervention services to individuals seeking help at any
time, day or night;
``(2) maintaining a suicide prevention hotline to link
callers to local emergency, mental health, and social
services resources; and
``(3) consulting with the Secretary of Veterans Affairs to
ensure that veterans calling the suicide prevention hotline
have access to a specialized veterans' suicide prevention
hotline.
``(c) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $7,198,000
for each of fiscal years 2018 through 2022.''.
SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb-31 et seq.), as amended by section 9005,
is further amended by inserting after section 520E-3 the
following:
``SEC. 520E-4. TREATMENT REFERRAL ROUTING SERVICE.
``(a) In General.--The Secretary, acting through the
Assistant Secretary, shall maintain the National Treatment
Referral Routing Service (referred to in this section as the
`Routing Service') to assist individuals and families in
locating mental and substance use disorders treatment
providers.
[[Page H6952]]
``(b) Activities of the Secretary.--To maintain the Routing
Service, the activities of the Assistant Secretary shall
include administering--
``(1) a nationwide, telephone number providing year-round
access to information that is updated on a regular basis
regarding local behavioral health providers and community-
based organizations in a manner that is confidential, without
requiring individuals to identify themselves, is in languages
that include at least English and Spanish, and is at no cost
to the individual using the Routing Service; and
``(2) an Internet website to provide a searchable, online
treatment services locator of behavioral health treatment
providers and community-based organizations, which shall
include information on the name, location, contact
information, and basic services provided by such providers
and organizations.
``(c) Removing Practitioner Contact Information.--In the
event that the Internet website described in subsection
(b)(2) contains information on any qualified practitioner
that is certified to prescribe medication for opioid
dependency under section 303(g)(2)(B) of the Controlled
Substances Act, the Assistant Secretary--
``(1) shall provide an opportunity to such practitioner to
have the contact information of the practitioner removed from
the website at the request of the practitioner; and
``(2) may evaluate other methods to periodically update the
information displayed on such website.
``(d) Rule of Construction.--Nothing in this section shall
be construed to prevent the Assistant Secretary from using
any unobligated amounts otherwise made available to the
Administration to maintain the Routing Service.''.
SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
Section 520F of the Public Health Service Act (42 U.S.C.
290bb-37) is amended to read as follows:
``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
``(a) In General.--The Secretary shall award competitive
grants to--
``(1) State and local governments and Indian tribes and
tribal organizations, to enhance community-based crisis
response systems; or
``(2) States to develop, maintain, or enhance a database of
beds at inpatient psychiatric facilities, crisis
stabilization units, and residential community mental health
and residential substance use disorder treatment facilities,
for adults with a serious mental illness, children with a
serious emotional disturbance, or individuals with a
substance use disorder.
``(b) Applications.--
``(1) In general.--To receive a grant under subsection (a),
an entity shall submit to the Secretary an application, at
such time, in such manner, and containing such information as
the Secretary may require.
``(2) Community-based crisis response plan.--An application
for a grant under subsection (a)(1) shall include a plan
for--
``(A) promoting integration and coordination between local
public and private entities engaged in crisis response,
including first responders, emergency health care providers,
primary care providers, law enforcement, court systems,
health care payers, social service providers, and behavioral
health providers;
``(B) developing memoranda of understanding with public and
private entities to implement crisis response services;
``(C) addressing gaps in community resources for crisis
intervention and prevention; and
``(D) developing models for minimizing hospital
readmissions, including through appropriate discharge
planning.
``(3) Beds database plan.--An application for a grant under
subsection (a)(2) shall include a plan for developing,
maintaining, or enhancing a real-time, Internet-based bed
database to collect, aggregate, and display information about
beds in inpatient psychiatric facilities and crisis
stabilization units, and residential community mental health
and residential substance use disorder treatment facilities
to facilitate the identification and designation of
facilities for the temporary treatment of individuals in
mental or substance use disorder crisis.
``(c) Database Requirements.--A bed database described in
this section is a database that--
``(1) includes information on inpatient psychiatric
facilities, crisis stabilization units, and residential
community mental health and residential substance use
disorder facilities in the State involved, including contact
information for the facility or unit;
``(2) provides real-time information about the number of
beds available at each facility or unit and, for each
available bed, the type of patient that may be admitted, the
level of security provided, and any other information that
may be necessary to allow for the proper identification of
appropriate facilities for treatment of individuals in mental
or substance use disorder crisis; and
``(3) enables searches of the database to identify
available beds that are appropriate for the treatment of
individuals in mental or substance use disorder crisis.
``(d) Evaluation.--An entity receiving a grant under
subsection (a)(1) shall submit to the Secretary, at such
time, in such manner, and containing such information as the
Secretary may reasonably require, a report, including an
evaluation of the effect of such grant on--
``(1) local crisis response services and measures for
individuals receiving crisis planning and early intervention
supports;
``(2) individuals reporting improved functional outcomes;
and
``(3) individuals receiving regular followup care following
a crisis.
``(e) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$12,500,000 for the period of fiscal years 2018 through
2022.''.
SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
(a) Suicide Prevention Technical Assistance Center.--
Section 520C of the Public Health Service Act (42 U.S.C.
290bb-34), as amended by section 6001, is further amended--
(1) in the section heading, by striking ``youth interagency
research, training, and technical assistance centers'' and
inserting ``suicide prevention technical assistance center'';
(2) in subsection (a), by striking ``acting through the
Assistant Secretary for Mental Health and Substance Use'' and
all that follows through the period at the end of paragraph
(2) and inserting ``acting through the Assistant Secretary,
shall establish a research, training, and technical
assistance resource center to provide appropriate
information, training, and technical assistance to States,
political subdivisions of States, federally recognized Indian
tribes, tribal organizations, institutions of higher
education, public organizations, or private nonprofit
organizations regarding the prevention of suicide among all
ages, particularly among groups that are at a high risk for
suicide.'';
(3) by striking subsections (b) and (c);
(4) by redesignating subsection (d) as subsection (b);
(5) in subsection (b), as so redesignated--
(A) in the subsection heading, by striking ``Additional
Center'' and inserting ``Responsibilities of the Center'';
(B) in the matter preceding paragraph (1), by striking
``The additional research'' and all that follows through
``nonprofit organizations for'' and inserting ``The center
established under subsection (a) shall conduct activities for
the purpose of'';
(C) by striking ``youth suicide'' each place such term
appears and inserting ``suicide'';
(D) in paragraph (1)--
(i) by striking ``the development or continuation of'' and
inserting ``developing and continuing''; and
(ii) by inserting ``for all ages, particularly among groups
that are at a high risk for suicide'' before the semicolon at
the end;
(E) in paragraph (2), by inserting ``for all ages,
particularly among groups that are at a high risk for
suicide'' before the semicolon at the end;
(F) in paragraph (3), by inserting ``and tribal'' after
``statewide'';
(G) in paragraph (5), by inserting ``and prevention'' after
``intervention'';
(H) in paragraph (8), by striking ``in youth'';
(I) in paragraph (9), by striking ``and behavioral health''
and inserting ``health and substance use disorder''; and
(J) in paragraph (10), by inserting ``conducting'' before
``other''; and
(6) by striking subsection (e) and inserting the following:
``(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,988,000 for each of fiscal years 2018 through
2022.
``(d) Annual Report.--Not later than 2 years after the date
of enactment of this subsection, the Secretary shall submit
to Congress a report on the activities carried out by the
center established under subsection (a) during the year
involved, including the potential effects of such activities,
and the States, organizations, and institutions that have
worked with the center.''.
(b) Youth Suicide Early Intervention and Prevention
Strategies.--Section 520E of the Public Health Service Act
(42 U.S.C. 290bb-36) is amended--
(1) in paragraph (1) of subsection (a) and in subsection
(c), by striking ``substance abuse'' each place such term
appears and inserting ``substance use disorder'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking ``ensure that each State is awarded only 1
grant or cooperative agreement under this section'' and
inserting ``ensure that a State does not receive more than 1
grant or cooperative agreement under this section at any 1
time''; and
(ii) by striking ``been awarded'' and inserting
``received''; and
(B) by adding after paragraph (2) the following:
``(3) Consideration.--In awarding grants under this
section, the Secretary shall take into consideration the
extent of the need of the applicant, including the incidence
and prevalence of suicide in the State and among the
populations of focus, including rates of suicide determined
by the Centers for Disease Control and Prevention for the
State or population of focus.'';
(3) in subsection (g)(2), by striking ``2 years after the
date of enactment of this section,'' and insert ``2 years
after the date of enactment of Helping Families in Mental
Health Crisis Reform Act of 2016,''; and
(4) by striking subsection (m) and inserting the following:
``(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $30,000,000 for each of fiscal years 2018
through 2022.''.
SEC. 9009. ADULT SUICIDE PREVENTION.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb-31 et seq.) is amended by adding at the
end the following:
``SEC. 520L. ADULT SUICIDE PREVENTION.
``(a) Grants.--
``(1) In general.--The Assistant Secretary shall award
grants to eligible entities described in paragraph (2) to
implement suicide prevention and intervention programs, for
individuals
[[Page H6953]]
who are 25 years of age or older, that are designed to raise
awareness of suicide, establish referral processes, and
improve care and outcomes for such individuals who are at
risk of suicide.
``(2) Eligible entities.--To be eligible to receive a grant
under this section, an entity shall be a community-based
primary care or behavioral health care setting, an emergency
department, a State mental health agency (or State health
agency with mental or behavioral health functions), public
health agency, a territory of the United States, or an Indian
tribe or tribal organization (as the terms `Indian tribe' and
`tribal organization' are defined in section 4 of the Indian
Self-Determination and Education Assistance Act).
``(3) Use of funds.--The grants awarded under paragraph (1)
shall be used to implement programs, in accordance with such
paragraph, that include one or more of the following
components:
``(A) Screening for suicide risk, suicide intervention
services, and services for referral for treatment for
individuals at risk for suicide.
``(B) Implementing evidence-based practices to provide
treatment for individuals at risk for suicide, including
appropriate followup services.
``(C) Raising awareness and reducing stigma of suicide.
``(b) Evaluations and Technical Assistance.--The Assistant
Secretary shall--
``(1) evaluate the activities supported by grants awarded
under subsection (a), and disseminate, as appropriate, the
findings from the evaluation; and
``(2) provide appropriate information, training, and
technical assistance, as appropriate, to eligible entities
that receive a grant under this section, in order to help
such entities to meet the requirements of this section,
including assistance with selection and implementation of
evidence-based interventions and frameworks to prevent
suicide.
``(c) Duration.--A grant under this section shall be for a
period of not more than 5 years.
``(d) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$30,000,000 for the period of fiscal years 2018 through
2022.''.
SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
Section 520J of the Public Health Service Act (42 U.S.C.
290bb-41) is amended--
(1) in the section heading, by inserting ``mental health
awareness'' before ``training''; and
(2) in subsection (b)--
(A) in the subsection heading, by striking ``Illness'' and
inserting ``Health'';
(B) in paragraph (1), by inserting ``veterans, law
enforcement, and other categories of individuals, as
determined by the Secretary,'' after ``emergency services
personnel'';
(C) in paragraph (5)--
(i) in the matter preceding subparagraph (A), by striking
``to'' and inserting ``for evidence-based programs that
provide training and education in accordance with paragraph
(1) on matters including''; and
(ii) by striking subparagraphs (A) through (C) and
inserting the following:
``(A) recognizing the signs and symptoms of mental illness;
and
``(B)(i) resources available in the community for
individuals with a mental illness and other relevant
resources; or
``(ii) safely de-escalating crisis situations involving
individuals with a mental illness.''; and
(D) in paragraph (7), by striking ``, $25,000,000'' and all
that follows through the period at the end and inserting
``$14,693,000 for each of fiscal years 2018 through 2022.''.
SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS
AND ALASKA NATIVE YOUTH WITHIN SUICIDE
PREVENTION PROGRAMS.
(a) Findings.--The Congress finds as follows:
(1) Suicide is the eighth leading cause of death among
American Indians and Alaska Natives across all ages.
(2) Among American Indians and Alaska Natives who are 10 to
34 years of age, suicide is the second leading cause of
death.
(3) The suicide rate among American Indian and Alaska
Native adolescents and young adults ages 15 to 34 (17.9 per
100,000) is approximately 1.3 times higher than the national
average for that age group (13.3 per 100,000).
(b) Sense of Congress.--It is the sense of Congress that
the Secretary of Health and Human Services, in carrying out
suicide prevention and intervention programs, should
prioritize programs and activities for populations with
disproportionately high rates of suicide, such as American
Indians and Alaska Natives.
SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
Section 520A(e) of the Public Health Service Act (42 U.S.C.
290bb-32(e)) is amended by adding at the end the following:
``(3) Geriatric mental disorders.--The Secretary shall, as
appropriate, provide technical assistance to grantees
regarding evidence-based practices for the prevention and
treatment of geriatric mental disorders and co-occurring
mental health and substance use disorders among geriatric
populations, as well as disseminate information about such
evidence-based practices to States and nongrantees throughout
the United States.''.
SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
The Secretary of Health and Human Services, acting through
the Director of the Centers for Disease Control and
Prevention, is encouraged to improve, particularly through
the inclusion of additional States, the National Violent
Death Reporting System as authorized by title III of the
Public Health Service Act (42 U.S.C. 241 et seq.).
Participation in the system by the States shall be voluntary.
SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
Section 224 of the Protecting Access to Medicare Act of
2014 (42 U.S.C. 290aa note) is amended--
(1) in subsection (e), by striking ``and 2018,'' and
inserting ``2018, 2019, 2020, 2021, and 2022,''; and
(2) in subsection (g)--
(A) in paragraph (1), by striking ``2018'' and inserting
``2022''; and
(B) in paragraph (2), by striking ``is authorized to be
appropriated to carry out this section $15,000,000 for each
of fiscal years 2015 through 2018'' and inserting ``are
authorized to be appropriated to carry out this section
$15,000,000 for each of fiscal years 2015 through 2017,
$20,000,000 for fiscal year 2018, $19,000,000 for each of
fiscal years 2019 and 2020, and $18,000,000 for each of
fiscal years 2021 and 2022''.
SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
Part B of title V of the Public Health Service Act (42
U.S.C. 290bb et seq.), as amended by section 9009, is further
amended by adding at the end the following:
``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
``(a) In General.--The Assistant Secretary shall award
grants to eligible entities--
``(1) to establish assertive community treatment programs
for adults with a serious mental illness; or
``(2) to maintain or expand such programs.
``(b) Eligible Entities.--To be eligible to receive a grant
under this section, an entity shall be a State, political
subdivision of a State, Indian tribe or tribal organization
(as such terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act), mental health
system, health care facility, or any other entity the
Assistant Secretary deems appropriate.
``(c) Special Consideration.--In selecting among applicants
for a grant under this section, the Assistant Secretary may
give special consideration to the potential of the
applicant's program to reduce hospitalization, homelessness,
and involvement with the criminal justice system while
improving the health and social outcomes of the patient.
``(d) Additional Activities.--The Assistant Secretary
shall--
``(1) not later than the end of fiscal year 2021, submit a
report to the appropriate congressional committees on the
grant program under this section, including an evaluation
of--
``(A) any cost savings and public health outcomes such as
mortality, suicide, substance use disorders, hospitalization,
and use of services;
``(B) rates of involvement with the criminal justice system
of patients;
``(C) rates of homelessness among patients; and
``(D) patient and family satisfaction with program
participation; and
``(2) provide appropriate information, training, and
technical assistance to grant recipients under this section
to help such recipients to establish, maintain, or expand
their assertive community treatment programs.
``(e) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there is
authorized to be appropriated $5,000,000 for the period of
fiscal years 2018 through 2022.
``(2) Use of certain funds.--Of the funds appropriated to
carry out this section in any fiscal year, not more than 5
percent shall be available to the Assistant Secretary for
carrying out subsection (d).''.
SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
REAUTHORIZATION.
Section 519B of the Public Health Service Act (42 U.S.C.
290bb-25b) is amended--
(1) in subsection (c)(3), by striking ``fiscal year 2007''
and all that follows through the period at the end and
inserting ``each of the fiscal years 2018 through 2022.'';
(2) in subsection (d)(4), by striking ``fiscal year 2007''
and all that follows through the period at the end and
inserting ``each of the fiscal years 2018 through 2022.'';
(3) in subsection (e)(1)(I), by striking ``fiscal year
2007'' and all that follows through the period at the end and
inserting ``each of the fiscal years 2018 through 2022.'';
(4) in subsection (f)(2), by striking ``$6,000,000 for
fiscal year 2007'' and all that follows through the period at
the end and inserting ``$3,000,000 for each of the fiscal
years 2018 through 2022''; and
(5) by adding at the end the following new subsection:
``(g) Reducing Underage Drinking Through Screening and
Brief Intervention.--
``(1) Grants to pediatric health care providers to reduce
underage drinking.--The Assistant Secretary may make grants
to eligible entities to increase implementation of practices
for reducing the prevalence of alcohol use among individuals
under the age of 21, including college students.
``(2) Purposes.--Grants under this subsection shall be made
to improve--
``(A) screening children and adolescents for alcohol use;
``(B) offering brief interventions to children and
adolescents to discourage such use;
``(C) educating parents about the dangers of, and methods
of discouraging, such use;
``(D) diagnosing and treating alcohol use disorders; and
``(E) referring patients, when necessary, to other
appropriate care.
``(3) Use of funds.--An entity receiving a grant under this
subsection may use such funding for the purposes identified
in paragraph (2) by--
``(A) providing training to health care providers;
[[Page H6954]]
``(B) disseminating best practices, including culturally
and linguistically appropriate best practices, as
appropriate, and developing and distributing materials; and
``(C) supporting other activities, as determined
appropriate by the Assistant Secretary.
``(4) Application.--To be eligible to receive a grant under
this subsection, an entity shall submit an application to the
Assistant Secretary at such time, and in such manner, and
accompanied by such information as the Assistant Secretary
may require. Each application shall include--
``(A) a description of the entity;
``(B) a description of activities to be completed;
``(C) a description of how the services specified in
paragraphs (2) and (3) will be carried out and the
qualifications for providing such services; and
``(D) a timeline for the completion of such activities.
``(5) Definitions.--For the purpose of this subsection:
``(A) Brief intervention.--The term `brief intervention'
means, after screening a patient, providing the patient with
brief advice and other brief motivational enhancement
techniques designed to increase the insight of the patient
regarding the patient's alcohol use, and any realized or
potential consequences of such use, to effect the desired
related behavioral change.
``(B) Children and adolescents.--The term `children and
adolescents' means any person under 21 years of age.
``(C) Eligible entity.--The term `eligible entity' means an
entity consisting of pediatric health care providers and that
is qualified to support or provide the activities identified
in paragraph (2).
``(D) Pediatric health care provider.--The term `pediatric
health care provider' means a provider of primary health care
to individuals under the age of 21 years.
``(E) Screening.--The term `screening' means using
validated patient interview techniques to identify and assess
the existence and extent of alcohol use in a patient.''.
SEC. 9017. CENTER AND PROGRAM REPEALS.
Part B of title V of the Public Health Service Act (42
U.S.C. 290bb et seq.) is amended by striking section 506B (42
U.S.C. 290aa-5b), the second section 514 (42 U.S.C. 290bb-9)
relating to methamphetamine and amphetamine treatment
initiatives, and each of sections 514A, 517, 519A, 519C,
519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23,
290bb-25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and
290bb-39).
Subtitle B--Strengthening the Health Care Workforce
SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND
TRAINING GRANTS.
Section 756 of the Public Health Service Act (42 U.S.C.
294e-1) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking ``of
higher education''; and
(B) by striking paragraphs (1) through (4) and inserting
the following:
``(1) accredited institutions of higher education or
accredited professional training programs that are
establishing or expanding internships or other field
placement programs in mental health in psychiatry,
psychology, school psychology, behavioral pediatrics,
psychiatric nursing (which may include master's and doctoral
level programs), social work, school social work, substance
use disorder prevention and treatment, marriage and family
therapy, occupational therapy, school counseling, or
professional counseling, including such programs with a focus
on child and adolescent mental health and transitional-age
youth;
``(2) accredited doctoral, internship, and post-doctoral
residency programs of health service psychology (including
clinical psychology, counseling, and school psychology) for
the development and implementation of interdisciplinary
training of psychology graduate students for providing
behavioral health services, including substance use disorder
prevention and treatment services, as well as the development
of faculty in health service psychology;
``(3) accredited master's and doctoral degree programs of
social work for the development and implementation of
interdisciplinary training of social work graduate students
for providing behavioral health services, including substance
use disorder prevention and treatment services, and the
development of faculty in social work; and
``(4) State-licensed mental health nonprofit and for-profit
organizations to enable such organizations to pay for
programs for preservice or in-service training in a
behavioral health-related paraprofessional field with
preference for preservice or in-service training of
paraprofessional child and adolescent mental health
workers.'';
(2) in subsection (b)--
(A) by striking paragraph (5);
(B) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(C) by inserting before paragraph (2), as so redesignated,
the following:
``(1) an ability to recruit and place the students
described in subsection (a) in areas with a high need and
high demand population;'';
(D) in paragraph (3), as so redesignated, by striking
``subsection (a)'' and inserting ``paragraph (2), especially
individuals with mental disorder symptoms or diagnoses,
particularly children and adolescents, and transitional-age
youth'';
(E) in paragraph (4), as so redesignated, by striking ``;''
and inserting ``; and''; and
(F) in paragraph (5), as so redesignated, by striking ``;
and'' and inserting a period;
(3) in subsection (c), by striking ``authorized under
subsection (a)(1)'' and inserting ``awarded under paragraphs
(2) and (3) of subsection (a)'';
(4) by amending subsection (d) to read as follows:
``(d) Priority.--In selecting grant recipients under this
section, the Secretary shall give priority to--
``(1) programs that have demonstrated the ability to train
psychology, psychiatry, and social work professionals to work
in integrated care settings for purposes of recipients under
paragraphs (1), (2), and (3) of subsection (a); and
``(2) programs for paraprofessionals that emphasize the
role of the family and the lived experience of the consumer
and family-paraprofessional partnerships for purposes of
recipients under subsection (a)(4).''; and
(5) by striking subsection (e) and inserting the following:
``(e) Report to Congress.--Not later than 4 years after the
date of enactment of the Helping Families in Mental Health
Crisis Reform Act of 2016, the Secretary shall include in the
biennial report submitted to Congress under section 501(m) an
assessment on the effectiveness of the grants under this
section in--
``(1) providing graduate students support for experiential
training (internship or field placement);
``(2) recruiting students interested in behavioral health
practice;
``(3) recruiting students in accordance with subsection
(b)(1);
``(4) developing and implementing interprofessional
training and integration within primary care;
``(5) developing and implementing accredited field
placements and internships; and
``(6) collecting data on the number of students trained in
behavioral health care and the number of available accredited
internships and field placements.
``(f) Authorization of Appropriations.--For each of fiscal
years 2018 through 2022, there are authorized to be
appropriated to carry out this section $50,000,000, to be
allocated as follows:
``(1) For grants described in subsection (a)(1),
$15,000,000.
``(2) For grants described in subsection (a)(2),
$15,000,000.
``(3) For grants described in subsection (a)(3),
$10,000,000.
``(4) For grants described in subsection (a)(4),
$10,000,000.''.
SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE
DISORDERS WORKFORCE.
Part D of title VII of the Public Health Service Act (42
U.S.C. 294 et seq.) is amended by adding at the end the
following:
``SEC. 760. TRAINING DEMONSTRATION PROGRAM.
``(a) In General.--The Secretary shall establish a training
demonstration program to award grants to eligible entities to
support--
``(1) training for medical residents and fellows to
practice psychiatry and addiction medicine in underserved,
community-based settings that integrate primary care with
mental and substance use disorders prevention and treatment
services;
``(2) training for nurse practitioners, physician
assistants, health service psychologists, and social workers
to provide mental and substance use disorders services in
underserved community-based settings that integrate primary
care and mental and substance use disorders services; and
``(3) establishing, maintaining, or improving academic
units or programs that--
``(A) provide training for students or faculty, including
through clinical experiences and research, to improve the
ability to be able to recognize, diagnose, and treat mental
and substance use disorders, with a special focus on
addiction; or
``(B) develop evidence-based practices or recommendations
for the design of the units or programs described in
subparagraph (A), including curriculum content standards.
``(b) Activities.--
``(1) Training for residents and fellows.--A recipient of a
grant under subsection (a)(1)--
``(A) shall use the grant funds--
``(i)(I) to plan, develop, and operate a training program
for medical psychiatry residents and fellows in addiction
medicine practicing in eligible entities described in
subsection (c)(1); or
``(II) to train new psychiatric residents and fellows in
addiction medicine to provide and expand access to integrated
mental and substance use disorders services; and
``(ii) to provide at least 1 training track that is--
``(I) a virtual training track that includes an in-person
rotation at a teaching health center or in a community-based
setting, followed by a virtual rotation in which the resident
or fellow continues to support the care of patients at the
teaching health center or in the community-based setting
through the use of health information technology and, as
appropriate, telehealth services;
``(II) an in-person training track that includes a
rotation, during which the resident or fellow practices at a
teaching health center or in a community-based setting; or
``(III) an in-person training track that includes a
rotation during which the resident practices in a community-
based setting that specializes in the treatment of infants,
children, adolescents, or pregnant or postpartum women; and
``(B) may use the grant funds to provide additional support
for the administration of the program or to meet the costs of
projects to establish, maintain, or improve faculty
development, or departments, divisions, or other units
necessary to implement such training.
``(2) Training for other providers.--A recipient of a grant
under subsection (a)(2)--
``(A) shall use the grant funds to plan, develop, or
operate a training program to provide
[[Page H6955]]
mental and substance use disorders services in underserved,
community-based settings, as appropriate, that integrate
primary care and mental and substance use disorders
prevention and treatment services; and
``(B) may use the grant funds to provide additional support
for the administration of the program or to meet the costs of
projects to establish, maintain, or improve faculty
development, or departments, divisions, or other units
necessary to implement such program.
``(3) Academic units or programs.--A recipient of a grant
under subsection (a)(3) shall enter into a partnership with
organizations such as an education accrediting organization
(such as the Liaison Committee on Medical Education, the
Accreditation Council for Graduate Medical Education, the
Commission on Osteopathic College Accreditation, the
Accreditation Commission for Education in Nursing, the
Commission on Collegiate Nursing Education, the Accreditation
Council for Pharmacy Education, the Council on Social Work
Education, American Psychological Association Commission on
Accreditation, or the Accreditation Review Commission on
Education for the Physician Assistant) to carry out
activities under subsection (a)(3).
``(c) Eligible Entities.--
``(1) Training for residents and fellows.--To be eligible
to receive a grant under subsection (a)(1), an entity shall--
``(A) be a consortium consisting of--
``(i) at least one teaching health center; and
``(ii) the sponsoring institution (or parent institution of
the sponsoring institution) of--
``(I) a psychiatry residency program that is accredited by
the Accreditation Council of Graduate Medical Education (or
the parent institution of such a program); or
``(II) a fellowship in addiction medicine, as determined
appropriate by the Secretary; or
``(B) be an entity described in subparagraph (A)(ii) that
provides opportunities for residents or fellows to train in
community-based settings that integrate primary care with
mental and substance use disorders prevention and treatment
services.
``(2) Training for other providers.--To be eligible to
receive a grant under subsection (a)(2), an entity shall be--
``(A) a teaching health center (as defined in section
749A(f));
``(B) a Federally qualified health center (as defined in
section 1905(l)(2)(B) of the Social Security Act);
``(C) a community mental health center (as defined in
section 1861(ff)(3)(B) of the Social Security Act);
``(D) a rural health clinic (as defined in section 1861(aa)
of the Social Security Act);
``(E) a health center operated by the Indian Health
Service, an Indian tribe, a tribal organization, or an urban
Indian organization (as defined in section 4 of the Indian
Health Care Improvement Act); or
``(F) an entity with a demonstrated record of success in
providing training for nurse practitioners, physician
assistants, health service psychologists, and social workers.
``(3) Academic units or programs.--To be eligible to
receive a grant under subsection (a)(3), an entity shall be a
school of medicine or osteopathic medicine, a nursing school,
a physician assistant training program, a school of pharmacy,
a school of social work, an accredited public or nonprofit
private hospital, an accredited medical residency program, or
a public or private nonprofit entity which the Secretary has
determined is capable of carrying out such grant.
``(d) Priority.--
``(1) In general.--In awarding grants under subsection
(a)(1) or (a)(2), the Secretary shall give priority to
eligible entities that--
``(A) demonstrate sufficient size, scope, and capacity to
undertake the requisite training of an appropriate number of
psychiatric residents, fellows, nurse practitioners,
physician assistants, or social workers in addiction medicine
per year to meet the needs of the area served;
``(B) demonstrate experience in training providers to
practice team-based care that integrates mental and substance
use disorder prevention and treatment services with primary
care in community-based settings;
``(C) demonstrate experience in using health information
technology and, as appropriate, telehealth to support--
``(i) the delivery of mental and substance use disorders
services at the eligible entities described in subsections
(c)(1) and (c)(2); and
``(ii) community health centers in integrating primary care
and mental and substance use disorders treatment; or
``(D) have the capacity to expand access to mental and
substance use disorders services in areas with demonstrated
need, as determined by the Secretary, such as tribal, rural,
or other underserved communities.
``(2) Academic units or programs.--In awarding grants under
subsection (a)(3), the Secretary shall give priority to
eligible entities that--
``(A) have a record of training the greatest percentage of
mental and substance use disorders providers who enter and
remain in these fields or who enter and remain in settings
with integrated primary care and mental and substance use
disorder prevention and treatment services;
``(B) have a record of training individuals who are from
underrepresented minority groups, including native
populations, or from a rural or disadvantaged background;
``(C) provide training in the care of vulnerable
populations such as infants, children, adolescents, pregnant
and postpartum women, older adults, homeless individuals,
victims of abuse or trauma, individuals with disabilities,
and other groups as defined by the Secretary;
``(D) teach trainees the skills to provide
interprofessional, integrated care through collaboration
among health professionals; or
``(E) provide training in cultural competency and health
literacy.
``(e) Duration.--Grants awarded under this section shall be
for a minimum of 5 years.
``(f) Study and Report.--
``(1) Study.--
``(A) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall conduct a study on the results of the
demonstration program under this section.
``(B) Data submission.--Not later than 90 days after the
completion of the first year of the training program and each
subsequent year that the program is in effect, each recipient
of a grant under subsection (a) shall submit to the Secretary
such data as the Secretary may require for analysis for the
report described in paragraph (2).
``(2) Report to congress.--Not later than 1 year after
receipt of the data described in paragraph (1)(B), the
Secretary shall submit to Congress a report that includes--
``(A) an analysis of the effect of the demonstration
program under this section on the quality, quantity, and
distribution of mental and substance use disorders services;
``(B) an analysis of the effect of the demonstration
program on the prevalence of untreated mental and substance
use disorders in the surrounding communities of health
centers participating in the demonstration; and
``(C) recommendations on whether the demonstration program
should be expanded.
``(g) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$10,000,000 for each of fiscal years 2018 through 2022.''.
SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR LOAN
REPAYMENT PROGRAMS.
The Administrator of the Health Resources and Services
Administration shall clarify the eligibility pursuant to
section 338B(b)(1)(B) of the Public Health Service Act (42
U.S.C. 254l-1(b)(1)(B)) of child and adolescent psychiatrists
for the National Health Service Corps Loan Repayment Program
under subpart III of part D of title III of such Act (42
U.S.C. 254l et seq.).
SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
Title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by adding at the end the following:
``PART K--MINORITY FELLOWSHIP PROGRAM
``SEC. 597. FELLOWSHIPS.
``(a) In General.--The Secretary shall maintain a program,
to be known as the Minority Fellowship Program, under which
the Secretary shall award fellowships, which may include
stipends, for the purposes of--
``(1) increasing the knowledge of mental and substance use
disorders practitioners on issues related to prevention,
treatment, and recovery support for individuals who are from
racial and ethnic minority populations and who have a mental
or substance use disorder;
``(2) improving the quality of mental and substance use
disorder prevention and treatment services delivered to
racial and ethnic minority populations; and
``(3) increasing the number of culturally competent mental
and substance use disorders professionals who teach,
administer services, conduct research, and provide direct
mental or substance use disorder services to racial and
ethnic minority populations.
``(b) Training Covered.--The fellowships awarded under
subsection (a) shall be for postbaccalaureate training
(including for master's and doctoral degrees) for mental and
substance use disorder treatment professionals, including in
the fields of psychiatry, nursing, social work, psychology,
marriage and family therapy, mental health counseling, and
substance use disorder and addiction counseling.
``(c) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $12,669,000
for each of fiscal years 2018 through 2022.''.
SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL
VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
Section 224 of the Public Health Service Act (42 U.S.C.
233) is amended by adding at the end the following:
``(q)(1) For purposes of this section, a health
professional volunteer at a deemed entity described in
subsection (g)(4) shall, in providing a health professional
service eligible for funding under section 330 to an
individual, be deemed to be an employee of the Public Health
Service for a calendar year that begins during a fiscal year
for which a transfer was made under paragraph (4)(C). The
preceding sentence is subject to the provisions of this
subsection.
``(2) In providing a health service to an individual, a
health care practitioner shall for purposes of this
subsection be considered to be a health professional
volunteer at an entity described in subsection (g)(4) if the
following conditions are met:
``(A) The service is provided to the individual at the
facilities of an entity described in subsection (g)(4), or
through offsite programs or events carried out by the entity.
``(B) The entity is sponsoring the health care practitioner
pursuant to paragraph (3)(B).
``(C) The health care practitioner does not receive any
compensation for the service from the individual, the entity
described in subsection (g)(4), or any third-party payer
(including reimbursement under any insurance policy or health
plan, or under any Federal or State health benefits program),
except that the health care practitioner may receive
repayment from the entity described in subsection (g)(4) for
reasonable expenses incurred by the health care practitioner
in the provision of the service to the individual, which may
include travel expenses to or from the site of services.
[[Page H6956]]
``(D) Before the service is provided, the health care
practitioner or the entity described in subsection (g)(4)
posts a clear and conspicuous notice at the site where the
service is provided of the extent to which the legal
liability of the health care practitioner is limited pursuant
to this subsection.
``(E) At the time the service is provided, the health care
practitioner is licensed or certified in accordance with
applicable Federal and State laws regarding the provision of
the service.
``(F) At the time the service is provided, the entity
described in subsection (g)(4) maintains relevant
documentation certifying that the health care practitioner
meets the requirements of this subsection.
``(3) Subsection (g) (other than paragraphs (3) and (5))
and subsections (h), (i), and (l) apply to a health care
practitioner for purposes of this subsection to the same
extent and in the same manner as such subsections apply to an
officer, governing board member, employee, or contractor of
an entity described in subsection (g)(4), subject to
paragraph (4), and subject to the following:
``(A) The first sentence of paragraph (1) applies in lieu
of the first sentence of subsection (g)(1)(A).
``(B) With respect to an entity described in subsection
(g)(4), a health care practitioner is not a health
professional volunteer at such entity unless the entity
sponsors the health care practitioner. For purposes of this
subsection, the entity shall be considered to be sponsoring
the health care practitioner if--
``(i) with respect to the health care practitioner, the
entity submits to the Secretary an application meeting the
requirements of subsection (g)(1)(D); and
``(ii) the Secretary, pursuant to subsection (g)(1)(E),
determines that the health care practitioner is deemed to be
an employee of the Public Health Service.
``(C) In the case of a health care practitioner who is
determined by the Secretary pursuant to subsection (g)(1)(E)
to be a health professional volunteer at such entity, this
subsection applies to the health care practitioner (with
respect to services performed on behalf of the entity
sponsoring the health care practitioner pursuant to
subparagraph (B)) for any cause of action arising from an act
or omission of the health care practitioner occurring on or
after the date on which the Secretary makes such
determination.
``(D) Subsection (g)(1)(F) applies to a health care
practitioner for purposes of this subsection only to the
extent that, in providing health services to an individual,
each of the conditions specified in paragraph (2) is met.
``(4)(A) Amounts in the fund established under subsection
(k)(2) shall be available for transfer under subparagraph (C)
for purposes of carrying out this subsection.
``(B)(i) Not later than May 1 of each fiscal year, the
Attorney General, in consultation with the Secretary, shall
submit to the Congress a report providing an estimate of the
amount of claims (together with related fees and expenses of
witnesses) that, by reason of the acts or omissions of health
professional volunteers, will be paid pursuant to this
section during the calendar year that begins in the following
fiscal year.
``(ii) Subsection (k)(1)(B) applies to the estimate under
clause (i) regarding health professional volunteers to the
same extent and in the same manner as such subsection applies
to the estimate under such subsection regarding officers,
governing board members, employees, and contractors of
entities described in subsection (g)(4).
``(iii) The report shall include a summary of the data
relied upon for the estimate in clause (i), including the
number of claims filed and paid from the previous calendar
year.
``(C) Not later than December 31 of each fiscal year, the
Secretary shall transfer from the fund under subsection
(k)(2) to the appropriate accounts in the Treasury an amount
equal to the estimate made under subparagraph (B) for the
calendar year beginning in such fiscal year, subject to the
extent of amounts in the fund.
``(5)(A) This subsection shall take effect on October 1,
2017, except as provided in subparagraph (B) and paragraph
(6).
``(B) Effective on the date of the enactment of this
subsection--
``(i) the Secretary may issue regulations for carrying out
this subsection, and the Secretary may accept and consider
applications submitted pursuant to paragraph (3)(B); and
``(ii) reports under paragraph (4)(B) may be submitted to
Congress.
``(6) Beginning on October 1, 2022, this subsection shall
cease to have any force or effect.''.
SEC. 9026. REPORTS.
(a) Workforce Development Report.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Administrator of the Health
Resources and Services Administration, in consultation with
the Assistant Secretary for Mental Health and Substance Use,
shall conduct a study and publicly post on the appropriate
Internet website of the Department of Health and Human
Services a report on the adult and pediatric mental health
and substance use disorder workforce in order to inform
Federal, State, and local efforts related to workforce
enhancement.
(2) Contents.--The report under this subsection shall
contain--
(A) national and State-level projections of the supply and
demand of the mental health and substance use disorder health
workforce, disaggregated by profession;
(B) an assessment of the mental health and substance use
disorder workforce capacity, strengths, and weaknesses as of
the date of the report, including the extent to which primary
care providers are preventing, screening, or referring for
mental and substance use disorder services;
(C) information on trends within the mental health and
substance use disorder provider workforce, including the
number of individuals expected to enter the mental health
workforce over the next 5 years; and
(D) any additional information determined by the
Administrator of the Health Resources and Services
Administration, in consultation with the Assistant Secretary
for Mental Health and Substance Use, to be relevant to the
mental health and substance use disorder provider workforce.
(b) Peer-Support Specialist Programs.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on peer-support specialist
programs in up to 10 States that receive funding from the
Substance Abuse and Mental Health Services Administration.
(2) Contents of study.--In conducting the study under
paragraph (1), the Comptroller General of the United States
shall examine and identify best practices, in the States
selected pursuant to such paragraph, related to training and
credential requirements for peer-support specialist programs,
such as--
(A) hours of formal work or volunteer experience related to
mental and substance use disorders conducted through such
programs;
(B) types of peer-support specialist exams required for
such programs in the selected States;
(C) codes of ethics used by such programs in the selected
States;
(D) required or recommended skill sets for such programs in
the selected States; and
(E) requirements for continuing education.
(3) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
study conducted under paragraph (1).
Subtitle C--Mental Health on Campus Improvement
SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES
ON CAMPUS.
Section 520E-2 of the Public Health Service Act (42 U.S.C.
290bb-36b) is amended--
(1) in the section heading, by striking ``and behavioral
health'' and inserting ``health and substance use disorder'';
(2) in subsection (a)--
(A) by striking ``Services,'' and inserting ``Services
and'';
(B) by striking ``and behavioral health problems'' and
inserting ``health or substance use disorders'';
(C) by striking ``substance abuse'' and inserting
``substance use disorders''; and
(D) by adding after, ``suicide attempts,'' the following:
``prevent mental and substance use disorders, reduce stigma,
and improve the identification and treatment for students at
risk,'';
(3) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking
``for--'' and inserting ``for one or more of the
following:''; and
(B) by striking paragraphs (1) through (6) and inserting
the following:
``(1) Educating students, families, faculty, and staff to
increase awareness of mental and substance use disorders.
``(2) The operation of hotlines.
``(3) Preparing informational material.
``(4) Providing outreach services to notify students about
available mental and substance use disorder services.
``(5) Administering voluntary mental and substance use
disorder screenings and assessments.
``(6) Supporting the training of students, faculty, and
staff to respond effectively to students with mental and
substance use disorders.
``(7) Creating a network infrastructure to link
institutions of higher education with health care providers
who treat mental and substance use disorders.
``(8) Providing mental and substance use disorders
prevention and treatment services to students, which may
include recovery support services and programming and early
intervention, treatment, and management, including through
the use of telehealth services.
``(9) Conducting research through a counseling or health
center at the institution of higher education involved
regarding improving the behavioral health of students through
clinical services, outreach, prevention, or academic success,
in a manner that is in compliance with all applicable
personal privacy laws.
``(10) Supporting student groups on campus, including
athletic teams, that engage in activities to educate
students, including activities to reduce stigma surrounding
mental and behavioral disorders, and promote mental health.
``(11) Employing appropriately trained staff.
``(12) Developing and supporting evidence-based and
emerging best practices, including a focus on culturally and
linguistically appropriate best practices.'';
(4) in subsection (c)(5), by striking ``substance abuse''
and inserting ``substance use disorder'';
(5) in subsection (d)--
(A) in the matter preceding paragraph (1), by striking ``An
institution of higher education desiring a grant under this
section'' and inserting ``To be eligible to receive a grant
under this section, an institution of higher education'';
(B) by striking paragraph (1) and inserting--
``(1) A description of the population to be targeted by the
program carried out under the grant, including veterans
whenever possible and appropriate, and of identified mental
and substance use disorder needs of students at the
institution of higher education.'';
(C) in paragraph (2), by inserting ``, which may include,
as appropriate and in accordance with subsection (b)(7), a
plan to seek input from relevant stakeholders in the
community, including appropriate public and private entities,
in
[[Page H6957]]
order to carry out the program under the grant'' before the
period at the end; and
(D) by adding after paragraph (5) the following new
paragraphs:
``(6) An outline of the objectives of the program carried
out under the grant.
``(7) For an institution of higher education proposing to
use the grant for an activity described in paragraph (8) or
(9) of subsection (b), a description of the policies and
procedures of the institution of higher education that are
related to applicable laws regarding access to, and sharing
of, treatment records of students at any campus-based mental
health center or partner organization, including the policies
and State laws governing when such records can be accessed
and shared for non-treatment purposes and a description of
the process used by the institution of higher education to
notify students of these policies and procedures, including
the extent to which written consent is required.
``(8) An assurance that grant funds will be used to
supplement and not supplant any other Federal, State, or
local funds available to carry out activities of the type
carried out under the grant.'';
(6) in subsection (e)(1), by striking ``and behavioral
health problems'' and inserting ``health and substance use
disorders'';
(7) in subsection (f)(2)--
(A) by striking ``and behavioral health'' and inserting
``health and substance use disorder''; and
(B) by striking ``suicide and substance abuse'' and
inserting ``suicide and substance use disorders'';
(8) by redesignating subsection (h) as subsection (i);
(9) by inserting after subsection (g) the following new
subsection:
``(h) Technical Assistance.--The Secretary may provide
technical assistance to grantees in carrying out this
section.''; and
(10) in subsection (i), as redesignated by paragraph (8),
by striking ``$5,000,000 for fiscal year 2005'' and all that
follows through the period at the end and inserting
``$7,000,000 for each of fiscal years 2018 through 2022.''.
SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE MENTAL
HEALTH.
(a) Purpose.--It is the purpose of this section to provide
for the establishment of a College Campus Task Force to
discuss mental and behavioral health concerns on campuses of
institutions of higher education.
(b) Establishment.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall establish a College Campus Task Force (referred to in
this section as the ``Task Force'') to discuss mental and
behavioral health concerns on campuses of institutions of
higher education.
(c) Membership.--The Task Force shall be composed of a
representative from each Federal agency (as appointed by the
head of the agency) that has jurisdiction over, or is
affected by, mental health and education policies and
projects, including--
(1) the Department of Education;
(2) the Department of Health and Human Services;
(3) the Department of Veterans Affairs; and
(4) such other Federal agencies as the Assistant Secretary
for Mental Health and Substance Use, in consultation with the
Secretary, determines to be appropriate.
(d) Duties.--The Task Force shall--
(1) serve as a centralized mechanism to coordinate a
national effort to--
(A) discuss and evaluate evidence and knowledge on mental
and behavioral health services available to, and the
prevalence of mental illness among, the age population of
students attending institutions of higher education in the
United States;
(B) determine the range of effective, feasible, and
comprehensive actions to improve mental and behavioral health
on campuses of institutions of higher education;
(C) examine and better address the needs of the age
population of students attending institutions of higher
education dealing with mental illness;
(D) survey Federal agencies to determine which policies are
effective in encouraging, and how best to facilitate outreach
without duplicating, efforts relating to mental and
behavioral health promotion;
(E) establish specific goals within and across Federal
agencies for mental health promotion, including
determinations of accountability for reaching those goals;
(F) develop a strategy for allocating responsibilities and
ensuring participation in mental and behavioral health
promotion, particularly in the case of competing agency
priorities;
(G) coordinate plans to communicate research results
relating to mental and behavioral health amongst the age
population of students attending institutions of higher
education to enable reporting and outreach activities to
produce more useful and timely information;
(H) provide a description of evidence-based practices,
model programs, effective guidelines, and other strategies
for promoting mental and behavioral health on campuses of
institutions of higher education;
(I) make recommendations to improve Federal efforts
relating to mental and behavioral health promotion on
campuses of institutions of higher education and to ensure
Federal efforts are consistent with available standards,
evidence, and other programs in existence as of the date of
enactment of this Act;
(J) monitor Federal progress in meeting specific mental and
behavioral health promotion goals as they relate to settings
of institutions of higher education; and
(K) examine and disseminate best practices related to
intracampus sharing of treatment records;
(2) consult with national organizations with expertise in
mental and behavioral health, especially those organizations
working with the age population of students attending
institutions of higher education; and
(3) consult with and seek input from mental health
professionals working on campuses of institutions of higher
education as appropriate.
(e) Meetings.--
(1) In general.--The Task Force shall meet not fewer than
three times each year.
(2) Annual conference.--The Secretary shall sponsor an
annual conference on mental and behavioral health in settings
of institutions of higher education to enhance coordination,
build partnerships, and share best practices in mental and
behavioral health promotion, data collection, analysis, and
services.
(f) Definition.--In this section, the term ``institution of
higher education'' has the meaning given such term in section
101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
(g) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $1,000,000
for the period of fiscal years 2018 through 2022.
SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAMPUSES.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.) is amended by adding at the end the
following:
``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND
EDUCATION ON COLLEGE CAMPUSES.
``(a) Purpose.--It is the purpose of this section to
increase access to, and reduce the stigma associated with,
mental health services to ensure that students at
institutions of higher education have the support necessary
to successfully complete their studies.
``(b) National Public Education Campaign.--The Secretary,
acting through the Assistant Secretary and in collaboration
with the Director of the Centers for Disease Control and
Prevention, shall convene an interagency, public-private
sector working group to plan, establish, and begin
coordinating and evaluating a targeted public education
campaign that is designed to focus on mental and behavioral
health on the campuses of institutions of higher education.
Such campaign shall be designed to--
``(1) improve the general understanding of mental health
and mental disorders;
``(2) encourage help-seeking behaviors relating to the
promotion of mental health, prevention of mental disorders,
and treatment of such disorders;
``(3) make the connection between mental and behavioral
health and academic success; and
``(4) assist the general public in identifying the early
warning signs and reducing the stigma of mental illness.
``(c) Composition.--The working group convened under
subsection (b) shall include--
``(1) mental health consumers, including students and
family members;
``(2) representatives of institutions of higher education;
``(3) representatives of national mental and behavioral
health associations and associations of institutions of
higher education;
``(4) representatives of health promotion and prevention
organizations at institutions of higher education;
``(5) representatives of mental health providers, including
community mental health centers; and
``(6) representatives of private-sector and public-sector
groups with experience in the development of effective public
health education campaigns.
``(d) Plan.--The working group under subsection (b) shall
develop a plan that--
``(1) targets promotional and educational efforts to the
age population of students at institutions of higher
education and individuals who are employed in settings of
institutions of higher education, including through the use
of roundtables;
``(2) develops and proposes the implementation of research-
based public health messages and activities;
``(3) provides support for local efforts to reduce stigma
by using the National Health Information Center as a primary
point of contact for information, publications, and service
program referrals; and
``(4) develops and proposes the implementation of a social
marketing campaign that is targeted at the population of
students attending institutions of higher education and
individuals who are employed in settings of institutions of
higher education.
``(e) Definition.--In this section, the term `institution
of higher education' has the meaning given such term in
section 101 of the Higher Education Act of 1965 (20 U.S.C.
1001).
``(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $1,000,000
for the period of fiscal years 2018 through 2022.''.
TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR
CHILDREN AND ADOLESCENTS
SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
DISTURBANCE.
(a) Comprehensive Community Mental Health Services for
Children With a Serious Emotional Disturbance.--Section
561(a)(1) of the Public Health Service Act (42 U.S.C.
290ff(a)(1)) is amended by inserting ``, which may include
efforts to identify and serve children at risk'' before the
period.
(b) Requirements With Respect to Carrying Out Purpose of
Grants.--Section 562(b) of the Public Health Service Act (42
U.S.C. 290ff-1(b)) is amended by striking ``will not provide
an individual with access to the system if the individual is
more than 21 years of age'' and inserting ``will provide an
individual with access to the system through the age of 21
years''.
(c) Additional Provisions.--Section 564(f) of the Public
Health Service Act (42 U.S.C. 290ff-
[[Page H6958]]
3(f)) is amended by inserting ``(and provide a copy to the
State involved)'' after ``to the Secretary''.
(d) General Provisions.--Section 565 of the Public Health
Service Act (42 U.S.C. 290ff-4) is amended--
(1) in subsection (b)(1)--
(A) in the matter preceding subparagraph (A), by striking
``receiving a grant under section 561(a)'' and inserting ``,
regardless of whether such public entity is receiving a grant
under section 561(a)''; and
(B) in subparagraph (B), by striking ``pursuant to'' and
inserting ``described in'';
(2) in subsection (d)(1), by striking ``not more than 21
years of age'' and inserting ``through the age of 21 years'';
and
(3) in subsection (f)(1), by striking ``$100,000,000 for
fiscal year 2001, and such sums as may be necessary for each
of the fiscal years 2002 and 2003'' and inserting
``$119,026,000 for each of fiscal years 2018 through 2022''.
SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH
CARE.
Title III of the Public Health Service Act is amended by
inserting after section 330L of such Act (42 U.S.C. 254c-18)
the following new section:
``SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
``(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration and in coordination with other relevant
Federal agencies, shall award grants to States, political
subdivisions of States, and Indian tribes and tribal
organizations (for purposes of this section, as such terms
are defined in section 4 of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b)) to promote
behavioral health integration in pediatric primary care by--
``(1) supporting the development of statewide or regional
pediatric mental health care telehealth access programs; and
``(2) supporting the improvement of existing statewide or
regional pediatric mental health care telehealth access
programs.
``(b) Program Requirements.--
``(1) In general.--A pediatric mental health care
telehealth access program referred to in subsection (a), with
respect to which a grant under such subsection may be used,
shall--
``(A) be a statewide or regional network of pediatric
mental health teams that provide support to pediatric primary
care sites as an integrated team;
``(B) support and further develop organized State or
regional networks of pediatric mental health teams to provide
consultative support to pediatric primary care sites;
``(C) conduct an assessment of critical behavioral
consultation needs among pediatric providers and such
providers' preferred mechanisms for receiving consultation,
training, and technical assistance;
``(D) develop an online database and communication
mechanisms, including telehealth, to facilitate consultation
support to pediatric practices;
``(E) provide rapid statewide or regional clinical
telephone or telehealth consultations when requested between
the pediatric mental health teams and pediatric primary care
providers;
``(F) conduct training and provide technical assistance to
pediatric primary care providers to support the early
identification, diagnosis, treatment, and referral of
children with behavioral health conditions;
``(G) provide information to pediatric providers about, and
assist pediatric providers in accessing, pediatric mental
health care providers, including child and adolescent
psychiatrists, and licensed mental health professionals, such
as psychologists, social workers, or mental health counselors
and in scheduling and conducting technical assistance;
``(H) assist with referrals to specialty care and community
or behavioral health resources; and
``(I) establish mechanisms for measuring and monitoring
increased access to pediatric mental health care services by
pediatric primary care providers and expanded capacity of
pediatric primary care providers to identify, treat, and
refer children with mental health problems.
``(2) Pediatric mental health teams.--In this subsection,
the term `pediatric mental health team' means a team
consisting of at least one case coordinator, at least one
child and adolescent psychiatrist, and at least one licensed
clinical mental health professional, such as a psychologist,
social worker, or mental health counselor. Such a team may be
regionally based.
``(c) Application.--A State, political subdivision of a
State, Indian tribe, or tribal organization seeking a grant
under this section shall submit an application to the
Secretary at such time, in such manner, and containing such
information as the Secretary may require, including a plan
for the comprehensive evaluation of activities that are
carried out with funds received under such grant.
``(d) Evaluation.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under this section shall prepare and submit an
evaluation of activities that are carried out with funds
received under such grant to the Secretary at such time, in
such manner, and containing such information as the Secretary
may reasonably require, including a process and outcome
evaluation.
``(e) Access to Broadband.--In administering grants under
this section, the Secretary may coordinate with other
agencies to ensure that funding opportunities are available
to support access to reliable, high-speed Internet for
providers.
``(f) Matching Requirement.--The Secretary may not award a
grant under this section unless the State, political
subdivision of a State, Indian tribe, or tribal organization
involved agrees, with respect to the costs to be incurred by
the State, political subdivision of a State, Indian tribe, or
tribal organization in carrying out the purpose described in
this section, to make available non-Federal contributions (in
cash or in kind) toward such costs in an amount that is not
less than 20 percent of Federal funds provided in the grant.
``(g) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated, $9,000,000
for the period of fiscal years 2018 through 2022.''.
SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
INTERVENTION SERVICES FOR CHILDREN AND
ADOLESCENTS.
The first section 514 of the Public Health Service Act (42
U.S.C. 290bb-7), relating to substance abuse treatment
services for children and adolescents, is amended--
(1) in the section heading, by striking ``abuse treatment''
and inserting ``use disorder treatment and early
intervention'';
(2) by striking subsection (a) and inserting the following:
``(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to public and private
nonprofit entities, including Indian tribes or tribal
organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act), or
health facilities or programs operated by or in accordance
with a contract or grant with the Indian Health Service, for
the purpose of--
``(1) providing early identification and services to meet
the needs of children and adolescents who are at risk of
substance use disorders;
``(2) providing substance use disorder treatment services
for children, including children and adolescents with co-
occurring mental illness and substance use disorders; and
``(3) providing assistance to pregnant women, and parenting
women, with substance use disorders, in obtaining treatment
services, linking mothers to community resources to support
independent family lives, and staying in recovery so that
children are in safe, stable home environments and receive
appropriate health care services.'';
(3) in subsection (b)--
(A) by striking paragraph (1) and inserting the following:
``(1) apply evidence-based and cost-effective methods;'';
(B) in paragraph (2)--
(i) by striking ``treatment''; and
(ii) by inserting ``substance abuse,'' after ``child
welfare,'';
(C) in paragraph (3), by striking ``substance abuse
disorders'' and inserting ``substance use disorders,
including children and adolescents with co-occurring mental
illness and substance use disorders,'';
(D) in paragraph (5), by striking ``treatment;'' and
inserting ``services; and'';
(E) in paragraph (6), by striking ``substance abuse
treatment; and'' and inserting ``treatment.''; and
(F) by striking paragraph (7); and
(4) in subsection (f), by striking ``$40,000,000'' and all
that follows through the period and inserting ``$29,605,000
for each of fiscal years 2018 through 2022.''.
SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
The first section 582 of the Public Health Service Act (42
U.S.C. 290hh-1; relating to grants to address the problems of
persons who experience violence related stress) is amended--
(1) in subsection (a), by striking ``developing programs''
and all that follows through the period at the end and
inserting the following: ``developing and maintaining
programs that provide for--
``(1) the continued operation of the National Child
Traumatic Stress Initiative (referred to in this section as
the `NCTSI'), which includes a cooperative agreement with a
coordinating center, that focuses on the mental, behavioral,
and biological aspects of psychological trauma response,
prevention of the long-term consequences of child trauma, and
early intervention services and treatment to address the
long-term consequences of child trauma; and
``(2) the development of knowledge with regard to evidence-
based practices for identifying and treating mental,
behavioral, and biological disorders of children and youth
resulting from witnessing or experiencing a traumatic
event.'';
(2) in subsection (b)--
(A) by striking ``subsection (a) related'' and inserting
``subsection (a)(2) (related'';
(B) by striking ``treating disorders associated with
psychological trauma'' and inserting ``treating mental,
behavioral, and biological disorders associated with
psychological trauma)''; and
(C) by striking ``mental health agencies and programs that
have established clinical and basic research'' and inserting
``universities, hospitals, mental health agencies, and other
programs that have established clinical expertise and
research'';
(3) by redesignating subsections (c) through (g) as
subsections (g) through (k), respectively;
(4) by inserting after subsection (b), the following:
``(c) Child Outcome Data.--The NCTSI coordinating center
described in subsection (a)(1) shall collect, analyze,
report, and make publicly available, as appropriate, NCTSI-
wide child treatment process and outcome data regarding the
early identification and delivery of evidence-based treatment
and services for children and families served by the NCTSI
grantees.
``(d) Training.--The NCTSI coordinating center shall
facilitate the coordination of training initiatives in
evidence-based and trauma-informed treatments, interventions,
and practices offered to NCTSI grantees, providers, and
partners.
``(e) Dissemination and Collaboration.--The NCTSI
coordinating center shall, as appropriate, collaborate with--
[[Page H6959]]
``(1) the Secretary, in the dissemination of evidence-based
and trauma-informed interventions, treatments, products, and
other resources to appropriate stakeholders; and
``(2) appropriate agencies that conduct or fund research
within the Department of Health and Human Services, for
purposes of sharing NCTSI expertise, evaluation data, and
other activities, as appropriate.
``(f) Review.--The Secretary shall, consistent with the
peer-review process, ensure that NCTSI applications are
reviewed by appropriate experts in the field as part of a
consensus-review process. The Secretary shall include review
criteria related to expertise and experience in child trauma
and evidence-based practices.'';
(5) in subsection (g) (as so redesignated), by striking
``with respect to centers of excellence are distributed
equitably among the regions of the country'' and inserting
``are distributed equitably among the regions of the United
States'';
(6) in subsection (i) (as so redesignated), by striking
``recipient may not exceed 5 years'' and inserting
``recipient shall not be less than 4 years, but shall not
exceed 5 years''; and
(7) in subsection (j) (as so redesignated), by striking
``$50,000,000'' and all that follows through ``2006'' and
inserting ``$46,887,000 for each of fiscal years 2018 through
2022''.
SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section
317L (42 U.S.C. 247b-13) the following:
``SEC. 317L-1. SCREENING AND TREATMENT FOR MATERNAL
DEPRESSION.
``(a) Grants.--The Secretary shall make grants to States to
establish, improve, or maintain programs for screening,
assessment, and treatment services, including culturally and
linguistically appropriate services, as appropriate, for
women who are pregnant, or who have given birth within the
preceding 12 months, for maternal depression.
``(b) Application.--To seek a grant under this section, a
State shall submit an application to the Secretary at such
time, in such manner, and containing such information as the
Secretary may require. At a minimum, any such application
shall include explanations of--
``(1) how a program, or programs, will increase the
percentage of women screened and treated, as appropriate, for
maternal depression in 1 or more communities; and
``(2) how a program, or programs, if expanded, would
increase access to screening and treatment services for
maternal depression.
``(c) Priority.--In awarding grants under this section, the
Secretary may give priority to States proposing to improve or
enhance access to screening services for maternal depression
in primary care settings.
``(d) Use of Funds.--The activities eligible for funding
through a grant under subsection (a)--
``(1) shall include--
``(A) providing appropriate training to health care
providers; and
``(B) providing information to health care providers,
including information on maternal depression screening,
treatment, and followup support services, and linkages to
community-based resources; and
``(2) may include--
``(A) enabling health care providers (including
obstetrician-gynecologists, pediatricians, psychiatrists,
mental health care providers, and adult primary care
clinicians) to provide or receive real-time psychiatric
consultation (in-person or remotely) to aid in the treatment
of pregnant and parenting women;
``(B) establishing linkages with and among community-based
resources, including mental health resources, primary care
resources, and support groups; and
``(C) utilizing telehealth services for rural areas and
medically underserved areas (as defined in section 330I(a)).
``(e) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $5,000,000
for each of fiscal years 2018 through 2022.''.
SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH
PROMOTION, INTERVENTION, AND TREATMENT.
Part Q of title III of the Public Health Service Act (42
U.S.C. 280h et seq.) is amended by adding at the end the
following:
``SEC. 399Z-2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH
PROMOTION, INTERVENTION, AND TREATMENT.
``(a) Grants.--The Secretary shall--
``(1) award grants to eligible entities to develop,
maintain, or enhance infant and early childhood mental health
promotion, intervention, and treatment programs, including--
``(A) programs for infants and children at significant risk
of developing, showing early signs of, or having been
diagnosed with mental illness, including a serious emotional
disturbance; and
``(B) multigenerational therapy and other services that
support the caregiving relationship; and
``(2) ensure that programs funded through grants under this
section are evidence-informed or evidence-based models,
practices, and methods that are, as appropriate, culturally
and linguistically appropriate, and can be replicated in
other appropriate settings.
``(b) Eligible Children and Entities.--In this section:
``(1) Eligible child.--The term `eligible child' means a
child from birth to not more than 12 years of age who--
``(A) is at risk for, shows early signs of, or has been
diagnosed with a mental illness, including a serious
emotional disturbance; and
``(B) may benefit from infant and early childhood
intervention or treatment programs or specialized preschool
or elementary school programs that are evidence-based or that
have been scientifically demonstrated to show promise but
would benefit from further applied development.
``(2) Eligible entity.--The term `eligible entity' means a
human services agency or nonprofit institution that--
``(A) employs licensed mental health professionals who have
specialized training and experience in infant and early
childhood mental health assessment, diagnosis, and treatment,
or is accredited or approved by the appropriate State agency,
as applicable, to provide for children from infancy to 12
years of age mental health promotion, intervention, or
treatment services; and
``(B) provides services or programs described in subsection
(a) that are evidence-based or that have been scientifically
demonstrated to show promise but would benefit from further
applied development.
``(c) Application.--An eligible entity seeking a grant
under subsection (a) shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require.
``(d) Use of Funds for Early Intervention and Treatment
Programs.--An eligible entity may use amounts awarded under a
grant under subsection (a)(1) to carry out the following:
``(1) Provide age-appropriate mental health promotion and
early intervention services or mental illness treatment
services, which may include specialized programs, for
eligible children at significant risk of developing, showing
early signs of, or having been diagnosed with a mental
illness, including a serious emotional disturbance. Such
services may include social and behavioral services as well
as multigenerational therapy and other services that support
the caregiving relationship.
``(2) Provide training for health care professionals with
expertise in infant and early childhood mental health care
with respect to appropriate and relevant integration with
other disciplines such as primary care clinicians, early
intervention specialists, child welfare staff, home visitors,
early care and education providers, and others who work with
young children and families.
``(3) Provide mental health consultation to personnel of
early care and education programs (including licensed or
regulated center-based and home-based child care, home
visiting, preschool special education, and early intervention
programs) who work with children and families.
``(4) Provide training for mental health clinicians in
infant and early childhood in promising and evidence-based
practices and models for infant and early childhood mental
health treatment and early intervention, including with
regard to practices for identifying and treating mental
illness and behavioral disorders of infants and children
resulting from exposure or repeated exposure to adverse
childhood experiences or childhood trauma.
``(5) Provide age-appropriate assessment, diagnostic, and
intervention services for eligible children, including early
mental health promotion, intervention, and treatment
services.
``(e) Matching Funds.--The Secretary may not award a grant
under this section to an eligible entity unless the eligible
entity agrees, with respect to the costs to be incurred by
the eligible entity in carrying out the activities described
in subsection (d), to make available non-Federal
contributions (in cash or in kind) toward such costs in an
amount that is not less than 10 percent of the total amount
of Federal funds provided in the grant.
``(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $20,000,000
for the period of fiscal years 2018 through 2022.''.
TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA
SEC. 11001. SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) According to the National Survey on Drug Use and
Health, in 2015, there were approximately 9,800,000 adults in
the United States with serious mental illness.
(2) The Substance Abuse and Mental Health Services
Administration defines the term ``serious mental illness'' as
an illness affecting individuals 18 years of age or older as
having, at any time in the past year, a diagnosable mental,
behavioral, or emotional disorder that results in serious
functional impairment and substantially interferes with or
limits one or more major life activities.
(3) In reporting on the incidence of serious mental
illness, the Substance Abuse and Mental Health Services
Administration includes major depression, schizophrenia,
bipolar disorder, and other mental disorders that cause
serious impairment.
(4) Adults with a serious mental illness are at a higher
risk for chronic physical illnesses and premature death.
(5) According to the World Health Organization, adults with
a serious mental illness have lifespans that are 10 to 25
years shorter than those without serious mental illness. The
vast majority of these deaths are due to chronic physical
medical conditions, such as cardiovascular, respiratory, and
infectious diseases, as well as diabetes and hypertension.
(6) According to the World Health Organization, the
majority of deaths of adults with a serious mental illness
that are due to physical medical conditions are preventable.
(7) Supported decision making can facilitate care decisions
in areas where serious mental illness may impact the capacity
of an individual to determine a course of treatment while
still allowing the individual to make decisions
independently.
(8) Help should be provided to adults with a serious mental
illness to address their acute or chronic physical illnesses,
make informed choices about treatment, and understand and
follow through with appropriate treatment.
[[Page H6960]]
(9) There is confusion in the health care community
regarding permissible practices under the regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996 (commonly known as ``HIPAA'').
This confusion may hinder appropriate communication of health
care information or treatment preferences with appropriate
caregivers.
(b) Sense of Congress.--It is the sense of Congress that
clarification is needed regarding the privacy rule
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note) regarding existing permitted uses and disclosures of
health information by health care professionals to
communicate with caregivers of adults with a serious mental
illness to facilitate treatment.
SEC. 11002. CONFIDENTIALITY OF RECORDS.
Not later than 1 year after the date on which the Secretary
of Health and Human Services (in this title referred to as
the ``Secretary'') first finalizes regulations updating part
2 of title 42, Code of Federal Regulations, relating to
confidentiality of alcohol and drug abuse patient records,
after the date of enactment of this Act, the Secretary shall
convene relevant stakeholders to determine the effect of such
regulations on patient care, health outcomes, and patient
privacy.
SEC. 11003. CLARIFICATION ON PERMITTED USES AND DISCLOSURES
OF PROTECTED HEALTH INFORMATION.
(a) In General.--The Secretary, acting through the Director
of the Office for Civil Rights, shall ensure that health care
providers, professionals, patients and their families, and
others involved in mental or substance use disorder treatment
have adequate, accessible, and easily comprehensible
resources relating to appropriate uses and disclosures of
protected health information under the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note).
(b) Guidance.--
(1) Issuance.--In carrying out subsection (a), not later
than 1 year after the date of enactment of this section, the
Secretary shall issue guidance clarifying the circumstances
under which, consistent with regulations promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, a health care provider or covered
entity may use or disclose protected health information.
(2) Circumstances addressed.--The guidance issued under
this section shall address circumstances including those
that--
(A) require the consent of the patient;
(B) require providing the patient with an opportunity to
object;
(C) are based on the exercise of professional judgment
regarding whether the patient would object when the
opportunity to object cannot practicably be provided because
of the incapacity of the patient or an emergency treatment
circumstance; and
(D) are determined, based on the exercise of professional
judgment, to be in the best interest of the patient when the
patient is not present or otherwise incapacitated.
(3) Communication with family members and caregivers.--In
addressing the circumstances described in paragraph (2), the
guidance issued under this section shall clarify permitted
uses or disclosures of protected health information for
purposes of--
(A) communicating with a family member of the patient,
caregiver of the patient, or other individual, to the extent
that such family member, caregiver, or individual is involved
in the care of the patient;
(B) in the case that the patient is an adult, communicating
with a family member of the patient, caregiver of the
patient, or other individual involved in the care of the
patient;
(C) in the case that the patient is a minor, communicating
with the parent or caregiver of the patient;
(D) involving the family members or caregivers of the
patient, or others involved in the patient's care or care
plan, including facilitating treatment and medication
adherence;
(E) listening to the patient, or receiving information with
respect to the patient from the family or caregiver of the
patient;
(F) communicating with family members of the patient,
caregivers of the patient, law enforcement, or others when
the patient presents a serious and imminent threat of harm to
self or others; and
(G) communicating to law enforcement and family members or
caregivers of the patient about the admission of the patient
to receive care at, or the release of a patient from, a
facility for an emergency psychiatric hold or involuntary
treatment.
SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING
PROGRAMS.
(a) Initial Programs and Materials.--Not later than 1 year
after the date of the enactment of this Act, the Secretary,
in consultation with appropriate experts, shall identify the
following model programs and materials, or (in the case that
no such programs or materials exist) recognize private or
public entities to develop and disseminate each of the
following:
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, including child and adolescent psychiatrists,
psychologists, counselors, therapists, nurse practitioners,
physician assistants, behavioral health facilities and
clinics, care managers, and hospitals, including individuals
such as general counsels or regulatory compliance staff who
are responsible for establishing provider privacy policies)
regarding the permitted uses and disclosures, consistent with
the standards governing the privacy and security of
individually identifiable health information promulgated by
the Secretary under part C of title XI of the Social Security
Act (42 U.S.C. 1320d et seq.) and regulations promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and such
part C, of the protected health information of patients
seeking or undergoing mental or substance use disorder
treatment.
(2) A model program and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations specified in
paragraph (1).
(b) Periodic Updates.--The Secretary shall--
(1) periodically review and update the model programs and
materials identified or developed under subsection (a); and
(2) disseminate the updated model programs and materials to
the individuals described in subsection (a).
(c) Coordination.--The Secretary shall carry out this
section in coordination with the Director of the Office for
Civil Rights within the Department of Health and Human
Services, the Assistant Secretary for Mental Health and
Substance Use, the Administrator of the Health Resources and
Services Administration, and the heads of other relevant
agencies within the Department of Health and Human Services.
(d) Input of Certain Entities.--In identifying, reviewing,
or updating the model programs and materials under
subsections (a) and (b), the Secretary shall solicit the
input of relevant national, State, and local associations;
medical societies; licensing boards; providers of mental and
substance use disorder treatment; organizations with
expertise on domestic violence, sexual assault, elder abuse,
and child abuse; and organizations representing patients and
consumers and the families of patients and consumers.
(e) Funding.--There are authorized to be appropriated to
carry out this section--
(1) $4,000,000 for fiscal year 2018;
(2) $2,000,000 for each of fiscal years 2019 and 2020; and
(3) $1,000,000 for each of fiscal years 2021 and 2022.
TITLE XII--MEDICAID MENTAL HEALTH COVERAGE
SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COVERAGE
OF MENTAL HEALTH SERVICES AND PRIMARY CARE
SERVICES FURNISHED ON THE SAME DAY.
Nothing in title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) shall be construed as prohibiting separate
payment under the State plan under such title (or under a
waiver of the plan) for the provision of a mental health
service or primary care service under such plan, with respect
to an individual, because such service is--
(1) a primary care service furnished to the individual by a
provider at a facility on the same day a mental health
service is furnished to such individual by such provider (or
another provider) at the facility; or
(2) a mental health service furnished to the individual by
a provider at a facility on the same day a primary care
service is furnished to such individual by such provider (or
another provider) at the facility.
SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE
REGULATION.
(a) Study.--The Secretary of Health and Human Services,
acting through the Administrator of the Centers for Medicare
& Medicaid Services, shall conduct a study on coverage under
the Medicaid program under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) of services provided through a
medicaid managed care organization (as defined in section
1903(m) of such Act (42 U.S.C. 1396b(m)) or a prepaid
inpatient health plan (as defined in section 438.2 of title
42, Code of Federal Regulations (or any successor
regulation)) with respect to individuals over the age of 21
and under the age of 65 for the treatment of a mental health
disorder in institutions for mental diseases (as defined in
section 1905(i) of such Act (42 U.S.C. 1396d(i))). Such study
shall include information on the following:
(1) The extent to which States, including the District of
Columbia and each territory or possession of the United
States, are providing capitated payments to such
organizations or plans for enrollees who are receiving
services in institutions for mental diseases.
(2) The number of individuals receiving medical assistance
under a State plan under such title XIX, or a waiver of such
plan, who receive services in institutions for mental
diseases through such organizations and plans.
(3) The range of and average number of months, and the
length of stay during such months, that such individuals are
receiving such services in such institutions.
(4) How such organizations or plans determine when to
provide for the furnishing of such services through an
institution for mental diseases in lieu of other benefits
(including the full range of community-based services) under
their contract with the State agency administering the State
plan under such title XIX, or a waiver of such plan, to
address psychiatric or substance use disorder treatment.
(5) The extent to which the provision of services within
such institutions has affected the capitated payments for
such organizations or plans.
(b) Report.--Not later than 3 years after the date of the
enactment of this Act, the Secretary shall submit to Congress
a report on the study conducted under subsection (a).
SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVATION.
Not later than 1 year after the date of the enactment of
this Act, the Administrator of the Centers for Medicare &
Medicaid Services shall issue a State Medicaid Director
letter regarding opportunities to design innovative service
delivery systems, including systems for providing
[[Page H6961]]
community-based services, for adults with a serious mental
illness or children with a serious emotional disturbance who
are receiving medical assistance under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.). The letter
shall include opportunities for demonstration projects under
section 1115 of such Act (42 U.S.C. 1315) to improve care for
such adults and children.
SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY
PSYCHIATRIC DEMONSTRATION PROJECT.
(a) Collection of Information.--The Secretary of Health and
Human Services, acting through the Administrator of the
Centers for Medicare & Medicaid Services, shall, to the
extent practical and data is available, with respect to each
State that has participated in the demonstration project
established under section 2707 of the Patient Protection and
Affordable Care Act (42 U.S.C. 1396a note), collect from each
such State information on the following:
(1) The number of institutions for mental diseases (as
defined in section 1905(i) of the Social Security Act (42
U.S.C. 1396d(i))) and beds in such institutions that received
payment for the provision of services to individuals who
receive medical assistance under a State plan under the
Medicaid program under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.) (or under a waiver of such plan)
through the demonstration project in each such State as
compared to the total number of institutions for mental
diseases and beds in the State.
(2) The extent to which there is a reduction in
expenditures under the Medicaid program under title XIX of
the Social Security Act (42 U.S.C. 1396 et seq.) or other
spending on the full continuum of physical or mental health
care for individuals who receive treatment in an institution
for mental diseases under the demonstration project,
including outpatient, inpatient, emergency, and ambulatory
care, that is attributable to such individuals receiving
treatment in institutions for mental diseases under the
demonstration project.
(3) The number of forensic psychiatric hospitals, the
number of beds in such hospitals, and the number of forensic
psychiatric beds in other hospitals in such State, based on
the most recent data available, to the extent practical, as
determined by such Administrator.
(4) The amount of any disproportionate share hospital
payments under section 1923 of the Social Security Act (42
U.S.C. 1396r-4) that institutions for mental diseases in the
State received during the period beginning on July 1, 2012,
and ending on June 30, 2015, and the extent to which the
demonstration project reduced the amount of such payments.
(5) The most recent data regarding all facilities or sites
in the State in which any adults with a serious mental
illness who are receiving medical assistance under a State
plan under the Medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) (or under a waiver of
such plan) are treated during the period referred to in
paragraph (4), to the extent practical, as determined by the
Administrator, including--
(A) the types of such facilities or sites (such as an
institution for mental diseases, a hospital emergency
department, or other inpatient hospital);
(B) the average length of stay in such a facility or site
by such an individual, disaggregated by facility type; and
(C) the payment rate under the State plan (or a waivers of
such plan) for services furnished to such an individual for
that treatment, disaggregated by facility type, during the
period in which the demonstration project is in operation.
(6) The extent to which the utilization of hospital
emergency departments during the period in which the
demonstration project was is in operation differed, with
respect to individuals who are receiving medical assistance
under a State plan under the Medicaid program under title XIX
of the Social Security Act (42 U.S.C. 1396 et seq.) (or under
a waiver of such plan), between--
(A) those individuals who received treatment in an
institution for mental diseases under the demonstration
project;
(B) those individuals who met the eligibility requirements
for the demonstration project but who did not receive
treatment in an institution for mental diseases under the
demonstration project; and
(C) those adults with a serious mental illness who did not
meet such eligibility requirements and did not receive
treatment for such illness in an institution for mental
diseases.
(b) Report.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall submit to Congress a report that summarizes
and analyzes the information collected under subsection (a).
Such report may be submitted as part of the report required
under section 2707(f) of the Patient Protection and
Affordable Care Act (42 U.S.C. 1396a note) or separately.
SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS.
(a) In General.--Section 1905(a)(16) of the Social Security
Act (42 U.S.C. 1396d(a)(16)) is amended--
(1) by striking ``effective January 1, 1973'' and inserting
``(A) effective January 1, 1973''; and
(2) by inserting before the semicolon at the end the
following: ``, and, (B) for individuals receiving services
described in subparagraph (A), early and periodic screening,
diagnostic, and treatment services (as defined in subsection
(r)), whether or not such screening, diagnostic, and
treatment services are furnished by the provider of the
services described in such subparagraph''.
(b) Effective Date.--The amendments made by subsection (a)
shall apply with respect to items and services furnished in
calendar quarters beginning on or after January 1, 2019.
SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
PERSONAL CARE SERVICES AND HOME HEALTH CARE
SERVICES UNDER MEDICAID.
(a) In General.--Section 1903 of the Social Security Act
(42 U.S.C. 1396b) is amended by inserting after subsection
(k) the following new subsection:
``(l)(1) Subject to paragraphs (3) and (4), with respect to
any amount expended for personal care services or home health
care services requiring an in-home visit by a provider that
are provided under a State plan under this title (or under a
waiver of the plan) and furnished in a calendar quarter
beginning on or after January 1, 2019 (or, in the case of
home health care services, on or after January 1, 2023),
unless a State requires the use of an electronic visit
verification system for such services furnished in such
quarter under the plan or such waiver, the Federal medical
assistance percentage shall be reduced--
``(A) in the case of personal care services--
``(i) for calendar quarters in 2019 and 2020, by .25
percentage points;
``(ii) for calendar quarters in 2021, by .5 percentage
points;
``(iii) for calendar quarters in 2022, by .75 percentage
points; and
``(iv) for calendar quarters in 2023 and each year
thereafter, by 1 percentage point; and
``(B) in the case of home health care services--
``(i) for calendar quarters in 2023 and 2024, by .25
percentage points;
``(ii) for calendar quarters in 2025, by .5 percentage
points;
``(iii) for calendar quarters in 2026, by .75 percentage
points; and
``(iv) for calendar quarters in 2027 and each year
thereafter, by 1 percentage point.
``(2) Subject to paragraphs (3) and (4), in implementing
the requirement for the use of an electronic visit
verification system under paragraph (1), a State shall--
``(A) consult with agencies and entities that provide
personal care services, home health care services, or both
under the State plan (or under a waiver of the plan) to
ensure that such system--
``(i) is minimally burdensome;
``(ii) takes into account existing best practices and
electronic visit verification systems in use in the State;
and
``(iii) is conducted in accordance with the requirements of
HIPAA privacy and security law (as defined in section 3009 of
the Public Health Service Act);
``(B) take into account a stakeholder process that includes
input from beneficiaries, family caregivers, individuals who
furnish personal care services or home health care services,
and other stakeholders, as determined by the State in
accordance with guidance from the Secretary; and
``(C) ensure that individuals who furnish personal care
services, home health care services, or both under the State
plan (or under a waiver of the plan) are provided the
opportunity for training on the use of such system.
``(3) Paragraphs (1) and (2) shall not apply in the case of
a State that, as of the date of the enactment of this
subsection, requires the use of any system for the electronic
verification of visits conducted as part of both personal
care services and home health care services, so long as the
State continues to require the use of such system with
respect to the electronic verification of such visits.
``(4)(A) In the case of a State described in subparagraph
(B), the reduction under paragraph (1) shall not apply--
``(i) in the case of personal care services, for calendar
quarters in 2019; and
``(ii) in the case of home health care services, for
calendar quarters in 2023.
``(B) For purposes of subparagraph (A), a State described
in this subparagraph is a State that demonstrates to the
Secretary that the State--
``(i) has made a good faith effort to comply with the
requirements of paragraphs (1) and (2) (including by taking
steps to adopt the technology used for an electronic visit
verification system); and
``(ii) in implementing such a system, has encountered
unavoidable system delays.
``(5) In this subsection:
``(A) The term `electronic visit verification system'
means, with respect to personal care services or home health
care services, a system under which visits conducted as part
of such services are electronically verified with respect
to--
``(i) the type of service performed;
``(ii) the individual receiving the service;
``(iii) the date of the service;
``(iv) the location of service delivery;
``(v) the individual providing the service; and
``(vi) the time the service begins and ends.
``(B) The term `home health care services' means services
described in section 1905(a)(7) provided under a State plan
under this title (or under a waiver of the plan).
``(C) The term `personal care services' means personal care
services provided under a State plan under this title (or
under a waiver of the plan), including services provided
under section 1905(a)(24), 1915(c), 1915(i), 1915(j), or
1915(k) or under a wavier under section 1115.
``(6)(A) In the case in which a State requires personal
care service and home health care service providers to
utilize an electronic visit verification system operated by
the State or a contractor on behalf of the State, the
Secretary shall pay to the State, for each quarter, an amount
equal to 90 per centum of so much of the sums expended during
such quarter as are attributable to the design, development,
or installation of such system, and 75 per centum of so much
of the sums for the operation and maintenance of such system.
``(B) Subparagraph (A) shall not apply in the case in which
a State requires personal care service and home health care
service providers
[[Page H6962]]
to utilize an electronic visit verification system that is
not operated by the State or a contractor on behalf of the
State.''.
(b) Collection and Dissemination of Best Practices.--Not
later than January 1, 2018, the Secretary of Health and Human
Services shall, with respect to electronic visit verification
systems (as defined in subsection (l)(5) of section 1903 of
the Social Security Act (42 U.S.C. 1396b), as inserted by
subsection (a)), collect and disseminate best practices to
State Medicaid Directors with respect to--
(1) training individuals who furnish personal care
services, home health care services, or both under the State
plan under title XIX of such Act (or under a waiver of the
plan) on such systems and the operation of such systems and
the prevention of fraud with respect to the provision of
personal care services or home health care services (as
defined in such subsection (l)(5)); and
(2) the provision of notice and educational materials to
family caregivers and beneficiaries with respect to the use
of such electronic visit verification systems and other means
to prevent such fraud.
(c) Rules of Construction.--
(1) No employer-employee relationship established.--Nothing
in the amendment made by this section may be construed as
establishing an employer-employee relationship between the
agency or entity that provides for personal care services or
home health care services and the individuals who, under a
contract with such an agency or entity, furnish such services
for purposes of part 552 of title 29, Code of Federal
Regulations (or any successor regulations).
(2) No particular or uniform electronic visit verification
system required.--Nothing in the amendment made by this
section shall be construed to require the use of a particular
or uniform electronic visit verification system (as defined
in subsection (l)(5) of section 1903 of the Social Security
Act (42 U.S.C. 1396b), as inserted by subsection (a)) by all
agencies or entities that provide personal care services or
home health care under a State plan under title XIX of the
Social Security Act (or under a waiver of the plan) (42
U.S.C. 1396 et seq.).
(3) No limits on provision of care.--Nothing in the
amendment made by this section may be construed to limit,
with respect to personal care services or home health care
services provided under a State plan under title XIX of the
Social Security Act (or under a waiver of the plan) (42
U.S.C. 1396 et seq.), provider selection, constrain
beneficiaries' selection of a caregiver, or impede the manner
in which care is delivered.
(4) No prohibition on state quality measures
requirements.--Nothing in the amendment made by this section
shall be construed as prohibiting a State, in implementing an
electronic visit verification system (as defined in
subsection (l)(5) of section 1903 of the Social Security Act
(42 U.S.C. 1396b), as inserted by subsection (a)), from
establishing requirements related to quality measures for
such system.
TITLE XIII--MENTAL HEALTH PARITY
SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND
SUBSTANCE USE DISORDER COVERAGE REQUIREMENTS.
(a) Compliance Program Guidance Document.--Section 2726(a)
of the Public Health Service Act (42 U.S.C. 300gg-26(a)) is
amended by adding at the end the following:
``(6) Compliance program guidance document.--
``(A) In general.--Not later than 12 months after the date
of enactment of the Helping Families in Mental Health Crisis
Reform Act of 2016, the Secretary, the Secretary of Labor,
and the Secretary of the Treasury, in consultation with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of Labor,
and the Inspector General of the Department of the Treasury,
shall issue a compliance program guidance document to help
improve compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, and section
9812 of the Internal Revenue Code of 1986, as applicable. In
carrying out this paragraph, the Secretaries may take into
consideration the 2016 publication of the Department of
Health and Human Services and the Department of Labor,
entitled `Warning Signs - Plan or Policy Non-Quantitative
Treatment Limitations (NQTLs) that Require Additional
Analysis to Determine Mental Health Parity Compliance'.
``(B) Examples illustrating compliance and noncompliance.--
``(i) In general.--The compliance program guidance document
required under this paragraph shall provide illustrative, de-
identified examples (that do not disclose any protected
health information or individually identifiable information)
of previous findings of compliance and noncompliance with
this section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable, based on investigations of
violations of such sections, including--
``(I) examples illustrating requirements for information
disclosures and nonquantitative treatment limitations; and
``(II) descriptions of the violations uncovered during the
course of such investigations.
``(ii) Nonquantitative treatment limitations.--To the
extent that any example described in clause (i) involves a
finding of compliance or noncompliance with regard to any
requirement for nonquantitative treatment limitations, the
example shall provide sufficient detail to fully explain such
finding, including a full description of the criteria
involved for approving medical and surgical benefits and the
criteria involved for approving mental health and substance
use disorder benefits.
``(iii) Access to additional information regarding
compliance.--In developing and issuing the compliance program
guidance document required under this paragraph, the
Secretaries specified in subparagraph (A)--
``(I) shall enter into interagency agreements with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of Labor,
and the Inspector General of the Department of the Treasury
to share findings of compliance and noncompliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable; and
``(II) shall seek to enter into an agreement with a State
to share information on findings of compliance and
noncompliance with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section 9812 of
the Internal Revenue Code of 1986, as applicable.
``(C) Recommendations.--The compliance program guidance
document shall include recommendations to advance compliance
with this section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, and encourage the
development and use of internal controls to monitor adherence
to applicable statutes, regulations, and program
requirements. Such internal controls may include illustrative
examples of nonquantitative treatment limitations on mental
health and substance use disorder benefits, which may fail to
comply with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section 9812 of
the Internal Revenue Code of 1986, as applicable, in relation
to nonquantitative treatment limitations on medical and
surgical benefits.
``(D) Updating the compliance program guidance document.--
The Secretary, the Secretary of Labor, and the Secretary of
the Treasury, in consultation with the Inspector General of
the Department of Health and Human Services, the Inspector
General of the Department of Labor, and the Inspector General
of the Department of the Treasury, shall update the
compliance program guidance document every 2 years to include
illustrative, de-identified examples (that do not disclose
any protected health information or individually identifiable
information) of previous findings of compliance and
noncompliance with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section 9812 of
the Internal Revenue Code of 1986, as applicable.''.
(b) Additional Guidance.--Section 2726(a) of the Public
Health Service Act (42 U.S.C. 300gg-26(a)), as amended by
subsection (a), is further amended by adding at the end the
following:
``(7) Additional guidance.--
``(A) In general.--Not later than 12 months after the date
of enactment of the Helping Families in Mental Health Crisis
Reform Act of 2016, the Secretary, the Secretary of Labor,
and the Secretary of the Treasury shall issue guidance to
group health plans and health insurance issuers offering
group or individual health insurance coverage to assist such
plans and issuers in satisfying the requirements of this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable.
``(B) Disclosure.--
``(i) Guidance for plans and issuers.--The guidance issued
under this paragraph shall include clarifying information and
illustrative examples of methods that group health plans and
health insurance issuers offering group or individual health
insurance coverage may use for disclosing information to
ensure compliance with the requirements under this section,
section 712 of the Employee Retirement Income Security Act of
1974, or section 9812 of the Internal Revenue Code of 1986,
as applicable, (and any regulations promulgated pursuant to
such sections, as applicable).
``(ii) Documents for participants, beneficiaries,
contracting providers, or authorized representatives.--The
guidance issued under this paragraph shall include clarifying
information and illustrative examples of methods that group
health plans and health insurance issuers offering group or
individual health insurance coverage may use to provide any
participant, beneficiary, contracting provider, or authorized
representative, as applicable, with documents containing
information that the health plans or issuers are required to
disclose to participants, beneficiaries, contracting
providers, or authorized representatives to ensure compliance
with this section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, compliance with any
regulation issued pursuant to such respective section, or
compliance with any other applicable law or regulation. Such
guidance shall include information that is comparative in
nature with respect to--
``(I) nonquantitative treatment limitations for both
medical and surgical benefits and mental health and substance
use disorder benefits;
``(II) the processes, strategies, evidentiary standards,
and other factors used to apply the limitations described in
subclause (I); and
``(III) the application of the limitations described in
subclause (I) to ensure that such limitations are applied in
parity with respect to both medical and surgical benefits and
mental health and substance use disorder benefits.
``(C) Nonquantitative treatment limitations.--The guidance
issued under this paragraph shall include clarifying
information and illustrative examples of methods, processes,
strategies, evidentiary standards, and other factors that
group health plans and health insurance issuers offering
group or individual health insurance coverage may use
regarding the development and application of nonquantitative
treatment limitations to ensure compliance with this section,
section 712 of the Employee Retirement Income Security Act of
1974, or section 9812
[[Page H6963]]
of the Internal Revenue Code of 1986, as applicable, (and any
regulations promulgated pursuant to such respective section),
including--
``(i) examples of methods of determining appropriate types
of nonquantitative treatment limitations with respect to both
medical and surgical benefits and mental health and substance
use disorder benefits, including nonquantitative treatment
limitations pertaining to--
``(I) medical management standards based on medical
necessity or appropriateness, or whether a treatment is
experimental or investigative;
``(II) limitations with respect to prescription drug
formulary design; and
``(III) use of fail-first or step therapy protocols;
``(ii) examples of methods of determining--
``(I) network admission standards (such as credentialing);
and
``(II) factors used in provider reimbursement methodologies
(such as service type, geographic market, demand for
services, and provider supply, practice size, training,
experience, and licensure) as such factors apply to network
adequacy;
``(iii) examples of sources of information that may serve
as evidentiary standards for the purposes of making
determinations regarding the development and application of
nonquantitative treatment limitations;
``(iv) examples of specific factors, and the evidentiary
standards used to evaluate such factors, used by such plans
or issuers in performing a nonquantitative treatment
limitation analysis;
``(v) examples of how specific evidentiary standards may be
used to determine whether treatments are considered
experimental or investigative;
``(vi) examples of how specific evidentiary standards may
be applied to each service category or classification of
benefits;
``(vii) examples of methods of reaching appropriate
coverage determinations for new mental health or substance
use disorder treatments, such as evidence-based early
intervention programs for individuals with a serious mental
illness and types of medical management techniques;
``(viii) examples of methods of reaching appropriate
coverage determinations for which there is an indirect
relationship between the covered mental health or substance
use disorder benefit and a traditional covered medical and
surgical benefit, such as residential treatment or
hospitalizations involving voluntary or involuntary
commitment; and
``(ix) additional illustrative examples of methods,
processes, strategies, evidentiary standards, and other
factors for which the Secretary determines that additional
guidance is necessary to improve compliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable.
``(D) Public comment.--Prior to issuing any final guidance
under this paragraph, the Secretary shall provide a public
comment period of not less than 60 days during which any
member of the public may provide comments on a draft of the
guidance.''.
(c) Availability of Plan Information.--
(1) Solicitation of public feedback.--Not later than 6
months after the date of enactment of this Act, the Secretary
of Health and Human Services, the Secretary of Labor, and the
Secretary of the Treasury shall solicit feedback from the
public on how the disclosure request process for documents
containing information that health plans or health insurance
issuers are required under Federal or State law to disclose
to participants, beneficiaries, contracting providers, or
authorized representatives to ensure compliance with existing
mental health parity and addiction equity requirements can be
improved while continuing to ensure consumers' rights to
access all information required by Federal or State law to be
disclosed.
(2) Public availability.--Not later than 12 months after
the date of the enactment of this Act, the Secretary of
Health and Human Services, the Secretary of Labor, and the
Secretary of the Treasury shall make such feedback publicly
available.
(3) NAIC.--The Secretary of Health and Human Services, the
Secretary of Labor, and the Secretary of the Treasury shall
share feedback obtained pursuant to paragraph (1) directly
with the National Association of Insurance Commissioners to
the extent such feedback includes recommendations for the
development of simplified information disclosure tools to
provide consistent information for consumers. Such feedback
may be taken into consideration by the National Association
of Insurance Commissioners and other appropriate entities for
the voluntary development and voluntary use of common
templates and other sample standardized forms to improve
consumer access to plan information.
(d) Improving Compliance.--
(1) In general.--In the case that the Secretary of Health
and Human Services, the Secretary of Labor, or the Secretary
of the Treasury determines that a group health plan or health
insurance issuer offering group or individual health
insurance coverage has violated, at least 5 times, section
2726 of the Public Health Service Act (42 U.S.C. 300gg-26),
section 712 of the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1185a), or section 9812 of the Internal
Revenue Code of 1986, respectively, the appropriate Secretary
shall audit plan documents for such health plan or issuer in
the plan year following the Secretary's determination in
order to help improve compliance with such section.
(2) Rule of construction.--Nothing in this subsection shall
be construed to limit the authority, as in effect on the day
before the date of enactment of this Act, of the Secretary of
Health and Human Services, the Secretary of Labor, or the
Secretary of the Treasury to audit documents of health plans
or health insurance issuers.
SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL
HEALTH AND SUBSTANCE USE DISORDER COVERAGE.
(a) Public Meeting.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall convene a public meeting of stakeholders
described in paragraph (2) to produce an action plan for
improved Federal and State coordination related to the
enforcement of section 2726 of the Public Health Service Act
(42 U.S.C. 300gg-26), section 712 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1185a), and section
9812 of the Internal Revenue Code of 1986, and any comparable
provisions of State law (in this section such sections and
provisions are collectively referred to as ``mental health
parity and addiction equity requirements'').
(2) Stakeholders.--The stakeholders described in this
paragraph shall include each of the following:
(A) The Federal Government, including representatives
from--
(i) the Department of Health and Human Services;
(ii) the Department of the Treasury;
(iii) the Department of Labor; and
(iv) the Department of Justice.
(B) State governments, including--
(i) State health insurance commissioners;
(ii) appropriate State agencies, including agencies on
public health or mental health; and
(iii) State attorneys general or other representatives of
State entities involved in the enforcement of mental health
parity and addiction equity requirements.
(C) Representatives from key stakeholder groups,
including--
(i) the National Association of Insurance Commissioners;
(ii) health insurance issuers;
(iii) providers of mental health and substance use disorder
treatment;
(iv) employers; and
(v) patients or their advocates.
(b) Action Plan.--Not later than 6 months after the
conclusion of the public meeting under subsection (a), the
Secretary of Health and Human Services shall finalize the
action plan described in such subsection and make it plainly
available on the Internet website of the Department of Health
and Human Services.
(c) Content.--The action plan under this section shall--
(1) take into consideration the recommendations of the
Mental Health and Substance Use Disorder Parity Task Force in
its final report issued in October of 2016, and any
subsequent Federal and State actions in relation to such
recommendations;
(2) reflect the input of the stakeholders participating in
the public meeting under subsection (a);
(3) identify specific strategic objectives regarding how
the various Federal and State agencies charged with
enforcement of mental health parity and addiction equity
requirements will collaborate to improve enforcement of such
requirements;
(4) provide a timeline for implementing the action plan;
and
(5) provide specific examples of how such objectives may be
met, which may include--
(A) providing common educational information and documents,
such as the Consumer Guide to Disclosure Rights, to patients
about their rights under mental health parity and addiction
equity requirements;
(B) facilitating the centralized collection of, monitoring
of, and response to patient complaints or inquiries relating
to mental health parity and addiction equity requirements,
which may be through the development and administration of--
(i) a single, toll-free telephone number; and
(ii) a new parity website--
(I) to help consumers find the appropriate Federal or State
agency to assist with their parity complaints, appeals, and
other actions; and
(II) that takes into consideration, but is not duplicative
of, the parity beta site being tested, and released for
public comment, by the Department of Health and Human
Services as of the date of the enactment of this Act;
(C) Federal and State law enforcement agencies entering
into memoranda of understanding to better coordinate
enforcement responsibilities and information sharing--
(i) including whether such agencies should make the results
of enforcement actions related to mental health parity and
addiction equity requirements publicly available; and
(ii) which may include State Policy Academies on Parity
Implementation for State Officials and other forums to bring
together national experts to provide technical assistance to
teams of State officials on strategies to advance compliance
with mental health parity and addiction equity requirements
in both the commercial market, and in the Medicaid program
under title XIX of the Social Security Act and the State
Children's Health Insurance Program under title XXI of such
Act; and
(D) recommendations to the Congress regarding the need for
additional legal authority to improve enforcement of mental
health parity and addiction equity requirements, including
the need for additional legal authority to ensure that
nonquantitative treatment limitations are applied, and the
extent and frequency of the applications of such limitations,
both to medical and surgical benefits and to mental health
and substance use disorder benefits in a comparable manner.
SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN
MENTAL HEALTH AND SUBSTANCE USE DISORDER
BENEFITS.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, and annually
[[Page H6964]]
thereafter for the subsequent 5 years, the Assistant
Secretary of Labor of the Employee Benefits Security
Administration, in collaboration with the Administrator of
the Centers for Medicare & Medicaid Services and the
Secretary of the Treasury, shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report summarizing the results of all closed Federal
investigations completed during the preceding 12-month period
with findings of any serious violation regarding compliance
with mental health and substance use disorder coverage
requirements under section 2726 of the Public Health Service
Act (42 U.S.C. 300gg-26), section 712 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1185a), and
section 9812 of the Internal Revenue Code of 1986.
(b) Contents.--Subject to subsection (c), a report under
subsection (a) shall, with respect to investigations
described in such subsection, include each of the following:
(1) The number of closed Federal investigations conducted
during the covered reporting period.
(2) Each benefit classification examined by any such
investigation conducted during the covered reporting period.
(3) Each subject matter, including compliance with
requirements for quantitative and nonquantitative treatment
limitations, of any such investigation conducted during the
covered reporting period.
(4) A summary of the basis of the final decision rendered
for each closed investigation conducted during the covered
reporting period that resulted in a finding of a serious
violation.
(c) Limitation.--Any individually identifiable information
shall be excluded from reports under subsection (a)
consistent with protections under the health privacy and
security rules promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42
U.S.C. 1320d-2 note).
SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND
SUBSTANCE USE DISORDER BENEFITS.
Not later than 3 years after the date of enactment of this
Act, the Comptroller General of the United States, in
consultation with the Secretary of Health and Human Services,
the Secretary of Labor, and the Secretary of the Treasury,
shall submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
detailing the extent to which group health plans or health
insurance issuers offering group or individual health
insurance coverage that provides both medical and surgical
benefits and mental health or substance use disorder
benefits, medicaid managed care organizations with a contract
under section 1903(m) of the Social Security Act (42 U.S.C.
1396b(m)), and health plans provided under the State
Children's Health Insurance Program under title XXI of the
Social Security Act (42 U.S.C. 1397aa et seq.) comply with
section 2726 of the Public Health Service Act (42 U.S.C.
300gg-26), section 712 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of
the Internal Revenue Code of 1986, including--
(1) how nonquantitative treatment limitations, including
medical necessity criteria, of such plans or issuers comply
with such sections;
(2) how the responsible Federal departments and agencies
ensure that such plans or issuers comply with such sections,
including an assessment of how the Secretary of Health and
Human Services has used its authority to conduct audits of
such plans to ensure compliance;
(3) a review of how the various Federal and State agencies
responsible for enforcing mental health parity requirements
have improved enforcement of such requirements in accordance
with the objectives and timeline described in the action plan
under section 13002; and
(4) recommendations for how additional enforcement,
education, and coordination activities by responsible Federal
and State departments and agencies could better ensure
compliance with such sections, including recommendations
regarding the need for additional legal authority.
SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS.
(a) Information.--The Secretary of Health and Human
Services, acting through the Director of the Office on
Women's Health, may--
(1) update information, related fact sheets, and resource
lists related to eating disorders that are available on the
public Internet website of the National Women's Health
Information Center sponsored by the Office on Women's Health,
to include--
(A) updated findings and current research related to eating
disorders, as appropriate; and
(B) information about eating disorders, including
information related to males and females;
(2) incorporate, as appropriate, and in coordination with
the Secretary of Education, information from publicly
available resources into appropriate obesity prevention
programs developed by the Office on Women's Health; and
(3) make publicly available (through a public Internet
website or other method) information, related fact sheets,
and resource lists, as updated under paragraph (1), and the
information incorporated into appropriate obesity prevention
programs under paragraph (2).
(b) Awareness.--The Secretary of Health and Human Services
may advance public awareness on--
(1) the types of eating disorders;
(2) the seriousness of eating disorders, including
prevalence, comorbidities, and physical and mental health
consequences;
(3) methods to identify, intervene, refer for treatment,
and prevent behaviors that may lead to the development of
eating disorders;
(4) discrimination and bullying based on body size;
(5) the effects of media on self-esteem and body image; and
(6) the signs and symptoms of eating disorders.
SEC. 13006. EDUCATION AND TRAINING ON EATING DISORDERS.
The Secretary of Health and Human Services may facilitate
the identification of model programs and materials for
educating and training health professionals in effective
strategies to--
(1) identify individuals with eating disorders;
(2) provide early intervention services for individuals
with eating disorders;
(3) refer patients with eating disorders for appropriate
treatment;
(4) prevent the development of eating disorders; and
(5) provide appropriate treatment services for individuals
with eating disorders.
SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES.
If a group health plan or a health insurance issuer
offering group or individual health insurance coverage
provides coverage for eating disorder benefits, including
residential treatment, such group health plan or health
insurance issuer shall provide such benefits consistent with
the requirements of section 2726 of the Public Health Service
Act (42 U.S.C. 300gg-26), section 712 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1185a), and
section 9812 of the Internal Revenue Code of 1986.
TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A--Mental Health and Safe Communities
SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION
TEAMS, MENTAL HEALTH PURPOSES.
(a) Edward Byrne Memorial Justice Assistance Grant
Program.--Section 501(a)(1) of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3751(a)(1))
is amended by adding at the end the following:
``(H) Mental health programs and related law enforcement
and corrections programs, including behavioral programs and
crisis intervention teams.''.
(b) Community Oriented Policing Services Program.--Section
1701(b) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796dd(b)) is amended--
(1) in paragraph (17), by striking ``and'' at the end;
(2) by redesignating paragraph (18) as paragraph (22);
(3) by inserting after paragraph (17) the following:
``(18) to provide specialized training to law enforcement
officers to--
``(A) recognize individuals who have a mental illness; and
``(B) properly interact with individuals who have a mental
illness, including strategies for verbal de-escalation of
crises;
``(19) to establish collaborative programs that enhance the
ability of law enforcement agencies to address the mental
health, behavioral, and substance abuse problems of
individuals encountered by law enforcement officers in the
line of duty;
``(20) to provide specialized training to corrections
officers to recognize individuals who have a mental illness;
``(21) to enhance the ability of corrections officers to
address the mental health of individuals under the care and
custody of jails and prisons, including specialized training
and strategies for verbal de-escalation of crises; and''; and
(4) in paragraph (22), as redesignated, by striking
``through (17)'' and inserting ``through (21)''.
(c) Modifications to the Staffing for Adequate Fire and
Emergency Response Grants.--Section 34(a)(1)(B) of the
Federal Fire Prevention and Control Act of 1974 (15 U.S.C.
2229a(a)(1)(B)) is amended by inserting before the period at
the end the following: ``and to provide specialized training
to paramedics, emergency medical services workers, and other
first responders to recognize individuals who have mental
illness and how to properly intervene with individuals with
mental illness, including strategies for verbal de-escalation
of crises''.
SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
(a) In General.--Section 2201 of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii)
is amended in paragraph (2)(B), by inserting before the
semicolon the following: ``, or court-ordered assisted
outpatient treatment when the court has determined such
treatment to be necessary''.
(b) Definitions.--Section 2202 of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C.
3796ii--1) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting a semicolon; and
(3) by adding at the end the following:
``(3) the term `court-ordered assisted outpatient
treatment' means a program through which a court may order a
treatment plan for an eligible patient that--
``(A) requires such patient to obtain outpatient mental
health treatment while the patient is not currently residing
in a correctional facility or inpatient treatment facility;
and
``(B) is designed to improve access and adherence by such
patient to intensive behavioral health services in order to--
``(i) avert relapse, repeated hospitalizations, arrest,
incarceration, suicide, property destruction, and violent
behavior; and
``(ii) provide such patient with the opportunity to live in
a less restrictive alternative to incarceration or
involuntary hospitalization; and
[[Page H6965]]
``(4) the term `eligible patient' means an adult, mentally
ill person who, as determined by a court--
``(A) has a history of violence, incarceration, or
medically unnecessary hospitalizations;
``(B) without supervision and treatment, may be a danger to
self or others in the community;
``(C) is substantially unlikely to voluntarily participate
in treatment;
``(D) may be unable, for reasons other than indigence, to
provide for any of his or her basic needs, such as food,
clothing, shelter, health, or safety;
``(E) has a history of mental illness or a condition that
is likely to substantially deteriorate if the person is not
provided with timely treatment; or
``(F) due to mental illness, lacks capacity to fully
understand or lacks judgment to make informed decisions
regarding his or her need for treatment, care, or
supervision.''.
SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS.
(a) Definitions.--In this section--
(1) the term ``eligible offender'' means a person who--
(A)(i) previously or currently has been diagnosed by a
qualified mental health professional as having a mental
illness, mental retardation, or co-occurring mental illness
and substance abuse disorders; or
(ii) manifests obvious signs of mental illness, mental
retardation, or co-occurring mental illness and substance
abuse disorders during arrest or confinement or before any
court;
(B) comes into contact with the criminal justice system or
is arrested or charged with an offense that is not--
(i) a crime of violence, as defined under applicable State
law or in section 3156 of title 18, United States Code; or
(ii) a serious drug offense, as defined in section
924(e)(2)(A) of title 18, United States Code; and
(C) is determined by a judge to be eligible; and
(2) the term ``mental illness'' means a diagnosable mental,
behavioral, or emotional disorder--
(A) of sufficient duration to meet diagnostic criteria
within the most recent edition of the Diagnostic and
Statistical Manual of Mental Disorders published by the
American Psychiatric Association; and
(B) that has resulted in functional impairment that
substantially interferes with or limits 1 or more major life
activities.
(b) Establishment of Program.--Not later than 1 year after
the date of enactment of this Act, the Attorney General shall
establish a pilot program to determine the effectiveness of
diverting eligible offenders from Federal prosecution,
Federal probation, or a Bureau of Prisons facility, and
placing such eligible offenders in drug or mental health
courts.
(c) Program Specifications.--The pilot program established
under subsection (b) shall involve--
(1) continuing judicial supervision, including periodic
review, of program participants who have a substance abuse
problem or mental illness; and
(2) the integrated administration of services and
sanctions, which shall include--
(A) mandatory periodic testing, as appropriate, for the use
of controlled substances or other addictive substances during
any period of supervised release or probation for each
program participant;
(B) substance abuse treatment for each program participant
who requires such services;
(C) diversion, probation, or other supervised release with
the possibility of prosecution, confinement, or incarceration
based on noncompliance with program requirements or failure
to show satisfactory progress toward completing program
requirements;
(D) programmatic offender management, including case
management, and aftercare services, such as relapse
prevention, health care, education, vocational training, job
placement, housing placement, and child care or other family
support services for each program participant who requires
such services;
(E) outpatient or inpatient mental health treatment, as
ordered by the court, that carries with it the possibility of
dismissal of charges or reduced sentencing upon successful
completion of such treatment;
(F) centralized case management, including--
(i) the consolidation of all cases, including violations of
probations, of the program participant; and
(ii) coordination of all mental health treatment plans and
social services, including life skills and vocational
training, housing and job placement, education, health care,
and relapse prevention for each program participant who
requires such services; and
(G) continuing supervision of treatment plan compliance by
the program participant for a term not to exceed the maximum
allowable sentence or probation period for the charged or
relevant offense and, to the extent practicable, continuity
of psychiatric care at the end of the supervised period.
(d) Implementation; Duration.--The pilot program
established under subsection (b) shall be conducted--
(1) in not less than 1 United States judicial district,
designated by the Attorney General in consultation with the
Director of the Administrative Office of the United States
Courts, as appropriate for the pilot program; and
(2) during fiscal year 2017 through fiscal year 2021.
(e) Criteria for Designation.--Before making a designation
under subsection (d)(1), the Attorney General shall--
(1) obtain the approval, in writing, of the United States
Attorney for the United States judicial district being
designated;
(2) obtain the approval, in writing, of the chief judge for
the United States judicial district being designated; and
(3) determine that the United States judicial district
being designated has adequate behavioral health systems for
treatment, including substance abuse and mental health
treatment.
(f) Assistance From Other Federal Entities.--The
Administrative Office of the United States Courts and the
United States Probation Offices shall provide such assistance
and carry out such functions as the Attorney General may
request in monitoring, supervising, providing services to,
and evaluating eligible offenders placed in a drug or mental
health court under this section.
(g) Reports.--The Attorney General, in consultation with
the Director of the Administrative Office of the United
States Courts, shall monitor the drug and mental health
courts under this section, and shall submit a report to
Congress on the outcomes of the program at the end of the
period described in subsection (d)(2).
SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM.
Part V of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796ii et seq.) is amended by
inserting at the end the following:
``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
``(a) Pretrial Screening and Supervision.--
``(1) In general.--The Attorney General may award grants to
States, units of local government, territories, Indian
Tribes, nonprofit agencies, or any combination thereof, to
develop, implement, or expand pretrial services programs to
improve the identification and outcomes of individuals with
mental illness.
``(2) Allowable uses.--Grants awarded under this subsection
may be may be used for--
``(A) behavioral health needs and risk screening of
defendants, including verification of interview information,
mental health evaluation, and criminal history screening;
``(B) assessment of risk of pretrial misconduct through
objective, statistically validated means, and presentation to
the court of recommendations based on such assessment,
including services that will reduce the risk of pre-trial
misconduct;
``(C) followup review of defendants unable to meet the
conditions of pretrial release;
``(D) evaluation of process and results of pre-trial
service programs;
``(E) supervision of defendants who are on pretrial
release, including reminders to defendants of scheduled court
dates;
``(F) reporting on process and results of pretrial services
programs to relevant public and private mental health
stakeholders; and
``(G) data collection and analysis necessary to make
available information required for assessment of risk.
``(b) Behavioral Health Assessments and Intervention.--
``(1) In general.--The Attorney General may award grants to
States, units of local government, territories, Indian
Tribes, nonprofit agencies, or any combination thereof, to
develop, implement, or expand a behavioral health screening
and assessment program framework for State or local criminal
justice systems.
``(2) Allowable uses.--Grants awarded under this subsection
may be used for--
``(A) promotion of the use of validated assessment tools to
gauge the criminogenic risk, substance abuse needs, and
mental health needs of individuals;
``(B) initiatives to match the risk factors and needs of
individuals to programs and practices associated with
research-based, positive outcomes;
``(C) implementing methods for identifying and treating
individuals who are most likely to benefit from coordinated
supervision and treatment strategies, and identifying
individuals who can do well with fewer interventions; and
``(D) collaborative decision-making among the heads of
criminal justice agencies, mental health systems, judicial
systems, substance abuse systems, and other relevant systems
or agencies for determining how treatment and intensive
supervision services should be allocated in order to maximize
benefits, and developing and utilizing capacity accordingly.
``(c) Use of Grant Funds.--A State, unit of local
government, territory, Indian Tribe, or nonprofit agency that
receives a grant under this section shall, in accordance with
subsection (b)(2), use grant funds for the expenses of a
treatment program, including--
``(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program,
including costs relating to enforcement;
``(2) payments for treatment providers that are approved by
the State or Indian Tribe and licensed, if necessary, to
provide needed treatment to program participants, including
aftercare supervision, vocational training, education, and
job placement; and
``(3) payments to public and nonprofit private entities
that are approved by the State or Indian Tribe and licensed,
if necessary, to provide alcohol and drug addiction treatment
to offenders participating in the program.
``(d) Supplement of Non-Federal Funds.--
``(1) In general.--Grants awarded under this section shall
be used to supplement, and not supplant, non-Federal funds
that would otherwise be available for programs described in
this section.
``(2) Federal share.--The Federal share of a grant made
under this section may not exceed 50 percent of the total
costs of the program described in an application under
subsection (e).
``(e) Applications.--To request a grant under this section,
a State, unit of local government, territory, Indian Tribe,
or nonprofit agency shall submit an application to the
Attorney General in such form and containing such information
as the Attorney General may reasonably require.
[[Page H6966]]
``(f) Geographic Distribution.--The Attorney General shall
ensure that, to the extent practicable, the distribution of
grants under this section is equitable and includes--
``(1) each State; and
``(2) a unit of local government, territory, Indian Tribe,
or nonprofit agency--
``(A) in each State; and
``(B) in rural, suburban, Tribal, and urban jurisdictions.
``(g) Reports and Evaluations.--For each fiscal year, each
grantee under this section during that fiscal year shall
submit to the Attorney General a report on the effectiveness
of activities carried out using such grant. Each report shall
include an evaluation in such form and containing such
information as the Attorney General may reasonably require.
The Attorney General shall specify the dates on which such
reports shall be submitted.
``(h) Accountability.--Grants awarded under this section
shall be subject to the following accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term `unresolved
audit finding' means a finding in the final audit report of
the Inspector General of the Department of Justice under
subparagraph (C) that the audited grantee has used grant
funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within 1 year
after the date on which final audit report is issued.
``(B) Audits.--Beginning in the first fiscal year beginning
after the date of enactment of this section, and in each
fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of grantees under
this section to prevent waste, fraud, and abuse of funds by
grantees. The Inspector General shall determine the
appropriate number of grantees to be audited each year.
``(C) Final audit report.--The Inspector General of the
Department of Justice shall submit to the Attorney General a
final report on each audit conducted under subparagraph (B).
``(D) Mandatory exclusion.--Grantees under this section
about which there is an unresolved audit finding shall not be
eligible to receive a grant under this section during the 2
fiscal years beginning after the end of the 1-year period
described in subparagraph (A).
``(E) Priority.--In making grants under this section, the
Attorney General shall give priority to applicants that did
not have an unresolved audit finding during the 3 fiscal
years before submitting an application for a grant under this
section.
``(F) Reimbursement.--If an entity receives a grant under
this section during the 2-fiscal-year period during which the
entity is prohibited from receiving grants under subparagraph
(D), the Attorney General shall--
``(i) deposit an amount equal to the amount of the grant
that was improperly awarded to the grantee into the General
Fund of the Treasury; and
``(ii) seek to recoup the costs of the repayment under
clause (i) from the grantee that was erroneously awarded
grant funds.
``(2) Nonprofit agency requirements.--
``(A) Definition.--For purposes of this paragraph and the
grant program under this section, the term `nonprofit agency'
means an organization that is described in section 501(c)(3)
of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3))
and is exempt from taxation under section 501(a) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
``(B) Prohibition.--The Attorney General may not award a
grant under this section to a nonprofit agency that holds
money in an offshore account for the purpose of avoiding
paying the tax described in section 511(a) of the Internal
Revenue Code of 1986 (26 U.S.C. 511(a)).
``(C) Disclosure.--Each nonprofit agency that is awarded a
grant under this section and uses the procedures prescribed
in regulations to create a rebuttable presumption of
reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to the
Attorney General, in the application for the grant, the
process for determining such compensation, including the
independent persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make the
information disclosed under this subparagraph available for
public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--Not more than $20,000 of the amounts
made available to the Department of Justice to carry out this
section may be used by the Attorney General, or by any
individual or entity awarded a grant under this section to
host, or make any expenditures relating to, a conference
unless the Deputy Attorney General provides prior written
authorization that the funds may be expended to host the
conference or make such expenditure.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost of
all food, beverages, audio-visual equipment, honoraria for
speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall submit an
annual report to the Committee on the Judiciary of the Senate
and the Committee on the Judiciary of the House of
Representatives on all conference expenditures approved under
this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this
subsection, the Attorney General shall submit to the
Committee on the Judiciary and the Committee on
Appropriations of the Senate and the Committee on the
Judiciary and the Committee on Appropriations of the House of
Representatives an annual certification--
``(A) indicating whether--
``(i) all final audit reports issued by the Office of the
Inspector General under paragraph (1) have been completed and
reviewed by the appropriate Assistant Attorney General or
Director;
``(ii) all mandatory exclusions required under paragraph
(1)(D) have been issued; and
``(iii) any reimbursements required under paragraph (1)(F)
have been made; and
``(B) that includes a list of any grantees excluded under
paragraph (1)(D) from the previous year.
``(i) Preventing Duplicative Grants.--
``(1) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney
General shall compare the possible grant with any other
grants awarded to the applicant under this Act to determine
whether the grants are for the same purpose.
``(2) Report.--If the Attorney General awards multiple
grants to the same applicant for the same purpose, the
Attorney General shall submit to the Committee on the
Judiciary of the Senate and the Committee on the Judiciary of
the House of Representatives a report that includes--
``(A) a list of all duplicate grants awarded, including the
total dollar amount of any such grants awarded; and
``(B) the reason the Attorney General awarded the duplicate
grants.''.
SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT
INITIATIVES.
Section 2991 of the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3797aa) is amended by--
(1) redesignating subsection (j) as subsection (o); and
(2) inserting after subsection (i) the following:
``(j) Forensic Assertive Community Treatment (FACT)
Initiative Program.--
``(1) In general.--The Attorney General may make grants to
States, units of local government, territories, Indian
Tribes, nonprofit agencies, or any combination thereof, to
develop, implement, or expand Assertive Community Treatment
initiatives to develop forensic assertive community treatment
(referred to in this subsection as `FACT') programs that
provide high intensity services in the community for
individuals with mental illness with involvement in the
criminal justice system to prevent future incarcerations.
``(2) Allowable uses.--Grant funds awarded under this
subsection may be used for--
``(A) multidisciplinary team initiatives for individuals
with mental illnesses with criminal justice involvement that
address criminal justice involvement as part of treatment
protocols;
``(B) FACT programs that involve mental health
professionals, criminal justice agencies, chemical dependency
specialists, nurses, psychiatrists, vocational specialists,
forensic peer specialists, forensic specialists, and
dedicated administrative support staff who work together to
provide recovery oriented, 24/7 wraparound services;
``(C) services such as integrated evidence-based practices
for the treatment of co-occurring mental health and
substance-related disorders, assertive outreach and
engagement, community-based service provision at
participants' residence or in the community, psychiatric
rehabilitation, recovery oriented services, services to
address criminogenic risk factors, and community tenure;
``(D) payments for treatment providers that are approved by
the State or Indian Tribe and licensed, if necessary, to
provide needed treatment to eligible offenders participating
in the program, including behavioral health services and
aftercare supervision; and
``(E) training for all FACT teams to promote high-fidelity
practice principles and technical assistance to support
effective and continuing integration with criminal justice
agency partners.
``(3) Supplement and not supplant.--Grants made under this
subsection shall be used to supplement, and not supplant,
non-Federal funds that would otherwise be available for
programs described in this subsection.
``(4) Applications.--To request a grant under this
subsection, a State, unit of local government, territory,
Indian Tribe, or nonprofit agency shall submit an application
to the Attorney General in such form and containing such
information as the Attorney General may reasonably
require.''.
SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
SYSTEMS.
Section 2976(f) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period at the end and
inserting a semicolon; and
(3) by adding at the end the following:
``(7) provide mental health treatment and transitional
services for those with mental illnesses or with co-occurring
disorders, including housing placement or assistance; and''.
SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN DRUG COURTS.
Part EE of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797u et seq.) is amended--
(1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
inserting ``, including co-occurring substance abuse and
mental health problems,'' after ``problems''; and
(2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting
``, including training for drug court personnel and officials
on identifying and addressing co-occurring substance abuse
and mental health problems'' after ``part''.
SEC. 14008. MENTAL HEALTH TRAINING FOR FEDERAL UNIFORMED
SERVICES.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Defense, the
Secretary of Homeland
[[Page H6967]]
Security, the Secretary of Health and Human Services, and the
Secretary of Commerce shall provide the following to each of
the uniformed services (as that term is defined in section
101 of title 10, United States Code) under their direction:
(1) Training programs.--Programs that offer specialized and
comprehensive training in procedures to identify and respond
appropriately to incidents in which the unique needs of
individuals with mental illnesses are involved.
(2) Improved technology.--Computerized information systems
or technological improvements to provide timely information
to Federal law enforcement personnel, other branches of the
uniformed services, and criminal justice system personnel to
improve the Federal response to mentally ill individuals.
(3) Cooperative programs.--The establishment and expansion
of cooperative efforts to promote public safety through the
use of effective intervention with respect to mentally ill
individuals encountered by members of the uniformed services.
SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER
REENTRY.
(a) Reentry Demonstration Projects.--Section 2976(f) of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3797w(f)), as amended by section 14006, is
amended--
(1) in paragraph (3)(C), by inserting ``mental health
services,'' before ``drug treatment''; and
(2) by adding at the end the following:
``(8) target offenders with histories of homelessness,
substance abuse, or mental illness, including a prerelease
assessment of the housing status of the offender and
behavioral health needs of the offender with clear
coordination with mental health, substance abuse, and
homelessness services systems to achieve stable and permanent
housing outcomes with appropriate support service.''.
(b) Mentoring Grants.--Section 211(b)(2) of the Second
Chance Act of 2007 (42 U.S.C. 17531(b)(2)) is amended by
inserting ``, including mental health care'' after
``community''.
SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
Section 2701(b) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
(1) by redesignating paragraphs (4) and (5) as paragraphs
(5) and (6), respectively; and
(2) by inserting after paragraph (3) the following:
``(4) The development and operation of crisis intervention
teams that may include coordination with law enforcement
agencies and specialized training for school officials in
responding to mental health crises.''.
SEC. 14011. ACTIVE-SHOOTER TRAINING FOR LAW ENFORCEMENT.
The Attorney General, as part of the Preventing Violence
Against Law Enforcement and Ensuring Officer Resilience and
Survivability Initiative (VALOR) of the Department of
Justice, may provide safety training and technical assistance
to local law enforcement agencies, including active-shooter
response training.
SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN RESIDENTIAL SUBSTANCE ABUSE
TREATMENT PROGRAMS.
Section 1901(a) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(3) developing and implementing specialized residential
substance abuse treatment programs that identify and provide
appropriate treatment to inmates with co-occurring mental
health and substance abuse disorders or challenges.''.
SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
INCARCERATION PROGRAMS.
Title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3711 et seq.) is amended by striking part
CC and inserting the following:
``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
INCARCERATION PROGRAMS
``SEC. 2901. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO
INCARCERATION PROGRAMS.
``(a) Definitions.--In this section--
``(1) the term `eligible entity' means a State, unit of
local government, Indian tribe, or nonprofit organization;
and
``(2) the term `eligible participant' means an individual
who--
``(A) comes into contact with the criminal justice system
or is arrested or charged with an offense that is not--
``(i) a crime of violence, as defined under applicable
State law or in section 3156 of title 18, United States Code;
or
``(ii) a serious drug offense, as defined in section
924(e)(2)(A) of title 18, United States Code;
``(B) has a history of, or a current--
``(i) substance use disorder;
``(ii) mental illness; or
``(iii) co-occurring mental illness and substance use
disorder; and
``(C) has been approved for participation in a program
funded under this section by the relevant law enforcement
agency, prosecuting attorney, defense attorney, probation
official, corrections official, judge, representative of a
mental health agency, or representative of a substance abuse
agency, as required by law.
``(b) Program Authorized.--The Attorney General may make
grants to eligible entities to develop, implement, or expand
a treatment alternative to incarceration program for eligible
participants, including--
``(1) pre-booking treatment alternative to incarceration
programs, including--
``(A) law enforcement training on substance use disorders,
mental illness, and co-occurring mental illness and substance
use disorders;
``(B) receiving centers as alternatives to incarceration of
eligible participants;
``(C) specialized response units for calls related to
substance use disorders, mental illness, or co-occurring
mental illness and substance use disorders; and
``(D) other arrest and pre-booking treatment alternatives
to incarceration models; or
``(2) post-booking treatment alternative to incarceration
programs, including--
``(A) specialized clinical case management;
``(B) pre-trial services related to substances use
disorders, mental illness, and co-occurring mental illness
and substance use disorders;
``(C) prosecutor and defender based programs;
``(D) specialized probation;
``(E) treatment and rehabilitation programs; and
``(F) problem-solving courts, including mental health
courts, drug courts, co-occurring mental health and substance
abuse courts, DWI courts, and veterans treatment courts.
``(c) Application.--
``(1) In general.--An eligible entity desiring a grant
under this section shall submit an application to the
Attorney General--
``(A) that meets the criteria under paragraph (2); and
``(B) at such time, in such manner, and accompanied by such
information as the Attorney General may require.
``(2) Criteria.--An eligible entity, in submitting an
application under paragraph (1), shall--
``(A) provide extensive evidence of collaboration with
State and local government agencies overseeing health,
community corrections, courts, prosecution, substance abuse,
mental health, victims services, and employment services, and
with local law enforcement agencies;
``(B) demonstrate consultation with the Single State
Authority for Substance Abuse of the State (as that term is
defined in section 201(e) of the Second Chance Act of 2007);
``(C) demonstrate that evidence-based treatment practices
will be utilized; and
``(D) demonstrate that evidence-based screening and
assessment tools will be used to place participants in the
treatment alternative to incarceration program.
``(d) Requirements.--Each eligible entity awarded a grant
for a treatment alternative to incarceration program under
this section shall--
``(1) determine the terms and conditions of participation
in the program by eligible participants, taking into
consideration the collateral consequences of an arrest,
prosecution or criminal conviction;
``(2) ensure that each substance abuse and mental health
treatment component is licensed and qualified by the relevant
jurisdiction;
``(3) for programs described in subsection (b)(2), organize
an enforcement unit comprised of appropriately trained law
enforcement professionals under the supervision of the State,
Tribal, or local criminal justice agency involved, the duties
of which shall include--
``(A) the verification of addresses and other contact
information of each eligible participant who participates or
desires to participate in the program; and
``(B) if necessary, the location, apprehension, arrest, and
return to custody of an eligible participant in the program
who has absconded from the facility of a treatment provider
or has otherwise significantly violated the terms and
conditions of the program, consistent with Federal and State
confidentiality requirements;
``(4) notify the relevant criminal justice entity if any
eligible participant in the program absconds from the
facility of the treatment provider or otherwise violates the
terms and conditions of the program, consistent with Federal
and State confidentiality requirements;
``(5) submit periodic reports on the progress of treatment
or other measured outcomes from participation in the program
of each eligible participant in the program to the relevant
State, Tribal, or local criminal justice agency, including
mental health courts, drug courts, co-occurring mental health
and substance abuse courts, DWI courts, and veterans
treatment courts;
``(6) describe the evidence-based methodology and outcome
measurements that will be used to evaluate the program, and
specifically explain how such measurements will provide valid
measures of the impact of the program; and
``(7) describe how the program could be broadly replicated
if demonstrated to be effective.
``(e) Use of Funds.--An eligible entity shall use a grant
received under this section for expenses of a treatment
alternative to incarceration program, including--
``(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program,
including the enforcement unit;
``(2) payments for treatment providers that are approved by
the relevant State or Tribal jurisdiction and licensed, if
necessary, to provide needed treatment to eligible offenders
participating in the program, including aftercare
supervision, vocational training, education, and job
placement; and
``(3) payments to public and nonprofit private entities
that are approved by the State or Tribal jurisdiction and
licensed, if necessary, to provide alcohol and drug addiction
treatment to eligible offenders participating in the program.
``(f) Supplement Not Supplant.--An eligible entity shall
use Federal funds received under this section only to
supplement the funds that would, in the absence of those
Federal funds, be made available from other Federal and non-
Federal sources for the activities described in this section,
and not to supplant those funds. The Federal share of a grant
made under this section may not exceed 50 percent of the
total costs of the program described in an application under
subsection (d).
[[Page H6968]]
``(g) Geographic Distribution.--The Attorney General shall
ensure that, to the extent practicable, the geographical
distribution of grants under this section is equitable and
includes a grant to an eligible entity in--
``(1) each State;
``(2) rural, suburban, and urban areas; and
``(3) Tribal jurisdictions.
``(h) Reports and Evaluations.--Each fiscal year, each
recipient of a grant under this section during that fiscal
year shall submit to the Attorney General a report on the
outcomes of activities carried out using that grant in such
form, containing such information, and on such dates as the
Attorney General shall specify.
``(i) Accountability.--All grants awarded by the Attorney
General under this section shall be subject to the following
accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term `unresolved
audit finding' means a finding in the final audit report of
the Inspector General of the Department of Justice that the
audited grantee has utilized grant funds for an unauthorized
expenditure or otherwise unallowable cost that is not closed
or resolved within 12 months from the date on which the final
audit report is issued.
``(B) Audits.--Beginning in the first fiscal year beginning
after the date of enactment of this subsection, and in each
fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of recipients of
grants under this section to prevent waste, fraud, and abuse
of funds by grantees. The Inspector General shall determine
the appropriate number of grantees to be audited each year.
``(C) Mandatory exclusion.--A recipient of grant funds
under this section that is found to have an unresolved audit
finding shall not be eligible to receive grant funds under
this section during the first 2 fiscal years beginning after
the end of the 12-month period described in subparagraph (A).
``(D) Priority.--In awarding grants under this section, the
Attorney General shall give priority to eligible applicants
that did not have an unresolved audit finding during the 3
fiscal years before submitting an application for a grant
under this section.
``(E) Reimbursement.--If an entity is awarded grant funds
under this section during the 2-fiscal-year period during
which the entity is barred from receiving grants under
subparagraph (C), the Attorney General shall--
``(i) deposit an amount equal to the amount of the grant
funds that were improperly awarded to the grantee into the
General Fund of the Treasury; and
``(ii) seek to recoup the costs of the repayment to the
fund from the grant recipient that was erroneously awarded
grant funds.
``(2) Nonprofit organization requirements.--
``(A) Definition.--For purposes of this paragraph and the
grant programs under this part, the term `nonprofit
organization' means an organization that is described in
section 501(c)(3) of the Internal Revenue Code of 1986 and is
exempt from taxation under section 501(a) of such Code.
``(B) Prohibition.--The Attorney General may not award a
grant under this part to a nonprofit organization that holds
money in offshore accounts for the purpose of avoiding paying
the tax described in section 511(a) of the Internal Revenue
Code of 1986.
``(C) Disclosure.--Each nonprofit organization that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption
of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to the
Attorney General, in the application for the grant, the
process for determining such compensation, including the
independent persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make the
information disclosed under this subparagraph available for
public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by the
Attorney General, or by any individual or entity awarded
discretionary funds through a cooperative agreement under
this section, to host or support any expenditure for
conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head of
the relevant agency or department, provides prior written
authorization that the funds may be expended to host the
conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost of
all food, beverages, audio-visual equipment, honoraria for
speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall submit an
annual report to the Committee on the Judiciary of the Senate
and the Committee on the Judiciary of the House of
Representatives on all conference expenditures approved under
this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this
subsection, the Attorney General shall submit, to the
Committee on the Judiciary and the Committee on
Appropriations of the Senate and the Committee on the
Judiciary and the Committee on Appropriations of the House of
Representatives, an annual certification--
``(A) indicating whether--
``(i) all audits issued by the Office of the Inspector
General under paragraph (1) have been completed and reviewed
by the appropriate Assistant Attorney General or Director;
``(ii) all mandatory exclusions required under paragraph
(1)(C) have been issued; and
``(iii) all reimbursements required under paragraph (1)(E)
have been made; and
``(B) that includes a list of any grant recipients excluded
under paragraph (1) from the previous year.
``(5) Preventing duplicative grants.--
``(A) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney
General shall compare potential grant awards with other
grants awarded under this Act to determine if duplicate grant
awards are awarded for the same purpose.
``(B) Report.--If the Attorney General awards duplicate
grants to the same applicant for the same purpose the
Attorney General shall submit to the Committee on the
Judiciary of the Senate and the Committee on the Judiciary of
the House of Representatives a report that includes--
``(i) a list of all duplicate grants awarded, including the
total dollar amount of any duplicate grants awarded; and
``(ii) the reason the Attorney General awarded the
duplicate grants.''.
SEC. 14014. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH
TRAINING AND TECHNICAL ASSISTANCE.
Part HH of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa et seq.) is amended by
adding at the end the following:
``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH
TRAINING AND TECHNICAL ASSISTANCE.
``(a) Authority.--The Attorney General may make grants to
eligible organizations to provide for the establishment of a
National Criminal Justice and Mental Health Training and
Technical Assistance Center.
``(b) Eligible Organization.--For purposes of subsection
(a), the term `eligible organization' means a national
nonprofit organization that provides technical assistance and
training to, and has special expertise and broad, national-
level experience in, mental health, crisis intervention,
criminal justice systems, law enforcement, translating
evidence into practice, training, and research, and education
and support of people with mental illness and the families of
such individuals.
``(c) Use of Funds.--Any organization that receives a grant
under subsection (a) shall collaborate with other grant
recipients to establish and operate a National Criminal
Justice and Mental Health Training and Technical Assistance
Center to--
``(1) provide law enforcement officer training regarding
mental health and working with individuals with mental
illnesses, with an emphasis on de-escalation of encounters
between law enforcement officers and those with mental
disorders or in crisis, which shall include support the
development of in-person and technical information exchanges
between systems and the individuals working in those systems
in support of the concepts identified in the training;
``(2) provide education, training, and technical assistance
for States, Indian tribes, territories, units of local
government, service providers, nonprofit organizations,
probation or parole officers, prosecutors, defense attorneys,
emergency response providers, and corrections institutions to
advance practice and knowledge relating to mental health
crisis and approaches to mental health and criminal justice
across systems;
``(3) provide training and best practices to mental health
providers and criminal justice agencies relating to diversion
initiatives, jail and prison strategies, reentry of
individuals with mental illnesses into the community, and
dispatch protocols and triage capabilities, including the
establishment of learning sites;
``(4) develop suicide prevention and crisis intervention
training and technical assistance for criminal justice
agencies;
``(5) develop a receiving center system and pilot strategy
that provides, for a jurisdiction, a single point of entry
into the mental health and substance abuse system for
assessments and appropriate placement of individuals
experiencing a crisis;
``(6) collect data and best practices in mental health and
criminal health and criminal justice initiatives and policies
from grantees under this part, other recipients of grants
under this section, Federal, State, and local agencies
involved in the provision of mental health services, and
nongovernmental organizations involved in the provision of
mental health services;
``(7) develop and disseminate to mental health providers
and criminal justice agencies evaluation tools, mechanisms,
and measures to better assess and document performance
measures and outcomes relating to the provision of mental
health services;
``(8) disseminate information to States, units of local
government, criminal justice agencies, law enforcement
agencies, and other relevant entities about best practices,
policy standards, and research findings relating to the
provision of mental health services; and
``(9) provide education and support to individuals with
mental illness involved with, or at risk of involvement with,
the criminal justice system, including the families of such
individuals.
``(d) Accountability.--Grants awarded under this section
shall be subject to the following accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term `unresolved
audit finding' means a finding in the final audit report of
the Inspector General of the Department of Justice under
subparagraph (C) that the audited grantee has used grant
funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within 1 year
after the date on which the final audit report is issued.
[[Page H6969]]
``(B) Audits.--Beginning in the first fiscal year beginning
after the date of enactment of this section, and in each
fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of grantees under
this section to prevent waste, fraud, and abuse of funds by
grantees. The Inspector General shall determine the
appropriate number of grantees to be audited each year.
``(C) Final audit report.--The Inspector General of the
Department of Justice shall submit to the Attorney General a
final report on each audit conducted under subparagraph (B).
``(D) Mandatory exclusion.--Grantees under this section
about which there is an unresolved audit finding shall not be
eligible to receive a grant under this section during the 2
fiscal years beginning after the end of the 1-year period
described in subparagraph (A).
``(E) Priority.--In making grants under this section, the
Attorney General shall give priority to applicants that did
not have an unresolved audit finding during the 3 fiscal
years before submitting an application for a grant under this
section.
``(F) Reimbursement.--If an entity receives a grant under
this section during the 2-fiscal-year period during which the
entity is prohibited from receiving grants under subparagraph
(D), the Attorney General shall--
``(i) deposit an amount equal to the amount of the grant
that was improperly awarded to the grantee into the General
Fund of the Treasury; and
``(ii) seek to recoup the costs of the repayment under
clause (i) from the grantee that was erroneously awarded
grant funds.
``(2) Nonprofit agency requirements.--
``(A) Definition.--For purposes of this paragraph and the
grant program under this section, the term `nonprofit agency'
means an organization that is described in section 501(c)(3)
of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3))
and is exempt from taxation under section 501(a) of the
Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
``(B) Prohibition.--The Attorney General may not award a
grant under this section to a nonprofit agency that holds
money in an offshore account for the purpose of avoiding
paying the tax described in section 511(a) of the Internal
Revenue Code of 1986 (26 U.S.C. 511(a)).
``(C) Disclosure.--Each nonprofit agency that is awarded a
grant under this section and uses the procedures prescribed
in regulations to create a rebuttable presumption of
reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to the
Attorney General, in the application for the grant, the
process for determining such compensation, including the
independent persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make the
information disclosed under this subparagraph available for
public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by the
Attorney General, or by any individual or entity awarded
discretionary funds through a cooperative agreement under
this section, to host or support any expenditure for
conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head of
the relevant agency or department, provides prior written
authorization that the funds may be expended to host the
conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost of
all food, beverages, audio-visual equipment, honoraria for
speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall submit an
annual report to the Committee on the Judiciary of the Senate
and the Committee on the Judiciary of the House of
Representatives on all conference expenditures approved under
this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this
subsection, the Attorney General shall submit to the
Committee on the Judiciary and the Committee on
Appropriations of the Senate and the Committee on the
Judiciary and the Committee on Appropriations of the House of
Representatives an annual certification--
``(A) indicating whether--
``(i) all final audit reports issued by the Office of the
Inspector General under paragraph (1) have been completed and
reviewed by the appropriate Assistant Attorney General or
Director;
``(ii) all mandatory exclusions required under paragraph
(1)(D) have been issued; and
``(iii) any reimbursements required under paragraph (1)(F)
have been made; and
``(B) that includes a list of any grantees excluded under
paragraph (1)(D) from the previous year.
``(5) Preventing duplicative grants.--
``(A) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney
General shall compare potential grant awards with other
grants awarded under this Act to determine if duplicate grant
awards are awarded for the same purpose.
``(B) Report.--If the Attorney General awards duplicate
grants to the same applicant for the same purpose the
Attorney General shall submit to the Committee on the
Judiciary of the Senate and the Committee on the Judiciary of
the House of Representatives a report that includes--
``(i) a list of all duplicate grants awarded, including the
total dollar amount of any duplicate grants awarded; and
``(ii) the reason the Attorney General awarded the
duplicate grants.''.
SEC. 14015. IMPROVING DEPARTMENT OF JUSTICE DATA COLLECTION
ON MENTAL ILLNESS INVOLVED IN CRIME.
(a) In General.--Notwithstanding any other provision of
law, on or after the date that is 90 days after the date on
which the Attorney General promulgates regulations under
subsection (b), any data prepared by, or submitted to, the
Attorney General or the Director of the Federal Bureau of
Investigation with respect to the incidences of homicides,
law enforcement officers killed, seriously injured, and
assaulted, or individuals killed or seriously injured by law
enforcement officers shall include data with respect to the
involvement of mental illness in such incidences, if any.
(b) Regulations.--Not later than 90 days after the date of
the enactment of this Act, the Attorney General shall
promulgate or revise regulations as necessary to carry out
subsection (a).
SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS
IN PRISON.
(a) Report on the Cost of Treating the Mentally Ill in the
Criminal Justice System.--Not later than 12 months after the
date of enactment of this Act, the Comptroller General of the
United States shall submit to Congress a report detailing the
cost of imprisonment for individuals who have serious mental
illness by the Federal Government or a State or unit of local
government, which shall include--
(1) the number and type of crimes committed by individuals
with serious mental illness each year; and
(2) detail strategies or ideas for preventing crimes by
those individuals with serious mental illness from occurring.
(b) Definition.--For purposes of this section, the Attorney
General, in consultation with the Assistant Secretary of
Mental Health and Substance Use Disorders, shall define
``serious mental illness'' based on the ``Health Care Reform
for Americans with Severe Mental Illnesses: Report'' of the
National Advisory Mental Health Council, American Journal of
Psychiatry 1993; 150:1447-1465.
SEC. 14017. CODIFICATION OF DUE PROCESS FOR DETERMINATIONS BY
SECRETARY OF VETERANS AFFAIRS OF MENTAL
CAPACITY OF BENEFICIARIES.
(a) In General.--Chapter 55 of title 38, United States
Code, is amended by inserting after section 5501 the
following new section:
``Sec. 5501A. Beneficiaries' rights in mental competence
determinations
``The Secretary may not make an adverse determination
concerning the mental capacity of a beneficiary to manage
monetary benefits paid to or for the beneficiary by the
Secretary under this title unless such beneficiary has been
provided all of the following, subject to the procedures and
timelines prescribed by the Secretary for determinations of
incompetency:
``(1) Notice of the proposed adverse determination and the
supporting evidence.
``(2) An opportunity to request a hearing.
``(3) An opportunity to present evidence, including an
opinion from a medical professional or other person, on the
capacity of the beneficiary to manage monetary benefits paid
to or for the beneficiary by the Secretary under this title.
``(4) An opportunity to be represented at no expense to the
Government (including by counsel) at any such hearing and to
bring a medical professional or other person to provide
relevant testimony at any such hearing.''.
(b) Clerical Amendment.--The table of sections at the
beginning of such chapter 55 is amended by inserting after
the item relating to section 5501 the following new item:
``5501A. Beneficiaries' rights in mental competence determinations''.
(c) Effective Date.--Section 5501A of title 38, United
States Code, as added by subsection (a), shall apply to
determinations made by the Secretary of Veterans Affairs on
or after the date of the enactment of this Act.
SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.
Subsection (o) of section 2991 of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3797aa), as
redesignated by section 14006, is amended--
(1) in paragraph (1)(C), by striking ``2009 through 2014''
and inserting ``2017 through 2021''; and
(2) by adding at the end the following:
``(3) Limitation.--Not more than 20 percent of the funds
authorized to be appropriated under this section may be used
for purposes described in subsection (i) (relating to
veterans).''.
Subtitle B--Comprehensive Justice and Mental Health
SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa), as amended by
section 14005, is amended by inserting after subsection (j),
the following:
``(k) Sequential Intercept Grants.--
``(1) Definition.--In this subsection, the term `eligible
entity' means a State, unit of local government, Indian
tribe, or tribal organization.
``(2) Authorization.--The Attorney General may make grants
under this subsection to an eligible entity for sequential
intercept mapping and implementation in accordance with
paragraph (3).
``(3) Sequential intercept mapping; implementation.--An
eligible entity that receives a grant under this subsection
may use funds for--
``(A) sequential intercept mapping, which--
``(i) shall consist of--
``(I) convening mental health and criminal justice
stakeholders to--
``(aa) develop a shared understanding of the flow of
justice-involved individuals with mental illnesses through
the criminal justice system; and
[[Page H6970]]
``(bb) identify opportunities for improved collaborative
responses to the risks and needs of individuals described in
item (aa); and
``(II) developing strategies to address gaps in services
and bring innovative and effective programs to scale along
multiple intercepts, including--
``(aa) emergency and crisis services;
``(bb) specialized police-based responses;
``(cc) court hearings and disposition alternatives;
``(dd) reentry from jails and prisons; and
``(ee) community supervision, treatment and support
services; and
``(ii) may serve as a starting point for the development of
strategic plans to achieve positive public health and safety
outcomes; and
``(B) implementation, which shall--
``(i) be derived from the strategic plans described in
subparagraph (A)(ii); and
``(ii) consist of--
``(I) hiring and training personnel;
``(II) identifying the eligible entity's target population;
``(III) providing services and supports to reduce
unnecessary penetration into the criminal justice system;
``(IV) reducing recidivism;
``(V) evaluating the impact of the eligible entity's
approach; and
``(VI) planning for the sustainability of effective
interventions.''.
SEC. 14022. PRISON AND JAILS.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by
inserting after subsection (k), as added by section 14021,
the following:
``(l) Correctional Facilities.--
``(1) Definitions.--
``(A) Correctional facility.--The term `correctional
facility' means a jail, prison, or other detention facility
used to house people who have been arrested, detained, held,
or convicted by a criminal justice agency or a court.
``(B) Eligible inmate.--The term `eligible inmate' means an
individual who--
``(i) is being held, detained, or incarcerated in a
correctional facility; and
``(ii) manifests obvious signs of a mental illness or has
been diagnosed by a qualified mental health professional as
having a mental illness.
``(2) Correctional facility grants.--The Attorney General
may award grants to applicants to enhance the capabilities of
a correctional facility--
``(A) to identify and screen for eligible inmates;
``(B) to plan and provide--
``(i) initial and periodic assessments of the clinical,
medical, and social needs of inmates; and
``(ii) appropriate treatment and services that address the
mental health and substance abuse needs of inmates;
``(C) to develop, implement, and enhance--
``(i) post-release transition plans for eligible inmates
that, in a comprehensive manner, coordinate health, housing,
medical, employment, and other appropriate services and
public benefits;
``(ii) the availability of mental health care services and
substance abuse treatment services; and
``(iii) alternatives to solitary confinement and segregated
housing and mental health screening and treatment for inmates
placed in solitary confinement or segregated housing; and
``(D) to train each employee of the correctional facility
to identify and appropriately respond to incidents involving
inmates with mental health or co-occurring mental health and
substance abuse disorders.''.
SEC. 14023. ALLOWABLE USES.
Section 2991(b)(5)(I) of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C.
3797aa(b)(5)(I)) is amended by adding at the end the
following:
``(v) Teams addressing frequent users of crisis services.--
Multidisciplinary teams that--
``(I) coordinate, implement, and administer community-based
crisis responses and long-term plans for frequent users of
crisis services;
``(II) provide training on how to respond appropriately to
the unique issues involving frequent users of crisis services
for public service personnel, including criminal justice,
mental health, substance abuse, emergency room, healthcare,
law enforcement, corrections, and housing personnel;
``(III) develop or support alternatives to hospital and
jail admissions for frequent users of crisis services that
provide treatment, stabilization, and other appropriate
supports in the least restrictive, yet appropriate,
environment; and
``(IV) develop protocols and systems among law enforcement,
mental health, substance abuse, housing, corrections, and
emergency medical service operations to provide coordinated
assistance to frequent users of crisis services.''.
SEC. 14024. LAW ENFORCEMENT TRAINING.
Section 2991(h) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
(1) in paragraph (1), by adding at the end the following:
``(F) Academy training.--To provide support for academy
curricula, law enforcement officer orientation programs,
continuing education training, and other programs that teach
law enforcement personnel how to identify and respond to
incidents involving persons with mental health disorders or
co-occurring mental health and substance abuse disorders.'';
and
(2) by adding at the end the following:
``(4) Priority consideration.--The Attorney General, in
awarding grants under this subsection, shall give priority to
programs that law enforcement personnel and members of the
mental health and substance abuse professions develop and
administer cooperatively.''.
SEC. 14025. FEDERAL LAW ENFORCEMENT TRAINING.
Not later than 1 year after the date of enactment of this
Act, the Attorney General shall provide direction and
guidance for the following:
(1) Training programs.--Programs that offer specialized and
comprehensive training, in procedures to identify and
appropriately respond to incidents in which the unique needs
of individuals who have a mental illness are involved, to
first responders and tactical units of--
(A) Federal law enforcement agencies; and
(B) other Federal criminal justice agencies such as the
Bureau of Prisons, the Administrative Office of the United
States Courts, and other agencies that the Attorney General
determines appropriate.
(2) Improved technology.--The establishment of, or
improvement of existing, computerized information systems to
provide timely information to employees of Federal law
enforcement agencies, and Federal criminal justice agencies
to improve the response of such employees to situations
involving individuals who have a mental illness.
SEC. 14026. GAO REPORT.
No later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States, in
coordination with the Attorney General, shall submit to
Congress a report on--
(1) the practices that Federal first responders, tactical
units, and corrections officers are trained to use in
responding to individuals with mental illness;
(2) procedures to identify and appropriately respond to
incidents in which the unique needs of individuals who have a
mental illness are involved, to Federal first responders and
tactical units;
(3) the application of evidence-based practices in criminal
justice settings to better address individuals with mental
illnesses; and
(4) recommendations on how the Department of Justice can
expand and improve information sharing and dissemination of
best practices.
SEC. 14027. EVIDENCE BASED PRACTICES.
Section 2991(c) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
(1) in paragraph (3), by striking ``or'' at the end;
(2) by redesignating paragraph (4) as paragraph (6); and
(3) by inserting after paragraph (3), the following:
``(4) propose interventions that have been shown by
empirical evidence to reduce recidivism;
``(5) when appropriate, use validated assessment tools to
target preliminarily qualified offenders with a moderate or
high risk of recidivism and a need for treatment and
services; or''.
SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND
ENHANCEMENT OF LOCAL AUTHORITY.
(a) In General.--Section 2991(a) of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C.
3797aa(a)) is amended--
(1) in paragraph (7)--
(A) in the heading, by striking ``Mental illness'' and
inserting ``Mental illness; mental health disorder''; and
(B) by striking ``term `mental illness' means'' and
inserting ``terms `mental illness' and `mental health
disorder' mean''; and
(2) by striking paragraph (9) and inserting the following:
``(9) Preliminarily qualified offender.--
``(A) In general.--The term `preliminarily qualified
offender' means an adult or juvenile accused of an offense
who--
``(i)(I) previously or currently has been diagnosed by a
qualified mental health professional as having a mental
illness or co-occurring mental illness and substance abuse
disorders;
``(II) manifests obvious signs of mental illness or co-
occurring mental illness and substance abuse disorders during
arrest or confinement or before any court; or
``(III) in the case of a veterans treatment court provided
under subsection (i), has been diagnosed with, or manifests
obvious signs of, mental illness or a substance abuse
disorder or co-occurring mental illness and substance abuse
disorder;
``(ii) has been unanimously approved for participation in a
program funded under this section by, when appropriate--
``(I) the relevant--
``(aa) prosecuting attorney;
``(bb) defense attorney;
``(cc) probation or corrections official; and
``(dd) judge; and
``(II) a representative from the relevant mental health
agency described in subsection (b)(5)(B)(i);
``(iii) has been determined, by each person described in
clause (ii) who is involved in approving the adult or
juvenile for participation in a program funded under this
section, to not pose a risk of violence to any person in the
program, or the public, if selected to participate in the
program; and
``(iv) has not been charged with or convicted of--
``(I) any sex offense (as defined in section 111 of the Sex
Offender Registration and Notification Act (42 U.S.C. 16911))
or any offense relating to the sexual exploitation of
children; or
``(II) murder or assault with intent to commit murder.
``(B) Determination.--In determining whether to designate a
defendant as a preliminarily qualified offender, the relevant
prosecuting attorney, defense attorney, probation or
corrections official, judge, and mental health or substance
abuse agency representative shall take into account--
``(i) whether the participation of the defendant in the
program would pose a substantial risk of violence to the
community;
[[Page H6971]]
``(ii) the criminal history of the defendant and the nature
and severity of the offense for which the defendant is
charged;
``(iii) the views of any relevant victims to the offense;
``(iv) the extent to which the defendant would benefit from
participation in the program;
``(v) the extent to which the community would realize cost
savings because of the defendant's participation in the
program; and
``(vi) whether the defendant satisfies the eligibility
criteria for program participation unanimously established by
the relevant prosecuting attorney, defense attorney,
probation or corrections official, judge and mental health or
substance abuse agency representative.''.
(b) Technical and Conforming Amendment.--Section 2927(2) of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3797s-6(2)) is amended by striking ``has the
meaning given that term in section 2991(a).'' and inserting
``means an offense that--
``(A) does not have as an element the use, attempted use,
or threatened use of physical force against the person or
property of another; or
``(B) is not a felony that by its nature involves a
substantial risk that physical force against the person or
property of another may be used in the course of committing
the offense.''.
SEC. 14029. GRANT ACCOUNTABILITY.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by
inserting after subsection (l), as added by section 14022,
the following:
``(m) Accountability.--All grants awarded by the Attorney
General under this section shall be subject to the following
accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the term `unresolved
audit finding' means a finding in the final audit report of
the Inspector General of the Department of Justice that the
audited grantee has utilized grant funds for an unauthorized
expenditure or otherwise unallowable cost that is not closed
or resolved within 12 months from the date when the final
audit report is issued.
``(B) Audits.--Beginning in the first fiscal year beginning
after the date of enactment of this subsection, and in each
fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of recipients of
grants under this section to prevent waste, fraud, and abuse
of funds by grantees. The Inspector General shall determine
the appropriate number of grantees to be audited each year.
``(C) Mandatory exclusion.--A recipient of grant funds
under this section that is found to have an unresolved audit
finding shall not be eligible to receive grant funds under
this section during the first 2 fiscal years beginning after
the end of the 12-month period described in subparagraph (A).
``(D) Priority.--In awarding grants under this section, the
Attorney General shall give priority to eligible applicants
that did not have an unresolved audit finding during the 3
fiscal years before submitting an application for a grant
under this section.
``(E) Reimbursement.--If an entity is awarded grant funds
under this section during the 2-fiscal-year period during
which the entity is barred from receiving grants under
subparagraph (C), the Attorney General shall--
``(i) deposit an amount equal to the amount of the grant
funds that were improperly awarded to the grantee into the
General Fund of the Treasury; and
``(ii) seek to recoup the costs of the repayment to the
fund from the grant recipient that was erroneously awarded
grant funds.
``(2) Nonprofit organization requirements.--
``(A) Definition.--For purposes of this paragraph and the
grant programs under this part, the term `nonprofit
organization' means an organization that is described in
section 501(c)(3) of the Internal Revenue Code of 1986 and is
exempt from taxation under section 501(a) of such Code.
``(B) Prohibition.--The Attorney General may not award a
grant under this part to a nonprofit organization that holds
money in offshore accounts for the purpose of avoiding paying
the tax described in section 511(a) of the Internal Revenue
Code of 1986.
``(C) Disclosure.--Each nonprofit organization that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption
of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to the
Attorney General, in the application for the grant, the
process for determining such compensation, including the
independent persons involved in reviewing and approving such
compensation, the comparability data used, and
contemporaneous substantiation of the deliberation and
decision. Upon request, the Attorney General shall make the
information disclosed under this subparagraph available for
public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made available to the
Department of Justice under this section may be used by the
Attorney General, or by any individual or entity awarded
discretionary funds through a cooperative agreement under
this section, to host or support any expenditure for
conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head of
the relevant agency or department, provides prior written
authorization that the funds may be expended to host the
conference.
``(B) Written approval.--Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost of
all food, beverages, audio-visual equipment, honoraria for
speakers, and entertainment.
``(C) Report.--The Deputy Attorney General shall submit an
annual report to the Committee on the Judiciary of the Senate
and the Committee on the Judiciary of the House of
Representatives on all conference expenditures approved under
this paragraph.
``(4) Annual certification.--Beginning in the first fiscal
year beginning after the date of enactment of this
subsection, the Attorney General shall submit, to the
Committee on the Judiciary and the Committee on
Appropriations of the Senate and the Committee on the
Judiciary and the Committee on Appropriations of the House of
Representatives, an annual certification--
``(A) indicating whether--
``(i) all audits issued by the Office of the Inspector
General under paragraph (1) have been completed and reviewed
by the appropriate Assistant Attorney General or Director;
``(ii) all mandatory exclusions required under paragraph
(1)(C) have been issued; and
``(iii) all reimbursements required under paragraph (1)(E)
have been made; and
``(B) that includes a list of any grant recipients excluded
under paragraph (1) from the previous year.
``(n) Preventing Duplicative Grants.--
``(1) In general.--Before the Attorney General awards a
grant to an applicant under this section, the Attorney
General shall compare potential grant awards with other
grants awarded under this Act to determine if duplicate grant
awards are awarded for the same purpose.
``(2) Report.--If the Attorney General awards duplicate
grants to the same applicant for the same purpose the
Attorney General shall submit to the Committee on the
Judiciary of the Senate and the Committee on the Judiciary of
the House of Representatives a report that includes--
``(A) a list of all duplicate grants awarded, including the
total dollar amount of any duplicate grants awarded; and
``(B) the reason the Attorney General awarded the duplicate
grants.''.
DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR
AMERICANS
SEC. 15000. SHORT TITLE.
This division may be cited as the ``Increasing Choice,
Access, and Quality in Health Care for Americans Act''.
TITLE XV--PROVISIONS RELATING TO MEDICARE PART A
SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG
CODES FOR SIMILAR HOSPITAL SERVICES.
Section 1886 of the Social Security Act (42 U.S.C. 1395ww)
is amended by adding at the end the following new subsection:
``(t) Relating Similar Inpatient and Outpatient Hospital
Services.--
``(1) Development of hcpcs version of ms-drg codes.--Not
later than January 1, 2018, the Secretary shall develop HCPCS
versions for MS-DRGs that are similar to the ICD-10-PCS for
such MS-DRGs such that, to the extent possible, the MS-DRG
assignment shall be similar for a claim coded with the HCPCS
version as an identical claim coded with a ICD-10-PCS code.
``(2) Coverage of surgical ms-drgs.--In carrying out
paragraph (1), the Secretary shall develop HCPCS versions of
MS-DRG codes for not fewer than 10 surgical MS-DRGs.
``(3) Publication and dissemination of the hcpcs versions
of ms-drgs.--
``(A) In general.--The Secretary shall develop a HCPCS MS-
DRG definitions manual and software that is similar to the
definitions manual and software for ICD-10-PCS codes for such
MS-DRGs. The Secretary shall post the HCPCS MS-DRG
definitions manual and software on the Internet website of
the Centers for Medicare & Medicaid Services. The HCPCS MS-
DRG definitions manual and software shall be in the public
domain and available for use and redistribution without
charge.
``(B) Use of previous analysis done by medpac.--In
developing the HCPCS MS-DRG definitions manual and software
under subparagraph (A), the Secretary shall consult with the
Medicare Payment Advisory Commission and shall consider the
analysis done by such Commission in translating outpatient
surgical claims into inpatient surgical MS-DRGs in preparing
chapter 7 (relating to hospital short-stay policy issues) of
its `Medicare and the Health Care Delivery System' report
submitted to Congress in June 2015.
``(4) Definition and reference.--In this subsection:
``(A) HCPCS.--The term `HCPCS' means, with respect to
hospital items and services, the code under the Healthcare
Common Procedure Coding System (HCPCS) (or a successor code)
for such items and services.
``(B) ICD-10-PCS.--The term `ICD-10-PCS' means the
International Classification of Diseases, 10th Revision,
Procedure Coding System, and includes any subsequent revision
of such International Classification of Diseases, Procedure
Coding System.''.
SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE
HOSPITAL READMISSION PROGRAM.
(a) Transitional Adjustment for Dual Eligible Population.--
Section 1886(q)(3) of the Social Security Act (42 U.S.C.
1395ww(q)(3)) is amended--
(1) in subparagraph (A), by inserting ``subject to
subparagraph (D),'' after ``purposes of paragraph (1),''; and
(2) by adding at the end the following new subparagraph:
``(D) Transitional adjustment for dual eligibles.--
``(i) In general.--In determining a hospital's adjustment
factor under this paragraph for purposes of making payments
for discharges occurring during and after fiscal year 2019,
and before the application of clause (i) of subparagraph (E),
the Secretary shall assign hospitals
[[Page H6972]]
to groups (as defined by the Secretary under clause (ii)) and
apply the applicable provisions of this subsection using a
methodology in a manner that allows for separate comparison
of hospitals within each such group, as determined by the
Secretary.
``(ii) Defining groups.--For purposes of this subparagraph,
the Secretary shall define groups of hospitals, based on
their overall proportion, of the inpatients who are entitled
to, or enrolled for, benefits under part A, and who are full-
benefit dual eligible individuals (as defined in section
1935(c)(6)). In defining groups, the Secretary shall consult
the Medicare Payment Advisory Commission and may consider the
analysis done by such Commission in preparing the portion of
its report submitted to Congress in June 2013 relating to
readmissions.
``(iii) Minimizing reporting burden on hospitals.--In
carrying out this subparagraph, the Secretary shall not
impose any additional reporting requirements on hospitals.
``(iv) Budget neutral design methodology.--The Secretary
shall design the methodology to implement this subparagraph
so that the estimated total amount of reductions in payments
under this subsection equals the estimated total amount of
reductions in payments that would otherwise occur under this
subsection if this subparagraph did not apply.''.
(b) Changes in Risk Adjustment.--Section 1886(q)(3) of the
Social Security Act (42 U.S.C. 1395ww(q)(3)), as amended by
subsection (a), is further amended by adding at the end the
following new subparagraph:
``(E) Changes in risk adjustment.--
``(i) Consideration of recommendations in impact reports.--
The Secretary may take into account the studies conducted and
the recommendations made by the Secretary under section
2(d)(1) of the IMPACT Act of 2014 (Public Law 113-185; 42
U.S.C. 1395lll note) with respect to the application under
this subsection of risk adjustment methodologies. Nothing in
this clause shall be construed as precluding consideration of
the use of groupings of hospitals.
``(ii) Consideration of exclusion of patient cases based on
v or other appropriate codes.--In promulgating regulations to
carry out this subsection with respect to discharges
occurring after fiscal year 2018, the Secretary may consider
the use of V or other ICD-related codes for removal of a
readmission. The Secretary may consider modifying measures
under this subsection to incorporate V or other ICD-related
codes at the same time as other changes are being made under
this subparagraph.
``(iii) Removal of certain readmissions.--In promulgating
regulations to carry out this subsection, with respect to
discharges occurring after fiscal year 2018, the Secretary
may consider removal as a readmission of an admission that is
classified within one or more of the following: transplants,
end-stage renal disease, burns, trauma, psychosis, or
substance abuse. The Secretary may consider modifying
measures under this subsection to remove readmissions at the
same time as other changes are being made under this
subparagraph.''.
(c) MedPAC Study on Readmissions Program.--The Medicare
Payment Advisory Commission shall conduct a study to review
overall hospital readmissions described in section
1886(q)(5)(E) of the Social Security Act (42 U.S.C.
1395ww(q)(5)(E)) and whether such readmissions are related to
any changes in outpatient and emergency services furnished.
The Commission shall submit to Congress a report on such
study in its report to Congress in June 2018.
SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY
HOSPITAL DEMONSTRATION PROGRAM.
(a) Extension.--Section 410A of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law
108-173; 42 U.S.C. 1395ww note) is amended--
(1) in subsection (a)(5), by striking ``5-year extension
period'' and inserting ``10-year extension period''; and
(2) in subsection (g)--
(A) in the subsection heading, by striking ``Five-Year''
and inserting ``Ten-Year'';
(B) in paragraph (1), by striking ``additional 5-year'' and
inserting ``additional 10-year'';
(C) by striking ``5-year extension period'' and inserting
``10-year extension period'' each place it appears;
(D) in paragraph (4)(B)--
(i) in the matter preceding clause (i), by inserting ``each
5-year period in'' after ``hospital during''; and
(ii) in clause (i), by inserting ``each applicable 5-year
period in'' after ``the first day of''; and
(E) by adding at the end the following new paragraphs:
``(5) Other hospitals in demonstration program.--During the
second 5 years of the 10-year extension period, the Secretary
shall apply the provisions of paragraph (4) to rural
community hospitals that are not described in paragraph (4)
but are participating in the demonstration program under this
section as of December 30, 2014, in a similar manner as such
provisions apply to rural community hospitals described in
paragraph (4).
``(6) Expansion of demonstration program to rural areas in
any state.--
``(A) In general.--The Secretary shall, notwithstanding
subsection (a)(2) or paragraph (2) of this subsection, not
later than 120 days after the date of the enactment of this
paragraph, issue a solicitation for applications to select up
to the maximum number of additional rural community hospitals
located in any State to participate in the demonstration
program under this section for the second 5 years of the 10-
year extension period without exceeding the limitation under
paragraph (3) of this subsection.
``(B) Priority.--In determining which rural community
hospitals that submitted an application pursuant to the
solicitation under subparagraph (A) to select for
participation in the demonstration program, the Secretary--
``(i) shall give priority to rural community hospitals
located in one of the 20 States with the lowest population
densities (as determined by the Secretary using the 2015
Statistical Abstract of the United States); and
``(ii) may consider--
``(I) closures of hospitals located in rural areas in the
State in which the rural community hospital is located during
the 5-year period immediately preceding the date of the
enactment of this paragraph; and
``(II) the population density of the State in which the
rural community hospital is located.''.
(b) Change in Timing for Report.--Subsection (e) of such
section 410A is amended--
(1) by striking ``Not later than 6 months after the
completion of the demonstration program under this section''
and inserting ``Not later than August 1, 2018''; and
(2) by striking ``such program'' and inserting ``the
demonstration program under this section''.
SEC. 15004. REGULATORY RELIEF FOR LTCHS.
(a) Technical Change to the Medicare Long-Term Care
Hospital Moratorium Exception.--
(1) In general.--Section 114(d)(7) of the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww
note), as amended by sections 3106(b) and 10312(b) of Public
Law 111-148, section 1206(b)(2) of the Pathway for SGR Reform
Act of 2013 (division B of Public Law 113-67), and section
112 of the Protecting Access to Medicare Act of 2014 (Public
Law 113-93), is amended by striking ``The moratorium under
paragraph (1)(A)'' and inserting ``Any moratorium under
paragraph (1)''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect as if included in the enactment of section
112 of the Protecting Access to Medicare Act of 2014.
(b) Modification to Medicare Long-Term Care Hospital High
Cost Outlier Payments.--Section 1886(m) of the Social
Security Act (42 U.S.C. 1395ww(m)) is amended by adding at
the end the following new paragraph:
``(7) Treatment of high cost outlier payments.--
``(A) Adjustment to the standard federal payment rate for
estimated high cost outlier payments.--Under the system
described in paragraph (1), for fiscal years beginning on or
after October 1, 2017, the Secretary shall reduce the
standard Federal payment rate as if the estimated aggregate
amount of high cost outlier payments for standard Federal
payment rate discharges for each such fiscal year would be
equal to 8 percent of estimated aggregate payments for
standard Federal payment rate discharges for each such fiscal
year.
``(B) Limitation on high cost outlier payment amounts.--
Notwithstanding subparagraph (A), the Secretary shall set the
fixed loss amount for high cost outlier payments such that
the estimated aggregate amount of high cost outlier payments
made for standard Federal payment rate discharges for fiscal
years beginning on or after October 1, 2017, shall be equal
to 99.6875 percent of 8 percent of estimated aggregate
payments for standard Federal payment rate discharges for
each such fiscal year.
``(C) Waiver of budget neutrality.--Any reduction in
payments resulting from the application of subparagraph (B)
shall not be taken into account in applying any budget
neutrality provision under such system.
``(D) No effect on site neutral high cost outlier payment
rate.--This paragraph shall not apply with respect to the
computation of the applicable site neutral payment rate under
paragraph (6).''.
SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT
APPLYING DOCUMENTATION AND CODING ADJUSTMENTS.
Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI
Programs Extension Act of 2007 (Public Law 110-90), as
amended by section 631(b) of the American Taxpayer Relief Act
of 2012 (Public Law 112-240) and section 414(1)(B)(iii) of
the Medicare Access and CHIP Reauthorization Act of 2015
(Public Law 114-10), is amended in clause (iii) by striking
``an increase of 0.5 percentage points for discharges
occurring during each of fiscal years 2018 through 2023'' and
inserting ``an increase of 0.4588 percentage points for
discharges occurring during fiscal year 2018 and 0.5
percentage points for discharges occurring during each of
fiscal years 2019 through 2023''.
SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT RULES.
(a) 25-Percent Patient Threshold Payment Adjustment.--
Section 114(c)(1)(A) of the Medicare, Medicaid, and SCHIP
Extension Act of 2007 (42 U.S.C. 1395ww note), as amended by
section 4302(a) of division B of the American Recovery and
Reinvestment Act (Public Law 111-5), sections 3106(a) and
10312(a) of Public Law 111-148, and section 1206(b)(1)(B) of
the Pathway for SGR Reform Act of 2013 (division B of Public
Law 113-67), is amended by striking ``for a 9-year period''
and inserting ``through June 30, 2016, and for discharges
occurring on or after October 1, 2016, and before October 1,
2017''.
(b) Payment for Hospitals-Within-Hospitals.--Section
114(c)(2) of the Medicare, Medicaid, and SCHIP Extension Act
of 2007 (42 U.S.C. 1395ww note), as amended by section
4302(a) of division B of the American Recovery and
Reinvestment Act (Public Law 111-5), sections 3106(a) and
10312(a) of Public Law 111-148, and section 1206(b)(1)(A) of
the Pathway for SGR Reform Act of 2013 (division B of Public
Law 113-67), is amended--
(1) in subparagraph (A), by inserting ``or any similar
provision,'' after ``Regulations,'';
[[Page H6973]]
(2) in subparagraph (B)--
(A) in clause (i), by inserting ``or any similar
provision,'' after ``Regulations,''; and
(B) in clause (ii), by inserting ``, or any similar
provision,'' after ``Regulations''; and
(3) in subparagraph (C), by striking ``for a 9-year
period'' and inserting ``through June 30, 2016, and for
discharges occurring on or after October 1, 2016, and before
October 1, 2017''.
SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF
HOSPITAL LENGTH OF STAY TO ALL LTCHS.
(a) In General.--Section 1206(a)(3) of the Pathway for SGR
Reform Act of 2013 (division B of Public Law 113-67; 42
U.S.C. 1395ww note) is amended--
(1) by striking subparagraph (B);
(2) by striking ``site neutral basis.--'' and all that
follows through ``For discharges occurring'' and inserting
``site neutral basis.--For discharges occurring'';
(3) by striking ``subject to subparagraph (B),''; and
(4) by redesignating clauses (i) and (ii) as subparagraphs
(A) and (B), respectively, and moving each of such
subparagraphs (as so redesignated) 2 ems to the left.
(b) Effective Date.--The amendments made by subsection (a)
shall be effective as if included in the enactment of section
1206(a)(3) of the Pathway for SGR Reform Act of 2013
(division B of Public Law 113-67; 42 U.S.C. 1395ww note).
SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN
HOSPITALS.
(a) In General.--Subsection (d)(1)(B)(iv) of section 1886
of the Social Security Act (42 U.S.C. 1395ww) is amended--
(1) in subclause (I), by striking ``or'' at the end;
(2) in subclause (II)--
(A) by striking ``, or'' at the end and inserting a
semicolon;
(B) by redesignating such subclause as clause (vi) and by
moving it to immediately follow clause (v); and
(C) in clause (v), by striking the semicolon at the end and
inserting ``, or''; and
(3) by striking ``(iv)(I) a hospital'' and inserting ``(iv)
a hospital''.
(b) Conforming Payment References.--The second sentence of
subsection (d)(1)(B) of such section is amended--
(1) by inserting ``(as in effect as of such date)'' after
``clause (iv)''; and
(2) by inserting ``(or, in the case of a hospital described
in clause (iv)(II), as so in effect, shall be classified
under clause (vi) on and after the effective date of such
clause (vi) and for cost reporting periods beginning on or
after January 1, 2015, shall not be subject to subsection (m)
as of the date of such classification)'' after ``so
classified''.
(c) Application.--
(1) In general.--For cost reporting periods beginning on or
after January 1, 2015, in the case of an applicable hospital
(as defined in paragraph (3)), the following shall apply:
(A) Payment for inpatient operating costs shall be made on
a reasonable cost basis in the manner provided in section
412.526(c)(3) of title 42, Code of Federal Regulations (as in
effect on January 1, 2015) and in any subsequent
modifications.
(B) Payment for capital costs shall be made in the manner
provided by section 412.526(c)(4) of title 42, Code of
Federal Regulations (as in effect on such date).
(C) Claims for payment for Medicare beneficiaries who are
discharged on or after January 1, 2017, shall be processed as
claims which are paid on a reasonable cost basis as described
in section 412.526(c) of title 42, Code of Federal
Regulations (as in effect on such date).
(2) Applicable hospital defined.--In this subsection, the
term ``applicable hospital'' means a hospital that is
classified under clause (iv)(II) of section 1886(d)(1)(B) of
the Social Security Act (42 U.S.C. 1395ww(d)(1)(B)) on the
day before the date of the enactment of this Act and which is
classified under clause (vi) of such section, as redesignated
and moved by subsection (a), on or after such date of
enactment.
(d) Conforming Technical Amendments.--
(1) Section 1899B(a)(2)(A)(iv) of the Social Security Act
(42 U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking
``1886(d)(1)(B)(iv)(II)'' and inserting
``1886(d)(1)(B)(vi)''.
(2) Section 1886(m)(5)(F) of such Act (42 U.S.C.
1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii)
by striking ``(d)(1)(B)(iv)(II)'' and inserting
``(d)(1)(B)(vi)''.
SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR
CERTAIN SPINAL CORD SPECIALTY HOSPITALS.
(a) Exception.--Section 1886(m)(6) of the Social Security
Act (42 U.S.C. 1395ww(m)(6)) is amended--
(1) in subparagraph (A)(i), by striking ``and (E)'' and
inserting ``, (E), and (F)''; and
(2) by adding at the end the following new subparagraph:
``(F) Temporary exception for certain spinal cord specialty
hospitals.--For discharges in cost reporting periods
beginning during fiscal years 2018 and 2019, subparagraph
(A)(i) shall not apply (and payment shall be made to a long-
term care hospital without regard to this paragraph) if such
discharge is from a long-term care hospital that meets each
of the following requirements:
``(i) Not-for-profit.--The long-term care hospital was a
not-for-profit long-term care hospital on June 1, 2014, as
determined by cost report data.
``(ii) Primarily providing treatment for catastrophic
spinal cord or acquired brain injuries or other paralyzing
neuromuscular conditions.--Of the discharges in calendar year
2013 from the long-term care hospital for which payment was
made under this section, at least 50 percent were classified
under MS-LTCH-DRGs 28, 29, 52, 57, 551, 573, and 963.
``(iii) Significant out-of-state admissions.--
``(I) In general.--The long-term care hospital discharged
inpatients (including both individuals entitled to, or
enrolled for, benefits under this title and individuals not
so entitled or enrolled) during fiscal year 2014 who had been
admitted from at least 20 of the 50 States, determined by the
States of residency of such inpatients and based on such data
submitted by the hospital to the Secretary as the Secretary
may require.
``(II) Implementation.--Notwithstanding any other provision
of law, the Secretary may implement subclause (I) by program
instruction or otherwise.
``(III) Non-application of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not apply
to data collected under this clause.''.
(b) Study and Report on the Status and Viability of Certain
Spinal Cord Specialty Long-Term Care Hospitals.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on long-term care hospitals described
in section 1886(m)(6)(F) of the Social Security Act, as added
by subsection (a). Such report shall include an analysis of
the following:
(A) The impact on such hospitals of the classification and
facility licensure by State agencies of such hospitals.
(B) The Medicare payment rates for such hospitals.
(C) Data on the number and health care needs of Medicare
beneficiaries who have been diagnosed with catastrophic
spinal cord or acquired brain injuries or other paralyzing
neuromuscular conditions (as described within the discharge
classifications specified in clause (ii) of such section) who
are receiving services from such hospitals.
(2) Report.--Not later than October 1, 2018, the
Comptroller General shall submit to Congress a report on the
study conducted under paragraph (1), including
recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR
CERTAIN DISCHARGES WITH SEVERE WOUNDS.
(a) In General.--Section 1886(m)(6) of the Social Security
Act (42 U.S.C. 1395ww(m)(6)), as amended by section 15009, is
further amended--
(1) in subparagraph (A)(i) by striking ``and (F)'' and
inserting ``(F), and (G)'';
(2) in subparagraph (E)(i)(I)(aa), by striking ``the
amendment made'' and all that follows before the semicolon
and inserting ``the last sentence of subsection (d)(1)(B)'';
and
(3) by adding at the end the following new subparagraph:
``(G) Additional temporary exception for certain severe
wound discharges from certain long-term care hospitals.--
``(i) In general.--For a discharge occurring in a cost
reporting period beginning during fiscal year 2018,
subparagraph (A)(i) shall not apply (and payment shall be
made to a long-term care hospital without regard to this
paragraph) if such discharge--
``(I) is from a long-term care hospital identified by the
last sentence of subsection (d)(1)(B);
``(II) is classified under MS-LTCH-DRG 602, 603, 539, or
540; and
``(III) is with respect to an individual treated by a long-
term care hospital for a severe wound.
``(ii) Severe wound defined.--In this subparagraph, the
term `severe wound' means a wound which is a stage 3 wound,
stage 4 wound, unstageable wound, non-healing surgical wound,
or fistula as identified in the claim from the long-term care
hospital.
``(iii) Wound defined.--In this subparagraph, the term
`wound' means an injury involving division of tissue or
rupture of the integument or mucous membrane with exposure to
the external environment.''.
(c) Study and Report to Congress.--
(1) Study.--The Comptroller General of the United States
shall, in consultation with relevant stakeholders, conduct a
study on the treatment needs of individuals entitled to
benefits under part A of title XVIII of the Social Security
Act or enrolled under part B of such title who require
specialized wound care, and the cost, for such individuals
and the Medicare program under such title, of treating severe
wounds in rural and urban areas. Such study shall include an
assessment of--
(A) access of such individuals to appropriate levels of
care for such cases;
(B) the potential impact that section 1886(m)(6)(A)(i) of
such Act (42 U.S.C. 1395ww(m)(6)(A)(i)) will have on the
access, quality, and cost of care for such individuals; and
(C) how to appropriately pay for such care under the
Medicare program under such title.
(2) Report.--Not later than October 1, 2020, the
Comptroller General shall submit to Congress a report on the
study conducted under paragraph (1), including
recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B
SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD
PROSPECTIVE PAYMENT SYSTEM FOR SERVICES
FURNISHED BY MID-BUILD OFF-CAMPUS OUTPATIENT
DEPARTMENTS OF PROVIDERS.
(a) In General.--Section 1833(t)(21) of the Social Security
Act (42 U.S.C. 1395l(t)(21)) is amended--
(1) in subparagraph (B)--
(A) in clause (i), by striking ``clause (ii)'' and
inserting ``the subsequent provisions of this subparagraph'';
and
[[Page H6974]]
(B) by adding at the end the following new clauses:
``(iii) Deemed treatment for 2017.--For purposes of
applying clause (ii) with respect to applicable items and
services furnished during 2017, a department of a provider
(as so defined) not described in such clause is deemed to be
billing under this subsection with respect to covered OPD
services furnished prior to November 2, 2015, if the
Secretary received from the provider prior to December 2,
2015, an attestation (pursuant to section 413.65(b)(3) of
title 42 of the Code of Federal Regulations) that such
department was a department of a provider (as so defined).
``(iv) Alternative exception beginning with 2018.--For
purposes of paragraph (1)(B)(v) and this paragraph with
respect to applicable items and services furnished during
2018 or a subsequent year, the term `off-campus outpatient
department of a provider' also shall not include a department
of a provider (as so defined) that is not described in clause
(ii) if--
``(I) the Secretary receives from the provider an
attestation (pursuant to such section 413.65(b)(3)) not later
than December 31, 2016 (or, if later, 60 days after the date
of the enactment of this clause), that such department met
the requirements of a department of a provider specified in
section 413.65 of title 42 of the Code of Federal
Regulations;
``(II) the provider includes such department as part of the
provider on its enrollment form in accordance with the
enrollment process under section 1866(j); and
``(III) the department met the mid-build requirement of
clause (v) and the Secretary receives, not later than 60 days
after the date of the enactment of this clause, from the
chief executive officer or chief operating officer of the
provider a written certification that the department met such
requirement.
``(v) Mid-build requirement described.--The mid-build
requirement of this clause is, with respect to a department
of a provider, that before November 2, 2015, the provider had
a binding written agreement with an outside unrelated party
for the actual construction of such department.
``(vii) Audit.--Not later than December 31, 2018, the
Secretary shall audit the compliance with requirements of
clause (iv) with respect to each department of a provider to
which such clause applies. If the Secretary finds as a result
of an audit under this clause that the applicable
requirements were not met with respect to such department,
the department shall not be excluded from the term `off-
campus outpatient department of a provider' under such
clause.
``(viii) Implementation.--For purposes of implementing
clauses (iii) through (vii):
``(I) Notwithstanding any other provision of law, the
Secretary may implement such clauses by program instruction
or otherwise.
``(II) Subchapter I of chapter 35 of title 44, United
States Code, shall not apply.
``(III) For purposes of carrying out this subparagraph with
respect to clauses (iii) and (iv) (and clause (vii) insofar
as it relates to clause (iv)), $10,000,000 shall be available
from the Federal Supplementary Medical Insurance Trust Fund
under section 1841, to remain available until December 31,
2018.''; and
(2) in subparagraph (E), by adding at the end the following
new clause:
``(iv) The determination of an audit under subparagraph
(B)(vii).''.
(b) Effective Date.--The amendments made by this section
shall be effective as if included in the enactment of section
603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS
OUTPATIENT DEPARTMENT OF A PROVIDER POLICY.
(a) In General.--Section 1833(t)(21)(B) of the Social
Security Act (42 U.S.C. 1395l(t)(21)(B)), as amended by
section 16001(a), is amended--
(1) by inserting after clause (v) the following new clause:
``(vi) Exclusion for certain cancer hospitals.--For
purposes of paragraph (1)(B)(v) and this paragraph with
respect to applicable items and services furnished during
2017 or a subsequent year, the term `off-campus outpatient
department of a provider' also shall not include a department
of a provider (as so defined) that is not described in clause
(ii) if the provider is a hospital described in section
1886(d)(1)(B)(v) and--
``(I) in the case of a department that met the requirements
of section 413.65 of title 42 of the Code of Federal
Regulations after November 1, 2015, and before the date of
the enactment of this clause, the Secretary receives from the
provider an attestation that such department met such
requirements not later than 60 days after such date of
enactment; or
``(II) in the case of a department that meets such
requirements after such date of enactment, the Secretary
receives from the provider an attestation that such
department meets such requirements not later than 60 days
after the date such requirements are first met with respect
to such department.'';
(2) in clause (vii), by inserting after the first sentence
the following: ``Not later than 2 years after the date the
Secretary receives an attestation under clause (vi) relating
to compliance of a department of a provider with requirements
referred to in such clause, the Secretary shall audit the
compliance with such requirements with respect to the
department.''; and
(3) in clause (viii)(III), by adding at the end the
following: ``For purposes of carrying out this subparagraph
with respect to clause (vi) (and clause (vii) insofar as it
relates to such clause), $2,000,000 shall be available from
the Federal Supplementary Medical Insurance Trust Fund under
section 1841, to remain available until expended.''.
(b) Offsetting Savings.--Section 1833(t)(18) of the Social
Security Act (42 U.S.C. 1395l(t)(18)) is amended--
(1) in subparagraph (B), by inserting ``, subject to
subparagraph (C),'' after ``shall''; and
(2) by adding at the end the following new subparagraph:
``(C) Target pcr adjustment.--In applying section 419.43(i)
of title 42 of the Code of Federal Regulations to implement
the appropriate adjustment under this paragraph for services
furnished on or after January 1, 2018, the Secretary shall
use a target PCR that is 1.0 percentage points less than the
target PCR that would otherwise apply. In addition to the
percentage point reduction under the previous sentence, the
Secretary may consider making an additional percentage point
reduction to such target PCR that takes into account payment
rates for applicable items and services described in
paragraph (21)(C) other than for services furnished by
hospitals described in section 1886(d)(1)(B)(v). In making
any budget neutrality adjustments under this subsection for
2018 or a subsequent year, the Secretary shall not take into
account the reduced expenditures that result from the
application of this subparagraph.''.
(c) Effective Date.--The amendments made by this section
shall be effective as if included in the enactment of section
603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY
SURGICAL CENTERS FOR MEANINGFUL USE AND MIPS.
Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C.
1395w-4(a)(7)(D)) is amended--
(1) by striking ``hospital-based eligible professionals''
and all that follows through ``No payment'' and inserting the
following: ``hospital-based and ambulatory surgical center-
based eligible professionals.--
``(i) Hospital-based.--No payment''; and
(2) by adding at the end the following new clauses:
``(ii) Ambulatory surgical center-based.--Subject to clause
(iv), no payment adjustment may be made under subparagraph
(A) for 2017 and 2018 in the case of an eligible professional
with respect to whom substantially all of the covered
professional services furnished by such professional are
furnished in an ambulatory surgical center.
``(iii) Determination.--The determination of whether an
eligible professional is an eligible professional described
in clause (ii) may be made on the basis of--
``(I) the site of service (as defined by the Secretary); or
``(II) an attestation submitted by the eligible
professional.
Determinations made under subclauses (I) and (II) shall be
made without regard to any employment or billing arrangement
between the eligible professional and any other supplier or
provider of services.
``(iv) Sunset.--Clause (ii) shall no longer apply as of the
first year that begins more than 3 years after the date on
which the Secretary determines, through notice and comment
rulemaking, that certified EHR technology applicable to the
ambulatory surgical center setting is available.''.
SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016.
(a) Extension of Enforcement Instruction on Supervision
Requirements for Outpatient Therapeutic Services in Critical
Access and Small Rural Hospitals Through 2016.--Section 1 of
Public Law 113-198, as amended by section 1 of Public Law
114-112, is amended--
(1) in the heading, by striking ``2014 and 2015'' and
inserting ``2016''; and
(2) by striking ``and 2015'' and inserting ``, 2015, and
2016''.
(b) Report.--Not later than 1 year after the date of the
enactment of this Act, the Medicare Payment Advisory
Commission (established under section 1805 of the Social
Security Act (42 U.S.C. 1395b-6)) shall submit to Congress a
report analyzing the effect of the extension of the
enforcement instruction under section 1 of Public Law 113-
198, as amended by section 1 of Public Law 114-112 and
subsection (a) of this section, on the access to health care
by Medicare beneficiaries, on the economic impact and the
impact upon hospital staffing needs, and on the quality of
health care furnished to such beneficiaries.
SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE SCHEDULE
ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES AND
SEATING SYSTEMS WHEN USED IN CONJUNCTION WITH
COMPLEX REHABILITATION TECHNOLOGY (CRT)
WHEELCHAIRS.
Section 2(a) of the Patient Access and Medicare Protection
Act (42 U.S.C. 1305 note) is amended by striking ``January 1,
2017'' and inserting ``July 1, 2017''.
SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM
TENENS ARRANGEMENTS UNDER MEDICARE.
(a) In General.--The first sentence of section 1842(b)(6)
of the Social Security Act (42 U.S.C. 1395u(b)(6)), as
amended by section 5012, is further amended--
(1) by striking ``and'' before ``(I)''; and
(2) by inserting before the period at the end the
following: ``, and (J) in the case of outpatient physical
therapy services furnished by physical therapists in a health
professional shortage area (as defined in section
332(a)(1)(A) of the Public Health Service Act), a medically
underserved area (as designated pursuant to section
330(b)(3)(A) of such Act), or a rural area (as defined in
section 1886(d)(2)(D)), subparagraph (D) of this sentence
shall apply to such services and therapists in the same
manner as such subparagraph applies to physicians' services
furnished by physicians''.
(b) Effective Date; Implementation.--
(1) Effective date.--The amendments made by subsection (a)
shall apply to services furnished beginning not later than
six months after the date of the enactment of this Act.
[[Page H6975]]
(2) Implementation.--The Secretary of Health and Human
Services may implement subparagraph (J) of section 1842(b)(6)
of the Social Security Act (42 U.S.C. 1395u(b)(6)), as added
by subsection (a)(2), by program instruction or otherwise.
SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES
FOR DURABLE MEDICAL EQUIPMENT UNDER THE
MEDICARE PROGRAM.
(a) In General.--The Secretary of Health and Human Services
shall extend the transition period described in clause (i) of
section 414.210(g)(9) of title 42, Code of Federal
Regulations, from June 30, 2016, to December 31, 2016 (with
the full implementation described in clause (ii) of such
section applying to items and services furnished with dates
of service on or after January 1, 2017).
(b) Study and Report.--
(1) Study.--
(A) In general.--The Secretary of Health and Human Services
shall conduct a study that examines the impact of applicable
payment adjustments upon--
(i) the number of suppliers of durable medical equipment
that, on a date that is not before January 1, 2016, and not
later than December 31, 2016, ceased to conduct business as
such suppliers; and
(ii) the availability of durable medical equipment, during
the period beginning on January 1, 2016, and ending on
December 31, 2016, to individuals entitled to benefits under
part A of title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.) or enrolled under part B of such title.
(B) Definitions.--For purposes of this subsection, the
following definitions apply:
(i) Supplier; durable medical equipment.--The terms
``supplier'' and ``durable medical equipment'' have the
meanings given such terms by section 1861 of the Social
Security Act (42 U.S.C. 1395x).
(ii) Applicable payment adjustment.--The term ``applicable
payment adjustment'' means a payment adjustment described in
section 414.210(g) of title 42, Code of Federal Regulations,
that is phased in by paragraph (9)(i) of such section. For
purposes of the preceding sentence, a payment adjustment that
is phased in pursuant to the extension under subsection (a)
shall be considered a payment adjustment that is phased in by
such paragraph (9)(i).
(2) Report.--The Secretary of Health and Human Services
shall, not later than January 12, 2017, submit to the
Committees on Ways and Means and on Energy and Commerce of
the House of Representatives, and to the Committee on Finance
of the Senate, a report on the findings of the study
conducted under paragraph (1).
SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING
INFORMATION FROM COMPETITIVE BIDDING PROGRAMS.
(a) In General.--Section 1834(a)(1)(G) of the Social
Security Act (42 U.S.C. 1395m(a)(1)(G)) is amended by adding
at the end the following new sentence: ``In the case of items
and services furnished on or after January 1, 2019, in making
any adjustments under clause (ii) or (iii) of subparagraph
(F), under subsection (h)(1)(H)(ii), or under section
1842(s)(3)(B), the Secretary shall--
``(i) solicit and take into account stakeholder input; and
``(ii) take into account the highest amount bid by a
winning supplier in a competitive acquisition area and a
comparison of each of the following with respect to non-
competitive acquisition areas and competitive acquisition
areas:
``(I) The average travel distance and cost associated with
furnishing items and services in the area.
``(II) The average volume of items and services furnished
by suppliers in the area.
``(III) The number of suppliers in the area.''.
(b) Conforming Amendments.--(1) Section 1834(h)(1)(H)(ii)
of the Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is
amended by striking ``the Secretary'' and inserting ``subject
to subsection (a)(1)(G), the Secretary''.
(2) Section 1842(s)(3)(B) of the Social Security Act (42
U.S.C. 1395m(s)(3)(B)) is amended by striking ``the
Secretary'' and inserting ``subject to section 1834(a)(1)(G),
the Secretary''.
TITLE XVII--OTHER MEDICARE PROVISIONS
SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR
MEDICARE ADVANTAGE PLANS FAILING TO ACHIEVE
MINIMUM QUALITY RATINGS.
(a) Findings.--Consistent with the studies provided under
the IMPACT Act of 2014 (Public Law 113-185), it is the intent
of Congress--
(1) to continue to study and request input on the effects
of socioeconomic status and dual-eligible populations on the
Medicare Advantage STARS rating system before reforming such
system with the input of stakeholders; and
(2) pending the results of such studies and input, to
provide for a temporary delay in authority of the Centers for
Medicare & Medicaid Services (CMS) to terminate Medicare
Advantage plan contracts solely on the basis of performance
of plans under the STARS rating system.
(b) Delay in MA Contract Termination Authority for Plans
Failing To Achieve Minimum Quality Ratings.--Section 1857(h)
of the Social Security Act (42 U.S.C. 1395w-27(h)) is amended
by adding at the end the following new paragraph:
``(3) Delay in contract termination authority for plans
failing to achieve minimum quality rating.--During the period
beginning on the date of the enactment of this paragraph and
through the end of plan year 2018, the Secretary may not
terminate a contract under this section with respect to the
offering of an MA plan by a Medicare Advantage organization
solely because the MA plan has failed to achieve a minimum
quality rating under the 5-star rating system under section
1853(o)(4).''.
SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA REPORTING FOR
MEDICARE.
Section 1874 of the Social Security Act (42 U.S.C. 1395kk)
is amended by adding at the end the following new subsection:
``(g) Requirement for Enrollment Data Reporting.--
``(1) In general.--Each year (beginning with 2016), the
Secretary shall submit to the Committees on Ways and Means
and Energy and Commerce of the House of Representatives and
the Committee on Finance of the Senate a report on Medicare
enrollment data (and, in the case of part A, on data on
individuals receiving benefits under such part) as of a date
in such year specified by the Secretary. Such data shall be
presented--
``(A) by Congressional district and State; and
``(B) in a manner that provides for such data based on--
``(i) fee-for-service enrollment (as defined in paragraph
(2));
``(ii) enrollment under part C (including separate for
aggregate enrollment in MA-PD plans and aggregate enrollment
in MA plans that are not MA-PD plans); and
``(iii) enrollment under part D.
``(2) Fee-for-service enrollment defined.--For purpose of
paragraph (1)(B)(i), the term `fee-for-service enrollment'
means aggregate enrollment (including receipt of benefits
other than through enrollment) under--
``(A) part A only;
``(B) part B only; and
``(C) both part A and part B.''.
SEC. 17003. UPDATING THE WELCOME TO MEDICARE PACKAGE.
(a) In General.--Not later than 12 months after the last
day of the period for the request of information described in
subsection (b), the Secretary of Health and Human Services
shall, taking into consideration information collected
pursuant to subsection (b), update the information included
in the Welcome to Medicare package to include information,
presented in a clear and simple manner, about options for
receiving benefits under the Medicare program under title
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.),
including through the original medicare fee-for-service
program under parts A and B of such title (42 U.S.C. 1395c et
seq., 42 U.S.C. 1395j et seq.), Medicare Advantage plans
under part C of such title (42 U.S.C. 1395w-21 et seq.), and
prescription drug plans under part D of such title (42 U.S.C.
1395w-101 et seq.)). The Secretary shall make subsequent
updates to the information included in the Welcome to
Medicare package as appropriate.
(b) Request for Information.--Not later than 6 months after
the date of the enactment of this Act, the Secretary of
Health and Human Services shall request information,
including recommendations, from stakeholders (including
patient advocates, issuers, and employers) on information
included in the Welcome to Medicare package, including
pertinent data and information regarding enrollment and
coverage for Medicare eligible individuals.
SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY
NEWLY ENROLLED PROVIDERS OR SUPPLIERS WITHIN A
TEMPORARY MORATORIUM AREA.
(a) Medicare.--Section 1866(j)(7) of the Social Security
Act (42 U.S.C. 1395cc(j)(7)) is amended--
(1) in the paragraph heading, by inserting ``; nonpayment''
before the period; and
(2) by adding at the end the following new subparagraph:
``(C) Nonpayment.--
``(i) In general.--No payment may be made under this title
or under a program described in subparagraph (A) with respect
to an item or service described in clause (ii) furnished on
or after October 1, 2017.
``(ii) Item or service described.--An item or service
described in this clause is an item or service furnished--
``(I) within a geographic area with respect to which a
temporary moratorium imposed under subparagraph (A) is in
effect; and
``(II) by a provider of services or supplier that meets the
requirements of clause (iii).
``(iii) Requirements.--For purposes of clause (ii), the
requirements of this clause are that a provider of services
or supplier--
``(I) enrolls under this title on or after the effective
date of such temporary moratorium; and
``(II) is within a category of providers of services and
suppliers (as described in subparagraph (A)) subject to such
temporary moratorium.
``(iv) Prohibition on charges for specified items or
services.--In no case shall a provider of services or
supplier described in clause (ii)(II) charge an individual or
other person for an item or service described in clause (ii)
furnished on or after October 1, 2017, to an individual
entitled to benefits under part A or enrolled under part B or
an individual under a program specified in subparagraph
(A).''.
(b) Conforming Amendments.--
(1) Medicaid.--
(A) In general.--Section 1903(i)(2) of the Social Security
Act (42 U.S.C. 1396b(i)(2)), as amended by section
5005(a)(4), is further amended--
(i) in subparagraph (C), by striking ``or'' at the end; and
(ii) by adding at the end the following new subparagraph:
``(E) with respect to any amount expended for such an item
or service furnished during calendar quarters beginning on or
after October 1, 2017, subject to section
1902(kk)(4)(A)(ii)(II), within a geographic area that is
subject to a moratorium imposed under section 1866(j)(7) by a
provider or supplier that meets the requirements specified in
subparagraph (C)(iii) of such section, during the period of
such moratorium; or''.
[[Page H6976]]
(B) Exception with respect to access.--Section
1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C.
1396a(kk)(4)(A)(ii)) is amended to read as follows:
``(ii) Exceptions.--
``(I) Compliance with moratorium.--A State shall not be
required to comply with a temporary moratorium described in
clause (i) if the State determines that the imposition of
such temporary moratorium would adversely impact
beneficiaries' access to medical assistance.
``(II) FFP available.--Notwithstanding section
1903(i)(2)(E), payment may be made to a State under this
title with respect to amounts expended for items and services
described in such section if the Secretary, in consultation
with the State agency administering the State plan under this
title (or a waiver of the plan), determines that denying
payment to the State pursuant to such section would adversely
impact beneficiaries' access to medical assistance. ''.
(C) State plan requirement with respect to limitation on
charges to beneficiaries.--Section 1902(kk)(4)(A) of the
Social Security Act (42 U.S.C. 1396a(kk)(4)(A)) is amended by
adding at the end the following new clause:
``(iii) Limitation on charges to beneficiaries.--With
respect to any amount expended for items or services
furnished during calendar quarters beginning on or after
October 1, 2017, the State prohibits, during the period of a
temporary moratorium described in clause (i), a provider
meeting the requirements specified in subparagraph (C)(iii)
of section 1866(j)(7) from charging an individual or other
person eligible to receive medical assistance under the State
plan under this title (or a waiver of the plan) for an item
or service described in section 1903(i)(2)(E) furnished to
such an individual.''.
(2) Correcting amendments to related provisions.--
(A) Section 1866(j).--Section 1866(j) of the Social
Security Act (42 U.S.C. 1395cc(j)) is amended--
(i) in paragraph (1)(A)--
(I) by striking ``paragraph (4)'' and inserting ``paragraph
(5)'';
(II) by striking ``moratoria in accordance with paragraph
(5)'' and inserting ``moratoria in accordance with paragraph
(7)''; and
(III) by striking ``paragraph (6)'' and inserting
``paragraph (9)''; and
(ii) by redesignating the second paragraph (8)
(redesignated by section 1304(1) of Public Law 111-152) as
paragraph (9).
(B) Section 1902(kk).--Section 1902(kk) of such Act (42
U.S.C. 1396a(kk)) is amended--
(i) in paragraph (1), by striking ``section 1886(j)(2)''
and inserting ``section 1866(j)(2)'';
(ii) in paragraph (2), by striking ``section 1886(j)(3)''
and inserting ``section 1866(j)(3)'';
(iii) in paragraph (3), by striking ``section 1886(j)(4)''
and inserting ``section 1866(j)(5)''; and
(iv) in paragraph (4)(A), by striking ``section
1886(j)(6)'' and inserting ``section 1866(j)(7)''.
SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE UNDER
MEDICARE ADVANTAGE.
Section 1851(e)(2) of the Social Security Act (42 U.S.C.
1395w-21(e)(2)) is amended--
(1) in subparagraph (C)--
(A) in the heading, by inserting ``from 2011 through 2018''
after ``45-day period''; and
(B) by inserting ``and ending with 2018'' after ``beginning
with 2011''; and
(2) by adding at the end the following new subparagraph:
``(G) Continuous open enrollment and disenrollment for
first 3 months in 2016 and subsequent years.--
``(i) In general.--Subject to clause (ii) and subparagraph
(D)--
``(I) in the case of an MA eligible individual who is
enrolled in an MA plan, at any time during the first 3 months
of a year (beginning with 2019); or
``(II) in the case of an individual who first becomes an MA
eligible individual during a year (beginning with 2019) and
enrolls in an MA plan, during the first 3 months during such
year in which the individual is an MA eligible individual;
such MA eligible individual may change the election under
subsection (a)(1).
``(ii) Limitation of one change during open enrollment
period each year.--An individual may change the election
pursuant to clause (i) only once during the applicable 3-
month period described in such clause in each year. The
limitation under this clause shall not apply to changes in
elections effected during an annual, coordinated election
period under paragraph (3) or during a special enrollment
period under paragraph (4).
``(iii) Limited application to part d.--Clauses (i) and
(ii) of this subparagraph shall only apply with respect to
changes in enrollment in a prescription drug plan under part
D in the case of an individual who, previous to such change
in enrollment, is enrolled in a Medicare Advantage plan.
``(iv) Limitations on marketing.--Pursuant to subsection
(j), no unsolicited marketing or marketing materials may be
sent to an individual described in clause (i) during the
continuous open enrollment and disenrollment period
established for the individual under such clause,
notwithstanding marketing guidelines established by the
Centers for Medicare & Medicaid Services.''.
SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES TO
CHOOSE A MEDICARE ADVANTAGE PLAN.
(a) Removing Prohibition.--
(1) In general.--Section 1851(a)(3) of the Social Security
Act (42 U.S.C. 1395w-21(a)(3)) is amended--
(A) by striking subparagraph (B); and
(B) by striking ``eligible individual'' and all that
follows through ``In this title, subject to subparagraph
(B),'' and inserting ``eligible individual.--In this
title,''.
(2) Conforming amendments.--
(A) Section 1852(b)(1) of the Social Security Act (42
U.S.C. 1395w-22(b)(1)) is amended--
(i) by striking subparagraph (B); and
(ii) by striking ``Beneficiaries'' and all that follows
through ``A Medicare+Choice organization'' and inserting
``Beneficiaries.--A Medicare Advantage organization''.
(B) Section 1859(b)(6) of the Social Security Act (42
U.S.C. 1395w-28(b)(6)) is amended, in the last sentence, by
striking ``may waive'' and all that follows through
``subparagraph and''.
(3) Effective date.--The amendments made by this subsection
shall apply with respect to plan years beginning on or after
January 1, 2021.
(b) Excluding Costs for Kidney Acquisitions From MA
Benchmark.--Section 1853 of the Social Security Act (42
U.S.C. 1395w-23) is amended--
(1) in subsection (k)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``paragraphs (2) and (4)'' and inserting ``paragraphs (2),
(4), and (5)''; and
(ii) in subparagraph (B)(i), by striking ``paragraphs (2)
and (4)'' and inserting ``paragraphs (2), (4), and (5)''; and
(B) by adding at the end the following new paragraph:
``(5) Exclusion of costs for kidney acquisitions from
capitation rates.--After determining the applicable amount
for an area for a year under paragraph (1) (beginning with
2021), the Secretary shall adjust such applicable amount to
exclude from such applicable amount the Secretary's estimate
of the standardized costs for payments for organ acquisitions
for kidney transplants covered under this title (including
expenses covered under section 1881(d)) in the area for the
year.''; and
(2) in subsection (n)(2)--
(A) in subparagraph (A)(i), by inserting ``and, for 2021
and subsequent years, the exclusion of payments for organ
acquisitions for kidney transplants from the capitation rate
as described in subsection (k)(5)'' before the semicolon at
the end;
(B) in subparagraph (E), in the matter preceding clause
(i), by striking ``subparagraph (F)'' and inserting
``subparagraphs (F) and (G)''; and
(C) by adding at the end the following new subparagraph:
``(G) Application of kidney acquisitions adjustment.--The
base payment amount specified in subparagraph (E) for a year
(beginning with 2021) shall be adjusted in the same manner
under paragraph (5) of subsection (k) as the applicable
amount is adjusted under such subsection.''.
(c) FFS Coverage of Kidney Acquisitions.--
(1) In general.--Section 1852(a)(1)(B)(i) of the Social
Security Act (42 U.S.C. 1395w-22(a)(1)(B)(i)) is amended by
inserting ``or coverage for organ acquisitions for kidney
transplants, including as covered under section 1881(d)''
after ``hospice care''.
(2) Conforming amendment.--Section 1851(i) of the Social
Security Act (42 U.S.C. 1395w-21(i)) is amended by adding at
the end the following new paragraph:
``(3) FFS payment for expenses for kidney acquisitions.--
Paragraphs (1) and (2) shall not apply with respect to
expenses for organ acquisitions for kidney transplants
described in section 1852(a)(1)(B)(i).''.
(3) Effective date.--The amendments made by this subsection
shall apply with respect to plan years beginning on or after
January 1, 2021.
(d) Evaluation of Quality.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
conduct an evaluation of whether the 5-star rating system
based on the data collected under section 1852(e) of the
Social Security Act (42 U.S.C. 1395w-22(e)) should include a
quality measure specifically related to care for enrollees in
Medicare Advantage plans under part C of title XVIII of such
Act determined to have end-stage renal disease.
(2) Public availability.--Not later than April 1, 2020, the
Secretary shall post on the Internet website of the Centers
for Medicare & Medicaid Services the results of the
evaluation under paragraph (1).
(e) Report.--Not later than December 31, 2023, the
Secretary of Health and Human Services (in this subsection
referred to as the ``Secretary'') shall submit to Congress a
report on the impact of the provisions of, and amendments
made by, this section with respect to the following:
(1) Spending under--
(A) the original Medicare fee-for-service program under
parts A and B of title XVIII of the Social Security Act; and
(B) the Medicare Advantage program under part C of such
title.
(2) The number of enrollees determined to have end-stage
renal disease--
(A) in the original Medicare fee-for-service program; and
(B) in the Medicare Advantage program.
(3) The sufficiency of the amount of data under the
original Medicare fee-for-service program for individuals
determined to have end-stage renal disease for purposes of
determining payment rates for end-stage renal disease under
the Medicare Advantage program.
(f) Improvements to Risk Adjustment Under Medicare
Advantage.--
(1) In general.--Section 1853(a)(1) of the Social Security
Act (42 U.S.C. 1395w-23(a)(1)) is amended--
(A) in subparagraph (C)(i), by striking ``The Secretary''
and inserting ``Subject to subparagraph (I), the Secretary'';
and
(B) by adding at the end the following new subparagraph:
[[Page H6977]]
``(I) Improvements to risk adjustment for 2019 and
subsequent years.--
``(i) In general.--In order to determine the appropriate
adjustment for health status under subparagraph (C)(i), the
following shall apply:
``(I) Taking into account total number of diseases or
conditions.--The Secretary shall take into account the total
number of diseases or conditions of an individual enrolled in
an MA plan. The Secretary shall make an additional adjustment
under such subparagraph as the number of diseases or
conditions of an individual increases.
``(II) Using at least 2 years of diagnostic data.--The
Secretary may use at least 2 years of diagnosis data.
``(III) Providing separate adjustments for dual eligible
individuals.--With respect to individuals who are dually
eligible for benefits under this title and title XIX, the
Secretary shall make separate adjustments for each of the
following:
``(aa) Full-benefit dual eligible individuals (as defined
in section 1935(c)(6)).
``(bb) Such individuals not described in item (aa).
``(IV) Evaluation of mental health and substance use
disorders.--The Secretary shall evaluate the impact of
including additional diagnosis codes related to mental health
and substance use disorders in the risk adjustment model.
``(V) Evaluation of chronic kidney disease.--The Secretary
shall evaluate the impact of including the severity of
chronic kidney disease in the risk adjustment model.
``(VI) Evaluation of payment rates for end-stage renal
disease.--The Secretary shall evaluate whether other factors
(in addition to those described in subparagraph (H)) should
be taken into consideration when computing payment rates
under such subparagraph.
``(ii) Phased-in implementation.--The Secretary shall
phase-in any changes to risk adjustment payment amounts under
subparagraph (C)(i) under this subparagraph over a 3-year
period, beginning with 2019, with such changes being fully
implemented for 2022 and subsequent years.
``(iii) Opportunity for review and public comment.--The
Secretary shall provide an opportunity for review of the
proposed changes to such risk adjustment payment amounts
under this subparagraph and a public comment period of not
less than 60 days before implementing such changes.''.
(2) Studies and reports.--
(A) Reports on the risk adjustment system.--
(i) Medpac evaluation and report.--
(I) Evaluation.--The Medicare Payment Advisory Commission
shall conduct an evaluation of the impact of the provisions
of, and amendments made by, this section on risk scores for
enrollees in Medicare Advantage plans under part C of title
XVIII of the Social Security Act and payments to Medicare
Advantage plans under such part, including the impact of such
provisions and amendments on the overall accuracy of risk
scores under the Medicare Advantage program.
(II) Report.--Not later than July 1, 2020, the Medicare
Payment Advisory Commission shall submit to Congress a report
on the evaluation under subclause (I), together with
recommendations for such legislation and administrative
action as the Commission determines appropriate.
(ii) Reports by secretary of health and human services.--
Not later than December 31, 2018, and every 3 years
thereafter, the Secretary of Health and Human Services shall
submit to Congress a report on the risk adjustment model and
the ESRD risk adjustment model under the Medicare Advantage
program under part C of title XVIII of the Social Security
Act, including any revisions to either such model since the
previous report. Such report shall include information on how
such revisions impact the predictive ratios under either such
model for groups of enrollees in Medicare Advantage plans,
including very high and very low cost enrollees, and groups
defined by the number of chronic conditions of enrollees.
(B) Study and report on functional status.--
(i) Study.--The Comptroller General of the United States
(in this subparagraph referred to as the ``Comptroller
General'') shall conduct a study on how to most accurately
measure the functional status of enrollees in Medicare
Advantage plans and whether the use of such functional status
would improve the accuracy of risk adjustment payments under
the Medicare Advantage program under part C of title XVIII of
the Social Security Act. Such study shall include an analysis
of the challenges in collecting and reporting functional
status information for Medicare Advantage plans under such
part, providers of services and suppliers under the Medicare
program, and the Centers for Medicare & Medicaid Services.
(ii) Report.--Not later than June 30, 2018, the Comptroller
General shall submit to Congress a report containing the
results of the study under clause (i), together with
recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES
UNDER THE MEDICARE SHARED SAVINGS PROGRAM.
Section 1899(c) of the Social Security Act (42 U.S.C.
1395jjj(c)) is amended--
(1) by striking ``utilization of primary'' and inserting
``utilization of--
``(1) in the case of performance years beginning on or
after April 1, 2012, primary'';
(2) in paragraph (1), as added by paragraph (1) of this
section, by striking the period at the end and inserting ``;
and'';
(3) by adding at the end the following new paragraph:
``(2) in the case of performance years beginning on or
after January 1, 2019, services provided under this title by
a Federally qualified health center or rural health clinic
(as those terms are defined in section 1861(aa)), as may be
determined by the Secretary.''.
TITLE XVIII--OTHER PROVISIONS
SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN REQUIREMENTS FOR
QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT
ARRANGEMENTS.
(a) Amendments to the Internal Revenue Code of 1986 and the
Patient Protection and Affordable Care Act.--
(1) In general.--Section 9831 of the Internal Revenue Code
of 1986 is amended by adding at the end the following new
subsection:
``(d) Exception for Qualified Small Employer Health
Reimbursement Arrangements.--
``(1) In general.--For purposes of this title (except as
provided in section 4980I(f)(4) and notwithstanding any other
provision of this title), the term `group health plan' shall
not include any qualified small employer health reimbursement
arrangement.
``(2) Qualified small employer health reimbursement
arrangement.--For purposes of this subsection--
``(A) In general.--The term `qualified small employer
health reimbursement arrangement' means an arrangement
which--
``(i) is described in subparagraph (B), and
``(ii) is provided on the same terms to all eligible
employees of the eligible employer.
``(B) Arrangement described.--An arrangement is described
in this subparagraph if--
``(i) such arrangement is funded solely by an eligible
employer and no salary reduction contributions may be made
under such arrangement,
``(ii) such arrangement provides, after the employee
provides proof of coverage, for the payment of, or
reimbursement of, an eligible employee for expenses for
medical care (as defined in section 213(d)) incurred by the
eligible employee or the eligible employee's family members
(as determined under the terms of the arrangement), and
``(iii) the amount of payments and reimbursements described
in clause (ii) for any year do not exceed $4,950 ($10,000 in
the case of an arrangement that also provides for payments or
reimbursements for family members of the employee).
``(C) Certain variation permitted.--For purposes of
subparagraph (A)(ii), an arrangement shall not fail to be
treated as provided on the same terms to each eligible
employee merely because the employee's permitted benefit
under such arrangement varies in accordance with the
variation in the price of an insurance policy in the relevant
individual health insurance market based on--
``(i) the age of the eligible employee (and, in the case of
an arrangement which covers medical expenses of the eligible
employee's family members, the age of such family members),
or
``(ii) the number of family members of the eligible
employee the medical expenses of which are covered under such
arrangement.
The variation permitted under the preceding sentence shall be
determined by reference to the same insurance policy with
respect to all eligible employees.
``(D) Rules relating to maximum dollar limitation.--
``(i) Amount prorated in certain cases.--In the case of an
individual who is not covered by an arrangement for the
entire year, the limitation under subparagraph (B)(iii) for
such year shall be an amount which bears the same ratio to
the amount which would (but for this clause) be in effect for
such individual for such year under subparagraph (B)(iii) as
the number of months for which such individual is covered by
the arrangement for such year bears to 12.
``(ii) Inflation adjustment.--In the case of any year
beginning after 2016, each of the dollar amounts in
subparagraph (B)(iii) shall be increased by an amount equal
to--
``(I) such dollar amount, multiplied by
``(II) the cost-of-living adjustment determined under
section 1(f)(3) for the calendar year in which the taxable
year begins, determined by substituting `calendar year 2015'
for `calendar year 1992' in subparagraph (B) thereof.
If any dollar amount increased under the preceding sentence
is not a multiple of $50, such dollar amount shall be rounded
to the next lowest multiple of $50.
``(3) Other definitions.--For purposes of this subsection--
``(A) Eligible employee.--The term `eligible employee'
means any employee of an eligible employer, except that the
terms of the arrangement may exclude from consideration
employees described in any clause of section 105(h)(3)(B)
(applied by substituting `90 days' for `3 years' in clause
(i) thereof).
``(B) Eligible employer.--The term `eligible employer'
means an employer that--
``(i) is not an applicable large employer as defined in
section 4980H(c)(2), and
``(ii) does not offer a group health plan to any of its
employees.
``(C) Permitted benefit.--The term `permitted benefit'
means, with respect to any eligible employee, the maximum
dollar amount of payments and reimbursements which may be
made under the terms of the qualified small employer health
reimbursement arrangement for the year with respect to such
employee.
``(4) Notice.--
``(A) In general.--An employer funding a qualified small
employer health reimbursement arrangement for any year shall,
not later than 90 days before the beginning of such year (or,
in the case of an employee who is not eligible to participate
in the arrangement as of the beginning of such year, the date
on which such employee is first so eligible), provide a
written notice to each eligible employee which includes the
information described in subparagraph (B).
[[Page H6978]]
``(B) Contents of notice.--The notice required under
subparagraph (A) shall include each of the following:
``(i) A statement of the amount which would be such
eligible employee's permitted benefit under the arrangement
for the year.
``(ii) A statement that the eligible employee should
provide the information described in clause (i) to any health
insurance exchange to which the employee applies for advance
payment of the premium assistance tax credit.
``(iii) A statement that if the employee is not covered
under minimum essential coverage for any month the employee
may be subject to tax under section 5000A for such month and
reimbursements under the arrangement may be includible in
gross income.''.
(2) Limitation on exclusion from gross income.--Section 106
of such Code is amended by adding at the end the following:
``(g) Qualified Small Employer Health Reimbursement
Arrangement.--For purposes of this section and section 105,
payments or reimbursements from a qualified small employer
health reimbursement arrangement (as defined in section
9831(d)) of an individual for medical care (as defined in
section 213(d)) shall not be treated as paid or reimbursed
under employer-provided coverage for medical expenses under
an accident or health plan if for the month in which such
medical care is provided the individual does not have minimum
essential coverage (within the meaning of section
5000A(f)).''.
(3) Coordination with health insurance premium credit.--
Section 36B(c) of such Code is amended by adding at the end
the following new paragraph:
``(4) Special rules for qualified small employer health
reimbursement arrangements.--
``(A) In general.--The term `coverage month' shall not
include any month with respect to an employee (or any spouse
or dependent of such employee) if for such month the employee
is provided a qualified small employer health reimbursement
arrangement which constitutes affordable coverage.
``(B) Denial of double benefit.--In the case of any
employee who is provided a qualified small employer health
reimbursement arrangement for any coverage month (determined
without regard to subparagraph (A)), the credit otherwise
allowable under subsection (a) to the taxpayer for such month
shall be reduced (but not below zero) by the amount described
in subparagraph (C)(i)(II) for such month.
``(C) Affordable coverage.--For purposes of subparagraph
(A), a qualified small employer health reimbursement
arrangement shall be treated as constituting affordable
coverage for a month if--
``(i) the excess of--
``(I) the amount that would be paid by the employee as the
premium for such month for self-only coverage under the
second lowest cost silver plan offered in the relevant
individual health insurance market, over
``(II) \1/12\ of the employee's permitted benefit (as
defined in section 9831(d)(3)(C)) under such arrangement,
does not exceed--
``(ii) \1/12\ of 9.5 percent of the employee's household
income.
``(D) Qualified small employer health reimbursement
arrangement.--For purposes of this paragraph, the term
`qualified small employer health reimbursement arrangement'
has the meaning given such term by section 9831(d)(2).
``(E) Coverage for less than entire year.--In the case of
an employee who is provided a qualified small employer health
reimbursement arrangement for less than an entire year,
subparagraph (C)(i)(II) shall be applied by substituting `the
number of months during the year for which such arrangement
was provided' for `12'.
``(F) Indexing.--In the case of plan years beginning in any
calendar year after 2014, the Secretary shall adjust the 9.5
percent amount under subparagraph (C)(ii) in the same manner
as the percentages are adjusted under subsection
(b)(3)(A)(ii).''.
(4) Application of excise tax on high cost employer-
sponsored health coverage.--
(A) In general.--Section 4980I(f)(4) of such Code is
amended by adding at the end the following: ``Section
9831(d)(1) shall not apply for purposes of this section.''.
(B) Determination of cost of coverage.--Section 4980I(d)(2)
of such Code is amended by redesignating subparagraph (D) as
subparagraph (E) and by inserting after subparagraph (C) the
following new subparagraph:
``(D) Qualified small employer health reimbursement
arrangements.--In the case of applicable employer-sponsored
coverage consisting of coverage under any qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2)), the cost of coverage shall be equal to
the amount described in section 6051(a)(15).''.
(5) Enforcement of notice requirement.--Section 6652 of
such Code is amended by adding at the end the following new
subsection:
``(o) Failure to Provide Notices With Respect to Qualified
Small Employer Health Reimbursement Arrangements.--In the
case of each failure to provide a written notice as required
by section 9831(d)(4), unless it is shown that such failure
is due to reasonable cause and not willful neglect, there
shall be paid, on notice and demand of the Secretary and in
the same manner as tax, by the person failing to provide such
written notice, an amount equal to $50 per employee per
incident of failure to provide such notice, but the total
amount imposed on such person for all such failures during
any calendar year shall not exceed $2,500.''.
(6) Reporting.--
(A) W-2 reporting.--Section 6051(a) of such Code is amended
by striking ``and'' at the end of paragraph (13), by striking
the period at the end of paragraph (14) and inserting ``,
and'', and by inserting after paragraph (14) the following
new paragraph:
``(15) the total amount of permitted benefit (as defined in
section 9831(d)(3)(C)) for the year under a qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2)) with respect to the employee.''.
(B) Information required to be provided by exchange subsidy
applicants.--Section 1411(b)(3) of the Patient Protection and
Affordable Care Act is amended by redesignating subparagraph
(B) as subparagraph (C) and by inserting after subparagraph
(A) the following new subparagraph:
``(B) Certain individual health insurance policies obtained
through small employers.--The amount of the enrollee's
permitted benefit (as defined in section 9831(d)(3)(C) of the
Internal Revenue Code of 1986) under a qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2) of such Code).''.
(7) Effective dates.--
(A) In general.--Except as otherwise provided in this
paragraph, the amendments made by this subsection shall apply
to years beginning after December 31, 2016.
(B) Transition relief.--The relief under Treasury Notice
2015-17 shall be treated as applying to any plan year
beginning on or before December 31, 2016.
(C) Coordination with health insurance premium credit.--The
amendments made by paragraph (3) shall apply to taxable years
beginning after December 31, 2016.
(D) Employee notice.--
(i) In general.--The amendments made by paragraph (5) shall
apply to notices with respect to years beginning after
December 31, 2016.
(ii) Transition relief.--For purposes of section 6652(o) of
the Internal Revenue Code of 1986 (as added by this Act), a
person shall not be treated as failing to provide a written
notice as required by section 9831(d)(4) of such Code if such
notice is so provided not later than 90 days after the date
of the enactment of this Act.
(E) W-2 reporting.--The amendments made by paragraph (6)(A)
shall apply to calendar years beginning after December 31,
2016.
(F) Information provided by exchange subsidy applicants.--
(i) In general.--The amendments made by paragraph (6)(B)
shall apply to applications for enrollment made after
December 31, 2016.
(ii) Verification.--Verification under section 1411 of the
Patient Protection and Affordable Care Act of information
provided under section 1411(b)(3)(B) of such Act shall apply
with respect to months beginning after October 2016.
(iii) Transitional relief.--In the case of an application
for enrollment under section 1411(b) of the Patient
Protection and Affordable Care Act made before April 1, 2017,
the requirement of section 1411(b)(3)(B) of such Act shall be
treated as met if the information described therein is
provided not later than 30 days after the date on which the
applicant receives the notice described in section 9831(d)(4)
of the Internal Revenue Code of 1986.
(8) Substantiation requirements.--The Secretary of the
Treasury (or his designee) may issue substantiation
requirements as necessary to carry out this subsection.
(b) Amendments to the Employee Retirement Income Security
Act of 1974.--
(1) In general.--Section 733(a)(1) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1191b(a)(1)) is amended by adding at the end the following:
``Such term shall not include any qualified small employer
health reimbursement arrangement (as defined in section
9831(d)(2) of the Internal Revenue Code of 1986).''.
(2) Exception from continuation coverage requirements,
etc.--Section 607(1) of such Act (29 U.S.C. 1167(1)) is
amended by adding at the end the following: ``Such term shall
not include any qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2) of the Internal
Revenue Code of 1986).''.
(3) Effective date.--The amendments made by this subsection
shall apply to plan years beginning after December 31, 2016.
(c) Amendments to the Public Health Service Act.--
(1) In general.--Section 2791(a)(1) of the Public Health
Service Act (42 U.S.C. 300gg-91(a)(1)) is amended by adding
at the end the following: ``Except for purposes of part C of
title XI of the Social Security Act (42 U.S.C. 1320d et
seq.), such term shall not include any qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2) of the Internal Revenue Code of 1986).''.
(2) Exception from continuation coverage requirements.--
Section 2208(1) of the Public Health Service Act (42 U.S.C.
300bb-8(1)) is amended by adding at the end the following:
``Such term shall not include any qualified small employer
health reimbursement arrangement (as defined in section
9831(d)(2) of the Internal Revenue Code of 1986).''.
(3) Effective date.--The amendments made by this subsection
shall apply to plan years beginning after December 31, 2016.
TITLE XIX--INVESTING IN PREVENTION AND FAMILY SERVICES
SEC. 19001. PURPOSE.
The purpose of this title is to enable States to use
Federal funds available under parts B and E of title IV of
the Social Security Act to provide enhanced support to
children and families and prevent foster care placements
through the provision of mental health and substance abuse
prevention and treatment services, in-home parent skill-based
programs, and kinship navigator services.
[[Page H6979]]
Subtitle A--Prevention Activities Under Title IV-E
SEC. 19011. FOSTER CARE PREVENTION SERVICES AND PROGRAMS.
(a) State Option.--Section 471 of the Social Security Act
(42 U.S.C. 671) is amended--
(1) in subsection (a)(1), by striking ``and'' and all that
follows through the semicolon and inserting ``, adoption
assistance in accordance with section 473, and, at the option
of the State, services or programs specified in subsection
(e)(1) of this section for children who are candidates for
foster care or who are pregnant or parenting foster youth and
the parents or kin caregivers of the children, in accordance
with the requirements of that subsection;''; and
(2) by adding at the end the following:
``(e) Prevention and Family Services and Programs.--
``(1) In general.--Subject to the succeeding provisions of
this subsection, the Secretary may make a payment to a State
for providing the following services or programs for a child
described in paragraph (2) and the parents or kin caregivers
of the child when the need of the child, such a parent, or
such a caregiver for the services or programs are directly
related to the safety, permanence, or well-being of the child
or to preventing the child from entering foster care:
``(A) Mental health and substance abuse prevention and
treatment services.--Mental health and substance abuse
prevention and treatment services provided by a qualified
clinician for not more than a 12-month period that begins on
any date described in paragraph (3) with respect to the
child.
``(B) In-home parent skill-based programs.--In-home parent
skill-based programs for not more than a 12-month period that
begins on any date described in paragraph (3) with respect to
the child and that include parenting skills training, parent
education, and individual and family counseling.
``(2) Child described.--For purposes of paragraph (1), a
child described in this paragraph is the following:
``(A) A child who is a candidate for foster care (as
defined in section 475(13)) but can remain safely at home or
in a kinship placement with receipt of services or programs
specified in paragraph (1).
``(B) A child in foster care who is a pregnant or parenting
foster youth.
``(3) Date described.--For purposes of paragraph (1), the
dates described in this paragraph are the following:
``(A) The date on which a child is identified in a
prevention plan maintained under paragraph (4) as a child who
is a candidate for foster care (as defined in section
475(13)).
``(B) The date on which a child is identified in a
prevention plan maintained under paragraph (4) as a pregnant
or parenting foster youth in need of services or programs
specified in paragraph (1).
``(4) Requirements related to providing services and
programs.--Services and programs specified in paragraph (1)
may be provided under this subsection only if specified in
advance in the child's prevention plan described in
subparagraph (A) and the requirements in subparagraphs (B)
through (E) are met:
``(A) Prevention plan.--The State maintains a written
prevention plan for the child that meets the following
requirements (as applicable):
``(i) Candidates.--In the case of a child who is a
candidate for foster care described in paragraph (2)(A), the
prevention plan shall--
``(I) identify the foster care prevention strategy for the
child so that the child may remain safely at home, live
temporarily with a kin caregiver until reunification can be
safely achieved, or live permanently with a kin caregiver;
``(II) list the services or programs to be provided to or
on behalf of the child to ensure the success of that
prevention strategy; and
``(III) comply with such other requirements as the
Secretary shall establish.
``(ii) Pregnant or parenting foster youth.--In the case of
a child who is a pregnant or parenting foster youth described
in paragraph (2)(B), the prevention plan shall--
``(I) be included in the child's case plan required under
section 475(1);
``(II) list the services or programs to be provided to or
on behalf of the youth to ensure that the youth is prepared
(in the case of a pregnant foster youth) or able (in the case
of a parenting foster youth) to be a parent;
``(III) describe the foster care prevention strategy for
any child born to the youth; and
``(IV) comply with such other requirements as the Secretary
shall establish.
``(B) Trauma-informed.--The services or programs to be
provided to or on behalf of a child are provided under an
organizational structure and treatment framework that
involves understanding, recognizing, and responding to the
effects of all types of trauma and in accordance with
recognized principles of a trauma-informed approach and
trauma-specific interventions to address trauma's
consequences and facilitate healing.
``(C) Only services and programs provided in accordance
with promising, supported, or well-supported practices
permitted.--
``(i) In general.--Only State expenditures for services or
programs specified in subparagraph (A) or (B) of paragraph
(1) that are provided in accordance with practices that meet
the requirements specified in clause (ii) of this
subparagraph and that meet the requirements specified in
clause (iii), (iv), or (v), respectively, for being a
promising, supported, or well-supported practice, shall be
eligible for a Federal matching payment under section
474(a)(6)(A).
``(ii) General practice requirements.--The general practice
requirements specified in this clause are the following:
``(I) The practice has a book, manual, or other available
writings that specify the components of the practice protocol
and describe how to administer the practice.
``(II) There is no empirical basis suggesting that,
compared to its likely benefits, the practice constitutes a
risk of harm to those receiving it.
``(III) If multiple outcome studies have been conducted,
the overall weight of evidence supports the benefits of the
practice.
``(IV) Outcome measures are reliable and valid, and are
administrated consistently and accurately across all those
receiving the practice.
``(V) There is no case data suggesting a risk of harm that
was probably caused by the treatment and that was severe or
frequent.
``(iii) Promising practice.--A practice shall be considered
to be a `promising practice' if the practice is superior to
an appropriate comparison practice using conventional
standards of statistical significance (in terms of
demonstrated meaningful improvements in validated measures of
important child and parent outcomes, such as mental health,
substance abuse, and child safety and well-being), as
established by the results or outcomes of at least one study
that--
``(I) was rated by an independent systematic review for the
quality of the study design and execution and determined to
be well-designed and well-executed; and
``(II) utilized some form of control (such as an untreated
group, a placebo group, or a wait list study).
``(iv) Supported practice.--A practice shall be considered
to be a `supported practice' if--
``(I) the practice is superior to an appropriate comparison
practice using conventional standards of statistical
significance (in terms of demonstrated meaningful
improvements in validated measures of important child and
parent outcomes, such as mental health, substance abuse, and
child safety and well-being), as established by the results
or outcomes of at least one study that--
``(aa) was rated by an independent systematic review for
the quality of the study design and execution and determined
to be well-designed and well-executed;
``(bb) was a rigorous random-controlled trial (or, if not
available, a study using a rigorous quasi-experimental
research design); and
``(cc) was carried out in a usual care or practice setting;
and
``(II) the study described in subclause (I) established
that the practice has a sustained effect (when compared to a
control group) for at least 6 months beyond the end of the
treatment.
``(v) Well-supported practice.--A practice shall be
considered to be a `well-supported practice' if--
``(I) the practice is superior to an appropriate comparison
practice using conventional standards of statistical
significance (in terms of demonstrated meaningful
improvements in validated measures of important child and
parent outcomes, such as mental health, substance abuse, and
child safety and well-being), as established by the results
or outcomes of at least two studies that--
``(aa) were rated by an independent systematic review for
the quality of the study design and execution and determined
to be well-designed and well-executed;
``(bb) were rigorous random-controlled trials (or, if not
available, studies using a rigorous quasi-experimental
research design); and
``(cc) were carried out in a usual care or practice
setting; and
``(II) at least one of the studies described in subclause
(I) established that the practice has a sustained effect
(when compared to a control group) for at least 1 year beyond
the end of treatment.
``(D) Guidance on practices criteria and pre-approved
services and programs.--
``(i) In general.--Not later than October 1, 2018, the
Secretary shall issue guidance to States regarding the
practices criteria required for services or programs to
satisfy the requirements of subparagraph (C). The guidance
shall include a pre-approved list of services and programs
that satisfy the requirements.
``(ii) Updates.--The Secretary shall issue updates to the
guidance required by clause (i) as often as the Secretary
determines necessary.
``(E) Outcome assessment and reporting.--The State shall
collect and report to the Secretary the following information
with respect to each child for whom, or on whose behalf
mental health and substance abuse prevention and treatment
services or in-home parent skill-based programs are provided
during a 12-month period beginning on the date the child is
determined by the State to be a child described in paragraph
(2):
``(i) The specific services or programs provided and the
total expenditures for each of the services or programs.
``(ii) The duration of the services or programs provided.
``(iii) In the case of a child described in paragraph
(2)(A), the child's placement status at the beginning, and at
the end, of the 1-year period, respectively, and whether the
child entered foster care within 2 years after being
determined a candidate for foster care.
``(5) State plan component.--
``(A) In general.--A State electing to provide services or
programs specified in paragraph (1) shall submit as part of
the State plan required by subsection (a) a prevention
services and programs plan component that meets the
requirements of subparagraph (B).
``(B) Prevention services and programs plan component.--In
order to meet the requirements of this subparagraph, a
prevention services and programs plan component, with respect
to each 5-year period for which the plan component is in
operation in the State, shall include the following:
``(i) How providing services and programs specified in
paragraph (1) is expected to improve specific outcomes for
children and families.
``(ii) How the State will monitor and oversee the safety of
children who receive services and
[[Page H6980]]
programs specified in paragraph (1), including through
periodic risk assessments throughout the period in which the
services and programs are provided on behalf of a child and
reexamination of the prevention plan maintained for the child
under paragraph (4) for the provision of the services or
programs if the State determines the risk of the child
entering foster care remains high despite the provision of
the services or programs.
``(iii) With respect to the services and programs specified
in subparagraphs (A) and (B) of paragraph (1), information on
the specific promising, supported, or well-supported
practices the State plans to use to provide the services or
programs, including a description of--
``(I) the services or programs and whether the practices
used are promising, supported, or well-supported;
``(II) how the State plans to implement the services or
programs, including how implementation of the services or
programs will be continuously monitored to ensure fidelity to
the practice model and to determine outcomes achieved and how
information learned from the monitoring will be used to
refine and improve practices;
``(III) how the State selected the services or programs;
``(IV) the target population for the services or programs;
and
``(V) how each service or program provided will be
evaluated through a well-designed and rigorous process, which
may consist of an ongoing, cross-site evaluation approved by
the Secretary.
``(iv) A description of the consultation that the State
agencies responsible for administering the State plans under
this part and part B engage in with other State agencies
responsible for administering health programs, including
mental health and substance abuse prevention and treatment
services, and with other public and private agencies with
experience in administering child and family services,
including community-based organizations, in order to foster a
continuum of care for children described in paragraph (2) and
their parents or kin caregivers.
``(v) A description of how the State shall assess children
and their parents or kin caregivers to determine eligibility
for services or programs specified in paragraph (1).
``(vi) A description of how the services or programs
specified in paragraph (1) that are provided for or on behalf
of a child and the parents or kin caregivers of the child
will be coordinated with other child and family services
provided to the child and the parents or kin caregivers of
the child under the State plan under part B.
``(vii) Descriptions of steps the State is taking to
support and enhance a competent, skilled, and professional
child welfare workforce to deliver trauma-informed and
evidence-based services, including--
``(I) ensuring that staff is qualified to provide services
or programs that are consistent with the promising,
supported, or well-supported practice models selected; and
``(II) developing appropriate prevention plans, and
conducting the risk assessments required under clause (iii).
``(viii) A description of how the State will provide
training and support for caseworkers in assessing what
children and their families need, connecting to the families
served, knowing how to access and deliver the needed trauma-
informed and evidence-based services, and overseeing and
evaluating the continuing appropriateness of the services.
``(ix) A description of how caseload size and type for
prevention caseworkers will be determined, managed, and
overseen.
``(x) An assurance that the State will report to the
Secretary such information and data as the Secretary may
require with respect to the provision of services and
programs specified in paragraph (1), including information
and data necessary to determine the performance measures for
the State under paragraph (6) and compliance with paragraph
(7).
``(C) Reimbursement for services under the prevention plan
component.--
``(i) Limitation.--Except as provided in subclause (ii), a
State may not receive a Federal payment under this part for a
given promising, supported, or well-supported practice unless
(in accordance with subparagraph (B)(iii)(V)) the plan
includes a well-designed and rigorous evaluation strategy for
that practice.
``(ii) Waiver of limitation.--The Secretary may waive the
requirement for a well-designed and rigorous evaluation of
any well-supported practice if the Secretary deems the
evidence of the effectiveness of the practice to be
compelling and the State meets the continuous quality
improvement requirements included in subparagraph
(B)(iii)(II) with regard to the practice.
``(6) Prevention services measures.--
``(A) Establishment; annual updates.--Beginning with fiscal
year 2021, and annually thereafter, the Secretary shall
establish the following prevention services measures based on
information and data reported by States that elect to provide
services and programs specified in paragraph (1):
``(i) Percentage of candidates for foster care who do not
enter foster care.--The percentage of candidates for foster
care for whom, or on whose behalf, the services or programs
are provided who do not enter foster care, including those
placed with a kin caregiver outside of foster care, during
the 12-month period in which the services or programs are
provided and through the end of the succeeding 12-month-
period.
``(ii) Per-child spending.--The total amount of
expenditures made for mental health and substance abuse
prevention and treatment services or in-home parent skill-
based programs, respectively, for, or on behalf of, each
child described in paragraph (2).
``(B) Data.--The Secretary shall establish and annually
update the prevention services measures--
``(i) based on the median State values of the information
reported under each clause of subparagraph (A) for the 3 then
most recent years; and
``(ii) taking into account State differences in the price
levels of consumption goods and services using the most
recent regional price parities published by the Bureau of
Economic Analysis of the Department of Commerce or such other
data as the Secretary determines appropriate.
``(C) Publication of state prevention services measures.--
The Secretary shall annually make available to the public the
prevention services measures of each State.
``(7) Maintenance of effort for state foster care
prevention expenditures.--
``(A) In general.--If a State elects to provide services
and programs specified in paragraph (1) for a fiscal year,
the State foster care prevention expenditures for the fiscal
year shall not be less than the amount of the expenditures
for fiscal year 2014 (or, at the option of a State described
in subparagraph (E), fiscal year 2015 or fiscal year 2016
(whichever the State elects)).
``(B) State foster care prevention expenditures.--The term
`State foster care prevention expenditures' means the
following:
``(i) TANF; iv-b; ssbg.--State expenditures for foster care
prevention services and activities under the State program
funded under part A (including from amounts made available by
the Federal Government), under the State plan developed under
part B (including any such amounts), or under the Social
Services Block Grant Programs under subtitle A of title XX
(including any such amounts).
``(ii) Other state programs.--State expenditures for foster
care prevention services and activities under any State
program that is not described in clause (i) (other than any
State expenditures for foster care prevention services and
activities under the State program under this part (including
under a waiver of the program)).
``(C) State expenditures.--The term `State expenditures'
means all State or local funds that are expended by the State
or a local agency including State or local funds that are
matched or reimbursed by the Federal Government and State or
local funds that are not matched or reimbursed by the Federal
Government.
``(D) Determination of prevention services and
activities.--The Secretary shall require each State that
elects to provide services and programs specified in
paragraph (1) to report the expenditures specified in
subparagraph (B) for fiscal year 2014 and for such fiscal
years thereafter as are necessary to determine whether the
State is complying with the maintenance of effort requirement
in subparagraph (A). The Secretary shall specify the specific
services and activities under each program referred to in
subparagraph (B) that are `prevention services and
activities' for purposes of the reports.
``(E) State described.--For purposes of subparagraph (A), a
State is described in this subparagraph if the population of
children in the State in 2014 was less than 200,000 (as
determined by the Bureau of the Census).
``(8) Prohibition against use of state foster care
prevention expenditures and federal iv-e prevention funds for
matching or expenditure requirement.--A State that elects to
provide services and programs specified in paragraph (1)
shall not use any State foster care prevention expenditures
for a fiscal year for the State share of expenditures under
section 474(a)(6) for a fiscal year.
``(9) Administrative costs.--Expenditures described in
section 474(a)(6)(B)--
``(A) shall not be eligible for payment under subparagraph
(A), (B), or (E) of section 474(a)(3); and
``(B) shall be eligible for payment under section
474(a)(6)(B) without regard to whether the expenditures are
incurred on behalf of a child who is, or is potentially,
eligible for foster care maintenance payments under this
part.
``(10) Application.--
``(A) In general.--The provision of services or programs
under this subsection to or on behalf of a child described in
paragraph (2) shall not be considered to be receipt of aid or
assistance under the State plan under this part for purposes
of eligibility for any other program established under this
Act.
``(B) Candidates in kinship care.--A child described in
paragraph (2) for whom such services or programs under this
subsection are provided for more than 6 months while in the
home of a kin caregiver, and who would satisfy the AFDC
eligibility requirement of section 472(a)(3)(A)(ii)(II) but
for residing in the home of the caregiver for more than 6
months, is deemed to satisfy that requirement for purposes of
determining whether the child is eligible for foster care
maintenance payments under section 472.''.
(b) Definition.--Section 475 of such Act (42 U.S.C. 675) is
amended by adding at the end the following:
``(13) The term `child who is a candidate for foster care'
means, a child who is identified in a prevention plan under
section 471(e)(4)(A) as being at imminent risk of entering
foster care (without regard to whether the child would be
eligible for foster care maintenance payments under section
472 or is or would be eligible for adoption assistance or
kinship guardianship assistance payments under section 473)
but who can remain safely in the child's home or in a kinship
placement as long as services or programs specified in
section 471(e)(1) that are necessary to prevent the entry of
the child into foster care are provided. The term includes a
child whose adoption or guardianship arrangement is at risk
of a disruption or dissolution that would result in a foster
care placement.''.
[[Page H6981]]
(c) Payments Under Title IV-E.--Section 474(a) of such Act
(42 U.S.C. 674(a)) is amended--
(1) in paragraph (5), by striking the period at the end and
inserting ``; plus''; and
(2) by adding at the end the following:
``(6) subject to section 471(e)--
``(A) for each quarter--
``(i) subject to clause (ii)--
``(I) beginning after September 30, 2019, and before
October 1, 2025, an amount equal to 50 percent of the total
amount expended during the quarter for the provision of
services or programs specified in subparagraph (A) or (B) of
section 471(e)(1) that are provided in accordance with
promising, supported, or well-supported practices that meet
the applicable criteria specified for the practices in
section 471(e)(4)(C); and
``(II) beginning after September 30, 2025, an amount equal
to the Federal medical assistance percentage (which shall be
as defined in section 1905(b), in the case of a State other
than the District of Columbia, or 70 percent, in the case of
the District of Columbia) of the total amount expended during
the quarter for the provision of services or programs
specified in subparagraph (A) or (B) of section 471(e)(1)
that are provided in accordance with promising, supported, or
well-supported practices that meet the applicable criteria
specified for the practices in section 471(e)(4)(C) (or, with
respect to the payments made during the quarter under a
cooperative agreement or contract entered into by the State
and an Indian tribe, tribal organization, or tribal
consortium for the administration or payment of funds under
this part, an amount equal to the Federal medical assistance
percentage that would apply under section 479B(d) (in this
paragraph referred to as the `tribal FMAP') if the Indian
tribe, tribal organization, or tribal consortium made the
payments under a program operated under that section, unless
the tribal FMAP is less than the Federal medical assistance
percentage that applies to the State); except that
``(ii) not less than 50 percent of the total amount payable
to a State under clause (i) for a fiscal year shall be for
the provision of services or programs specified in
subparagraph (A) or (B) of section 471(e)(1) that are
provided in accordance with well-supported practices; plus
``(B) for each quarter specified in subparagraph (A), an
amount equal to the sum of the following proportions of the
total amount expended during the quarter:
``(i) 50 percent of so much of the expenditures as are
found necessary by the Secretary for the proper and efficient
administration of the State plan for the provision of
services or programs specified in section 471(e)(1),
including expenditures for activities approved by the
Secretary that promote the development of necessary processes
and procedures to establish and implement the provision of
the services and programs for individuals who are eligible
for the services and programs and expenditures attributable
to data collection and reporting; and
``(ii) 50 percent of so much of the expenditures with
respect to the provision of services and programs specified
in section 471(e)(1) as are for training of personnel
employed or preparing for employment by the State agency or
by the local agency administering the plan in the political
subdivision and of the members of the staff of State-licensed
or State-approved child welfare agencies providing services
to children described in section 471(e)(2) and their parents
or kin caregivers, including on how to determine who are
individuals eligible for the services or programs, how to
identify and provide appropriate services and programs, and
how to oversee and evaluate the ongoing appropriateness of
the services and programs.''.
(d) Technical Assistance and Best Practices, Clearinghouse,
and Data Collection and Evaluations.--Section 476 of such Act
(42 U.S.C. 676) is amended by adding at the end the
following:
``(d) Technical Assistance and Best Practices,
Clearinghouse, Data Collection, and Evaluations Relating to
Prevention Services and Programs.--
``(1) Technical assistance and best practices.--The
Secretary shall provide to States and, as applicable, to
Indian tribes, tribal organizations, and tribal consortia,
technical assistance regarding the provision of services and
programs described in section 471(e)(1) and shall disseminate
best practices with respect to the provision of the services
and programs, including how to plan and implement a well-
designed and rigorous evaluation of a promising, supported,
or well-supported practice.
``(2) Clearinghouse of promising, supported, and well-
supported practices.--The Secretary shall, directly or
through grants, contracts, or interagency agreements,
evaluate research on the practices specified in clauses
(iii), (iv), and (v), respectively, of section 471(e)(4)(C),
and programs that meet the requirements described in section
427(a)(1), including culturally specific, or location- or
population-based adaptations of the practices, to identify
and establish a public clearinghouse of the practices that
satisfy each category described by such clauses. In addition,
the clearinghouse shall include information on the specific
outcomes associated with each practice, including whether the
practice has been shown to prevent child abuse and neglect
and reduce the likelihood of foster care placement by
supporting birth families and kinship families and improving
targeted supports for pregnant and parenting youth and their
children.
``(3) Data collection and evaluations.--The Secretary,
directly or through grants, contracts, or interagency
agreements, may collect data and conduct evaluations with
respect to the provision of services and programs described
in section 471(e)(1) for purposes of assessing the extent to
which the provision of the services and programs--
``(A) reduces the likelihood of foster care placement;
``(B) increases use of kinship care arrangements; or
``(C) improves child well-being.
``(4) Reports to congress.--
``(A) In general.--The Secretary shall submit to the
Committee on Finance of the Senate and the Committee on Ways
and Means of the House of Representatives periodic reports
based on the provision of services and programs described in
section 471(e)(1) and the activities carried out under this
subsection.
``(B) Public availability.--The Secretary shall make the
reports to Congress submitted under this paragraph publicly
available.
``(5) Appropriation.--Out of any money in the Treasury of
the United States not otherwise appropriated, there is
appropriated to the Secretary $1,000,000 for fiscal year 2017
and each fiscal year thereafter to carry out this
subsection.''.
(e) Application to Programs Operated by Indian Tribal
Organizations.--
(1) In general.--Section 479B of such Act (42 U.S.C. 679c)
is amended--
(A) in subsection (c)(1)--
(i) in subparagraph (C)(i)--
(I) in subclause (II), by striking ``and'' after the
semicolon;
(II) in subclause (III), by striking the period at the end
and inserting ``; and''; and
(III) by adding at the end the following:
``(IV) at the option of the tribe, organization, or
consortium, services and programs specified in section
471(e)(1) to children described in section 471(e)(2) and
their parents or kin caregivers, in accordance with section
471(e) and subparagraph (E).''; and
(ii) by adding at the end the following:
``(E) Prevention services and programs for children and
their parents and kin caregivers.--
``(i) In general.--In the case of a tribe, organization, or
consortium that elects to provide services and programs
specified in section 471(e)(1) to children described in
section 471(e)(2) and their parents or kin caregivers under
the plan, the Secretary shall specify the requirements
applicable to the provision of the services and programs. The
requirements shall, to the greatest extent practicable, be
consistent with the requirements applicable to States under
section 471(e) and shall permit the provision of the services
and programs in the form of services and programs that are
adapted to the culture and context of the tribal communities
served.
``(ii) Performance measures.--The Secretary shall establish
specific performance measures for each tribe, organization,
or consortium that elects to provide services and programs
specified in section 471(e)(1). The performance measures
shall, to the greatest extent practicable, be consistent with
the prevention services measures required for States under
section 471(e)(6) but shall allow for consideration of
factors unique to the provision of the services by tribes,
organizations, or consortia.''; and
(B) in subsection (d)(1), by striking ``and (5)'' and
inserting ``(5), and (6)(A)''.
(2) Conforming amendment.--The heading for subsection (d)
of section 479B of such Act (42 U.S.C. 679c) is amended by
striking ``for Foster Care Maintenance and Adoption
Assistance Payments''.
(f) Application to Programs Operated by Territories.--
Section 1108(a)(2) of the Social Security Act (42 U.S.C.
1308(a)(2)) is amended by striking ``or 413(f)'' and
inserting ``413(f), or 474(a)(6)''.
SEC. 19012. FOSTER CARE MAINTENANCE PAYMENTS FOR CHILDREN
WITH PARENTS IN A LICENSED RESIDENTIAL FAMILY-
BASED TREATMENT FACILITY FOR SUBSTANCE ABUSE.
(a) In General.--Section 472 of the Social Security Act (42
U.S.C. 672) is amended--
(1) in subsection (a)(2)(C), by striking ``or'' and
inserting ``, with a parent residing in a licensed
residential family-based treatment facility, but only to the
extent permitted under subsection (j), or in a''; and
(2) by adding at the end the following:
``(j) Children Placed With a Parent Residing in a Licensed
Residential Family-Based Treatment Facility for Substance
Abuse.--
``(1) In general.--Notwithstanding the preceding provisions
of this section, a child who is eligible for foster care
maintenance payments under this section, or who would be
eligible for the payments if the eligibility were determined
without regard to paragraphs (1)(B) and (3) of subsection
(a), shall be eligible for the payments for a period of not
more than 12 months during which the child is placed with a
parent who is in a licensed residential family-based
treatment facility for substance abuse, but only if--
``(A) the recommendation for the placement is specified in
the child's case plan before the placement;
``(B) the treatment facility provides, as part of the
treatment for substance abuse, parenting skills training,
parent education, and individual and family counseling; and
``(C) the substance abuse treatment, parenting skills
training, parent education, and individual and family
counseling is provided under an organizational structure and
treatment framework that involves understanding, recognizing,
and responding to the effects of all types of trauma and in
accordance with recognized principles of a trauma-informed
approach and trauma-specific interventions to address the
consequences of trauma and facilitate healing.
``(2) Application.--With respect to children for whom
foster care maintenance payments are made under paragraph
(1), only the children who satisfy the requirements of
paragraphs (1)(B) and (3) of subsection (a) shall be
considered to be children with respect to whom foster care
maintenance payments are made under this section for purposes
of subsection (h) or section 473(b)(3)(B).''.
[[Page H6982]]
(b) Conforming Amendment.--Section 474(a)(1) of such Act
(42 U.S.C. 674(a)(1)) is amended by inserting ``subject to
section 472(j),'' before ``an amount equal to the Federal''
the first place it appears.
SEC. 19013. TITLE IV-E PAYMENTS FOR EVIDENCE-BASED KINSHIP
NAVIGATOR PROGRAMS.
Section 474(a) of the Social Security Act (42 U.S.C.
674(a)), as amended by section 19011(c), is amended--
(1) in paragraph (6), by striking the period at the end and
inserting ``; plus''; and
(2) by adding at the end the following:
``(7) an amount equal to 50 percent of the amounts expended
by the State during the quarter as the Secretary determines
are for kinship navigator programs that meet the requirements
described in section 427(a)(1) and that the Secretary
determines are operated in accordance with promising,
supported, or well-supported practices that meet the
applicable criteria specified for the practices in section
471(e)(4)(C), without regard to whether the expenditures are
incurred on behalf of children who are, or are potentially,
eligible for foster care maintenance payments under this
part.''.
Subtitle B--Enhanced Support Under Title IV-B
SEC. 19021. ELIMINATION OF TIME LIMIT FOR FAMILY
REUNIFICATION SERVICES WHILE IN FOSTER CARE AND
PERMITTING TIME-LIMITED FAMILY REUNIFICATION
SERVICES WHEN A CHILD RETURNS HOME FROM FOSTER
CARE.
(a) In General.--Section 431(a)(7) of the Social Security
Act (42 U.S.C. 629a(a)(7)) is amended--
(1) in the paragraph heading, by striking ``Time-limited
family'' and inserting ``Family''; and
(2) in subparagraph (A)--
(A) by striking ``time-limited family'' and inserting
``family'';
(B) by inserting ``or a child who has been returned home''
after ``child care institution''; and
(C) by striking ``, but only during the 15-month period
that begins on the date that the child, pursuant to section
475(5)(F), is considered to have entered foster care'' and
inserting ``and to ensure the strength and stability of the
reunification. In the case of a child who has been returned
home, the services and activities shall only be provided
during the 15-month period that begins on the date that the
child returns home''.
(b) Conforming Amendments.--
(1) Section 430 of such Act (42 U.S.C. 629) is amended in
the matter preceding paragraph (1), by striking ``time-
limited''.
(2) Subsections (a)(4), (a)(5)(A), and (b)(1) of section
432 of such Act (42 U.S.C. 629b) are amended by striking
``time-limited'' each place it appears.
SEC. 19022. REDUCING BUREAUCRACY AND UNNECESSARY DELAYS WHEN
PLACING CHILDREN IN HOMES ACROSS STATE LINES.
(a) State Plan Requirement.--Section 471(a)(25) of the
Social Security Act (42 U.S.C. 671(a)(25)) is amended--
(1) by striking ``provide'' and insert ``provides''; and
(2) by inserting ``, which, not later than October 1, 2026,
shall include the use of an electronic interstate case-
processing system'' before the first semicolon.
(b) Grants for the Development of an Electronic Interstate
Case-Processing System To Expedite the Interstate Placement
of Children in Foster Care or Guardianship, or for
Adoption.--Section 437 of such Act (42 U.S.C. 629g) is
amended by adding at the end the following:
``(g) Grants for the Development of an Electronic
Interstate Case-Processing System To Expedite the Interstate
Placement of Children in Foster Care or Guardianship, or for
Adoption.--
``(1) Purpose.--The purpose of this subsection is to
facilitate the development of an electronic interstate case-
processing system for the exchange of data and documents to
expedite the placements of children in foster, guardianship,
or adoptive homes across State lines.
``(2) Application requirements.--A State that desires a
grant under this subsection shall submit to the Secretary an
application containing the following:
``(A) A description of the goals and outcomes to be
achieved during the period for which grant funds are sought,
which goals and outcomes must result in--
``(i) reducing the time it takes for a child to be provided
with a safe and appropriate permanent living arrangement
across State lines;
``(ii) improving administrative processes and reducing
costs in the foster care system; and
``(iii) the secure exchange of relevant case files and
other necessary materials in real time, and timely
communications and placement decisions regarding interstate
placements of children.
``(B) A description of the activities to be funded in whole
or in part with the grant funds, including the sequencing of
the activities.
``(C) A description of the strategies for integrating
programs and services for children who are placed across
State lines.
``(D) Such other information as the Secretary may require.
``(3) Grant authority.--The Secretary may make a grant to a
State that complies with paragraph (2).
``(4) Use of funds.--A State to which a grant is made under
this subsection shall use the grant to support the State in
connecting with the electronic interstate case-processing
system described in paragraph (1).
``(5) Evaluations.--Not later than 1 year after the final
year in which grants are awarded under this subsection, the
Secretary shall submit to the Congress, and make available to
the general public by posting on a website, a report that
contains the following information:
``(A) How using the electronic interstate case-processing
system developed pursuant to paragraph (4) has changed the
time it takes for children to be placed across State lines.
``(B) The number of cases subject to the Interstate Compact
on the Placement of Children that were processed through the
electronic interstate case-processing system, and the number
of interstate child placement cases that were processed
outside the electronic interstate case-processing system, by
each State in each year.
``(C) The progress made by States in implementing the
electronic interstate case-processing system.
``(D) How using the electronic interstate case-processing
system has affected various metrics related to child safety
and well-being, including the time it takes for children to
be placed across State lines.
``(E) How using the electronic interstate case-processing
system has affected administrative costs and caseworker time
spent on placing children across State lines.
``(6) Data integration.--The Secretary, in consultation
with the Secretariat for the Interstate Compact on the
Placement of Children and the States, shall assess how the
electronic interstate case-processing system developed
pursuant to paragraph (4) could be used to better serve and
protect children that come to the attention of the child
welfare system, by--
``(A) connecting the system with other data systems (such
as systems operated by State law enforcement and judicial
agencies, systems operated by the Federal Bureau of
Investigation for the purposes of the Innocence Lost National
Initiative, and other systems);
``(B) simplifying and improving reporting related to
paragraphs (34) and (35) of section 471(a) regarding children
or youth who have been identified as being a sex trafficking
victim or children missing from foster care; and
``(C) improving the ability of States to quickly comply
with background check requirements of section 471(a)(20),
including checks of child abuse and neglect registries as
required by section 471(a)(20)(B).''.
(c) Reservation of Funds To Improve the Interstate
Placement of Children.--Section 437(b) of such Act (42 U.S.C.
629g(b)) is amended by adding at the end the following:
``(4) Improving the interstate placement of children.--The
Secretary shall reserve $5,000,000 of the amount made
available for fiscal year 2017 for grants under subsection
(g), and the amount so reserved shall remain available
through fiscal year 2021.''.
SEC. 19023. ENHANCEMENTS TO GRANTS TO IMPROVE WELL-BEING OF
FAMILIES AFFECTED BY SUBSTANCE ABUSE.
Section 437(f) of the Social Security Act (42 U.S.C.
629g(f)) is amended--
(1) in the subsection heading, by striking ``Increase the
Well-Being of, and To Improve the Permanency Outcomes for,
Children Affected by'' and inserting ``Implement IV-E
Prevention Services, and Improve the Well-Being of, and
Improve Permanency Outcomes for, Children and Families
Affected by Heroin, Opioids, and Other'';
(2) by striking paragraph (2) and inserting the following:
``(2) Regional partnership defined.--In this subsection,
the term `regional partnership' means a collaborative
agreement (which may be established on an interstate, State,
or intrastate basis) entered into by the following:
``(A) Mandatory partners for all partnership grants.--
``(i) The State child welfare agency that is responsible
for the administration of the State plan under this part and
part E.
``(ii) The State agency responsible for administering the
substance abuse prevention and treatment block grant provided
under subpart II of part B of title XIX of the Public Health
Service Act.
``(B) Mandatory partners for partnership grants proposing
to serve children in out-of-home placements.--If the
partnership proposes to serve children in out-of-home
placements, the Juvenile Court or Administrative Office of
the Court that is most appropriate to oversee the
administration of court programs in the region to address the
population of families who come to the attention of the court
due to child abuse or neglect.
``(C) Optional partners.--At the option of the partnership,
any of the following:
``(i) An Indian tribe or tribal consortium.
``(ii) Nonprofit child welfare service providers.
``(iii) For-profit child welfare service providers.
``(iv) Community health service providers, including
substance abuse treatment providers.
``(v) Community mental health providers.
``(vi) Local law enforcement agencies.
``(vii) School personnel.
``(viii) Tribal child welfare agencies (or a consortia of
the agencies).
``(ix) Any other providers, agencies, personnel, officials,
or entities that are related to the provision of child and
family services under a State plan approved under this
subpart.
``(D) Exception for regional partnerships where the lead
applicant is an indian tribe or tribal consortia.--If an
Indian tribe or tribal consortium enters into a regional
partnership for purposes of this subsection, the Indian tribe
or tribal consortium--
``(i) may (but is not required to) include the State child
welfare agency as a partner in the collaborative agreement;
``(ii) may not enter into a collaborative agreement only
with tribal child welfare agencies (or a consortium of the
agencies); and
``(iii) if the condition described in paragraph (2)(B)
applies, may include tribal court organizations in lieu of
other judicial partners.'';
[[Page H6983]]
(3) in paragraph (3)--
(A) in subparagraph (A)--
(i) by striking ``2012 through 2016'' and inserting ``2017
through 2021''; and
(ii) by striking ``$500,000 and not more than $1,000,000''
and inserting ``$250,000 and not more than $1,000,000'';
(B) in subparagraph (B)--
(i) in the subparagraph heading, by inserting ``;
planning'' after ``approval'';
(ii) in clause (i), by striking ``clause (ii)'' and
inserting ``clauses (ii) and (iii)''; and
(iii) by adding at the end the following:
``(iii) Sufficient planning.--A grant awarded under this
subsection shall be disbursed in two phases: a planning phase
(not to exceed 2 years); and an implementation phase. The
total disbursement to a grantee for the planning phase may
not exceed $250,000, and may not exceed the total anticipated
funding for the implementation phase.''; and
(C) by adding at the end the following:
``(D) Limitation on payment for a fiscal year.--No payment
shall be made under subparagraph (A) or (C) for a fiscal year
until the Secretary determines that the eligible partnership
has made sufficient progress in meeting the goals of the
grant and that the members of the eligible partnership are
coordinating to a reasonable degree with the other members of
the eligible partnership.'';
(4) in paragraph (4)--
(A) in subparagraph (B)--
(i) in clause (i), by inserting ``, parents, and families''
after ``children'';
(ii) in clause (ii), by striking ``safety and permanence
for such children; and'' and inserting ``safe, permanent
caregiving relationships for the children;'';
(iii) in clause (iii), by striking ``or'' and inserting
``increase reunification rates for children who have been
placed in out of home care, or decrease''; and
(iv) by redesignating clause (iii) as clause (v) and
inserting after clause (ii) the following:
``(iii) improve the substance abuse treatment outcomes for
parents including retention in treatment and successful
completion of treatment;
``(iv) facilitate the implementation, delivery, and
effectiveness of prevention services and programs under
section 471(e); and'';
(B) in subparagraph (D), by striking ``where
appropriate,''; and
(C) by striking subparagraphs (E) and (F) and inserting the
following:
``(E) A description of a plan for sustaining the services
provided by or activities funded under the grant after the
conclusion of the grant period, including through the use of
prevention services and programs under section 471(e) and
other funds provided to the State for child welfare and
substance abuse prevention and treatment services.
``(F) Additional information needed by the Secretary to
determine that the proposed activities and implementation
will be consistent with research or evaluations showing which
practices and approaches are most effective.'';
(5) in paragraph (5)(A), by striking ``abuse treatment''
and inserting ``use disorder treatment including medication
assisted treatment and in-home substance abuse disorder
treatment and recovery'';
(6) in paragraph (7)--
(A) by striking ``and'' at the end of subparagraph (C); and
(B) by redesignating subparagraph (D) as subparagraph (E)
and inserting after subparagraph (C) the following:
``(D) demonstrate a track record of successful
collaboration among child welfare, substance abuse disorder
treatment and mental health agencies; and'';
(7) in paragraph (8)--
(A) in subparagraph (A)--
(i) by striking ``establish indicators that will be'' and
inserting ``review indicators that are''; and
(ii) by striking ``in using funds made available under such
grants to achieve the purpose of this subsection'' and
inserting ``and establish a set of core indicators related to
child safety, parental recovery, parenting capacity, and
family well-being. In developing the core indicators, to the
extent possible, indicators shall be made consistent with the
outcome measures described in section 471(e)(6)''; and
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by inserting ``base
the performance measures on lessons learned from prior rounds
of regional partnership grants under this subsection, and''
before ``consult''; and
(ii) by striking clauses (iii) and (iv) and inserting the
following:
``(iii) Other stakeholders or constituencies as determined
by the Secretary.'';
(8) in paragraph (9)(A), by striking clause (i) and
inserting the following:
``(i) Semiannual reports.--Not later than September 30 of
each fiscal year in which a recipient of a grant under this
subsection is paid funds under the grant, and every 6 months
thereafter, the grant recipient shall submit to the Secretary
a report on the services provided and activities carried out
during the reporting period, progress made in achieving the
goals of the program, the number of children, adults, and
families receiving services, and such additional information
as the Secretary determines is necessary. The report due not
later than September 30 of the last such fiscal year shall
include, at a minimum, data on each of the performance
indicators included in the evaluation of the regional
partnership.''; and
(9) in paragraph (10), by striking ``2012 through 2016''
and inserting ``2017 through 2021''.
Subtitle C--Miscellaneous
SEC. 19031. REVIEWING AND IMPROVING LICENSING STANDARDS FOR
PLACEMENT IN A RELATIVE FOSTER FAMILY HOME.
(a) Identification of Reputable Model Licensing
Standards.--Not later than October 1, 2017, the Secretary of
Health and Human Services shall identify reputable model
licensing standards with respect to the licensing of foster
family homes (as defined in section 472(c)(1) of the Social
Security Act).
(b) State Plan Requirement.--Section 471(a) of the Social
Security Act (42 U.S.C. 671(a)) is amended--
(1) in paragraph (34)(B), by striking ``and'' after the
semicolon;
(2) in paragraph (35)(B), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
``(36) provides that, not later than April 1, 2018, the
State shall submit to the Secretary information addressing--
``(A) whether the State licensing standards are in accord
with model standards identified by the Secretary, and if not,
the reason for the specific deviation and a description as to
why having a standard that is reasonably in accord with the
corresponding national model standards is not appropriate for
the State;
``(B) whether the State has elected to waive standards
established in 471(a)(10)(A) for relative foster family homes
(pursuant to waiver authority provided by 471(a)(10)(D)), a
description of which standards the State most commonly
waives, and if the State has not elected to waive the
standards, the reason for not waiving these standards;
``(C) if the State has elected to waive standards specified
in subparagraph (B), how caseworkers are trained to use the
waiver authority and whether the State has developed a
process or provided tools to assist caseworkers in waiving
nonsafety standards per the authority provided in
471(a)(10)(D) to quickly place children with relatives; and
``(D) a description of the steps the State is taking to
improve caseworker training or the process, if any; and''.
SEC. 19032. DEVELOPMENT OF A STATEWIDE PLAN TO PREVENT CHILD
ABUSE AND NEGLECT FATALITIES.
Section 422(b)(19) of the Social Security Act (42 U.S.C.
622(b)(19)) is amended to read as follows:
``(19) document steps taken to track and prevent child
maltreatment deaths by including--
``(A) a description of the steps the State is taking to
compile complete and accurate information on the deaths
required by Federal law to be reported by the State agency
referred to in paragraph (1), including gathering relevant
information on the deaths from the relevant organizations in
the State including entities such as State vital statistics
department, child death review teams, law enforcement
agencies, offices of medical examiners or coroners; and
``(B) a description of the steps the state is taking to
develop and implement of a comprehensive, statewide plan to
prevent the fatalities that involves and engages relevant
public and private agency partners, including those in public
health, law enforcement, and the courts.''.
SEC. 19033. MODERNIZING THE TITLE AND PURPOSE OF TITLE IV-E.
(a) Part Heading.--The heading for part E of title IV of
the Social Security Act (42 U.S.C. 670 et seq.) is amended to
read as follows:
``PART E--FEDERAL PAYMENTS FOR FOSTER CARE, PREVENTION, AND
PERMANENCY''.
(b) Purpose.--The first sentence of section 470 of such Act
(42 U.S.C. 670) is amended--
(1) by striking ``1995) and'' and inserting ``1995),'';
(2) by inserting ``kinship guardianship assistance, and
prevention services or programs specified in section
471(e)(1),'' after ``needs,''; and
(3) by striking ``(commencing with the fiscal year which
begins October 1, 1980)''.
SEC. 19034. EFFECTIVE DATES.
(a) Effective Dates.--
(1) In general.--Except as provided in paragraph (2),
subject to subsection (b), the amendments made by this title
shall take effect on January 1, 2017.
(2) Exceptions.--The amendments made by sections 19031 and
19033 shall take effect on the date of enactment of this Act.
(b) Transition Rule.--
(1) In general.--In the case of a State plan under part B
or E of title IV of the Social Security Act which the
Secretary of Health and Human Services determines requires
State legislation (other than legislation appropriating
funds) in order for the plan to meet the additional
requirements imposed by the amendments made by this title,
the State plan shall not be regarded as failing to comply
with the requirements of such part solely on the basis of the
failure of the plan to meet such additional requirements
before the first day of the first calendar quarter beginning
after the close of the first regular session of the State
legislature that begins after the date of enactment of this
Act. For purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year of the
session shall be deemed to be a separate regular session of
the State legislature.
(2) Application to programs operated by indian tribal
organizations.--In the case of an Indian tribe, tribal
organization, or tribal consortium which the Secretary of
Health and Human Services determines requires time to take
action necessary to comply with the additional requirements
imposed by the amendments made by this title (whether the
tribe, organization, or tribal consortium has a plan under
section 479B of the Social Security Act or a cooperative
agreement or contract entered into with a State), the
Secretary shall provide the tribe, organization, or tribal
consortium with such additional time as the Secretary
determines is necessary for the tribe, organization, or
tribal consortium to take the action to comply with the
[[Page H6984]]
additional requirements before being regarded as failing to
comply with the requirements.
TITLE XX--ENSURING THE NECESSITY OF A PLACEMENT THAT IS NOT IN A FOSTER
FAMILY HOME
SEC. 20001. LIMITATION ON FEDERAL FINANCIAL PARTICIPATION FOR
PLACEMENTS THAT ARE NOT IN FOSTER FAMILY HOMES.
(a) Limitation on Federal Financial Participation.--
(1) In general.--Section 472 of the Social Security Act (42
U.S.C. 672), as amended by section 19012, is amended--
(A) in subsection (a)(2)(C), by inserting ``, but only to
the extent permitted under subsection (k)'' after
``institution''; and
(B) by adding at the end the following:
``(k) Limitation on Federal Financial Participation.--
``(1) In general.--Beginning with the third week for which
foster care maintenance payments are made under this section
on behalf of a child placed in a child-care institution, no
Federal payment shall be made to the State under section
474(a)(1) for amounts expended for foster care maintenance
payments on behalf of the child unless--
``(A) the child is placed in a child-care institution that
is a setting specified in paragraph (2) (or is placed in a
licensed residential family-based treatment facility
consistent with subsection (j)); and
``(B) in the case of a child placed in a qualified
residential treatment program (as defined in paragraph (4)),
the requirements specified in paragraph (3) and section
475A(c) are met.
``(2) Specified settings for placement.--The settings for
placement specified in this paragraph are the following:
``(A) A qualified residential treatment program (as defined
in paragraph (4)).
``(B) A setting specializing in providing prenatal, post-
partum, or parenting supports for youth.
``(C) In the case of a child who has attained 18 years of
age, a supervised setting in which the child is living
independently.
``(D) A setting providing high-quality residential care and
supportive services to children and youth who have been found
to be, or are at risk of becoming, sex trafficking victims,
in accordance with section 471(a)(9)(C).
``(3) Assessment to determine appropriateness of placement
in a qualified residential treatment program.--
``(A) Deadline for assessment.--In the case of a child who
is placed in a qualified residential treatment program, if
the assessment required under section 475A(c)(1) is not
completed within 30 days after the placement is made, no
Federal payment shall be made to the State under section
474(a)(1) for any amounts expended for foster care
maintenance payments on behalf of the child during the
placement.
``(B) Deadline for transition out of placement.--If the
assessment required under section 475A(c)(1) determines that
the placement of a child in a qualified residential treatment
program is not appropriate, a court disapproves such a
placement under section 475A(c)(2), or a child who has been
in an approved placement in a qualified residential treatment
program is going to return home or be placed with a fit and
willing relative, a legal guardian, or an adoptive parent, or
in a foster family home, Federal payments shall be made to
the State under section 474(a)(1) for amounts expended for
foster care maintenance payments on behalf of the child while
the child remains in the qualified residential treatment
program only during the period necessary for the child to
transition home or to such a placement. In no event shall a
State receive Federal payments under section 474(a)(1) for
amounts expended for foster care maintenance payments on
behalf of a child who remains placed in a qualified
residential treatment program after the end of the 30-day
period that begins on the date a determination is made that
the placement is no longer the recommended or approved
placement for the child.
``(4) Qualified residential treatment program.--For
purposes of this part, the term `qualified residential
treatment program' means a program that--
``(A) has a trauma-informed treatment model that is
designed to address the needs, including clinical needs as
appropriate, of children with serious emotional or behavioral
disorders or disturbances and, with respect to a child, is
able to implement the treatment identified for the child by
the assessment of the child required under section 475A(c);
``(B) subject to paragraph (5), has registered or licensed
nursing staff and other licensed clinical staff who--
``(i) provide care within the scope of their practice as
defined by State law;
``(ii) are on-site during business hours; and
``(iii) are available 24 hours a day and 7 days a week;
``(C) to extent appropriate, and in accordance with the
child's best interests, facilitates participation of family
members in the child's treatment program;
``(D) facilitates outreach to the family members of the
child, including siblings, documents how the outreach is made
(including contact information), and maintains contact
information for any known biological family and fictive kin
of the child;
``(E) documents how family members are integrated into the
treatment process for the child, including post-discharge,
and how sibling connections are maintained;
``(F) provides discharge planning and family-based
aftercare support for at least 6 months post-discharge; and
``(G) is licensed in accordance with section 471(a)(10) and
is accredited by any of the following independent, not-for-
profit organizations:
``(i) The Commission on Accreditation of Rehabilitation
Facilities (CARF).
``(ii) The Joint Commission on Accreditation of Healthcare
Organizations (JCAHO).
``(iii) The Council on Accreditation (COA).
``(iv) Any other independent, not-for-profit accrediting
organization approved by the Secretary.
``(5) Flexibility in staffing requirements for qualified
residential treatment programs.--
``(A) In general.--In the case of any State that the
Secretary determines is described in subparagraph (B) and
satisfies the requirements of subparagraphs (C) and (D),
respectively, the State may elect to satisfy the requirement
of paragraph (4)(B) that a qualified residential treatment
program have registered or licensed nursing staff and other
licensed clinical staff with clinical staff which include
staff licensed to monitor medications and physical and
behavioral health staff with demonstrated training in child
development and trauma, in lieu of with registered or
licensed nursing staff and other licensed clinical staff.
``(B) State described.--Subject to subparagraph (E), a
State is described in this subparagraph if for the most
recent fiscal year for which data are available--
``(i) the percentage of children in foster care under the
responsibility of the State who have been placed in
congregate care settings--
``(I) is at or below 5 percent for the fiscal year; or
``(II) has been reduced by at least 20 percent from the
preceding fiscal year; and
``(ii) the average length of stay for children in foster
care under the responsibility of the State in congregate care
settings is at or below 9 months.
``(C) Demonstration of capacity and need.--A State
described in subparagraph (B) shall be eligible to use the
alternative staffing model permitted under subparagraph (A)
if the State can demonstrate to the satisfaction of the
Secretary that the qualified residential treatment programs
utilizing the alternative staffing models permitted under
subparagraph (A) have the capacity to serve children and
youth whose treatment plans--
``(i) indicate a need for increased supervision based on
behavioral history, history of juvenile delinquency, or
history of sexual offenses; and
``(ii) require a placement that conforms to the alternative
staffing model permitted under subparagraph (A).
``(D) Equitable distribution of congregate care
population.--A State described in subparagraph (B) shall be
eligible to use the alternative staffing model permitted
under subparagraph (A) if the State annually demonstrates to
the satisfaction of the Secretary that the State is reducing
the number of children in foster care under the
responsibility of the State who are in congregate care
placements on a general statewide basis and without wide
disparities between rural, suburban, and urban areas in the
rates of such children in congregate care placements.
``(E) Annual determination of state eligibility based on
afcars and other data.--The Secretary annually shall make the
determinations required under subparagraph (B) with respect
to a State and a fiscal year, on the basis of data meeting
the requirements of the system established pursuant to
section 479, as reported by the State and approved by the
Secretary, and, to the extent the Secretary determines
necessary, on the basis of such other information reported to
the Secretary as the Secretary may require to determine that
a State is, or continues to be, a State described in
subparagraph (B).
``(F) Congregate care settings.--In this paragraph, the
term `congregate care settings' includes any settings
described as `group homes' or `institutions' for purposes of
data reported in accordance with the requirements of the
system established pursuant to section 479 or any similar
placement settings reported in accordance with such
requirements.
``(6) Administrative costs.--The prohibition in paragraph
(1) on Federal payments under section 474(a)(1) shall not be
construed as prohibiting Federal payments for administrative
expenditures incurred on behalf of a child placed in a child-
care institution and for which payment is available under
section 474(a)(3).''.
(2) Conforming amendment.--Section 474(a)(1) of the Social
Security Act (42 U.S.C. 674(a)(1)), as amended by section
19012(b), is amended by striking ``section 472(j)'' and
inserting ``subsections (j) and (k) of section 472''.
(b) Definition of Foster Family Home, Child-Care
Institution.--Section 472(c) of such Act (42 U.S.C.
672(c)(1)) is amended to read as follows:
``(c) Definitions.--For purposes of this part:
``(1) Foster family home.--
``(A) In general.--The term `foster family home' means the
home of an individual or family--
``(i) that is licensed or approved by the State in which it
is situated as a foster family home that meets the standards
established for the licensing or approval; and
``(ii) in which a child in foster care has been placed in
the care of an individual, who resides with the child and who
has been licensed or approved by the State to be a foster
parent--
``(I) that the State deems capable of adhering to the
reasonable and prudent parent standard;
``(II) that provides 24-hour substitute care for children
placed away from their parents or other caretakers; and
``(III) that provides the care for not more than six
children in foster care.
``(B) State flexibility.--The number of foster children
that may be cared for in a home under subparagraph (A) may
exceed the numerical limitation in subparagraph (A)(ii)(III),
at the option of the State, for any of the following reasons:
[[Page H6985]]
``(i) To allow a parenting youth in foster care to remain
with the child of the parenting youth.
``(ii) To allow siblings to remain together.
``(iii) To allow a child with an established meaningful
relationship with the family to remain with the family.
``(iv) To allow a family with special training or skills to
provide care to a child who has a severe disability.
``(C) Rule of construction.--Subparagraph (A) shall not be
construed as prohibiting a foster parent from renting the
home in which the parent cares for a foster child placed in
the parent's care.
``(2) Child-care institution.--
``(A) In general.--The term `child-care institution' means
a private child-care institution, or a public child-care
institution which accommodates no more than 25 children,
which is licensed by the State in which it is situated or has
been approved by the agency of the State responsible for
licensing or approval of institutions of this type as meeting
the standards established for the licensing.
``(B) Supervised settings.--In the case of a child who has
attained 18 years of age, the term shall include a supervised
setting in which the individual is living independently, in
accordance with such conditions as the Secretary shall
establish in regulations.
``(C) Exclusions.--The term shall not include detention
facilities, forestry camps, training schools, or any other
facility operated primarily for the detention of children who
are determined to be delinquent.''.
(c) Training for State Judges, Attorneys, and Other Legal
Personnel in Child Welfare Cases.--Section 438(b)(1) of such
Act (42 U.S.C. 629h(b)(1)) is amended in the matter preceding
subparagraph (A) by inserting ``shall provide for the
training of judges, attorneys, and other legal personnel in
child welfare cases on Federal child welfare policies and
payment limitations with respect to children in foster care
who are placed in settings that are not a foster family
home,'' after ``with respect to the child,''.
(d) Assurance of Nonimpact on Juvenile Justice System.--
(1) State plan requirement.--Section 471(a) of such Act (42
U.S.C. 671(a)), as amended by section 19031, is further
amended by adding at the end the following:
``(37) includes a certification that, in response to the
limitation imposed under section 472(k) with respect to
foster care maintenance payments made on behalf of any child
who is placed in a setting that is not a foster family home,
the State will not enact or advance policies or practices
that would result in a significant increase in the population
of youth in the State's juvenile justice system.''.
(2) GAO study and report.--The Comptroller General of the
United States shall evaluate the impact, if any, on State
juvenile justice systems of the limitation imposed under
section 472(k) of the Social Security Act (as added by
section 19001(a)(1)) on foster care maintenance payments made
on behalf of any child who is placed in a setting that is not
a foster family home, in accordance with the amendments made
by subsections (a) and (b) of this section. In particular,
the Comptroller General shall evaluate the extent to which
children in foster care who also are subject to the juvenile
justice system of the State are placed in a facility under
the jurisdiction of the juvenile justice system and whether
the lack of available congregate care placements under the
jurisdiction of the child welfare systems is a contributing
factor to that result. Not later than December 31, 2023, the
Comptroller General shall submit to Congress a report on the
results of the evaluation.
SEC. 20002. ASSESSMENT AND DOCUMENTATION OF THE NEED FOR
PLACEMENT IN A QUALIFIED RESIDENTIAL TREATMENT
PROGRAM.
Section 475A of the Social Security Act (42 U.S.C. 675a) is
amended by adding at the end the following:
``(c) Assessment, Documentation, and Judicial Determination
Requirements for Placement in a Qualified Residential
Treatment Program.--In the case of any child who is placed in
a qualified residential treatment program (as defined in
section 472(k)(4)), the following requirements shall apply
for purposes of approving the case plan for the child and the
case system review procedure for the child:
``(1)(A) Within 30 days of the start of each placement in
such a setting, a qualified individual (as defined in
subparagraph (D)) shall--
``(i) assess the strengths and needs of the child using an
age-appropriate, evidence-based, validated, functional
assessment tool approved by the Secretary;
``(ii) determine whether the needs of the child can be met
with family members or through placement in a foster family
home or, if not, which setting from among the settings
specified in section 472(k)(2) would provide the most
effective and appropriate level of care for the child in the
least restrictive environment and be consistent with the
short- and long-term goals for the child, as specified in the
permanency plan for the child; and
``(iii) develop a list of child-specific short- and long-
term mental and behavioral health goals.
``(B)(i) The State shall assemble a family and permanency
team for the child in accordance with the requirements of
clauses (ii) and (iii). The qualified individual conducting
the assessment required under subparagraph (A) shall work in
conjunction with the family of, and permanency team for, the
child while conducting and making the assessment.
``(ii) The family and permanency team shall consist of all
appropriate biological family members, relative, and fictive
kin of the child, as well as, as appropriate, professionals
who are a resource to the family of the child, such as
teachers, medical or mental health providers who have treated
the child, or clergy. In the case of a child who has attained
age 14, the family and permanency team shall include the
members of the permanency planning team for the child that
are selected by the child in accordance with section
475(5)(C)(iv).
``(iii) The State shall document in the child's case plan--
``(I) the reasonable and good faith effort of the State to
identify and include all such individuals on the family of,
and permanency team for, the child;
``(II) all contact information for members of the family
and permanency team, as well as contact information for other
family members and fictive kin who are not part of the family
and permanency team;
``(III) evidence that meetings of the family and permanency
team, including meetings relating to the assessment required
under subparagraph (A), are held at a time and place
convenient for family;
``(IV) if reunification is the goal, evidence demonstrating
that the parent from whom the child was removed provided
input on the members of the family and permanency team;
``(V) evidence that the assessment required under
subparagraph (A) is determined in conjunction with the family
and permanency team; and
``(VI) the placement preferences of the family and
permanency team relative to the assessment and, if the
placement preferences of the family and permanency team and
child are not the placement setting recommended by the
qualified individual conducting the assessment under
subparagraph (A), the reasons why the preferences of the team
and of the child were not recommended.
``(C) In the case of a child who the qualified individual
conducting the assessment under subparagraph (A) determines
should not be placed in a foster family home, the qualified
individual shall specify in writing the reasons why the needs
of the child cannot be met by the family of the child or in a
foster family home. A shortage or lack of foster family homes
shall not be an acceptable reason for determining that a
needs of the child cannot be met in a foster family home. The
qualified individual also shall specify in writing why the
recommended placement in a qualified residential treatment
program is the setting that will provide the child with the
most effective and appropriate level of care in the least
restrictive environment and how that placement is consistent
with the short- and long-term goals for the child, as
specified in the permanency plan for the child.
``(D)(i) Subject to clause (ii), in this subsection, the
term `qualified individual' means a trained professional or
licensed clinician who is not an employee of the State agency
and who is not connected to, or affiliated with, any
placement setting in which children are placed by the State.
``(ii) The Secretary may approve a request of a State to
waive any requirement in clause (i) upon a submission by the
State, in accordance with criteria established by the
Secretary, that certifies that the trained professionals or
licensed clinicians with responsibility for performing the
assessments described in subparagraph (A) shall maintain
objectivity with respect to determining the most effective
and appropriate placement for a child.
``(2) Within 60 days of the start of each placement in a
qualified residential treatment program, a family or juvenile
court or another court (including a tribal court) of
competent jurisdiction, or an administrative body appointed
or approved by the court, independently, shall--
``(A) consider the assessment, determination, and
documentation made by the qualified individual conducting the
assessment under paragraph (1);
``(B) determine whether the needs of the child can be met
through placement in a foster family home or, if not, whether
placement of the child in a qualified residential treatment
program provides the most effective and appropriate level of
care for the child in the least restrictive environment and
whether that placement is consistent with the short- and
long-term goals for the child, as specified in the permanency
plan for the child; and
``(C) approve or disapprove the placement.
``(3) The written documentation made under paragraph (1)(C)
and documentation of the determination and approval or
disapproval of the placement in a qualified residential
treatment program by a court or administrative body under
paragraph (2) shall be included in and made part of the case
plan for the child.
``(4) As long as a child remains placed in a qualified
residential treatment program, the State agency shall submit
evidence at each status review and each permanency hearing
held with respect to the child--
``(A) demonstrating that ongoing assessment of the
strengths and needs of the child continues to support the
determination that the needs of the child cannot be met
through placement in a foster family home, that the placement
in a qualified residential treatment program provides the
most effective and appropriate level of care for the child in
the least restrictive environment, and that the placement is
consistent with the short- and long-term goals for the child,
as specified in the permanency plan for the child;
``(B) documenting the specific treatment or service needs
that will be met for the child in the placement and the
length of time the child is expected to need the treatment or
services; and
``(C) documenting the efforts made by the State agency to
prepare the child to return home or to be placed with a fit
and willing relative, a legal guardian, or an adoptive
parent, or in a foster family home.
[[Page H6986]]
``(5) In the case of any child who is placed in a qualified
residential treatment program for more than 12 consecutive
months or 18 nonconsecutive months (or, in the case of a
child who has not attained age 13, for more than 6
consecutive or nonconsecutive months), the State agency shall
submit to the Secretary--
``(A) the most recent versions of the evidence and
documentation specified in paragraph (4); and
``(B) the signed approval of the head of the State agency
for the continued placement of the child in that setting.''.
SEC. 20003. PROTOCOLS TO PREVENT INAPPROPRIATE DIAGNOSES.
(a) State Plan Requirement.--Section 422(b)(15)(A) of the
Social Security Act (42 U.S.C. 622(b)(15)(A)) is amended--
(1) in clause (vi), by striking ``and'' after the
semicolon;
(2) by redesignating clause (vii) as clause (viii); and
(3) by inserting after clause (vi) the following:
``(vii) the procedures and protocols the State has
established to ensure that children in foster care placements
are not inappropriately diagnosed with mental illness, other
emotional or behavioral disorders, medically fragile
conditions, or developmental disabilities, and placed in
settings that are not foster family homes as a result of the
inappropriate diagnoses; and''.
(b) Evaluation.--Section 476 of such Act (42 U.S.C. 676),
as previously amended, is further amended by adding at the
end the following:
``(e) Evaluation of State Procedures and Protocols To
Prevent Inappropriate Diagnoses of Mental Illness or Other
Conditions.--The Secretary shall conduct an evaluation of the
procedures and protocols established by States in accordance
with the requirements of section 422(b)(15)(A)(vii). The
evaluation shall analyze the extent to which States comply
with and enforce the procedures and protocols and the
effectiveness of various State procedures and protocols and
shall identify best practices. Not later than January 1,
2019, the Secretary shall submit a report on the results of
the evaluation to Congress.''.
SEC. 20004. ADDITIONAL DATA AND REPORTS REGARDING CHILDREN
PLACED IN A SETTING THAT IS NOT A FOSTER FAMILY
HOME.
Section 479A(a)(7)(A) of the Social Security Act (42 U.S.C.
679b(a)(7)(A)) is amended by striking clauses (i) through
(vi) and inserting the following:
``(i) with respect to each such placement--
``(I) the type of the placement setting, including whether
the placement is shelter care, a group home and if so, the
range of the child population in the home, a residential
treatment facility, a hospital or institution providing
medical, rehabilitative, or psychiatric care, a setting
specializing in providing prenatal, post-partum or parenting
supports, or some other kind of child-care institution and if
so, what kind;
``(II) the number of children in the placement setting and
the age, race, ethnicity, and gender of each of the children;
``(III) for each child in the placement setting, the length
of the placement of the child in the setting, whether the
placement of the child in the setting is the first placement
of the child and if not, the number and type of previous
placements of the child, and whether the child has special
needs or another diagnosed mental or physical illness or
condition; and
``(IV) the extent of any specialized education, treatment,
counseling, or other services provided in the setting; and
``(ii) separately, the number and ages of children in the
placements who have a permanency plan of another planned
permanent living arrangement; and''.
SEC. 20005. EFFECTIVE DATES; APPLICATION TO WAIVERS.
(a) Effective Dates.--
(1) In general.--Subject to paragraph (2) and subsections
(b) and (c), the amendments made by this title shall take
effect on January 1, 2017.
(2) Transition rule.--In the case of a State plan under
part B or E of title IV of the Social Security Act which the
Secretary of Health and Human Services determines requires
State legislation (other than legislation appropriating
funds) in order for the plan to meet the additional
requirements imposed by the amendments made by this title,
the State plan shall not be regarded as failing to comply
with the requirements of such part solely on the basis of the
failure of the plan to meet the additional requirements
before the first day of the first calendar quarter beginning
after the close of the first regular session of the State
legislature that begins after the date of enactment of this
Act. For purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year of the
session shall be deemed to be a separate regular session of
the State legislature.
(b) Limitation on Federal Financial Participation for
Placements That Are Not in Foster Family Homes and Related
Provisions.--
(1) In general.--The amendments made by sections 20001(a),
20001(b), 20001(d), and 20002 shall take effect on October 1,
2019.
(2) State option to delay effective date for not more than
2 years.--At the sole discretion of a State and for not more
than 2 years, the Secretary of Health and Human Services
shall delay the effective date provided for in paragraph (1)
with respect to the State. If the effective date is so
delayed for a period with respect to a State under the
preceding sentence, then--
(A) notwithstanding section 1904, the date that the
amendments made by section 19011(c) take effect with respect
to the State shall be delayed for the period; and
(B) in applying section 474(a)(6) of the Social Security
Act with respect to the State, ``on or after the date this
paragraph takes effect with respect to the State'' is deemed
to be substituted for ``after September 30, 2019'' in
subparagraph (A)(i)(I) of such section.
(c) Application to States With Waivers.--In the case of a
State that, on the date of enactment of this Act, has in
effect a waiver approved under section 1130 of the Social
Security Act (42 U.S.C. 1320a-9), the amendments made by this
title shall not apply with respect to the State before the
expiration (determined without regard to any extensions) of
the waiver to the extent the amendments are inconsistent with
the terms of the waiver.
TITLE XXI--CONTINUING SUPPORT FOR CHILD AND FAMILY SERVICES
SEC. 21001. SUPPORTING AND RETAINING FOSTER FAMILIES FOR
CHILDREN.
(a) Supporting and Retaining Foster Parents as a Family
Support Service.--Section 431(a)(2)(B) of the Social Security
Act (42 U.S.C. 631(a)(2)(B)) is amended by redesignating
clauses (iii) through (vi) as clauses (iv) through (vii),
respectively, and inserting after clause (ii) the following:
``(iii) To support and retain foster families so they can
provide quality family-based settings for children in foster
care.''.
(b) Support for Foster Family Homes.--Section 436 of such
Act (42 U.S.C. 629f) is amended by adding at the end the
following:
``(c) Support for Foster Family Homes.--Out of any money in
the Treasury of the United States not otherwise appropriated,
there are appropriated to the Secretary for fiscal year 2018,
$8,000,000 for the Secretary to make competitive grants to
States, Indian tribes, or tribal consortia to support the
recruitment and retention of high-quality foster families to
increase their capacity to place more children in family
settings, focused on States, Indian tribes, or tribal
consortia with the highest percentage of children in non-
family settings. The amount appropriated under this
subparagraph shall remain available through fiscal year
2022.''.
SEC. 21002. EXTENSION OF CHILD AND FAMILY SERVICES PROGRAMS.
(a) Extension of Stephanie Tubbs Jones Child Welfare
Services Program.--Section 425 of the Social Security Act (42
U.S.C. 625) is amended by striking ``2012 through 2016'' and
inserting ``2017 through 2021''.
(b) Extension of Promoting Safe and Stable Families Program
Authorizations.--
(1) In general.--Section 436(a) of such Act (42 U.S.C.
629f(a)) is amended by striking all that follows
``$345,000,000'' and inserting ``for each of fiscal years
2017 through 2021.''.
(2) Discretionary grants.--Section 437(a) of such Act (42
U.S.C. 629g(a)) is amended by striking ``2012 through 2016''
and inserting ``2017 through 2021''.
(c) Extension of Funding Reservations for Monthly
Caseworker Visits and Regional Partnership Grants.--Section
436(b) of such Act (42 U.S.C. 629f(b)) is amended--
(1) in paragraph (4)(A), by striking ``2012 through 2016''
and inserting ``2017 through 2021''; and
(2) in paragraph (5), by striking ``2012 through 2016'' and
inserting ``2017 through 2021''.
(d) Reauthorization of Funding for State Courts.--
(1) Extension of program.--Section 438(c)(1) of such Act
(42 U.S.C. 629h(c)(1)) is amended by striking ``2012 through
2016'' and inserting ``2017 through 2021''.
(2) Extension of federal share.--Section 438(d) of such Act
(42 U.S.C. 629h(d)) is amended by striking ``2012 through
2016'' and inserting ``2017 through 2021''.
(e) Repeal of Expired Provisions.--Section 438(e) of such
Act (42 U.S.C. 629h(e)) is repealed.
SEC. 21003. IMPROVEMENTS TO THE JOHN H. CHAFEE FOSTER CARE
INDEPENDENCE PROGRAM AND RELATED PROVISIONS.
(a) Authority To Serve Former Foster Youth Up To Age 23.--
Section 477 of the Social Security Act (42 U.S.C. 677) is
amended--
(1) in subsection (a)(5), by inserting ``(or 23 years of
age, in the case of a State with a certification under
subsection (b)(3)(A)(ii) to provide assistance and services
to youths who have aged out of foster care and have not
attained such age, in accordance with such subsection)''
after ``21 years of age'';
(2) in subsection (b)(3)(A)--
(A) by inserting ``(i)'' before ``A certification'';
(B) by striking ``children who have left foster care'' and
all that follows through the period and inserting ``youths
who have aged out of foster care and have not attained 21
years of age.''; and
(C) by adding at the end the following:
``(ii) If the State has elected under section 475(8)(B) to
extend eligibility for foster care to all children who have
not attained 21 years of age, or if the Secretary determines
that the State agency responsible for administering the State
plans under this part and part B uses State funds or any
other funds not provided under this part to provide services
and assistance for youths who have aged out of foster care
that are comparable to the services and assistance the youths
would receive if the State had made such an election, the
certification required under clause (i) may provide that the
State will provide assistance and services to youths who have
aged out of foster care and have not attained 23 years of
age.''; and
(3) in subsection (b)(3)(B), by striking ``children who
have left foster care'' and all that follows through the
period and inserting ``youths who have aged out of foster
care and have not attained 21 years of age (or 23 years of
age, in the case of a State with a certification under
subparagraph (A)(i) to provide assistance and services to
youths who have aged out of foster care and have not attained
such age, in accordance with subparagraph (A)(ii)).''.
(b) Authority to Redistribute Unspent Funds.--Section
477(d) of such Act (42 U.S.C. 677(d)) is amended--
[[Page H6987]]
(1) in paragraph (4), by inserting ``or does not expend
allocated funds within the time period specified under
section 477(d)(3)'' after ``provided by the Secretary''; and
(2) by adding at the end the following:
``(5) Redistribution of unexpended amounts.--
``(A) Availability of amounts.--To the extent that amounts
paid to States under this section in a fiscal year remain
unexpended by the States at the end of the succeeding fiscal
year, the Secretary may make the amounts available for
redistribution in the second succeeding fiscal year among the
States that apply for additional funds under this section for
that second succeeding fiscal year.
``(B) Redistribution.--
``(i) In general.--The Secretary shall redistribute the
amounts made available under subparagraph (A) for a fiscal
year among eligible applicant States. In this subparagraph,
the term `eligible applicant State' means a State that has
applied for additional funds for the fiscal year under
subparagraph (A) if the Secretary determines that the State
will use the funds for the purpose for which originally
allotted under this section.
``(ii) Amount to be redistributed.--The amount to be
redistributed to each eligible applicant State shall be the
amount so made available multiplied by the State foster care
ratio, (as defined in subsection (c)(4), except that, in such
subsection, `all eligible applicant States (as defined in
subsection (d)(5)(B)(i))' shall be substituted for `all
States').
``(iii) Treatment of redistributed amount.--Any amount made
available to a State under this paragraph shall be regarded
as part of the allotment of the State under this section for
the fiscal year in which the redistribution is made.
``(C) Tribes.--For purposes of this paragraph, the term
`State' includes an Indian tribe, tribal organization, or
tribal consortium that receives an allotment under this
section.''.
(c) Expanding and Clarifying the Use of Education and
Training Vouchers.--
(1) In general.--Section 477(i)(3) of such Act (42 U.S.C.
677(i)(3)) is amended--
(A) by striking ``on the date'' and all that follows
through ``23'' and inserting ``to remain eligible until they
attain 26''; and
(B) by inserting ``, but in no event may a youth
participate in the program for more than 5 years (whether or
not consecutive)'' before the period.
(2) Conforming amendment.--Section 477(i)(1) of such Act
(42 U.S.C. 677(i)(1)) is amended by inserting ``who have
attained 14 years of age'' before the period.
(d) Other Improvements.--Section 477 of such Act (42 U.S.C.
677), as amended by subsections (a), (b), and (c), is
amended--
(1) in the section heading, by striking ``independence
program'' and inserting ``program for successful transition
to adulthood'';
(2) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``identify children who are likely to
remain in foster care until 18 years of age and to help these
children make the transition to self-sufficiency by providing
services'' and inserting ``support all youth who have
experienced foster care at age 14 or older in their
transition to adulthood through transitional services'';
(ii) by inserting ``and post-secondary education'' after
``high school diploma''; and
(iii) by striking ``training in daily living skills,
training in budgeting and financial management skills'' and
inserting ``training and opportunities to practice daily
living skills (such as financial literacy training and
driving instruction)'';
(B) in paragraph (2), by striking ``who are likely to
remain in foster care until 18 years of age receive the
education, training, and services necessary to obtain
employment'' and inserting ``who have experienced foster care
at age 14 or older achieve meaningful, permanent connections
with a caring adult'';
(C) in paragraph (3), by striking ``who are likely to
remain in foster care until 18 years of age prepare for and
enter postsecondary training and education institutions'' and
inserting ``who have experienced foster care at age 14 or
older engage in age or developmentally appropriate
activities, positive youth development, and experiential
learning that reflects what their peers in intact families
experience''; and
(D) by striking paragraph (4) and redesignating paragraphs
(5) through (8) as paragraphs (4) through (7);
(3) in subsection (b)--
(A) in paragraph (2)(D), by striking ``adolescents'' and
inserting ``youth''; and
(B) in paragraph (3)--
(i) in subparagraph (D)--
(I) by inserting ``including training on youth
development'' after ``to provide training''; and
(II) by striking ``adolescents preparing for independent
living'' and all that follows through the period and
inserting ``youth preparing for a successful transition to
adulthood and making a permanent connection with a caring
adult.'';
(ii) in subparagraph (H), by striking ``adolescents'' each
place it appears and inserting ``youth''; and
(iii) in subparagraph (K)--
(I) by striking ``an adolescent'' and inserting ``a
youth''; and
(II) by striking ``the adolescent'' each place it appears
and inserting ``the youth''; and
(4) in subsection (f), by striking paragraph (2) and
inserting the following:
``(2) Report to congress.--Not later than October 1, 2017,
the Secretary shall submit to the Committee on Ways and Means
of the House of Representatives and the Committee on Finance
of the Senate a report on the National Youth in Transition
Database and any other databases in which States report
outcome measures relating to children in foster care and
children who have aged out of foster care or left foster care
for kinship guardianship or adoption. The report shall
include the following:
``(A) A description of the reasons for entry into foster
care and of the foster care experiences, such as length of
stay, number of placement settings, case goal, and discharge
reason of 17-year-olds who are surveyed by the National Youth
in Transition Database and an analysis of the comparison of
that description with the reasons for entry and foster care
experiences of children of other ages who exit from foster
care before attaining age 17.
``(B) A description of the characteristics of the
individuals who report poor outcomes at ages 19 and 21 to the
National Youth in Transition Database.
``(C) Benchmarks for determining what constitutes a poor
outcome for youth who remain in or have exited from foster
care and plans the Executive branch will take to incorporate
these benchmarks in efforts to evaluate child welfare agency
performance in providing services to children transitioning
from foster care.
``(D) An analysis of the association between types of
placement, number of overall placements, time spent in foster
care, and other factors, and outcomes at ages 19 and 21.
``(E) An analysis of the differences in outcomes for
children in and formerly in foster care at age 19 and 21
among States.''.
(e) Clarifying Documentation Provided to Foster Youth
Leaving Foster Care.--Section 475(5)(I) of such Act (42
U.S.C. 675(5)(I)) is amended by inserting after ``REAL ID Act
of 2005'' the following: ``, and any official documentation
necessary to prove that the child was previously in foster
care''.
TITLE XXII--CONTINUING INCENTIVES TO STATES TO PROMOTE ADOPTION AND
LEGAL GUARDIANSHIP
SEC. 22001. REAUTHORIZING ADOPTION AND LEGAL GUARDIANSHIP
INCENTIVE PROGRAMS.
Section 473A of the Social Security Act (42 U.S.C. 673b) is
amended--
(1) in subsection (b)(4), by striking ``2013 through 2015''
and inserting ``2016 through 2020'';
(2) in subsection (h)(1)(D), by striking ``2016'' and
inserting ``2021''; and
(3) in subsection (h)(2), by striking ``2016'' and
inserting ``2021''.
TITLE XXIII--TECHNICAL CORRECTIONS
SEC. 23001. TECHNICAL CORRECTIONS TO DATA EXCHANGE STANDARDS
TO IMPROVE PROGRAM COORDINATION.
(a) In General.--Section 440 of the Social Security Act (42
U.S.C. 629m) is amended to read as follows:
``SEC. 440. DATA EXCHANGE STANDARDS FOR IMPROVED
INTEROPERABILITY.
``(a) Designation.--The Secretary shall, in consultation
with an interagency work group established by the Office of
Management and Budget and considering State government
perspectives, by rule, designate data exchange standards to
govern, under this part and part E--
``(1) necessary categories of information that State
agencies operating programs under State plans approved under
this part are required under applicable Federal law to
electronically exchange with another State agency; and
``(2) Federal reporting and data exchange required under
applicable Federal law.
``(b) Requirements.--The data exchange standards required
by paragraph (1) shall, to the extent practicable--
``(1) incorporate a widely accepted, non-proprietary,
searchable, computer-readable format, such as the eXtensible
Markup Language;
``(2) contain interoperable standards developed and
maintained by intergovernmental partnerships, such as the
National Information Exchange Model;
``(3) incorporate interoperable standards developed and
maintained by Federal entities with authority over
contracting and financial assistance;
``(4) be consistent with and implement applicable
accounting principles;
``(5) be implemented in a manner that is cost-effective and
improves program efficiency and effectiveness; and
``(6) be capable of being continually upgraded as
necessary.
``(c) Rule of Construction.--Nothing in this subsection
shall be construed to require a change to existing data
exchange standards found to be effective and efficient.''.
(b) Effective Date.--Not later than the date that is 24
months after the date of the enactment of this section, the
Secretary of Health and Human Services shall issue a proposed
rule that--
(1) identifies federally required data exchanges, include
specification and timing of exchanges to be standardized, and
address the factors used in determining whether and when to
standardize data exchanges; and
(2) specifies State implementation options and describes
future milestones.
SEC. 23002. TECHNICAL CORRECTIONS TO STATE REQUIREMENT TO
ADDRESS THE DEVELOPMENTAL NEEDS OF YOUNG
CHILDREN.
Section 422(b)(18) of the Social Security Act (42 U.S.C.
622(b)(18)) is amended by striking ``such children'' and
inserting ``all vulnerable children under 5 years of age''.
[[Page H6988]]
TITLE XXIV--ENSURING STATES REINVEST SAVINGS RESULTING FROM INCREASE IN
ADOPTION ASSISTANCE
SEC. 24001. DELAY OF ADOPTION ASSISTANCE PHASE-IN.
(a) In General.--The table in section 473(e)(1)(B) of the
Social Security Act (42 U.S.C. 673(e)(1)(B)) is amended--
(1) by striking ``2016'' and inserting ``2016, 2017, 2018,
or 2019'';
(2) by striking ``2017'' and inserting ``2020''; and
(3) by striking ``2018'' and inserting ``2021''.
(b) Special Rule.--Section 473(e) of the Social Security
Act (42 U.S.C. 673(e)) is amended by adding at the end the
following new paragraph:
``(3) Additional exception.--Notwithstanding paragraph (1)
of this subsection, during the period that begins on October
1, 2016, and ends on December 31, 2016, such term shall
include a child--
``(A) who satisfies the requirements for being considered
an applicable child under paragraph (1) (as in effect during
that period);
``(B) who meets the requirements of subsection
(a)(2)(A)(ii); and
``(C) on whose behalf an adoption assistance agreement is
entered into under this section during that period.''.
(c) Effective Date.--The amendments made by this section
take effect on January 1, 2017.
SEC. 24002. GAO STUDY AND REPORT ON STATE REINVESTMENT OF
SAVINGS RESULTING FROM INCREASE IN ADOPTION
ASSISTANCE.
(a) Study.--The Comptroller General of the United States
shall study the extent to which States are complying with the
requirements of section 473(a)(8) of the Social Security Act
relating to the effects of phasing out the AFDC income
eligibility requirements for adoption assistance payments
under section 473 of the Social Security Act, as enacted by
section 402 of the Fostering Connections to Success and
Increasing Adoptions Act of 2008 (Public Law 110-351; 122
Stat. 3975) and amended by section 206 of the Preventing Sex
Trafficking and Strengthening Families Act (Public Law 113-
183; 128 Stat. 1919). In particular, the Comptroller General
shall analyze the extent to which States are complying with
the following requirements under section 473(a)(8)(D) of the
Social Security Act:
(1) The requirement to spend an amount equal to the amount
of the savings (if any) in State expenditures under part E of
title IV of the Social Security resulting from phasing out
the AFDC income eligibility requirements for adoption
assistance payments under section 473 of such Act to provide
to children of families any service that may be provided
under part B or E of title IV of such Act.
(2) The requirement that a State shall spend not less than
30 percent of the amount of any savings described in
subparagraph (A) on post-adoption services, post-guardianship
services, and services to support and sustain positive
permanent outcomes for children who otherwise might enter
into foster care under the responsibility of the State, with
at least \2/3\ of the spending by the State to comply with
the 30 percent requirement being spent on post-adoption and
post-guardianship services.
(b) Report.--The Comptroller General of the United States
shall submit to the Committee on Finance of the Senate, the
Committee on Ways and Means of the House of Representatives,
and the Secretary of Health and Human Services a report that
contains the results of the study required by subsection (a),
including recommendations to ensure compliance with laws
referred to in subsection (a).
TITLE XXV--SOCIAL IMPACT PARTNERSHIPS TO PAY FOR RESULTS
SEC. 25001. SHORT TITLE.
This title may be cited as the ``Social Impact Partnership
to Pay for Results Act''.
SEC. 25002. SOCIAL IMPACT PARTNERSHIPS TO PAY FOR RESULTS.
Section 403 of the Social Security Act (42 U.S.C. 603) is
amended by adding at the end the following:
``(c) Social Impact Demonstration Projects.--
``(1) Purposes.--The purposes of this subsection are the
following:
``(A) To improve the lives of families and individuals in
need in the United States by funding social programs that
achieve real results.
``(B) To redirect funds away from programs that, based on
objective data, are ineffective, and into programs that
achieve demonstrable, measurable results.
``(C) To ensure Federal funds are used effectively on
social services to produce positive outcomes for both service
recipients and taxpayers.
``(D) To establish the use of social impact partnerships to
address some of our Nation's most pressing problems.
``(E) To facilitate the creation of public-private
partnerships that bundle philanthropic or other private
resources with existing public spending to scale up effective
social interventions already being implemented by private
organizations, nonprofits, charitable organizations, and
State and local governments across the country.
``(F) To bring pay-for-performance to the social sector,
allowing the United States to improve the impact and
effectiveness of vital social services programs while
redirecting inefficient or duplicative spending.
``(G) To incorporate outcomes measurement and randomized
controlled trials or other rigorous methodologies for
assessing program impact.
``(2) Social impact partnership application.--
``(A) Notice.--Not later than 1 year after the date of the
enactment of this subsection, the Secretary of the Treasury,
in consultation with the Federal Interagency Council on
Social Impact Partnerships, shall publish in the Federal
Register a request for proposals from States or local
governments for social impact partnership projects in
accordance with this paragraph.
``(B) Required outcomes for social impact partnership
project.--To qualify as a social impact partnership project
under this subsection, a project must produce one or more
measurable, clearly defined outcomes that result in social
benefit and Federal, State, or local savings through any of
the following:
``(i) Increasing work and earnings by individuals in the
United States who are unemployed for more than 6 consecutive
months.
``(ii) Increasing employment and earnings of individuals
who have attained 16 years of age but not 25 years of age.
``(iii) Increasing employment among individuals receiving
Federal disability benefits.
``(iv) Reducing the dependence of low-income families on
Federal means-tested benefits.
``(v) Improving rates of high school graduation.
``(vi) Reducing teen and unplanned pregnancies.
``(vii) Improving birth outcomes and early childhood health
and development among low-income families and individuals.
``(viii) Reducing rates of asthma, diabetes, or other
preventable diseases among low-income families and
individuals to reduce the utilization of emergency and other
high-cost care.
``(ix) Increasing the proportion of children living in two-
parent families.
``(x) Reducing incidences and adverse consequences of child
abuse and neglect.
``(xi) Reducing the number of youth in foster care by
increasing adoptions, permanent guardianship arrangements,
reunifications, or placements with a fit and willing
relative, or by avoiding placing children in foster care by
ensuring they can be cared for safely in their own homes.
``(xii) Reducing the number of children and youth in foster
care residing in group homes, child care institutions,
agency-operated foster homes, or other non-family foster
homes, unless it is determined that it is in the interest of
the child's long-term health, safety, or psychological well-
being to not be placed in a family foster home.
``(xiii) Reducing the number of children returning to
foster care.
``(xiv) Reducing recidivism among juvenile offenders,
individuals released from prison, or other high-risk
populations.
``(xv) Reducing the rate of homelessness among our most
vulnerable populations.
``(xvi) Improving the health and well-being of those with
mental, emotional, and behavioral health needs.
``(xvii) Improving the educational outcomes of special-
needs or low-income children.
``(xviii) Improving the employment and well-being of
returning United States military members.
``(xix) Increasing the financial stability of low-income
families.
``(xx) Increasing the independence and employability of
individuals who are physically or mentally disabled.
``(xxi) Other measurable outcomes defined by the State or
local government that result in positive social outcomes and
Federal savings.
``(C) Application required.--The notice described in
subparagraph (A) shall require a State or local government to
submit an application for the social impact partnership
project that addresses the following:
``(i) The outcome goals of the project.
``(ii) A description of each intervention in the project
and anticipated outcomes of the intervention.
``(iii) Rigorous evidence demonstrating that the
intervention can be expected to produce the desired outcomes.
``(iv) The target population that will be served by the
project.
``(v) The expected social benefits to participants who
receive the intervention and others who may be impacted.
``(vi) Projected Federal, State, and local government costs
and other costs to conduct the project.
``(vii) Projected Federal, State, and local government
savings and other savings, including an estimate of the
savings to the Federal Government, on a program-by-program
basis and in the aggregate, if the project is implemented and
the outcomes are achieved as a result of the intervention.
``(viii) If savings resulting from the successful
completion of the project are estimated to accrue to the
State or local government, the likelihood of the State or
local government to realize those savings.
``(ix) A plan for delivering the intervention through a
social impact partnership model.
``(x) A description of the expertise of each service
provider that will administer the intervention, including a
summary of the experience of the service provider in
delivering the proposed intervention or a similar
intervention, or demonstrating that the service provider has
the expertise necessary to deliver the proposed intervention.
``(xi) An explanation of the experience of the State or
local government, the intermediary, or the service provider
in raising private and philanthropic capital to fund social
service investments.
``(xii) The detailed roles and responsibilities of each
entity involved in the project, including any State or local
government entity, intermediary, service provider,
independent evaluator, investor, or other stakeholder.
``(xiii) A summary of the experience of the service
provider in delivering the proposed intervention or a similar
intervention, or a summary demonstrating the service provider
has the expertise necessary to deliver the proposed
intervention.
[[Page H6989]]
``(xiv) A summary of the unmet need in the area where the
intervention will be delivered or among the target population
who will receive the intervention.
``(xv) The proposed payment terms, the methodology used to
calculate outcome payments, the payment schedule, and
performance thresholds.
``(xvi) The project budget.
``(xvii) The project timeline.
``(xviii) The criteria used to determine the eligibility of
an individual for the project, including how selected
populations will be identified, how they will be referred to
the project, and how they will be enrolled in the project.
``(xix) The evaluation design.
``(xx) The metrics that will be used in the evaluation to
determine whether the outcomes have been achieved as a result
of the intervention and how the metrics will be measured.
``(xxi) An explanation of how the metrics used in the
evaluation to determine whether the outcomes achieved as a
result of the intervention are independent, objective
indicators of impact and are not subject to manipulation by
the service provider, intermediary, or investor.
``(xxii) A summary explaining the independence of the
evaluator from the other entities involved in the project and
the evaluator's experience in conducting rigorous evaluations
of program effectiveness including, where available, well-
implemented randomized controlled trials on the intervention
or similar interventions.
``(xxiii) The capacity of the service provider to deliver
the intervention to the number of participants the State or
local government proposes to serve in the project.
``(xxiv) A description of whether and how the State or
local government and service providers plan to sustain the
intervention, if it is timely and appropriate to do so, to
ensure that successful interventions continue to operate
after the period of the social impact partnership.
``(D) Project intermediary information required.--The
application described in subparagraph (C) shall also contain
the following information about any intermediary for the
social impact partnership project (whether an intermediary is
a service provider or other entity):
``(i) Experience and capacity for providing or facilitating
the provision of the type of intervention proposed.
``(ii) The mission and goals.
``(iii) Information on whether the intermediary is already
working with service providers that provide this intervention
or an explanation of the capacity of the intermediary to
begin working with service providers to provide the
intervention.
``(iv) Experience working in a collaborative environment
across government and nongovernmental entities.
``(v) Previous experience collaborating with public or
private entities to implement evidence-based programs.
``(vi) Ability to raise or provide funding to cover
operating costs (if applicable to the project).
``(vii) Capacity and infrastructure to track outcomes and
measure results, including--
``(I) capacity to track and analyze program performance and
assess program impact; and
``(II) experience with performance-based awards or
performance-based contracting and achieving project
milestones and targets.
``(viii) Role in delivering the intervention.
``(ix) How the intermediary would monitor program success,
including a description of the interim benchmarks and outcome
measures.
``(E) Feasibility studies funded through other sources.--
The notice described in subparagraph (A) shall permit a State
or local government to submit an application for social
impact partnership funding that contains information from a
feasibility study developed for purposes other than applying
for funding under this subsection.
``(3) Awarding social impact partnership agreements.--
``(A) Timeline in awarding agreement.--Not later than 6
months after receiving an application in accordance with
paragraph (2), the Secretary, in consultation with the
Federal Interagency Council on Social Impact Partnerships,
shall determine whether to enter into an agreement for a
social impact partnership project with a State or local
government.
``(B) Considerations in awarding agreement.--In determining
whether to enter into an agreement for a social impact
partnership project (the application for which was submitted
under paragraph (2)) the Secretary, in consultation with the
Federal Interagency Council on Social Impact Partnerships
(established by paragraph (6)) and the head of any Federal
agency administering a similar intervention or serving a
population similar to that served by the project, shall
consider each of the following:
``(i) The recommendations made by the Commission on Social
Impact Partnerships.
``(ii) The value to the Federal Government of the outcomes
expected to be achieved if the outcomes specified in the
agreement are achieved as a result of the intervention.
``(iii) The likelihood, based on evidence provided in the
application and other evidence, that the State or local
government in collaboration with the intermediary and the
service providers will achieve the outcomes.
``(iv) The savings to the Federal Government if the
outcomes specified in the agreement are achieved as a result
of the intervention.
``(v) The savings to the State and local governments if the
outcomes specified in the agreement are achieved as a result
of the intervention.
``(vi) The expected quality of the evaluation that would be
conducted with respect to the agreement.
``(vii) The capacity and commitment of the State or local
government to sustain the intervention, if appropriate and
timely and if the intervention is successful, beyond the
period of the social impact partnership.
``(C) Agreement authority.--
``(i) Agreement requirements.--In accordance with this
paragraph, the Secretary, in consultation with the Federal
Interagency Council on Social Impact Partnerships and the
head of any Federal agency administering a similar
intervention or serving a population similar to that served
by the project, may enter into an agreement for a social
impact partnership project with a State or local government
if the Secretary, in consultation with the Federal
Interagency Council on Social Impact Partnerships, determines
that each of the following requirements are met:
``(I) The State or local government agrees to achieve one
or more outcomes as a result of the intervention, as
specified in the agreement and validated by independent
evaluation, in order to receive payment.
``(II) The Federal payment to the State or local government
for each specified outcome achieved as a result of the
intervention is less than or equal to the value of the
outcome to the Federal Government over a period not to exceed
10 years, as determined by the Secretary, in consultation
with the State or local government.
``(III) The duration of the project does not exceed 10
years.
``(IV) The State or local government has demonstrated,
through the application submitted under paragraph (2), that,
based on prior rigorous experimental evaluations or rigorous
quasi-experimental studies, the intervention can be expected
to achieve each outcome specified in the agreement.
``(V) The State, local government, intermediary, or service
provider has experience raising private or philanthropic
capital to fund social service investments (if applicable to
the project).
``(VI) The State or local government has shown that each
service provider has experience delivering the intervention,
a similar intervention, or has otherwise demonstrated the
expertise necessary to deliver the intervention.
``(ii) Payment.--The Secretary shall pay the State or local
government only if the independent evaluator described in
paragraph (5) determines that the social impact partnership
project has met the requirements specified in the agreement
and achieved an outcome as a result of the intervention, as
specified in the agreement and validated by independent
evaluation.
``(D) Notice of agreement award.--Not later than 30 days
after entering into an agreement under this paragraph, the
Secretary shall publish a notice in the Federal Register that
includes, with regard to the agreement, the following:
``(i) The outcome goals of the social impact partnership
project.
``(ii) A description of each intervention in the project.
``(iii) The target population that will be served by the
project.
``(iv) The expected social benefits to participants who
receive the intervention and others who may be impacted.
``(v) The detailed roles, responsibilities, and purposes of
each Federal, State, or local government entity,
intermediary, service provider, independent evaluator,
investor, or other stakeholder.
``(vi) The payment terms, the methodology used to calculate
outcome payments, the payment schedule, and performance
thresholds.
``(vii) The project budget.
``(viii) The project timeline.
``(ix) The project eligibility criteria.
``(x) The evaluation design.
``(xi) The metrics that will be used in the evaluation to
determine whether the outcomes have been achieved as a result
of each intervention and how these metrics will be measured.
``(xii) The estimate of the savings to the Federal, State,
and local government, on a program-by-program basis and in
the aggregate, if the agreement is entered into and
implemented and the outcomes are achieved as a result of each
intervention.
``(E) Authority to transfer administration of agreement.--
The Secretary may transfer to the head of another Federal
agency the authority to administer (including making payments
under) an agreement entered into under subparagraph (C), and
any funds necessary to do so.
``(F) Requirement on funding used to benefit children.--Not
less than 50 percent of all Federal payments made to carry
out agreements under this paragraph shall be used for
initiatives that directly benefit children.
``(4) Feasibility study funding.--
``(A) Requests for funding for feasibility studies.--The
Secretary shall reserve a portion of the amount reserved to
carry out this subsection to assist States or local
governments in developing feasibility studies to apply for
social impact partnership funding under paragraph (2). To be
eligible to receive funding to assist with completing a
feasibility study, a State or local government shall submit
an application for feasibility study funding addressing the
following:
``(i) A description of the outcome goals of the social
impact partnership project.
``(ii) A description of the intervention, including
anticipated program design, target population, an estimate
regarding the number of individuals to be served, and setting
for the intervention.
``(iii) Evidence to support the likelihood that the
intervention will produce the desired outcomes.
``(iv) A description of the potential metrics to be used.
``(v) The expected social benefits to participants who
receive the intervention and others who may be impacted.
``(vi) Estimated costs to conduct the project.
``(vii) Estimates of Federal, State, and local government
savings and other savings if the
[[Page H6990]]
project is implemented and the outcomes are achieved as a
result of each intervention.
``(viii) An estimated timeline for implementation and
completion of the project, which shall not exceed 10 years.
``(ix) With respect to a project for which the State or
local government selects an intermediary to operate the
project, any partnerships needed to successfully execute the
project and the ability of the intermediary to foster the
partnerships.
``(x) The expected resources needed to complete the
feasibility study for the State or local government to apply
for social impact partnership funding under paragraph (2).
``(B) Federal selection of applications for feasibility
study.--Not later than 6 months after receiving an
application for feasibility study funding under subparagraph
(A), the Secretary, in consultation with the Federal
Interagency Council on Social Impact Partnerships and the
head of any Federal agency administering a similar
intervention or serving a population similar to that served
by the project, shall select State or local government
feasibility study proposals for funding based on the
following:
``(i) The recommendations made by the Commission on Social
Impact Partnerships.
``(ii) The likelihood that the proposal will achieve the
desired outcomes.
``(iii) The value of the outcomes expected to be achieved
as a result of each intervention.
``(iv) The potential savings to the Federal Government if
the social impact partnership project is successful.
``(v) The potential savings to the State and local
governments if the project is successful.
``(C) Public disclosure.--Not later than 30 days after
selecting a State or local government for feasibility study
funding under this paragraph, the Secretary shall cause to be
published on the website of the Federal Interagency Council
on Social Impact Partnerships information explaining why a
State or local government was granted feasibility study
funding.
``(D) Funding restriction.--
``(i) Feasibility study restriction.--The Secretary may not
provide feasibility study funding under this paragraph for
more than 50 percent of the estimated total cost of the
feasibility study reported in the State or local government
application submitted under subparagraph (A).
``(ii) Aggregate restriction.--Of the total amount reserved
to carry out this subsection, the Secretary may not use more
than $10,000,000 to provide feasibility study funding to
States or local governments under this paragraph.
``(iii) No guarantee of funding.--The Secretary shall have
the option to award no funding under this paragraph.
``(E) Submission of feasibility study required.--Not later
than 9 months after the receipt of feasibility study funding
under this paragraph, a State or local government receiving
the funding shall complete the feasibility study and submit
the study to the Federal Interagency Council on Social Impact
Partnerships.
``(F) Delegation of authority.--The Secretary may transfer
to the head of another Federal agency the authorities
provided in this paragraph and any funds necessary to
exercise the authorities.
``(5) Evaluations.--
``(A) Authority to enter into agreements.--For each State
or local government awarded a social impact partnership
project approved by the Secretary under this subsection, the
head of the relevant agency, as recommended by the Federal
Interagency Council on Social Impact Partnerships and
determined by the Secretary, shall enter into an agreement
with the State or local government to pay for all or part of
the independent evaluation to determine whether the State or
local government project has achieved a specific outcome as a
result of the intervention in order for the State or local
government to receive outcome payments under this subsection.
``(B) Evaluator qualifications.--The head of the relevant
agency may not enter into an agreement with a State or local
government unless the head determines that the evaluator is
independent of the other parties to the agreement and has
demonstrated substantial experience in conducting rigorous
evaluations of program effectiveness including, where
available and appropriate, well-implemented randomized
controlled trials on the intervention or similar
interventions.
``(C) Methodologies to be used.--The evaluation used to
determine whether a State or local government will receive
outcome payments under this subsection shall use experimental
designs using random assignment or other reliable, evidence-
based research methodologies, as certified by the Federal
Interagency Council on Social Impact Partnerships, that allow
for the strongest possible causal inferences when random
assignment is not feasible.
``(D) Progress report.--
``(i) Submission of report.--The independent evaluator
shall--
``(I) not later than 2 years after a project has been
approved by the Secretary and biannually thereafter until the
project is concluded, submit to the head of the relevant
agency and the Federal Interagency Council on Social Impact
Partnerships a written report summarizing the progress that
has been made in achieving each outcome specified in the
agreement; and
``(II) before the scheduled time of the first outcome
payment and before the scheduled time of each subsequent
payment, submit to the head of the relevant agency and the
Federal Interagency Council on Social Impact Partnerships a
written report that includes the results of the evaluation
conducted to determine whether an outcome payment should be
made along with information on the unique factors that
contributed to achieving or failing to achieve the outcome,
the challenges faced in attempting to achieve the outcome,
and information on the improved future delivery of this or
similar interventions.
``(ii) Submission to the secretary and congress.--Not later
than 30 days after receipt of the written report pursuant to
clause (i)(II), the Federal Interagency Council on Social
Impact Partnerships shall submit the report to the Secretary
and each committee of jurisdiction in the House of
Representatives and the Senate.
``(E) Final report.--
``(i) Submission of report.--Within 6 months after the
social impact partnership project is completed, the
independent evaluator shall--
``(I) evaluate the effects of the activities undertaken
pursuant to the agreement with regard to each outcome
specified in the agreement; and
``(II) submit to the head of the relevant agency and the
Federal Interagency Council on Social Impact Partnerships a
written report that includes the results of the evaluation
and the conclusion of the evaluator as to whether the State
or local government has fulfilled each obligation of the
agreement, along with information on the unique factors that
contributed to the success or failure of the project, the
challenges faced in attempting to achieve the outcome, and
information on the improved future delivery of this or
similar interventions.
``(ii) Submission to the secretary and congress.--Not later
than 30 days after receipt of the written report pursuant to
clause (i)(II), the Federal Interagency Council on Social
Impact Partnerships shall submit the report to the Secretary
and each committee of jurisdiction in the House of
Representatives and the Senate.
``(F) Limitation on cost of evaluations.--Of the amount
reserved under this subsection for social impact partnership
projects, the Secretary may not obligate more than 15 percent
to evaluate the implementation and outcomes of the projects.
``(G) Delegation of authority.--The Secretary may transfer
to the head of another Federal agency the authorities
provided in this paragraph and any funds necessary to
exercise the authorities.
``(6) Federal interagency council on social impact
partnerships.--
``(A) Establishment.--There is established the Federal
Interagency Council on Social Impact Partnerships (in this
paragraph referred to as the `Council') to--
``(i) coordinate with the Secretary on the efforts of
social impact partnership projects funded under this
subsection;
``(ii) advise and assist the Secretary in the development
and implementation of the projects;
``(iii) advise the Secretary on specific programmatic and
policy matter related to the projects;
``(iv) provide subject-matter expertise to the Secretary
with regard to the projects;
``(v) certify to the Secretary that each State or local
government that has entered into an agreement with the
Secretary for a social impact partnership project under this
subsection and each evaluator selected by the head of the
relevant agency under paragraph (5) has access to Federal
administrative data to assist the State or local government
and the evaluator in evaluating the performance and outcomes
of the project;
``(vi) address issues that will influence the future of
social impact partnership projects in the United States;
``(vii) provide guidance to the executive branch on the
future of social impact partnership projects in the United
States;
``(viii) prior to approval by the Secretary, certify that
each State and local government application for a social
impact partnership contains rigorous, independent data and
reliable, evidence-based research methodologies to support
the conclusion that the project will yield savings to the
State or local government or the Federal Government if the
project outcomes are achieved;
``(ix) certify to the Secretary, in the case of each
approved social impact partnership that is expected to yield
savings to the Federal Government, that the project will
yield a projected savings to the Federal Government if the
project outcomes are achieved, and coordinate with the
relevant Federal agency to produce an after-action accounting
once the project is complete to determine the actual Federal
savings realized, and the extent to which actual savings
aligned with projected savings; and
``(x) provide periodic reports to the Secretary and make
available reports periodically to Congress and the public on
the implementation of this subsection.
``(B) Composition of council.--The Council shall have 11
members, as follows:
``(i) Chair.--The Chair of the Council shall be the
Director of the Office of Management and Budget.
``(ii) Other members.--The head of each of the following
entities shall designate one officer or employee of the
entity to be a Council member:
``(I) The Department of Labor.
``(II) The Department of Health and Human Services.
``(III) The Social Security Administration.
``(IV) The Department of Agriculture.
``(V) The Department of Justice.
``(VI) The Department of Housing and Urban Development.
``(VII) The Department of Education.
``(VIII) The Department of Veterans Affairs.
``(IX) The Department of the Treasury.
``(X) The Corporation for National and Community Service.
``(7) Commission on social impact partnerships.--
``(A) Establishment.--There is established the Commission
on Social Impact Partnerships (in this paragraph referred to
as the `Commission').
``(B) Duties.--The duties of the Commission shall be to--
[[Page H6991]]
``(i) assist the Secretary and the Federal Interagency
Council on Social Impact Partnerships in reviewing
applications for funding under this subsection;
``(ii) make recommendations to the Secretary and the
Federal Interagency Council on Social Impact Partnerships
regarding the funding of social impact partnership agreements
and feasibility studies; and
``(iii) provide other assistance and information as
requested by the Secretary or the Federal Interagency Council
on Social Impact Partnerships.
``(C) Composition.--The Commission shall be composed of
nine members, of whom--
``(i) one shall be appointed by the President, who will
serve as the Chair of the Commission;
``(ii) one shall be appointed by the Majority Leader of the
Senate;
``(iii) one shall be appointed by the Minority Leader of
the Senate;
``(iv) one shall be appointed by the Speaker of the House
of Representatives;
``(v) one shall be appointed by the Minority Leader of the
House of Representatives;
``(vi) one shall be appointed by the Chairman of the
Committee on Finance of the Senate;
``(vii) one shall be appointed by the ranking member of the
Committee on Finance of the Senate;
``(viii) one member shall be appointed by the Chairman of
the Committee on Ways and Means of the House of
Representatives; and
``(ix) one shall be appointed by the ranking member of the
Committee on Ways and Means of the House of Representatives.
``(D) Qualifications of commission members.--The members of
the Commission shall--
``(i) be experienced in finance, economics, pay for
performance, or program evaluation;
``(ii) have relevant professional or personal experience in
a field related to one or more of the outcomes listed in this
subsection; or
``(iii) be qualified to review applications for social
impact partnership projects to determine whether the proposed
metrics and evaluation methodologies are appropriately
rigorous and reliant upon independent data and evidence-based
research.
``(E) Timing of appointments.--The appointments of the
members of the Commission shall be made not later than 120
days after the date of the enactment of this subsection, or,
in the event of a vacancy, not later than 90 days after the
date the vacancy arises. If a member of Congress fails to
appoint a member by that date, the President may select a
member of the President's choice on behalf of the member of
Congress. Notwithstanding the preceding sentence, if not all
appointments have been made to the Commission as of that
date, the Commission may operate with no fewer than five
members until all appointments have been made.
``(F) Term of appointments.--
``(i) In general.--The members appointed under subparagraph
(C) shall serve as follows:
``(I) Three members shall serve for 2 years.
``(II) Three members shall serve for 3 years.
``(III) Three members (one of which shall be Chair of the
Commission appointed by the President) shall serve for 4
years.
``(ii) Assignment of terms.--The Commission shall designate
the term length that each member appointed under subparagraph
(C) shall serve by unanimous agreement. In the event that
unanimous agreement cannot be reached, term lengths shall be
assigned to the members by a random process.
``(G) Vacancies.--Subject to subparagraph (E), in the event
of a vacancy in the Commission, whether due to the
resignation of a member, the expiration of a member's term,
or any other reason, the vacancy shall be filled in the
manner in which the original appointment was made and shall
not affect the powers of the Commission.
``(H) Appointment power.--Members of the Commission
appointed under subparagraph (C) shall not be subject to
confirmation by the Senate.
``(8) Limitation on use of funds.--Of the amounts reserved
to carry out this subsection, the Secretary may not use more
than $2,000,000 in any fiscal year to support the review,
approval, and oversight of social impact partnership
projects, including activities conducted by--
``(A) the Federal Interagency Council on Social Impact
Partnerships; and
``(B) any other agency consulted by the Secretary before
approving a social impact partnership project or a
feasibility study under paragraph (4).
``(9) No federal funding for credit enhancements.--No
amount reserved to carry out this subsection may be used to
provide any insurance, guarantee, or other credit enhancement
to a State or local government under which a Federal payment
would be made to a State or local government as the result of
a State or local government failing to achieve an outcome
specified in a contract.
``(10) Availability of funds.--Amounts reserved to carry
out this subsection shall remain available until 10 years
after the date of the enactment of this subsection.
``(11) Website.--The Federal Interagency Council on Social
Impact Partnerships shall establish and maintain a public
website that shall display the following:
``(A) A copy of, or method of accessing, each notice
published regarding a social impact partnership project
pursuant to this subsection.
``(B) A copy of each feasibility study funded under this
subsection.
``(C) For each State or local government that has entered
into an agreement with the Secretary for a social impact
partnership project, the website shall contain the following
information:
``(i) The outcome goals of the project.
``(ii) A description of each intervention in the project.
``(iii) The target population that will be served by the
project.
``(iv) The expected social benefits to participants who
receive the intervention and others who may be impacted.
``(v) The detailed roles, responsibilities, and purposes of
each Federal, State, or local government entity,
intermediary, service provider, independent evaluator,
investor, or other stakeholder.
``(vi) The payment terms, methodology used to calculate
outcome payments, the payment schedule, and performance
thresholds.
``(vii) The project budget.
``(viii) The project timeline.
``(ix) The project eligibility criteria.
``(x) The evaluation design.
``(xi) The metrics used to determine whether the proposed
outcomes have been achieved and how these metrics are
measured.
``(D) A copy of the progress reports and the final reports
relating to each social impact partnership project.
``(E) An estimate of the savings to the Federal, State, and
local government, on a program-by-program basis and in the
aggregate, resulting from the successful completion of the
social impact partnership project.
``(12) Regulations.--The Secretary, in consultation with
the Federal Interagency Council on Social Impact
Partnerships, may issue regulations as necessary to carry out
this subsection.
``(13) Definitions.--In this subsection:
``(A) Agency.--The term `agency' has the meaning given that
term in section 551 of title 5, United States Code.
``(B) Intervention.--The term `intervention' means a
specific service delivered to achieve an impact through a
social impact partnership project.
``(C) Secretary.--The term `Secretary' means the Secretary
of the Treasury.
``(D) Social impact partnership project.--The term `social
impact partnership project' means a project that finances
social services using a social impact partnership model.
``(E) Social impact partnership model.--The term `social
impact partnership model' means a method of financing social
services in which--
``(i) Federal funds are awarded to a State or local
government only if a State or local government achieves
certain outcomes agreed on by the State or local government
and the Secretary; and
``(ii) the State or local government coordinates with
service providers, investors (if applicable to the project),
and (if necessary) an intermediary to identify--
``(I) an intervention expected to produce the outcome;
``(II) a service provider to deliver the intervention to
the target population; and
``(III) investors to fund the delivery of the intervention.
``(F) State.--The term `State' means each State of the
United States, the District of Columbia, each commonwealth,
territory or possession of the United States, and each
federally recognized Indian tribe.
``(14) Funding.--Of the amounts made available to carry out
subsection (b) for fiscal year 2017, the Secretary shall
reserve $100,000,000 to carry out this subsection.''.
SEC. 25003. EXTENSION OF TANF PROGRAM.
(a) Family Assistance Grants.--Section 403(a)(1) of the
Social Security Act (42 U.S.C. 603(a)(1)) is amended in each
of subparagraphs (A) and (C), by striking ``2012'' and
inserting ``2017''.
(b) Healthy Marriage Promotion and Responsible Fatherhood
Grants.--Section 403(a)(2)(D) of such Act (42 U.S.C.
603(a)(2)(D)) is amended by striking ``2012'' each place it
appears and inserting ``2017''.
(c) Tribal Grants.--Section 412(a) of such Act (42 U.S.C.
612(a)) is amended in each of paragraphs (1)(A) and (2)(A) by
striking ``2012'' and inserting ``2017''.
(d) Child Care Entitlement.--Section 418(a)(3) of such Act
(42 U.S.C. 618(a)(3)) is amended by striking ``2012'' and
inserting ``2017''.
(e) Grants to the Territories.--Section 1108(b)(2) of such
Act (42 U.S.C. 1308(b)(2)) is amended by striking ``2012''
and inserting ``2017''.
SEC. 25004. STRENGTHENING WELFARE RESEARCH AND EVALUATION AND
DEVELOPMENT OF A WHAT WORKS CLEARINGHOUSE.
(a) In General.--Section 413 of the Social Security Act (42
U.S.C. 613) is amended to read as follows:
``SEC. 413. EVALUATION OF TEMPORARY ASSISTANCE FOR NEEDY
FAMILIES AND RELATED PROGRAMS.
``(a) Evaluation of the Impacts of TANF.--The Secretary
shall conduct research on the effect of State programs funded
under this part and any other State program funded with
qualified State expenditures (as defined in section
409(a)(7)(B)(i)) on employment, self-sufficiency, child well-
being, unmarried births, marriage, poverty, economic
mobility, and other factors as determined by the Secretary.
``(b) Evaluation of Grants to Improve Child Well-Being by
Promoting Healthy Marriage and Responsible Fatherhood.--The
Secretary shall conduct research to determine the effects of
the grants made under section 403(a)(2) on child well-being,
marriage, family stability, economic mobility, poverty, and
other factors as determined by the Secretary.
``(c) Dissemination of Information.--The Secretary shall,
in consultation with States receiving funds provided under
this part, develop methods of disseminating information on
any research, evaluation, or study conducted under this
section, including facilitating the sharing of information
and best practices among States and localities.
[[Page H6992]]
``(d) State-Initiated Evaluations.--A State shall be
eligible to receive funding to evaluate the State program
funded under this part or any other State program funded with
qualified State expenditures (as defined in section
409(a)(7)(B)(i)) if--
``(1) the State submits to the Secretary a description of
the proposed evaluation;
``(2) the Secretary determines that the design and approach
of the proposed evaluation is rigorous and is likely to yield
information that is credible and will be useful to other
States; and
``(3) unless waived by the Secretary, the State contributes
to the cost of the evaluation, from non-Federal sources, an
amount equal to at least 25 percent of the cost of the
proposed evaluation.
``(e) Census Bureau Research.--
``(1) The Bureau of the Census shall implement or enhance
household surveys of program participation, in consultation
with the Secretary and the Bureau of Labor Statistics and
made available to interested parties, to allow for the
assessment of the outcomes of continued welfare reform on the
economic and child well-being of low-income families with
children, including those who received assistance or services
from a State program funded under this part or any other
State program funded with qualified State expenditures (as
defined in section 409(a)(7)(B)(i)). The content of the
surveys should include such information as may be necessary
to examine the issues of unmarried childbearing, marriage,
welfare dependency and compliance with work requirements, the
beginning and ending of spells of assistance, work, earnings
and employment stability, and the well-being of children.
``(2) To carry out the activities specified in paragraph
(1), the Bureau of the Census, the Secretary, and the Bureau
of Labor Statistics shall consider ways to improve the
surveys and data derived from the surveys to--
``(A) address under reporting of the receipt of means-
tested benefits and tax benefits for low-income individuals
and families;
``(B) increase understanding of poverty spells and long-
term poverty, including by facilitating the matching of
information to better understand intergenerational poverty;
``(C) generate a better geographical understanding of
poverty such as through State-based estimates and measures of
neighborhood poverty;
``(D) increase understanding of the effects of means-tested
benefits and tax benefits on the earnings and incomes of low-
income families; and
``(E) improve how poverty and economic well-being are
measured, including through the use of consumption measures,
material deprivation measures, social exclusion measures, and
economic and social mobility measures.
``(f) Research and Evaluation Conducted Under This
Section.--Research and evaluation conducted under this
section designed to determine the effects of a program or
policy (other than research conducted under subsection (e))
shall use experimental designs using random assignment or
other reliable, evidence-based research methodologies that
allow for the strongest possible causal inferences when
random assignment is not feasible.
``(g) Development of What Works Clearinghouse of Proven and
Promising Approaches To Move Welfare Recipients Into Work.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor, shall develop a database (which shall be
referred to as the `What Works Clearinghouse of Proven and
Promising Projects to Move Welfare Recipients into Work') of
the projects that used a proven approach or a promising
approach in moving welfare recipients into work, based on
independent, rigorous evaluations of the projects. The
database shall include a separate listing of projects that
used a developmental approach in delivering services and a
further separate listing of the projects with no or negative
effects. The Secretary shall add to the What Works
Clearinghouse of Proven and Promising Projects to Move
Welfare Recipients into Work data about the projects that,
based on an independent, well-conducted experimental
evaluation of a program or project, using random assignment
or other research methodologies that allow for the strongest
possible causal inferences, have shown they are proven,
promising, developmental, or ineffective approaches.
``(2) Criteria for evidence of effectiveness of approach.--
The Secretary, in consultation with the Secretary of Labor
and organizations with experience in evaluating research on
the effectiveness of various approaches in delivering
services to move welfare recipients into work, shall--
``(A) establish criteria for evidence of effectiveness; and
``(B) ensure that the process for establishing the
criteria--
``(i) is transparent;
``(ii) is consistent across agencies;
``(iii) provides opportunity for public comment; and
``(iv) takes into account efforts of Federal agencies to
identify and publicize effective interventions, including
efforts at the Department of Health and Human Services, the
Department of Education, and the Department of Justice.
``(3) Definitions.--In this subsection:
``(A) Approach.--The term `approach' means a process,
product, strategy, or practice that is--
``(i) research-based, based on the results of one or more
empirical studies, and linked to program-determined outcomes;
and
``(ii) evaluated using rigorous research designs.
``(B) Proven approach.--The term `proven approach' means an
approach that--
``(i) meets the requirements of a promising approach; and
``(ii) has demonstrated significant and substantively
important positive outcomes at more than one site in terms of
increasing work and earnings of participants, reducing
poverty and dependence, improving child well-being, or
strengthening families.
``(C) Promising approach.--The term `promising approach'
means an approach--
``(i) that meets the requirements of subparagraph (D)(i);
``(ii) that has been evaluated using well-designed and
rigorous randomized controlled trials (or, if not available,
rigorous quasi-experimental research designs);
``(iii) that has demonstrated significant and substantively
important positive outcomes at one site in terms of
increasing work and earnings of participants, reducing
poverty and dependence, improving child well-being, or
strengthening families; and
``(iv) under which the benefits of the positive outcomes
have exceeded the costs of achieving the outcomes.
``(D) Developmental approach.--The term `developmental
approach' means an approach that--
``(i) is research-based, grounded in relevant empirically-
based knowledge, and linked to program-determined outcomes;
``(ii) is evaluated using rigorous research designs; and
``(iii) has yet to demonstrate a significant positive
outcome in terms of increasing work and earnings of
participants in a cost-effective way.
``(h) Appropriation.--
``(1) In general.--Of the amount appropriated by section
403(a)(1) for each fiscal year, 0.33 percent shall be
available for research, technical assistance, and evaluation
under this section.
``(2) Allocation.--Of the amount made available under
paragraph (1) for each fiscal year, the Secretary shall make
available $10,000,000 plus such additional amount as the
Secretary deems necessary and appropriate, to carry out
subsection (e).''.
(b) Conforming Amendment.--Section 403(a)(1)(B) of such Act
(42 U.S.C. 603(a)(1)(B)) is amended by inserting ``, reduced
by the percentage specified in section 413(h) with respect to
the fiscal year,'' before ``as the amount''.
SEC. 25005. TECHNICAL CORRECTIONS TO DATA EXCHANGE STANDARDS
TO IMPROVE PROGRAM COORDINATION.
(a) In General.--Section 411(d) of the Social Security Act
(42 U.S.C. 611(d)) is amended to read as follows:
``(d) Data Exchange Standards for Improved
Interoperability.--
``(1) Designation.--The Secretary shall, in consultation
with an interagency work group established by the Office of
Management and Budget and considering State government
perspectives, by rule, designate data exchange standards to
govern, under this part--
``(A) necessary categories of information that State
agencies operating programs under State plans approved under
this part are required under applicable Federal law to
electronically exchange with another State agency; and
``(B) Federal reporting and data exchange required under
applicable Federal law.
``(2) Requirements.--The data exchange standards required
by paragraph (1) shall, to the extent practicable--
``(A) incorporate a widely accepted, non-proprietary,
searchable, computer-readable format, such as the eXtensible
Markup Language;
``(B) contain interoperable standards developed and
maintained by intergovernmental partnerships, such as the
National Information Exchange Model;
``(C) incorporate interoperable standards developed and
maintained by Federal entities with authority over
contracting and financial assistance;
``(D) be consistent with and implement applicable
accounting principles;
``(E) be implemented in a manner that is cost-effective and
improves program efficiency and effectiveness; and
``(F) be capable of being continually upgraded as
necessary.
``(3) Rule of construction.--Nothing in this subsection
shall be construed to require a change to existing data
exchange standards found to be effective and efficient.''.
(b) Effective Date.--Not later than the date that is 24
months after the date of the enactment of this section, the
Secretary of Health and Human Services shall issue a proposed
rule that--
(1) identifies federally required data exchanges, include
specification and timing of exchanges to be standardized, and
address the factors used in determining whether and when to
standardize data exchanges; and
(2) specifies State implementation options and describes
future milestones.
The SPEAKER pro tempore. Pursuant to House Resolution 934, the motion
shall be debatable for 80 minutes, with 60 minutes equally divided and
controlled by the chair and ranking minority member of the Committee on
Energy and Commerce and 20 minutes equally divided and controlled by
the chair and ranking minority member of the Committee on Ways and
Means.
The gentleman from Michigan (Mr. Upton) and the gentleman from New
Jersey (Mr. Pallone) each will control 30 minutes. The gentleman from
Texas (Mr. Brady) and the gentleman from Michigan (Mr. Levin) each will
control 10 minutes.
The Chair recognizes the gentleman from Michigan (Mr. Upton).
[[Page H6993]]
{time} 1345
General Leave
Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous material on H.R. 34.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. UPTON. Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, there is not a single person in this Chamber or watching
at home today who has not been touched by disease in some way. We have
all said too many early good-byes to folks that we hold dear--families
robbed of a parent who will never get to see their child's milestones,
a child born without the gift of a future.
Every day, countless folks living vibrant lives are delivered
unexpected diagnoses. It is a cycle that repeats itself over and over
in every community. Life changes in an instant, and hope seems out of
reach, whether it be Alzheimer's, lupus, MS, cancer, you name it.
No matter where you are from, one thing that binds us all together is
that we all want more time with our loved ones. That is why we are here
today, because the clock is ticking for patients and their families.
So, Mr. Speaker, this brings us to the 21st Century Cures Act. This
bipartisan bill will ensure that our health system can keep pace with
the incredible advances in science and technology. In Cures, we have
got a medical innovation game-changer that will deliver hope to
patients across the country.
We have been here before. In July of 2015, after a series of
roundtables, hearings, white papers, and public feedback, the House
overwhelmingly voted in support of 21st Century Cures.
Sure, we have encountered a number of detours and obstacles along the
path to Cures, but we have taken great inspiration in those patients
who have partnered in this effort to persevere, stay positive, and
continue forward to get the job done, just like my two little Michigan
girls, Brooke and Brielle, who are battling SMA, do every day. Each
day, they muster incredible strength and courage, conquering challenges
that most folks will never encounter in a lifetime.
So 3 years ago, we had an idea that, yes, we could do better. We
needed to do something to transform our health research system to
effectively fight disease in this century. Finding cures and boosting
research and innovation was absent from any policy to-do list. People
didn't seem to care that the gap between biomedical innovation and our
regulatory process was widening, or that of the 10,000 known diseases--
7,000 of which are rare--there are treatments for only about 500. We
needed to change the conversation and restore urgency. And working
together, we have.
First, we listened to more than just Brooke and Brielle, but to Barb,
Becky, Lisa, Geno, the Dons, the Betsys, little Max, and our own little
Steve LaTourette who always sat in the corner. Virtually everyone here
had a story to tell and for folks here to listen to.
Science and biomedical innovation have made incredible strides over
the last two decades: mapping the human genome, new biomarkers, and
personal healthcare apps. Each have offered new opportunities to find
new treatment and cures. But the way the FDA and the NIH apply these
new innovations to our regulatory process, in fact, has lagged behind.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. UPTON. Mr. Speaker, I yield myself an additional 2 minutes.
These agencies and the rules and regs they produce, affecting the
discovery, development, and delivery of lifesaving drugs and devices,
also need modernization and innovation. They need a game-changer, and
now we have it. This legislation breaks down regulatory barriers and
expedites the approvals for drugs and devices, coupled with billions
more for research.
The former head of the NCI and the FDA, Andy von Eschenbach, has
called this the most transformational biomedical legislation in the
past 3 years. He is right.
But this package is not just about Cures. No. It also achieves
several additional top-line priorities for our Energy and Commerce
Committee, including valuable resources to fight the opioid epidemic
and delivering landmark mental health reforms spearheaded by Dr. Tim
Murphy to help families in crisis and treat mental illnesses rather
than incarceration. This is, without a doubt, the most important and
impactful bill that we will enact in this Congress.
Patients aren't interested in debating the timelines. The failure
rates, the size and cost of conducting clinical trials, are at an all-
time high. They just know that despite the promise of scientific
breakthroughs, they can't get the therapy that might save their life.
That is why we need this bill.
I want to give a special thanks to my many partners, including
especially Diana DeGette, not to mention Joe Pitts, Frank Pallone, Tim
Murphy, and Lamar Alexander, the leadership on both sides of the aisle
in both Chambers. I thank my truly brilliant committee and personal
staff led by Gary Andres and Joan Hillebrands, Health Counsel Paul
Edattel, and, of course, my wife, Amey.
We are on the cusp of something special, a once-in-a-generation
opportunity to transform how we treat disease. With this vote, we are
taking a giant leap on the path to Cures. Working together, we will
deliver Cures now.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. DeGette), who is the Democratic sponsor of the bill and
who has worked so hard to make this day a reality.
Ms. DeGETTE. Mr. Speaker, I rise today in strong support of the 21st
Century Cures Act, knowing that I am far from alone in supporting this
bill. More than 700 groups representing patients, healthcare providers,
researchers, and others have voiced support for the bill, as has the
White House, which provided its enthusiastic endorsement last night.
This is a watershed moment in this country for biomedical research.
With this bill, we bring hope to millions of patients who suffer from
cancer, Alzheimer's, diabetes, and a host of other ailments.
As my cosponsor and partner in crime, Fred Upton, just said, we
started working on this measure 3 years ago. We traveled the country
together to gather information about much-needed reforms, and we had
tremendous participation in the process from patient groups, medical
professionals, academia, and Federal and State healthcare authorities,
not to mention the entire Democratic and Republican membership of the
Energy and Commerce Committee who worked so closely together to make
this happen.
All of this led to a bill that was passed in July, 2015, by 344-77.
We can barely pass the Journal every day by that amount, Mr. Speaker.
Now, this was in the summer of 2015, and we have worked tirelessly in
a bipartisan way since then to improve and expand the bill and to make
sure it can pass through the Senate and be signed by the White House.
The result will help to overcome obstacles to medical progress from
discovery to development to delivery through investing in innovation,
incorporating the patient perspective, and modernizing clinical trials.
Among the key provisions, this consensus version of the bill will
provide $4.8 billion to the National Institutes of Health, including
money for Vice President Biden's Cancer Moonshot initiative, including
money for Precision Medicine and the BRAIN Initiative. It will provide
almost $1 billion in grants to the States to address the urgent opioid
crisis in this country.
It removes the silos at the Food and Drug Administration by
transitioning it to a disease-centric approach, and it gives $500
million so the FDA can implement these reforms. It includes all-
important mental health legislation that we have also worked on so hard
for so long, and it will catalyze cutting-edge research by supporting
potentially transformative efforts.
Mr. Speaker, at a time of heightened acrimony in Washington and in
the wake of one of the most rancorous elections we have ever had, isn't
it wonderful that we can come together to find cures that affect
millions of Americans?
Disease doesn't discriminate according to political party. It knows
nothing of claims and counterclaims. It responds only to carefully
developed
[[Page H6994]]
treatments and cures. What we are doing today is we are voting to put
vital innovations in biomedical research within reach, potentially
saving countless lives. I urge all of our colleagues to think about the
millions of Americans who will be heartened by this bill's progress,
and I urge you to vote ``yes'' on the 21st Century Cures Act.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from Texas
(Mr. Barton), who is the former chairman and now chairman emeritus of
the Energy and Commerce Committee. My friend, the Honorable Joe Barton,
really helped us push this bill every step of the way.
(Mr. BARTON asked and was given permission to revise and extend his
remarks.)
Mr. BARTON. Mr. Speaker, the Affordable Care Act failed because it
was a one-sided, partisan, and close-looped system. This bill, the 21st
Century Cures Act, will succeed because it has been done just the
opposite.
Chairman Upton, Diana DeGette, Frank Pallone, and many other people
have worked together, as they said, for the last 3 years to find the
best pathway forward to get new drugs and new therapies to our
citizenship more quickly and efficiently. I want to congratulate both
of them plus Chairman Brady, Dr. Murphy, and the others that have
worked on this.
This bill makes it possible for cures to actually be put into
practice without all the red tape and regulatory overkill. Let me give
you an example. This bill makes possible the use of what is called
regenerative medicine which we call stem cell therapy.
My 11-year-old son, Jack, last week played football with Coach Sam
Harrell of Ennis, Texas, who 3 years ago could not get out of bed
because of his disease. He had to go out of the country twice to get
stem cell therapy. He can now act normally.
This bill makes possible those kinds of cures. I rise in strong
support and thank Chairman Upton for his strong work on this.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, over the past 2 years, my colleagues and I on the Energy
and Commerce Committee have worked to craft the 21st Century Cures Act
with the goal of getting new treatments and cures to the people who
need them the most. It has been a long journey, and I want to thank my
colleagues, Chairman Upton, Representatives DeGette and Gene Green of
Texas for their commitment to this important legislation.
This is not a perfect bill, but, after much consideration, I believe
the benefits outweigh my concerns, and I fully support its passage.
This final bill includes many provisions that my Democratic colleagues
and I, as well as the administration, fought hard to have included.
The bill provides new funding for the National Institutes of Health,
the President's Precision Medicine Initiative, and the Vice President's
Cancer Moonshot initiative. It also provides new resources for the Food
and Drug Administration and grants for States currently battling the
opioid abuse crisis.
This final legislation also includes important policy changes that
break down the research silos that have existed for years. The bill
includes data sharing among NIH-supported scientists and increases the
number of racial and ethnic minorities and women that are included in
NIH-funded clinical trials.
These important changes will allow the entire scientific community to
learn lessons from this critical NIH-funded research and will
strengthen research for diverse populations.
I am also pleased, Mr. Speaker, that the bill includes a new FDA
grant program to study the process of continuous drug manufacturing.
This innovative process will allow for more effective drug production
without sacrificing quality. The bill also includes important hiring
provisions to help the FDA recruit and retain the best and the
brightest and policies to move us closer to ensuring we have
interoperable electronic health records, which are critical to reducing
costs and improving care.
As I said, this is not a perfect bill, and I have some concerns with
the final product. I am disappointed that the bill does not contain
guaranteed funding. Instead, we must ensure each year that the
Appropriations Committee and the Republican majority lives up to the
promises they make today, and we will hold them to these promises. The
lack of immediate funding for the FDA is a particular concern given the
fact that this bill asks the FDA to take on significantly more
responsibilities that we know are extremely resource intensive.
I am also concerned that the bill removes certain categories of
medical software from FDA oversight. This makes it difficult for FDA,
in the future, to bring software that is used to support or sustain
human life back under FDA's jurisdiction.
I am also troubled by the new priority review voucher program which
will likely require the FDA to issue significantly more PRVs. This
could pose a burden on FDA drug reviewers when redeemed and could
prevent the FDA from being able to prioritize its review of drugs based
on public health priorities.
The bill includes new language added without full consideration by
the House or Senate regarding FDA oversight of regenerative medicine
products.
{time} 1400
While most of the harmful language was taken out, I do remain
troubled that the bill creates a new designation process under FDA's
accelerated approval pathway.
I am pleased, Mr. Speaker, that this package includes the Helping
Families in Mental Health Crisis Act. This is a helpful step towards
the more substantial reforms our broken mental health system needs.
I am specifically proud that the bill expands an important set of
Medicaid benefits to kids receiving inpatient psychiatric treatment.
However, let's be clear, the benefits of the mental health bill will be
far outweighed by the catastrophic harm caused by individuals with
mental illness if the Republicans move forward with their radical plans
to repeal the Affordable Care Act or block grants for Medicaid or cut
benefits for low-income individuals.
Again, on balance, this is a good bill. I fully support it. I want to
thank all of my committee colleagues and their staff for their hard
work on this legislation.
I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 30 seconds to the gentleman from
Illinois (Mr. Shimkus), one of the senior subcommittee chairmen on the
Energy and Commerce Committee, one that helped lead the fight all
across the Nation in support of this bill.
(Mr. SHIMKUS asked and was given permission to revise and extend his
remarks.)
Mr. SHIMKUS. Mr. Speaker, I thank Chairman Upton, and I congratulate
my friend Diana DeGette. Also, I thank Frank Pallone for a good job. I
thank him for being supportive, especially today, as we move this
forward.
Thank you for including six of my bills that I had involved, one that
deals with the lack of antibiotics in the market in the pipeline. So
that is helpful. Four other bills help innovation to get lifesaving
devices to the market.
I encourage all of my colleagues on both sides of the aisle to
support this bill.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
Texas (Mr. Gene Green), the ranking member of the Health Subcommittee,
who, again, has been critical, particularly in the last 3 months, in
putting this bill together.
Mr. GENE GREEN of Texas. Mr. Speaker, I thank my colleague for
providing the time.
I rise to express strong support for the 21st Century Cures Act.
Almost 3 years ago, we set out on a mission to do something positive
to boost medical research and innovation and accelerate the discovery,
development, and delivery of new cures and treatments.
After countless hours devoted to roundtables, white papers, hearings,
and drafts, today, Cures has bipartisan support and endorsements from
over 700 organizations representing a full spectrum of stakeholders and
the strong support of the administration. My Houston area neighbors,
Congressmen Pete Olson and Mike Burgess, and I held a roundtable in the
Houston area with the great institutions at our
[[Page H6995]]
Texas Media Center in the Houston area.
It dedicates $6.3 billion in new investments to support priorities
like the Cancer Moonshot and Precision Medicine Initiative within the
National Institutes of Health, and to combat prescription drug abuse.
This also provides money for the Food and Drug Administration to
advance the agency's mission and implement the policies in the
underlying bill. This influx of investment will be put towards solving
today's complex scientific problems, getting new treatments from the
lab table to the bedside, and improving public health.
In addition to this much-needed funding, there are so many provisions
in this package worthy of support. From facilitating the development of
new antibiotics to fight against superbugs, to advancing the use of
modern clinical trial designs, to fostering the next generation of
medical researchers, the 21st Century Cures Act will develop hope and
new treatments for Americans in need. While some of these provisions
are technical in nature, the real-world impact they will have is not
abstract. Patients and families deserve to have their elected officials
respond to their needs, and this bill does that.
Eighteen months ago, 344 Members supported Cures when it passed the
House of Representatives. Since then, we have responded to feedback and
tailored the bill, and it now includes additional priorities like
improvements to our mental health system and nonpartisan provisions to
strengthen Medicare on behalf of beneficiaries.
I want to thank Chairman Upton, Ranking Member Pallone, Congresswoman
DeGette, and Chairman Pitts for their leadership, vision, and
determination. I also want to thank our staff, the House Legislative
Counsel, and the countless stakeholders without whom we would not be
here today.
It was a privilege to be part of this landmark effort. As an original
sponsor and coauthor of the 21st Century Cures Act, I urge my
colleagues to vote ``yes.''
Mr. Speaker, the following is my complete statement: I rise to
express my strong support for the 21st Century Cures Act.
Almost three years ago, we set out on a mission: do something
positive to boost medical research and innovation, and accelerate the
discovery, development, and delivery of new cures and treatments.
After countless hours devoted to roundtables, whitepapers, hearings
and drafts, today Cures has bipartisan support and endorsements from
over 700 organizations representing the full spectrum of stakeholders,
and the strong support of the Administration. My Houston area neighbors
Congressmen Pete Olson and Mike Burgess held a roundtable with the many
great institutions at our Texas Media Center.
It dedicates $6.3 billion in new investments to support priorities
like the Cancer Moonshot and Precision Medicine Initiative within the
National Institutes of Health (NIH), and to combat prescription drug
abuse.
It also provides money to the Food and Drug Administration (FDA) to
advance the agency's mission and implement the policies in the
underlying bill.
This influx of investment will be put towards solving today's complex
scientific problems, getting new treatments from the lab table to the
bedside, and improving public health.
In addition to this much needed funding, there are so many provisions
in this package worthy of support.
From facilitating the development of new antibiotics to fight against
superbugs to advancing the use of modern clinical trial designs to the
fostering of the next generation of medical researchers, the 21st
Century Cures Act will deliver hope and new treatments to Americans in
need.
While some of the provisions are technical in nature, the real-world
impact they will have is not abstract.
Patients and families deserve to have their elected officials respond
to their needs.
This bill does that.
Eighteen months ago, 344 members supported Cures (H.R. 6) when it
passed the House of Representatives.
Since then, we have responded to feedback and tailored the bill, and
it now includes additional priorities like improvements to our mental
health care system and non-partisan provisions to strengthen Medicare
on behalf of beneficiaries.
I want to thank Chairman Upton, Ranking Member Pallone, Congresswoman
DeGette, and Chairman Pitts for their leadership, vision, and
determination.
I also want to thank our staff, House Legislative Council, and the
countless stakeholders without whom we would not be here today.
I want to particularly thank Tiffany Guarascio, Arielle Woronoff,
Rachel Pryor, Kimberlee Trzeciak, Megan Velez, Waverly Gordon, Polly
Webster, Kristen O'Neill, Paul Edattel, John Stone, Carly McWilliams,
Adriana Simonelli, JP Paluskiewicz, Tim Pataki, Josh Trent and others
on the Energy and Commerce Committee staff for all their work.
It was a privilege to be a part of this landmark effort.
As an original sponsor and co-author of the 21st Century Cures Act, I
urge my colleagues to vote yes.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from
Pennsylvania (Mr. Murphy), one of the subcommittee chairmen who helped
craft the bipartisan Murphy mental health bill, which passed the House
422-2 earlier this year, and is a very valuable member of the
committee.
Mr. MURPHY of Pennsylvania. Mr. Speaker, this is a moment of great
joy out of a situation of tremendous tragedy.
After the last 4 years, since the time of the terrible tragedy at
Sandy Hook Elementary School followed by repeated other ones, our
Nation has awoken from a slumber of ignoring the problems of mental
illness in America, one that when we closed down our institutions
decades ago, we turned our eye to those who lay homeless on the street,
who filled our prisons, who filled our cemeteries or lay on a gurney in
an emergency room or were sent back home to a family who felt helpless
and hopeless.
We have changed now to a situation where we are coming together on a
bill that will save lives. This is a new era of health care and the
next generation of hope for Americans that really transcends
boundaries.
To all of the families who brought their stories out of the shadows,
that dared to share their sorrows, their hopes, their shattered dreams,
today is a day of joy. And today is only possible, I say to all of
those families, because they dared to step forward. There is not time
enough to thank all of those involved, but to those families who have
helped, I say thank you.
I also want to make sure I thank Chairman Upton, Speaker Ryan, Eddie
Bernice Johnson, Diana DeGette, Frank Pallone, Senators Bill Cassidy
and Chris Murphy, Leader Kevin McCarthy, Whip Steve Scalise, and so
many others from our committee who have worked so hard to make this
happen. And a special shout-out to some of the staff: Scott
Dziengelski, Gary Andres, Karen Christian, Paul Edattel, Susan
Mosychuk, and so many other staff who worked so hard on this.
We can look back on this moment in history and say today that,
although we have much to do and although we didn't get everything we
needed, we needed everything that we did get. But this is the moment
from this day forward we can say today that we took action to save
lives.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Florida (Ms. Castor).
Ms. CASTOR of Florida. Mr. Speaker, I rise today in support of the
21st Century Cures Act legislation and the important investment that it
will make in medical research across America.
This legislation supports an additional $4.8 billion for the National
Institutes of Health, specifically for President Obama's Precision
Medicine Initiative and the BRAIN Initiative so we can tackle the
challenge of Alzheimer's. It supports Vice President Biden's Cancer
Moonshot initiative. Hopefully, it will keep the young scientists on
the job at institutions like the Moffitt Cancer Center and the
University of South Florida's Alzheimer's Research Institute back home
in Tampa.
While additional support for NIH is vital and this is a move in the
right direction, I would have much preferred that we put this in the
mandatory category as we voted on in H.R. 6 earlier in the year. I know
many of you agree with that, that medical research in America today
shouldn't be subject to the whims of congressional budget battles or
political fights. I will continue to advocate for mandatory funding for
NIH so that we can remain on the cutting edge of medical innovation and
boost higher wage jobs back home. These initiatives save lives and
provide investments that we need to make sure that we are developing
the cures of tomorrow.
[[Page H6996]]
I am very pleased that legislation I introduced with my colleague
Representative Herrera Beutler was included in this package. The Safe
Medications for Moms and Babies Act ensures that expectant mothers and
doctors have accurate information about medications used during
pregnancy and when nursing to facilitate the best health outcomes.
Representative Herrera Beutler has been a champion for families, and I
am grateful to her for leading this effort to improve the quality of
data and information on medication used during pregnancy and
breastfeeding.
I also applaud the inclusion of language to improve our mental health
system, the $1 billion to address the opioid epidemic. This is very
positive. I would like to thank Chairman Fred Upton for his devotion to
the issue, to Congresswoman DeGette, and to all of my colleagues on the
Energy and Commerce Committee.
The SPEAKER pro tempore. The time of the gentlewoman has expired.
Mr. PALLONE. I yield the gentlewoman an additional 30 seconds.
Ms. CASTOR of Florida. This is the way legislation is supposed to be
developed: in a bipartisan way, through studies, through asking,
reaching out, and working with experts all across the country, because
all of the answers do not emanate from a congressional committee in
Washington. It is very important that we tap the expertise all across
the country to get something done.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentlewoman from
Tennessee (Mrs. Blackburn), the vice chairman of the Energy and
Commerce Committee, who, again, helped so much with the medical
community to rally around and provide us the input necessary to move
this bill to where it is today.
Mrs. BLACKBURN. Mr. Speaker, I congratulate Chairman Upton and all of
our colleagues on the Energy and Commerce Committee for a job well
done, and done in the appropriate manner. It really has, as Ms. DeGette
said, been so interesting to work across the country and work with
patients, with physicians, with researchers, with those who are
innovating new concepts, who are delving into delivery systems that are
necessary for precision medicine which underpins 21st century health
care.
There are three components that I want to bring attention to. First
of all, section 3060 is there addressing medical technology and
software. This is so important that we get the FDA on the right track
and move components of this away so that it does not face FDA approval
processes that will slow down access to the marketplace for patients.
Also, section 2038, the Children's Count Act--Mrs. Capps and I worked
on this--allowing children access to clinical trials, and section 3076,
the reauthorization of the Reagan-Udall language.
I congratulate my colleagues.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Oregon (Mr. Schrader).
Mr. SCHRADER. Mr. Speaker, I rise today in strong support of the 21st
Century Cures Act and to thank Chairman Upton and my friends, Mr.
Pallone, Ms. DeGette, and Mr. Green, for their leadership and
willingness to work across the aisle to produce this quality piece of
legislation.
For too long, Congress has been shirking its responsibility when it
comes to funding the critical research that will lead to cures and
treatments at the NIH. Our scientists, physicians, and medical
institutions are getting closer every day to medical breakthroughs that
will help families and save lives. In my State alone, the NIH is
funding research into new therapeutic avenues to combat cancer, heart
disease, and illness born by pollution. It is time to streamline the
path for critically needed medical devices and pharmaceuticals for
vulnerable populations that can't afford to wait.
This bill takes a giant step forward to help fix the mental health
infrastructure of our country. Currently, as a result of the mental
health system's inadequacy, our emergency rooms, our prisons, and our
homeless shelters are full of people who are having trouble getting the
care they need. The status quo is not okay.
This bill moves us in the right direction through innovation and
integration of mental health services for the overall healthcare
system. The Cures Act enhances the capabilities of our law enforcement
and first responders, strengthens our crisis intervention programs, and
ensures that our Medicaid program does not deny access to beneficiaries
seeking mental health care. It also includes a number of Medicare
provisions to make sure seniors aren't left behind by bureaucratic red
tape.
Getting to this point wasn't easy. Democrats and Republicans didn't
always agree on every provision of this bill, but we were able to work
together and find common ground and produce a bill that takes great
strides toward producing better healthcare outcomes for Americans.
I hope the President-elect and Members of this body are taking note
of this achievement today as we move forward instead of pushing through
divisive harmful policies that will reduce access to quality health
care. Let's work together and produce better results for all Americans.
{time} 1415
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Kentucky (Mr. Guthrie), a member of the committee and a leader in
pushing this bill forward.
Mr. GUTHRIE. I thank the chairman for yielding.
Mr. Speaker, all of us have families who come to our offices, and
they are advocating for research or for cures for diseases to which
they have lost a parent or a child, or they have their children with
them who have the diseases, and they are just hoping for a move
forward.
In being on the Health Subcommittee, at least weekly and sometimes
daily, innovators and entrepreneurs come to my office, and they talk
about a new procedure or a new product--something that is innovative,
that will change the lives of these families--but they are having
trouble getting them through the system and getting them approved.
It hurts families, though, like a family in Elizabethtown, who has
someone with a degenerative disease. This family is trying to beat the
clock because they think there is some kind of help out there. I have a
friend of mine from Bowling Green whose son went through a diabetes
trial. The first time they said they got any sleep through the night
was when their kid was in this trial. Then they called me, crying,
saying they were out of the trial and that it may be another year
before they get in. So, in taking our entrepreneurs and our innovators
and putting together these cures, it is not just about getting these
products to market--it is about changing the dynamics of these families
who are suffering.
Our chairman and Ms. DeGette from Colorado put together this effort
to move forward, and I urge support for this bill because it will
change families' lives.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Tennessee (Mr. Cohen).
Mr. COHEN. I thank the gentleman.
Mr. Speaker, I think everybody has been thanked who should be
thanked, but I certainly want to thank Mr. Upton for all of his work
and Mr. Pallone for his time and his work and Ms. DeGette. I also want
to thank Senator Roger Wicker, who worked on a bill that is
incorporated into this bill that Congressman Duncan and I sponsored,
called the EUREKA Act, which will incentivize and reward research on
diseases for which there is not great public-private partnerships but
for which there is a great handicap and problem for the American public
because of the particular disease. It will reward successful treatments
through a competition, which I think is a great way to go about
encouraging research and then paying for it. Roger Wicker, I think,
came up with the idea, and I sponsored it with John Duncan, and it is
included in the bill. It was originally aimed at Alzheimer's. It is now
for other diseases, but Alzheimer's is one of them.
Alzheimer's is a disease that is going to have a particularly
crippling effect on our country economically in the future. Beyond
that, it will affect many of us, and it will affect our pocketbooks; so
it is important that this bill goes after Alzheimer's and that it deals
with the opioid crisis, which is great in my State and across the
country. It
[[Page H6997]]
works against all diseases and it encourages moneys in the National
Institutes of Health.
I have long said, while we need to have a strong Defense Department,
that my Secretary of Defense is Francis Collins, the head of the NIH,
because the true enemy of each and every one of us isn't somebody in
South Korea or somebody in Iran or ISIS or one of those folk--it is
cancer; it is Alzheimer's; it is AIDS; it is diabetes; it is heart
disease; it is Parkinson's. It is all of those diseases--the dreadful,
awful, awful diseases for which the NIH is looking for cures. That is
our Secretary of Defense, and that is what we need to invest our moneys
in. I don't think there is enough money that we can put into the NIH,
because it is important and it affects all Americans independent of
political party, race, sexual orientation--you name it.
I thank the Members for their work on this, and I am proud to vote
for it.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from
Florida (Mr. Bilirakis), a valuable member of the Health Subcommittee
and whose father once chaired that subcommittee.
Mr. BILIRAKIS. I thank the chairman for all of his hard work on this
great bill.
Mr. Speaker, I rise to talk about the incredible impact the 21st
Century Cures Act would have on so many Americans.
Deadly diseases like cancer, Alzheimer's, ALS, and more affect each
and every one of us. Within Cures, one will find the voices of
patients, doctors, advocacy groups, and families I have met with from
throughout Florida's 12th Congressional District. I am proud to say
that a lot of their input is reflected in this final bill.
Samantha Lindsay, from Lutz, Florida, has Alpha-1, which is a rare
genetic condition that results in serious lung problems. When we met,
she talked about the need to use biomarkers for the faster approval of
drugs for rare diseases. We did that. We have a framework for biomarker
qualifications in this legislation.
Wayne Taylor, from Hudson, Florida, was a leukemia patient. He talked
about the difficulty of participating in the clinical trials that
eventually saved his life. This bill has reforms to make clinical
trials more patient-focused and input-driven.
Dr. David Morgan, the CEO of the Health Byrd Alzheimer's Institute at
the University of South Florida, talked about the need for stable
funding for Alzheimer's and about reforming institutional review
boards.
This bill invests in the NIH, and it reforms the IRB system. Cures
also includes my provisions to reform the FDA's Office of Combination
Products in order to streamline the approval of these products; to
establish a new Medicare Web site to help seniors price shop; and to
allow physical therapists to enter into locum tenens arrangements so
they can take maternity leave or sick time without having to turn away
patients.
For many families, including my own, the potential impact of 21st
Century Cures could change their lives. Let's get this meaningful bill
across the finish line.
Mr. PALLONE. Mr. Speaker, I have a few additional speakers on their
way; so I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from Ohio
(Mr. Johnson), a valuable member of our committee who has worked so
hard to get this bill to where it is today.
Mr. JOHNSON of Ohio. I thank the chairman.
Mr. Speaker, I rise in support of the 21st Century Cures Act and add
my voice to the steady stream of acclaim this legislation has already
received.
American families and communities are suffering from rare diseases,
and this innovative legislation works to align Federal incentives and
regulations with the science and technology that make treatments and
cures possible and attainable. I am proud to have supported this bill
all along the way.
This package includes mental health reform--work that I am grateful
to have been a part of during my time on the Oversight and
Investigations Subcommittee with Chairman Murphy. His tireless efforts
will benefit many individuals and families who struggle with mental
illness and substance abuse. This bill also includes $1 billion for
grants to States to fight opioid abuse. A recent report shows that my
home State of Ohio leads the Nation in opioid overdose deaths. This
funding is sorely needed to address the issue head on.
I ask my colleagues to support the Cures bill today.
Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentlewoman from
North Carolina (Mrs. Ellmers), a member of the important Health
Subcommittee and a real proponent of this legislation from day one.
Mrs. ELLMERS of North Carolina. I thank Chairman Upton; Ranking
Member Pallone; Ms. DeGette, my good friend; Tim Murphy from
Pennsylvania, who worked so hard on the mental health reforms; and
Chairman Pitts, the Health Subcommittee's chairman.
Mr. Speaker, there has been a great deal of effort put into this
great piece of legislation, which basically has the goal of bringing
our healthcare innovation infrastructure into the 21st Century Cures so
that real hope for patients and loved ones can be achieved.
From removing barriers in the mental health system, to ensuring
collaboration, to modernizing the clinical trial pathways, to boosting
modern medical interventions, 21st Century Cures is a win for everyone.
It will accelerate the discovery, development, and delivery of
lifesaving therapies in a safe and effective way. It will also empower
families to support their loved ones.
In closing, Cures will change lives. I, personally, as a nurse, would
like to say that this is one of the most important pieces of
legislation we will pass here in the House.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Massachusetts (Mr. Kennedy), who has been such a strong advocate on
mental health issues.
Mr. KENNEDY. I thank the ranking member for yielding. I also thank
him, as well as Chairman Upton and Congresswoman DeGette, for being
tireless throughout the entire process in their advocacy of trying to
get this bill as a bipartisan compromise and for creating an
environment that allows for our committee's members to raise their
voices and shape this legislation.
Mr. Speaker, when we first passed the version of this bill last year,
it was as a result of strong, bipartisan compromise and sacrifice. It
certainly was not easy, but the legislative process is not intended to
be.
While I am disappointed that the funding levels for the NIH were cut
even further and that the investment is no longer mandatory, I take my
Republican colleagues at their word that it will be appropriated in the
years ahead. I am also pleased that this legislation includes language
to remove obstacles for children who are covered by Medicaid; but my
real concerns with the legislation lie with the mental health reform
proposals, which don't go nearly far enough. Mental health parity is
already the law, thanks to the Mental Health Parity and Addiction
Equity Act and the Affordable Care Act; but each study we read, Mr.
Speaker, and each story we hear proves that insurance companies are
skirting those rules.
Instead of further guidance or meetings or studies carried out years
down the road, we need enforcement and transparency today. We need
random audits before there have been violations, not after. We need
insurers to publicly disclose the rates and reasons for denials in a
way that patients and their families can understand, not in a way that
mental health advocates can't even obtain. We need to increase Medicaid
reimbursements in order to expand access to care, not to reduce them or
roll back expansion; and we need to appreciate the difference the ACA
has made for mental health patients, especially for the most vulnerable
among us. Until we do, we cannot consider these proposals
comprehensive, and we certainly can't pretend that they are nearly
enough.
This is an important compromise forged from an awful lot of hard
work. I am happy and pleased to support this proposal, and I thank my
colleagues on both sides of the aisle for getting it here today.
Mr. UPTON. Mr. Speaker, I yield myself 15 seconds.
[[Page H6998]]
I appreciate the gentleman from Massachusetts' statement. He is a
very valuable player as we move this legislation on all fronts forward.
I look very forward to working with the gentleman and with every Member
of this body to make sure that the funding is there as we have laid out
in this bill and to work with our colleagues in the Senate to make sure
that it happens.
Mr. Speaker, how much time remains on both sides?
The SPEAKER pro tempore. The gentleman from Michigan has 15\1/4\
minutes remaining, and the gentleman from New Jersey has 12 minutes
remaining.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New
Jersey (Mr. Lance), another valuable member of the Health Subcommittee
and someone who pursued this legislation from the very get-go.
Mr. LANCE. Mr. Speaker, I rise in strong support of the 21st Century
Cures legislation.
This bill provides significant investments to accelerate the
discovery, development, and delivery of new cures and treatments for
millions of Americans. The passage of this legislation will protect and
create American jobs and will ensure that the United States remains the
global leader in biomedical innovation and discovery. The measure
reforms and strengthens the country's mental health system and makes
mental health a strong national priority. The legislation includes
critical funding for States to prevent opioid abuse and provide the
needed treatment for those suffering from this public health crisis.
Reducing bureaucratic redtape, advancing lifesaving research,
reforming our broken mental health system, and tackling opioid abuse in
our communities will reduce healthcare costs and give many Americans
new opportunities to live long, healthy, and productive lives.
I thank Chairman Upton for his unparalleled leadership on this issue.
It is an honor to have worked with him and all of our colleagues on the
Energy and Commerce Committee to have crafted this landmark
legislation.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Ohio (Ms. Kaptur).
Ms. KAPTUR. I thank Ranking Member Pallone for yielding me the time.
Mr. Speaker, I rise in strong support of the bipartisan 21st Century
Cures Act, which dedicates more than $6 billion to implement key health
priorities, such as combating the heroin and prescription opioid
epidemic across this country and the Vice President's Cancer Moonshot.
It also takes steps to improve mental health, including provisions that
build on the work of the President's Mental Health and Substance Use
Disorder Parity Task Force and policies to further modernize the drug
approval process. This will mean so much to the researchers across this
country who are trying to unlock the mysteries of the human brain and
heal.
{time} 1430
The legislation includes $1 billion over 2 years, including $500
million in fiscal year 2017, to combat the prescription opioid and
heroin epidemic as well. The legislation dedicates support for other
key research initiatives with the goal of helping researchers find new
ways to treat, cure, and prevent brain disorders, such as Alzheimer's
disease, epilepsy, and traumatic brain injury.
This legislation includes a much-needed renewed emphasis on evidence-
based strategies for treating serious mental illness, improved
coordination between primary care and behavioral health services,
reauthorization of important programs focused on suicide prevention and
other prevention services, and mental health and substance use disorder
parity provisions.
I would like to thank Dr. Joseph Calabrese at Case Western Reserve
University in Cleveland and my good friend, Representative Tim Murphy,
who came to Ohio and hosted a roundtable on mental health that can be
added to this major bill in order to move America forward.
I thank Chairman Fred Upton, knowing the deep commitment that he has
to so many Americans who desperately need the help that this bill will
provide. Again, to Congressman Frank Pallone of New Jersey, I want to
compliment both men for working together to do something great for this
country for so many Americans who are desperate to find answers for
those who are ill. I want to thank Congresswoman Diana DeGette of
Colorado who has shepherded this to this point.
Although not perfect or complete, this legislation offers advances in
health that greatly outweigh any concerns we might have. I am proud to
add my strong support for 21st Century Cures Act.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Indiana (Mr. Bucshon), who again hosted a number of roundtables and
discussions throughout the country and a very valuable member of the
committee.
Mr. BUCSHON. Mr. Speaker, I urge my colleagues to support the Senate
amendment to H.R. 34, the 21st Century Cures Act.
Over our country's history, American innovators have proven among the
best in the world, especially in the field of drug and device research.
21st Century Cures streamlines the process for American innovators to
see their research and development reach patients faster than ever,
while maintaining a safe and effective review process.
It also invests in the areas we need it the most, to advance research
and testing on the most complex and devastating diseases in our
country. It also gives young scientists the support they need to bring
new ideas to the scientific community.
The mental health and opioid abuse provisions in this legislation are
also critical. As a physician who has relied on medical innovation to
care for patients, working to pass the 21st Century Cures Act and
ensuring America remains on the forefront of cutting edge research has
been one of the highlights of my time in Congress.
I thank Chairman Upton and Representative DeGette for their
leadership and commitment to this legislation.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Connecticut (Ms. DeLauro).
Ms. DeLAURO. Mr. Speaker, I rise in opposition to this bill. The 21st
Century Cures bill aims to promote biomedical innovation and mental
health, noble goals that I share. Unfortunately, this bill sets a
dangerous precedent and has the potential to do more harm than good for
millions of Americans.
In its attempt to speed up the drug and device approval process, this
legislation neglects the very people whom clinical trials are meant to
help, that is, the patients. Rather than protect those who rely on the
healthcare system, it reduces the already weak regulation on medical
devices, allows drugs to be approved with only limited evidence of the
drug's safety and efficacy, and rushes the use of new and unproven
antibiotics.
An example, 13 models of the St. Jude's defibrillators are currently
being recalled for sudden battery failure that has been linked to at
least two deaths, 10 people fainting, and 37 people feeling dizzy.
When the cost of our prescription drugs is skyrocketing, this bill
does nothing to combat excessive prices.
Finally, this bill strips away funding from the public health and
prevention fund. While the bill authorizes $4.8 billion to the NIH over
the next 10 years--on average, a mere $480 million a year--this is
barely a quarter per year of what the House passed last year. Let us
not forget that we would need to provide $7 billion a year to keep up
where we were in 2003.
There is also no guarantee that the appropriators will follow through
and provide funding each year, as we have seen with the public health
prevention fund, which has been used to fill appropriations shortfalls.
Illness touches us all. We owe it to the patients who depend on the
standards that we set. Unfortunately, I believe the standards in this
bill are both weak and dangerous. This legislation is the wrong path
forward, and I strongly oppose it.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from New
York (Mr. Collins), whose personal knowledge of the maze of the
regulatory approval process made him a very valuable member of the
Health Subcommittee in pushing this legislation forward.
Mr. COLLINS of New York. Mr. Speaker, I thank all the people who
worked tirelessly to make this legislation a reality.
[[Page H6999]]
Simply stated, the goal of this legislation is to incentivize
innovation to defeat disease. Today, the 21st Century Cures Act will do
that and much more for patients suffering from currently incurable
diseases.
This legislation provides substantial funding to the National
Institutes of Health, including $1.8 billion to speed up cancer
research, $1.5 billion to improve our understanding of debilitating
diseases such as Alzheimer's, and another $1.5 billion to assist in
genetic and other individual specific research efforts.
This bill provides funding to fight the opioid addiction crisis,
which has been particularly devastating to western New York, and it
includes mental health legislation to improve those services
nationwide.
I am excited that this final bill contains a few provisions I
authored and worked on over the past 2 years. Section 3021 encourages
the broader application of innovative clinical trial designs to enhance
and accelerate effective clinical trials.
Section 3071 will expedite and improve drug approval processes by
increasing the allowable number of senior biomedical researchers the
FDA is allowed to hire and making their salary more competitive with
the private industry.
Section 9023, which I worked on with Representative Joe Courtney,
incentivizes child and adolescent psychiatrists to begin their
practices in underserved areas like those in rural western New York.
Lastly, Section 5006, which I worked on with Congressman Paul Tonko,
includes the House-passed Medicaid DOC Act, which requires States to
publish an online directory of physicians who have billed Medicaid in
the past year and indicate whether those physicians are accepting new
patients.
None of this would have been possible without the tireless work of
Chairman Fred Upton and the entire staff on Energy and Commerce. I
thank them for their tremendous effort and look forward to seeing
innovation defeat disease because of this game-changing legislation.
Mr. PALLONE. Mr. Speaker, how much time remains on both sides?
The SPEAKER pro tempore. The gentleman from New Jersey has 8 minutes
remaining, and the gentleman from Michigan has 11\1/4\ minutes
remaining.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from New
Mexico (Mr. Ben Ray Lujan).
Mr. BEN RAY LUJAN of New Mexico. Mr. Speaker, I begin by thanking
Chairman Upton and Ranking Member Pallone of the Energy and Commerce
Committee, as well as Congresswoman DeGette, for their bipartisan
cooperation during this long legislative process.
This is a good, if imperfect, bill that will provide vital funding to
the National Institutes of Health and the Vice President's Cancer
Moonshot while taking steps to strengthen our mental health system. I
want to focus my remarks on the critical investments this bill promises
to combat the opioid epidemic.
In communities across our country, families are struggling with the
pain of addiction to opioids. Earlier this year, Congress took an
important step against substance abuse by passing the Comprehensive
Addiction and Recovery Act, or CARA.
Unfortunately, congressional Republicans did not support including
the necessary funding to CARA's success. This was a missed opportunity.
In the months since Congress passed CARA, we have lost parents,
siblings, children, and friends--129 people every day.
When I talk to New Mexicans on the front lines of this crisis, the
most urgent need is for more resources. That is why I introduced the
Opioid and Heroin Abuse Crisis Investment Act. This bill, cosponsored
by nearly 100 of my colleagues, sought to advance the President's
proposal to combat this epidemic.
This legislation we are considering today--like my bill--promises $1
billion for the opioid crisis. Though we cannot bring back those that
we have lost, we owe it to them and their families to pass this bill.
This funding will make a real difference in people's lives.
While I am relieved that we will soon be able to get the resources to
our communities, I am fearful that some of my colleagues will see this
as a mission accomplished instead of what it must be, which is only a
first step toward healing our communities.
I can't help but ask my Republican colleagues, who support the
advances we are making today for mental health: Why are they preparing
to roll back the most important advances we made for mental health in
the past 8 years by promising to repeal the Affordable Care Act?
The 21st Century Cures Act shows what we can do and what can happen
when we work across the aisle, and I hope we will truly continue to
work together to strengthen our Nation's health system.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentlewoman from
California (Mrs. Mimi Walters), an original cosponsor of our bill and
great proponent from day one.
Mrs. MIMI WALTERS of California. Mr. Speaker, over the last 2 years,
I have worked with organizations in my district, including the
Children's Hospital of Orange County, the Juvenile Diabetes Research
Foundation, and Alzheimer's Orange County.
During my visits with these groups, I have met with constituents who
are suffering from incurable diseases. I have met with parents of
children suffering from prescription drug addiction and families
struggling to find adequate mental health care for their loved ones.
All of these people have one thing in common. The 21st Century Cures
Act would directly improve the care they receive. This innovative
legislation will provide them with faster and better cures and
treatment.
In passing this legislation, we have the opportunity to accelerate
the discovery, development, and delivery of lifesaving and life-
improving therapies.
I urge my colleagues to join me in supporting the 21st Century Cures
Act. It is time for cures now.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. DeGette).
Ms. DeGETTE. Mr. Speaker, I thank Mr. Pallone for yielding me the
time and for being an unerring partner on this quest that we have had.
I just want to take a few minutes to talk about the extraordinary
journey that we have had here. When Representative Fred Upton came up
to me on the floor about 3 years ago and asked if I would help him work
on a bill to help modernize and update the way we do biomedical
research in this country, little did I realize the road that lay ahead.
There have been a lot of twists and turns in that road. There have been
some very interesting sightings along that road, and it has been an
extraordinary effort for all of us. It has really brought the Energy
and Commerce Committee together in a bipartisan way, and I am hoping
that we can continue those efforts in the next Congress.
So many of my colleagues are right. We still have a lot that we have
to do in the area of mental health, in the area of biomedical research,
and so much more.
I want to thank a number of people because they really all deserve to
be thanked: Of course, Energy and Commerce Committee Chairman Upton and
Ranking Member Pallone, and Subcommittee on Health Ranking Member Gene
Green and Chairman Joe Pitts. I want to thank the entire committee, as
I said.
I want to thank the patient advocacy community who have been with us
unerringly throughout this process. I want to thank the researchers. I
want to thank the entrepreneurs who came and talked to us about what
they needed. I want to thank the agencies themselves, specifically the
FDA and the NIH, for technical assistance, and the entire executive
branch.
I want to thank a number of people. First of all, I want to thank
Lisa Cohen, my chief of staff, who has been with me for 20 years
through thick and thin. I want to thank Polly Webster, my health policy
director, who took the bar exam, got married, and actually helped pass
this bill all during this process. I want to thank Lynne Weil, my
communications director, and Eleanor Bastian, my legislative director.
I want to thank Rachel Stauffer, my former health policy director who
started this, and Matt Inzeo, who is Lynne's predecessor.
From the Upton staff, I want to thank Gary Andres, Joan Hillebrand,
[[Page H7000]]
Paul Edattel, John Stone, Carly McWilliams, Adrianna Simonelli, and
J.P. Paluskiewicz. All of you guys have worked together as a team with
my team.
{time} 1445
I want to thank Kristen O'Neill from Mr. Green's staff. I don't think
I thanked Mr. Green. I want to thank Mr. Green, who has done such an
extraordinary job and who has really been my wingman. I want to thank
Wendell Primus, who is Leader Pelosi's senior adviser; and Charlene
MacDonald, who is Mr. Hoyer's adviser. Finally, I want to thank the
entire Pallone team, who has worked as our committee staff tirelessly:
Jeff Carroll, Tiffany, Kim, Arielle, Waverly, and Megan. They have been
fabulous. We haven't always agreed on everything, but in the end we
have all worked together. It really is a great team. I hope we can use
this in the next Congress to get to even greater heights.
I urge the House to pass this bill on a strong bipartisan basis, and
I urge the other body to take it up.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Georgia (Mr. Carter), the only pharmacist in the Congress.
Mr. CARTER of Georgia. Mr. Speaker, I rise today in support of H.R.
34, the 21st Century Cures Act. This long-awaited legislation promotes
medical innovation by streamlining the discovery, development, and
delivery of critical medicines. This bill also helps reform our
Nation's deteriorating mental health system to ensure that millions of
Americans receive the care they need. Such reforms include the
reduction of regulatory red tape that slows prescription drugs' entry
to the market, the breaking down of barriers that restrict data
sharing, and expediting the review of potentially breakthrough devices.
While some may believe that the resources needed to develop new cures
or new devices are too costly and time consuming, the potential savings
to the broader healthcare system will be significant. By modernizing
the governance surrounding the development of new medicines and
treatment, we ensure that the lives of millions--not only here in the
U.S., but across the world--will improve.
I want to thank Chairman Upton and Chairman Murphy for their
unrelenting determination to bring this negotiated piece of legislation
to the floor for a vote. I urge my colleagues to support H.R. 34.
Mr. PALLONE. Mr. Speaker, I have no additional speakers other than
myself to close, so I am going to continue to reserve the balance of my
time.
Mr. UPTON. Mr. Speaker, we have a good number of speakers left, and
we will use all of our time.
I yield 1 minute to the gentleman from Pennsylvania (Mr. Rothfus).
Mr. ROTHFUS. Mr. Speaker, I rise today in strong support of this
important legislation that provides significant investments and reforms
to accelerate the discovery of new treatments and cures for Americans.
I also applaud the inclusion of a provision I authored that is crucial
for our seniors. It would restore the open enrollment period for
Medicare Advantage beneficiaries, who until 2011 had the ability to
change Medicare Advantage plans during the first 3 months of the year.
Unfortunately, those 3 months of flexibility have been replaced with
an annual Medicare Advantage disenrollment period during the first 45
days of the year. Given Medicare Advantage's popularity and history of
success, seniors should be given the choice of changing to a plan that
addresses their needs. Restoring this 90-day open enrollment window
will allow seniors who find that their plan is not working for them to
make the change that does work for them.
This bill also contains very important legislation authored by my
colleague from Pennsylvania, Representative Murphy, to help families
dealing with a mental health crisis by significantly reforming our
mental healthcare system. These reforms are crucial for families,
veterans, and all individuals dealing with a mental health crisis and
the drug addictions that can often accompany such illnesses.
I commend Chairman Upton's work in bringing this critical legislation
to the floor. I urge its passage.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New
Jersey (Mr. Smith), my dear friend who I have served with all my years
here in Congress.
Mr. SMITH of New Jersey. I thank the gentleman for yielding and for
his extraordinary leadership on this legislation.
Mr. Speaker, in 1992, 24 years ago, I met--along with a great
advocate, Pat Smith--with top officials of NIH and CDC on Federal
guidelines that precluded the existence of chronic Lyme disease.
Subsequently, every Congress, I would introduce legislation trying to
get a diversity of viewpoints so that clinicians, patients, and other
advocates could be heard.
Today, CDC estimates there are about 380,000 cases of Lyme disease;
and a provision in this bill, an important, game-changing provision,
insisted upon by Majority Leader Kevin McCarthy and Chairman Upton
requires that a new working group on tickborne disease includes members
with a diversity of viewpoints, including patients, clinicians, and
researchers. This working group will make a difference. Those
patients--and there are tens of thousands of them--have been told
chronic Lyme disease doesn't exist, what you are feeling can be
attributable to some other disease, and they don't get better.
I thank the chairman for doing this. Also, as cofounder and co-
chairman of both the Alzheimer's Caucus 16 years ago and the Autism
Caucus 16 years ago, I am thankful for the great work that this will do
for those patients as well.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentlewoman from
Washington (Ms. Herrera Beutler).
Ms. HERRERA BEUTLER. Mr. Speaker, I am really excited about this
bill, and I am excited about an inclusion in the 21st Century bill that
we are voting today that is going to help moms and babies. Nearly all
of the 400 million women who give birth each year in the U.S. and the 3
million women who breast-feed will take medications or receive a
vaccine during their pregnancy or while they are nursing.
This bill that we are voting on, that we hope is going to pass and be
signed into law, contains a provision that will reduce the health risks
faced by these moms. Here is where the risk lies. Pregnant women are
often not included in clinical trials on medications, so we really
don't know what the effects are of drugs on a woman and on her
pregnancy.
Without reliable information, women and doctors are really just
playing a guessing game, trying to figure out the impacts of
medication, and that could be on medication that is a prescription for
a chronic disease: hypertension, diabetes, or severe depression.
The other undesirable choice for moms is whether or not to choose
just not to treat their condition. If they don't know what the impact
is, maybe they are just going to forgo their therapy altogether.
Moms should be able to safely manage ongoing conditions throughout
their pregnancies and while breast-feeding without playing this
guessing game. Fortunately, the Safe Medications for Moms and Babies
Act is included in the bill that we are voting on. I urge its support.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Pennsylvania (Mr. Costello), a long-time supporter of this legislation.
Mr. COSTELLO of Pennsylvania. Mr. Speaker, I rise today in support of
the 21st Century Cures Act, and I want to thank the chairman and
ranking member for their advocacy and leadership to bring this bill to
the floor today.
I also congratulate my colleague and neighbor, Congressman Joe Pitts,
for his leadership as chairman of the Health Subcommittee. Mr. Pitts
and I represent adjoining and very similar districts in Pennsylvania,
each including parts of Chester and Berks counties. He has done
outstanding work for our constituencies by incorporating the concerns
and issues important to southeastern Pennsylvania into the Cures Act.
This bill will make an immediate, long-lasting impact on the families
and communities we represent. It supports medical research, helps fight
the opioid epidemic, and would improve the delivery of mental health
care by putting
[[Page H7001]]
patients at the center of the review process. In short, this bill
includes major priorities that will make our communities healthier and
safer.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New
York (Mr. Gibson). This may be his last speech on the House floor, as
he announced his retirement some time ago. He is a good Member in
support of this legislation. He hounded us from the get-go.
Mr. GIBSON. Mr. Speaker, I rise in strong support of 21st Century
Cures. I want to thank the chairman, and I want to thank Majority
Leader Kevin McCarthy and my colleague Chris Smith for insisting that
we restore original language that deals with chronic Lyme and tickborne
diseases. This was critically important to my district and to the
Nation. I have so many friends and neighbors who are sick, chronically
sick, and they are desperate for cures and solutions. Thanks to this
bill, they now have a voice and a fighting chance. I am deeply
grateful.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentlewoman from
Arizona (Ms. McSally), my friend who is, again, a strong advocate of
this legislation.
Ms. McSALLY. Mr. Speaker, I rise in strong support of this important
legislation. I want to thank Chairman Upton for his tireless leadership
on the 21st Century Cures Act. The bill is the result of years of hard
work and brings hope to countless Americans suffering from incurable
diseases in all of our districts around this country.
I also want to recognize the work of Congressman Tim Murphy, who has
served as a leader and a champion on the critical issue of mental
health and is the author of legislation included in this bill that will
overhaul our mental health system for the first time in 50 years.
Additionally, this legislation includes parts of a bill that I
introduced with Senator John Cornyn to improve mental health
collaboration between Federal, State, and local justice systems to
allow better responses to mental health crises. These provisions will
also divert low-level offenders from incarceration to treatment
programs, help reduce recidivism and provide support to mentally ill
offenders reentering the community.
Many diverse groups came together in support of these bipartisan
efforts, including mental health advocates and law enforcement
organizations. I urge all of my colleagues to vote in favor of this
very important bill. I thank the chairman for his leadership.
Mr. UPTON. Mr. Speaker, I have no further speakers. Therefore, I will
let Mr. Pallone use the balance of his time to close, and then I will
use the balance of mine.
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, may I inquire how much time remains on each
side?
The SPEAKER pro tempore. The gentleman from New Jersey has 2\1/2\
minutes remaining. The gentleman from Michigan (Mr. Upton) has 3\1/2\
minutes remaining.
Mr. PALLONE. I yield myself such time as I may consume.
Mr. Speaker, I would like to conclude by referencing the Statement of
Administration Policy because I believe it reflects my position for the
most part.
If I could just read some sections--I am not reading the whole
thing--it says:
``The Administration strongly supports passage of the bipartisan
House Amendment to the Senate Amendment to H.R. 34, the 21st Century
Cures Act, which dedicates more than $6 billion to implement key
priorities such as the President's proposal to combat the heroin and
prescription opioid epidemic; the Vice President's Cancer Moonshot; and
the President's signature biomedical research initiatives, the
Precision Medicine and Brain Research through Advancing Innovative
Neurotechnologies (BRAIN) Initiatives. It also takes important steps to
improve mental health . . .
``The Administration is committed to taking immediate action to lay
the groundwork to ensure that the funds in the bill would be disbursed
quickly and effectively so we can begin to address these important
public health challenges . . .
``There are . . . provisions in the bill that raise concerns, but
that have been modified from previous versions to help address those
concerns, such as provisions that allow for the marketing of drugs to
payers for off-label uses. In addition, a number of effective dates
will be challenging to meet, especially without additional
administrative funding . . .
``That said, this legislation offers advances in health that far
outweigh these concerns. As such, the Administration strongly supports
passage of the House Amendment to the Senate Amendment to H.R. 34, the
21st Century Cures Act.''
Let me just say also in conclusion, I believe that this is an
important piece of legislation that we need to pass, and I would hope
that the Senate would take it up and pass it, and, obviously, the
administration or the President will sign it.
From the very beginning, when we passed the 21st Century Cures Act, I
thought that it would make important strides in actually dealing with
those diseases for which we have not made a lot of progress in terms of
advancing and finding cures, but, at the same time, I am happy that
this legislation has now become a little more of a catch-all or a lot
more of a catch-all, if you will, because it is addressing funding for
opioids. Many of us know we passed an opioid package that the President
signed in July, but it is not funded. So there will be funding for that
bill now.
As far as the mental health reforms, our committee spent a tremendous
amount of time over the last 2 years trying to address that
legislation. We passed a bill here in the House. Again, I am happy that
this is included because the kinds of reforms that were in that bill
are now in this bill, and I think they are important strides in terms
of addressing some of the mental health concerns that we have in this
country.
The same is true for Cancer Moonshot. The President spent a lot of
time, the Vice President as well, and this will make at least a down
payment on that. So, overall, this is a good bill. I support it. I urge
my colleagues to support it as well.
Mr. Speaker, I yield back the balance of my time.
Mr. UPTON. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I just want to thank all the people who have been
involved in this Chamber, our staff, our Members, the Senate as well. I
want to thank all the people outside the Chamber who brought their
message to us because one of the things that we wanted to do from the
very start was listen. You tell us what we need to do so we can find
these cures for you--name the disease. I will confess that some of us
had probably never heard of some of the diseases and some of the
disease patient advocacy groups that actually came to us.
We are doing the right thing because, yes, we listened; yes, we knew
we needed more research; and as fiscal conservatives--and we all care
about the deficit, we all do--we want to make sure that we can actually
have the resources and a timeline to spend it in a prudent manner,
really outlining the priorities that both sides of the aisle share.
{time} 1500
I commend the President. He was personally involved in this issue,
not a Johnny-come-lately, coming up this aisle with his last couple of
State of the Union Addresses on both Precision Medicine and the Cancer
Moonshot. Vice President Biden spent weeks of his time and many hours
with us helping us draft the legislation that we all care about and is
included in this legislation. There are Lamar Alexander, Mitch
McConnell, Patty Murray, Chuck Schumer, and others in the Senate caring
about this legislation, knowing its impact on so many millions of
people--our researchers, who have devoted their lives, and, again, many
of us here.
We traveled to MD Anderson, the Mayo Clinic, Ann Arbor, the Cleveland
Clinic, and other great places to do research that actually can save
people's lives. And we learned a lot. We learned a lot that, working
together, we can get something done, and that is what this bill does.
But I will tell you why this vote is important when we take it at
about 5 p.m. or so. We don't want to win by a narrow margin. We want to
win by a
[[Page H7002]]
huge margin. We want to send a message to the Senate that what we did
in countless hearings and roundtables has made a difference, that it is
a strong bipartisan message, including the mental health legislation,
again, which we debated for weeks and months here in the House, not
only in the committee, but on the House floor. It is very important. It
is important to people like Joe Kennedy, who spoke on the floor earlier
today. The Ways and Means provisions that passed on a voice vote here
are included so we can get the job done.
Our leadership on both sides--John Boehner, Paul Ryan, Kevin
McCarthy, Steve Scalise, Cathy McMorris Rodgers, Nancy Pelosi, Steny
Hoyer--have really been outstanding. They knew from the get-go that we
needed to get this thing done. Patients can't wait. They cannot wait.
We are going to have the cure to get this thing done, and, yes, it will
impact millions of lives.
So, in an hour or two, when we vote on this, I would urge all my
colleagues on both sides of the aisle to vote ``yes'' for patients.
Madam Speaker, I yield back the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield myself such time as I may
consume.
America has always been a leader in developing cutting-edge medical
treatments and technologies, breakthroughs that have saved countless
lives; but due to outdated and burdensome Federal healthcare policies,
medical innovation in our country is failing to keep pace with the 21st
century challenges facing doctors and families.
Today, Americans nationwide are being forced to wait for the
lifesaving treatments they need while important advancements are held
up by unnecessary red tape. Chairman Upton's 21st Century Cures Act
provides an opportunity to put America back at the forefront of medical
innovation and the delivery of cutting-edge care.
This legislation will empower America's researchers and doctors with
the tools needed to solve the biggest healthcare challenges of our
time. It includes many bipartisan solutions that will increase
healthcare choice, access, and affordability for the American people.
Thanks to Chairman Upton's leadership and the hard work of many
Members of Congress from multiple committees, the 21st Century Cures
Act brings together a variety of solutions that will help Americans
throughout the country.
Ten of these patient-focused measures are from the Ways and Means
Committee. All 10 are bipartisan. More than 20 of our members crafted
and introduced these bills. Many more helped move them forward.
In particular, I would like to recognize the leadership of
Congressman Pat Tiberi and Jim McDermott, the chairman and ranking
member of our Health Subcommittee.
Ranking Member McDermott, by the way, is retiring at the end of this
Congress. I want to take this moment to thank him for his years of
service and friendship. I want to thank him and Chairman Tiberi for
their efforts in support of the 21st Century Cures Act.
The Ways and Means healthcare provisions in the bill will remove
harmful regulations on providers to impede the delivery of care. They
will increase healthcare options for job creators and families. They
will expand access to high-quality, affordable care for America's most
vulnerable patients.
I am also excited that this legislation includes a policy by
Representative Engel and Chairman Tiberi to ensure patients have access
to new home infusion benefits. We look forward to working with the
Energy and Commerce Committee next year to quickly implement this
solution so that more patients have access to this vital service.
In closing, I want to thank all the Members on both sides of the
aisle who helped develop the bill before us today. I again want to
thank Chairman Upton for his leadership. This historic legislation has
been years in the making. We would not be here today without Chairman
Upton's dedication, vision, and commitment to bipartisan collaboration.
The 21st Century Cures Act is an incredible opportunity to help
Americans from all walks of life for generations to come. I urge all my
colleagues to join me in supporting its passage.
Madam Speaker, I reserve the balance of my time.
Mr. McDERMOTT. Madam Speaker, I yield myself such time as I may
consume.
This bill is a typical lameduck bill. It has one provision in it that
people really want, and that is a giveaway to the pharmaceutical
industry.
Every provision that Mr. Brady has talked about with respect to the
Ways and Means Committee has already been passed out of here, and none
of them are harmless, but the issue here is reducing the effect of the
FDA in protecting the American public. My colleague, Ms. DeLauro from
Connecticut, was absolutely right: the weakening of the FDA in
protecting the American public is the central part of this bill.
Now, it is wrapped in $4 billion worth of inadequate money for NIH.
It would take $7 billion to keep us where we are today. The money that
went out of here a few months ago was mandatory, and now it is subject
to appropriation. Everybody says: Oh, well, there are commitments made.
There are commitments made.
Anybody who believes in the tooth fairy will believe that money is
going to go to NIH. But the changes in law in how we push drugs, that
is going to be in law.
Now, let me tell you what the problem with that is. If you push drugs
out there quickly, there are some side effects and people die and
people say, Well, it is too bad; the FDA approved it. We put the FDA in
the position of protecting the American public, and then we cut them
out at the knees.
Once we have done these cures, we come up with these great drugs, who
can afford them? The other thing that is wrong with this bill and that
this House has failed to do is to deal with the cost of pharmaceuticals
in this country. There is not one single thing in this bill.
There is a specialty drug called Sovaldi. It is a treatment for
hepatitis C. There are actually several million people in this country
who need that drug. One pill costs $1,000. Full treatment costs
$84,000. Who can afford it? Who is going to pay for that? Are you going
to be willing to put the money into part D of Medicare to pay for it?
The question here is: What are we doing in giving away to the
pharmaceutical companies an open door to push any drug out they want or
that they can get through the screen, make the screen big so that it is
easy to get them out, and then we pick up the pieces for the American
people? That is the reason I oppose this bill. I think there are good
things in it.
I come from a university that is the number one recipient of research
money in this country. The University of Washington is the number one
public university. We have so little money at NIH now that you have to
be 40 years old until you get a grant from NIH for a research project.
It used to be that 17 percent of all the grants were approved. Now we
are down to 6 percent. That is because we have been squeezing the life
out of NIH. And this $4 billion sounds like a lot of money, but it
isn't even the $7 billion to keep us at the present level. That is what
is wrong with this bill.
Madam Speaker, I reserve the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the gentleman
from Ohio (Mr. Tiberi), the chairman of the Health Subcommittee who
shepherded these bills through the House earlier and leads the effort
to correct issues so important to our hospitals and cancer hospitals,
as well as some new reforms for infusion healthcare patients.
Mr. TIBERI. Madam Speaker, I thank Chairman Brady for his leadership
on this issue.
Madam Speaker, Chairman Upton unveiled the 21st Century Cures Act
back in 2014 to initiate quicker development and pathways to approve
treatments and cure diseases. This bipartisan and bicameral bill is
another example how the House is delivering on patient-focused
solutions for Americans.
I am incredibly pleased that three of my initiatives are included in
this final package, the first of which is a bill that provides
necessary regulatory relief to providers and fixes a site-neutral
policy to hospitals that were in the middle of construction when the
policy went into effect.
[[Page H7003]]
Second, the 21st Century Cures Act gives relief to long-term care
hospitals from the 25 percent rule and commonsense Medicare reforms.
Lastly, the bill includes a provision of a bill I sponsored that
provides infusion therapy to Medicare beneficiaries in their home.
I look forward to continuing work on these issues with my colleagues
in the next session of Congress. I want to congratulate Chairman Upton
for his incredible work on this. He solicited feedback from
stakeholders, Members, patients, and has worked tirelessly to make this
bill the best version possible. His accomplishments during his
chairmanship are admirable, and I am grateful to call him a close
friend.
Let's pass the 21st Century Cures Act on a bipartisan basis, Madam
Speaker, and get America back in the driver's seat on medical
innovation.
Mr. McDERMOTT. Madam Speaker, I yield 3 minutes to the gentleman from
Texas (Mr. Doggett).
Mr. DOGGETT. Madam Speaker, while certainly saluting the many Members
who have worked so diligently on this measure, I cannot vote for it.
In a wide and endless desert of support for research funding, even
getting a few drops of rain is understandably welcomed by the thirsty.
Under Republican rule, we have seen a dreadful drought in research
funding. This is a bill that attempts to address that shortfall. I
voted for the bill when it was on the floor of the House at a previous
time. At that point, it promised the hope, after this long drought of
almost $10 billion in assured, certain funding, for research so that we
might find cures for some of these diseases before we get them
ourselves--the concern of so many people.
Now, under this new measure, we have only about a fourth of the
funding previously approved in the House, and it is no longer certain
money; it is maybe money for the future. So there may be bipartisan
agreement, but there is not a bipartisan advancement.
At the same time that research dollars are dramatically cut--the very
research dollars that were the reason for having this bill in the first
place--Big Pharma got some of its wish list approved. And how very
appropriate that this measure and so many other moving parts have been
packed into what it calls the Tsunami Warning bill.
If there is one thing we can be sure of this past year, it is that
those people who rely on lifesaving drugs and who want to be able to
have a prescription that the doctor prescribes have been hit by a real
tsunami. They have been buried in one wave after another wave after
another giant wave of pharmaceutical price gouging. Whether it is the
EpiPen for a child who is might have an allergic reaction, whether it
is insulin for someone who is diabetic and relies on that insulin,
whether it is an oncology drug that costs over $100,000, it is wave
after wave of a tsunami of price gouging.
{time} 1515
And what has this Congress done about that?
Absolutely nothing. I must say, the administration has done very
little more. They have looked at it. There have been a few speeches
about it, but there has not been effective action.
So what we get in this bill are a few things that Big Pharma wants
that have been on its wish list for a long time, and consumers, they
get nothing to look forward to other than more of those big waves of
huge price increases.
I am also concerned that the policy arm that publishes Consumer
Reports magazine has expressed deep concerns about additional patient
risk as a result of some of the provisions that the pharmaceutical
companies and the medical device manufacturers have insisted as the
price for getting a little additional research funding.
So I am voting ``no,'' not because this provides some research
dollars. It ought to be providing the level of certain research funding
we approved already, but because it fails to address this critical
health need.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the
gentlewoman from Kansas (Ms. Jenkins), one of our key members of the
Health Subcommittee who also focuses on rural hospitals and access to
care for rural communities.
Ms. JENKINS of Kansas. Madam Speaker, I rise today to support this
legislation. It improves access to health care for rural communities
through measures I introduced, such as the Continuing Access to
Hospitals Act, which stops unjustified regulations from interfering
with rural healthcare providers offering quality services; and the
Rural ACO Provider Equity Act, which will ensure the work of PAs and
nurse practitioners is recognized so that rural hospitals can join ACOs
and afford to remain open and serve our rural communities.
Finally, it will help the 40 million Americans who deal with a mental
illness each year through inclusion of my Mental Health First Aid Act.
This bipartisan legislation delivers $15 million every year to train
police officers, teachers, veterans' advocates, and others to identify
and aid those with a mental illness, building a stronger mental health
safety net in America that addresses the needs of millions of
Americans.
I urge my colleagues to pass this legislation.
Mr. McDERMOTT. Madam Speaker, I reserve the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the gentleman
from Minnesota (Mr. Paulsen), one of our leaders in medical devices
innovation and bringing lifesaving cures to the market sooner.
Mr. PAULSEN. Madam Speaker, I rise in strong support of the
bipartisan 21st Century Cures Act.
There are more than 10,000 known diseases in the world, and many of
them are rare diseases. Yet, there are only 500 of them that have an
FDA-approved treatment. Millions of Americans today feel powerless
because they have a deadly disease and they have no hope of a cure
because there aren't enough resources for research or the regulatory
barriers are discouraging innovation.
This bipartisan initiative today gives patients new hope. It supports
more NIH research; it streamlines the regulatory approval process; and
it gives patients more input in the treatment and delivery process.
I am also pleased today, Madam Speaker, that we are providing
important reforms to our mental health system. For too long, patients
and families, mental healthcare professionals, and law enforcement have
been crying for help. This legislative effort represents the most
significant improvement to the mental health system that we have seen
in over a decade.
Madam Speaker, this is an innovation game-changer. It is a once-in-a-
generation, transformational opportunity to change the way we treat
disease. It expedites the discovery, the development, and the delivery
of new treatments and cures; and it ensures that America will be a
leader in the global fight for medical innovation.
Mr. McDERMOTT. Madam Speaker, I reserve the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the gentleman
from Ohio (Mr. Renacci), who has, among many healthcare issues, led the
charge to create much smarter measurements in hospital readmissions.
Mr. RENACCI. Madam Speaker, I rise in support of H.R. 34, the 21st
Century Cures Act. At its core, this legislation, while not perfect,
ensures our country will continue to be at the forefront of medical
innovations and breakthroughs.
Also important is what the bill does for States like Ohio that are
fighting the opioid epidemic. Just today it was reported that Ohio has
seen more opioid overdose deaths than any other State in the Nation.
This bill would especially help Ohio reverse this devastating trend.
I also applaud the inclusion of my bill, H.R. 1343, the Establishing
Equity in the Hospital Readmission Program. The Hospital Readmission
Program was created due to concerns that too few resources were being
spent on reducing acute care hospital readmissions. While reducing
acute care hospital readmissions is important, my bill ensures that we
are not disproportionately penalizing those who see a large number of
our most vulnerable patients.
This is one of the many commonsense, bipartisan reforms to improve
our healthcare system included in the 21st Century Cures Act, and I
urge all Members to support this bill.
Mr. McDERMOTT. Madam Speaker, I reserve the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the gentleman
[[Page H7004]]
from Pennsylvania (Mr. Meehan), again, another key member of our
committee who is focused on health care and, in this case, increasing
information to seniors about their Medicare plans in advance, and also
improving physical therapy, so critical to so many in health care.
Mr. MEEHAN. Madam Speaker, the 21st Century Cures Act is a historic,
bipartisan legislation that will eliminate the barriers standing
between us and cures for diseases like Alzheimer's and diabetes, and
cancer.
The bill fosters coordination and research related to pediatric
diseases and birth defects, and we encourage the NIH and FDA to
establish a global pediatric clinical study network with the hope that
more collaboration will lead to new treatments, and it will help build
our understanding of how treatments geared for adults can help to lead
to cures for children.
Just 3 years ago, after a fight with Washington bureaucrats, Sarah
Murnaghan, a 10-year-old young woman from my district, received an
adult lung transplant. She is now a thriving 14-year-old. And through
``Sarah's Heroes,'' we highlight the stories of other children who are
courageously working to overcome challenges presented by cystic
fibrosis and lung transplant.
Schizophrenia and mental illness are among other conditions without a
cure. The bill improves access to mental health by increasing the
number of healthcare professionals trained to treat patients. It also
strengthens the requirement that mental health coverage be on par with
coverage for physical ailments; many good reasons to continue to
support. I urge my colleagues to do so.
Mr. McDERMOTT. Madam Speaker, I reserve the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield 1 minute to the gentleman
from Illinois (Mr. Dold), one of our smartest members on the Ways and
Means Committee who has really carved out a niche in support of medical
innovation, really bringing these breakthroughs to the community and
patients quickly.
Mr. DOLD. Madam Speaker, I certainly thank the chairman for his
leadership.
I also stand here today in strong support of the 21st Century Cures
Act. I want to thank Chairman Upton for his leadership, and Ranking
Member Pallone, Congresswoman DeGette, and Congressman Murphy for their
great work on compiling things that are in this bill.
I have been a longtime advocate for both the 21st Century Cures Act
and the Helping Families in Mental Health Crisis Act because I believe
it is critically important that we modernize how we treat mental health
and how we develop lifesaving cures. This package accomplishes both of
these important goals and many more.
Over the next 10 years, we will provide an additional $4.8 billion to
the National Institutes of Health in support of groundbreaking medical
research and an additional $500 million to the FDA to help bring drugs
and devices to patients more quickly.
We will also be providing States with $1 billion in grants over the
next 2 years to help combat the opioid epidemic, which is impacting
every single community across our Nation.
Finally, we will increase choice, access, and quality in health care
by making serious improvements to Medicare.
The SPEAKER pro tempore (Mrs. Lummis). The time of the gentleman has
expired.
Mr. BRADY of Texas. I yield the gentleman an additional 1\1/2\
minutes.
Mr. DOLD. This package is proof that when we are willing to work
together, we can improve our healthcare system for all Americans
through changes large and small. I encourage all of my colleagues to
join me in supporting the 21st Century Cures Act.
I also want to thank, again, Chairman Upton, Congressman Murphy,
Congresswoman DeGette, and all those that helped put this together, and
the staff that were so instrumental in making this become a reality
today.
Mr. BRADY of Texas. Madam Speaker, I have no further speakers and I
am prepared to close if the gentleman would like to close.
I reserve the balance of my time.
Mr. McDERMOTT. Madam Speaker, I yield myself such time as I may
consume. I want to thank my colleagues for their interest in children.
I hear some of the speakers stand up and say they are really interested
in kids, yet they oppose the CHIP program. They talk about cutting back
the help to children.
Now, the problem here is that if you are talking about cures, and you
are going to create a magnificent cure that costs $80,000, if you don't
provide Medicaid, the children who are poor in this country aren't
going to get access to that cure. That is a cure for rich people who
could pay it out of their clippings on their bonds and their stock.
The EPSDT program, which is the program that covers kids, the
President-elect has put in the charge of that a woman from Indiana who
testified against it. This is the benefit that ensures sick kids will
get cures.
Now, you are setting in motion something here for pharmaceutical
companies to find a way to take as much money out of the system as they
can with every drug they can put out there, and you are, at the same
time, moving in the direction of making it impossible for poor children
to be taken care of in this country.
How many States have the Governors said: We don't believe in
Medicaid; we don't believe that the government should give Medicaid; we
believe the government should stay out of medicine?
So they deny their own people health care, simple, everyday, ordinary
health care; and we are talking about cures for disease. As somebody
said, there were 50 cases in the United States of it last year. One
feels for those 50.
I am a physician. I have listened to those people. I know that it is
awful, but you have to keep in balance and say to yourself: Are we
going to spend all the money there or are we going to spend it dealing
with all the Americans?
That is what is wrong with this bill. The pharmaceutical industry has
no control on it whatsoever. When you put in that benefit, in part D,
you tied the Secretary of Health and Human Services' hands, and he or
she cannot negotiate lower prices. You said: Whatever the
pharmaceutical company says the cost is, that is what we are going to
pay.
Now, the Veterans Administration--veterans are different than
ordinary people in this country. They have an administration that has
the right to negotiate changes in prices, and their pharmaceutical
prices are down 50, 60 percent from what people pay in Medicare.
Now, as long as you have that kind of giveaway going on to the
pharmaceutical companies, this bill is just kind of frosting on the
cake, and I guess Members will vote for it. In the short run it will
seem like, you know, it didn't make any difference, but you are going
to pay down the line.
This is going to be a Fram commercial. You either pay now or you are
going to pay later, because if you do not screen those drugs carefully
and make sure that they are really doing something, and let the
pharmaceutical companies add a Chlorine ion or a Boron or whatever,
they are simply putting drugs out on the table that cost too much for
the Americans to buy.
I urge a ``no'' vote.
I yield back the balance of my time.
Mr. BRADY of Texas. Madam Speaker, I yield myself the balance of my
time.
There are so many Americans who could be watching today who wonder
when that lifesaving drug, that new treatment will be made available to
them. They know it is in other countries. They read about it in other
places, but they can't get it here in America. The Cures Act changes
that. It streamlines it, moves things faster; and when you are in that
tough situation, it provides options for health care, experimental
drugs never before available to them. This is important to patients and
it is important to doing it better in America. I urge its support.
I yield back the balance of my time.
Mr. THOMPSON of California. Madam Speaker, I rise in support of this
bill.
H.R. 34, the 21st Century Cures Act, is the product of extensive
bipartisan, bicameral collaboration between stakeholders and policy
makers.
This bill stands to help us make significant progress when it comes
to keeping Americans healthy, and keeping America on the forefront of
medical innovation.
[[Page H7005]]
Included in the bill text are provisions based on legislation I
authored, known as the Small Business Healthcare Relief Act.
These provisions would allow small businesses with fewer than 50
employees to offer tax preferred Health Reimbursement Arrangements, or
HRAs, to their workforce.
The HRAs can be used to buy health insurance in the individual
market, or pay for qualified health expenses if an individual already
has coverage.
This targeted bill seeks not to override those long-standing
responsibilities between employers and their employees, nor does it
seek to override ERISA protections that existed before the Affordable
Care Act was enacted, but to provide small employers an option for
coverage in a robust individual market.
Given that this bill will be passed late in the year, it's my hope
that the incoming Administration acts promptly to ensure a smooth
transition for employers, employees, and the current exchange
infrastructure.
Small businesses drive job creation and grow our economy. We should
be going out of our way to help them support their employees so that
they can focus on what they do best: running their business.
I urge my colleagues to support this bill.
Ms. EDDIE BERNICE JOHNSON of Texas. Madam Speaker, I rise in support
of H.R. 34, the 21st Century Cures Act which will encourage innovation
in biomedical research and development of new treatments.
The bill contains $6.3 billion in spending over the next ten years.
With $4.8 billion in funding over the next ten years delivered to
Innovation Funds within the National Institutes of Health and $500
million for the Food and Drug Administration over the next five years,
it is clear that Congress is committed to investing in health research.
Developing a better system of funding towards high-risk high reward
research and research by early stage investigators is crucial to
finding better health outcomes. With a better focus on infectious
disease, precision medicine, and biomarkers, I strongly believe that we
will finally address these areas of unmet medical needs, which are
often the most pervasive issues in our health system.
The legislation also includes elements of H.R. 2646, the Helping
Families in Mental Health Crisis Act, in order to get mental health
reforms across the Senate's finish line. I am proud that this
legislation will include many of the provisions that Congressman Tim
Murphy (R-PA) and I worked on for several years. The bill establishes
an Assistant Secretary for Mental Health and Substance Use within the
Substance Abuse and Mental Health Services Administration; reauthorizes
Assisted Outpatient Treatment grant programs; and requires the
Secretary to clarify HIPAA rules regarding circumstances when a
provider can share information. Among other provisions, these
aforementioned are just a few that will benefit patients directly and
immediately.
While H.R. 34 contains many provisions regarding the biomedical
research workforce, clinical trials, FDA improvements, I strongly
believe that the Congress has not placed enough importance on
scientific research and this is a way to get us back on track.
Investing in innovation will yield high rewards for the medical
community, especially patients. I am proud to support H.R. 34, the 21st
Century Cures Act and urge my Senate colleagues to pass this
legislation swiftly.
Ms. JACKSON LEE. Madam Speaker, I rise in support of the House
Amendment to the Senate Amendment to H.R. 34, the ``21st Century Cures
Act,'' a bipartisan piece of legislation that is vital to the future
and health of our Nation's citizens and ecosystem.
This thoughtful legislation is the culmination of the hard work of my
dedicated colleagues who have sought out and engaged in public
conversations with patients, innovators, providers, regulators and
researchers about how to move advances in science and medicine into new
therapies.
This outreach has garnered the critical input and support of more
than 370 patient and physician groups, state and local organizations,
cancer centers, and research and life sciences.
I am proud to be one of the cosponsors of 21st Century Cures Act,
which represents a new national effort to find treatment and cures for
thousands of unknown and rare diseases.
Looking to the various policies this legislation aims to address, it
is important to highlight the commendable objectives and that will not
only accelerate the discovery, development and delivery of new
treatments and cures for thousands of serious and rare diseases, but it
will also open the doors of innovation and the growth of health care
system by enhancing and enriching the medical field for all Americans.
The most ambitious action calls for $6.3 billion in mandatory funding
to be delivered over the next ten years to the National Institutes of
Health (NIH).
NIH is part of our nation's top ranked educational research
institutions in the world.
In order to maintain our global competitiveness in the biomedical
field, we must invest in the industries that guarantee economic
prosperity for our current and future economies.
It has been estimated that every $1 of NIH funding generates about
$2.21 in local economic growth, and, in 2012, NIH-funded research
supported an estimated 402,000 jobs all across the U.S.
The bill's funding for NIH would provide for an annual 3 percent
increase in the NIH budget, which has been stagnant for the past few
years and which desperately needs more funding to capitalize on
emerging scientific insights.
This increased funding not only aims to continue the sustainability
of our economy but it also supports our President's initiative to
provide more resources to the biomedical field.
The 21st Century Cures Act supports the President's Precision
Medicine Initiative, which would advance a new model of participant-
centered research to accelerate biomedical discoveries and provide
clinicians with new tools and therapies tailored to individual
patients' needs.
The Obama Administration believes we can build on the progress in
improving the drug development and approval process made to date by:
Incorporating patients' voices into the Food and Drug Administration
(FDA) decision-making; encouraging the development and qualification of
reliable biomarkers to accelerate work on important new therapies; and
reducing barriers to initiating medical device trials.
In furtherance of this initiative, the legislation before us allows,
for the creation of an ``Innovation Fund'' through the National
Institute of Health.
This ``Innovation Fund'' is a welcome effort because it promotes the
maintenance of the best biomedical workforce in the world and help to
increase the diversity of the biomedical workforce.
In particular, the $4.8 billion provided for the Innovation Fund,
will not only increase the number of the research projects it supports
but it also increases the cap for NIH's loan repayment programs.
This would include a repayment program for clinical scientists who do
research in health disparities and for clinical scientist from
disadvantaged backgrounds, from $35,000 per year to $50,000 per year
plus a yearly inflation for adjustment.
With the support of H.R. 34, underrepresented communities and those
with disadvantaged backgrounds from across the country can undoubtedly
provide the future researchers and workers of the biomedical workforce.
The Journal on STEM Education reported in 2011 that only 8.34 percent
of the STEM doctorates awarded in 2006 were given to underrepresented
minorities, despite making up approximately 28 percent of the U.S.
population.
Furthermore, GAO found noted that while the percentage of
underrepresented minorities nationwide increased from 13 percent to 19
percent from 1994 to 2003, the total number of STEM doctorates awarded
to the same group dropped during this period from 8,335 to 7,310.
In response, the National Institute of General Medical Sciences
(NIGMS) created the Minority Opportunities in Research (MORE) Division
and similar academic intervention programs.
The MORE programs are comprised of four primary components: research
experience, mentoring and advisement, supplemental instruction and
workshops, and financial support.
In 2007, NIGMS' annual budget was $1.9 billion, of which nearly $126
million was spent on its MORE programs.
This amount includes the Minority Biomedical Research Support-
Research Initiative for Scientific Enhancement (MBRS-RISE) program, the
Minority Access to Research Careers (MARC), Post-baccalaureate Research
Education Program (PREP), and the Bridges to the Baccalaureate and
Bridges to the PhD programs.
The amount of funds dedicated to these programs reflects the
commitment by the science and research community to the goals of the
MORE Division in addressing this problem.
Increased funding set forth in H.R. 34 will only strengthen NIH's
focus on diversifying the biomedical workforce by requiring NIH to
focus on ensuring participation from scientists from underrepresented
communities.
In addition to addressing the needs of underrepresented communities,
H.R. 34 also calls for specific action to increase representation of
racial minorities.
The 21st Century Cures Act acknowledges that there are disturbing
statistics on the low numbers of African Americans, Hispanics and
Native Americans pursuing academic qualification and participating in
scientific research.
Under H.R. 34, the National Institute on Minority Health and Health
Disparities will necessarily include strategies for increasing
representation of minority communities in its strategic plan.
[[Page H7006]]
I am proud that H.R. 34 incorporates the Jackson Lee Amendment which
I offered during the initial consideration of the 21st Century Cures
Act by the House which will help ensure that the national goals of
finding and bringing more cures and treatments to patients and
strengthening the biomedical innovation ecosystem in the United States
is aided by an expanding pool of diverse and talented medical
researchers.
Specifically, the Jackson Lee Amendment instructed the Secretary of
Health and Human Services to conduct outreach to historically Black
colleges and universities, Hispanic-serving institutions, Native
American colleges, and rural colleges to ensure that health
professionals from underrepresented populations are aware of research
opportunities under this Act.
Many racial health disparities stem from lack of access to effective
test, treatments and cures for illnesses that have devastating
consequences for African American, Hispanic and Native American
populations.
For example:
1. African-Americans (represent 12 percent of the U.S. population but
only 5 percent of clinical trial participants.
2. Hispanics make up 16 percent of the population but only 1 percent
of clinical trial participants.
3. Women are under-represented in cardiovascular device trials, which
have 67 percent male participation.
The most significant barriers limiting clinical participation are
race, age, and sex of participants:
1. Women and minority patients are more difficult to recruit.
2. Women and minority physicians have less experience and are
relatively more costly to engage.
3. Minority patients with limited English proficiency can require
costly translation services.
Physicians are the gateway to the patient. Increasing diversity of
those conducting research will have implications on the types of
conditions that are researched and the participants in clinical trials
that are seeking answers to illnesses like lupus, triple negative
breast cancer, and sickle cell disease that can be difficult to detect,
treat and cure.
Certain medical illnesses have been known to have higher prevalence
in certain demographic groups, including type II diabetes, lupus,
sickle cell anemia, and Triple Negative Breast Cancer for which African
Americans are more than twice as likely to be diagnosed on average.
Lupus, triple negative breast cancer and sickle cell disease are of
particular concern because they are often difficult to diagnose and
disproportionately impact persons of color and especially women.
In particular, Lupus is a chronic, complex and prevalent autoimmune
disease that affects more than 1.5 million Americans. Yet, Lupus is one
of America's least recognized major diseases.
More than 90 percent of lupus sufferers are women, mostly young women
between the ages of 15 to 44, and women of color are two to three times
more at risk for lupus than Caucasians.
Triple negative breast cancer also disproportionately impacts younger
women, African American women, Hispanic/Latina women, and women with a
``BRCA1'' genetic mutation, which is prevalent in Jewish women.
More than 30 percent of all breast cancer diagnoses in African
American are of the triple negative variety, and African American women
are far more susceptible to this dangerous subtype than white or
Hispanic women.
Additionally, there are about 2 million people who carry the sickle
cell trait and with about 100,000 having the disease. According to the
Centers for Disease Control and Prevention, sickle cell trait is common
among African Americans and occurs in about 1 in 12, and sickle cell
disease occurs in about 1 out of every 500 African-American births,
compared to about 1 out of every 36,000 Hispanic-American births.
Treatments for Lupus, triple negative breast cancer and sickle cell
disease are not progressing as quickly as desired by patients,
researchers, and policy makers. We must support the advancement of
legislation that will allow for the remediation and end of health care
disparities and the promotion of research parity for diseases such as
lupus, triple negative breast cancer, sickle cell disease, and
countless other rare and serious diseases.
Race and ethnicity have also been shown to affect the effectiveness
of and response to certain drugs, such as anti-hypertensive therapies
in the treatment of hypertension in African Americans and anti-
depressants in Hispanics.
Increased diversity in research trials could help researchers find
better, more precise ways to fight diseases that disproportionately
impact certain populations, and may be important for the safe and
effective use of new therapies. As one of the most diverse cities in
the country, Houston is the 4th largest city in the United States and
the 5th most populated metropolitan area in the nation. Houston is home
to the largest medical complex in the world--the Texas Medical Center,
which provides clinical health care, research and education at its 54
institutions.
The University of Houston, ranked number three out of all other
colleges and universities in Texas, is an example of a premier
institution that can produce students with advanced STEM degrees who
would be able to join a progressing biomedical field.
Another important requirement of H.R. 34 is that it would require
National Institute of Health to publically report the number of
children by race and gender who participate in NIH funded clinical
trials.
This legislation would help ensure that children of all races are
adequately represented in clinical trials and that we can determine the
safety and effectiveness of drugs on children of all demographic
backgrounds.
With 10,000 known diseases, 7,000 of which are rare, and treatments
for only 500 of them--clear there is much work to do. Medical research
saves lives and improves the quality of life for millions of Americans
because the government provides a steady and reliable commitment to
basic research into cures for debilitating and deadly diseases.
Given the array of commendable initiatives, H.R. 34 is a necessary
piece of legislation that will accelerate the discovery, development,
and delivery of promising new treatments and cures for all patients
while investing in our nation's ability to maintain the best and most
diverse biomedical workforce in the world.
Madam Speaker, I call for the support of all of my colleagues in
ensuring the passage of the important legislation.
The SPEAKER pro tempore. All time for debate has expired.
Pursuant to House Resolution 934, the previous question is ordered on
the motion to concur.
The question is on the motion to concur offered by the gentleman from
Michigan (Mr. Upton).
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. McDERMOTT. Madam Speaker, I demand a recorded vote.
A recorded vote was ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, and the
order of the House of today, further proceedings on this question will
be postponed.
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