[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 14 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 14
To increase the Federal commitment to defeating the virus that causes
COVID-19 and prepare for future pandemics, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 30, 2020
Mr. Hudson (for himself, Mr. McCarthy, Mr. Walden, Mr. Brady, and Ms.
Granger) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Homeland Security, Transportation and Infrastructure, the Judiciary,
Ways and Means, the Budget, and Science, Space, and Technology, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To increase the Federal commitment to defeating the virus that causes
COVID-19 and prepare for future pandemics, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Commitment to Defeat the Virus and
Keep America Healthy Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--PANDEMIC PREPAREDNESS AND RESPONSE
Subtitle A--Clarifying the Role of the Department of Health and Human
Services During Public Health Emergencies
Sec. 1001. Lead agency for Federal public health and medical response
to public health emergencies.
Sec. 1002. Deployment by the Secretary of Health and Human Services of
National Strategic Stockpile.
Sec. 1003. Authority and responsibilities of the Federal Emergency
Management Agency regarding the Strategic
National Stockpile.
Subtitle B--Reagan-Udall Foundation and Foundation for the National
Institutes of Health
Sec. 1011. Reagan-Udall Foundation and Foundation for the National
Institutes of Health.
Subtitle C--Protections for Good Samaritan Health Professionals
Sec. 1021. Limitation on liability for volunteer health care
professionals.
Sec. 1022. Sense of the Congress.
Subtitle D--Medical Sheltering
Sec. 1031. Reducing the spread of COVID-19 through payments to States
to lease hotels to temporarily house
eligible individuals.
Subtitle E--CDC Campaign on COVID-19 Awareness
Sec. 1041. COVID-19 public awareness campaign.
Subtitle F--Protecting Children From COVID-19
Sec. 1051. Study on children's role in transmitting SARS-CoV-2.
Subtitle G--Ensuring Understanding of COVID-19
Sec. 1061. Study on the impact of COVID-19.
Subtitle H--Safeguarding Therapeutics
Sec. 1071. Authority to destroy counterfeit devices.
Sec. 1072. Determination of budgetary effects.
Subtitle I--Advisory Committee on Immunization Practices
Sec. 1081. Expedited meeting of ACIP for COVID-19 vaccines.
Subtitle J--Improvements to Transparency of the Pricing of Diagnostic
Testing for COVID-19
Sec. 1091. Improvements to transparency of the pricing of diagnostic
testing for COVID-19.
TITLE II--DOMESTIC MANUFACTURING AND SUPPLY CHAIN
Subtitle A--Sustained On-Shore Manufacturing Capacity for Public Health
Emergencies
Sec. 2001. Sustained on-shore manufacturing capacity for public health
emergencies.
Subtitle B--Manufacturing API, Drugs, and Excipients in America
Sec. 2011. Report to Congress on barriers to domestic manufacturing of
medical products and supplies.
Sec. 2012. Enhancing intra-agency coordination and public health
assessment with regard to compliance
activities.
Sec. 2013. Encouraging international harmonization.
Sec. 2014. Mutual recognition agreements for inspections and review
activities.
Sec. 2015. Enhancing transparency of drug facility inspection
timelines.
Sec. 2016. Advanced manufacturing technologies program.
Subtitle C--Improving the American Drug Supply Chain
Sec. 2021. Study and reporting on domestic and foreign production.
Subtitle D--Essential Medicines Strategic Stockpile
Sec. 2031. Pilot program on ensuring medication supply stability.
Subtitle E--National Centers of Excellence in Continuous Pharmaceutical
Manufacturing
Sec. 2041. National Centers of Excellence in Continuous Pharmaceutical
Manufacturing.
TITLE III--STRATEGIC NATIONAL STOCKPILE IMPROVEMENTS
Subtitle A--Stockpiling for America's Future Endeavors
Sec. 3001. Strategic National Stockpile.
Subtitle B--Stockpile Inventory Modernization
Sec. 3011. Reimbursable transfers.
Subtitle C--Equipment Maintenance
Sec. 3021. Equipment maintenance.
Subtitle D--Medical Supplies for Pandemics
Sec. 3031. Supply chain flexibility manufacturing pilot.
Subtitle E--State Stockpile Readiness
Sec. 3041. Grants for State strategic stockpiles.
Subtitle F--Process Improvements and Reports
Sec. 3051. GAO study on the feasibility and benefits of user fee
agreements.
Sec. 3052. Action reporting.
Sec. 3053. Improved, transparent processes.
Subtitle G--Strategic National Stockpile Funding
Sec. 3061. Authorization of appropriations.
TITLE IV--PUBLIC HEALTH INFRASTRUCTURE IMPROVEMENTS
Subtitle A--Public Health Infrastructure Modernization
Sec. 4001. Public health data system transformation.
Subtitle B--Modernizing Infectious Disease Data Collection
Sec. 4011. Modernizing infectious disease data collection.
Subtitle C--Diagnostic Testing for Public Health Labs
Sec. 4021. Grants for public health laboratories to acquire high-
throughput diagnostic equipment.
Subtitle D--Rapid Testing for Communities
Sec. 4031. Grants for same-day point-of-care clinical laboratory
diagnostic testing in communities.
Subtitle E--Public Health Workforce Loan Repayment
Sec. 4041. Public Health Workforce Loan Repayment Program.
Subtitle F--Vaccine Awareness and Disease Prevention
Sec. 4051. Improving awareness of disease prevention.
Subtitle G--Protecting the Health of America's Older Adults During
COVID-19 & Beyond
Sec. 4061. National COVID-19 Resource Center for Older Adults.
Sec. 4062. Healthy Aging Program.
Sec. 4063. Authorization of appropriations.
Subtitle H--Expanding Capacity for Health Outcomes
Sec. 4071. Expanding capacity for health outcomes.
Subtitle I--Community Readiness
Sec. 4081. Grants for research on, or establishing, wastewater
surveillance and other early warning
systems.
TITLE V--ADDRESSING COVID-19 HEALTH DISPARITIES
Subtitle A--Tribal Health Data Improvement
Sec. 5001. Collection and availability of health data with respect to
Indian Tribes.
Sec. 5002. Improving health statistics reporting with respect to Indian
Tribes.
Subtitle B--Tribal Medical Supplies Stockpile Access
Sec. 5011. Provision of items to Indian programs and facilities.
Subtitle C--Native American Suicide Prevention
Sec. 5021. Native American suicide prevention.
Subtitle D--Pursuing Equity in Mental Health
Part 1--Health Equity and Accountability
Sec. 5031. Integrated Health Care Demonstration Program.
Sec. 5032. Addressing racial and ethnic minority mental health
disparities research gaps.
Sec. 5033. Health professions competencies to address racial and ethnic
minority mental health disparities.
Sec. 5034. Racial and ethnic minority behavioral and mental health
outreach and education strategy.
Sec. 5035. Additional funds for National Institutes of Health.
Sec. 5036. Additional funds for National Institute on Minority Health
and Health Disparities.
Part 2--Other Provisions
Sec. 5037. Reauthorization of Minority Fellowship Program.
Sec. 5038. Study on the Effects of Smartphone and Social Media Use on
Adolescents.
Sec. 5039. Technical correction.
Subtitle E--Maternal Health Quality Improvement
Sec. 5041. Innovation for maternal health.
Sec. 5042. Training for health care providers.
Sec. 5043. Study on training to reduce and prevent discrimination.
Sec. 5044. Perinatal quality collaboratives.
Sec. 5045. Integrated services for pregnant and postpartum women.
Sec. 5046. Improving rural maternal and obstetric care data.
Sec. 5047. Rural obstetric network grants.
Sec. 5048. Telehealth network and telehealth resource centers grant
programs.
Sec. 5049. Rural maternal and obstetric care training demonstration.
TITLE VI--ADDRESSING THE IMPACTS OF COVID-19 ON MENTAL HEALTH
Subtitle A--Creating Resources To Improve Situations of Inherent
Severity
Sec. 6001. Set-aside for evidence-based crisis care services.
Subtitle B--Emergency Mental Health and Substance Use Training and
Technical Assistance Center
Sec. 6011. Emergency mental health and substance use training and
technical assistance center.
Subtitle C--Suicide Prevention Grants
Sec. 6021. Syndromic surveillance of self-harm behaviors program.
Sec. 6022. Grants to provide self-harm and suicide prevention services.
Subtitle D--Effective Suicide Screening in the Emergency Department
Sec. 6031. Program to improve the care provided to patients in the
emergency department who are at risk of
suicide.
Subtitle E--Suicide Prevention Lifeline Improvement
Sec. 6041. Suicide Prevention Lifeline.
Sec. 6042. Pilot program on innovative technologies.
Sec. 6043. HHS study and report.
Sec. 6044. GAO study and report.
Sec. 6045. Definition.
Subtitle F--Campaign To Prevent Suicide
Sec. 6051. National Suicide Prevention Lifeline.
Sec. 6052. National suicide prevention media campaign.
Subtitle G--Helping Emergency Responders Overcome
Sec. 6061. Data system to capture national public safety officer
suicide incidence.
Sec. 6062. Peer-support behavioral health and wellness programs within
fire departments and emergency medical
service agencies.
Sec. 6063. Health care provider behavioral health and wellness
programs.
Sec. 6064. Development of resources for educating mental health
professionals about treating fire fighters
and emergency medical services personnel.
Sec. 6065. Best practices and other resources for addressing
posttraumatic stress disorder in public
safety officers.
Subtitle H--Behavioral Health Intervention Guidelines
Sec. 6071. Best practices for behavioral intervention teams.
Subtitle I--Suicide Training and Awareness Nationally Delivered for
Universal Prevention
Sec. 6081. Student suicide awareness and prevention training.
Sec. 6082. Effective date.
TITLE VII--ADDRESSING THE IMPACTS OF COVID-19 ON SUBSTANCE USE
DISORDERS
Subtitle A--Easy Medication Access and Treatment for Opioid Addiction
Sec. 7001. Dispensation of narcotic drugs for the purpose of relieving
acute withdrawal symptoms from opioid use
disorder.
Subtitle B--Access to Remote Behavioral Health Treatment
Sec. 7011. Registration of qualified community mental health centers.
Subtitle C--PDMP Pilot Program
Sec. 7021. Pilot program for integrating substance use disorder and
behavioral health treatment locator tool
into State prescription drug monitoring
programs.
Subtitle D--Family Support Services for Addiction
Sec. 7031. Family support services for individuals struggling with
substance use disorder.
Subtitle E--Block, Report, And Suspend Suspicious Shipments
Sec. 7041. Clarification of process for registrants to exercise due
diligence upon discovering a suspicious
order.
Subtitle F--Debarment Enforcement of Bad Actor Registrants
Sec. 7051. Debarment of certain registrants.
Subtitle G--Ensuring Compliance Against Opioid Diversion
Sec. 7061. Modification, transfer, and termination of registration to
manufacture, distribute, or dispense
controlled substances.
Subtitle H--Opioid Prescription Verification
Sec. 7071. Materials for training pharmacists on certain circumstances
under which a pharmacist may decline to
fill a prescription.
Sec. 7072. Incentivizing States to facilitate responsible, informed
dispensing of controlled substances.
Subtitle I--Suspicious Order Identification
Sec. 7081. Strengthening ARCOS.
Sec. 7082. Suspicious Orders Task Force.
Subtitle J--Stop the Importation and Manufacturing of Synthetic
Analogues
Sec. 7091. Establishment of schedule A.
Sec. 7092. Temporary and permanent scheduling of schedule A substances.
Sec. 7093. Penalties.
Sec. 7094. False labeling of schedule A controlled substances.
Sec. 7095. Registration requirements for importers and exporters of
schedule A substances.
Sec. 7096. Additional conforming amendments.
Sec. 7097. Sentencing review.
Sec. 7098. Rules of construction.
Sec. 7099. Clarification of certain registration requirements related
to research.
Sec. 7100. Review of research registration process.
TITLE VIII--TAX INCENTIVES TO IMPROVE HEALTH CARE
Sec. 8001. Domestic medical and drug manufacturing credit.
Sec. 8002. Qualifying advanced medical manufacturing equipment credit.
Sec. 8003. New medical research expenditure component of credit for
increasing research activities.
Sec. 8004. Refundable portion of research credit for small businesses
engaging in specified medical research.
Sec. 8005. Exception from passive loss rules for investments in
specified medical research small business
pass-thru entities.
Sec. 8006. Temporary carryover for health and dependent care flexible
spending arrangements.
Sec. 8007. Increase in exclusion for employer-provided dependent care
assistance.
Sec. 8008. Temporary increase in contribution limits for health savings
accounts.
Sec. 8009. Temporary allowance of payments for employment-related
expenses under health savings accounts.
Sec. 8010. Treatment of direct primary care service arrangements.
Sec. 8011. Allow both spouses to make catch-up contributions to the
same HSA account.
Sec. 8012. Repeal of ceiling on deductible and out-of-pocket expenses
under a high deductible health plan.
Sec. 8013. On-site employee clinics.
Sec. 8014. Adjustment of medical expense deduction.
Sec. 8015. Healthy workplace tax credit.
TITLE IX--MEDICARE PROVISIONS
Subtitle A--Telehealth
Sec. 9001. Removing certain geographic and originating site
restrictions on the furnishing of
telehealth services under the Medicare
program.
Sec. 9002. Making permanent FQHC and RHC telehealth payments.
Sec. 9003. Expanding the list of practitioners eligible to furnish
telehealth services.
Sec. 9004. Allowing for the provision of telehealth services via audio-
only telecommunications systems.
Sec. 9005. Making permanent the safe harbor for absence of deductible
for telehealth.
Sec. 9006. Removing requirement for face-to-face visits between home
dialysis patients and physicians.
Sec. 9007. Report on telehealth payment integrity.
Sec. 9008. Increasing funding for review of telehealth claims.
Sec. 9009. Telehealth resources.
Subtitle B--Protecting Access to Innovation During COVID-19
Sec. 9011. Authorizing the extension of pass-through status under the
Medicare program for certain drugs and
devices impacted by COVID-19.
Subtitle C--Reducing Unnecessary Senior Hospitalizations
Sec. 9021. SNF-based provision of preventive acute care and
hospitalization reduction program.
TITLE X--APPROPRIATIONS
Sec. 10001. Appropriations.
Subtitle A--Health Programs
Subtitle B--General Provisions-This Title
TITLE I--PANDEMIC PREPAREDNESS AND RESPONSE
Subtitle A--Clarifying the Role of the Department of Health and Human
Services During Public Health Emergencies
SEC. 1001. LEAD AGENCY FOR FEDERAL PUBLIC HEALTH AND MEDICAL RESPONSE
TO PUBLIC HEALTH EMERGENCIES.
Section 2801 of the Public Health Service Act (42 U.S.C. 300hh) is
amended--
(1) in subsection (a), by inserting after ``shall lead all
Federal public health and medical response to public health
emergencies and incidents'' the following: ``(including
emergencies and disasters declared by the President pursuant to
the National Emergencies Act or the Robert T. Stafford Disaster
Relief and Emergency Assistance Act)''; and
(2) in subsection (b), by inserting after ``shall assume
operational control of emergency public health and medical
response assets, as necessary, in the event of a public health
emergency'' the following: ``or in the event of an emergency or
disaster declared by the President under the National
Emergencies Act or the Robert T. Stafford Disaster Relief and
Emergency Assistance Act''.
SEC. 1002. DEPLOYMENT BY THE SECRETARY OF HEALTH AND HUMAN SERVICES OF
NATIONAL STRATEGIC STOCKPILE.
Section 319F-2(a)(3)(F) of the Public Health Service Act (42 U.S.C.
247d-6b(a)(3)(F)) is amended by striking ``as required by'' and
inserting ``in consultation with''.
SEC. 1003. AUTHORITY AND RESPONSIBILITIES OF THE FEDERAL EMERGENCY
MANAGEMENT AGENCY REGARDING THE STRATEGIC NATIONAL
STOCKPILE.
The Homeland Security Act of 2002 is amended--
(1) in subparagraph (A) of section 503(b)(2) (6 U.S.C.
313(b)(2)), by inserting ``, in coordination with relevant
Federal agencies,'' after ``lead''; and
(2) in subparagraph (D) of section 504(a)(3) (6 U.S.C.
314(a)(3)), by striking ``requiring'' and inserting ``, at the
direction of the Secretary of Health and Human Services,
assisting in''.
Subtitle B--Reagan-Udall Foundation and Foundation for the National
Institutes of Health
SEC. 1011. REAGAN-UDALL FOUNDATION AND FOUNDATION FOR THE NATIONAL
INSTITUTES OF HEALTH.
(a) Reagan-Udall Foundation for the Food and Drug Administration.--
Section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(n)) is amended by striking ``$500,000 and not more than
$1,250,000'' and inserting ``$1,250,000 and not more than $5,000,000''.
(b) Foundation for the National Institutes of Health.--Section
499(l) of the Public Health Service Act (42 U.S.C. 290b(l)) is amended
by striking ``$500,000 and not more than $1,250,000'' and inserting
``$1,250,000 and not more than $5,000,000''.
Subtitle C--Protections for Good Samaritan Health Professionals
SEC. 1021. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
PROFESSIONALS.
(a) In General.--Title II of the Public Health Service Act (42
U.S.C. 202 et seq.) is amended by inserting after section 224 the
following:
``SEC. 224A. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
PROFESSIONALS.
``(a) Limitation on Liability.--Except as provided in subsection
(b), a health care professional shall not be liable under Federal or
State law for any harm caused by an act or omission of the professional
in the provision of health care services if--
``(1) the professional is serving, for purposes of
responding to a disaster, as a volunteer; and
``(2) the act or omission occurs--
``(A) during the period of the disaster, as
determined under the laws listed in subsection (d)(1);
``(B) in the State or States for which the disaster
is declared;
``(C) in the health care professional's capacity as
a volunteer;
``(D) in the course of providing services that are
within the scope of the license, registration, or
certification of the volunteer, as defined by the State
of licensure, registration, or certification; and
``(E) in a good faith belief that the individual
being treated is in need of health care services.
``(b) Exceptions.--Subsection (a) does not apply if--
``(1) the harm was caused by an act or omission
constituting willful or criminal misconduct, gross negligence,
reckless misconduct, or a conscious flagrant indifference to
the rights or safety of the individual harmed by the health
care professional; or
``(2) the health care professional rendered the health care
services under the influence (as determined pursuant to
applicable State law) of alcohol or an intoxicating drug.
``(c) Preemption.--
``(1) In general.--This section preempts the laws of a
State or any political subdivision of a State to the extent
that such laws are inconsistent with this section, unless such
laws provide greater protection from liability.
``(2) Volunteer protection act.--Protections afforded by
this section are in addition to those provided by the Volunteer
Protection Act of 1997.
``(d) Definitions.--In this section:
``(1) The term `disaster' means--
``(A) a national emergency declared by the
President under the National Emergencies Act;
``(B) an emergency or major disaster declared by
the President under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act; or
``(C) a public health emergency that is determined
by the Secretary under section 319 of this Act with
respect to one or more States specified in such
determination--
``(i) during only the initial period
covered by such determination; and
``(ii) excluding any period covered by a
renewal of such determination.
``(2) The term `harm' includes physical, nonphysical,
economic, and noneconomic losses.
``(3) The term `health care professional' means an
individual who is licensed, registered, or certified under
Federal or State law to provide health care services.
``(4) The term `health care services' means any services
provided by a health care professional, or by any individual
working under the supervision of a health care professional,
that relate to--
``(A) the diagnosis, prevention, or treatment of
any human disease or impairment; or
``(B) the assessment or care of the health of a
human being.
``(5) The term `State' includes each of the several States,
the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa, the Northern Mariana
Islands, and any other territory or possession of the United
States.
``(6)(A) The term `volunteer' means a health care
professional who, with respect to the health care services
rendered, does not receive--
``(i) compensation; or
``(ii) any other thing of value in lieu of
compensation, in excess of $500 per year.
``(B) For purposes of subparagraph (A), the term
`compensation'--
``(i) includes payment under any insurance policy
or health plan, or under any Federal or State health
benefits program; and
``(ii) excludes--
``(I) reasonable reimbursement or allowance
for expenses actually incurred;
``(II) receipt of paid leave; and
``(III) receipt of items to be used
exclusively for rendering the health services
in the health care professional's capacity as a
volunteer described in subsection (a)(1).''.
(b) Effective Date.--
(1) In general.--Section 224A of the Public Health Service
Act, as added by subsection (a), shall take effect 90 days
after the date of the enactment of this Act.
(2) Application.--Section 224A of the Public Health Service
Act, as added by subsection (a), applies to a claim for harm
only if the act or omission that caused such harm occurred on
or after the effective date described in paragraph (1).
SEC. 1022. SENSE OF THE CONGRESS.
It is the sense of Congress that--
(1) health care professionals should be encouraged to
register with the Emergency System for Advance Registration of
Volunteer Health Professionals (ESAR-VHP), and States should
employ online registration with the promptest processing
possible of such registrations to foster the rapid deployment
and utilization of volunteer health care professionals
following a disaster;
(2) Federal and State agencies and licensing boards should
cooperate to facilitate the timely movement of properly
licensed volunteer health care professionals to areas affected
by a disaster; and
(3) the appropriate licensing entities should verify the
licenses of volunteer health care professionals serving
disaster victims as soon as is reasonably practical following a
disaster.
Subtitle D--Medical Sheltering
SEC. 1031. REDUCING THE SPREAD OF COVID-19 THROUGH PAYMENTS TO STATES
TO LEASE HOTELS TO TEMPORARILY HOUSE ELIGIBLE
INDIVIDUALS.
(a) In General.--The Secretary of Health and Human Services may
make payments to States to lease hotels to temporarily house, on a
voluntary basis, eligible individuals.
(b) Formula.--The Secretary shall allocate the amount appropriated
to carry out this section pursuant to a formula developed by the
Secretary that--
(1) distributes the amount among the States that--
(A) submit applications in accordance with
subsection (c); and
(B) are determined by the Secretary to need such
payments; and
(2) takes into consideration--
(A) the number of active cases of individuals
infected with COVID-19 in the applying State relative
to the overall population of the State; and
(B) the average income of individuals in the
applying State relative to the average income of
individuals in the United States.
(c) Applications.--
(1) In general.--To seek a payment under this section, a
State shall submit an application to the Secretary at such
time, in such manner, and containing such information and
assurances as the Secretary may require.
(2) Process.--The Secretary shall--
(A) not later than 15 days after the date of
enactment of this Act, publish the process for States
to apply for payments under this section; and
(B) not later than 15 days after the submission of
an application in accordance with such process, approve
or disapprove the application.
(3) Contents.--The Secretary shall require the application
of a State under this section to include--
(A) a plan for leasing hotels as described in
subsection (a);
(B) health guidelines which the State will require
to be implemented to protect the staff of the hotels;
(C) the rates to be paid to lease the hotels;
(D) a plan to ensure that the hotels each have--
(i) workplace safety standards for their
staff;
(ii) proper personal protective equipment
and sanitation supplies;
(iii) a cleaning protocol for rooms and
facilities; and
(iv) at least one qualified health care
professional onsite or on call to monitor the
health of individuals being housed at the
hotels;
(E) a plan to feed and provide other necessary
materials to individuals described in subsection (a) at
the hotels, including medications and hygiene products,
without letting such individuals leave their rooms or
accept visitors;
(F) a plan to assist the hotels in removing
individuals who attempt to continue their stay after
the allotted time;
(G) a plan for hospital networks, local health
departments, and the hotels to coordinate on the
exchange and protection of patient information in
accordance with other applicable law;
(H) a plan to effectively communicate the State's
program funded through this section to racial and
ethnic minority groups and low-income communities; and
(I) each funding assurance listed in subsection
(e).
(d) No Responsibility for Diet or Administration of Medicine.--
Notwithstanding subsection (c)(3)(E), a contract between a State and a
hotel pursuant to this section shall not make the hotel responsible for
the diet of, or the administration of medications to, individuals
described in subsection (a).
(e) Funding Assurances.--As a condition on receipt of a payment of
this section, a State shall give such assurances as the Secretary may
require that--
(1) each contract between the State and a hotel pursuant to
this section will be entered into on a voluntary basis, and no
hotel will be required by the State to participate in the
program under this section;
(2) individuals described in subsection (a) will not be
charged for their lodging at a hotel pursuant to this section,
except that such individuals may be required to reimburse the
costs of receiving food and beverages;
(3) individuals described in subsection (a) will retain the
option of self-isolating at home (including the option of
checking out early and returning to their homes) rather than
being required to stay at a hotel funded pursuant to this
section;
(4) before an individual is allowed to stay at a hotel
pursuant to this section, the individual will be required to
present, in such form and manner as may be required by the
local department of health, documentation from a physician that
the individual meets the criteria described in subsection (a);
(5) any non-transient homeless population residing at a
hotel will not be displaced for purposes of entering into or
carrying out a contract between the State and the hotel under
this section; and
(6) the State will pay (from funds provided to the State
under this section or from other State funds)--
(A) at least 40 percent of the costs of the
personal protective equipment and sanitation supplies
needed by individuals staying at a hotel pursuant to
this section and the staff of such hotel; and
(B) all of the costs of having one or more
qualified health care professionals described in
subsection (c)(3)(D)(iii) for the provision of
monitoring described in such subsection (whether by
being onsite or on call).
(f) Review.--At the conclusion of the program under this section,
the Inspector General of the Department of Health and Human Services
shall--
(1) review the program and activities of each State funded
pursuant to this section; and
(2) submit a report on the results of the review to--
(A) the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of
Representatives; and
(B) the Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of the Senate.
(g) Liability Protection.--
(1) In general.--Except as provided under paragraph (2), a
hotel or member of the staff shall not be liable under Federal
or State law for--
(A) any harm caused by an act or omission in the
provision of hotel services pursuant to this section;
or
(B) failing to keep an individual who is staying at
a hotel pursuant to this section isolated from people
other than the staff of the hotel and any qualified
health care professional described in subsection
(c)(3)(D)(iii).
(2) Exception.--Paragraph (1) does not apply in the case
that the harm was caused by an act or omission constituting
willful or criminal misconduct, gross negligence, reckless
misconduct, or a conscious flagrant indifference to the rights
or safety of the individual harmed.
(h) Definitions.--In this section:
(1) The term ``eligible individual'' means an individual
who is unable to self-isolate at home, does not require
inpatient or outpatient health care treatment, and--
(A) has a laboratory-confirmed case of COVID-19;
(B) has a presumptive positive case of COVID-19; or
(C) is a person under investigation who is
displaying symptoms of COVID-19.
(2) The terms ``Indian tribe'' and ``tribal organization''
have the meanings given to those terms in section 4 of the
Indian Self-Determination and Education Assistance Act (25
U.S.C. 5304).
(3) The term ``Secretary'' means the Secretary of Health
and Human Services.
(4) The term ``State'' includes each of 50 States, the
District of Columbia, each Indian Tribe and tribal
organization, Guam, American Samoa, the United States Virgin
Islands, the Commonwealth of Puerto Rico, and the Commonwealth
of the Northern Mariana Islands.
(i) Funding.--To carry out this section, there is authorized to be
appropriated $1,000,000,000, to remain available through the earlier
of--
(1) the end of calendar year 2021; or
(2) the end of the emergency period (as defined in section
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-
5(g)(1)(B))).
Subtitle E--CDC Campaign on COVID-19 Awareness
SEC. 1041. COVID-19 PUBLIC AWARENESS CAMPAIGN.
The Secretary of Health and Human Services, acting through the
Director of the Centers for Disease Control and Prevention and in
coordination with other offices and agencies, as appropriate, shall
award competitive grants or contracts to one or more public or private
entities to carry out a national campaign that is multilingual and
culturally competent and based on available scientific evidence to
increase awareness and knowledge of COVID-19, including reducing stigma
associated with COVID-19 and improving information on the availability
of diagnostic testing and other related services at community health
centers.
Subtitle F--Protecting Children From COVID-19
SEC. 1051. STUDY ON CHILDREN'S ROLE IN TRANSMITTING SARS-COV-2.
(a) Study.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary''), in
coordination with the heads of agencies of the Department of
Health and Human Services and experts from outside of the
Department, as appropriate, shall complete a study on
children's role in transmitting SARS-CoV-2.
(2) Issues to be studied.--The study under paragraph (1)
shall address--
(A) the transmissibility of COVID-19 from child to
child, child to adult, and adult to child;
(B) the vulnerability of children, especially those
with underlying health conditions, to severe illness as
such vulnerability relates to COVID-19;
(C) the vulnerability of adults, especially those
with underlying health conditions, who send their
children back to school; and
(D) the vulnerability of adults, especially those
with underlying health conditions, who interact with
children who may be asymptomatic but infectious.
(3) Considerations.--In carrying out the study under
paragraph (1), the Secretary shall--
(A) take into consideration the best available
science, including as provided by the National Academy
of Sciences; and
(B) ensure that such study includes consideration
of children who are members of racial or ethnic
minority groups.
(b) Reporting.--The Secretary shall submit a report to the Congress
on children's role in transmitting SARS-CoV-2. The report shall include
the results of the study under subsection (a).
(c) Dissemination of Best Practices.--The Secretary shall
disseminate to stakeholders best practices for protecting children and
adults in educational settings. The first best practices disseminated
pursuant to the preceding sentence shall include any best practices for
protecting children and adults in educational settings identified
through the study under subsection (a).
(d) Definition.--In this section, the term ``emergency period'' has
the meaning given to such term in section 1135(g)(1)(B) of the Social
Security Act (42 U.S.C. 1320b-5(g)(1)(B)).
Subtitle G--Ensuring Understanding of COVID-19
SEC. 1061. STUDY ON THE IMPACT OF COVID-19.
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. 404O. STUDY ON THE IMPACT OF COVID-19.
``(a) In General.--The Secretary shall conduct a longitudinal
study, over not less than 10 years, on the full impact of COVID-19 on
infected individuals, including both short-term and long-term health
impacts.
``(b) Timing.--The Secretary shall begin enrolling patients in the
study under this section not later than 6 months after the date of
enactment of this section.
``(c) Requirements.--The study under this section shall--
``(1) be nationwide;
``(2) include diversity of enrollees to account for gender,
age, race, ethnicity, geography, comorbidities, and
underrepresented populations, including pregnant and lactating
women;
``(3) study individuals who were infected with COVID-19 who
experienced mild symptoms, such individuals who experienced
moderate symptoms, and such individuals who experienced severe
symptoms;
``(4) monitor the health outcomes and symptoms of
individuals who were infected with COVID-19, or had prenatal
exposure to COVID-19, including lung capacity and function, and
immune response, taking into account any pharmaceutical
interventions such individuals may have received;
``(5) monitor the mental health outcomes of individuals
infected with COVID-19, taking into account any interventions
that affected mental health; and
``(6) monitor individuals enrolled in the study not less
frequently that twice per year after the first year of the
individual's infection with COVID-19.
``(d) Public-Private Research Network.--For purposes of carrying
out the study under this section, the Director of NIH may develop a
network of public-private research partners, provided that all
research, including the research carried out through any such partner,
is available publicly.
``(e) Summaries of Findings.--The Director of NIH shall make public
a summary of findings under this section not less frequently than once
every 3 months for the first 2 years of the study, and not less
frequently than every 6 months thereafter. Such summaries may include
information about how the findings of the study under this section
compare with findings from research conducted abroad.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section.''.
Subtitle H--Safeguarding Therapeutics
SEC. 1071. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.
(a) In General.--Section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) is amended--
(1) in the fourth sentence, by inserting ``or counterfeit
device'' after ``counterfeit drug''; and
(2) by striking ``The Secretary of the Treasury shall cause
the destruction of'' and all that follows through ``liable for
costs pursuant to subsection (c).'' and inserting the
following: ``The Secretary of the Treasury shall cause the
destruction of any such article refused admission unless such
article is exported, under regulations prescribed by the
Secretary of the Treasury, within 90 days of the date of notice
of such refusal or within such additional time as may be
permitted pursuant to such regulations, except that the
Secretary of Health and Human Services may destroy, without the
opportunity for export, any drug or device refused admission
under this section, if such drug or device is valued at an
amount that is $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation pursuant to
section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C.
1498(a)(1))) and was not brought into compliance as described
under subsection (b). The Secretary of Health and Human
Services shall issue regulations providing for notice and an
opportunity to appear before the Secretary of Health and Human
Services and introduce testimony, as described in the first
sentence of this subsection, on destruction of a drug or device
under the seventh sentence of this subsection. The regulations
shall provide that prior to destruction, appropriate due
process is available to the owner or consignee seeking to
challenge the decision to destroy the drug or device. Where the
Secretary of Health and Human Services provides notice and an
opportunity to appear and introduce testimony on the
destruction of a drug or device, the Secretary of Health and
Human Services shall store and, as applicable, dispose of the
drug or device after the issuance of the notice, except that
the owner and consignee shall remain liable for costs pursuant
to subsection (c).''.
(b) Definition.--Section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h)) is amended--
(1) by redesignating subparagraphs (1), (2), and (3) as
clauses (A), (B), and (C), respectively; and
(2) after making such redesignations--
(A) by striking ``(h) The term'' and inserting
``(h)(1) The term''; and
(B) by adding at the end the following:
``(2) The term `counterfeit device' means a device which, or the
container, packaging, or labeling of which, without authorization,
bears a trademark, trade name, or other identifying mark, imprint, or
symbol, or any likeness thereof, or is manufactured using a design, of
a device manufacturer, packer, or distributor other than the person or
persons who in fact manufactured, packed, or distributed such device
and which thereby falsely purports or is represented to be the product
of, or to have been packed or distributed by, such other device
manufacturer, packer, or distributor.
``(3) For purposes of subparagraph (2)--
``(A) the term `manufactured' refers to any of the
following activities: manufacture, preparation, propagation,
compounding, assembly, or processing; and
``(B) the term `manufacturer' means a person who is engaged
in any of the activities listed in clause (A).''.
SEC. 1072. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this subtitle, for the purpose of
complying with the Statutory Pay-As-You-Go Act of 2010, shall be
determined by reference to the latest statement titled ``Budgetary
Effects of PAYGO Legislation'' for this subtitle, submitted for
printing in the Congressional Record by the Chairman of the House
Budget Committee, provided that such statement has been submitted prior
to the vote on passage.
Subtitle I--Advisory Committee on Immunization Practices
SEC. 1081. EXPEDITED MEETING OF ACIP FOR COVID-19 VACCINES.
(a) In General.--Notwithstanding section 3091 of the 21st Century
Cures Act (21 U.S.C. 360bbb-4 note), the Advisory Committee on
Immunization Practices shall meet and issue a recommendation with
respect to a vaccine that is intended to prevent or treat COVID-19 not
later than 15 business days after the date on which such vaccine is
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262) or authorized under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3).
(b) 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.
Subtitle J--Improvements to Transparency of the Pricing of Diagnostic
Testing for COVID-19
SEC. 1091. IMPROVEMENTS TO TRANSPARENCY OF THE PRICING OF DIAGNOSTIC
TESTING FOR COVID-19.
(a) In General.--Section 3202 of the CARES Act (Public Law 116-136)
is amended--
(1) in subsection (b)--
(A) in the heading, by inserting ``and Related
Items and Services'' after ``Diagnostic Testing for
COVID-19'';
(B) in paragraph (1)--
(i) by striking ``a diagnostic test for
COVID-19'' and inserting ``a test, item, or
service described in section 6001(a) of
division F of the Families First Coronavirus
Response Act (Public Law 116-127)''; and
(ii) by striking ``such test'' and
inserting ``such test, item, or service''; and
(C) in paragraph (2), by striking ``a diagnostic
test for COVID-19'' and inserting ``a test, item, or
service described in section 6001(a) of division F of
the Families First Coronavirus Response Act (Public Law
116-127)''; and
(2) by adding at the end the following new subsections:
``(c) Improvements to Transparency Policy.--
``(1) In general.--Not later than 30 days after the date of
the enactment of this subsection, the Secretary of Health and
Human Services shall survey providers subject to the
requirement under subsection (b) regarding the cash prices
referred to in such subsection.
``(2) Representative sample.--In carrying out paragraph
(1), the Secretary shall survey a sample of providers that is
representative of the diversity of sizes, geographic locations,
and care settings (such as hospitals, laboratories, and
independent freestanding emergency departments) in which
diagnostic testing for COVID-19 is performed.
``(3) Consumer complaints.--The Secretary shall ensure that
consumers have a method to submit complaints to the Department
of Health and Human Services that identify providers that--
``(A) may be in violation of subsection (b); and
``(B) have not made public a cash price in
accordance with such subsection.
``(d) Public Report.--Not later than 60 days after the date of the
enactment of this subsection, the Secretary of Health and Human
Services shall publish on the internet website of the Department of
Health and Human Services a report on cash prices for items and
services published under subsection (b)(1) during the period beginning
on the date of the enactment of this Act and ending on the date of the
enactment of this subsection, which shall include--
``(1) the percentage of providers that comply with the
requirement under such subsection;
``(2) the average cash price for each such item and service
published under such subsection; and
``(3) any providers identified pursuant to paragraph (2) or
(3) of subsection (c) and found to be in violation of such
requirement.''.
TITLE II--DOMESTIC MANUFACTURING AND SUPPLY CHAIN
Subtitle A--Sustained On-Shore Manufacturing Capacity for Public Health
Emergencies
SEC. 2001. SUSTAINED ON-SHORE MANUFACTURING CAPACITY FOR PUBLIC HEALTH
EMERGENCIES.
(a) In General.--Section 319L of the Public Health Service Act (42
U.S.C. 247d-7e) is amended--
(1) in subsection (a)(6)(B)--
(A) by redesignating clauses (iv) and (v) as
clauses (v) and (vi), respectively;
(B) by inserting after clause (iii), the following:
``(iv) activities to support domestic
manufacturing surge capacity of products or
platform technologies, including manufacturing
capacity and capabilities to utilize platform
technologies to provide for flexible
manufacturing initiatives;''; and
(C) in clause (vi) (as so redesignated), by
inserting ``manufacture,'' after ``improvement,'';
(2) in subsection (b)--
(A) in the first sentence of paragraph (1), by
inserting ``support for domestic manufacturing surge
capacity,'' after ``initiatives for innovation,''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking
``and'' at the end;
(ii) by redesignating subparagraph (C) as
subparagraph (D); and
(iii) by inserting after subparagraph (B),
the following:
``(C) activities to support manufacturing surge
capacities and capabilities to increase the
availability of existing medical countermeasures and
utilize existing novel platforms to manufacture new
medical countermeasures to meet manufacturing demands
to address threats that pose a significant level of
risk to national security; and'';
(3) in subsection (c)--
(A) in paragraph (2)--
(i) in subparagraph (C), by striking
``and'' at the end;
(ii) in subparagraph (D), by striking the
period and inserting ``; and''; and
(iii) by adding at the end the following:
``(E) promoting domestic manufacturing surge
capacity and capabilities for countermeasure advanced
research and development, including facilitating
contracts to support flexible or surge
manufacturing.'';
(B) in paragraph (4)--
(i) in subparagraph (B)--
(I) in clause (iii), by striking
``and'' at the end;
(II) in clause (iv), by striking
the period and inserting ``; and''; and
(III) by adding at the end the
following:
``(v) support and maintain domestic
manufacturing surge capacity and capabilities,
including through contracts to support flexible
or surge manufacturing, to ensure that
additional production of countermeasures is
available in the event that the Secretary
determines there is such a need for additional
production.'';
(ii) in subparagraph (D)--
(I) in clause (ii), by striking
``and'' at the end;
(II) by redesignating clause (iii)
as clause (iv); and
(III) by inserting after clause
(ii) the following:
``(iii) research to advance manufacturing
capacities and capabilities for medical
countermeasures and platform technologies that
may be utilized for medical countermeasures;
and''; and
(iii) in subparagraph (E), by striking
clause (ix); and
(C) in paragraph (7)(C)(i), by striking ``up to 100
highly qualified individuals, or up to 50 percent of
the total number of employees, whichever is less,'' and
inserting ``75 percent of the total number of
employees'';
(4) in subsection (e)(1)--
(A) by redesignating subparagraphs (B) through (D)
as subparagraphs (C) through (E), respectively; and
(B) by inserting after subparagraph (A), the
following:
``(B) Temporary flexibility.--During a public
health emergency under section 319, the Secretary shall
be provided with an additional 60 business days to
comply with information requests for the disclosure of
information under section 552 of title 5, United States
Code, related to the activities under this section
(unless such activities are otherwise exempt under
subparagraph (A)).''; and
(5) in subsection (f)--
(A) in paragraph (1), by striking ``Not later than
180 days after the date of enactment of this
subsection'' and inserting ``Not later than 180 days
after the date of enactment of the Commitment to Defeat
the Virus and Keep America Healthy Act''; and
(B) in paragraph (2), by striking ``Not later than
1 year after the date of enactment of this subsection''
and inserting ``Not later than 1 year after the date of
enactment of the Commitment to Defeat the Virus and
Keep America Healthy Act''.
(b) Medical Countermeasure Innovation Partner.--The restrictions
under section 202 of division A of the Further Consolidated
Appropriations Act, 2020 (Public Law 116-94), or any other provision of
law imposing a restriction on salaries of individuals related to a
previous appropriation to the Department of Health and Human Services,
shall not apply with respect to salaries paid pursuant to an agreement
under the medical countermeasure innovation partner program under
section 319L(c)(4)(E) of the Public Health Service Act (42 U.S.C. 247d-
7e(c)(4)(E)).
Subtitle B--Manufacturing API, Drugs, and Excipients in America
SEC. 2011. REPORT TO CONGRESS ON BARRIERS TO DOMESTIC MANUFACTURING OF
MEDICAL PRODUCTS AND SUPPLIES.
(a) Report.--Not later than January 1, 2021, the Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') 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 barriers to domestic
manufacturing of active pharmaceutical ingredients, drugs, and devices
that are manufactured outside of the United States.
(b) Contents.--Such report shall--
(1) identify factors that limit or otherwise discourage the
domestic manufacturing of active pharmaceutical ingredients,
drugs, and devices that are currently manufactured outside of
the United States, including any Federal, State, local, or
Tribal laws and regulations that hinder domestic manufacturing
opportunities; and
(2) recommend specific strategies to overcome the
challenges identified under paragraph (1), including
strategies--
(A) to develop effective incentives for domestic
manufacturing; and
(B) to make changes to laws or regulations that
hinder domestic manufacturing opportunities.
(c) Consultation.--In carrying out the report under subsection (a),
the Secretary shall consult with--
(1) the Food and Drug Administration, the Centers for
Medicare & Medicaid Services, the Department of Defense, the
Department of Commerce, the Department of State, the Department
of Veterans Affairs, the Department of Justice, and any other
Federal agencies as appropriate; and
(2) relevant stakeholders, including drug, device, and
active pharmaceutical ingredient manufacturers, and other
entities, as appropriate.
(d) Definition.--In this section, the term ``active pharmaceutical
ingredient'' has the meaning given to such term in section 207.1 of
title 21, Code of Federal Regulations (and any successor regulations).
(e) Publication.--The Secretary shall make the report under
subsection (a) available on the public website of the Department of
Health and Human Services.
SEC. 2012. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC HEALTH
ASSESSMENT WITH REGARD TO COMPLIANCE ACTIVITIES.
(a) Benefit/Risk Framework.--
(1) In general.--Paragraph (2) of section 704(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) is
amended by adding at the end the following: ``The Secretary
shall ensure timely and effective coordination among such
offices regarding the reviews of such report and the alignment
of any feedback regarding such report, and any corrective or
preventive actions in response to such report, after
consideration of the benefits and risks to the public health,
patient safety, the drug supply and drug supply chain, and
timely patient access to drugs.''.
(2) Annual reporting.--Subsection (b) of section 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended
by adding at the end the following new paragraph:
``(3) On an annual basis, the Secretary shall prepare a report on
the utilization of the framework described in paragraph (2) and post
such report on the public website of the Food and Drug
Administration.''.
(3) Applicability.--The amendments made by paragraphs (1)
and (2) shall take effect on the effective date described in
section 3112 of the CARES Act (Public Law 116-136), after
executing the amendments made by such section 3112, and shall
apply beginning on the date that is 1 year after the date of
enactment of this Act.
(b) Public Meeting.--The Secretary of Health and Human Services
shall publish in the Federal Register a notice of a public meeting to
be held no later than six months after the date of enactment of this
Act to discuss and obtain input and recommendations from public
stakeholders, including patient advocates, consumers, regulated
industry, and health care providers, regarding the contents of a
benefit/risk framework described in section 704(b)(2) of the Federal
Food, Drug, and Cosmetic Act, as amended by subsection (a), that
supports a safe, stable, redundant drug supply chain.
(c) Guidance.--The Secretary of Health and Human Services shall--
(1) not later than one year after the date on which the
public meeting described in subsection (b) is held, issue draft
guidance regarding the goals and implementation of a benefit/
risk framework described in subsection (b); and
(2) not later than two years after such date of enactment,
issue final guidance with respect to the implementation of such
a framework.
SEC. 2013. ENCOURAGING INTERNATIONAL HARMONIZATION.
(a) GAO Study.--Not later than one year after the date of enactment
of this Act, the Comptroller General of the United States shall issue a
report evaluating--
(1) the consistency with which the International Conference
on Harmonisation (in this section referred to as ``ICH'')
guidelines on good manufacturing practices, including ICH
Guidelines Q8-11, are being implemented by drug regulatory
authorities across countries and international regions;
(2) whether domestic active pharmaceutical ingredient
manufacturers (including any such contract manufacturers) are
provided sufficient opportunity to participate with regulatory
authorities in the development of guidelines prior to
implementation;
(3) whether divergence from ICH guidelines or differing
regulatory standards or requirements by drug regulatory
authorities across countries and international regions
creates--
(A) inefficiencies in drug manufacturing;
(B) incompatible requirements that can contribute
to or exacerbate drug shortages; and
(C) the most common areas of divergence between ICH
guidelines and regulatory standards and requirements by
drug regulatory authorities across countries and
international regions that, if rectified, may reduce
the inefficiencies and incompatibilities identified
pursuant to subparagraphs (A) and (B).
(b) International Training Program.--Not later than two years after
the date of enactment of this Act, informed by the needs identified in
the report issued pursuant to subsection (a), the Secretary of Health
and Human Services, in conjunction with drug regulatory authorities
across countries and international regions and the ICH, shall develop
and implement a training program for drug regulatory authorities across
countries and international regions to promote consistent application
of and reduce divergence from ICH guidelines on good manufacturing
practices.
SEC. 2014. MUTUAL RECOGNITION AGREEMENTS FOR INSPECTIONS AND REVIEW
ACTIVITIES.
(a) Mutual Recognition of Inspections.--Pursuant to section 809 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e), the
Secretary of Health and Human Services (in this section referred to as
the ``Secretary'') shall establish or expand initiatives for mutual
sharing of review and inspection findings between drug regulatory
authorities across countries and international regions, such as through
the Pharmaceutical Cooperation Inspection Scheme, the Mutual
Recognition Agreement with the European Union, and the Australia-
Canada-Singapore-Switzerland Consortium, to--
(1) reduce the potential for duplicative regulatory
evaluation of medical products regulated by the Food and Drug
Administration; and
(2) more constructively allocate appropriations to the Food
and Drug Administration, including those attributable to user
fees, to harmonized regulatory processes.
(b) Additional Countries, Regions, and Evaluation.--In carrying out
subsection (a), the Secretary may expand the initiatives to include--
(1) additional countries and geographic regions with
established and competent regulatory frameworks; and
(2) additional types of regulatory evaluation, including
with respect to--
(A) good manufacturing practice inspections; and
(B) approval of changes to the manufacturing of
drugs for which an approval or licensure is in effect
under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C. 262).
(c) Implementation Framework.--
(1) Publication.--Not later than one year after the date of
enactment of this Act, the Secretary shall publish an
implementation framework for the agreements to share review and
inspection findings under subsection (a) on the public website
of the Food and Drug Administration.
(2) Contents.--The implementation framework under this
subsection shall--
(A) include the timeline for establishing or
expanding initiatives described in subsection (a);
(B) describe additional types of regulatory
processes that will become subject to such initiatives;
(C) specify the countries and geographic regions
where such initiatives will be established or expanded;
and
(D) identify additional opportunities and
challenges for expanding mutual recognition agreements
in drug and biologic regulation.
(d) Annual Reporting.--
(1) In general.--Not later than the end of calendar year
2020 and annually thereafter, the Secretary shall publish a
report on the public website of the Food and Drug
Administration on the utilization of agreements described in
subsection (c)(1) in the previous fiscal year.
(2) Contents.--The report under paragraph (1) shall include
each of the following:
(A) The total number of establishments that are
registered under section 510(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360) and located
outside of the United States, and of these
establishments, the number in each region of interest.
(B) The total number of inspections conducted at
establishments described in subparagraph (A).
(C) Of the inspections described in subparagraph
(B), the total number of inspections in each of region
of interest.
(D) Of the inspections in each region of interest
reported pursuant to subparagraph (C), the number of
inspections in each FDA inspection category.
(E) Of the number of inspections reported under
each of subparagraphs (B), (C), and (D)--
(i) the number of inspections which have
been conducted pursuant to an agreement
described in subsection (c)(1); and
(ii) the number of inspections which have
been conducted by employees or other agents of
the Food and Drug Administration.
(3) Definitions.--In this subsection:
(A) The term ``region of interest'' refers to
China, India, the European Union, and any other
geographic region as determined appropriate by the
Secretary.
(B) The term ``FDA inspection category'' means
refers to the following inspection categories:
(i) Inspections to support an approval of a
drug under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act
(42 U.S.C. 262).
(ii) Good manufacturing practice
inspections.
(iii) For-cause inspections.
SEC. 2015. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION
TIMELINES.
Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355
note) is amended to read as follows:
``SEC. 902. ANNUAL REPORT ON INSPECTIONS.
``Not later than March 1 of each year, the Secretary of Health and
Human Services shall post on the public website of the Food and Drug
Administration information related to inspections of facilities
necessary for approval of a drug under subsection (c) or (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355),
approval of a device under section 515 of such Act (21 U.S.C. 360e), or
clearance of a device under section 510(k) of such Act (21 U.S.C.
360(k)) that were conducted during the previous calendar year. Such
information shall include the following:
``(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or report
to the beginning of the inspection, and the median time from
the beginning of an inspection to the issuance of a report
pursuant to section 704(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(b)), including--
``(A) the median time for drugs described in
505(j)(11)(A)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
``(B) the median time for drugs described in
section 506C(a) of such Act (21 U.S.C. 356c(a)) only;
and
``(C) the median time for drugs on the drug
shortage list in effect under section 506E of such Act
(21 U.S.C. 356f).
``(2) The median time from the issuance of a report
pursuant to such section 704(b) to the sending of a warning
letter, issuance of an import alert, or holding of a regulatory
meeting for inspections for which the Secretary concluded that
regulatory or enforcement action was indicated, including the
median time for each category of drugs listed in subparagraphs
(A) through (C) of paragraph (1).
``(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
to resolution of the regulatory or enforcement action indicated
for inspections for which the Secretary concluded that such
action was indicated.
``(4) The number of times that a facility was issued a
report pursuant to such section 704(b) and approval of an
application was delayed due to the issuance of a withhold
recommendation, including the number of such times for each
category of drugs listed in subparagraphs (A) through (C) of
paragraph (1).''.
SEC. 2016. ADVANCED MANUFACTURING TECHNOLOGIES PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
``SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES PROGRAM.
``(a) In General.--Not later than 1 year after the date of
enactment of the Commitment to Defeat the Virus and Keep America
Healthy Act, the Secretary shall continue in effect the program to
evaluate new drug manufacturing technologies that are included in an
application, or supplement to an application, for a drug under
subsection (b) or (j) of section 505 of this Act or for a biological
product submitted under subsection (a) or (k) of section 351 of the
Public Health Service Act.
``(b) Designation.--The Secretary shall designate a method of
manufacturing a drug as an advanced manufacturing technology under this
section if the drug manufacturer demonstrates that such technology is
likely to--
``(1) prevent or resolve a drug shortage;
``(2) maintain an adequate supply of critical medications
for national emergencies; or
``(3) promote the adoption of innovative approaches to drug
product design and manufacturing.
``(c) Consultation.--If the Secretary designates a method of
manufacturing as an advanced manufacturing technology under this
section, the Secretary shall take actions to expedite the development
and implementation of such method of manufacture for purposes of
approval of the application under subsection (c) or (j) of section 505
of this Act or subsection (a) or (k) of section 351 of the Public
Health Service Act, which may include, as appropriate--
``(1) holding meetings between the sponsor of the
application and appropriate Food and Drug Administration staff
throughout the development of the technology;
``(2) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the technology; and
``(3) involving senior managers and experienced staff of
the Food and Drug Administration, as appropriate, in a
collaborative, cross-disciplinary review of the method of
manufacturing.
``(d) Evaluation of an Advanced Manufacturing Technology.--
``(1) Package.--A sponsor who receives designation of an
advanced manufacturing technology under this section shall
provide the Secretary with a package of scientific evidence
supporting the implementation of the advanced manufacturing
technology in a particular context-of-use.
``(2) Evaluation.--Within 90 days of receiving the package,
the Secretary shall determine whether a designated advanced
manufacturing technology is validated for the proposed context
of use based on the scientific merit the supporting evidence
provided by the sponsor.
``(3) Effect of approval.--Upon approval, the same sponsor
may rely upon the advanced manufacturing technology for use
across multiple manufacturing product lines within the same
context-of-use without having to re-submit data to the
Secretary validating the underlying technology.
``(e) Implementation and Reporting.--
``(1) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting to be held no
later than 1 year after the date of enactment of the Commitment
to Defeat the Virus and Keep America Healthy Act to discuss and
obtain input and recommendations from stakeholders regarding
the goals and scope of, and a suitable framework and procedures
and requirements for, the program under this section.
``(2) Program guidance.--The Secretary shall--
``(A) not later than 1 year after the date of
enactment of the Commitment to Defeat the Virus and
Keep America Healthy Act, issue draft guidance
regarding the goals and implementation of the program
under this section; and
``(B) not later than 2 years after the date of
enactment of the Commitment to Defeat the Virus and
Keep America Healthy Act, issue final guidance with
respect to the implementation of such program.
``(3) Report.--The Secretary shall make available on the
public website of the Food and Drug Administration an annual
report on the progress of the program under this section.''.
Subtitle C--Improving the American Drug Supply Chain
SEC. 2021. STUDY AND REPORTING ON DOMESTIC AND FOREIGN PRODUCTION.
(a) In General.--The Secretary of Health and Human Services shall
enter into an agreement with the National Academies of Sciences,
Engineering, and Medicine (referred to in this section as the
``National Academies'') under which, not later than 24 months after the
date of enactment of this Act, the National Academies will--
(1) study the current and historical production of drugs
and key ingredients thereof (including active pharmaceutical
ingredients) in the United States and in foreign countries;
(2) formulate recommendations for promoting increased
production of drugs and key ingredients thereof (including
active pharmaceutical ingredients) in the United States; and
(3) in a manner that does not compromise national security
or disclose trade secrets or other confidential commercial
information that is subject to section 552(b)(4) of title 5,
United States Code, or section 1905 of title 18, United States
Code, submit a report to the Congress on--
(A) the findings and conclusions of the study under
paragraph (1); and
(B) the recommendations under paragraph (2).
(b) Study Topics.--The study pursuant to subsection (a)(1) shall
include--
(1) evaluation of--
(A) the extent to which production of drugs for use
in the United States and key ingredients thereof
(including active pharmaceutical ingredients) takes
place in the United States; and
(B) the extent to which such production takes place
in foreign countries;
(2) identification of the foreign countries in which such
production takes place;
(3) evaluation of historical changes in the countries in
which such production takes place;
(4) determination of the reasons why such production takes
place in foreign countries, including why such production takes
place in particular foreign countries, including consideration
of--
(A) the reasons for historical migration of such
production to foreign countries, or from foreign
countries to other foreign countries or the United
States;
(B) economic factors, including economic
impediments to domestic production and incentives for
foreign production; and
(C) regulatory, intellectual property,
international trade, and other legal and policy
factors; and
(5) evaluation of the benefits of redundancies in the
supply chain of drugs in the United States in the event of a
public health emergency.
(c) Recommendations.--The agreement under subsection (a) shall--
(1) provide for inclusion in the recommendations under
subsection (a)(2) of measures (which may include statutory,
regulatory, and other policy changes) that should be taken--
(A) to encourage the domestic production of drugs
for use in the United States and key ingredients
thereof (including active pharmaceutical ingredients);
or
(B) to otherwise reduce the risks to the
availability of drugs in the United States in the event
of a public health emergency; and
(2) require consideration, in developing such
recommendations, of--
(A) factors affecting the production of drugs,
including--
(i) access to skilled labor;
(ii) the cost of raw materials, the cost of
energy, and related costs;
(iii) taxes and other incentives; and
(iv) the effects of regulations; and
(B) the costs and consequences of implementing, or
failing to implement, each such recommendation.
(d) Input.--The agreement under subsection (a) shall require--
(1) consideration of input from the Department of Health
and Human Services, the Department of Commerce, and, as
appropriate, other Federal agencies; and
(2) consultation with relevant stakeholders, which--
(A) may include conducting public meetings and
other forms of engagement, as appropriate;
(B) shall include consultation with experts in--
(i) the manufacturing of drugs;
(ii) pharmaceutical industry business and
economics;
(iii) drug purchasing, pricing, and
reimbursement;
(iv) regulatory and intellectual property
issues affecting drug manufacturing;
(v) economics;
(vi) international trade policy; and
(vii) emergency planning; and
(C) may include consultation with other entities
with experience in drug manufacturing and pricing, as
appropriate.
(e) Definitions.--In this section, 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).
Subtitle D--Essential Medicines Strategic Stockpile
SEC. 2031. PILOT PROGRAM ON ENSURING MEDICATION SUPPLY STABILITY.
Part D of title III of the Public Health Service Act (42 U.S.C.
254b et seq.) is amended by adding at the end the following new
subpart:
``Subpart XIII--Ensuring Medication Supply Stability
``SEC. 340J. ENSURING MEDICATION SUPPLY STABILITY.
``(a) Award of Contracts.--Beginning not later than January 1,
2021, the Secretary shall award contracts to eligible entities to each
implement and test the effectiveness of acquiring, maintaining,
managing, and distributing a stockpile that--
``(1) consists of generic drugs at risk of shortage; and
``(2) is of sufficient quantity to ensure that customers in
the United States of the respective eligible entity have access
to such drugs for at least 6 months (as specified by the
Secretary based on the historic demand for those drugs).
``(b) Selection of Drugs.--
``(1) In general.--The Secretary shall--
``(A) select not more than 50 types of drugs that
may be included by eligible entities in a stockpile
pursuant to a contract under this section;
``(B) maintain an up-to-date list of such drugs;
and
``(C) make such list publicly available.
``(2) Choice of eligible entities.--A contract awarded to
an eligible entity under this section need not require the
stockpile of the eligible entity to include all 50 types of
drugs listed pursuant to paragraph (1).
``(c) Sufficient Quantity.--For each generic drug in a stockpile
maintained pursuant to subsection (a), the Secretary shall specify the
quantity of such drug that is sufficient for purposes of such
subsection to ensure that consumers in the United States of the
respective eligible entity have access to such drug for at least 6
months.
``(d) Duration; Liquidation of Inventory.--
``(1) Duration.--A contract awarded under this section
shall be for a term of no more than 3 years.
``(2) Liquidation of inventory.--A drug held in a stockpile
pursuant to a contract under this section may be liquidated by
the eligible entity at the end of the period of the contract.
``(e) Stockpile Requirements.--
``(1) Ensuring availability of unexpired products.--Each
eligible entity with a contract under this section for a
stockpile of generic drugs at risk of shortage shall--
``(A) ensure that each drug maintained in the
stockpile has an expiration date at least 1 year beyond
the current date; and
``(B) to comply with subparagraph (A)--
``(i) sell drugs in the stockpile through
normal commercial channels and replace those
drugs; or
``(ii) if there is no commercial market for
a drug in the stockpile, dispose of the drug,
report such disposal to the Secretary, and
replace the drug.
``(2) Management of stockpile.--
``(A) In general.--Each eligible entity with a
contract under this section for a stockpile of generic
drugs at risk of shortage shall--
``(i) acquire not later than 6 months
following the date the contract is awarded, and
maintain thereafter, a 6-month supply of each
type of drug the eligible entity has contracted
to stockpile, which 6-month supply shall be in
addition to the average levels of inventory
held by such eligible entity over the previous
year for such drug; and
``(ii) if it is not possible to comply with
clause (i), notify the Secretary, citing the
reason why it is not possible and the expected
time of acquisition of the drug.
``(B) Inventory management.--Each eligible entity
with a contract under this section for a stockpile of
generic drugs at risk of shortage shall manage
inventory to ensure that drugs in the stockpile are
efficiently cycled to the commercial market and--
``(i) may stockpile inventory at the
eligible entity's distribution center with
specified inventory amounts virtually reserved
for the Federal Government with constant
cycling to reduce product expiration; or
``(ii) may store stockpiled inventory
separately in a different location and replace
drugs in the stockpile inventory with the same
drug with newer dating.
``(C) Insufficient funds.--If amounts available to
an eligible entity through contracts under this section
are not sufficient to acquire or maintain a 6-month
supply of any drug in the stockpile of the eligible
entity funded under this section, the eligible entity--
``(i) may acquire and maintain less than a
6-month supply, but in no case less than a 3-
month supply; and
``(ii) shall submit a report to the
Secretary identifying--
``(I) each such drug; and
``(II) the reasons why such amounts
are not sufficient to acquire or
maintain a 6-month supply.
``(D) Annual audits.--Not more than annually, the
Secretary may request a physical audit count of the
inventories of all eligible entities with a contract
under this section to validate that each such entity is
maintaining the appropriate amount of stockpiled
inventory.
``(3) Periodic product review.--
``(A) Use of proceeds.--An eligible entity with a
contract under this section for a stockpile of generic
drugs at risk of shortage shall use the proceeds of the
sale of any drugs in the stockpile to purchase drugs
for the stockpile in accordance with this section.
``(B) Market inflation or deflation.--In the case
of market inflation or deflation affecting the price of
a drug in the stockpile of an eligible entity
maintained pursuant to a contract under this section,
the contract shall ensure that the Federal Government
does not profit or suffer loss on items of such drug as
a result of such inflation or deflation.
``(4) Reporting.--Each eligible entity with a contract
under this section shall submit reports at such time and in
such manner as the Secretary may require regarding--
``(A) current inventory levels of stockpiled drugs
at a drug level;
``(B) indicators of current inventory levels of
stockpiled drugs relative to acceptable minimums; and
``(C) such other matters as the Secretary
determines appropriate.
``(f) Contract Terms.--
``(1) Payment of monthly fees for management.--Subject to
paragraph (2), the Secretary shall pay to each eligible entity
with a contract under this section for a stockpile of generic
drugs at risk of shortage appropriate monthly fees for the
management of the stockpile.
``(2) Payment conditioned on stockpile adequacy.--
``(A) In general.--Except as provided in
subparagraph (B), each contract with an eligible entity
under this section shall provide that no payment under
the contract may be made until the entity demonstrates
to the Secretary that the entity has stockpiled such
portion of the total quantity of drugs to be stockpiled
under the contract as the Secretary determines to be
acceptable for payment.
``(B) Exceptions for advance payments.--
``(i) In general.--A contract under this
section may provide that, if the Secretary
determines (in the Secretary's discretion) that
an advance payment, partial payment for
significant milestones, or payment to increase
capacity is necessary to ensure success of the
terms of the contract, the Secretary shall pay,
in advance of delivery, an amount not to exceed
10 percent of the total contract amount to be
paid to the eligible entity by the Secretary
pursuant to the contract over the full period
of the contract.
``(ii) Cost of capital.--A contract under
this section may provide for payments to
compensate the contracting eligible entity for
additional capital requirements related to the
additional inventory to be maintained.
``(iii) Timing.--The Secretary shall, to
the extent practicable, make any determination
under clause (i) to make an advance payment at
the same time as the issuance of a
solicitation.
``(iv) Repayment.--If the Secretary makes
an advance payment pursuant to clause (i), the
Secretary shall require the eligible entity
receiving such advance payment to repay it if
there is a failure to perform by the eligible
entity.
``(3) Termination.--
``(A) In general.--Subject to subparagraph (B),
nothing in this section shall be construed as affecting
the rights of eligible entities under provisions of
statute or regulation (including the Federal
Acquisition Regulation) relating to the termination of
contracts for the convenience of the Government.
``(B) Liquidation of stockpile.--If a contract
under this section is terminated, the eligible entity
with the contract shall liquidate the drugs comprising
the stockpile funded through the contract and return to
the Government any amounts owed in relation to such
drugs, but shall collect the management fees associated
with such liquidation.
``(g) Congressional Oversight.--
``(1) Independent evaluation and report.--Not later than 1
year after the date of enactment of this section and annually
thereafter, the Comptroller General of the United States shall
conduct an independent evaluation, and submit to the
appropriate congressional committees a report, concerning the
program under this section.
``(2) Contents of report.--The report under paragraph (1)
shall review, assess, and provide recommendations, as
appropriate, on the following:
``(A) Details on likely costs and resultant savings
as compared to a stockpiling method that does not
incorporate perpetual inventory cycling.
``(B) Identification of drawdowns from the
stockpile, as evidence of market shortage avoidance.
``(C) The allocation of drugs included in the
stockpiles funded pursuant to this section to the
customers of the eligible entities with contracts under
this section.
``(D) The degree to which eligible entities with
contracts under this section fulfilled their
obligations under such contracts.
``(h) Definitions.--In this section:
``(1) The term `eligible entity' means an entity that meets
each of the following criteria:
``(A) The entity is licensed or registered in
accordance with applicable Federal and State law and in
good standing with respect to such licensure or
registration.
``(B) The entity agrees--
``(i) to purchase all drugs to be
maintained in its stockpile funded under this
section directly from the manufacturers of the
drugs or the exclusive distributors of such
manufacturers; or
``(ii) in the case of an entity that is a
co-op or chain pharmacy warehouse--
``(I) to purchase drugs to be
maintained in its stockpile funded
under this section from an authorized
distributor; and
``(II) distribute those drugs only
to its member pharmacies.
``(C) The entity holds a verified authorized
wholesale distributor certification issued by the
National Association of Boards of Pharmacy.
``(D) The entity sells more than 90 percent of its
drugs to dispensers.
``(E) The entity agrees to distribute inventory
from its stockpile funded under this section only to
dispensers that are customers of the entity.
``(2) The term `generic drug at risk of shortage' means a
drug (as defined in section 201 of the Federal Food, Drug, and
Cosmetic Act) that--
``(A) is approved pursuant to section 505(j) of
such Act;
``(B) is included in the World Health
Organization's most recent Model List of Essential
Medicines;
``(C) is included, at any point during the
preceding 36 months, on the drug shortage list in
effect under section 506E of the Federal Food, Drug,
and Cosmetic Act; and
``(D) is manufactured by 3 or fewer persons that
are registered under section 510 of the Federal Food,
Drug, and Cosmetic Act for purposes of such
manufacture.
``(i) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $120,000,000 for fiscal years
2021 through 2023, to remain available until expended.''.
Subtitle E--National Centers of Excellence in Continuous Pharmaceutical
Manufacturing
SEC. 2041. NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS PHARMACEUTICAL
MANUFACTURING.
(a) In General.--Section 3016 of the 21st Century Cures Act (21
U.S.C. 399h) is amended to read as follows:
``SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS
PHARMACEUTICAL MANUFACTURING.
``(a) In General.--The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs--
``(1) shall solicit and, beginning not later than one year
after the date of enactment of the Commitment to Defeat the
Virus and Keep America Healthy Act, receive requests from
institutions of higher education to be designated as a National
Center of Excellence in Continuous Pharmaceutical Manufacturing
(in this section referred to as a `National Center of
Excellence') to support the advancement and development of
continuous manufacturing; and
``(2) shall so designate any institution of higher
education that--
``(A) requests such designation; and
``(B) meets the criteria specified in subsection
(c).
``(b) Request for Designation.--A request for designation under
subsection (a) shall be made to the Secretary at such time, in such
manner, and containing such information as the Secretary may require.
Any such request shall include a description of how the institution of
higher education meets or plans to meet each of the criteria specified
in subsection (c).
``(c) Criteria for Designation Described.--The criteria specified
in this subsection with respect to an institution of higher education
are that the institution has, as of the date of the submission of a
request under subsection (a) by such institution--
``(1) physical and technical capacity for research and
development of continuous manufacturing;
``(2) manufacturing knowledge-sharing networks with other
institutions of higher education, large and small
pharmaceutical manufacturers, generic and nonprescription
manufacturers, contract manufacturers, and other entities;
``(3) proven capacity to design and demonstrate new, highly
effective technology for use in continuous manufacturing;
``(4) a track record for creating and transferring
knowledge with respect to continuous manufacturing;
``(5) the potential to train a future workforce for
research on and implementation of advanced manufacturing and
continuous manufacturing; and
``(6) experience in participating in and leading a
continuous manufacturing technology partnership with other
institutions of higher education, large and small
pharmaceutical manufacturers, generic and nonprescription
manufacturers, contract manufacturers, and other entities--
``(A) to support companies with continuous
manufacturing in the United States;
``(B) to support Federal agencies with technical
assistance, which may include regulatory and quality
metric guidance as applicable, for advanced
manufacturing and continuous manufacturing;
``(C) with respect to continuous manufacturing, to
organize and conduct research and development
activities needed to create new and more effective
technology, capture and disseminate expertise, create
intellectual property, and maintain technological
leadership;
``(D) to develop best practices for designing
continuous manufacturing; and
``(E) to assess and respond to the workforce needs
for continuous manufacturing, including the development
of training programs if needed.
``(d) Termination of Designation.--The Secretary may terminate the
designation of any National Center of Excellence designated under this
section if the Secretary determines such National Center of Excellence
no longer meets the criteria specified in subsection (c). Not later
than 60 days before the effective date of such a termination, the
Secretary shall provide written notice to the National Center of
Excellence, including the rationale for such termination.
``(e) Conditions for Designation.--As a condition of designation as
a National Center of Excellence under this section, the Secretary shall
require that an institution of higher education enter into an agreement
with the Secretary under which the institution agrees--
``(1) to collaborate directly with the Food and Drug
Administration to publish the reports required by subsection
(g);
``(2) to share data with the Food and Drug Administration
regarding best practices and research generated through the
funding under subsection (f);
``(3) to develop, along with industry partners (which may
include large and small biopharmaceutical manufacturers,
generic and nonprescription manufacturers, and contract
manufacturers) and another institution or institutions
designated under this section, if any, a roadmap for developing
a continuous manufacturing workforce;
``(4) to develop, along with industry partners and other
institutions designated under this section, a roadmap for
strengthening existing, and developing new, relationships with
other institutions; and
``(5) to provide an annual report to the Food and Drug
Administration regarding the institution's activities under
this section, including a description of how the institution
continues to meet and make progress on the criteria listed in
subsection (c).
``(f) Funding.--
``(1) In general.--The Secretary shall award funding,
through grants, contracts, or cooperative agreements, to the
National Centers of Excellence designated under this section
for the purpose of studying and recommending improvements to
continuous manufacturing, including such improvements as may
enable the Centers--
``(A) to continue to meet the conditions specified
in subsection (e); and
``(B) to expand capacity for research on, and
development of, continuing manufacturing.
``(2) Consistency with fda mission.--As a condition on
receipt of funding under this subsection, a National Center of
Excellence shall agree to consider any input from the Secretary
regarding the use of funding that would--
``(A) help to further the advancement of continuous
manufacturing through the National Center of
Excellence; and
``(B) be relevant to the mission of the Food and
Drug Administration.
``(3) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $80,000,000 for
the period of fiscal years 2021 through 2025.
``(4) Rule of construction.--Nothing in this section shall
be construed as precluding a National Center for Excellence
designated under this section from receiving funds under any
other provision of this Act or any other Federal law.
``(g) Annual Review and Reports.--
``(1) Annual report.--Beginning not later than one year
after the date on which the first designation is made under
subsection (a), and annually thereafter, the Secretary shall--
``(A) submit to Congress a report describing the
activities, partnerships and collaborations, Federal
policy recommendations, previous and continuing
funding, and findings of, and any other applicable
information from, the National Centers of Excellence
designated under this section; and
``(B) make such report available to the public in
an easily accessible electronic format on the website
of the Food and Drug Administration.
``(2) Review of national centers of excellence and
potential designees.--The Secretary shall periodically review
the National Centers of Excellence designated under this
section to ensure that such National Centers of Excellence
continue to meet the criteria for designation under this
section.
``(3) Report on long-term vision of fda role.--Not later
than 2 years after the date on which the first designation is
made under subsection (a), the Secretary, in consultation with
the National Centers of Excellence designated under this
section, shall submit a report to the Congress on the long-term
vision of the Department of Health and Human Services on the
role of the Food and Drug Administration in supporting
continuous manufacturing, including--
``(A) a national framework of principles related to
the implementation and regulation of continuous
manufacturing;
``(B) a plan for the development of Federal
regulations and guidance for how advanced manufacturing
and continuous manufacturing can be incorporated into
the development of pharmaceuticals and regulatory
responsibilities of the Food and Drug Administration;
and
``(C) appropriate feedback solicited from the
public, which may include other institutions, large and
small biopharmaceutical manufacturers, generic and
nonprescription manufacturers, and contract
manufacturers.
``(h) Definitions.--In this section:
``(1) Advanced manufacturing.--The term `advanced
manufacturing' means an approach for the manufacturing of
pharmaceuticals that incorporates novel technology, or uses an
established technique or technology in a new or innovative way
(such as continuous manufacturing where the input materials are
continuously transformed within the process by two or more unit
operations) that enhances drug quality or improves the
manufacturing process.
``(2) Continuous manufacturing.--The term `continuous
manufacturing'--
``(A) means a process where the input materials are
continuously fed into and transformed within the
process, and the processed output materials are
continuously removed from the system; and
``(B) consists of an integrated process that
consists of a series of two or more unit operations.
``(3) Institution of higher education.--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)).
``(4) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.''.
(b) Transition Rule.--Section 3016 of the 21st Century Cures Act
(21 U.S.C. 399h), as in effect on the day before the date of the
enactment of this section, shall apply with respect to grants awarded
under such section before such date of enactment.
TITLE III--STRATEGIC NATIONAL STOCKPILE IMPROVEMENTS
Subtitle A--Stockpiling for America's Future Endeavors
SEC. 3001. STRATEGIC NATIONAL STOCKPILE.
Section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-
6b(a)) is amended by adding at the end the following:
``(6) Acceptance of gifts.--
``(A) In general.--The Secretary may, without
further appropriation and without fiscal year
limitation, accept, use, and dispose of gifts,
bequests, or devises of money, services, or property,
both real and personal, for the purpose of carrying out
this subsection. Any such gift, bequest, or devise of
money and proceeds from sales of other property
received as a gift, bequest, or devise shall be
deposited in the Treasury and shall be available for
obligation and expenditure upon order of the Secretary.
``(B) Limitations.--
``(i) Compromising integrity.--The
Secretary may not accept a gift, bequest, or
devise under this paragraph if the Secretary
determines that the use of the property or
services would compromise the integrity or
appearance of integrity of--
``(I) a program of the Department
of Health and Human Services; or
``(II) an individual involved in a
program of the Department.
``(ii) Unapproved products.--The Secretary
may accept a drug or device (as those terms are
defined in section 201 of the Federal Food,
Drug, and Cosmetic Act) as part of a gift,
bequest, or devise under this paragraph only if
such drug or device is--
``(I) a drug that is approved under
section 505 of such Act, that meets the
requirements for marketing under
section 505G of such Act, or that is
licensed under section 351 of this Act;
``(II) a device that is approved
under section 515 of the Federal Food,
Drug, and Cosmetic Act, that is
classified under section 513(f)(2) of
such Act, that is licensed under
section 351 of this Act, that is
cleared under section 510(k) of the
Federal Food, Drug, and Cosmetic Act,
or for which a report is not required
under such section 510(k);
``(III) authorized for emergency
use in accordance with section 564 or
564A of the Federal Food, Drug, and
Cosmetic Act or prepositioned for use
in accordance with section 564B of such
Act;
``(IV) authorized for
investigational use under section 505,
512, or 520 of the Federal Food, Drug,
and Cosmetic Act or section 351 of this
Act;
``(V) determined by the
Commissioner of Food and Drugs to be
appropriate for use, without approval,
licensure, authorization, or clearance,
to respond to a shortage or potential
shortage situation; or
``(VI) a respiratory protective
device approved and determined to be a
priority, as described in section 319F-
3(i)(1)(D) of this Act.
``(C) Report.--
``(i) In general.--The Secretary 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 an annual report
disclosing--
``(I) any gift, bequest, or devise
that was accepted under this paragraph
during the year covered by the report;
``(II) how the gifts, bequests, and
devises contribute to the mission of
the stockpile; and
``(III) the amount of Federal
savings that were generated from the
acceptance of the gifts, bequests, and
devises.
``(ii) Publication.--Each report required
under clause (i) shall be made publicly
available.''.
Subtitle B--Stockpile Inventory Modernization
SEC. 3011. REIMBURSABLE TRANSFERS.
Section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-
6b(a)), as amended by section 3001, is further amended by adding at the
end the following:
``(7) Transfers and reimbursements.--
``(A) In general.--Without regard to chapter 5 of
title 40, United States Code, the Secretary may
transfer to any Federal department or agency, on a
reimbursable basis, any drugs, vaccines and other
biological products, medical devices, and other
supplies in the stockpile if--
``(i) the transferred supplies are less
than one year from expiry;
``(ii) the stockpile is able to replenish
the supplies, as appropriate; and
``(iii) the Secretary decides the transfer
is in the best interest of the United States
Government.
``(B) Use of reimbursement.--Reimbursement derived
from the transfer of supplies pursuant to subparagraph
(A) may, to the extent and in the amounts made
available in advance in appropriations Acts, be used by
the Secretary to carry out this section. Funds made
available pursuant to the preceding sentence are in
addition to any other funds that may be made available
for such purpose.
``(C) Rule of construction.--This paragraph shall
not be construed to preclude transfers of products in
the stockpile under other authorities.
``(D) Report.--Not later than September 30, 2022,
the Secretary 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 each transfer made under this
paragraph and the amount received by the Secretary in
exchange for that transfer.
``(E) Sunset.--The authority to make transfers
under this paragraph shall cease to be effective on
September 30, 2023.''.
Subtitle C--Equipment Maintenance
SEC. 3021. EQUIPMENT MAINTENANCE.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (I), by striking ``; and'' and
inserting a semicolon;
(B) in subparagraph (J), by striking the period at
the end and inserting a semicolon; and
(C) by inserting the following new subparagraph at
the end:
``(K) ensure contents of the stockpile remain in
good working order and, as appropriate, conduct
maintenance services on contents of the stockpile;
and''; and
(2) in subsection (c)(7)(B), by adding at the end the
following new clause:
``(ix) Equipment maintenance service.--In
carrying out this section, the Secretary may
enter into contracts for the procurement of
equipment maintenance services.''.
Subtitle D--Medical Supplies for Pandemics
SEC. 3031. SUPPLY CHAIN FLEXIBILITY MANUFACTURING PILOT.
(a) In General.--Section 319F-2(a)(3) of the Public Health Service
Act (42 U.S.C. 247d-6b(a)(3)), as amended by section 3012, is further
amended by adding at the end the following new subparagraph:
``(L) enhance medical supply chain elasticity and
establish and maintain domestic reserves of critical
medical supplies (including personal protective
equipment, ancillary medical supplies, and other
applicable supplies required for the administration of
drugs, vaccines and other biological products, and
other medical devices (including diagnostic tests))
by--
``(i) increasing emergency stock of
critical medical supplies;
``(ii) geographically diversifying domestic
production of such medical supplies, as
appropriate;
``(iii) entering into cooperative
agreements or partnerships with respect to
manufacturing lines, facilities, and equipment
for the domestic production of such medical
supplies; and
``(iv) managing, either directly or through
cooperative agreements with manufacturers and
distributors, domestic reserves established
under this subparagraph by refreshing and
replenishing stock of such medical supplies.''.
(b) Reporting; Sunset.--Section 319F-2(a) of the Public Health
Service Act (42 U.S.C. 247d-6b(a)), as amended by section 3011, is
further amended by adding at the end the following:
``(8) Reporting.--Not later than September 30, 2022, the
Secretary 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
details of each cooperative agreement or partnership entered
into under paragraph (3)(L), including the amount expended by
the Secretary on each such cooperative agreement or
partnership.
``(9) Sunset.--The authority to enter into cooperative
agreements or partnerships pursuant to paragraph (3)(L) shall
cease to be effective on September 30, 2023.''.
(c) Funding.--Section 319F-2(f) of the Public Health Service Act
(42 U.S.C. 247d-6b(f)) is amended by adding at the end the following:
``(3) Supply chain elasticity.--
``(A) In general.--For the purpose of carrying out
subsection (a)(3)(L), there is authorized to be
appropriated $500,000,000 for each of fiscal years 2021
through 2023, to remain available until expended.
``(B) Relation to other amounts.--The amount
authorized to be appropriated by subparagraph (A) for
the purpose of carrying out subsection (a)(3)(L) is in
addition to any other amounts available for such
purpose.''.
Subtitle E--State Stockpile Readiness
SEC. 3041. GRANTS FOR STATE STRATEGIC STOCKPILES.
Title III of the Public Health Service Act is amended by inserting
after section 319F-4 of such Act (42 U.S.C. 247d-6e) the following new
section:
``SEC. 319F-5. GRANTS FOR STATE STRATEGIC STOCKPILES.
``(a) In General.--The Secretary may establish a pilot program
consisting of awarding grants to States to expand or maintain a
strategic stockpile of commercially available drugs, devices, personal
protective equipment, and other products deemed by the State to be
essential in the event of a public health emergency.
``(b) Allowable Use of Funds.--
``(1) Uses.--A State receiving a grant under this section
may use the grant funds to--
``(A) acquire commercially available products
listed pursuant to paragraph (2) for inclusion in the
State's strategic stockpile;
``(B) store, maintain, and distribute products in
such stockpile; and
``(C) conduct planning in connection with such
activities.
``(2) List.--The Secretary shall develop and publish a list
of the products that are eligible, as described in subsection
(a), for inclusion in a State's strategic stockpile using funds
received under this section.
``(3) Consultation.--In developing the list under paragraph
(2) and otherwise determining the allowable uses of grant funds
under this section, the Secretary shall consult with States and
relevant stakeholders, including public health organizations.
``(c) Funding Requirement.--The Secretary may not obligate or
expend any funds to award grants or fund any previously awarded grants
under this section for a fiscal year unless the total amount made
available to carry out section 319F-2 for such fiscal year is equal to
or greater than the total amount of funds made available to carry out
section 319F-2 for fiscal year 2020.
``(d) Matching Funds.--
``(1) In general.--With respect to the costs of expanding
and maintaining a strategic stockpile through a grant under
this section, as a condition on receipt of the grant, a State
shall make available (directly) non-Federal contributions in
cash toward such costs in an amount that is equal to not less
than the amount of Federal funds provided through the grant.
``(2) Waiver.--The Secretary may waive the requirement of
paragraph (1) with respect to a State for the first two years
of the State receiving a grant under this section if the
Secretary determines that such waiver is needed for the State
to establish a strategic stockpile described in subsection (a).
``(e) Technical Assistance.--The Secretary shall provide technical
assistance to States in establishing, expanding, and maintaining a
stockpile described in subsection (a).
``(f) Definition.--In this section, the term `drug' has the meaning
given to that term in section 201 of the Federal Food, Drug, and
Cosmetic Act.
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $3,500,000,000 for each of
fiscal years 2021 through 2023, to remain available until expended.
``(h) Sunset.--The authority vested by this section terminates at
the end of fiscal year 2023.''.
Subtitle F--Process Improvements and Reports
SEC. 3051. GAO STUDY ON THE FEASIBILITY AND BENEFITS OF USER FEE
AGREEMENTS.
(a) In General.--The Comptroller General of the United States shall
conduct a study to investigate the feasibility of establishing user
fees to offset certain Federal costs attributable to the procurement of
single-source materials for the Strategic National Stockpile under
section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) and
distributions of such materials from the Stockpile. In conducting this
study, the Comptroller General shall consider, to the extent
information is available--
(1) whether entities receiving such distributions generate
profits from those distributions;
(2) any Federal costs attributable to such distributions;
(3) whether such user fees would provide the Secretary with
funding to potentially offset procurement costs of such
materials for the Strategic National Stockpile; and
(4) any other issues the Comptroller General identifies as
relevant.
(b) Report.--Not later than February 1, 2023, the Comptroller
General of the United States shall submit to the Congress a report on
the findings and conclusions of the study under subsection (a).
SEC. 3052. ACTION REPORTING.
(a) In General.--The Secretary of Health and Human Services or the
Assistant Secretary for Preparedness and Response, in consultation with
the Administrator of the Federal Emergency Management Agency, shall--
(1) not later than 30 days after the date of enactment of
this Act, issue a report to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate regarding
all State, local, Tribal, and territorial requests for supplies
from the Strategic National Stockpile related to COVID-19; and
(2) not less than every 30 days thereafter through the end
of the emergency period (as such term is defined in section
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-
5(g)(1)(B))), submit to such committees an updated version of
such report.
(b) Reporting Period.--
(1) Initial report.--The initial report under subsection
(a) shall address all requests described in such subsection
made during the period--
(A) beginning on January 31, 2020; and
(B) ending on the date that is 30 days before the
date of submission of the report.
(2) Updates.--Each update to the report under subsection
(a) shall address all requests described in such subsection
made during the period--
(A) beginning at the end of the previous reporting
period under this section; and
(B) ending on the date that is 30 days before the
date of submission of the updated report.
(c) Contents of Report.--The report under subsection (a) (and
updates thereto) shall include--
(1) the details of each request described in such
subsection, including--
(A) the specific medical countermeasures, devices,
personal protective equipment, and other materials
requested; and
(B) the amount of such materials requested; and
(2) the outcomes of each request described in subsection
(a), including--
(A) whether the request was wholly fulfilled,
partially fulfilled, or denied;
(B) if the request was wholly or partially
fulfilled, the fulfillment amount; and
(C) if the request was partially fulfilled or
denied, a rationale for such outcome.
SEC. 3053. IMPROVED, TRANSPARENT PROCESSES.
(a) In General.--Not later than January 1, 2021, the Secretary of
Health and Human Services shall develop and implement improved,
transparent processes for the use and distribution of drugs, vaccines
and other biological products, medical devices, and other supplies
(including personal protective equipment, ancillary medical supplies,
and other applicable supplies required for the administration of drugs,
vaccines and other biological products, medical devices, and diagnostic
tests) in the Strategic National Stockpile under section 319F-2 of the
Public Health Service Act (42 U.S.C. 247d-6b) (in this section referred
to as the ``Stockpile'').
(b) Processes.--The processes developed under subsection (a) shall
include--
(1) the form and manner in which States, localities,
Tribes, and territories are required to submit requests for
supplies from the Stockpile;
(2) the criteria used by the Secretary of Health and Human
Services in responding to such requests, including the reasons
for fulfilling or denying such requests;
(3) what circumstances result in prioritization of
distribution of supplies from the Stockpile to States,
localities, Tribes, or territories;
(4) clear plans for future, urgent communication between
the Secretary and States, localities, Tribes, and territories
regarding the outcome of such requests; and
(5) any differences in the processes developed under
subsection (a) for geographically related emergencies, such as
weather events, and national emergencies, such as pandemics.
(c) Classification.--The processes developed under subsection (a)
shall be unclassified to the greatest extent possible consistent with
national security. The Secretary of Health and Human Services may
classify portions of such processes as necessary to protect national
security.
(d) Report to Congress.--Not later than January 1, 2021, the
Secretary of Health and Human Services shall--
(1) submit a report to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate regarding the
improved, transparent processes developed under this section;
(2) include in such report recommendations for
opportunities for communication (by telebriefing, phone calls,
or in-person meetings) between the Secretary and States,
localities, Tribes, and territories regarding such improved,
transparent processes; and
(3) submit such report in unclassified form to the greatest
extent possible, except that the Secretary may include a
classified appendix if necessary to protect national security.
Subtitle G--Strategic National Stockpile Funding
SEC. 3061. AUTHORIZATION OF APPROPRIATIONS.
Section 319F-2(f)(1) of the Public Health Service Act (42 U.S.C.
247d-6b(f)(1)) is amended by striking ``$610,000,000 for each of fiscal
years 2019 through 2023'' and inserting ``$705,000,000 for each of
fiscal years 2021 through 2023''.
TITLE IV--PUBLIC HEALTH INFRASTRUCTURE IMPROVEMENTS
Subtitle A--Public Health Infrastructure Modernization
SEC. 4001. PUBLIC HEALTH DATA SYSTEM TRANSFORMATION.
Subtitle C of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:
``SEC. 2822. PUBLIC HEALTH DATA SYSTEM TRANSFORMATION.
``(a) Expanding CDC and Public Health Department Capabilities.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall--
``(A) conduct activities to expand, enhance, and
improve public health data systems used by the Centers
for Disease Control and Prevention, related to the
interoperability and improvement of such systems
(including with respect to preparedness for, prevention
and detection of, and response to public health
emergencies); and
``(B) award grants or cooperative agreements to
State, local, Tribal, or territorial public health
departments for the expansion and modernization of
public health data systems, to assist public health
departments in--
``(i) assessing current data infrastructure
capabilities and gaps to improve consistency in
data collection, storage, and analysis, and as
appropriate to improve dissemination of public
health-related information;
``(ii) improving secure public health data
collection, transmission, exchange,
maintenance, and analysis;
``(iii) improving the secure exchange of
data between the Centers for Disease Control
and Prevention, State, local, Tribal, and
territorial public health departments, public
health organizations, and health care
providers, including--
``(I) between public health
officials in multiple jurisdictions
within a State; and
``(II) by simplifying and
supporting reporting by health care
providers pursuant to State law,
including through the use of health
information technology;
``(iv) enhancing the interoperability of
public health data systems (including systems
created or accessed by public health
departments) with health information
technology, including with health information
technology certified under section 3001(c)(5);
``(v) supporting and training public health
data systems, data science, and informatics
personnel;
``(vi) supporting earlier disease and
health condition detection, such as through
near real-time data monitoring, to support
rapid public health responses;
``(vii) supporting activities within the
applicable jurisdiction related to the
expansion and modernization of electronic case
reporting; and
``(viii) developing and disseminating
information related to the use and importance
of public health data.
``(2) Data standards.--In carrying out paragraph (1), the
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall, as appropriate and in
coordination with the Office of the National Coordinator for
Health Information Technology, designate data and technology
standards (including standards for interoperability) for public
health data systems, with deference given to standards
published by consensus-based standards development
organizations with public input and voluntary consensus-based
standards bodies.
``(3) Public-private partnerships.--The Secretary may
develop and utilize public-private partnerships for technical
assistance, training, and related implementation support for
State, local, Tribal, and territorial public health
departments, and the Centers for Disease Control and
Prevention, on the expansion and modernization of electronic
case reporting and public health data systems, as applicable.
``(b) Requirements.--
``(1) Health information technology standards.--The
Secretary may not award a grant or cooperative agreement under
subsection (a)(1)(B) unless the applicant uses or agrees to use
standards endorsed by the National Coordinator for Health
Information Technology pursuant to section 3001(c)(1) or
adopted by the Secretary under section 3004.
``(2) Waiver.--The Secretary may waive the requirement
under paragraph (1) with respect to an applicant if the
Secretary determines that the activities under subsection
(a)(1)(B) cannot otherwise be carried out within the applicable
jurisdiction.
``(3) Application.--A State, local, Tribal, or territorial
health department applying for a grant or cooperative agreement
under this section shall submit an application to the Secretary
at such time and in such manner as the Secretary may require.
Such application shall include information describing--
``(A) the activities that will be supported by the
grant or cooperative agreement; and
``(B) how the modernization of the public health
data systems involved will support or impact the public
health infrastructure of the health department,
including a description of remaining gaps, if any, and
the actions needed to address such gaps.
``(c) Strategy and Implementation Plan.--Not later than 180 days
after the date of enactment of this section, the Secretary, acting
through the Director of the Centers for Disease Control and Prevention,
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 coordinated strategy and an accompanying
implementation plan that identifies and describes the measures the
Secretary will utilize to--
``(1) update and improve public health data systems used by
the Centers for Disease Control and Prevention; and
``(2) carry out the activities described in this section to
support the improvement of State, local, Tribal, and
territorial public health data systems.
``(d) Consultation.--In carrying out this section, the Secretary,
acting through the Director of the Centers for Disease Control and
Prevention, shall consult with State, local, Tribal, and territorial
public health departments, professional medical and public health
associations, associations representing hospitals or other health care
entities, health information technology experts, and other appropriate
public or private entities.
``(e) Report to Congress.--Not later than 1 year after the date of
enactment of this section, the Secretary shall 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
that includes--
``(1) a description of any barriers to--
``(A) public health authorities implementing
interoperable public health data systems and electronic
case reporting;
``(B) the exchange of information pursuant to
electronic case reporting; or
``(C) reporting by health care providers using such
public health data systems, as appropriate, and
pursuant to State law;
``(2) an assessment of the potential public health impact
of implementing electronic case reporting and interoperable
public health data systems; and
``(3) a description of the activities carried out pursuant
to this section.
``(f) Electronic Case Reporting.--In this section, the term
`electronic case reporting' means the automated identification,
generation, and bilateral exchange of reports of health events among
electronic health record or health information technology systems and
public health authorities.
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $100,000,000 for each of fiscal
years 2021 through 2025.''.
Subtitle B--Modernizing Infectious Disease Data Collection
SEC. 4011. MODERNIZING INFECTIOUS DISEASE DATA COLLECTION.
(a) Improving Infectious Disease Data Collection.--Section 319D of
the Public Health Service Act (42 U.S.C. 247d-4) is amended--
(1) in subsection (c)--
(A) in paragraph (3)(A)(iv), by inserting ``(such
as commercial, academic, and other hospital
laboratories)'' after ``clinical laboratories'';
(B) in paragraph (5)--
(i) in subparagraph (A)--
(I) in the matter preceding clause
(i), by striking ``and operating'' and
inserting ``, operating, and
updating'';
(II) in clause (iv), by striking
``and'' at the end;
(III) in clause (v), by striking
the period and inserting ``; and''; and
(IV) by adding at the end the
following:
``(vi) integrate and update applicable
existing Centers for Disease Control and
Prevention data systems and networks in
collaboration with State, local, tribal, and
territorial public health officials, including
public health surveillance and disease
detection systems.''; and
(ii) in subparagraph (B)--
(I) in clause (i), by inserting
``and 60 days after the date of
enactment of the Commitment to Defeat
the Virus and Keep America Healthy
Act'' after ``Innovation Act of 2019'';
(II) in clause (ii), by inserting
``epidemiologists, clinical
microbiologists, pathologists and
laboratory experts, experts in health
information technology, privacy, and
data security'' after
``forecasting);''; and
(III) in clause (iii)--
(aa) in subclause (V), by
striking ``and'' at the end;
(bb) in subclause (VI), by
striking the period; and
(cc) by adding at the end
the following:
``(VII) strategies to integrate
laboratory and epidemiology systems and
capabilities to conduct rapid and
accurate laboratory tests;
``(VIII) strategies to improve the
collection and reporting of
appropriate, aggregated, deidentified
demographic data to inform responses to
public health emergencies, including
identification of at-risk populations
and to address health disparities; and
``(IX) strategies to improve the
electronic exchange of health
information between State and local
health departments and health care
providers and facilities to improve
public health surveillance.''; and
(C) in paragraph (6)--
(i) in subparagraph (A)--
(I) in clause (iii)--
(aa) in subclause (III), by
striking ``and'' at the end;
(bb) in subclause (IV), by
inserting ``, including the
ability to conduct and report
on rapid and accurate
laboratory testing during a
public health emergency''
before the semicolon; and
(cc) by adding at the end
the following:
``(V) improve coordination and
collaboration, as appropriate, with
other Federal departments; and
``(VI) implement applicable lessons
learned from recent public health
emergencies to address gaps in
situational awareness and
biosurveillance capabilities, including
an evaluation of ways to improve the
collection and reporting of aggregated,
deidentified demographic data to inform
public health preparedness and
response'';
(II) in clause (iv), by striking
``and'' at the end;
(III) in clause (v), by striking
the period and inserting ``including a
description of how such steps will
further the goal of improving awareness
of and timely responses to emerging
infectious disease threats; and''; and
(IV) by adding at the end the
following:
``(vi) identifies and demonstrates
measurable steps the Secretary will take to
further develop and integrate infectious
disease detection, including expanding
capabilities to conduct rapid and accurate
diagnostic laboratory testing during a public
health emergency, and improve coordination and
collaboration with State, local, Tribal, and
territorial public health officials, clinical
laboratories (including commercial, hospital
and academic laboratories), and other entities
with expertise in public health
surveillance.''; and
(ii) by redesignating subparagraph (B) as
subparagraph (C); and
(iii) by inserting after subparagraph (A),
the following:
``(B) Reports.--
``(i) In general.--Not later than 1 month
after date of enactment of the Commitment to
Defeat the Virus and Keep America Healthy Act,
and as provided for in clause (ii), the
Secretary 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 status of the Department of Health and
Human Services' biosurveillance modernization
and assessment progress with respect to
emerging infectious disease threats.
``(ii) Additional reports.--During the 2-
year period beginning on the date of enactment
of the Commitment to Defeat the Virus and Keep
America Healthy Act, the Secretary shall
provide additional reports under clause (i)
every 90 days after the submission of the
initial report under such clause. The Secretary
shall provide such reports annually thereafter.
The Secretary may provide such additional
reports less frequently, but not less
frequently than every 180 days, during an
ongoing public health emergency or another
significant infectious disease outbreak.'';
(2) in subsection (d)--
(A) in paragraph (2)(C), by inserting ``, including
any public-private partnerships entered into to improve
such capacity'' before the semicolon; and
(B) in paragraph (3)--
(i) in subparagraph (B), by striking
``and'' at the end;
(ii) in subparagraph (C), by striking the
period and inserting ``; and''; and
(iii) by adding at the end the following:
``(D) may establish, enhance, or maintain a system
or network for the collection of data to provide for
early detection of infectious disease outbreaks, near
real-time access to relevant electronic data and
integration of electronic data and information from
public health and other appropriate sources, such as
laboratories, hospitals, and epidemiology systems, to
enhance the capability to conduct rapid and accurate
diagnostic laboratory tests to provide for disease
detection.'';
(3) in subsection (f)(1)(A), by inserting ``pathologists,
clinical microbiologists, laboratory professionals,
epidemiologists,'' after ``forecasting),''; and
(4) in subsection (h), by adding at the end the following:
``Such evaluation shall include identification of any gaps in
biosurveillance and situational awareness capabilities
identified related to recent public health emergencies, any
immediate steps taken to address such gaps, and any long-term
plans to address such gaps, including steps related to
activities authorized under this section.''.
(b) National Health Security Strategy.--Section 2802(b)(2) of the
Public Health Service Act (42 U.S.C. 300hh-1(b)(2)) is amended--
(1) in subparagraph (A), by inserting ``such as by
integrating laboratory and epidemiology systems and capability
to conduct rapid and accurate laboratory tests,'' after
``detection, identification,''; and
(2) in subparagraph (B), by inserting ``laboratory
testing,'' after ``services and supplies,''.
(c) Epidemiology-Laboratory Capacity Grants.--Section 2821(a) of
the Public Health Service Act (42 U.S.C. 300hh-31(a)) is amended--
(1) in paragraph (3), by striking ``and'';
(2) in paragraph (4), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(5) supporting activities of State and local public
health departments related to biosurveillance and disease
detection, which may include activities related to section
319D, as appropriate.''.
Subtitle C--Diagnostic Testing for Public Health Labs
SEC. 4021. GRANTS FOR PUBLIC HEALTH LABORATORIES TO ACQUIRE HIGH-
THROUGHPUT DIAGNOSTIC EQUIPMENT.
Section 2821 of the Public Health Service Act (42 U.S.C. 300hh-31)
is amended--
(1) by redesignating subsection (b) as subsection (c);
(2) by inserting after subsection (a) the following new
subsection:
``(b) Grants for Public Health Laboratories To Acquire High-
Throughput Diagnostic Equipment.--
``(1) Grants.--The Secretary shall award grants to eligible
entities to assist such entities in purchasing high-throughput
diagnostic equipment and related supplies and in hiring and
training staff to use such equipment.
``(2) Eligibility.--To be eligible for a grant under
paragraph (1), an entity shall--
``(A) be--
``(i) a State, local, or Tribal public
health laboratory;
``(ii) a laboratory within a public health
laboratory network coordinated or managed by
the Centers for Disease Control and Prevention;
``(iii) a laboratory not described in
clause (i) or (ii) that the Secretary
determines (at the Secretary's discretion)
provides population-based testing for the
prevention and control of infectious,
communicable, genetic, or chronic diseases; or
``(iv) a consortium of 2 or more entities
described in any of clauses (i) through (iii);
and
``(B) submit to the Secretary an application at
such time, in such manner, and containing such
information as the Secretary may reasonably require.
``(3) Use of funds.--Amounts received through a grant under
this subsection shall be used--
``(A) to purchase high-throughput diagnostic
equipment and such materials as are necessary to
administer, store, and process applicable tests,
including diagnostic and serological tests; and
``(B) to hire and train staff to use such
equipment.
``(4) Amount of grant.--The amount of a grant under
paragraph (1) may not exceed $2,000,000, except in the case of
eligible entity described in paragraph (2)(A)(iv).
``(5) High-throughput diagnostic equipment defined.--In
this subsection, the term `high-throughput diagnostic
equipment' means legally marketed equipment and supplies
capable of performing multichannel analysis for use in clinical
laboratory diagnostic testing.''; and
(3) in subsection (c), as so redesignated--
(A) by redesignating paragraphs (1), (2), and (3)
as subparagraphs (A), (B), and (C), respectively, and
moving the margin of each such redesignated
subparagraph 2 ems to the right;
(B) by striking ``There are authorized to be
appropriated to carry out this section'' and inserting
the following:
``(1) In general.--There are authorized to be appropriated
to carry out subsection (a)''; and
(C) by adding at the end the following new
paragraph:
``(2) Authorization of appropriations.--
``(A) In general.--For the purpose of carrying out
subsection (b), there is authorized to be appropriated
$250,000,000 for fiscal year 2021, to remain available
until expended.
``(B) Administrative expenses.--Of the amount made
available to carry out subsection (b) for any fiscal
year, the Secretary may not use more than 5 percent of
such amount for the expenses of administering
subsection (b).''.
Subtitle D--Rapid Testing for Communities
SEC. 4031. GRANTS FOR SAME-DAY POINT-OF-CARE CLINICAL LABORATORY
DIAGNOSTIC TESTING IN COMMUNITIES.
Section 2821 of the Public Health Service Act (42 U.S.C. 300hh-31)
is amended--
(1) by redesignating subsection (c), as redesignated by
section 4021, as subsection (d);
(2) by inserting after subsection (b), as added by section
4021, the following new subsection:
``(c) Grants for Same-Day Point-of-Care Clinical Laboratory
Diagnostic Testing in Communities.--
``(1) Grants.--The Secretary shall award grants to eligible
entities to assist such entities in acquiring legally marketed
equipment and supplies capable of performing same-day clinical
laboratory diagnostic testing in a point-of-care setting.
``(2) Eligibility.--To be eligible for a grant under
paragraph (1), an entity shall--
``(A) be--
``(i) a hospital;
``(ii) a primary care facility;
``(iii) a clinic;
``(iv) a physician; or
``(v) another type of health care provider
as the Secretary may define; and
``(B) submit to the Secretary an application at
such time, in such manner, and containing such
information as the Secretary may reasonably require.
``(3) Use of funds.--Amounts received through a grant under
this subsection shall be used to purchase legally marketed
rapid diagnostic equipment and such materials as are necessary
to administer, store, and process same-day clinical laboratory
diagnostic testing in a point-of-care setting, including
diagnostic and serological tests.
``(4) Amount of grant.--The amount of a grant under
paragraph (1) may not exceed $20,000.
``(5) Priority in making awards.--In awarding grants under
paragraph (1), the Secretary shall give priority to eligible
entities providing services to--
``(A) medically underserved populations (as defined
in section 330(b)(3)) in rural areas; and
``(B) all other areas.''; and
(3) by adding at the end of subsection (d), as
redesignated, the following new paragraph:
``(3) Authorization of appropriations.--
``(A) In general.--For the purpose of carrying out
subsection (c), there is authorized to be appropriated
$500,000,000 for fiscal year 2021, to remain available
until expended.
``(B) Administrative expenses.--Of the amount made
available to carry out subsection (c) for any fiscal
year, the Secretary may not use more than 5 percent of
such amount for the expenses of administering this
section.''.
Subtitle E--Public Health Workforce Loan Repayment
SEC. 4041. PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
Part D of title III of the Public Health Service Act (42 U.S.C.
254b et seq.), as amended by section 2031, is further amended by adding
at the end the following new subpart:
``Subpart XIV--Public Health Workforce
``SEC. 340K. LOAN REPAYMENT PROGRAM.
``(a) Establishment.--The Secretary of Health and Human Services
shall establish a program to be known as the Public Health Workforce
Loan Repayment Program (referred to in this section as the `Program')
to assure an adequate supply of and encourage recruitment of public
health professionals to eliminate critical public health workforce
shortages in local, State, and Tribal public health agencies.
``(b) Eligibility.--To be eligible to participate in the Program,
an individual shall--
``(1)(A) be accepted for enrollment, or be enrolled, as a
student in an accredited academic educational institution in a
State or territory in the final year of a course of study or
program leading to a public health or health professions degree
or certificate and have accepted employment with a local,
State, or Tribal public health agency, or a related training
fellowship, as recognized by the Secretary, to commence upon
graduation; or
``(B)(i) have graduated, during the preceding 10-year
period, from an accredited educational institution in a State
or territory and received a public health or health professions
degree or certificate; and
``(ii) be employed by, or have accepted employment with, a
local, State, or Tribal public health agency or a related
training fellowship, as recognized by the Secretary;
``(2) be a United States citizen;
``(3)(A) submit an application to the Secretary to
participate in the Program; and
``(B) execute a written contract as required in subsection
(c); and
``(4) not have received, for the same service, a reduction
of loan obligations under section 428J, 428K, 428L, 455(m), or
460 of the Higher Education Act of 1965 (20 U.S.C. 1078-10,
1078-11, 1078-12, 1087e(m), and 1087j).
``(c) Contract.--The written contract referred to in subsection
(b)(3)(B) between the Secretary and an individual shall contain--
``(1) an agreement on the part of the Secretary that the
Secretary will repay, on behalf of the individual, loans
incurred by the individual in the pursuit of the relevant
degree or certificate in accordance with the terms of the
contract;
``(2) an agreement on the part of the individual that the
individual will serve in the full-time employment of a local,
State, or Tribal public health agency or a related fellowship
program in a position related to the course of study or program
for which the contract was awarded for a period of time equal
to the greater of--
``(A) 3 years; or
``(B) such longer period of time as determined
appropriate by the Secretary and the individual;
``(3) an agreement, as appropriate, on the part of the
individual to relocate to a priority service area (as
determined by the Secretary) in exchange for an additional loan
repayment incentive amount to be determined by the Secretary;
``(4) a provision that any financial obligation of the
United States arising out of a contract entered into under this
section and any obligation of the individual that is
conditioned thereon, is contingent on funds being appropriated
for loan repayments under this section;
``(5) a statement of the damages to which the United States
is entitled, under this section for the individual's breach of
the contract; and
``(6) such other statements of the rights and liabilities
of the Secretary and of the individual as the Secretary
determines appropriate, not inconsistent with this section.
``(d) Payments.--
``(1) In general.--A loan repayment provided for an
individual under a written contract referred to in subsection
(b)(3)(B) shall consist of payment, in accordance with
paragraph (2), on behalf of the individual of the principal,
interest, and related expenses on government and commercial
loans received by the individual regarding the undergraduate or
graduate education of the individual (or both), which loans
were made for tuition expenses incurred by the individual.
``(2) Payments for years served.--For each year of service
that an individual contracts to serve pursuant to subsection
(c)(2), the Secretary may pay not more than $35,000 on behalf
of the individual for loans described in paragraph (1). With
respect to participants under the Program whose total eligible
loans are less than $105,000, the Secretary shall pay an amount
that does not exceed \1/3\ of the eligible loan balance for
each year of such service of such individual.
``(3) Tax liability.--For the purpose of providing
reimbursements for tax liability resulting from payments under
paragraph (2) on behalf of an individual, the Secretary shall,
in addition to such payments, make payments to the individual
in an amount not to exceed 39 percent of the total amount of
loan repayments made for the taxable year involved.
``(e) Postponing Obligated Service.--With respect to an individual
receiving a degree or certificate from a health professions or other
related school, the date of the initiation of the period of obligated
service may be postponed as approved by the Secretary.
``(f) Breach of Contract.--An individual who fails to comply with
the contract entered into under subsection (c) shall be subject to the
same financial penalties as provided for under section 338E of the
Public Health Service Act (42 U.S.C. 254o) for breaches of loan
repayment contracts under section 338B of such Act (42 U.S.C. section
254l-1).
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section--
``(1) $100,000,000 for fiscal year 2021; and
``(2) $75,000,000 for each of fiscal years 2022 through
2026.''.
Subtitle F--Vaccine Awareness and Disease Prevention
SEC. 4051. IMPROVING AWARENESS OF DISEASE PREVENTION.
(a) In General.--The Public Health Service Act is amended by
striking section 313 of such Act (42 U.S.C. 245) and inserting the
following:
``SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF
VACCINATIONS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination with
other offices and agencies, as appropriate, shall award competitive
grants or contracts to one or more public or private entities to carry
out a national, evidence-based campaign to increase awareness and
knowledge of the safety and effectiveness of vaccines for the
prevention and control of diseases, combat misinformation about
vaccines, and disseminate scientific and evidence-based vaccine-related
information, with the goal of increasing rates of vaccination across
all ages, as applicable, particularly in communities with low rates of
vaccination, to reduce and eliminate vaccine-preventable diseases.
``(b) Consultation.--In carrying out the campaign under this
section, the Secretary shall consult with appropriate public health and
medical experts, including the National Academy of Medicine and medical
and public health associations and nonprofit organizations, in the
development, implementation, and evaluation of the evidence-based
public awareness campaign.
``(c) Requirements.--The campaign under this section shall--
``(1) be a nationwide, evidence-based media and public
engagement initiative;
``(2) include the development of resources for communities
with low rates of vaccination, including culturally and
linguistically appropriate resources, as applicable;
``(3) include the dissemination of vaccine information and
communication resources to public health departments, health
care providers, and health care facilities, including such
providers and facilities that provide prenatal and pediatric
care;
``(4) be complementary to, and coordinated with, any other
Federal, State, local, or Tribal efforts, as appropriate; and
``(5) assess the effectiveness of communication strategies
to increase rates of vaccination.
``(d) Additional Activities.--The campaign under this section may--
``(1) include the use of television, radio, the internet,
and other media and telecommunications technologies;
``(2) include the use of in-person activities;
``(3) be focused to address specific needs of communities
and populations with low rates of vaccination; and
``(4) include the dissemination of scientific and evidence-
based vaccine-related information, such as--
``(A) advancements in evidence-based research
related to diseases that may be prevented by vaccines
and vaccine development;
``(B) information on vaccinations for individuals
and communities, including individuals for whom
vaccines are not recommended by the Advisory Committee
for Immunization Practices, and the effects of low
vaccination rates within a community on such
individuals;
``(C) information on diseases that may be prevented
by vaccines; and
``(D) information on vaccine safety and the systems
in place to monitor vaccine safety.
``(e) Evaluation.--The Secretary shall--
``(1) establish benchmarks and metrics to quantitatively
measure and evaluate the awareness campaign under this section;
``(2) conduct qualitative assessments regarding the
awareness campaign under this section; and
``(3) prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and Committee on
Energy and Commerce of the House of Representatives an
evaluation of the awareness campaign under this section.
``(f) Supplement Not Supplant.--Funds appropriated under this
section shall be used to supplement and not supplant other Federal,
State, and local public funds provided for activities described in this
section.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section and subsections (k) and (n) of
section 317 $10,000,000 for each of fiscal years 2021 through 2025.''.
(b) Grants To Address Vaccine-Preventable Diseases.--Section 317 of
the Public Health Service Act (42 U.S.C. 247b) is amended--
(1) in subsection (k)(1)--
(A) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(B) in subparagraph (D), by striking the period and
inserting a semicolon; and
(C) by adding at the end the following:
``(E) planning, implementation, and evaluation of
activities to address vaccine-preventable diseases,
including activities to--
``(i) identify communities at high risk of
outbreaks related to vaccine-preventable
diseases, including through improved data
collection and analysis;
``(ii) pilot innovative approaches to
improve vaccination rates in communities and
among populations with low rates of
vaccination;
``(iii) reduce barriers to accessing
vaccines and evidence-based information about
the health effects of vaccines;
``(iv) partner with community organizations
and health care providers to develop and
deliver evidence-based interventions, including
culturally and linguistically appropriate
interventions, to increase vaccination rates;
``(v) improve delivery of evidence-based,
vaccine-related information to parents and
others; and
``(vi) improve the ability of State, local,
Tribal, and territorial public health
departments to engage communities at high risk
for outbreaks related to vaccine-preventable
diseases, in coordination, as appropriate, with
local educational agencies, as defined in
section 8101 of the Elementary and Secondary
Education Act of 1965; and
``(F) research related to strategies for improving
awareness of scientific and evidence-based, vaccine-
related information, including for communities with low
rates of vaccination, in order to understand barriers
to vaccination, improve vaccination rates, and assess
the public health outcomes of such strategies.''; and
(2) by adding at the end the following:
``(n) Vaccination Data.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall expand and
enhance, and, as appropriate, establish and improve, programs and
conduct activities to collect, monitor, and analyze vaccination
coverage data to assess levels of protection from vaccine-preventable
diseases, including by assessing factors contributing to
underutilization of vaccines and variations of such factors, and
identifying communities at high risk of outbreaks associated with
vaccine-preventable diseases.''.
(c) Supplemental Grant Funds.--Section 330(d)(1) of the Public
Health Service Act (42 U.S.C. 254b) is amended--
(1) in subparagraph (F), by striking ``and'' at the end;
(2) in subparagraph (G), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following:
``(H) improving access to recommended
immunizations.''.
(d) Update of 2015 NVAC Report.--The National Vaccine Advisory
Committee established under section 2105 of the Public Health Service
Act (42 U.S.C. 300aa-5) shall, as appropriate, update the report
entitled, ``Assessing the State of Vaccine Confidence in the United
States: Recommendations from the National Vaccine Advisory Committee'',
approved by the National Vaccine Advisory Committee on June 10, 2015,
with respect to factors affecting childhood vaccination.
Subtitle G--Protecting the Health of America's Older Adults During
COVID-19 & Beyond
SEC. 4061. NATIONAL COVID-19 RESOURCE CENTER FOR OLDER ADULTS.
(a) In General.--The Secretary of Health and Human Services (in
this subtitle referred to as the ``Secretary'') shall establish within
the Office of the Assistant Secretary for Health a National COVID-19
Resource Center for Older Adults (in this section referred to as the
``Center'') to identify, curate, and disseminate, promising and proven
practices and tools for the care of older adults in their homes,
community-based care settings, hospitals, and nursing and acute care
facilities.
(b) Involvement by Federal Departments and All Levels of
Government.--The Center shall--
(1) be advised by a team of senior officials from--
(A) agencies across the Department of Health and
Human Services, including the Administration for
Community Living (including the Administration on
Aging), the Centers for Disease Control and Prevention,
the Centers for Medicare & Medicaid Services, the
Health Resources and Services Administration, the
Indian Health Service, and the Office of Minority
Health in the Office of the Secretary; and
(B) other Federal departments, including the
Department of Housing and Urban Development and the
Department of Veterans Affairs; and
(2) collaborate with State and local governments, Indian
tribes and Tribal organizations, and nonprofit organizations.
(c) Activities.--The Center shall perform the following activities:
(1) Develop a set of best practices for older adult health
and well-being during and beyond the period of the COVID-19
pandemic, including such best practices with respect to the
following focus areas:
(A) Providing specialized services to overcome the
risks associated with social isolation, such as
additional resources for home-delivered meals and other
nutrition programs to provide not only food but also
face-to-face interactions.
(B) Streamlining and improving access to screening,
testing, and health care services and resources, and
prioritizing venues older adults can reach.
(C) Expanding the use of telemedicine, including
the provision of technology to execute televisits that
safely and comprehensively address older adults' health
care needs.
(D) Supporting family caregivers, including those
with additional responsibilities for homebound
individuals.
(E) Reducing disparities among underserved
populations.
(F) Developing cross-sector collaborative efforts.
(2) Create and disseminate tools, technical assistance,
training, and funding to State, local, Tribal, and territorial
governments to adopt best practices developed under
subparagraphs (E) and (F) of paragraph (1).
(3) Establish mechanisms for providing training and
technical assistance to State, local, Tribal, and territorial
governments to ensure that complementary cross-sector
activities are replicated at the State, local, Tribal, and
territorial levels.
(4) Facilitate the development of learning networks of
practitioners at the hospital, nursing facility, and community
levels to disseminate the best practices developed under
paragraph (1) and ensure implementation of such best practices
to reduce morbidity and mortality of older adults affected by
COVID-19.
(5) Identify and disseminate approaches that strengthen
public health and health care system capacity to serve older
Americans with regard to health issues during and beyond the
COVID-19 pandemic.
SEC. 4062. HEALTHY AGING PROGRAM.
(a) In General.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall establish a Healthy
Aging Program for the purpose of promoting the health and well-being of
older adults by--
(1) improving the coordination of public health
interventions that promote the health and well-being of older
adults;
(2) disseminating and implementing evidence-based best
practices and programs with respect to promoting the health and
well-being of older adults; and
(3) coordinating multisectoral efforts to promote the
health and well-being of older adults across governmental and
nongovernmental health and related agencies.
(b) Activities.--For the purpose described in subsection (a), the
Secretary shall design the Healthy Aging Program to carry out the
following activities:
(1) Regularly assess the health-related needs of older
adults and promote policies addressing those needs through
evidence-based public health interventions to promote overall
health and well-being among older adults and reduce health care
costs.
(2) Identify disparities in health among vulnerable
populations of older adults.
(3) Identify gaps in existing public health programs and
policies that focus on older adults.
(4) Promote public health partnerships with aging and other
sector stakeholders to ensure nonduplication of efforts and
increase efficiency by working collaboratively across sectors.
(5) Work with multisectoral agencies to improve emergency
preparedness plans and activities for vulnerable older adult
populations.
(6) Coordinate efforts to promote the health of older
adults with the Administration for Community Living, other
Federal departments and agencies, and nonprofit organizations.
(7) Identify resources and evidence-based programs
available to local and State health departments, including
resources and programs that could be coordinated across
sectors, to address the health and well-being of older adults.
(c) Grants to Health Departments.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
award grants or cooperative agreements to eligible health departments
to carry out any of the following activities:
(1) Improving availability of data on the older adult
population, including through data-sharing with elder affairs
agencies.
(2) Linking the health care sector with the community
services sector (including aging services and supports) to
coordinate and promote community-based prevention services.
(3) Ensuring that State and local emergency preparedness
plans and activities address the special needs of older adults,
particularly the most vulnerable populations.
(4) Training State and local public health personnel to
implement or adapt evidence-based and innovative health
promotion and disease prevention programs and policies.
(5) Improving community conditions and addressing social
determinants to promote health and well-being and foster
independence among older adults, such as efforts to advance
age-friendly communities and dementia-friendly communities.
(d) Technical Assistance.--The Secretary shall (directly or through
grants, cooperative agreements, or contracts) provide technical
assistance to eligible health departments in carrying out activities
described in subsection (c).
(e) Evaluations.--The Secretary shall (directly or through grants,
cooperative agreements, or contracts) provide for the evaluation of
activities carried out under subsections (a), (b), and (c) in order to
determine the extent to which such activities have been effective in
carrying out the purpose described in subsection (a), including the
effects of such activities on addressing health disparities.
(f) Definition.--In this section, the term ``eligible health
department'' means a health department of a State, the District of
Columbia, the Commonwealth of Puerto Rico, the United States Virgin
Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana
Islands, a Tribe (as defined in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 5304)), or a
large city (as defined by the Director of the Centers for Disease
Control and Prevention for purposes of this section).
SEC. 4063. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated--
(1) $10,000,000 for the period of fiscal years 2021 through
2025 to carry out section 4061, to remain available until
September 30, 2025; and
(2) $20,000,000 for each of fiscal years 2021 through 2025
to carry out section 4062, including for grants under section
4062(c), to remain available until September 30, 2025.
Subtitle H--Expanding Capacity for Health Outcomes
SEC. 4071. EXPANDING CAPACITY FOR HEALTH OUTCOMES.
Title III of the Public Health Service Act is amended by inserting
after section 330M (42 U.S.C. 254c-19) the following:
``SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES.
``(a) Definitions.--In this section:
``(1) Eligible entity.--The term `eligible entity'--
``(A) means an entity that provides, or supports
the provision of, health care services--
``(i) in rural areas, frontier areas,
health professional shortage areas, or
medically underserved areas; or
``(ii) to medically underserved populations
or Native Americans, including Indian Tribes,
Tribal organizations, or urban Indian
organizations; and
``(B) may include entities leading, or capable of
leading, a technology-enabled collaborative learning
and capacity building model or engaging in technology-
enabled collaborative training of participants in such
model.
``(2) Health professional shortage area.--The term `health
professional shortage area' means a health professional
shortage area designated under section 332.
``(3) Indian tribe.--The terms `Indian Tribe' and `Tribal
organization' have the meanings given the terms `Indian tribe'
and `tribal organization' in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(4) Medically underserved population.--The term
`medically underserved population' has the meaning given the
term in section 330(b)(3).
``(5) Native americans.--The term `Native Americans' has
the meaning given such term in section 736 and includes Indian
Tribes and Tribal organizations.
``(6) Technology-enabled collaborative learning and
capacity building model.--The term `technology-enabled
collaborative learning and capacity building model' means a
distance health education model that connects health care
professionals, and particularly specialists, with multiple
other health care professionals through simultaneous
interactive videoconferencing for the purpose of facilitating
case-based learning, disseminating best practices, and
evaluating outcomes.
``(7) Urban indian organization.--The `urban Indian
organization' has the meaning given the term `Urban Indian
organization' in section 4 of the Indian Health Care
Improvement Act.
``(b) Program Established.--The Secretary shall, as appropriate,
award grants to evaluate, develop, and, as appropriate, expand the use
of technology-enabled collaborative learning and capacity building
models, to improve retention of health care providers and increase
access to health care services, such as those to address chronic
diseases and conditions, infectious diseases, mental health, substance
use disorders, prenatal and maternal health, pediatric care, pain
management, palliative care, and other specialty care in rural areas,
frontier areas, health professional shortage areas, or medically
underserved areas and for medically underserved populations or Native
Americans, including Indian Tribes and Tribal organizations.
``(c) Use of Funds.--
``(1) In general.--Grants awarded under subsection (b)
shall be used for--
``(A) the development and acquisition of
instructional programming, and the training of health
care providers and other professionals that provide or
assist in the provision of services through models
described in subsection (b), such as training on best
practices for data collection and leading or
participating in such technology-enabled activities
consistent with technology-enabled collaborative
learning and capacity building models;
``(B) information collection and evaluation
activities to study the impact of such models on
patient outcomes and health care providers, and to
identify best practices for the expansion and use of
such models; or
``(C) other activities consistent with achieving
the objectives of the grants awarded under this
section, as determined by the Secretary.
``(2) Other uses.--In addition to any of the uses under
paragraph (1), grants awarded under subsection (b) may be used
for--
``(A) equipment to support the use and expansion of
technology-enabled collaborative learning and capacity
building models, including for hardware and software
that enables distance learning, health care provider
support, and the secure exchange of electronic health
information; or
``(B) support for health care providers and other
professionals that provide or assist in the provision
of services through such models.
``(d) Length of Grants.--Grants awarded under subsection (b) shall
be for a period of up to 5 years.
``(e) Grant Requirements.--The Secretary may require entities
awarded a grant under this section to collect information on the effect
of the use of technology-enabled collaborative learning and capacity
building models, such as on health outcomes, access to health care
services, quality of care, and provider retention in areas and
populations described in subsection (b). The Secretary may award a
grant or contract to assist in the coordination of such models,
including to assess outcomes associated with the use of such models in
grants awarded under subsection (b), including for the purpose
described in subsection (c)(1)(B).
``(f) Application.--An eligible entity that seeks to receive a
grant under subsection (b) shall submit to the Secretary an
application, at such time, in such manner, and containing such
information as the Secretary may require. Such application shall
include plans to assess the effect of technology-enabled collaborative
learning and capacity building models on patient outcomes and health
care providers.
``(g) 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 grantees.
``(h) Technical Assistance.--The Secretary shall provide (either
directly through the Department of Health and Human Services or by
contract) technical assistance to eligible entities, including
recipients of grants under subsection (b), on the development, use, and
evaluation of technology-enabled collaborative learning and capacity
building models in order to expand access to health care services
provided by such entities, including for medically underserved areas
and to medically underserved populations or Native Americans, including
Indian Tribes and Tribal organizations.
``(i) Research and Evaluation.--The Secretary, in consultation with
stakeholders with appropriate expertise in such models, shall develop a
strategic plan to research and evaluate the evidence for such models.
The Secretary shall use such plan to inform the activities carried out
under this section.
``(j) Report by Secretary.--Not later than 4 years after the date
of enactment of this section, the Secretary shall prepare and 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 on the internet website of the Department of
Health and Human Services, a report including, at minimum--
``(1) a description of any new and continuing grants
awarded to entities under subsection (b) and the specific
purpose and amounts of such grants;
``(2) an overview of--
``(A) the evaluations conducted under subsection
(b);
``(B) technical assistance provided under
subsection (h); and
``(C) activities conducted by entities awarded
grants under subsection (b); and
``(3) a description of any significant findings or
developments related to patient outcomes or health care
providers and best practices for eligible entities expanding,
using, or evaluating technology-enabled collaborative learning
and capacity building models, including through the activities
described in subsection (h).
``(k) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $20,000,000 for each of fiscal
years 2021 through 2025.''.
Subtitle I--Community Readiness
SEC. 4081. GRANTS FOR RESEARCH ON, OR ESTABLISHING, WASTEWATER
SURVEILLANCE AND OTHER EARLY WARNING SYSTEMS.
Subtitle C of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:
``SEC. 2823. GRANTS FOR RESEARCH ON, OR ESTABLISHING, WASTEWATER
SURVEILLANCE AND OTHER EARLY WARNING SYSTEMS.
``(a) In General.--The Secretary, in consultation with the
Administrator of the Environmental Protection Agency, may award grants
to eligible entities to conduct research on, or to establish, a
wastewater surveillance or other early warning system through--
``(1) wastewater testing;
``(2) temperature tracking to monitor axillary body
temperature; and
``(3) other methods deemed permissible by the Secretary and
Administrator.
``(b) Permissible Uses of Funds.--A grant recipient under this
section may use grant funds to support the activities described in
subsection (a), including by--
``(1) paying for data-centric services that can detect
infectious diseases before positive cases or hospitalizations;
``(2) entering into contracts with private companies to
implement early warning detection methods; or
``(3) funding research to study early warning detection
methods.
``(c) Priority.--In selecting grant recipients under this section,
the Secretary shall give priority to eligible entities proposing to
conduct research on, or to establish, wastewater surveillance or other
early warning system in one or more areas that--
``(1) are (or include one or more areas that are) a hot
spot; or
``(2) a higher percentage of vulnerable populations than
the national average.
``(d) Federal Privacy Requirements.--Nothing in this section shall
be construed to supersede any Federal privacy or confidentiality
requirement, including the regulations promulgated under section 264(c)
of the Health Insurance Portability and Accountability Act of 1996 and
section 543 of this Act.
``(e) Definitions.--In this section:
``(1) The term `Administrator' means the Administrator of
the Environmental Protection Agency.
``(2) The term `eligible entity' means--
``(A) a State government;
``(B) a local government;
``(C) a Tribal government;
``(D) an entity that conducts health research; and
``(E) an academic institution.
``(3) The term `emergency period' has the meaning given to
that term in section 1135(g)(1)(B) of the Social Security Act.
``(4) The term `hot spot' means a geographic area where the
rate of infection with a particular pathogen exceeds the
national average.
``(5) The term `local government' means a county,
municipality, town, township, village, parish, borough, or
other unit of general local government.
``(6) The term `Secretary' means the Secretary of Health
and Human Services.
``(7) The term `State' means each of the several States,
the District of Columbia, the Commonwealth of Puerto Rico,
American Samoa, Guam, the Commonwealth of the Northern Mariana
Islands, the Virgin Islands, and the Trust Territory of the
Pacific Islands.
``(8) The term `vulnerable population' means people at
increased risk of severe illness.
``(f) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $18,000,000 for each of fiscal
years 2021 through 2025.''.
TITLE V--ADDRESSING COVID-19 HEALTH DISPARITIES
Subtitle A--Tribal Health Data Improvement
SEC. 5001. COLLECTION AND AVAILABILITY OF HEALTH DATA WITH RESPECT TO
INDIAN TRIBES.
(a) Data Collection.--Section 3101(a)(1) of the Public Health
Service Act (42 U.S.C. 300kk(a)(1)) is amended--
(1) by striking ``, by not later than 2 years after the
date of enactment of this title,''; and
(2) in subparagraph (B), by inserting ``Tribal,'' after
``State,''.
(b) Data Reporting and Dissemination.--Section 3101(c) of the
Public Health Service Act (42 U.S.C. 300kk(c)) is amended--
(1) by amending subparagraph (F) of paragraph (1) to read
as follows:
``(F) the Indian Health Service, Indian Tribes,
Tribal organizations, and epidemiology centers
authorized under the Indian Health Care Improvement
Act;''; and
(2) in paragraph (3), by inserting ``Indian Tribes, Tribal
organizations, and epidemiology centers,'' after ``Federal
agencies,''.
(c) Protection and Sharing of Data.--Section 3101(e) of the Public
Health Service Act (42 U.S.C. 300kk(e)) is amended by adding at the end
the following new paragraphs:
``(3) Data sharing strategy.--With respect to data access
for Tribal epidemiology centers and Tribes, the Secretary shall
create a data sharing strategy that takes into consideration
recommendations by the Secretary's Tribal Advisory Committee
for--
``(A) ensuring that Tribal epidemiology centers and
Indian Tribes have access to the data sources necessary
to accomplish their public health responsibilities; and
``(B) protecting the privacy and security of such
data.
``(4) Tribal public health authority.--
``(A) Availability.--Beginning not later than 180
days after the date of the enactment of the Commitment
to Defeat the Virus and Keep America Healthy Act, the
Secretary shall make available to the entities listed
in subparagraph (B) all data that is collected pursuant
to this title with respect to health care and public
health surveillance programs and activities, including
such programs and activities that are federally
supported or conducted, so long as--
``(i) such entities request the data
pursuant to statute; and
``(ii) the data is requested for use--
``(I) consistent with Federal law
and obligations; and
``(II) to satisfy a particular
purpose or carry out a specific
function consistent with the purpose
for which the data was collected.
``(B) Entities.--The entities listed in this
subparagraph are--
``(i) the Indian Health Service;
``(ii) Indian Tribes and Tribal
organizations; and
``(iii) epidemiology centers.''.
(d) Technical Updates.--Section 3101 of the Public Health Service
Act (42 U.S.C. 300kk) is amended--
(1) by striking subsections (g) and (h); and
(2) by redesignating subsection (i) as subsection (h).
(e) Definitions.--After executing the amendments made by subsection
(d), section 3101 of the Public Health Service Act (42 U.S.C. 300kk) is
amended by inserting after subsection (f) the following new subsection:
``(g) Definitions.--In this section:
``(1) The term `epidemiology center' means an epidemiology
center established under section 214 of the Indian Health Care
Improvement Act, including such Tribal epidemiology centers
serving Indian Tribes regionally and any Tribal epidemiology
center serving Urban Indian organizations nationally.
``(2) The term `Indian Tribe' has the meaning given to the
term `Indian tribe' in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(3) The term `Tribal organization' has the meaning given
to the term `tribal organization' in section 4 of the of the
Indian Self-Determination and Education Assistance Act.
``(4) The term `Urban Indian organization' has the meaning
given to that term in section 4 of the Indian Health Care
Improvement Act.''.
(f) Technical Correction.--Section 3101(b) of the Public Health
Service Act (42 U.S.C. 300kk(b)) is amended by striking ``Data
Analysis.--'' and all that follows through ``For each federally'' and
inserting ``Data Analysis.--For each federally''.
SEC. 5002. IMPROVING HEALTH STATISTICS REPORTING WITH RESPECT TO INDIAN
TRIBES.
(a) Technical Aid to States and Localities.--Section 306(d) of the
Public Health Service Act (42 U.S.C. 242k(d)) is amended by inserting
``, Indian Tribes, Tribal organizations, and epidemiology centers''
after ``jurisdictions''.
(b) Cooperative Health Statistics System.--Section 306(e)(3) of the
Public Health Service Act (42 U.S.C. 242k(e)(3)) is amended by
inserting ``, Indian Tribes, Tribal organizations, and epidemiology
centers'' after ``health agencies''.
(c) Federal-State-Tribal Cooperation.--Section 306(f) of the Public
Health Service Act (42 U.S.C. 242k(f)) is amended--
(1) by inserting ``the Indian Health Service,'' before
``the Departments of Commerce'';
(2) by inserting a comma after ``the Departments of
Commerce and Labor'';
(3) by inserting ``, Indian Tribes, Tribal organizations,
and epidemiology centers'' after ``State and local health
departments and agencies''; and
(4) by striking ``he shall'' and inserting ``the Secretary
shall''.
(d) Registration Area Records.--Section 306(h)(1) of the Public
Health Service Act (42 U.S.C. 242k(h)(1)) is amended--
(1) by striking ``in his discretion'' and inserting ``in
the discretion of the Secretary''; and
(2) by striking ``Hispanics, Asian Americans, and Pacific
Islanders'' and inserting ``American Indians and Alaska
Natives, Hispanics, Asian Americans, and Native Hawaiian and
other Pacific Islanders''.
(e) National Committee on Vital and Health Statistics.--Section
306(k) of the Public Health Service Act (42 U.S.C. 242k(k)) is
amended--
(1) in paragraph (3), by striking ``, not later than 60
days after the date of the enactment of the Health Insurance
Portability and Accountability Act of 1996,'' each place it
appears; and
(2) in paragraph (7), by striking ``Not later than 1 year
after the date of the enactment of the Health Insurance
Portability and Accountability Act of 1996, and annually
thereafter, the Committee shall'' and inserting ``The Committee
shall, on an biennial basis,''.
(f) Grants for Assembly and Analysis of Data on Ethnic and Racial
Populations.--Section 306(m)(4) of the Public Health Service Act (42
U.S.C. 242k(m)(4)) is amended--
(1) in subparagraph (A)--
(A) by striking ``Subject to subparagraph (B),
the'' and inserting ``The''; and
(B) by striking ``and major Hispanic subpopulation
groups and American Indians'' and inserting ``, major
Hispanic subgroups, and American Indians and Alaska
Natives''; and
(2) by amending subparagraph (B) to read as follows:
``(B) In carrying out subparagraph (A), with respect to American
Indians and Alaska Natives, the Secretary shall--
``(i) consult with Indian Tribes, Tribal organizations, the
Tribal Technical Advisory Group of the Centers for Medicare &
Medicaid Services maintained under section 5006(e) of the
American Recovery and Reinvestment Act of 2009, and the Tribal
Advisory Committee established by the Centers for Disease
Control and Prevention, in coordination with epidemiology
centers, to develop guidelines for State and local health
agencies to improve the quality and accuracy of data with
respect to the birth and death records of American Indians and
Alaska Natives;
``(ii) confer with Urban Indian organizations to develop
guidelines for State and local health agencies to improve the
quality and accuracy of data with respect to the birth and
death records of American Indians and Alaska Natives;
``(iii) enter into cooperative agreements with Indian
Tribes, Tribal organizations, Urban Indian organizations, and
epidemiology centers to address misclassification and
undersampling of American Indians and Alaska Natives with
respect to--
``(I) birth and death records; and
``(II) health care and public health surveillance
systems, including, but not limited to, data with
respect to chronic and infectious diseases,
unintentional injuries, environmental health, child and
adolescent health, maternal health and mortality,
foodborne and waterborne illness, reproductive health,
and any other notifiable disease or condition;
``(iv) encourage States to enter into data sharing
agreements with Indian Tribes, Tribal organizations, and
epidemiology centers to improve the quality and accuracy of
public health data; and
``(v) not later than 180 days after the date of enactment
of the Commitment to Defeat the Virus and Keep America Healthy
Act, and biennially thereafter, issue a report on the
following:
``(I) Which States have data sharing agreements
with Indian Tribes, Tribal organizations, Urban Indian
organizations, and Tribal epidemiology centers to
improve the quality and accuracy of health data.
``(II) What the Centers for Disease Control and
Prevention is doing to encourage States to enter into
data sharing agreements with Indian Tribes, Tribal
organizations, Urban Indian organizations, and Tribal
epidemiology centers to improve the quality and
accuracy of health data.
``(III) Best practices and guidance for States,
Indian Tribes, Tribal organizations, Urban Indian
organizations, and Tribal epidemiology centers that
wish to enter into data sharing agreements.
``(IV) Best practices and guidance for local,
State, Tribal, and Federal uniform standards for the
collection of data on race and ethnicity.''.
(g) Definitions.--Section 306 of the Public Health Service Act (42
U.S.C. 242k) is amended--
(1) by redesignating subsection (n) as subsection (o); and
(2) by inserting after subsection (m) the following:
``(n) In this section:
``(1) The term `epidemiology center' means an epidemiology
center established under section 214 of the Indian Health Care
Improvement Act, including such Tribal epidemiology centers
serving Indian Tribes regionally and any Tribal epidemiology
center serving Urban Indian organizations nationally.
``(2) The term `Indian Tribe' has the meaning given to the
term `Indian tribe' in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(3) The term `Tribal organization' has the meaning given
to the term `tribal organization' in section 4 of the Indian
Self-Determination and Education Assistance Act.
``(4) The term `Urban Indian organization' has the meaning
given to that term in section 4 of the Indian Health Care
Improvement Act.''.
(h) Authorization of Appropriations.--Section 306(o) of the Public
Health Service Act, as redesignated by subsection (g), is amended to
read as follows:
``(o)(1) To carry out this section, there is authorized to be
appropriated $185,000,000 for each of the fiscal years 2021 through
2025.
``(2) Of the amount authorized to be appropriated to carry out this
section for a fiscal year, the Secretary shall not use more than 10
percent for the combined costs of--
``(A) administration of this section; and
``(B) carrying out subsection (m)(2).''.
Subtitle B--Tribal Medical Supplies Stockpile Access
SEC. 5011. PROVISION OF ITEMS TO INDIAN PROGRAMS AND FACILITIES.
(a) Strategic National Stockpile.--Section 319F-2(a)(3)(G) of the
Public Health Service Act (42 U.S.C. 247d-6b(a)(3)(G)) is amended by
inserting ``, and, in the case that the Secretary deploys the stockpile
under this subparagraph, ensure that appropriate drugs, vaccines and
other biological products, medical devices, and other supplies are
deployed by the Secretary directly to health programs or facilities
operated by the Indian Health Service, an Indian tribe, a tribal
organization (as those terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C. 5304)), or
an inter-tribal consortium (as defined in section 501 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C. 5381)) or
through an urban Indian organization (as defined in section 4 of the
Indian Health Care Improvement Act), while avoiding duplicative
distributions to such programs or facilities'' before the semicolon.
(b) Distribution of Qualified Pandemic or Epidemic Products to IHS
Facilities.--Title III of the Public Health Service Act (42 U.S.C. 241
et seq.), as amended by section 3015, is further amended by inserting
after section 319F-5 the following:
``SEC. 319F-6. DISTRIBUTION OF QUALIFIED PANDEMIC OR EPIDEMIC PRODUCTS
TO INDIAN PROGRAMS AND FACILITIES.
``In the case that the Secretary distributes qualified pandemic or
epidemic products (as defined in section 319F-3(i)(7)) to States or
other entities, the Secretary shall ensure that, as appropriate, such
products are distributed directly to health programs or facilities
operated by the Indian Health Service, an Indian tribe, a tribal
organization (as those terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C. 5304)), or
an inter-tribal consortium (as defined in section 501 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C. 5381)) or
through an urban Indian organization (as defined in section 4 of the
Indian Health Care Improvement Act), while avoiding duplicative
distributions to such programs or facilities.''.
Subtitle C--Native American Suicide Prevention
SEC. 5021. NATIVE AMERICAN SUICIDE PREVENTION.
Section 520E(b) of the Public Health Service Act (42 U.S.C. 290bb-
36(b)) is amended by inserting after paragraph (3) the following:
``(4) Consultation.--A State applying for a grant or
cooperative agreement under this section shall, in the
development and implementation of a statewide early
intervention strategy, consult or confer with entities
described in paragraph (1)(C) in such State.''.
Subtitle D--Pursuing Equity in Mental Health
PART 1--HEALTH EQUITY AND ACCOUNTABILITY
SEC. 5031. INTEGRATED HEALTH CARE DEMONSTRATION PROGRAM.
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. 554. INTERPROFESSIONAL HEALTH CARE TEAMS FOR PROVISION OF
BEHAVIORAL HEALTH CARE IN PRIMARY CARE SETTINGS.
``(a) Grants.--The Secretary shall award grants to eligible
entities for the purpose of establishing interprofessional health care
teams that provide behavioral health care.
``(b) Eligible Entities.--To be eligible to receive a grant under
this section, an entity shall be a federally qualified health center
(as defined in section 1861(aa) of the Social Security Act), rural
health clinic, or behavioral health program, serving a high proportion
of individuals from racial and ethnic minority groups (as defined in
section 1707(g)).
``(c) Scientifically Based.--Integrated health care funded through
this section shall be scientifically based, taking into consideration
the results of the most recent peer-reviewed research available.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $20,000,000 for each of the
first 5 fiscal years following the date of enactment of the Commitment
to Defeat the Virus and Keep America Healthy Act.''.
SEC. 5032. ADDRESSING RACIAL AND ETHNIC MINORITY MENTAL HEALTH
DISPARITIES RESEARCH GAPS.
Not later than 6 months after the date of the enactment of this
Act, the Director of the National Institutes of Health shall enter into
an arrangement with the National Academies of Sciences, Engineering,
and Medicine (or, if the National Academies of Sciences, Engineering,
and Medicine decline to enter into such an arrangement, the Patient-
Centered Outcomes Research Institute, the Agency for Healthcare
Research and Quality, or another appropriate entity)--
(1) to conduct a study with respect to mental health
disparities in racial and ethnic minority groups (as defined in
section 1707(g) of the Public Health Service Act (42 U.S.C.
300u-6(g))); and
(2) to submit to the Congress a report on the results of
such study, including--
(A) a compilation of information on the dynamics of
mental disorders in such racial and ethnic minority
groups; and
(B) a compilation of information on the impact of
exposure to community violence, adverse childhood
experiences, structural racism, and other psychological
traumas on mental disorders in such racial and minority
groups.
SEC. 5033. HEALTH PROFESSIONS COMPETENCIES TO ADDRESS RACIAL AND ETHNIC
MINORITY MENTAL HEALTH DISPARITIES.
(a) In General.--The Secretary of Health and Human Services shall
award grants to qualified national organizations for the purposes of--
(1) developing, and disseminating to health professional
educational programs best practices or core competencies
addressing mental health disparities among racial and ethnic
minority groups for use in the training of students in the
professions of social work, psychology, psychiatry, marriage
and family therapy, mental health counseling, and substance
misuse counseling; and
(2) certifying community health workers and peer wellness
specialists with respect to such best practices and core
competencies and integrating and expanding the use of such
workers and specialists into health care to address mental
health disparities among racial and ethnic minority groups.
(b) Best Practices; Core Competencies.--Organizations receiving
funds under subsection (a) may use the funds to engage in the following
activities related to the development and dissemination of best
practices or core competencies described in subsection (a)(1):
(1) Formation of committees or working groups comprised of
experts from accredited health professions schools to identify
best practices and core competencies relating to mental health
disparities among racial and ethnic minority groups.
(2) Planning of workshops in national fora to allow for
public input into the educational needs associated with mental
health disparities among racial and ethnic minority groups.
(3) Dissemination and promotion of the use of best
practices or core competencies in undergraduate and graduate
health professions training programs nationwide.
(4) Establishing external stakeholder advisory boards to
provide meaningful input into policy and program development
and best practices to reduce mental health disparities among
racial and ethnic minority groups.
(c) Definitions.--In this section:
(1) Qualified national organization.--The term ``qualified
national organization'' means a national organization that
focuses on the education of students in one or more of the
professions of social work, psychology, psychiatry, marriage
and family therapy, mental health counseling, and substance
misuse counseling.
(2) Racial and ethnic minority group.--The term ``racial
and ethnic minority group'' has the meaning given to such term
in section 1707(g) of the Public Health Service Act (42 U.S.C.
300u-6(g)).
SEC. 5034. RACIAL AND ETHNIC MINORITY BEHAVIORAL AND MENTAL HEALTH
OUTREACH AND EDUCATION STRATEGY.
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd
et seq.), as amended by section 5031, is further amended by adding at
the end the following new section:
``SEC. 555. BEHAVIORAL AND MENTAL HEALTH OUTREACH AND EDUCATION
STRATEGY.
``(a) In General.--The Secretary shall, in consultation with
advocacy and behavioral and mental health organizations serving racial
and ethnic minority groups, develop and implement an outreach and
education strategy to promote behavioral and mental health and reduce
stigma associated with mental health conditions and substance abuse
among racial and ethnic minority groups. Such strategy shall--
``(1) be designed to--
``(A) meet the diverse cultural and language needs
of the various racial and ethnic minority groups; and
``(B) be developmentally and age-appropriate;
``(2) increase awareness of symptoms of mental illnesses
common among such groups, taking into account differences
within at-risk subgroups;
``(3) provide information on evidence-based, culturally and
linguistically appropriate and adapted interventions and
treatments;
``(4) ensure full participation of, and engage, both
consumers and community members in the development and
implementation of materials; and
``(5) seek to broaden the perspective among both
individuals in these groups and stakeholders serving these
groups to use a comprehensive public health approach to
promoting behavioral health that addresses a holistic view of
health by focusing on the intersection between behavioral and
physical health.
``(b) Reports.--Beginning not later than 1 year after the date of
the enactment of this section and annually thereafter, the Secretary
shall submit to Congress, and make publicly available, a report on the
extent to which the strategy developed and implemented under subsection
(a) increased behavioral and mental health outcomes associated with
mental health conditions and substance abuse among racial and ethnic
minority groups.
``(c) Definition.--In this section, the term `racial and ethnic
minority group' has the meaning given to that term in section 1707(g).
``(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $10,000,000 for each of fiscal
years 2021 through 2025.''.
SEC. 5035. ADDITIONAL FUNDS FOR NATIONAL INSTITUTES OF HEALTH.
(a) In General.--In addition to amounts otherwise authorized to be
appropriated to the National Institutes of Health, there is authorized
to be appropriated to such Institutes $100,000,000 for each of fiscal
years 2021 through 2025 to build relations with communities and conduct
or support clinical research, including clinical research on racial or
ethnic disparities in physical and mental health.
(b) Definition.--In this section, the term ``clinical research''
has the meaning given to such term in section 409 of the Public Health
Service Act (42 U.S.C. 284d).
SEC. 5036. ADDITIONAL FUNDS FOR NATIONAL INSTITUTE ON MINORITY HEALTH
AND HEALTH DISPARITIES.
In addition to amounts otherwise authorized to be appropriated to
the National Institute on Minority Health and Health Disparities, there
is authorized to be appropriated to such Institute $650,000,000 for
each of fiscal years 2021 through 2025.
PART 2--OTHER PROVISIONS
SEC. 5037. REAUTHORIZATION OF MINORITY FELLOWSHIP PROGRAM.
Section 597(c) of the Public Health Service Act (42 U.S.C.
297ll(c)) is amended by striking ``$12,669,000 for each of fiscal years
2018 through 2022'' and inserting ``$25,000,000 for each of fiscal
years 2021 through 2025''.
SEC. 5038. STUDY ON THE EFFECTS OF SMARTPHONE AND SOCIAL MEDIA USE ON
ADOLESCENTS.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services shall conduct
or support research on--
(1) smartphone and social media use by adolescents; and
(2) the effects of such use on--
(A) emotional, behavioral, and physical health and
development; and
(B) disparities in minority and underserved
populations.
(b) Report.--Not later than 5 years after the date of the enactment
of this Act, the Secretary shall submit to the Congress, and make
publicly available, a report on the findings of research described in
this section.
SEC. 5039. TECHNICAL CORRECTION.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
is amended--
(1) by redesignating the second section 550 of such Act (42
U.S.C. 290ee-10) (relating to Sobriety Treatment And Recovery
Teams) as section 553; and
(2) by moving such section 553, as so redesignated, so as
to appear after section 552 of such Act (42 U.S.C. 290ee-7).
Subtitle E--Maternal Health Quality Improvement
SEC. 5041. INNOVATION FOR MATERNAL HEALTH.
Part D of title III of the Public Health Service Act (42 U.S.C.
254b et seq.), as amended by section 4071, is further amended--
(1) in the section designation of section 330M of such Act
(42 U.S.C. 254c-19) by inserting a period after ``330M''; and
(2) by inserting after section 330N of such Act, as
inserted by section 4071, the following:
``SEC. 330O. INNOVATION FOR MATERNAL HEALTH.
``(a) In General.--The Secretary, in consultation with experts
representing a variety of clinical specialties, State, Tribal, or local
public health officials, researchers, epidemiologists, statisticians,
and community organizations, shall establish or continue a program to
award competitive grants to eligible entities for the purposes of--
``(1) identifying, developing, or disseminating best
practices to improve maternal health care quality and outcomes,
eliminate preventable maternal mortality and severe maternal
morbidity, and improve infant health outcomes, which may
include--
``(A) information on evidence-based practices to
improve the quality and safety of maternal health care
in hospitals and other health care settings of a State
or health care system, including by addressing topics
commonly associated with health complications or risks
related to prenatal care, labor care, birthing, and
postpartum care;
``(B) best practices for improving maternal health
care based on data findings and reviews conducted by a
State maternal mortality review committee that address
topics of relevance to common complications or health
risks related to prenatal care, labor care, birthing,
and postpartum care; and
``(C) information on addressing determinants of
health that impact maternal health outcomes for women
before, during, and after pregnancy;
``(2) collaborating with State maternal mortality review
committees to identify issues for the development and
implementation of evidence-based practices to improve maternal
health outcomes and reduce preventable maternal mortality and
severe maternal morbidity;
``(3) providing technical assistance and supporting the
implementation of best practices identified pursuant to
paragraph (1) to entities providing health care services to
pregnant and postpartum women; and
``(4) identifying, developing, and evaluating new models of
care that improve maternal and infant health outcomes, which
may include the integration of community-based services and
clinical care.
``(b) Eligible Entities.--To be eligible for a grant under
subsection (a), an entity shall--
``(1) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may require; and
``(2) demonstrate in such application that the entity is
capable of carrying out data-driven maternal safety and quality
improvement initiatives in the areas of obstetrics and
gynecology or maternal health.
``(c) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $5,000,000 for each of fiscal
years 2021 through 2025.''.
SEC. 5042. TRAINING FOR HEALTH CARE PROVIDERS.
Title VII of the Public Health Service Act is amended by striking
section 763 (42 U.S.C. 294p) and inserting the following:
``SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.
``(a) Grant Program.--The Secretary shall establish a program to
award grants to accredited schools of allopathic medicine, osteopathic
medicine, and nursing, and other health professional training programs
for the training of health care professionals to reduce and prevent
discrimination (including training related to implicit and explicit
biases) in the provision of health care services related to prenatal
care, labor care, birthing, and postpartum care.
``(b) Eligibility.--To be eligible for a grant under subsection
(a), an entity described in such subsection shall submit to the
Secretary an application at such time, in such manner, and containing
such information as the Secretary may require.
``(c) Reporting Requirement.--Each entity awarded a grant under
this section shall periodically submit to the Secretary a report on the
status of activities conducted using the grant, including a description
of the impact of such training on patient outcomes, as applicable.
``(d) Best Practices.--The Secretary may identify and disseminate
best practices for the training of health care professionals to reduce
and prevent discrimination (including training related to implicit and
explicit biases) in the provision of health care services related to
prenatal care, labor care, birthing, and postpartum care.
``(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $5,000,000 for each of fiscal
years 2021 through 2025.''.
SEC. 5043. STUDY ON TRAINING TO REDUCE AND PREVENT DISCRIMINATION.
Not later than 2 years after date of enactment of this Act, the
Secretary of Health and Human Services shall, through a contract with
an independent research organization, conduct a study and make
recommendations for accredited schools of allopathic medicine,
osteopathic medicine, and nursing, and other health professional
training programs, on best practices related to training to reduce and
prevent discrimination, including training related to implicit and
explicit biases, in the provision of health care services related to
prenatal care, labor care, birthing, and postpartum care.
SEC. 5044. PERINATAL QUALITY COLLABORATIVES.
Section 317K(a)(2) of the Public Health Service Act (42 U.S.C.
247b-12(a)(2)) is amended by adding at the end the following:
``(E)(i) The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and
in coordination with other offices and agencies, as
appropriate, shall establish or continue a competitive
grant program for the establishment or support of
perinatal quality collaboratives to improve perinatal
care and perinatal health outcomes for pregnant and
postpartum women and their infants. A State, Indian
Tribe, or Tribal organization may use funds received
through such grant to--
``(I) support the use of evidence-based or
evidence-informed practices to improve outcomes
for maternal and infant health;
``(II) work with clinical teams; experts;
State, local, and, as appropriate, Tribal
public health officials; and stakeholders,
including patients and families, to identify,
develop, or disseminate best practices to
improve perinatal care and outcomes; and
``(III) employ strategies that provide
opportunities for health care professionals and
clinical teams to collaborate across health
care settings and disciplines, including
primary care and mental health, as appropriate,
to improve maternal and infant health outcomes,
which may include the use of data to provide
timely feedback across hospital and clinical
teams to inform responses, and to provide
support and training to hospital and clinical
teams for quality improvement, as appropriate.
``(ii) To be eligible for a grant under clause (i),
an entity shall submit to the Secretary an application
in such form and manner and containing such information
as the Secretary may require.''.
SEC. 5045. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.
(a) Grants.--Title III of the Public Health Service Act is amended
by inserting after section 330O of such Act, as added by section 5041,
the following:
``SEC. 330P. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.
``(a) In General.--The Secretary may award grants to States, Indian
Tribes, and Tribal organizations for the purpose of establishing or
operating evidence-based or innovative, evidence-informed programs to
deliver integrated health care services to pregnant and postpartum
women to optimize the health of women and their infants, including to
reduce adverse maternal health outcomes, pregnancy-related deaths, and
related health disparities (including such disparities associated with
racial and ethnic minority populations), and, as appropriate, by
addressing issues researched under subsection (b)(2) of section 317K.
``(b) Integrated Services for Pregnant and Postpartum Women.--
``(1) Eligibility.--To be eligible to receive a grant under
subsection (a), a State, Indian Tribe, or Tribal organization
shall work with relevant stakeholders that coordinate care
(including coordinating resources and referrals for health care
and social services) to develop and carry out the program,
including--
``(A) State, Tribal, and local agencies responsible
for Medicaid, public health, social services, mental
health, and substance use disorder treatment and
services;
``(B) health care providers who serve pregnant and
postpartum women; and
``(C) community-based health organizations and
health workers, including providers of home visiting
services and individuals representing communities with
disproportionately high rates of maternal mortality and
severe maternal morbidity, and including individuals
representing racial and ethnic minority populations.
``(2) Terms.--
``(A) Period.--A grant awarded under subsection (a)
shall be made for a period of 5 years. Any supplemental
award made to a grantee under subsection (a) may be
made for a period of less than 5 years.
``(B) Preference.--In awarding grants under
subsection (a), the Secretary shall--
``(i) give preference to States, Indian
Tribes, and Tribal organizations that have the
highest rates of maternal mortality and severe
maternal morbidity relative to other such
States, Indian Tribes, or Tribal organizations,
respectively; and
``(ii) shall consider health disparities
related to maternal mortality and severe
maternal morbidity, including such disparities
associated with racial and ethnic minority
populations.
``(C) Priority.--In awarding grants under
subsection (a), the Secretary shall give priority to
applications from up to 15 entities described in
subparagraph (B)(i).
``(D) Evaluation.--The Secretary shall require
grantees to evaluate the outcomes of the programs
supported under the grant.
``(c) Definitions.--In this section, the terms `Indian Tribe' and
`Tribal organization' have the meanings given the terms `Indian tribe'
and `tribal organization', respectively, in section 4 of the Indian
Self-Determination and Education Assistance Act.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $10,000,000 for each of fiscal
years 2021 through 2025.''.
(b) Report on Grant Outcomes and Dissemination of Best Practices.--
(1) Report.--Not later than February 1, 2026, 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 that describes--
(A) the outcomes of the activities supported by the
grants awarded under the amendment made by this section
on maternal and child health;
(B) best practices and models of care used by
recipients of grants under such amendment; and
(C) obstacles identified by recipients of grants
under such amendment, and strategies used by such
recipients to deliver care, improve maternal and child
health, and reduce health disparities.
(2) Dissemination of best practices.--Not later than August
1, 2026, the Secretary of Health and Human Services shall
disseminate information on best practices and models of care
used by recipients of grants under the amendment made by this
section (including best practices and models of care relating
to the reduction of health disparities, including such
disparities associated with racial and ethnic minority
populations, in rates of maternal mortality and severe maternal
morbidity) to relevant stakeholders, which may include health
providers, medical schools, nursing schools, relevant State,
Tribal, and local agencies, and the general public.
SEC. 5046. IMPROVING RURAL MATERNAL AND OBSTETRIC CARE DATA.
(a) Maternal Mortality and Morbidity Activities.--Section 301(e) of
the Public Health Service Act (42 U.S.C. 241(e)) is amended by
inserting ``, preventable maternal mortality and severe maternal
morbidity,'' after ``delivery''.
(b) Office of Women's Health.--Section 310A(b)(1) of the Public
Health Service Act (42 U.S.C. 242s(b)(1)) is amended by striking ``and
sociocultural contexts,'' and inserting ``sociocultural (including
among American Indians, Native Hawaiians, and Alaska Natives), and
geographical contexts''.
(c) Safe Motherhood.--Section 317K of the Public Health Service Act
(42 U.S.C. 247b-12) is amended--
(1) in subsection (a)(2)(A), by inserting ``, including
improving collection of data on race, ethnicity, and other
demographic information'' before the period; and
(2) in subsection (b)(2)--
(A) in subparagraph (L), by striking ``and'' at the
end;
(B) by redesignating subparagraph (M) as
subparagraph (N); and
(C) by inserting after subparagraph (L) the
following:
``(M) an examination of the relationship between
maternal health and obstetric services in rural areas
and outcomes in delivery and postpartum care; and''.
(d) Office of Research on Women's Health.--Section 486 of the
Public Health Service Act (42 U.S.C. 287d) is amended--
(1) in subsection (b), by amending paragraph (3) to read as
follows:
``(3) carry out paragraphs (1) and (2) with respect to--
``(A) the aging process in women, with priority
given to menopause; and
``(B) pregnancy, with priority given to deaths
related to preventable maternal mortality and severe
maternal morbidity;''; and
(2) in subsection (d)(4)(A)(iv), by inserting ``, including
preventable maternal morbidity and severe maternal morbidity''
before the semicolon.
SEC. 5047. RURAL OBSTETRIC NETWORK GRANTS.
The Public Health Service Act is amended by inserting after section
330A-1 (42 U.S.C. 254c-1a) the following:
``SEC. 330A-2. RURAL OBSTETRIC NETWORK GRANTS.
``(a) Program Established.--The Secretary shall award grants or
cooperative agreements to eligible entities to establish collaborative
improvement and innovation networks (referred to in this section as
`rural obstetric networks') to improve maternal and infant health
outcomes and reduce preventable maternal mortality and severe maternal
morbidity by improving maternity care and access to care in rural
areas, frontier areas, maternity care health professional target areas,
or jurisdictions of Indian Tribes and Tribal organizations.
``(b) Use of Funds.--Grants or cooperative agreements awarded
pursuant to this section shall be used for the establishment or
continuation of collaborative improvement and innovation networks to
improve maternal health in rural areas by improving infant health and
maternal outcomes and reducing preventable maternal mortality and
severe maternal morbidity. Rural obstetric networks established in
accordance with this section may--
``(1) develop a network to improve coordination and
increase access to maternal health care and assist pregnant
women in the areas described in subsection (a) with accessing
and utilizing maternal and obstetric care, including health
care services related to prenatal care, labor care, birthing,
and postpartum care to improve outcomes in birth and maternal
mortality and morbidity;
``(2) identify and implement evidence-based and sustainable
delivery models for maternal and obstetric care (including
health care services related to prenatal care, labor care,
birthing, and postpartum care for women in the areas described
in subsection (a)), including home visiting programs and
culturally appropriate care models that reduce health
disparities;
``(3) develop a model for maternal health care
collaboration between health care settings to improve access to
care in areas described in subsection (a), which may include
the use of telehealth;
``(4) provide training for professionals in health care
settings that do not have specialty maternity care;
``(5) collaborate with academic institutions that can
provide regional expertise and help identify barriers to
providing maternal health care, including strategies for
addressing such barriers; and
``(6) assess and address disparities in infant and maternal
health outcomes, including among racial and ethnic minority
populations and underserved populations in areas described in
subsection (a).
``(c) Definitions.--In this section:
``(1) Eligible entities.--The term `eligible entities'
means entities providing maternal health care services in rural
areas, frontier areas, or medically underserved areas, or to
medically underserved populations or Indian Tribes or Tribal
organizations.
``(2) Frontier area.--The term `frontier area' means a
frontier county, as defined in section 1886(d)(3)(E)(iii)(III)
of the Social Security Act.
``(3) Indian tribes; tribal organization.--The terms
`Indian Tribe' and `Tribal organization' have the meanings
given the terms `Indian tribe' and `tribal organization',
respectively, in section 4 of the Indian Self-Determination and
Education Assistance Act.
``(4) Maternity care health professional target area.--The
term `maternity care health professional target area' has the
meaning described in section 332(k)(2).
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $3,000,000 for each of fiscal
years 2021 through 2025.''.
SEC. 5048. TELEHEALTH NETWORK AND TELEHEALTH RESOURCE CENTERS GRANT
PROGRAMS.
Section 330I of the Public Health Service Act (42 U.S.C. 254c-14)
is amended--
(1) in subsection (f)(3), by adding at the end the
following:
``(M) Providers of maternal care, including
prenatal, labor care, birthing, and postpartum care
services and entities operating obstetric care
units.''; and
(2) in subsection (h)(1)(B), by inserting ``labor care,
birthing care, postpartum care,'' before ``or prenatal''.
SEC. 5049. RURAL MATERNAL AND OBSTETRIC CARE TRAINING DEMONSTRATION.
Subpart 1 of part E of title VII of the Public Health Service Act
(42 U.S.C. 294n et seq.) is amended by adding at the end the following:
``SEC. 764. RURAL MATERNAL AND OBSTETRIC CARE TRAINING DEMONSTRATION.
``(a) In General.--The Secretary shall award grants to accredited
schools of allopathic medicine, osteopathic medicine, and nursing, and
other appropriate health professional training programs, to establish a
training demonstration program to support--
``(1) training for physicians, medical residents, fellows,
nurse practitioners, physician assistants, nurses, certified
nurse midwives, relevant home visiting workforce professionals
and paraprofessionals, or other professionals who meet relevant
State training and licensing requirements, as applicable, to
provide maternal health care services in rural community-based
settings; and
``(2) developing recommendations for such training
programs.
``(b) Application.--To be eligible 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.
``(c) Activities.--
``(1) Training for health care professionals.--A recipient
of a grant under subsection (a)--
``(A) shall use the grant funds to plan, develop,
and operate a training program to provide maternal
health care in rural areas; 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 program requirements.--The recipient of a
grant under subsection (a) shall ensure that training programs
carried out under the grant are evidence-based and address
improving maternal health care in rural areas, and such
programs may include training on topics such as--
``(A) maternal mental health, including perinatal
depression and anxiety;
``(B) substance use disorders;
``(C) social determinants of health that affect
individuals living in rural areas; and
``(D) implicit and explicit bias.
``(d) Evaluation and Report.--
``(1) Evaluation.--
``(A) In general.--The Secretary shall evaluate the
outcomes of the demonstration program under this
section.
``(B) Data submission.--Recipients of a grant under
subsection (a) shall submit to the Secretary
performance metrics and other related data in order to
evaluate the program for the report described in
paragraph (2).
``(2) Report to congress.--Not later than January 1, 2025,
the Secretary 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 includes--
``(A) an analysis of the effects of the
demonstration program under this section on the
quality, quantity, and distribution of maternal health
care services, including health care services related
to prenatal care, labor care, birthing, and postpartum
care, and the demographics of the recipients of those
services;
``(B) an analysis of maternal and infant health
outcomes (including quality of care, morbidity, and
mortality) before and after implementation of the
program in the communities served by entities
participating in the demonstration program; and
``(C) recommendations on whether the demonstration
program should be continued.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2021 through 2025.''.
TITLE VI--ADDRESSING THE IMPACTS OF COVID-19 ON MENTAL HEALTH
Subtitle A--Creating Resources To Improve Situations of Inherent
Severity
SEC. 6001. SET-ASIDE FOR EVIDENCE-BASED CRISIS CARE SERVICES.
Section 1920 of the Public Health Service Act (42 U.S.C. 300x-9) is
amended--
(1) in subsection (a), by striking ``$532,571,000 for each
of fiscal years 2018 through 2022'' and inserting
``$532,571,000 for each of fiscal years 2018 through 2020, and
$758,000,000 for each of fiscal years 2021 through 2022''; and
(2) by adding at the end the following:
``(d) Crisis Care.--
``(1) In general.--Except as provided in paragraph (3), a
State shall expend at least 5 percent of the amount the State
receives pursuant to section 1911 for each fiscal year to
support evidenced-based programs that address the crisis care
needs of individuals with serious mental disorders, and
children with serious mental and emotional disturbances.
``(2) Core elements.--At the discretion of the single State
agency responsible for the administration of the program of the
State under a grant under section 1911, funds expended pursuant
to paragraph (1) may be used to fund some or all of the core
crisis care service components, delivered according to
evidence-based principles, including the following:
``(A) Crisis call centers.
``(B) 24/7 mobile crisis services.
``(C) Crisis stabilization programs offering acute
care or subacute care in a hospital or appropriately
licensed facility, as determined by the Substance Abuse
and Mental Health Services Administration, with
referrals to inpatient or outpatient care.
``(3) State flexibility.--In lieu of expending 5 percent of
the amount the State receives pursuant to section 1911 for a
fiscal year to support evidence-based programs as required by
paragraph (1), a State may elect to expend not less than 10
percent of such amount to support such programs by the end of
two consecutive fiscal years.''.
Subtitle B--Emergency Mental Health and Substance Use Training and
Technical Assistance Center
SEC. 6011. EMERGENCY MENTAL HEALTH AND SUBSTANCE USE TRAINING AND
TECHNICAL ASSISTANCE CENTER.
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 520A (42
U.S.C. 290bb-32) the following:
``SEC. 520B. EMERGENCY MENTAL HEALTH AND SUBSTANCE USE TRAINING AND
TECHNICAL ASSISTANCE CENTER.
``(a) Establishment.--The Secretary, acting through the Assistant
Secretary, shall establish or operate a center to be known as the
Emergency Mental Health and Substance Use Training and Technical
Assistance Center (referred to in this section as the `Center') to
provide technical assistance and support--
``(1) to public or nonprofit entities seeking to establish
or expand access to mental health and substance use prevention,
treatment, and recovery support services, and increase
awareness of such services; and
``(2) to public health professionals, health care
professionals and support staff, essential workers (as defined
by a State, Tribe, locality, or territory), and members of the
public to address the trauma, stress, and mental health needs
associated with an emergency period.
``(b) Assistance and Support.--The assistance and support provided
under subsection (a) shall include assistance and support with respect
to--
``(1) training on identifying signs of trauma, stress, and
mental health needs;
``(2) providing accessible resources to assist individuals
and families experiencing trauma, stress, or other mental
health needs during and after an emergency period;
``(3) providing resources for substance use disorder
prevention, treatment, and recovery designed to assist
individuals and families during and after an emergency period;
``(4) the provision of language access services, including
translation services, interpretation, or other such services
for individuals with limited English speaking proficiency or
individuals with disabilities; and
``(5) evaluation and improvement, as necessary, of the
effectiveness of such services provided by public or nonprofit
entities.
``(c) Best Practices.--The Center shall periodically issue best
practices for use by organizations seeking to provide mental health
services or substance use disorder prevention, treatment, or recovery
services, including best practices for the following special
populations:
``(1) Incarcerated individuals.
``(2) Children.
``(3) Pregnant women.
``(4) Underserved populations.
``(5) Communities of color.
``(6) Health care providers and essential workers.
``(d) Emergency Period.--In this section, the term `emergency
period' has the meaning given such term in section 1135(g)(1)(A) of the
Social Security Act.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $20,000,000 for each of fiscal
years 2021 and 2022.''.
Subtitle C--Suicide Prevention Grants
SEC. 6021. SYNDROMIC SURVEILLANCE OF SELF-HARM BEHAVIORS PROGRAM.
Title III of the Public Health Service Act is amended by inserting
after section 317U of such Act (42 U.S.C. 247b-23) the following:
``SEC. 317V. SYNDROMIC SURVEILLANCE OF SELF-HARM BEHAVIORS PROGRAM.
``(a) In General.--The Secretary shall award grants to State,
local, Tribal, and territorial public health departments for the
expansion of surveillance of self-harm.
``(b) Data Sharing by Grantees.--As a condition of receipt of such
grant under subsection (a), each grantee shall agree to share with the
Centers for Disease Control and Prevention in real time, to the extent
feasible and as specified in the grant agreement, data on suicides and
self-harm for purposes of--
``(1) tracking and monitoring self-harm to inform response
activities to suicide clusters;
``(2) informing prevention programming for identified at-
risk populations; and
``(3) conducting or supporting research.
``(c) Disaggregation of Data.--The Secretary shall provide for the
data collected through surveillance of self-harm under subsection (b)
to be disaggregated by the following categories:
``(1) Nonfatal self-harm data of any intent.
``(2) Data on suicidal ideation.
``(3) Data on self-harm where there is no evidence, whether
implicit or explicit, of suicidal intent.
``(4) Data on self-harm where there is evidence, whether
implicit or explicit, of suicidal intent.
``(5) Data on self-harm where suicidal intent is unclear
based on the available evidence.
``(d) Priority.--In making awards under subsection (a), the
Secretary shall give priority to eligible entities that are--
``(1) located in a State with an age-adjusted rate of
nonfatal suicidal behavior that is above the national rate of
nonfatal suicidal behavior, as determined by the Director of
the Centers for Disease Control and Prevention;
``(2) serving an Indian Tribe (as defined in section 4 of
the Indian Self-Determination and Education Assistance Act)
with an age-adjusted rate of nonfatal suicidal behavior that is
above the national rate of nonfatal suicidal behavior, as
determined through appropriate mechanisms determined by the
Secretary in consultation with Indian Tribes; or
``(3) located in a State with a high rate of coverage of
statewide (or Tribal) emergency department visits, as
determined by the Director of the Centers for Disease Control
and Prevention.
``(e) Geographic Distribution.--In making grants under this
section, the Secretary shall make an effort to ensure geographic
distribution, taking into account the unique needs of rural
communities, including--
``(1) communities with an incidence of individuals with
serious mental illness, demonstrated suicidal ideation or
behavior, or suicide rates that are above the national average,
as determined by the Assistant Secretary for Mental Health and
Substance Use;
``(2) communities with a shortage of prevention and
treatment services, as determined by the Assistant Secretary
for Mental Health and Substance Use and the Administrator of
the Health Resources and Services Administration; and
``(3) other appropriate community-level factors and social
determinants of health such as income, employment, and
education.
``(f) Period of Participation.--To be selected as a grant recipient
under this section, a State, local, Tribal, or territorial public
health department shall agree to participate in the program for a
period of not less than 4 years.
``(g) Technical Assistance.--The Secretary shall provide technical
assistance and training to grantees for collecting and sharing the data
under subsection (b).
``(h) Data Sharing by HHS.--Subject to subsection (b), the
Secretary shall, with respect to data on self-harm that is collected
pursuant to this section, share and integrate such data through--
``(1) the National Syndromic Surveillance Program's Early
Notification of Community Epidemics (ESSENCE) platform (or any
successor platform);
``(2) the National Violent Death Reporting System, as
appropriate; or
``(3) another appropriate surveillance program, including
such a program that collects data on suicides and self-harm
among special populations, such as members of the military and
veterans.
``(i) Rule of Construction Regarding Applicability of Privacy
Protections.--Nothing in this section shall be construed to limit or
alter the application of Federal or State law relating to the privacy
of information to data or information that is collected or created
under this section.
``(j) Report.--
``(1) Submission.--Not later than 3 years after the date of
enactment of this Act, the Secretary shall evaluate the suicide
and self-harm syndromic surveillance systems at the Federal,
State, and local levels and submit a report to Congress on the
data collected under subsections (b) and (c) in a manner that
prevents the disclosure of individually identifiable
information, at a minimum, consistent with all applicable
privacy laws and regulations.
``(2) Contents.--In addition to the data collected under
subsections (b) and (c), the report under paragraph (1) shall
include--
``(A) challenges and gaps in data collection and
reporting;
``(B) recommendations to address such gaps and
challenges; and
``(C) a description of any public health responses
initiated at the Federal, State, or local level in
response to the data collected.
``(k) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $20,000,000 for each of fiscal
years 2021 through 2025.''.
SEC. 6022. GRANTS TO PROVIDE SELF-HARM AND SUICIDE PREVENTION SERVICES.
Part B of title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by adding at the end the following:
``SEC. 520N. GRANTS TO PROVIDE SELF-HARM AND SUICIDE PREVENTION
SERVICES.
``(a) In General.--The Secretary of Health and Human Services shall
award grants to hospital emergency departments to provide self-harm and
suicide prevention services.
``(b) Activities Supported.--
``(1) In general.--A hospital emergency department awarded
a grant under subsection (a) shall use amounts under the grant
to implement a program or protocol to better prevent suicide
attempts among hospital patients after discharge, which may
include--
``(A) screening patients for self-harm and suicide
in accordance with the standards of practice described
in subsection (e)(1) and standards of care established
by appropriate medical and advocacy organizations;
``(B) providing patients short-term self-harm and
suicide prevention services in accordance with the
results of the screenings described in subparagraph
(A); and
``(C) referring patients, as appropriate, to a
health care facility or provider for purposes of
receiving long-term self-harm and suicide prevention
services, and providing any additional follow up
services and care identified as appropriate as a result
of the screenings and short-term self-harm and suicide
prevention services described in subparagraphs (A) and
(B).
``(2) Use of funds to hire and train staff.--Amounts
awarded under subsection (a) may be used to hire clinical
social workers, mental and behavioral health care
professionals, and support staff as appropriate, and to train
existing staff and newly hired staff to carry out the
activities described in paragraph (1).
``(c) Grant Terms.--A grant awarded under subsection (a)--
``(1) shall be for a period of 3 years; and
``(2) may be renewed subject to the requirements of this
section.
``(d) Applications.--A hospital emergency department seeking a
grant under subsection (a) shall submit an application to the Secretary
at such time, in such manner, and accompanied by such information as
the Secretary may require.
``(e) Standards of Practice.--
``(1) In general.--Not later than 180 days after the date
of the enactment of this section, the Secretary shall develop
standards of practice for screening patients for self-harm and
suicide for purposes of carrying out subsection (b)(1)(C).
``(2) Consultation.--The Secretary shall develop the
standards of practice described in paragraph (1) in
consultation with individuals and entities with expertise in
self-harm and suicide prevention, including public, private,
and non-profit entities.
``(f) Reporting.--
``(1) Reports to the secretary.--
``(A) In general.--A hospital emergency department
awarded a grant under subsection (a) shall, at least
quarterly for the duration of the grant, submit to the
Secretary a report evaluating the activities supported
by the grant.
``(B) Matters to be included.--The report required
under subparagraph (A) shall include--
``(i) the number of patients receiving--
``(I) screenings carried out at the
hospital emergency department;
``(II) short-term self-harm and
suicide prevention services at the
hospital emergency department; and
``(III) referrals to health care
facilities for the purposes of
receiving long-term self-harm and
suicide prevention;
``(ii) information on the adherence of the
hospital emergency department to the standards
of practice described in subsection (f)(1); and
``(iii) other information as the Secretary
determines appropriate to evaluate the use of
grant funds.
``(2) Reports to congress.--Not later than 2 years after
the date of the enactment of the Commitment to Defeat the Virus
and Keep America Healthy Act, and biennially thereafter, the
Secretary 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
grant program under this section, including--
``(A) a summary of reports received by the
Secretary under paragraph (1); and
``(B) an evaluation of the program by the
Secretary.
``(g) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $30,000,000 for each of fiscal
years 2021 through 2025.''.
Subtitle D--Effective Suicide Screening in the Emergency Department
SEC. 6031. PROGRAM TO IMPROVE THE CARE PROVIDED TO PATIENTS IN THE
EMERGENCY DEPARTMENT WHO ARE AT RISK OF SUICIDE.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following new
section:
``SEC. 399V-7. PROGRAM TO IMPROVE THE CARE PROVIDED TO PATIENTS IN THE
EMERGENCY DEPARTMENT WHO ARE AT RISK OF SUICIDE.
``(a) In General.--The Secretary shall establish a program (in this
section referred to as the `Program') to improve the identification,
assessment, and treatment of patients in emergency departments who are
at risk for suicide, including by--
``(1) developing policies and procedures for identifying
and assessing individuals who are at risk of suicide; and
``(2) enhancing the coordination of care for such
individuals after discharge.
``(b) Grant Establishment and Participation.--
``(1) In general.--In carrying out the Program, the
Secretary shall award grants on a competitive basis to not more
than 40 eligible health care sites described in paragraph (2).
``(2) Eligibility.--To be eligible for a grant under this
section, a health care site shall--
``(A) submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may specify;
``(B) be a hospital (as defined in section 1861(e)
of the Social Security Act);
``(C) have an emergency department; and
``(D) deploy onsite health care or social service
professionals to help connect and integrate patients
who are at risk of suicide with treatment and mental
health support services.
``(3) Preference.--In awarding grants under this section,
the Secretary may give preference to eligible health care sites
described in paragraph (2) that meet at least one of the
following criteria:
``(A) The eligible health care site is a critical
access hospital (as defined in section 1861(mm)(1) of
the Social Security Act).
``(B) The eligible health care site is a sole
community hospital (as defined in section
1886(d)(5)(D)(iii) of the Social Security Act).
``(C) The eligible health care site is operated by
the Indian Health Service, by an Indian tribe or tribal
organization (as such terms are defined in section 4 of
the Indian Self-Determination and Education Assistance
Act), or by an urban Indian organization (as defined in
section 4 of the Indian Health Care Improvement Act).
``(D) The eligible health care site is located in a
geographic area with a suicide rate that is higher than
the national rate, as determined by the Secretary based
on the most recent data from the Centers for Disease
Control and Prevention.
``(c) Period of Grant.--A grant awarded to an eligible health care
site under this section shall be for a period of at least 2 years.
``(d) Grant Uses.--
``(1) Required uses.--A grant awarded under this section to
an eligible health care site shall be used for the following
purposes:
``(A) To train emergency department health care
professionals to identify, assess, and treat patients
who are at risk of suicide.
``(B) To establish and implement policies and
procedures for emergency departments to improve the
identification, assessment and treatment of individuals
who are at risk of suicide.
``(C) To establish and implement policies and
procedures with respect to care coordination,
integrated care models, or referral to evidence-based
treatment to be used upon the discharge from the
emergency department of patients who are at risk of
suicide.
``(2) Additional permissible uses.--In addition to the
required uses listed in paragraph (1), a grant awarded under
this section to an eligible health care site may be used for
any of the following purposes:
``(A) To hire emergency department psychiatrists,
psychologists, nurse practitioners, counselors,
therapists, or other licensed health care and
behavioral health professionals specializing in the
treatment of individuals at risk of suicide.
``(B) To develop and implement best practices for
the follow-up care and long-term treatment of
individuals who are at risk of suicide.
``(C) To increase the availability of and access to
evidence-based treatment for individuals who are at
risk of suicide, including through telehealth services
and strategies to reduce the boarding of these patients
in emergency departments.
``(D) To offer consultation with and referral to
other supportive services that provide evidence-based
treatment and recovery for individuals who are at risk
of suicide.
``(e) Reporting Requirements.--
``(1) Reports by grantees.--Each eligible health care site
receiving a grant under this section shall submit to the
Secretary an annual report for each year for which the grant is
received on the progress of the program funded through the
grant. Each such report shall include information on--
``(A) the number of individuals screened in the
site's emergency department for being at risk of
suicide;
``(B) the number of individuals identified in the
site's emergency department as being--
``(i) survivors of an attempted suicide; or
``(ii) are at risk of suicide;
``(C) the number of individuals who are identified
in the site's emergency department as being at risk of
suicide by a health care or behavioral health
professional hired pursuant to subsection (d)(2)(A);
``(D) the number of individuals referred by the
site's emergency department to other treatment
facilities, the types of such other facilities, and the
number of such individuals admitted to such other
facilities pursuant to such referrals;
``(E) the effectiveness of programs and activities
funded through the grant in preventing suicides and
suicide attempts; and
``(F) any other relevant additional data regarding
the programs and activities funded through the grant.
``(2) Report by secretary.--Not later than one year after
the end of fiscal year 2025, the Secretary shall submit to
Congress a report that includes--
``(A) findings on the Program;
``(B) overall patient outcomes achieved through the
Program;
``(C) an evaluation of the effectiveness of having
a trained health care or behavioral health professional
onsite to identify, assess, and treat patients who are
at risk of suicide; and
``(D) a compilation of policies, procedures, and
best practices established, developed, or implemented
by grantees under this section.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $20,000,000 for the period of
fiscal years 2021 through 2025.''.
Subtitle E--Suicide Prevention Lifeline Improvement
SEC. 6041. SUICIDE PREVENTION LIFELINE.
(a) Plan.--Section 520E-3 of the Public Health Service Act (42
U.S.C. 290bb-36c) is amended--
(1) by redesignating subsection (c) as subsection (e); and
(2) by inserting after subsection (b) the following:
``(c) Plan.--
``(1) In general.--For purposes of maintaining the suicide
prevention hotline under subsection (b)(2), the Secretary shall
develop and implement a plan to ensure the provision of high-
quality service.
``(2) Contents.--The plan required by paragraph (1) shall
include the following:
``(A) Quality assurance provisions, including--
``(i) clearly defined and measurable
performance indicators and objectives to
improve the responsiveness and performance of
the hotline, including at backup call centers;
and
``(ii) quantifiable timeframes to track the
progress of the hotline in meeting such
performance indicators and objectives.
``(B) Standards that crisis centers and backup
centers must meet--
``(i) to participate in the network under
subsection (b)(1); and
``(ii) to ensure that each telephone call,
online chat message, and other communication
received by the hotline, including at backup
call centers, is answered in a timely manner by
a person, consistent with the guidance
established by the American Association of
Suicidology or other guidance determined by the
Secretary to be appropriate.
``(C) Guidelines for crisis centers and backup
centers to implement evidence-based practices including
with respect to followup and referral to other health
and social services resources.
``(D) Guidelines to ensure that resources are
available and distributed to individuals using the
hotline who are not personally in a time of crisis but
know of someone who is.
``(E) Guidelines to carry out periodic testing of
the hotline, including at crisis centers and backup
centers, during each fiscal year to identify and
correct any problems in a timely manner.
``(F) Guidelines to operate in consultation with
the State department of health, local governments,
Indian tribes, and tribal organizations.
``(3) Initial plan; updates.--The Secretary shall--
``(A) not later than 6 months after the date of
enactment of the Commitment to Defeat the Virus and
Keep America Healthy Act, complete development of the
initial version of the plan required by paragraph (1),
begin implementation of such plan, and make such plan
publicly available; and
``(B) periodically thereafter, update such plan and
make the updated plan publicly available.''.
(b) Transmission of Data to CDC.--Section 520E-3 of the Public
Health Service Act (42 U.S.C. 290bb-36c) is amended by inserting after
subsection (c) of such section, as added by subsection (a) of this
section, the following:
``(d) Transmission of Data to CDC.--The Secretary shall formalize
and strengthen agreements between the National Suicide Prevention
Lifeline program and the Centers for Disease Control and Prevention to
transmit any necessary epidemiological data from the program to the
Centers, including local call center data, to assist the Centers in
suicide prevention efforts.''.
(c) Authorization of Appropriations.--Subsection (e) of section
520E-3 of the Public Health Service Act (42 U.S.C. 290bb-36c) is
amended to read as follows:
``(e) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there are
authorized to be appropriated $50,000,000 for each of fiscal
years 2021 through 2023.
``(2) Allocation.--Of the amount authorized to be
appropriated by paragraph (1) for each of fiscal years 2021
through 2023, at least 80 percent shall be made available to
crisis centers.''.
SEC. 6042. PILOT PROGRAM ON INNOVATIVE TECHNOLOGIES.
(a) Pilot Program.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Assistant Secretary for Mental
Health and Substance Use, shall carry out a pilot program to
research, analyze, and employ various technologies and
platforms of communication (including social media platforms,
texting platforms, and email platforms) for suicide prevention
in addition to the telephone and online chat service provided
by the Suicide Prevention Lifeline.
(2) Authorization of appropriations.--To carry out
paragraph (1), there is authorized to be appropriated
$5,000,000 for the period of fiscal years 2021 and 2022.
(b) Report.--Not later than 24 months after the date on which the
pilot program under subsection (a) commences, the Secretary of Health
and Human Services, acting through the Assistant Secretary for Mental
Health and Substance Use, shall submit to the Congress a report on the
pilot program. With respect to each platform of communication employed
pursuant to the pilot program, the report shall include--
(1) a full description of the program;
(2) the number of individuals served by the program;
(3) the average wait time for each individual to receive a
response;
(4) the cost of the program, including the cost per
individual served; and
(5) any other information the Secretary determines
appropriate.
SEC. 6043. HHS STUDY AND REPORT.
Not later than 24 months after the Secretary of Health and Human
Services begins implementation of the plan required by section 520E-
3(c) of the Public Health Service Act, as added by section 6041(a)(2)
of this subtitle, the Secretary shall--
(1) complete a study on--
(A) the implementation of such plan, including the
progress towards meeting the objectives identified
pursuant to paragraph (2)(A)(i) of such section 520E-
3(c) by the timeframes identified pursuant to paragraph
(2)(A)(ii) of such section 520E-3(c); and
(B) in consultation with the Director of the
Centers for Disease Control and Prevention, options to
expand data gathering from calls to the Suicide
Prevention Lifeline in order to better track aspects of
usage such as repeat calls, consistent with applicable
Federal and State privacy laws; and
(2) submit a report to the Congress on the results of such
study, including recommendations on whether additional
legislation or appropriations are needed.
SEC. 6044. GAO STUDY AND REPORT.
(a) In General.--Not later than 24 months after the Secretary of
Health and Human Services begins implementation of the plan required by
section 520E-3(c) of the Public Health Service Act, as added by section
6041(a)(2) of this subtitle, the Comptroller General of the United
States shall--
(1) complete a study on the Suicide Prevention Lifeline;
and
(2) submit a report to the Congress on the results of such
study.
(b) Issues To Be Studied.--The study required by subsection (a)
shall address--
(1) the feasibility of geolocating callers to direct calls
to the nearest crisis center;
(2) operation shortcomings of the Suicide Prevention
Lifeline;
(3) geographic coverage of each crisis call center;
(4) the call answer rate of each crisis call center;
(5) the call wait time of each crisis call center;
(6) the hours of operation of each crisis call center;
(7) funding avenues of each crisis call center;
(8) the implementation of the plan under section 520E-3(c)
of the Public Health Service Act, as added by section 6041(a)
of this subtitle, including the progress towards meeting the
objectives identified pursuant to paragraph (2)(A)(i) of such
section 520E-3(c) by the timeframes identified pursuant to
paragraph (2)(A)(ii) of such section 520E-3(c); and
(9) service to individuals requesting a foreign language
speaker, including--
(A) the number of calls or chats the Lifeline
receives from individuals speaking a foreign language;
(B) the capacity of the Lifeline to handle these
calls or chats; and
(C) the number of crisis centers with the capacity
to serve foreign language speakers, in house.
(c) Recommendations.--The report required by subsection (a) shall
include recommendations for improving the Suicide Prevention Lifeline,
including recommendations for legislative and administrative actions.
SEC. 6045. DEFINITION.
In this subtitle, the term ``Suicide Prevention Lifeline'' means
the suicide prevention hotline maintained pursuant to section 520E-3 of
the Public Health Service Act (42 U.S.C. 290bb-36c).
Subtitle F--Campaign To Prevent Suicide
SEC. 6051. NATIONAL SUICIDE PREVENTION LIFELINE.
Section 520E-3(b)(2) of the Public Health Service Act (42 U.S.C.
290bb-36c(b)(2)) is amended by inserting after ``suicide prevention
hotline'' the following: ``, which, beginning not later than one year
after the date of the enactment of the Commitment to Defeat the Virus
and Keep America Healthy Act, shall be a 3-digit nationwide toll-free
telephone number,''.
SEC. 6052. NATIONAL SUICIDE PREVENTION MEDIA CAMPAIGN.
(a) National Suicide Prevention Media Campaign.--
(1) In general.--Not later than the date that is three
years after the date of the enactment of this Act, the
Secretary of Health and Human Services (referred to in this
section as the ``Secretary''), in coordination with the
Assistant Secretary for Mental Health and Substance Use
(referred to in this section as the ``Assistant Secretary'')
and the Director of the Centers for Disease Control and
Prevention (referred to in this section as the ``Director''),
shall conduct a national suicide prevention media campaign
(referred to in this section as the ``national media
campaign''), in accordance with the requirements of this
section, for purposes of--
(A) preventing suicide in the United States;
(B) educating families, friends, and communities on
how to address suicide and suicidal thoughts, including
when to encourage individuals with suicidal risk to
seek help; and
(C) increasing awareness of suicide prevention
resources of the Centers for Disease Control and
Prevention and the Substance Abuse and Mental Health
Services Administration (including the suicide
prevention hotline maintained under section 520E-3 of
the Public Health Service Act (42 U.S.C. 290bb-36c)),
any suicide prevention mobile application of the
Centers for Disease Control and Prevention or the
Substance Abuse Mental Health Services Administration,
and other support resources determined appropriate by
the Secretary.
(2) Additional consultation.--In addition to coordinating
with the Assistant Secretary and the Director under this
section, the Secretary shall consult with, as appropriate,
State, local, Tribal, and territorial health departments,
primary health care providers, hospitals with emergency
departments, mental and behavioral health services providers,
crisis response services providers, first responders, suicide
prevention and mental health professionals, patient advocacy
groups, survivors of suicide attempts, and representatives of
television and social media platforms in planning the national
media campaign to be conducted under paragraph (1).
(b) Target Audiences.--
(1) Tailoring advertisements and other communications.--In
conducting the national media campaign under subsection (a)(1),
the Secretary may tailor culturally competent advertisements
and other communications of the campaign across all available
media for a target audience (such as a particular geographic
location or demographic) across the lifespan.
(2) Targeting certain local areas.--The Secretary shall, to
the maximum extent practicable, use amounts made available
under subsection (f) for media that targets individuals in
local areas with higher suicide rates.
(c) Use of Funds.--
(1) Required uses.--
(A) In general.--The Secretary shall, to the extent
reasonably feasible with the funds made available under
subsection (f), carry out the following, with respect
to the national media campaign:
(i) The purchase of advertising time and
space, including the strategic planning for,
and accounting of, any such purchase.
(ii) Creative services and talent costs.
(iii) Advertising production costs.
(iv) Testing and evaluation of advertising.
(v) Evaluation of the effectiveness of the
national media campaign.
(vi) Operational and management expenses.
(vii) The creation of an educational
toolkit for television and social media
platforms to use in discussing suicide and
raising awareness about how to prevent suicide.
(B) Specific requirements.--
(i) Testing and evaluation of
advertising.--In testing and evaluating
advertising under subparagraph (A)(iv), the
Secretary shall test all advertisements after
use in the national media campaign to evaluate
the extent to which such advertisements have
been effective in carrying out the purposes of
the national media campaign.
(ii) Evaluation of effectiveness of
national media campaign.--In evaluating the
effectiveness of the national media campaign
under subparagraph (A)(v), the Secretary shall
take into account--
(I) the number of unique calls that
are made to the suicide prevention
hotline maintained under section 520E-3
of the Public Health Service Act (42
U.S.C. 290bb-36c) and assess whether
there are any State and regional
variations with respect to the capacity
to answer such calls;
(II) the number of unique
encounters with suicide prevention and
support resources of the Centers for
Disease Control and Prevention and the
Substance Abuse and Mental Health
Services Administration and assess
engagement with such suicide prevention
and support resources;
(III) whether the national media
campaign has contributed to increased
awareness that suicidal individuals
should be engaged, rather than ignored;
and
(IV) such other measures of
evaluation as the Secretary determines
are appropriate.
(2) Optional uses.--The Secretary may use amounts made
available under subsection (f) for the following, with respect
to the national media campaign:
(A) Partnerships with professional and civic
groups, community-based organizations, including faith-
based organizations, and Government or Tribal
organizations that the Secretary determines have
experience in suicide prevention, including the
Substance Abuse and Mental Health Services
Administration and the Centers for Disease Control and
Prevention.
(B) Entertainment industry outreach, interactive
outreach, media projects and activities, public
information, news media outreach, outreach through
television programs, and corporate sponsorship and
participation.
(d) Prohibitions.--None of the amounts made available under
subsection (f) may be obligated or expended for any of the following:
(1) To supplant current suicide prevention campaigns.
(2) For partisan political purposes, or to express advocacy
in support of or to defeat any clearly identified candidate,
clearly identified ballot initiative, or clearly identified
legislative or regulatory proposal.
(e) Report to Congress.--Not later than 18 months after
implementation of the national media campaign has begun, the Secretary,
in coordination with the Assistant Secretary and the Director, shall,
with respect to the first year of the national media campaign, submit
to Congress a report that describes--
(1) the strategy of the national media campaign and whether
specific objectives of such campaign were accomplished,
including whether such campaign impacted the number of calls
made to lifeline crisis centers and the capacity of such
centers to manage such calls;
(2) steps taken to ensure that the national media campaign
operates in an effective and efficient manner consistent with
the overall strategy and focus of the national media campaign;
(3) plans to purchase advertising time and space;
(4) policies and practices implemented to ensure that
Federal funds are used responsibly to purchase advertising time
and space and eliminate the potential for waste, fraud, and
abuse; and
(5) all contracts entered into with a corporation, a
partnership, or an individual working on behalf of the national
media campaign.
(f) Authorization of Appropriations.--For purposes of carrying out
this section, there is authorized to be appropriated $10,000,000 for
each of fiscal years 2021 through 2025.
Subtitle G--Helping Emergency Responders Overcome
SEC. 6061. DATA SYSTEM TO CAPTURE NATIONAL PUBLIC SAFETY OFFICER
SUICIDE INCIDENCE.
The Public Health Service Act is amended by inserting before
section 318 of such Act (42 U.S.C. 247c) the following:
``SEC. 317W. DATA SYSTEM TO CAPTURE NATIONAL PUBLIC SAFETY OFFICER
SUICIDE INCIDENCE.
``(a) In General.--The Secretary, in coordination with the Director
of the Centers for Disease Control and Prevention and other agencies as
the Secretary determines appropriate, shall--
``(1) develop and maintain a data system, to be known as
the Public Safety Officer Suicide Reporting System, for the
purposes of--
``(A) collecting data on the suicide incidence
among public safety officers; and
``(B) facilitating the study of successful
interventions to reduce suicide among public safety
officers; and
``(2) integrate such system into the National Violent Death
Reporting System, so long as the Secretary determines such
integration to be consistent with the purposes described in
paragraph (1).
``(b) Data Collection.--In collecting data for the Public Safety
Officer Suicide Reporting System, the Secretary shall, at a minimum,
collect the following information:
``(1) The total number of suicides in the United States
among all public safety officers in a given calendar year.
``(2) Suicide rates for public safety officers in a given
calendar year, disaggregated by--
``(A) age and gender of the public safety officer;
``(B) State;
``(C) occupation; including both the individual's
role in their public safety agency and their primary
occupation in the case of volunteer public safety
officers;
``(D) where available, the status of the public
safety officer as volunteer, paid-on-call, or career;
and
``(E) status of the public safety officer as active
or retired.
``(c) Consultation During Development.--In developing the Public
Safety Officer Suicide Reporting System, the Secretary shall consult
with non-Federal experts to determine the best means to collect data
regarding suicide incidence in a safe, sensitive, anonymous, and
effective manner. Such non-Federal experts shall include, as
appropriate, the following:
``(1) Public health experts with experience in developing
and maintaining suicide registries.
``(2) Organizations that track suicide among public safety
officers.
``(3) Mental health experts with experience in studying
suicide and other profession-related traumatic stress.
``(4) Clinicians with experience in diagnosing and treating
mental health issues.
``(5) Active and retired volunteer, paid-on-call, and
career public safety officers.
``(6) Relevant national police, and fire and emergency
medical services, organizations.
``(d) Data Privacy and Security.--In developing and maintaining the
Public Safety Officer Suicide Reporting System, the Secretary shall
ensure that all applicable Federal privacy and security protections are
followed to ensure that--
``(1) the confidentiality and anonymity of suicide victims
and their families are protected, including so as to ensure
that data cannot be used to deny benefits; and
``(2) data is sufficiently secure to prevent unauthorized
access.
``(e) Reporting.--
``(1) Annual report.--Not later than 2 years after the date
of enactment of the Commitment to Defeat the Virus and Keep
America Healthy Act, and biannually thereafter, the Secretary
shall submit a report to the Congress on the suicide incidence
among public safety officers. Each such report shall--
``(A) include the number and rate of such suicide
incidence, disaggregated by age, gender, and State of
employment;
``(B) identify characteristics and contributing
circumstances for suicide among public safety officers;
``(C) disaggregate rates of suicide by--
``(i) occupation;
``(ii) status as volunteer, paid-on-call,
or career; and
``(iii) status as active or retired;
``(D) include recommendations for further study
regarding the suicide incidence among public safety
officers;
``(E) specify in detail, if found, any obstacles in
collecting suicide rates for volunteers and include
recommended improvements to overcome such obstacles;
``(F) identify options for interventions to reduce
suicide among public safety officers; and
``(G) describe procedures to ensure the
confidentiality and anonymity of suicide victims and
their families, as described in subsection (d)(1).
``(2) Public availability.--Upon the submission of each
report to the Congress under paragraph (1), the Secretary shall
make the full report publicly available on the website of the
Centers for Disease Control and Prevention.
``(f) Definition.--In this section, the term `public safety
officer' means--
``(1) a public safety officer as defined in section 1204 of
the Omnibus Crime Control and Safe Streets Act of 1968; or
``(2) a public safety telecommunicator as described in
detailed occupation 43-5031 in the Standard Occupational
Classification Manual of the Office of Management and Budget
(2018).
``(g) Prohibited Use of Information.--Notwithstanding any other
provision of law, if an individual is identified as deceased based on
information contained in the Public Safety Officer Suicide Reporting
System, such information may not be used to deny or rescind life
insurance payments or other benefits to a survivor of the deceased
individual.''.
SEC. 6062. PEER-SUPPORT BEHAVIORAL HEALTH AND WELLNESS PROGRAMS WITHIN
FIRE DEPARTMENTS AND EMERGENCY MEDICAL SERVICE AGENCIES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended by adding at the end the
following:
``SEC. 320B. PEER-SUPPORT BEHAVIORAL HEALTH AND WELLNESS PROGRAMS
WITHIN FIRE DEPARTMENTS AND EMERGENCY MEDICAL SERVICE
AGENCIES.
``(a) In General.--The Secretary shall award grants to eligible
entities for the purpose of establishing or enhancing peer-support
behavioral health and wellness programs within fire departments and
emergency medical services agencies.
``(b) Program Description.--A peer-support behavioral health and
wellness program funded under this section shall--
``(1) use career and volunteer members of fire departments
or emergency medical services agencies to serve as peer
counselors;
``(2) provide training to members of career, volunteer, and
combination fire departments or emergency medical service
agencies to serve as such peer counselors;
``(3) purchase materials to be used exclusively to provide
such training; and
``(4) disseminate such information and materials as are
necessary to conduct the program.
``(c) Definition.--In this section:
``(1) The term `eligible entity' means a nonprofit
organization with expertise and experience with respect to the
health and life safety of members of fire and emergency medical
services agencies.
``(2) The term `member'--
``(A) with respect to an emergency medical services
agency, means an employee, regardless of rank or
whether the employee receives compensation (as defined
in section 1204(7) of the Omnibus Crime Control and
Safe Streets Act of 1968); and
``(B) with respect to a fire department, means any
employee, regardless of rank or whether the employee
receives compensation, of a Federal, State, Tribal, or
local fire department who is responsible for responding
to calls for emergency service.''.
(b) Technical Correction.--Effective as if included in the
enactment of the Children's Health Act of 2000 (Public Law 106-310),
the amendment instruction in section 1603 of such Act is amended by
striking ``Part B of the Public Health Service Act'' and inserting
``Part B of title III of the Public Health Service Act''.
SEC. 6063. HEALTH CARE PROVIDER BEHAVIORAL HEALTH AND WELLNESS
PROGRAMS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by section 6062, is further amended by adding at
the end the following:
``SEC. 320C. HEALTH CARE PROVIDER BEHAVIORAL HEALTH AND WELLNESS
PROGRAMS.
``(a) In General.--The Secretary shall award grants to eligible
entities for the purpose of establishing or enhancing behavioral health
and wellness programs for health care providers.
``(b) Program Description.--A behavioral health and wellness
program funded under this section shall--
``(1) provide confidential support services for health care
providers to help handle stressful or traumatic patient-related
events, including counseling services and wellness seminars;
``(2) provide training to health care providers to serve as
peer counselors to other health care providers;
``(3) purchase materials to be used exclusively to provide
such training; and
``(4) disseminate such information and materials as are
necessary to conduct such training and provide such peer
counseling.
``(c) Definitions.--In this section, the term `eligible entity'
means a hospital, including a critical access hospital (as defined in
section 1861(mm)(1) of the Social Security Act) or a disproportionate
share hospital (as defined under section 1923(a)(1)(A) of such Act), a
federally qualified health center (as defined in section 1905(1)(2)(B)
of such Act), or any other health care facility.''.
SEC. 6064. DEVELOPMENT OF RESOURCES FOR EDUCATING MENTAL HEALTH
PROFESSIONALS ABOUT TREATING FIRE FIGHTERS AND EMERGENCY
MEDICAL SERVICES PERSONNEL.
(a) In General.--The Administrator of the United States Fire
Administration, in consultation with the Secretary of Health and Human
Services, shall develop and make publicly available resources that may
be used by the Federal Government and other entities to educate mental
health professionals about--
(1) the culture of Federal, State, Tribal, and local
career, volunteer, and combination fire departments and
emergency medical services agencies;
(2) the different stressors experienced by firefighters and
emergency medical services personnel, supervisory firefighters
and emergency medical services personnel, and chief officers of
fire departments and emergency medical services agencies;
(3) challenges encountered by retired firefighters and
emergency medical services personnel; and
(4) evidence-based therapies for mental health issues
common to firefighters and emergency medical services personnel
within such departments and agencies.
(b) Consultation.--In developing resources under subsection (a),
the Administrator of the United States Fire Administration and the
Secretary of Health and Human Services shall consult with national fire
and emergency medical services organizations.
(c) Definitions.--In this section:
(1) The term ``firefighter'' means any employee, regardless
of rank or whether the employee receives compensation, of a
Federal, State, Tribal, or local fire department who is
responsible for responding to calls for emergency service.
(2) The term ``emergency medical services personnel'' means
any employee, regardless of rank or whether the employee
receives compensation, as defined in section 1204(7) of the
Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C.
10284(7)).
(3) The term ``chief officer'' means any individual who is
responsible for the overall operation of a fire department or
an emergency medical services agency, irrespective of whether
such individual also serves as a firefighter or emergency
medical services personnel.
SEC. 6065. BEST PRACTICES AND OTHER RESOURCES FOR ADDRESSING
POSTTRAUMATIC STRESS DISORDER IN PUBLIC SAFETY OFFICERS.
(a) Development; Updates.--The Secretary of Health and Human
Services shall--
(1) develop and assemble evidence-based best practices and
other resources to identify, prevent, and treat posttraumatic
stress disorder and co-occurring disorders in public safety
officers; and
(2) reassess and update, as the Secretary determines
necessary, such best practices and resources, including based
upon the options for interventions to reduce suicide among
public safety officers identified in the annual reports
required by section 317W(e)(1)(F) of the Public Health Service
Act, as added by section 6061 of this subtitle.
(b) Consultation.--In developing, assembling, and updating the best
practices and resources under subsection (a), the Secretary of Health
and Human Services shall consult with, at a minimum, the following:
(1) Public health experts.
(2) Mental health experts with experience in studying
suicide and other profession-related traumatic stress.
(3) Clinicians with experience in diagnosing and treating
mental health issues.
(4) Relevant national police, fire, and emergency medical
services organizations.
(c) Availability.--The Secretary of Health and Human Services shall
make the best practices and resources under subsection (a) available to
Federal, State, and local fire, law enforcement, and emergency medical
services agencies.
(d) Federal Training and Development Programs.--The Secretary of
Health and Human Services shall work with Federal departments and
agencies, including the United States Fire Administration, to
incorporate education and training on the best practices and resources
under subsection (a) into Federal training and development programs for
public safety officers.
(e) Definition.--In this section, the term ``public safety
officer'' means--
(1) a public safety officer as defined in section 1204 of
the Omnibus Crime Control and Safe Streets Act of 1968 (34
U.S.C. 10284); or
(2) a public safety telecommunicator as described in
detailed occupation 43-5031 in the Standard Occupational
Classification Manual of the Office of Management and Budget
(2018).
Subtitle H--Behavioral Health Intervention Guidelines
SEC. 6071. BEST PRACTICES FOR BEHAVIORAL INTERVENTION TEAMS.
The Public Health Service Act is amended by inserting after section
520G of such Act (42 U.S.C. 290bb-38) the following new section:
``SEC. 520H. BEST PRACTICES FOR BEHAVIORAL INTERVENTION TEAMS.
``(a) In General.--The Secretary, acting through the Assistant
Secretary, shall develop and periodically update--
``(1) best practices to assist elementary schools,
secondary schools, and institutions of higher education in
establishing and using behavioral intervention teams; and
``(2) a list of evidence-based threat assessment training
providers to assist personnel in elementary schools, secondary
schools, and institutions of higher education in implementing
such best practices, including with respect to training
behavioral intervention teams.
``(b) Elements.--The best practices under subsection (a)(1) shall
include guidance on the following:
``(1) How behavioral intervention teams can operate
effectively from an evidence-based, objective perspective while
protecting the constitutional and civil rights of individuals,
including any individual of concern.
``(2) The use of behavioral intervention teams to identify
individuals of concern, implement interventions, and manage
risk through the framework of the school's or institution's
rules or code of conduct, as applicable.
``(3) How behavioral intervention teams can, when assessing
an individual of concern--
``(A) seek training on evidence-based, threat-
assessment rubrics;
``(B) ensure that such teams--
``(i) have adequately trained, diverse
stakeholders with varied expertise; and
``(ii) use cross validation by a wide-range
of individual perspectives on the team; and
``(C) use violence risk assessment.
``(4) How behavioral intervention teams can avoid--
``(A) attempting to predict future behavior by the
concept of pre-crime;
``(B) inappropriately using a mental health
assessment;
``(C) inappropriately limiting or restricting law
enforcement's jurisdiction over criminal matters;
``(D) attempting to substitute the behavioral
intervention process in place of a criminal process, or
impede a criminal process, when an individual of
concern's behavior has potential criminal implications;
``(E) endangering an individual's privacy by
failing to ensure that all applicable Federal and State
privacy laws are fully complied with; or
``(F) creating school-to-prison pipelines.
``(c) Consultation.--In carrying out subsection (a)(1), the
Secretary shall consult with--
``(1) the Secretary of Education;
``(2) the Director of the National Threat Assessment Center
of the Department of Homeland Security;
``(3) the Attorney General of the United States; and
``(4) as appropriate, relevant stakeholders including--
``(A) teachers and other educators, principals,
school administrators, school board members, school
psychologists, mental health professionals, and parents
of elementary school and secondary school students;
``(B) local law enforcement agencies and campus law
enforcement administrators;
``(C) mental health mobile crisis providers;
``(D) child and adolescent psychiatrists; and
``(E) other education and mental health
professionals.
``(d) Publication.--Not later than 2 years after the date of
enactment of this section, the Secretary shall publish the best
practices under subsection (a)(1) and the list under subsection (a)(2)
on a publicly accessible website of the Department of Health and Human
Services.
``(e) Technical Assistance.--The Secretary shall provide technical
assistance to institutions of higher education, elementary schools, and
secondary schools to assist such institutions and schools in
implementing the best practices under subsection (a).
``(f) Definitions.--In this section:
``(1) The term `behavioral intervention team' means a team
of qualified individuals who--
``(A) are responsible for identifying and assessing
individuals of concern; and
``(B) develop and facilitate implementation of
evidence-based interventions to mitigate the threat of
harm to self or others posed by individuals of concern
and address the mental and behavioral health needs of
individuals of concern to reduce such threat.
``(2) The terms `elementary school', `parent', and
`secondary school' have the meanings given to such terms in
section 8101 of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 7801).
``(3) The term `individual of concern' means an individual
whose behavior indicates a potential threat to self or others.
``(4) The term `institution of higher education' has the
meaning given to such term in section 102 of the Higher
Education Act of 1965 (20 U.S.C. 1002).
``(5) The term `mental health assessment' means an
evaluation, primarily focused on diagnosis, determining the
need for involuntary commitment, medication management, and on-
going treatment recommendations.
``(6) The term `pre-crime' means law-enforcement efforts
and strategies to deter crime by predicting when and where
criminal activity will occur.
``(7) The term `violence risk assessment' refers to a broad
determination of the potential risk of violence based on
evidence-based literature.''.
Subtitle I--Suicide Training and Awareness Nationally Delivered for
Universal Prevention
SEC. 6081. STUDENT SUICIDE AWARENESS AND PREVENTION TRAINING.
(a) In General.--Title V of the Public Health Service Act is
amended by inserting after section 520A of such Act (42 U.S.C. 290bb-
32) the following:
``SEC. 520B. STUDENT SUICIDE AWARENESS AND PREVENTION TRAINING
POLICIES.
``(a) In General.--As a condition on receipt of funds under section
520A, each State educational agency, local educational agency, and
Tribal educational agency that receives such funds, directly or through
a State or Indian Tribe, for activities to be performed within
secondary schools, including the Project AWARE State Education Agency
Grant Program, shall--
``(1) establish and implement a school-based student
suicide awareness and prevention training policy;
``(2) consult with stakeholders (including principals,
teachers, parents, local Tribal officials, and other school
leaders) in the development of the policy under subsection
(a)(1); and
``(3) collect and report information in accordance with
subsection (c).
``(b) School-Based Student Suicide Awareness and Prevention
Training Policy.--A school-based student suicide awareness and
prevention training policy implemented pursuant to subsection (a)--
``(1) shall be evidence-based;
``(2) shall be culturally and linguistically appropriate;
``(3) shall provide evidence-based training to students in
grades 6 through 12, in coordination with school-based mental
health service providers as defined in section 4102(6) of the
Elementary and Secondary Education Act of 1965, if applicable,
regarding--
``(A) suicide education and awareness, including
warning signs of self-harm or suicidal ideation;
``(B) methods that students can use to seek help
for themselves and others; and
``(C) student resources for suicide awareness and
prevention;
``(4) shall provide for retraining of such students every
school year;
``(5) may last for such period as the State educational
agency, local educational agency, or Tribal educational agency
involved determines to be appropriate;
``(6) may be implemented through any delivery method,
including in-person trainings, digital trainings, or train-the-
trainer models; and
``(7) may include discussion of comorbidities or risk
factors for suicidal ideation or self-harm, including substance
misuse, sexual or physical abuse, mental illness, or other
evidence-based comorbidities and risk factors.
``(c) Collection of Information and Reporting.--Each State
educational agency, local educational agency, and Tribal educational
agency that receives funds under section 520A shall, with respect to
each school served by the agency, collect and report to the Secretary
the following information:
``(1) The number of student trainings conducted.
``(2) The number of students trained, disaggregated by age
and grade level.
``(3) The number of help-seeking reports made by students
after implementation of such policy.
``(d) Evidence-Based Program Listing.--The Secretary of Health and
Human Services shall coordinate with the Secretary of Education to make
publicly available the policies established by State educational
agencies, local educational agencies, and Tribal educational agencies
pursuant to this section and the training that is available to students
and teams pursuant to such policies, including identification of
whether such training is available to trainees at no cost.
``(e) Implementation Timeline.--A State educational agency, local
educational agency, or Tribal educational agency shall establish and
begin implementation of the policies required by subsection (a)(1) not
later than the beginning of the third fiscal year following the date of
enactment of this section for which the agency receives funds under
section 520A.
``(f) Definitions.--In this section and section 520B-1:
``(1) The term `evidence-based' has the meaning given to
such term in section 8101 of the Elementary and Secondary
Education Act of 1965.
``(2) The term `local educational agency' has the meaning
given to such term in section 8101 of the Elementary and
Secondary Education Act of 1965.
``(3) The term `State educational agency' has the meaning
given to such term in section 8101 of the Elementary and
Secondary Education Act of 1965.
``(4) The term `Tribal educational agency' has the meaning
given to the term `tribal educational agency' in section 6132
of the Elementary and Secondary Education Act of 1965.
``SEC. 520B-1. BEST PRACTICES FOR STUDENT SUICIDE AWARENESS AND
PREVENTION TRAINING.
``The Secretary of Health and Human Services, in consultation with
the Secretary of Education and the Bureau of Indian Education, shall--
``(1) publish best practices for school-based student
suicide awareness and prevention training, pursuant to section
520B, that are based on--
``(A) evidence-based practices; and
``(B) input from relevant Federal agencies,
national organizations, Indian Tribes and Tribal
organizations, and related stakeholders;
``(2) publish guidance, based on the best practices under
paragraph (1), to provide State educational agencies, local
educational agencies, and Tribal educational agencies with
information on student suicide awareness and prevention best
practices;
``(3) disseminate such best practices to State educational
agencies, local educational agencies, and Tribal educational
agencies; and
``(4) provide technical assistance to State educational
agencies, local educational agencies, and Tribal educational
agencies.''.
SEC. 6082. EFFECTIVE DATE.
The amendments made by this subtitle shall only apply with respect
to applications for assistance under section 520A of the Public Health
Service Act (42 U.S.C. 290bb-32) that are submitted after the date of
enactment of this Act.
TITLE VII--ADDRESSING THE IMPACTS OF COVID-19 ON SUBSTANCE USE
DISORDERS
Subtitle A--Easy Medication Access and Treatment for Opioid Addiction
SEC. 7001. DISPENSATION OF NARCOTIC DRUGS FOR THE PURPOSE OF RELIEVING
ACUTE WITHDRAWAL SYMPTOMS FROM OPIOID USE DISORDER.
Not later than 180 days after the date of enactment of this Act,
the Attorney General shall revise section 1306.07(b) of title 21, Code
of Federal Regulations, so that practitioners, in accordance with
applicable State, Federal, or local laws relating to controlled
substances, are allowed to dispense not more than a three-day supply of
narcotic drugs to one person or for one person's use at one time for
the purpose of initiating maintenance treatment or detoxification
treatment (or both).
Subtitle B--Access to Remote Behavioral Health Treatment
SEC. 7011. REGISTRATION OF QUALIFIED COMMUNITY MENTAL HEALTH CENTERS.
(a) Definitions.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended--
(1) by striking paragraph (54)(A)(i) and inserting the
following:
``(i) while the patient is being treated by, and
physically located in--
``(I) a hospital or clinic registered under
section 303(f); or
``(II) a qualified community mental health
center registered under section 303(l); and'';
(2) by redesignating paragraph (58) as paragraph (59);
(3) by redesignating the second paragraph (57) (as added by
section 401(a) of the First Step Act of 2018 (Public Law 115-
391)) as paragraph (58); and
(4) by adding at the end the following:
``(60) The term `qualified community mental health center' means a
facility that--
``(A)(i) meets the criteria specified in section 1913(c) of
the Public Health Service Act to be considered a community
mental health center; or
``(ii) meets the criteria specified pursuant to section 223
of the Protecting Access to Medicare Act of 2014 to be
considered a certified community behavioral health clinic; and
``(B) is licensed, operated, authorized, certified, or
otherwise recognized by a State government.''.
(b) Registration.--Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended by adding at the end the following:
``(l) Qualified Community Mental Health Centers.--
``(1) Registration.--The Attorney General shall register
qualified community mental health centers to administer
controlled substances through the practice of telemedicine.
``(2) Denial of applications.--The Attorney General may
deny an application for registration under paragraph (1) if the
Attorney General determines that the registration would be
inconsistent with the public interest after considering--
``(A) any recommendation by the licensing board or
professional disciplinary authority of the State in
which the applicant is located;
``(B) the experience of the applicant in treating
patients;
``(C) any conviction of an employee of the
applicant under Federal or State law relating to
treatment of patients;
``(D) the compliance of the applicant with
applicable Federal, State, or local laws relating to
treatment of patients; and
``(E) any other conduct by the applicant that may
threaten the public's health and safety.''.
(c) Report to Congress.--Not later than 60 days after the date of
enactment of this Act, the Attorney General of the United States shall
submit to the Congress a plan for implementation of the amendments made
by subsections (a) and (b).
(d) Delayed Applicability.--The amendments made by subsections (a)
and (b) apply beginning on the date that is 120 days after the date of
enactment of this Act.
Subtitle C--PDMP Pilot Program
SEC. 7021. PILOT PROGRAM FOR INTEGRATING SUBSTANCE USE DISORDER AND
BEHAVIORAL HEALTH TREATMENT LOCATOR TOOL INTO STATE
PRESCRIPTION DRUG MONITORING PROGRAMS.
(a) In General.--The Secretary of Health and Human Services, in
consultation with the Assistant Secretary for Mental Health and
Substance Use, shall establish and implement a pilot program in which
the Secretary awards grants to, or enters into cooperative agreements
with, not more than 5 eligible States to test the feasibility and
outcomes of integrating a substance use disorder and behavioral health
treatment locator tool into the State's prescription drug monitoring
program.
(b) Grant Establishment and Participation.--
(1) In general.--In carrying out the pilot program under
this section, the Secretary shall, on a competitive basis,
award grants to, or enter into cooperative agreements with, not
more than 5 eligible States.
(2) Eligibility.--To be eligible for a grant under this
section, a State shall demonstrate to the Secretary's
satisfaction that the State is making progress in integrating
the State's PDMP with electronic health records and health
information technology infrastructure.
(3) Preference.--In awarding grants under this section, the
Secretary shall give preference to eligible States described in
paragraph (2) whose rates of death due to drug overdose per
population of 100,000 are in the top quartile according to the
most recent data of the Centers for Disease Control and
Prevention.
(c) Period of Grant.--A grant awarded to an eligible entity under
this section shall be for a period of 2 years.
(d) Grant Uses.--
(1) Required uses.--A grant awarded under this section to
an eligible State shall be used for both of the following
purposes:
(A) To integrate a substance use disorder and
behavioral health treatment locator tool into the PDMP.
(B) To develop and disseminate guidance for health
care providers on how to consult and share information
obtained through the substance use disorder and
behavioral health treatment locator tool when a
patient's PDMP information indicates possible misuse of
a controlled substance.
(2) Additional permissible uses.--A grant awarded under
this section to an eligible State may be used for any of the
following additional purposes:
(A) To integrate a substance use disorder and
behavioral health treatment locator tool into the PDMP
that incorporates direct referral capabilities that
enable the health care provider--
(i) to refer a patient to treatment or for
an assessment; and
(ii) consistent with the protection of
information by Federal and State privacy laws
and security rules, receive feedback about the
patient's engagement with such treatment or
assessment.
(B) To integrate a substance use disorder and
behavioral health treatment locator tool into the PDMP
that provides information regarding the current
capacity of inpatient or outpatient treatment resources
of a health care provider.
(e) Reporting Requirements.--
(1) Reports by states.--Each eligible State that
participates in the pilot program under this section shall
submit to the Secretary an annual report for each year of the
pilot program that includes information on--
(A) the number of health care providers and health
facilities with access to the substance use disorder
and behavioral health treatment locator tool;
(B) the number of individuals referred to treatment
with the assistance of the locator tool;
(C) aggregate, de-identified patient data related
to the type of treatment located by the locator tool,
how often patients followed through on seeking such
treatment, and the average duration of such treatment,
to the extent collected by the State;
(D) feedback from providers with access to the
locator tool on usability and any impact on outcomes;
(E) recommendations to improve the usability and
efficacy of a substance use disorder and behavioral
health treatment locator tool within the PDMP; and
(F) additional information and reporting metrics as
determined by the Secretary.
(2) Report by secretary.--Not less than 180 days after the
conclusion of the pilot program under this section, the
Secretary shall submit to the Congress a report on the findings
of the program, including--
(A) outcomes reported by the participating States;
(B) findings on the suitability of including a
substance use disorder and behavioral health treatment
locator tool within State PDMPs; and
(C) recommendations on best practices for
integrating a substance use disorder and behavioral
health treatment locator tool within State PDMPs.
(f) Definitions.--In this section:
(1) The term ``prescription drug monitoring program'' or
``PDMP'' has the meaning given to the term ``PDMP'' in section
399O of the Public Health Service Act (42 U.S.C. 280g-3).
(2) The term ``Secretary'' means the Secretary of Health
and Human Services.
(g) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $2,500,000 for each of fiscal
years 2021 and 2022.
Subtitle D--Family Support Services for Addiction
SEC. 7031. FAMILY SUPPORT SERVICES FOR INDIVIDUALS STRUGGLING WITH
SUBSTANCE USE DISORDER.
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. 553. FAMILY SUPPORT SERVICES FOR INDIVIDUALS STRUGGLING WITH
SUBSTANCE USE DISORDER.
``(a) Definitions.--In this section--
``(1) the term `family community organization' means an
independent nonprofit organization that--
``(A) mobilizes resources within and outside of the
community of families with individuals living with
addiction, to provide a support network, education, and
evidence-informed tools for families and loved ones of
individuals struggling with substance use disorders;
and
``(B) is governed by experts in the field of
addiction, which may include--
``(i) experts in evidence-informed
interventions for family members;
``(ii) experts in the impact of addiction
on family systems;
``(iii) families who have experience with
substance use disorders and addiction; and
``(iv) other experts in the field of
addiction; and
``(2) the term `family support services' means resources or
programs that support families that include an individual with
substance use disorder.
``(b) Grants Authorized.--The Secretary shall award grants to
family community organizations to enable such organizations to develop,
expand, and enhance evidence-informed family support services.
``(c) Federal Share.--The Federal share of the costs of a program
funded by a grant under this section may not exceed 85 percent.
``(d) Use of Funds.--Grants awarded under subsection (b)--
``(1) shall be used to develop, expand, and enhance
community and statewide evidence-informed family support
services; and
``(2) may be used to--
``(A) build connections between family support
networks, including providing technical assistance
between family community organizations and peer support
networks, and with other family support services,
focused on enhancing knowledge of evidence-informed
interventions for family members and loved ones of
individuals living with substance use disorders and
reducing harm by educating service providers on current
evidence regarding addiction and the family,
including--
``(i) behavioral health providers,
including such providers focused specifically
on family and couples therapy in the context of
addiction;
``(ii) primary care providers;
``(iii) providers of foster care services
or support services for grandparents,
guardians, and other extended family impacted
by addiction; and
``(iv) other family support services that
connect to community resources for individuals
with substance use disorders, including non-
clinical community services;
``(B) reduce stigma associated with the family of
individuals with substance use disorders by improving
knowledge about addiction and its treatment, providing
compassionate support, and dispelling myths that
perpetuate such stigma;
``(C) conduct outreach on issues relating to
substance use disorders and family support, which may
include education, training, and resources with respect
to--
``(i) building a resilience- and strengths-
based approach to prevention of, and living
with, addiction in the family;
``(ii) identifying the signs of substance
use disorder;
``(iii) adopting an approach that minimizes
harm to all family members; and
``(iv) families of individuals with a
substance use disorder, including with respect
to--
``(I) navigating the treatment and
recovery systems;
``(II) paying for addiction
treatment;
``(III) education about substance
use disorder; and
``(IV) avoiding predatory treatment
programs; and
``(D) connect families to evidence-informed peer
support programs.
``(e) Data Reporting and Program Oversight.--With respect to a
grant awarded under subsection (a), not later than 90 days after the
end of the first year of the grant period, and annually thereafter for
the duration of the grant period, the entity shall submit data, as
appropriate and to the extent practicable, to the Secretary regarding--
``(1) the programs and activities funded by the grant;
``(2) health outcomes of the population of individuals with
a substance use disorder who received services through programs
supported by the grant, as evaluated by an independent program
evaluator through the use of outcomes measures, as determined
by the Secretary; and
``(3) any other information that the secretary may require
for the purpose of ensuring that the grant recipient is
complying with all the requirements of the grant.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2021 through 2025.''.
Subtitle E--Block, Report, And Suspend Suspicious Shipments
SEC. 7041. CLARIFICATION OF PROCESS FOR REGISTRANTS TO EXERCISE DUE
DILIGENCE UPON DISCOVERING A SUSPICIOUS ORDER.
(a) In General.--Paragraph (3) of section 312(a) of the Controlled
Substances Act (21 U.S.C. 832(a)) is amended to read as follows:
``(3) upon discovering a suspicious order or series of
orders--
``(A) exercise due diligence;
``(B) establish and maintain (for not less than a
period to be determined by the Administrator of the
Drug Enforcement Administration) a record of the due
diligence that was performed;
``(C) decline to fill the order or series of orders
if the due diligence fails to resolve all of the
indicators that gave rise to the suspicion that filling
the order or series of orders would cause a violation
of this title by the registrant or the prospective
purchaser; and
``(D) notify the Administrator of the Drug
Enforcement Administration and the Special Agent in
Charge of the Division Office of the Drug Enforcement
Administration for the area in which the registrant is
located or conducts business of--
``(i) each suspicious order or series of
orders discovered by the registrant; and
``(ii) the indicators giving rise to the
suspicion that filling the order or series of
orders would cause a violation of this title by
the registrant or the prospective purchaser.''.
(b) Applicability.--Section 312(a)(3) of the Controlled Substances
Act, as amended by subsection (a), shall apply beginning on the day
that is 6 months after the date of enactment of this Act. Until such
day, section 312(a)(3) of the Controlled Substances Act shall apply as
such section 312(a)(3) was in effect on the day before the date of
enactment of this Act.
(c) Regulations.--The Attorney General shall, issue regulations
specifying, for purposes of paragraph (3) of section 312(a) of the
Controlled Substances Act, as added by subsection (a), the indicators
that give rise to a suspicion that filling an order or series of orders
would cause a violation of title III of the Controlled Substances Act
(21 U.S.C. 801 et seq.) by a registrant or a prospective purchaser.
Subtitle F--Debarment Enforcement of Bad Actor Registrants
SEC. 7051. DEBARMENT OF CERTAIN REGISTRANTS.
Section 304 of the Controlled Substances Act (21 U.S.C. 824) is
amended by adding at the end the following:
``(h) The Attorney General may issue an order to prohibit,
conditionally or unconditionally, and permanently or for such period as
the Attorney General may determine, any person from being registered
under this title to manufacture, distribute, or dispense a controlled
substance or a list I chemical, if the Attorney General finds that--
``(1) such person meets or has met any of the conditions
for suspension or revocation of registration under subsection
(a); and
``(2) such person has a history of prior suspensions or
revocations of registration.''.
Subtitle G--Ensuring Compliance Against Opioid Diversion
SEC. 7061. MODIFICATION, TRANSFER, AND TERMINATION OF REGISTRATION TO
MANUFACTURE, DISTRIBUTE, OR DISPENSE CONTROLLED
SUBSTANCES.
Subsection (a) of section 302 of the Controlled Substances Act (21
U.S.C. 822) is amended by adding at the end the following new
paragraph:
``(3)(A) Except as provided in subparagraph (C), the registration
of any registrant under this title to manufacture, distribute, or
dispense controlled substances or list I chemicals terminates if and
when such registrant--
``(i) dies;
``(ii) ceases legal existence;
``(iii) discontinues business or professional practice; or
``(iv) surrenders such registration.
``(B) In the case of such a registrant who ceases legal existence
or discontinues business or professional practice, such registrant
shall promptly notify the Attorney General in writing of such fact.
``(C) No registration under this title to manufacture, distribute,
or dispense controlled substances or list I chemicals, and no authority
conferred thereby, may be assigned or otherwise transferred except upon
such conditions as the Attorney General may specify and then only
pursuant to written consent. A registrant to whom a registration is
assigned or transferred pursuant to the preceding sentence may not
manufacture, distribute, or dispense controlled substances or list I
chemicals pursuant to such registration until the Attorney General
receives such written consent.
``(D) In the case of a registrant under this title to manufacture,
distribute, or dispense controlled substances or list I chemicals
desiring to discontinue business or professional practice altogether or
with respect to controlled substances and list I chemicals (without
assigning or transferring such business or professional practice to
another entity), such registrant shall return to the Attorney General
for cancellation--
``(i) the registrant's certificate of registration;
``(ii) any unexecuted order forms in the registrant's
possession; and
``(iii) any other documentation that the Attorney General
may require.''.
Subtitle H--Opioid Prescription Verification
SEC. 7071. MATERIALS FOR TRAINING PHARMACISTS ON CERTAIN CIRCUMSTANCES
UNDER WHICH A PHARMACIST MAY DECLINE TO FILL A
PRESCRIPTION.
(a) Updates to Materials.--Section 3212(a) of the SUPPORT for
Patients and Communities Act (Public Law 115-271) is amended by
striking ``Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services, in consultation with
the Administrator of the Drug Enforcement Administration, Commissioner
of Food and Drugs, Director of the Centers for Disease Control and
Prevention, and Assistant Secretary for Mental Health and Substance
Use, shall develop and disseminate'' and inserting ``The Secretary of
Health and Human Services, in consultation with the Administrator of
the Drug Enforcement Administration, Commissioner of Food and Drugs,
Director of the Centers for Disease Control and Prevention, and
Assistant Secretary for Mental Health and Substance Use, shall develop
and disseminate not later than 1 year after the date of enactment of
this Act, and update periodically thereafter''.
(b) Materials Included.--Section 3212(b) of the SUPPORT for
Patients and Communities Act (Public Law 115-271) is amended--
(1) by redesignating paragraphs (1) and (2) as paragraphs
(2) and (3), respectively; and
(2) by inserting before paragraph (2), as so redesignated,
the following new paragraph:
``(1) pharmacists on how to verify the identity of
individuals picking up prescriptions;''.
(c) Materials for Training on Verification of Identity.--Section
3212 of the SUPPORT for Patients and Communities Act (Public Law 115-
271) is amended by adding at the end the following new subsection:
``(d) Materials for Training on Verification of Identity of
Individuals Picking up Prescribed Medications.--Not later than 6 months
after the date of enactment of this subsection, the Secretary of Health
and Human Services, after seeking stakeholder input in accordance with
subsection (c), shall--
``(1) update the materials developed under subsection (a)
to include information for pharmacists on how to verify the
identity of individuals picking up prescribed medications; and
``(2) disseminate, as appropriate, the updated
materials.''.
SEC. 7072. INCENTIVIZING STATES TO FACILITATE RESPONSIBLE, INFORMED
DISPENSING OF CONTROLLED SUBSTANCES.
(a) In General.--Section 392A of the Public Health Service Act (42
U.S.C. 280b-1) is amended--
(1) by redesignating subsections (c) and (d) as subsections
(d) and (e), respectively; and
(2) by inserting after subsection (b) the following new
subsection:
``(c) Preference.--In determining the amounts of grants awarded to
States under subsections (a) and (b), the Director of the Centers for
Disease Control and Prevention may give preference to States in
accordance with such criteria as the Director may specify and may
choose to give preference to States that--
``(1) maintain a prescription drug monitoring program;
``(2) require dispensers of controlled substances in
schedule II, III, or IV to verify the identity of the person
who picks up a prescribed medication by requiring such person
to present a photo identification card that is valid as
determined by the respective State; and
``(3) require dispensers of such controlled substances to
enter certain information about the purchase of such controlled
substances into the respective State's prescription drug
monitoring program, including--
``(A) the National Drug Code or, in the case of
compounded medications, compound identifier;
``(B) the quantity dispensed;
``(C) the name of the patient;
``(D) the name of the ultimate user;
``(E) the name of the person who picks up the
controlled substance, if different from the patient and
ultimate user; and
``(F) the date filled.''.
(b) Definitions.--Subsection (d) of section 392A of the Public
Health Service Act (42 U.S.C. 280b-1), as redesignated by subsection
(a)(1), is amended to read as follows:
``(d) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled
substance' has the meaning given that term in section 102 of
the Controlled Substances.
``(2) Dispenser.--The term `dispenser' means a physician,
pharmacist, or other person that dispenses a controlled
substance to an ultimate user.
``(3) Indian tribe.--The term `Indian tribe' has the
meaning given that term in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(4) State.--The term `State' means each of the 50 States,
the District of Columbia, and any commonwealth or territory of
the United States.
``(5) Ultimate user.--The term `ultimate user' means a
person who has obtained from a dispenser, and who possesses, a
controlled substance for the person's own use, for the use of a
member of the person's household, or for the use of an
animal.''.
Subtitle I--Suspicious Order Identification
SEC. 7081. STRENGTHENING ARCOS.
Section 307(d) of the Controlled Substances Act (21 U.S.C. 827(d))
is amended to read as follows:
``(1)(A) Every registrant under section 303 shall and in such form
as the Attorney General may require, make reports in electronic format
to the Attorney General of every sale, delivery, or other disposal
(other than by dispensing by a practitioner) by the registrant of any
controlled substance, identifying by the registration number assigned
under this title the person or establishment (unless exempt from
registration under section 302(d)) to whom such sale, delivery, or
other disposal was made.
``(B) Every registrant shall make each report required under
subparagraph (A)--
``(i) not later than 30 days after the sale, delivery, or
other disposal; or
``(ii) after the date on which the real-time reporting
system is established under section 7082(e)(3) of the
Commitment to Defeat the Virus and Keep America Healthy Act is
implemented, in real time.''.
SEC. 7082. SUSPICIOUS ORDERS TASK FORCE.
(a) Definitions.--In this section:
(1) Administrator.--The term ``Administrator'' means the
Administrator of the Drug Enforcement Administration.
(2) Controlled substance; distributor; manufacturer.--The
terms ``controlled substance'', ``distributor'', and
``manufacturer'' have the meanings given those terms in section
102 of the Controlled Substances Act (21 U.S.C. 802).
(3) Real time.--The term ``real time'' means with as little
delay as technically and economically feasible, as determined
by the Attorney General following the program designed under
subsection (e)(1), but not to exceed 24 hours.
(4) Registrant.--The term ``registrant''--
(A) means a person registered under section 303 of
the Controlled Substances Act (21 U.S.C. 823); and
(B) does not include practitioner.
(b) Establishment.--The Attorney General, in consultation with the
Director of the Office of National Drug Control Policy and the
Secretary of Health and Human Services, shall establish a Suspicious
Order Monitoring Task Force (referred to in this section as the ``Task
Force'').
(c) Composition.--
(1) In general.--The Task Force shall be composed of
appropriate personnel from--
(A) the Department of Justice;
(B) the Drug Enforcement Administration;
(C) the Office of National Drug Control Policy;
(D) the National Institute of Standards and
Technology; and
(E) other appropriate Federal, State, and local law
enforcement and regulatory agencies with experience in
investigating and prosecuting illegal transactions of
controlled substances as determined by the Attorney
General, in consultation with the Secretary of Health
and Human Services.
(2) Consultants.--The Task Force shall consult with--
(A) industry members, including--
(i) data analytic professionals;
(ii) community pharmacies that dispense
controlled substances;
(iii) chain pharmacies that dispense
controlled substances;
(iv) distributors of controlled substances;
(v) manufacturers of controlled substances;
(vi) State and local public health
officials; and
(vii) other relevant industry
professionals; and
(B) relevant industry regulators and entities that
utilize real-time reporting of transactions, orders, or
other activities with the goal of identifying
suspicious activity, such as appropriate personnel from
the Financial Crimes Enforcement Network and money
transfer industry professionals.
(d) Meetings.--
(1) In general.--The Task Force shall meet not less
frequently than 4 times per year and at such other times as may
be determined necessary by the Task Force.
(2) Initial meeting.--Not later than 60 days after the date
of enactment of this Act, the Task Force shall hold the initial
meeting of the Task Force.
(e) Preliminary Order Evaluation Program.--
(1) In general.--
(A) Design.--Not later than 60 days after the date
on which the Task Force holds the initial meeting
required under subsection (d)(2), the Task Force shall
begin to design a program in accordance with paragraph
(2).
(B) Purpose.--The program described in subparagraph
(A) shall be designed to share necessary data, in a
limited capacity, with registrants in order to provide
registrants with information to identify suspicious
ordering in real time.
(C) Deadline for completion.--Not later than 8
months after the date of enactment of this Act, the
Task Force shall complete the design required under
subparagraph (A).
(2) Requirements.--
(A) In general.--The program required under
paragraph (1) shall establish a process for--
(i) transitioning to a requirement to
report in real time to the Attorney General
under section 307(d) of the Controlled
Substances Act (21 U.S.C. 827(d)) every sale,
delivery, or other disposal by a registrant of
any controlled substance;
(ii) limited sharing in real time of
Automation of Reports and Consolidated Orders
System (commonly known as ``ARCOS'') data with
registrants to share necessary data, in a
limited capacity, with registrants in order to
provide registrants with information to
identify suspicious ordering in real time; and
(iii) ensuring data privacy, data de-
identification, protection of trade secrets and
purchasing history.
(B) Other considerations.--In designing the program
under paragraph (1), the Task Force shall take into
consideration--
(i) the inclusion of a waiver process for
pharmacies and other registrants unable to
transmit orders electronically on the date of
enactment of this Act;
(ii) a mechanism to ensure that the costs
of running the program are not passed through
to customers of registrants, unless the
registrants are customers of other registrants;
(iii) technical requirements for ensuring
that registrants may access all relevant de-
identified data, with output provided in a
standard database file format; and
(iv) a mechanism to ensure that the program
required to be designed under subparagraph (A)
is updated based on feedback from industry
members and other relevant entities.
(3) Implementation.--Not later than 1 year after the date
of enactment of this Act, the Attorney General shall--
(A) implement the program designed under paragraph
(1) to collect and share in real time data for
registrants to evaluate the orders of controlled
substances from distributors to manufacturers and from
pharmacies to distributors; or
(B) otherwise implement a program to collect and
share in real time data for drug manufacturers and
distributors, by providing access to anonymized
information to help drug manufacturers and distributors
identify, report, and stop suspicious orders of
controlled substances and reduce diversion rates.
(4) Recommended statutory and regulatory changes.--In
designing the program required under paragraph (1), the Task
Force--
(A) shall submit to the Attorney General any
recommendations for necessary amendments to regulations
of the Department of Justice relating to the
requirements for ordering schedule II controlled
substances, so as to allow uniform electronic ordering
of controlled substances in schedules II, III, IV, and
V electronically through the program; and
(B) may submit to Congress any recommendations for
necessary legislative changes so that a real-time data
analytics solution can be used across the United
States.
(5) Responsibility of registrants.--All registered drug
manufacturers and distributors shall be responsible for
reviewing any information made available by the Attorney
General and complying with any regulations regarding the
program designed under paragraph (1) and implemented under
paragraph (3).
(f) Funding.--
(1) In general.--The Attorney General, acting through the
Administrator, shall use amounts collected as fees for
distributors and registrants under section 303 of the
Controlled Substances Act (21 U.S.C. 823) and section 1007 of
the Controlled Substances Import and Export Act (21 U.S.C. 957)
to carry out this section.
(2) Offset.--
(A) In general.--The Administrator may, on an equal
basis and in accordance with subparagraph (B), increase
the fees described in paragraph (1) for distributors
and registrants to the extent necessary to defray the
costs of this section.
(B) Tiered fee.--The Administrator shall establish
a tiered user fee for distributors and registrants in
proportion to the volume of sales and purchases.
(g) Applicability of FACA.--
(1) In general.--Except as provided in paragraph (2), the
Federal Advisory Committee Act (5 U.S.C. App.) shall apply to
the Task Force.
(2) Termination.--The Task Force shall terminate on the
date on which the program is fully implemented under subsection
(e)(3).
(h) Rules of Construction.--Nothing in this subtitle shall be
construed as relieving any manufacturer, distributor, or other
registrant from the responsibilities of the manufacturer, distributor,
or other registrant, as the case may be, to--
(1) identify, stop, and report suspicious orders;
(2) maintain effective controls against diversion in
accordance with section 303 of the Controlled Substances Act
(21 U.S.C. 823); and
(3) comply with the requirements established in section
1301.74(b) of title 21, Code of Federal Regulations, or any
successor regulation thereto, with respect to suspicious
orders.
Subtitle J--Stop the Importation and Manufacturing of Synthetic
Analogues
SEC. 7091. ESTABLISHMENT OF SCHEDULE A.
Section 202 of the Controlled Substances Act (21 U.S.C. 812) is
amended--
(1) in subsection (a), by striking ``five schedules of
controlled substances, to be known as schedules I, II, III, IV,
and V'' and inserting ``six schedules of controlled substances,
to be known as schedules I, II, III, IV, V, and A'';
(2) in subsection (b), by adding at the end the following:
``(6) Schedule A.--
``(A) In general.--The drug or substance--
``(i) is or has been imported, or is offered for
import, into the United States;
``(ii) has--
``(I) a chemical structure that is
substantially similar to the chemical structure
of a controlled substance in schedule I, II,
III, IV, or V; and
``(II) an actual or predicted stimulant,
depressant, or hallucinogenic effect on the
central nervous system that is substantially
similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the
central nervous system of a controlled
substance in schedule I, II, III, IV, or V; and
``(iii) is not--
``(I) listed or otherwise included in any
other schedule in this section or by regulation
of the Attorney General; and
``(II) with respect to a particular person,
subject to an exemption that is in effect for
investigational use, for that person, under
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) to the extent
conduct with respect to such substance is
pursuant to such exemption.
``(B) Predicted stimulant, depressant, or hallucinogenic
effect.--For purposes of this paragraph, a predicted stimulant,
depressant, or hallucinogenic effect on the central nervous
system may be based on--
``(i)(I) the chemical structure; and
``(II)(aa) the structure activity relationships; or
``(bb) binding receptor assays and other relevant
scientific information about the substance;
``(ii)(I) the current or relative potential for
abuse of the substance; and
``(II) the clandestine importation, manufacture, or
distribution, or diversion from legitimate channels, of
the substance; or
``(iii) the capacity of the substance to cause a
state of dependence, including physical or
psychological dependence that is similar to or greater
than that of a controlled substance in schedule I, II,
III, IV, or V.''; and
(3) in subsection (c)--
(A) in the matter preceding schedule I, by striking
``IV, and V'' and inserting ``IV, V, and A''; and
(B) by adding at the end the following:
``schedule a
``Any substance temporarily or permanently scheduled by the
Attorney General in accordance with section 201(k).''.
SEC. 7092. TEMPORARY AND PERMANENT SCHEDULING OF SCHEDULE A SUBSTANCES.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by adding at the end the following:
``(k) Temporary and Permanent Scheduling of Schedule A
Substances.--
``(1) In general.--The Attorney General may issue a
temporary order adding a drug or substance to schedule A if the
Attorney General finds that--
``(A) the drug or other substance satisfies the
criteria for being considered a schedule A substance;
and
``(B) adding such drug or substance to schedule A
will assist in preventing abuse of the drug or other
substance.
``(2) Duration of temporary scheduling order.--A temporary
scheduling order issued under paragraph (1) shall--
``(A) not take effect until 30 days after the date
of the publication by the Attorney General of a notice
in the Federal Register of the intention to issue such
order and the grounds upon which such order is to be
issued; and
``(B) expire not later than 5 years after the date
on which the order becomes effective, except that the
Attorney General may, during the pendency of
proceedings under paragraph (5), extend the temporary
scheduling order for up to 180 days.
``(3) Effect of issuance of permanent scheduling order.--A
temporary scheduling order issued under paragraph (1) shall be
vacated upon the issuance of a permanent order issued under
paragraph (5) with regard to the same substance, or upon the
subsequent issuance of any scheduling order under this section.
``(4) Limitation on judicial review.--A temporary
scheduling order issued under paragraph (1) shall not be
subject to judicial review.
``(5) Permanent scheduling order.--
``(A) In general.--Except as provided in
subparagraph (B), not earlier than 3 years after the
date on which the Attorney General issues an order
temporarily scheduling a drug or substance under this
subsection, the Attorney General may, by rule, issue a
permanent order adding the drug or other substance to
schedule A if such drug or substance satisfies the
criteria for being considered a schedule A substance.
``(B) Limitation.--If the Secretary of Health and
Human Services has determined, based on relevant
scientific studies and necessary data requested by the
Secretary of Health and Human Services and gathered by
the Attorney General, that a drug or other substance
that has been temporarily placed in schedule A does not
have sufficient potential for abuse to warrant control
in any schedule, and provides written notice of such
determination to the Attorney General, the Attorney
General--
``(i) may not issue a permanent scheduling
order under subparagraph (A); and
``(ii) not later than 30 days after the
date on which the Attorney General receives
such notice, shall issue an order immediately
terminating the temporary scheduling order for
the drug or other substance.
``(6) Notice to hhs.--Before initiating proceedings under
paragraph (1), the Attorney General shall transmit notice of a
temporary order proposed to be issued to the Secretary of
Health and Human Services. In issuing an order under paragraph
(1), the Attorney General shall take into consideration any
comments submitted by the Secretary of Health and Human
Services in response to a notice transmitted pursuant to this
paragraph.''.
SEC. 7093. PENALTIES.
Section 1010 of the Controlled Substances Import and Export Act (21
U.S.C. 960) is amended--
(1) in subsection (a), by inserting ``or a drug or
substance in schedule A'' after ``controlled substance'' each
place it appears; and
(2) in subsection (b), by adding at the end the following:
``(8) In the case of a violation under subsection (a) involving a
controlled substance in schedule A, the person committing such
violation shall be sentenced to a term of imprisonment of not more than
20 years and if death or serious bodily injury results from the use of
such substance shall be sentenced to a term of imprisonment for any
term of years or for life, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18, United States
Code, or $1,000,000 if the defendant is an individual or $5,000,000 if
the defendant is other than an individual, or both. If any person
commits such a violation after a prior conviction for a felony drug
offense has become final, such person shall be sentenced to a term of
imprisonment of not more than 30 years and if death or serious bodily
injury results from the use of such substance shall be sentenced to a
term of imprisonment for any term of years or for life, a fine not to
exceed the greater of twice that authorized in accordance with the
provisions of title 18, United States Code, or $2,000,000 if the
defendant is an individual or $10,000,000 if the defendant is other
than an individual, or both. Notwithstanding section 3583 of title 18,
United States Code, any sentence imposing a term of imprisonment under
this paragraph shall, in the absence of such a prior conviction, impose
a term of supervised release of not less than 3 years in addition to
such term of imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of not less than 6
years in addition to such term of imprisonment. Notwithstanding the
prior sentence, and notwithstanding any other provision of law, the
court shall not place on probation or suspend the sentence of any
person sentenced under the provisions of this paragraph which provide
for a mandatory term of imprisonment if death or serious bodily injury
results.''.
SEC. 7094. FALSE LABELING OF SCHEDULE A CONTROLLED SUBSTANCES.
(a) In General.--Section 305 of the Controlled Substances Act (21
U.S.C. 825) is amended by adding at the end the following:
``(f) False Labeling of Schedule A Controlled Substances.--
``(1) It shall be unlawful to import or export, with intent
to manufacture, distribute, or dispense, a schedule A substance
or product containing a schedule A substance, unless the
substance or product bears a label clearly identifying a
schedule A substance or product containing a schedule A
substance by the nomenclature used by the International Union
of Pure and Applied Chemistry (IUPAC).
``(2)(A) A product described in subparagraph (B) is exempt
from the International Union of Pure and Applied Chemistry
nomenclature requirement of this subsection if such product is
labeled in the manner required under the Federal Food, Drug,
and Cosmetic Act.
``(B) A product is described in this subparagraph if the
product--
``(i) is the subject of an approved application as
described in section 505(b) or (j) of the Federal Food,
Drug, and Cosmetic Act; or
``(ii) is exempt from the provisions of section 505
of such Act relating to new drugs because--
``(I) it is intended solely for
investigational use as described in section
505(i) of such Act; and
``(II) such product is being used
exclusively for purposes of a clinical trial
that is the subject of an effective
investigational new drug application.''.
(b) Penalties.--Section 402 of the Controlled Substances Act (21
U.S.C. 842) is amended--
(1) in subsection (a)--
(A) in paragraph (16), by striking ``or'' at the
end;
(B) by redesignating paragraph (17) as paragraph
(18); and
(C) by inserting after paragraph (16) the
following:
``(17) to violate section 305(f); or''; and
(2) in subsection (c)--
(A) in paragraph (1)--
(i) in subparagraph (B)(i), by striking
``(17)'' and inserting ``(18)''; and
(ii) in subparagraph (C), by inserting ``or
(17)'' after ``paragraph (16)'' each place it
appears; and
(B) in paragraph (2)(D), by striking ``(17)'' and
inserting ``(18)''.
SEC. 7095. REGISTRATION REQUIREMENTS FOR IMPORTERS AND EXPORTERS OF
SCHEDULE A SUBSTANCES.
Section 1008 of the Controlled Substances Import and Export Act (21
U.S.C. 958) is amended by adding at the end the following:
``(j)(1) The Attorney General shall register an applicant to import
or export a schedule A substance if--
``(A) the applicant demonstrates that the schedule A
substance will be used for research, analytical, or industrial
purposes approved by the Attorney General; and
``(B) the Attorney General determines that such
registration is consistent with the public interest and with
the United States obligations under international treaties,
conventions, or protocols in effect on the date of enactment of
this subsection.
``(2) In determining the public interest under paragraph (1)(B),
the Attorney General shall consider--
``(A) maintenance of effective controls against diversion
of particular controlled substances and any controlled
substance in schedule A compounded therefrom into other than
legitimate medical, scientific, research, or industrial
channels, by limiting the importation and bulk manufacture of
such controlled substances to a number of establishments which
can produce an adequate and uninterrupted supply of these
substances under adequately competitive conditions for
legitimate medical, scientific, research, and industrial
purposes;
``(B) compliance with applicable State and local law;
``(C) promotion of technical advances in the art of
manufacturing substances described in subparagraph (A) and the
development of new substances;
``(D) prior conviction record of applicant under Federal
and State laws relating to the importation, manufacture,
distribution, or dispensing of substances described in
subparagraph (A);
``(E) past experience in the importation and manufacture of
controlled substances, and the existence in the establishment
of effective control against diversion; and
``(F) such other factors as may be relevant to and
consistent with the public health and safety.
``(3) If an applicant is registered to import or export a
controlled substance in schedule I or II under subsection (a), the
applicant shall not be required to apply for a separate registration
under this subsection.''.
SEC. 7096. ADDITIONAL CONFORMING AMENDMENTS.
The Controlled Substances Import and Export Act (21 U.S.C. 951 et
seq.) is amended--
(1) in section 1002(a) (21 U.S.C. 952(a))--
(A) in the matter preceding paragraph (1), by
inserting ``or drug or substance in schedule A'' after
``schedule I or II''; and
(B) in paragraph (2), by inserting ``or drug or
substances in schedule A'' after ``schedule I or II'';
(2) in section 1003 (21 U.S.C. 953)--
(A) in subsection (c), in the matter preceding
paragraph (1), by inserting ``or drug or substance in
schedule A'' after ``schedule I or II''; and
(B) in subsection (d), by inserting ``or drug or
substance in schedule A'' after ``schedule I or II'';
(3) in section 1004(1) (21 U.S.C. 954(1)), in the matter
preceding subparagraph (A), by inserting ``or drug or substance
in schedule A'' after ``schedule I'';
(4) in section 1005 (21 U.S.C. 955), by inserting ``or drug
or substance in schedule A'' after ``schedule I or II''; and
(5) in section 1009(a) (21 U.S.C. 959(a)), by inserting
``or drug or substance in schedule A'' after ``schedule I or
II''.
SEC. 7097. SENTENCING REVIEW.
(a) Covered Offense Defined.--In this section, the term ``covered
offense'' means an offense involving a schedule A substance for which
the penalty was established under section 7093 or 7094 of this
subtitle.
(b) Sentencing Review.--
(1) Petition for review.--If a schedule A substance that is
temporarily or permanently scheduled under section 201(k) of
the Controlled Substances Act, as added by this subtitle, is
subsequently descheduled or rescheduled on a schedule with
lower penalties, any individual convicted of a covered offense
involving such schedule A substance who is awaiting sentencing
or is still serving a term of imprisonment for such covered
offense on the date of the descheduling or rescheduling may
petition the court that imposed the sentence for a sentencing
reduction hearing for such covered offense.
(2) Sentencing review.--Not later than 30 days after the
date on which a petition is filed under paragraph (1), the
court shall conduct a sentencing reduction hearing and may
modify the sentence of the petitioner as if the descheduling or
rescheduling described in paragraph (1) had been in effect on
the date the covered offense was committed.
SEC. 7098. RULES OF CONSTRUCTION.
Nothing in this subtitle, or the amendments made by this subtitle,
may be construed to limit--
(1) the prosecution of offenses involving controlled
substance analogues under the Controlled Substances Act (21
U.S.C. 801 et seq.); or
(2) the authority of the Attorney General to temporarily or
permanently schedule, reschedule, or decontrol controlled
substances under provisions of section 201 of the Controlled
Substances Act (21 U.S.C. 811) that are in effect on the day
before the date of enactment of this Act.
SEC. 7099. CLARIFICATION OF CERTAIN REGISTRATION REQUIREMENTS RELATED
TO RESEARCH.
(a) Exception for Agents or Employees of Registered Researchers.--
Section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)) is
amended in paragraph (1) by striking ``or dispenser'' and inserting
``dispenser, or researcher''.
(b) Conforming Amendment.--Section 102(3) of the Controlled
Substances Act (21 U.S.C. 802(3)) is amended by striking ``or
dispenser'' and inserting ``dispenser, or researcher''.
(c) Single Registration for Contiguous Research Sites.--Section
302(e) of the Controlled Substances Act (21 U.S.C. 822(e)) is amended
by adding at the end the following new paragraph:
``(3) Notwithstanding paragraph (1), a person registered to
conduct research with a controlled substance under section
303(f) may conduct such research under a single registration if
such research occurs exclusively on a single, contiguous campus
and the registrant notifies the Attorney General in writing of
all sites on the campus where the research will be conducted or
where the controlled substance will be stored or administered.
The registrant must so notify the Attorney General prior to
conducting research at such additional sites.''.
(d) New Inspection Not Required in Certain Situations.--Section
303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended--
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively, and by moving the
margins of such subparagraphs two ems to the right;
(2) by striking ``(f) The'' and inserting ``(f)(1) The'';
and
(3) by adding at the end, after the matter following
subparagraph (E), as so redesignated, the following new
paragraph:
``(2)(A) If a person is registered to conduct research with a
controlled substance and applies for a registration, or a modification
of a registration to conduct research with a second controlled
substance that is in the same schedule or in a schedule with a higher
numerical designation, a new inspection by the Attorney General of the
registered location is not required.
``(B) Nothing in this paragraph shall prohibit the Attorney General
from conducting any inspection if the Attorney General deems it
necessary.''.
(e) Continuation of Research on Substances Newly Added to Schedule
I; Authority To Conduct Research With Other Substances in Schedule I.--
Section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended
by adding at the end the following new subsection:
``(h) Continuation of Research on Substances Newly Added to
Schedule I; Authority To Conduct Research With Other Substances in
Schedule I.--
``(1) If a person is conducting research on a substance at
the time the substance is added to schedule I, and such person
is already registered to conduct research with a controlled
substance in schedule I or II then--
``(A) the person shall, within 30 days of the
scheduling of the newly scheduled substance, submit a
completed application for registration or modification
of existing registration, to conduct research on such
substance, in accordance with the regulations issued by
the Attorney General;
``(B) the person may, notwithstanding subsections
(a) and (b), continue to conduct the research on such
substance until the application referred to in
subparagraph (A) is withdrawn by the applicant or until
the Attorney General serves on the applicant an order
to show cause proposing the denial of the application
pursuant to section 304(c); and
``(C) if the Attorney General serves such an order
to show cause and the applicant requests a hearing,
such hearing shall be held on an expedited basis and
not later than 45 days after the request is made,
except that the hearing may be held at a later time if
so requested by the applicant.
``(2)(A) A person who is registered to conduct research
with a controlled substance in schedule I may, notwithstanding
subsections (a) and (b), conduct research with another
controlled substance in schedule I, provided the following
conditions are met:
``(i) The person has applied for a modification of
the person's registration to authorize research with
such other controlled substance in accordance with the
regulations issued by the Attorney General.
``(ii) The Attorney General has obtained
verification from the Secretary that the research
protocol submitted with the application is meritorious.
``(iii) The Attorney General has determined that
such activity is consistent with United States
obligations under the Single Convention on Narcotic
Drugs, 1961. The Attorney General shall make such
determination not later than 30 days after receiving
the application referred to in clause (i).
``(B) Nothing in this section shall be construed to alter
the authority of the Attorney General to initiate proceedings
to deny, suspend, or revoke any registration in accordance with
sections 303 and 304.''.
(f) Treatment of Certain Activities as Coincident to Research.--
Section 302 of the Controlled Substances Act (21 U.S.C. 822), as
amended by subsection (d), is further amended by adding at the end the
following new subsection:
``(i) Treatment of Certain Activities as Coincident to Research.--
``(1) In general.--Except as specified in paragraph (2), a
person who is registered to perform research with a controlled
substance may perform the following activities with small
quantities of that substance, as set forth in the relevant
statement or protocol filed with the application for
registration approved by the Attorney General without being
required to obtain a manufacturing registration:
``(A) Processing the substance to create extracts,
tinctures, oils, solutions, derivatives, or other forms
of the substance consistent with the approved research
protocol.
``(B) Dosage form development for the purpose of
satisfying regulatory requirements implemented by the
Food and Drug Administration for submitting an
investigational new drug application.
``(2) Exception regarding marihuana.--The authority under
paragraph (1) does not include authority to grow marihuana.''.
SEC. 7100. REVIEW OF RESEARCH REGISTRATION PROCESS.
(a) Review.--Not later than one year after the date of the
enactment of this section, the Attorney General and the Secretary of
Health and Human Services shall conduct a review of the processes used
to obtain or modify Federal authorization to conduct research with
controlled substances, including--
(1) an evaluation of the impacts of the amendments made by
section 7099 on the risk of the diversion of controlled
substances used in research and related public safety
considerations; and
(2) identification of opportunities to reduce any
unnecessary burden on persons seeking registration, potential
redundancies, and inefficiencies in the process to obtain or
modify Federal authorization to conduct research with
controlled substances, including the process for obtaining a
registration under section 303 of the Controlled Substances Act
(21 U.S.C. 823) and the process by which the Secretary of
Health and Human Services reviews research protocols.
(b) Guidance.--Following the review described in subsection (a),
the Attorney General and the Secretary of Health and Human Services
shall, as appropriate, jointly issue guidance to registrants and
potential registrants clarifying the process for registration under
section 303 of the Controlled Substances Act (21 U.S.C. 823).
TITLE VIII--TAX INCENTIVES TO IMPROVE HEALTH CARE
SEC. 8001. DOMESTIC MEDICAL AND DRUG MANUFACTURING CREDIT.
(a) In General.--Subpart D of part IV of subchapter A of chapter 1
of the Internal Revenue Code of 1986 is amended by adding at the end
the following new section:
``SEC. 45U. DOMESTIC MEDICAL AND DRUG MANUFACTURING CREDIT.
``(a) In General.--For purposes of section 38, the domestic medical
and drug manufacturing credit determined under this section for any
taxable year is an amount equal to 10.5 percent of the lesser of--
``(1) the qualified medical and drug manufacturing income
of the taxpayer for the taxable year, or
``(2) taxable income of the taxpayer for the taxable year.
``(b) Credit Limited to Wages Paid.--
``(1) In general.--The amount of the credit allowable under
subsection (a) for any taxable year shall not exceed 50 percent
of the W-2 wages of the taxpayer for the taxable year.
``(2) W-2 wages.--For purposes of this section--
``(A) In general.--The term `W-2 wages' means, with
respect to any person for any taxable year of such
person, the sum of the amounts described in paragraphs
(3) and (8) of section 6051(a) paid by such person with
respect to employment of employees by such person
during the calendar year ending during such taxable
year.
``(B) Limitation to wages attributable to domestic
production.--Such term shall not include any amount
which is not properly allocable to domestic medical and
drug manufacturing gross receipts for purposes of
subsection (c)(1).
``(C) Return requirement.--Such term shall not
include any amount which is not properly included in a
return filed with the Social Security Administration on
or before the 60th day after the due date (including
extensions) for such return.
``(3) Acquisitions, dispositions, and short taxable
years.--The Secretary shall provide for the application of this
subsection in cases of a short taxable year or where the
taxpayer acquires, or disposes of, the major portion of a trade
or business or the major portion of a separate unit of a trade
or business during the taxable year.
``(c) Qualified Medical and Drug Manufacturing Income.--For
purposes of this section--
``(1) In general.--The term `qualified medical and drug
manufacturing income' for any taxable year means an amount
equal to the excess (if any) of--
``(A) the taxpayer's domestic medical and drug
manufacturing gross receipts for the taxable year, over
``(B) the sum of--
``(i) the cost of goods sold that are
allocable to such receipts, and
``(ii) other expenses, losses, or
deductions which are properly allocable to such
receipts.
``(2) Allocation method.--The Secretary shall prescribe
rules for the proper allocation of items described in paragraph
(1)(B) for purposes of determining qualified medical and drug
manufacturing income. Such rules shall provide for the proper
allocation of items whether or not such items are directly
allocable to domestic medical and drug manufacturing gross
receipts.
``(3) Special rules for determining costs.--
``(A) In general.--For purposes of determining
costs under clause (i) of paragraph (1)(B), any item or
service brought into the United States shall be treated
as acquired by purchase, and its cost shall be treated
as not less than its value immediately after it entered
the United States.
``(B) Exports for further manufacture.--In the case
of any property described in subparagraph (A) that had
been exported by the taxpayer for further manufacture,
the increase in cost or adjusted basis under
subparagraph (A) shall not exceed the difference
between the value of the property when exported and the
value of the property when brought back into the United
States after the further manufacture.
``(4) Domestic medical and drug manufacturing gross
receipts.--
``(A) In general.--The term `domestic medical and
drug manufacturing gross receipts' means the gross
receipts of the taxpayer which are derived from any
sale, exchange, or other disposition of--
``(i) any active pharmaceutical ingredient,
or
``(ii) any qualified countermeasure,
which was manufactured or produced by the taxpayer in
whole or in significant part within the United States.
``(B) Active pharmaceutical ingredient.--The term
`active pharmaceutical ingredient' means any substance
or mixture of substances intended to be used in the
manufacture of a drug product and (when so used)
becomes an active ingredient in the drug product.
``(C) Qualified countermeasure.--The term
`qualified countermeasure' has the meaning given such
term in section 319F-1(a)(2) of the Public Health
Service Act (42 U.S.C. 247d-6a(a)(2)).''
``(D) Partnerships owned by expanded affiliated
groups.--For purposes of this paragraph, if all of the
interests in the capital and profits of a partnership
are owned by members of a single expanded affiliated
group at all times during the taxable year of such
partnership, the partnership and all members of such
group shall be treated as a single taxpayer during such
period.
``(d) Definitions and Special Rules.--For purposes of this
section--
``(1) Application of section to pass-thru entities.--
``(A) Partnerships and s corporations.--In the case
of a partnership or S corporation--
``(i) this section shall be applied at the
partner or shareholder level,
``(ii) each partner or shareholder shall
take into account such person's allocable share
of each item described in subparagraph (A) or
(B) of subsection (c)(1) (determined without
regard to whether the items described in such
subparagraph (A) exceed the items described in
such subparagraph (B)), and
``(iii) each partner or shareholder shall
be treated for purposes of subsection (b) as
having W-2 wages for the taxable year in an
amount equal to such person's allocable share
of the W-2 wages of the partnership or S
corporation for the taxable year (as determined
under regulations prescribed by the Secretary).
``(B) Trusts and estates.--In the case of a trust
or estate--
``(i) the items referred to in subparagraph
(A)(ii) (as determined therein) and the W-2
wages of the trust or estate for the taxable
year, shall be apportioned between the
beneficiaries and the fiduciary (and among the
beneficiaries) under regulations prescribed by
the Secretary, and
``(ii) for purposes of paragraph (2),
adjusted gross income of the trust or estate
shall be determined as provided in section
67(e) with the adjustments described in such
paragraph.
``(C) Regulations.--The Secretary may prescribe
rules requiring or restricting the allocation of items
and wages under this paragraph and may prescribe such
reporting requirements as the Secretary determines
appropriate.
``(2) Application to individuals.--In the case of an
individual, subsection (a)(2) shall be applied by substituting
`adjusted gross income' for `taxable income'. For purposes of
the preceding sentence, adjusted gross income shall be
determined after application of sections 86, 135, 137, 219,
221, 222, and 469.
``(3) Special rule for affiliated groups.--
``(A) In general.--All members of an expanded
affiliated group shall be treated as a single
corporation for purposes of this section.
``(B) Expanded affiliated group.--For purposes of
this section, the term `expanded affiliated group'
means an affiliated group as defined in section
1504(a), determined--
``(i) by substituting `more than 50
percent' for `at least 80 percent' each place
it appears, and
``(ii) without regard to paragraphs (2) and
(4) of section 1504(b).
``(C) Allocation of credit.--Except as provided in
regulations, the credit under subsection (a) shall be
allocated among the members of the expanded affiliated
group in proportion to each member's respective amount
(if any) of qualified medical and drug manufacturing
income.
``(4) Trade or business requirement.--This section shall be
applied by only taking into account items which are
attributable to the actual conduct of a trade or business.
``(5) Coordination with minimum tax.--For purposes of
determining alternative minimum taxable income under section
55, qualified medical and drug manufacturing income shall be
determined without regard to any adjustments under sections 56
through 59.
``(6) Unrelated business taxable income.--For purposes of
determining the tax imposed by section 511, subsection
(a)(1)(B) shall be applied by substituting `unrelated business
taxable income' for `taxable income'.
``(7) Regulations.--The Secretary shall prescribe such
regulations as are necessary to carry out the purposes of this
section, including regulations which prevent more than 1
taxpayer from being allowed a credit under this section with
respect to any activity described in subsection (c)(4)(A).''.
(b) Treatment Under Base Erosion Tax.--Section 59A(b)(1)(B)(ii) of
such Code is amended by striking ``plus'' at the end of subclause (I),
by redesignating subclause (II) as subclause (III), and by inserting
after subclause (I) the following new subclause:
``(II) the credit allowed under
section 38 for the taxable year which
is properly allocable to the domestic
medical and drug manufacturing credit
determined under section 45U(a),
plus''.
(c) Part of General Business Credit.--Section 38(b) of such Code is
amended by striking ``plus'' at the end of paragraph (32), by striking
the period at the end of paragraph (33) and inserting ``, plus'', and
by adding at the end the following new paragraph:
``(34) the domestic medical and drug manufacturing credit
determined under section 45U(a).''.
(d) Credit Allowed Against Alternative Minimum Tax.--Section
38(c)(4)(B) of such Code is amended by redesignating clauses (x)
through (xii) as clauses (xi) through (xiii), respectively, and by
inserting after clause (ix) the following new clause:
``(x) the credit determined under section
45U,''.
(e) Clerical Amendment.--The table of sections for subpart D of
part IV of subchapter A of chapter 1 of such Code is amended by adding
at the end the following new item:
``Sec. 45U. Domestic medical and drug manufacturing credit.''.
(f) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2020.
SEC. 8002. QUALIFYING ADVANCED MEDICAL MANUFACTURING EQUIPMENT CREDIT.
(a) In General.--Subpart E of part IV of subchapter A of chapter 1
of the Internal Revenue Code of 1986 is amended by adding at the end
the following new section:
``SEC. 48D. QUALIFYING ADVANCED MEDICAL MANUFACTURING EQUIPMENT CREDIT.
``(a) In General.--For purposes of section 46, the qualifying
advanced medical manufacturing equipment credit determined under this
section for any taxable year is the applicable percentage of the basis
of any qualifying advanced medical manufacturing equipment placed in
service during such taxable year.
``(b) Applicable Percentage.--For purposes of subsection (a), the
applicable percentage is--
``(1) 30 percent in the case of equipment which is placed
in service before January 1, 2028,
``(2) 20 percent in the case of equipment which is placed
in service during calendar year 2028,
``(3) 10 percent in the case of equipment which is placed
in service during calendar year 2029, and
``(4) 0 percent in the case of equipment which is placed in
service after December 31, 2029.
``(c) Qualifying Advanced Medical Manufacturing Equipment.--For
purposes of this section, the term `qualifying advanced medical
manufacturing equipment' means property of a character subject to the
allowance for depreciation--
``(1) which is machinery or equipment that is designed and
used to manufacture a--
``(A) drug (as such term is defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act),
``(B) device (as such term is defined in section
201(h) of such Act), or
``(C) biological product (as such term is defined
in section 351(i) of the Public Health Service Act),
``(2) which has been identified by the Secretary (after
consultation with the Secretary of Health and Human Services)
as machinery or equipment that--
``(A) incorporates novel technology or uses an
established technique or technology in a new or
innovative way, or
``(B) that can improve medical product quality,
address shortages of medicines, and speed time-to-
market,
``(3) which is placed in service in the United States by
the taxpayer, and
``(4) with respect to which depreciation is allowable.
``(d) Certain Qualified Progress Expenditures Rules Made
Applicable.--Rules similar to the rules of subsections (c)(4) and (d)
of section 46 (as in effect on the day before the enactment of the
Revenue Reconciliation Act of 1990) shall apply for purposes of this
section.
``(e) Regulations.--The Secretary shall prescribe such regulations
or other guidance as may be necessary to carry out the purposes of this
section, including regulations which prevent abuse or fraud.''.
(b) Treatment Under Base Erosion Tax.--Section 59A(b)(1)(B)(ii) of
such Code, as amended by section 8001 of this Act, is further amended
by striking ``plus'' at the end of subclause (II), by redesignating
subclause (III) as subclause (IV), and by inserting after subclause
(II) the following new subclause:
``(III) the credit allowed under
section 46 for the taxable year which
is properly allocable to the qualifying
advanced medical manufacturing
equipment credit determined under
section 48D(a), plus''.
(c) Part of Investment Credit.--Section 46 of such Code is amended
by striking ``and'' at the end of paragraph (5), by striking the period
at the end of paragraph (6) and inserting ``, and'', and by adding at
the end the following new paragraph:
``(7) the qualifying advanced medical manufacturing
equipment credit.''.
(d) Clerical Amendment.--The table of sections for subpart D of
part IV of subchapter A of chapter 1 of such Code is amended by adding
at the end the following new item:
``Sec. 48D. Qualifying advanced medical manufacturing equipment
credit.''.
(e) Effective Date.--The amendments made by this section shall
apply to periods after the date of the enactment of this section under
rules similar to the rules of section 48(m) of the Internal Revenue
Code of 1986 (as in effect on the date of the enactment fo the Revenue
Reconciliation Act of 1990).
SEC. 8003. NEW MEDICAL RESEARCH EXPENDITURE COMPONENT OF CREDIT FOR
INCREASING RESEARCH ACTIVITIES.
(a) In General.--Section 41(a) of the Internal Revenue Code of 1986
is amended by striking ``and'' at the end of paragraph (2), by striking
the period at the end of paragraph (3) and inserting ``, and'', and by
adding at the end the following new paragraph:
``(4) 14 percent of specified medical research
expenditures.''.
(b) Specified Medical Research Expenditures.--Section 41(f) of such
Code is amended by adding at the end the following new paragraph:
``(7) Specified medical research expenditures.--
``(A) In general.--The term `specified medical
research expenditures' means amounts paid or incurred
for qualified research with respect to any qualified
countermeasure.
``(B) Qualified countermeasure.--The term
`qualified countermeasure' has the meaning given to
such term in section 319F-1(a)(2) of the Public Health
Service Act (42 U.S.C. 247d-6a(a)(2)).''.
(c) Denial of Double Benefit.--
(1) Taxable years beginning before january 1, 2021.--In the
case of specified medical research expenditures (as defined in
section 41(f)(7) of such Code (as added by this section)) paid
or incurred in taxable years beginning before January 1, 2021--
(A) such expenditures shall be treated in the same
manner as qualified research expenses and basic
research expenses under section 280C(c)(1) of such Code
(as in effect on the day before the enactment of the
Tax Cuts and Jobs Act), and
(B) the amount determined under section
280C(c)(2)(A) (as in effect on such day) for the
taxable year shall be increased by the amount of credit
determined for the taxable year under section 41(a)(4)
(as added by this section).
(2) Taxable years beginning after december 31, 2020.--
Section 280C(c)(1) of such Code is amended by striking
``section 41(a)(1)'' and inserting ``paragraphs (1) and (4) of
section 41(a)''.
(d) Conforming Amendment.--Section 41(f)(1) of such Code is amended
by striking ``and amounts paid or incurred to energy research
consortiums'' each place it appears and inserting ``, amounts paid or
incurred to energy research consortiums, and specified medical research
expenditures''.
(e) Effective Date.--The amendments made by this section shall
apply to amounts paid or incurred after the date of the enactment of
this Act, in taxable years ending after such date.
SEC. 8004. REFUNDABLE PORTION OF RESEARCH CREDIT FOR SMALL BUSINESSES
ENGAGING IN SPECIFIED MEDICAL RESEARCH.
(a) In General.--Section 41 of the Internal Revenue Code of 1986 is
amended by adding at the end the following new subsection:
``(i) Refundable Portion for Small Businesses Engaging in Specified
Medical Research.--
``(1) In general.--At the election of a medical research
small business, the portion of the credit determined under this
section for the taxable year which is properly allocable to
specified medical research shall be treated (other than for
purposes of section 280C) as a credit allowed under subpart C
(and not this subpart).
``(2) Medical research small business.--For purposes of
this subsection, the term `medical research small business'
means any domestic C corporation--
``(A) which conducts any specified medical research
during the taxable year, and
``(B) the gross receipts of which (determined under
the rules of subsection (c)) for the taxable year do
not exceed $1,000,000.
``(3) Specified medical research.--For purposes of this
subsection, the term `specified medical research' means any
qualified research with respect to qualified countermeasures
(as defined in section 319F-1(a)(2) of the Public Health
Service Act (42 U.S.C. 247d-6a(a)(2))).
``(4) Election.--Any election under this subsection for any
taxable year--
``(A) shall specify the amount of the credit to
which such election applies,
``(B) shall be made on or before the due date
(including extensions) of the return of tax for the
taxable year,
``(C) may not be made for any taxable year with
respect to any portion of the credit determined under
this section with respect to which an election is made
under subsection (h), and
``(D) may be revoked only with the consent of the
Secretary.
``(5) Regulations.--The Secretary shall prescribe such
regulations for purposes of this subsection as may be necessary
or appropriate for determining proper allocation to specified
medical research of the portion of any credit allowed to a
taxpayer for a taxable year under this section.''.
(b) Conforming Amendment.--Section 1324(b) of title 31, United
States Code, is amended by inserting ``41(i),'' after ``6428,''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2020.
SEC. 8005. EXCEPTION FROM PASSIVE LOSS RULES FOR INVESTMENTS IN
SPECIFIED MEDICAL RESEARCH SMALL BUSINESS PASS-THRU
ENTITIES.
(a) In General.--Subsection (c) of section 469 of the Internal
Revenue Code of 1986 is amended by redesignating paragraphs (4) through
(7) as paragraphs (5) through (8), respectively, and by inserting after
paragraph (3) the following new paragraph:
``(4) Specified medical research activities.--
``(A) In general.--The term `passive activity'
shall not include any qualified medical research
activity of the taxpayer carried on by a specified
medical research small business pass-thru entity.
``(B) Treatment of losses and deductions.--
``(i) In general.--Losses or deductions of
a taxpayer in connection with qualified medical
research activities carried on by a specified
medical research small business pass-thru
entity shall not be treated as losses or
deductions, respectively, from a passive
activity except as provided in clause (ii) and
subparagraph (C).
``(ii) Limitation.--Clause (i) shall apply
to losses and deductions of a taxpayer in
connection with a specified medical small
business pass-thru entity for a taxable year
only to the extent that the aggregate losses
and deductions of the taxpayer in connection
with qualified medical research activities of
such entity for such taxable year do not exceed
the portion of the taxpayer's adjusted basis in
the taxpayer's ownership interest in such
entity that is attributable to money or other
property contributed--
``(I) in exchange for such
ownership interest, and
``(II) specifically for use in
connection with qualified medical
research activities.
For purposes of the preceding sentence, the
taxpayer's basis shall not include any portion
of such basis which is attributable to an
increase in a partner's share of the
liabilities of a partnership that is considered
under section 752(a) as a contribution of
money.
``(C) Treatment of carryovers.--Subparagraph (B)(i)
shall not apply to the portion of any loss or deduction
that is carried over under subsection (b) into a
taxable year other than the taxable year in which such
loss or deduction arose.
``(D) Qualified medical research activity.--For
purposes of this paragraph, the term `qualified medical
research activity' means any qualified research (within
the meaning of section 41(d)) with respect to qualified
countermeasures (as defined in section 319F-1(a)(2) of
the Public Health Service Act (42 U.S.C. 247d-
6a(a)(2))).
``(E) Specified medical research small business
pass-thru entity.--For purposes of this paragraph, the
term `specified medical research small business pass-
thru entity' means any domestic pass-thru entity for
any taxable year if--
``(i) more than 80 percent of such entity's
expenditures on qualified research for such
taxable year are paid or incurred in connection
with qualified medical research activities, and
``(ii) the gross receipts (as determined
under the rules of section 41(h)(3)) of such
entity for the taxable year (and each preceding
taxable year) is less than $1,000,000.
``(F) Capital expenditures taken into account for
expenditures test.--An expenditure shall not fail to be
taken into account under subparagraph (E)(i) merely
because such expenditure is chargeable to capital
account.
``(G) Pass-thru entity.--For purposes of this
paragraph, the term `pass-thru entity' means any
partnership, S corporation, or other entity identified
by the Secretary as a pass-thru entity for purposes of
this paragraph.
``(H) Aggregation rules.--
``(i) In general.--All persons treated as a
single employer under subsection (a) or (b) of
section 52, or subsection (m) or (o) of section
414, shall be treated as a single entity for
purposes of subparagraphs (E) and (F)(iii).
``(ii) Limitation where entity would not
qualify.--No entity shall be treated as a
specified medical research small business pass-
thru entity unless such entity qualifies as
such both with and without the application of
clause (i).''.
(b) Material Participation Not Required.--Paragraph (5) of section
469(c) of the Internal Revenue Code of 1986, as redesignated by
subsection (a), is amended by striking ``and (3)'' in the heading and
text and inserting ``, (3), and (4)''.
(c) Certain Research-Related Deductions and Credits of Specified
Medical Research Small Business Pass-Thru Entities Allowed for Purposes
of Determining Alternative Minimum Tax.--
(1) Deduction for research and experimental expenditures.--
Paragraph (2) of section 56(b) of the Internal Revenue Code of
1986 is amended by adding at the end the following new
subparagraph:
``(E) Exception for specified medical research
small business pass-thru entities.--In the case of a
specified medical research small business pass-thru
entity (as defined in section 469(c)(4)), this
paragraph shall not apply to any amount allowable as a
deduction under section 174(a).''.
(2) Allowance of certain research-related credits.--
Subparagraph (B) of section 38(c)(4) of such Code is amended by
redesignating clauses (ii) through (ix) as clauses (iii)
through (x), respectively, and by inserting after clause (i)
the following new clause:
``(ii) the credit of an individual taxpayer
determined under section 41 to the extent
attributable to a specified medical research
small business pass-thru entity (as defined in
section 469(c)(4)),''.
(d) Exception to Limitation on Pass-Thru of Research Credit.--
Subsection (g) of section 41 of such Code is amended by adding at the
end the following: ``Paragraphs (2) and (4) shall not apply with
respect to any specified medical research small business pass-thru
entity (as defined in section 469(c)(4)).''.
(e) Effective Date.--The amendments made by this section shall
apply to losses and credits arising in taxable years beginning after
December 31, 2020.
SEC. 8006. TEMPORARY CARRYOVER FOR HEALTH AND DEPENDENT CARE FLEXIBLE
SPENDING ARRANGEMENTS.
(a) In General.--With respect to the 2020 plan year for any health
flexible spending arrangement or any dependent care flexible spending
arrangement, an employer may elect to amend its cafeteria plan to
permit any unused amounts remaining in such flexible spending
arrangement at the end of such plan year to be carried over to the 2021
plan year, pursuant to rules similar to the rules established for
health flexible spending arrangements under Internal Revenue Service
Notice 2013-71.
(b) Retroactive Application.--An employer shall be permitted to
amend its cafeteria plan to effectuate the rule described in subsection
(a), provided that such amendment--
(1) is adopted before January 1, 2021; and
(2) provides that the rule described in such subsection
shall be in effect as of the first day of the 2020 plan year.
(c) Definitions.--Any term used in this section which is also used
in section 125 of the Internal Revenue Code of 1986 or the regulations
thereunder shall have the same meaning as when used in such section or
regulations.
SEC. 8007. INCREASE IN EXCLUSION FOR EMPLOYER-PROVIDED DEPENDENT CARE
ASSISTANCE.
(a) In General.--Section 129(a)(2) of the Internal Revenue Code of
1986 is amended by adding at the end the following new subparagraph:
``(D) Special rule for 2020 and 2021.--In the case
of any taxable year beginning during 2020 or 2021,
subparagraph (A) shall be applied by substituting
`$10,500 ($5,250' for `$5,000 ($2,500'.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after December 31, 2019.
(c) Retroactive Plan Amendments.--A plan or other arrangement that
otherwise satisfies all applicable requirements of sections 106, 125,
and 129 of the Internal Revenue Code of 1986 (including any rules or
regulations thereunder) shall not fail to be treated as a cafeteria
plan or dependent care flexible spending arrangement merely because
such plan or arrangement is amended pursuant to a provision under this
section and such amendment is retroactive, if--
(1) such amendment is adopted no later than the last day of
the plan year in which the amendment is effective, and
(2) the plan or arrangement is operated consistent with the
terms of such amendment during the period beginning on the
effective date of the amendment and ending on the date the
amendment is adopted.
SEC. 8008. TEMPORARY INCREASE IN CONTRIBUTION LIMITS FOR HEALTH SAVINGS
ACCOUNTS.
(a) In General.--Section 223(b) of the Internal Revenue Code of
1986 is amended by adding at the end the following new paragraph:
``(9) Increase in monthly limitations for taxable years
2020 and 2021.--In the case of any month during a taxable year
which begins after December 31, 2019, and before January 1,
2022, the dollar amount in effect under subparagraph (A) or (B)
of paragraph (2) for such month shall be twice the amount
otherwise applicable under such subparagraph, as determined--
``(A) before application of paragraph (3),
``(B) after application of subsection (g), and
``(C) without regard to this paragraph.''.
(b) Effective Date.--The amendment made by this section shall apply
with respect to taxable years beginning after December 31, 2019.
SEC. 8009. TEMPORARY ALLOWANCE OF PAYMENTS FOR EMPLOYMENT-RELATED
EXPENSES UNDER HEALTH SAVINGS ACCOUNTS.
(a) In General.--Section 223(d)(2) of the Internal Revenue Code of
1986 is amended by adding at the end the following new subparagraph:
``(E) Inclusion of employment-related expenses for
taxable years 2020 and 2021.--In the case of any
taxable year which begins after December 31, 2019, and
before January 1, 2022, the term `qualified medical
expenses' includes, with respect to an account
beneficiary, any amounts paid by such beneficiary for
employment-related expenses (as defined in section
21(b)(2)) which are incurred during such taxable
year.''.
(b) Conforming Amendment.--Section 21(c) of the Internal Revenue
Code of 1986 is amended by inserting ``and any amounts paid or
distributed out of a health savings account which are used exclusively
to pay expenses described in section 223(d)(2)(E) which are incurred by
the taxpayer during such taxable year'' before the period at the end of
the second sentence.
(c) Effective Date.--The amendments made by this section shall
apply with respect to taxable years beginning after December 31, 2019.
SEC. 8010. TREATMENT OF DIRECT PRIMARY CARE SERVICE ARRANGEMENTS.
(a) In General.--Section 223(c)(1) of the Internal Revenue Code of
1986 is amended by adding at the end the following new subparagraph:
``(D) Treatment of direct primary care service
arrangements.--
``(i) In general.--A direct primary care
service arrangement shall not be treated as a
health plan for purposes of subparagraph
(A)(ii).
``(ii) Direct primary care service
arrangement.--For purposes of this paragraph--
``(I) In general.--The term `direct
primary care service arrangement'
means, with respect to any individual,
an arrangement under which such
individual is provided medical care (as
defined in section 213(d)) consisting
solely of primary care services
provided by primary care practitioners
(as defined in section 1833(x)(2)(A) of
the Social Security Act, determined
without regard to clause (ii) thereof),
if the sole compensation for such care
is a fixed periodic fee.
``(II) Limitation.--With respect to
any individual for any month, such term
shall not include any arrangement if
the aggregate fees for all direct
primary care service arrangements
(determined without regard to this
subclause) with respect to such
individual for such month exceed $150
(twice such dollar amount in the case
of an individual with any direct
primary care service arrangement (as so
determined) that covers more than one
individual).
``(iii) Certain services specifically
excluded from treatment as primary care
services.--For purposes of this subparagraph,
the term `primary care services' shall not
include--
``(I) procedures that require the
use of general anesthesia, and
``(II) laboratory services not
typically administered in an ambulatory
primary care setting.
The Secretary, after consultation with the
Secretary of Health and Human Services, shall
issue regulations or other guidance regarding
the application of this clause.''.
(b) Direct Primary Care Service Arrangement Fees Treated as Medical
Expenses.--Section 223(d)(2)(C) of the Internal Revenue Code of 1986 is
amended by striking ``or'' at the end of clause (iii), by striking the
period at the end of clause (iv) and inserting ``, or'', and by adding
at the end the following new clause:
``(v) any direct primary care service arrangement.''.
(c) Inflation Adjustment.--Section 223(g)(1) of the Internal
Revenue Code of 1986 is amended--
(1) by inserting ``, (c)(1)(D)(ii)(II),'' after ``(b)(2),''
each place such term appears, and
(2) in subparagraph (B), by inserting ``and (iii)'' after
``clause (ii)'' in clause (i), by striking ``and'' at the end
of clause (i), by striking the period at the end of clause (ii)
and inserting ``, and'', and by inserting after clause (ii) the
following new clause:
``(iii) in the case of the dollar amount in
subsection (c)(1)(D)(ii)(II) for taxable years
beginning in calendar years after 2020,
`calendar year 2019'.''.
(d) Reporting of Direct Primary Care Service Arrangement Fees on W-
2.--Section 6051(a) of the Internal Revenue Code of 1986 is amended by
striking ``and'' at the end of paragraph (16), by striking the period
at the end of paragraph (17) and inserting ``, and'', and by inserting
after paragraph (17) the following new paragraph:
``(18) in the case of a direct primary care service
arrangement (as defined in section 223(c)(1)(D)(ii)) which is
provided in connection with employment, the aggregate fees for
such arrangement for such employee.''.
(e) Effective Date.--
(1) In general.--Except as provided under paragraph (2),
the amendments made by this section shall apply to months
beginning after December 31, 2019, in taxable years ending
after such date.
(2) Inflation adjustment.--The amendments made by
subsection (c) shall apply to taxable years beginning in
calendar years beginning after December 31, 2020.
SEC. 8011. ALLOW BOTH SPOUSES TO MAKE CATCH-UP CONTRIBUTIONS TO THE
SAME HSA ACCOUNT.
(a) In General.--Paragraph (5) of section 223(b) of the Internal
Revenue Code of 1986 is amended to read as follows:
``(5) Special rule for married individuals with family
coverage.--
``(A) In general.--In the case of individuals who
are married to each other, if both spouses are eligible
individuals and either spouse has family coverage under
a high deductible health plan as of the first day of
any month--
``(i) the limitation under paragraph (1)
shall be applied by not taking into account any
other high deductible health plan coverage of
either spouse (and if such spouses both have
family coverage under separate high deductible
health plans, only one such coverage shall be
taken into account),
``(ii) such limitation (after application
of clause (i)) shall be reduced by the
aggregate amount paid to Archer MSAs of such
spouses for the taxable year, and
``(iii) such limitation (after application
of clauses (i) and (ii)) shall be divided
equally between such spouses unless they agree
on a different division.
``(B) Treatment of additional contribution
amounts.--If both spouses referred to in subparagraph
(A) have attained age 55 before the close of the
taxable year, the limitation referred to in
subparagraph (A)(iii) which is subject to division
between the spouses shall include the additional
contribution amounts determined under paragraph (3) for
both spouses. In any other case, any additional
contribution amount determined under paragraph (3)
shall not be taken into account under subparagraph
(A)(iii) and shall not be subject to division between
the spouses.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after December 31, 2019.
SEC. 8012. REPEAL OF CEILING ON DEDUCTIBLE AND OUT-OF-POCKET EXPENSES
UNDER A HIGH DEDUCTIBLE HEALTH PLAN.
(a) In General.--Subparagraph (A) of section 223(c)(2) of the
Internal Revenue Code of 1986 is amended to read as follows:
``(A) High deductible health plan.--The term `high
deductible health plan' means a health plan which has
an annual deductible which is not less than--
``(i) $1,000 for self-only coverage, and
``(ii) twice the dollar amount in clause
(i) for family coverage.''.
(b) Conforming Amendments.--
(1) Subparagraph (D) of section 223(c)(2) of the Internal
Revenue Code of 1986 is amended to read as follows:
``(D) Special rule for network plans.--In the case
of a plan using a network of providers, such plan's
annual deductible for services provided outside of such
network shall not be taken into account for purposes of
subsection (b)(2).''.
(2) Clause (ii) of section 223(g)(1)(B) of such Code is
amended by striking ``each dollar amount in subsection
(c)(2)(A)'' and inserting ``the dollar amount in subsection
(c)(2)(A)(i)''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to taxable years beginning after December 31, 2019.
SEC. 8013. ON-SITE EMPLOYEE CLINICS.
(a) In General.--Paragraph (1) of section 223(c) of the Internal
Revenue Code of 1986, as amended by section 8010 of this Act, is
amended by adding at the end the following new subparagraph:
``(E) Special rule for qualified items and
services.--
``(i) In general.--For purposes of
subparagraph (A)(ii), an individual shall not
be treated as covered under a health plan
described in subclauses (I) and (II) of such
subparagraph merely because the individual is
eligible to receive, or receives, qualified
items and services--
``(I) at a healthcare facility
located at a facility owned or leased
by the employer of the individual (or
of the individual's spouse), or
``(II) at a healthcare facility
operated primarily for the benefit of
employees of the employer of the
individual (or of the individual's
spouse).
``(ii) Qualified items and services
defined.--For purposes of this subparagraph,
the term `qualified items and services' means
the following:
``(I) Physical examination.
``(II) Immunizations, including
injections of antigens provided by
employees.
``(III) Drugs or biologicals other
than a prescribed drug (as such term is
defined in section 213(d)(3)).
``(IV) Treatment for injuries
occurring in the course of employment.
``(V) Preventive care for chronic
conditions (as defined in clause (iv)).
``(VI) Drug testing.
``(VII) Hearing or vision
screenings and related services.
``(iii) Aggregation.--For purposes of
clause (i), all persons treated as a single
employer under subsection (b), (c), (m), or (o)
of section 414 shall be treated as a single
employer.
``(iv) Preventive care for chronic
conditions.--For purposes of this subparagraph,
the term `preventive care for chronic
conditions' means any item or service specified
in the Appendix of Internal Revenue Service
Notice 2019-45 which is prescribed to treat an
individual diagnosed with the associated
chronic condition specified in such Appendix
for the purpose of preventing the exacerbation
of such chronic condition or the development of
a secondary condition, including any amendment,
addition, removal, or other modification made
by the Secretary (pursuant to the authority
granted to the Secretary under paragraph
(2)(C)) to the items or services specified in
such Appendix subsequent to the date of
enactment of this subparagraph.''.
(b) Effective Date.--The amendments made by this section shall
apply to months in taxable years beginning after the date of enactment
of this Act.
SEC. 8014. ADJUSTMENT OF MEDICAL EXPENSE DEDUCTION.
(a) In General.--Section 213 of the Internal Revenue Code of 1986
is amended--
(1) in subsection (a), by striking ``10 percent'' and
inserting ``7.5 percent'', and
(2) by striking subsection (f) and inserting the following:
``(f) Temporary Special Rule.--In the case of any taxable year
beginning after December 31, 2019, and ending before January 1, 2022,
subsection (a) shall be applied with respect to a taxpayer by
substituting `5 percent' for `7.5 percent'.''.
(b) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2019.
SEC. 8015. HEALTHY WORKPLACE TAX CREDIT.
(a) In General.--In the case of an employer, there shall be allowed
as a credit against applicable employment taxes for each calendar
quarter an amount equal to 50 percent of the sum of--
(1) the qualified employee protection expenses paid or
incurred by the employer during such calendar quarter,
(2) the qualified workplace reconfiguration expenses paid
or incurred by the employer during such calendar quarter,
(3) the qualified workplace technology expenses paid or
incurred by the employer during such calendar quarter, and
(4) the qualified workplace training expenses paid or
incurred by the employer during such calendar quarter.
(b) Limitations and Refundability.--
(1) Overall dollar limitation on credit.--
(A) In general.--The amount of the credit allowed
under subsection (a) with respect to any employer for
any calendar quarter shall not exceed the excess (if
any) of--
(i) the applicable dollar limit with
respect to such employer for such calendar
quarter, over
(ii) the aggregate credits allowed under
subsection (a) with respect to such employer
for all preceding calendar quarters.
(B) Applicable dollar limit.--The term ``applicable
dollar limit'' means, with respect to any employer for
any calendar quarter, the sum of--
(i) $1,000, multiplied so much of the
average number of employees employed by such
employer during such calendar quarter as does
not exceed 500, plus
(ii) $750, multiplied by so much of such
average number of employees as exceeds 500 but
does not exceed 1,000, plus
(iii) $500, multiplied by so much of such
average number of employees as exceeds 1,000.
(2) Credit limited to employment taxes.--The credit allowed
by subsection (a) with respect to any calendar quarter shall
not exceed the applicable employment taxes (reduced by any
credits allowed under subsections (e) and (f) of section 3111
of the Internal Revenue Code of 1986, sections 7001 and 7003 of
the Families First Coronavirus Response Act, and section 2301
of the CARES Act) on the wages paid with respect to the
employment of all the employees of the eligible employer for
such calendar quarter.
(3) Refundability of excess credit.--
(A) In general.--If the amount of the credit under
subsection (a) exceeds the limitation of paragraph (2)
for any calendar quarter, such excess shall be treated
as an overpayment that shall be refunded under sections
6402(a) and 6413(b) of the Internal Revenue Code of
1986.
(B) Treatment of payments.--For purposes of section
1324 of title 31, United States Code, any amounts due
to the employer under this paragraph shall be treated
in the same manner as a refund due from a credit
provision referred to in subsection (b)(2) of such
section.
(c) Qualified Employee Protection Expenses.--For purposes of this
section, the term ``qualified employee protection expenses'' means
amounts paid or incurred by the employer for--
(1) testing employees of the employer for COVID-19
(including on a periodic basis),
(2) equipment to protect employees of the employer from
contracting COVID-19, including masks, gloves, and
disinfectants, and
(3) cleaning products or services (whether provided by an
employee of the taxpayer or a cleaning service provider)
related to preventing the spread of COVID-19.
(d) Qualified Workplace Reconfiguration Expenses.--For purposes of
this section--
(1) In general.--The term ``qualified workplace
reconfiguration expenses'' means amounts paid or incurred by
the employer to design and reconfigure retail space, work
areas, break areas, or other areas that employees or customers
regularly use in the ordinary course of the employer's trade or
business if such design and reconfiguration--
(A) has a primary purpose of preventing the spread
of COVID-19,
(B) is with respect to an area that is located in
the United States and that is leased or owned by the
employer,
(C) is consistent with the purpose of the property
immediately before the reconfiguration,
(D) is commensurate with the risks faced by the
employees or customers or is consistent with
recommendations made by the Centers for Disease Control
and Prevention or the Occupational Safety and Health
Administration,
(E) is completed pursuant to a reconfiguration plan
and no comparable reconfiguration plan was in place
before March 13, 2020, and
(F) is completed before January 1, 2021.
(2) Regulations.--The Secretary shall prescribe such
regulations and other guidance as may be necessary or
appropriate to carry out the purposes of this subsection,
including guidance defining primary purpose and reconfiguration
plan.
(e) Qualified Workplace Technology Expenses.--For purposes of this
section--
(1) In general.--The term ``qualified workplace technology
expenses'' means amounts paid or incurred by the employer for
technology systems that employees or customers use in the
ordinary course of the employer's trade or business if such
technology system--
(A) has a primary purpose of preventing the spread
of COVID-19,
(B) is used for limiting physical contact between
customers and employees in the United States,
(C) is commensurate with the risks faced by the
employees or customers or is consistent with
recommendations made by the Centers for Disease Control
and Prevention or the Occupational Safety and Health
Administration,
(D) is acquired by the taxpayer after March 12,
2020, and is not acquired pursuant to a written binding
contract entered into before such date, and
(E) is placed in service by the taxpayer before
January 1, 2021.
(2) Technology systems.--The term ``technology systems''
means computer software (as defined in section 167(f)(1)) and
qualified technological equipment (as defined in section
168(i)(2)).
(3) Regulations.--The Secretary shall prescribe such
regulations and other guidance as may be necessary or
appropriate to carry out the purposes of this subsection,
including guidance defining primary purpose.
(f) Qualified Workplace Training Expenses.--For purposes of this
section, the term ``qualified workplace training expenses'' means
amounts paid or incurred by the employer for education and training
with respect to industry best practices that ensure--
(1) the health and safety of employees in the workplace
with respect to COVID-19, and
(2) the prevention of the spread of COVID-19 in the
workplace.
(g) Other Definitions.--For purposes of this section--
(1) Applicable employment taxes.--The term ``applicable
employment taxes'' means the following:
(A) The taxes imposed under section 3111(a) of the
Internal Revenue Code of 1986.
(B) So much of the taxes imposed under section
3221(a) of such Code as are attributable to the rate in
effect under section 3111(a) of such Code.
(2) COVID-19.--Except where the context clearly indicates
otherwise, any reference in this section to COVID-19 shall be
treated as including a reference to the virus which causes
COVID-19.
(3) Secretary.--The term ``Secretary'' means the Secretary
of the Treasury or the Secretary's delegate.
(4) Other terms.--Any term used in this section (other than
subsection (b)(1)(B)) which is also used in chapter 21 or 22 of
the Internal Revenue Code of 1986 shall have the same meaning
as when used in such chapter.
(h) Certain Governmental Employers.--This credit shall not apply to
the Government of the United States, the government of any State or
political subdivision thereof, or any agency or instrumentality of any
of the foregoing.
(i) Special Rules.--
(1) Aggregation rule.--All persons treated as a single
employer under subsection (a) or (b) of section 52 of the
Internal Revenue Code of 1986, or subsection (m) or (o) of
section 414 of such Code, shall be treated as one employer for
purposes of this section.
(2) Denial of double benefit.--
(A) In general.--Rules similar to the rules of
paragraphs (1) and (2) of section 280C(b) shall apply
for purposes of this section.
(B) Expenses not taken into account more than
once.--Any qualified workplace reconfiguration expense
or qualified workplace technology expense shall not be
treated as a qualified employee protection expense and
any qualified workplace technology expense shall not be
treated as a qualified workplace reconfiguration
expense.
(3) Third-party payors.--Any credit allowed under this
section shall be treated as a credit described in section
3511(d)(2) of such Code.
(4) Election not to have section apply.--This section shall
not apply with respect to any eligible employer for any
calendar quarter if such employer elects (at such time and in
such manner as the Secretary may prescribe) not to have this
section apply.
(j) Transfers to Certain Trust Funds.--There are hereby
appropriated to the Federal Old-Age and Survivors Insurance Trust Fund
and the Federal Disability Insurance Trust Fund established under
section 201 of the Social Security Act (42 U.S.C. 401) and the Social
Security Equivalent Benefit Account established under section 15A(a) of
the Railroad Retirement Act of 1974 (45 U.S.C. 231n-1(a)) amounts equal
to the reduction in revenues to the Treasury by reason of this section
(without regard to this subsection). Amounts appropriated by the
preceding sentence shall be transferred from the general fund at such
times and in such manner as to replicate to the extent possible the
transfers which would have occurred to such Trust Fund or Account had
this section not been enacted.
(k) Treatment of Deposits.--The Secretary shall waive any penalty
under section 6656 of the Internal Revenue Code of 1986 for any failure
to make a deposit of any applicable employment taxes if the Secretary
determines that such failure was due to the reasonable anticipation of
the credit allowed under this section.
(l) Regulations and Guidance.--The Secretary shall prescribe such
regulations and other guidance as may be necessary or appropriate to
carry out the purposes of this section, including--
(1) with respect to the application of the credit under
subsection (a) to third-party payors (including professional
employer organizations, certified professional employer
organizations, or agents under section 3504 of the Internal
Revenue Code of 1986), regulations or other guidance allowing
such payors to submit documentation necessary to substantiate
the amount of the credit allowed under subsection (a), and
(2) regulations or other guidance to prevent abusive
transactions.
(m) Application.--This section shall only apply to amounts paid or
incurred after March 12, 2020, and before January 1, 2021.
TITLE IX--MEDICARE PROVISIONS
Subtitle A--Telehealth
SEC. 9001. REMOVING CERTAIN GEOGRAPHIC AND ORIGINATING SITE
RESTRICTIONS ON THE FURNISHING OF TELEHEALTH SERVICES
UNDER THE MEDICARE PROGRAM.
Section 1834(m)(4)(C) of the Social Security Act (42 U.S.C.
1395m(m)(4)(C)) is amended--
(1) in clause (i), by inserting ``, with respect to
services furnished on or after January 1, 2024,'' after
``telecommunications system and''; and
(2) in clause (ii)(X), by inserting ``, with respect to
services furnished on or after January 1, 2024,'' after
``but''.
SEC. 9002. MAKING PERMANENT FQHC AND RHC TELEHEALTH PAYMENTS.
Section 1834(m)(6) of the Social Security Act (42 U.S.C.
1395m(m)(8)), as so redesignated by section 2(7), is amended--
(1) in the header, by striking ``during emergency period'';
(2) in subparagraph (A), in the matter preceding clause
(i), by striking ``During'' and inserting ``With respect to
services furnished on or after the first day of''; and
(3) in subparagraph (B)(i), by striking ``during such
emergency period''.
SEC. 9003. EXPANDING THE LIST OF PRACTITIONERS ELIGIBLE TO FURNISH
TELEHEALTH SERVICES.
Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is
amended--
(1) in paragraph (1), by striking ``described in section
1842(b)(18)(C)'' and inserting ``as defined in paragraph
(4)(E)'';
(2) in paragraph (3)(B), by inserting ``described in
subparagraph (C) of such section'' after ``practitioners''; and
(3) in paragraph (4), by amending subparagraph (E) to read
as follows:
``(E) Practitioner.--The term `practitioner' means
a practitioner described in section 1842(b)(18)(C) and
includes, with respect to services furnished before
January 1, 2024, any supplier (other than a physician)
permitted to receive payment for a telehealth service
under this section as of the date of the enactment of
this subparagraph pursuant to a waiver in effect as of
such date under section 1135.''.
SEC. 9004. ALLOWING FOR THE PROVISION OF TELEHEALTH SERVICES VIA AUDIO-
ONLY TELECOMMUNICATIONS SYSTEMS.
Section 1834(m)(4) of the Social Security Act (42 U.S.C.
1395m(m)(4)) is amended by adding at the end the following new
subparagraph:
``(G) Telecommunications system.--
``(i) In general.--The term
`telecommunications system' includes, in the
case of a telehealth service furnished by a
qualified provider (as defined in clause (ii))
to an individual located at an originating site
before January 1, 2024, a communications system
consisting of only audio capabilities, but only
if such individual does not have access to a
communications system with audio-visual
capabilities at such site.
``(ii) Qualified provider.--For purposes of
clause (i), the term `qualified provider'
means, with respect a telehealth service
furnished to an individual, a physician or
practitioner who--
``(I) furnished to such individual
an item or service (other than such
telehealth service) for which payment
was made under any group health plan
(as defined in section 2791 of the
Public Health Service Act), health
insurance coverage (as so defined),
Federal health care program (as defined
in section 1128B(f)), or the health
care program under chapter 89 of title
5, United States Code, during the 3-
year period ending on the date such
telehealth service was furnished; or
``(II) is in the same practice (as
determined by tax identification
number) of a physician or practitioner
who furnished such an item or service
to such individual during such
period.''.
SEC. 9005. MAKING PERMANENT THE SAFE HARBOR FOR ABSENCE OF DEDUCTIBLE
FOR TELEHEALTH.
(a) In General.--Section 223(c)(2)(E) of the Internal Revenue Code
of 1986 is amended by striking ``In the case of plan years beginning on
or before December 31, 2021, a'' and inserting ``A''.
(b) Certain Coverage Disregarded.--Section 223(c)(1)(B)(ii) of the
Internal Revenue Code of 1986 is amended by striking ``(in the case of
plan years beginning on or before December 31, 2021)''.
SEC. 9006. REMOVING REQUIREMENT FOR FACE-TO-FACE VISITS BETWEEN HOME
DIALYSIS PATIENTS AND PHYSICIANS.
(a) In General.--Section 1881(b)(3)(B) of the Social Security Act
(42 U.S.C. 1395rr(b)(3)(B)) is amended--
(1) in clause (i), by striking ``clauses (ii) and (iii)''
and inserting ``clause (ii)'';
(2) in clause (ii), by inserting ``or (iv)'' after ``clause
(iii)'';
(3) by moving clause (iii) 6 ems to the left; and
(4) by adding at the end the following new clause:
``(iv) Clause (ii) shall not apply to monthly end stage renal
disease-related clinical assessments furnished before January 1, 2024,
in the case of an individual who has received in-person training with
respect to home dialysis.''.
(b) Waiver Authority.--
(1) In general.--Notwithstanding any provision of section
1135 of the Social Security Act (42 U.S.C. 1320b-5), the
Secretary of Health and Human Services may, with respect to a
specified waiver (as defined in paragraph (2)), continue such
waiver in effect for any period of time before January 1, 2024.
(2) Definition.--In this subsection, the term ``specified
waiver'' means a waiver in effect on the date of the enactment
of this Act that, with respect to any provision of title XVIII
of the Social Security Act (42 U.S.C. 1395 et seq.) that
requires an in-person visit with a provider of services or
supplier (as such terms are defined in section 1861 of such Act
(42 U.S.C. 1395x)) as a prerequisite for payment of any item or
service under such title or for any other purpose, modifies
such provision to allow such visit to be conducted through the
use of telehealth.
SEC. 9007. REPORT ON TELEHEALTH PAYMENT INTEGRITY.
Not later than 1 year after the date of the enactment of this Act,
the Inspector General of the Department of Health and Human Services
shall review claims for payment for telehealth services furnished under
the Medicare program during the emergency period described in section
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-5(g)(1)(B))
and submit to Congress a report on any instances of waste, fraud, or
abuse identified through such review.
SEC. 9008. INCREASING FUNDING FOR REVIEW OF TELEHEALTH CLAIMS.
There are authorized to be appropriated to the Inspector General of
the Department of Health and Human Services $10,000,000 for fiscal
years 2021 through 2023 for purposes of conducting audits and other
oversight activities with respect to payments made under section
1834(m) of the Social Security Act (42 U.S.C. 1395m(m)).
SEC. 9009. TELEHEALTH RESOURCES.
Not later than 6 months after the last day of the emergency period
described in section 1135(g)(1)(B) of the Social Security Act (42
U.S.C. 1320b-5(g)(1)(B)), the Secretary of Health and Human Services
shall develop and make available to physicians (as defined in section
1861(r) of such Act (42 U.S.C. 1395x(r))) and practitioners (as defined
in section 1834(m)(4)(E) of such Act (42 U.S.C. 1395m(m)(4)(E)))
educational resources and training sessions on requirements relating to
the furnishing of telehealth services under section 1834(m) of such Act
(42 U.S.C. 1395m(m)).
Subtitle B--Protecting Access to Innovation During COVID-19
SEC. 9011. AUTHORIZING THE EXTENSION OF PASS-THROUGH STATUS UNDER THE
MEDICARE PROGRAM FOR CERTAIN DRUGS AND DEVICES IMPACTED
BY COVID-19.
Section 1833(t)(6) of the Social Security Act (42 U.S.C.
1395l(t)(6)) is amended by adding at the end the following new
subparagraph:
``(K) Authority to extend pass-through status for
certain drugs and devices impacted by covid-19.--
``(i) In general.--Notwithstanding the
preceding provisions of this paragraph, in the
case of an eligible drug or device (as defined
in clause (iv)), if the Secretary determines,
prior to or on the date of the expiration of
pass-through status for such drug or device
(or, in the case of such a drug or device whose
pass-through status expired before the date of
the enactment of this subparagraph, not later
than 30 days after such date), that the cost of
such drug or device is unable to be accurately
calculated due to the effects of COVID-19, the
Secretary may extend the pass-through status of
such eligible drug or device in accordance with
clause (ii).
``(ii) Extension.--The Secretary may extend
the pass-through status of an eligible drug or
device described in clause (i) with respect to
which a determination has been made under such
clause--
``(I) in the case of a drug or
device whose period of pass-through
status expired during the emergency
period described in section
1135(g)(1)(B) before the date of the
enactment of this subparagraph, for a
period beginning on the first day after
such period of up to the number of days
occurring during such period during
which such drug or device had pass-
through status;
``(II) in the case of a drug or
device whose period of pass-through
status would otherwise expire during
such emergency period on or after such
date of enactment--
``(aa) for the remainder of
such period; and
``(bb) for a period
beginning on the first day
after such period of up to the
number of days occurring during
such period during which such
drug or device had pass-through
status (not taking into account
any extension of such status
pursuant to this subclause);
and
``(III) in the case of a drug or
device not described in subclause (I)
or (II), by the number of days
occurring during such emergency period
during which such drug or device had
pass-through status.
``(iii) Special rules for already-expired
drugs and devices.--In the case of an eligible
drug or device described in clause (ii)(I) for
which payment under this subsection was
packaged into a payment for a covered OPD
service (or group of services) and whose period
of pass-through status is extended in
accordance with such clause, the Secretary--
``(I) shall, for the period during
which such extension is in effect for
such drug or device--
``(aa) remove, during such
period, the packaged costs of
such drug or device (as
determined by the Secretary)
from the payment amount under
this subsection for the covered
OPD service (or group of
services) with which it is
packaged; and
``(bb) not make any
adjustments to payment amounts
under this subsection for a
covered OPD service (or group
of services) for which no costs
were removed under subclause
(I); and
``(II) may not, when calculating
the cost of such drug or device at the
end of such extension, take into
account claims for such drug or device
made while such drug or device was so
packaged.
``(iv) Eligible drug or device defined.--
For purposes of this subparagraph, the term
`eligible drug or device' means a drug,
biological, or device with pass-through status
in effect during any portion of the emergency
period described in section 1135(g)(1)(B) that
will not be (or was not) separately payable
upon the expiration of such status, but only
if, in the case of a drug or biological, such
drug or biological--
``(I) was payable based upon the
wholesale acquisition cost of such drug
or biological in lieu of the average
sales price of such drug or biological
on the first date of such emergency
period; and
``(II) will be (or was) packaged
into a payment for a covered OPD
service (or group of services) upon
expiration of such status.''.
Subtitle C--Reducing Unnecessary Senior Hospitalizations
SEC. 9021. SNF-BASED PROVISION OF PREVENTIVE ACUTE CARE AND
HOSPITALIZATION REDUCTION PROGRAM.
Title XVIII of the Social Security Act is amended by adding at the
end the following new section:
``SEC. 1899C. SNF-BASED PROVISION OF PREVENTIVE ACUTE CARE AND
HOSPITALIZATION REDUCTION PROGRAM.
``(a) Establishment.--There is established a program to be known as
the `SNF-based Provision of Preventive Acute Care and Hospitalization
Reduction Program' (in this section referred to as the `Program'), to
be administered by the Secretary, for purposes of reducing unnecessary
hospitalizations and emergency department visits by allowing qualified
group practices (as defined in section 1877(h)(4)) on or after January
1, 2022, to furnish items and services identified under subsection
(b)(3) to individuals entitled to benefits under part A and enrolled
under part B residing in qualified skilled nursing facilities.
``(b) Operation of Program.--Under the Program, the Secretary shall
provide for the following:
``(1) Certification of skilled nursing facilities as
qualified skilled nursing facilities under subsection (c)(1).
``(2) Certification of group practices as qualified group
practices under subsection (c)(2).
``(3) Identification of minimum required nonsurgical items
and services furnished at a hospital emergency department that
may be safely furnished by a qualified group practice at a
qualified skilled nursing facility under the Program, as
determined as clinically appropriate by the Secretary, and that
such qualified group practice shall offer to furnish under the
Program.
``(4) Annual identification of additional items and
services furnished at a hospital emergency department that may
be safely furnished by a qualified group practice at a
qualified skilled nursing facility under the Program during a
year and that such qualified group practice may offer to
furnish under the Program during such year.
``(5) Establishment of qualifications for nonphysician
employees who may furnish such items and services at a
qualified skilled nursing facility. Such qualifications shall
include the requirement that such an employee--
``(A) be certified in basic life support by a
nationally recognized specialty board of certification
or equivalent certification board; and
``(B) have--
``(i) clinical experience furnishing
medical care--
``(I) in a skilled nursing
facility;
``(II) in a hospital emergency
department setting; or
``(III) as an employee of a
provider or supplier of ambulance
services; or
``(ii) a certification in paramedicine.
``(6) Payment under this title for items and services
identified under paragraph (3) or (4) furnished by such
qualified group practices at such a facility in amounts
determined under subsection (d).
``(c) Certifications.--
``(1) Qualified skilled nursing facilities.--For purposes
of this section, the Secretary shall certify a skilled nursing
facility as a qualified skilled nursing facility if the
facility submits an application in a time and manner specified
by the Secretary and meets the following requirements:
``(A) The facility has on-site diagnostic equipment
necessary for a qualified group practice to furnish
items and services under the Program and real-time
audio and visual capabilities.
``(B) The facility has at least one individual who
meets the qualifications described in paragraph (5) or
a physician present 24 hours a day and 7 days a week to
work with the qualified group practice. Such individual
may be a member of the staff of the qualified skilled
nursing facility or of the qualified group practice.
``(C) The facility ensures that residents of such
facility, upon entering such facility, are allowed to
specify in an advanced care directive whether the
resident wishes to receive items and services furnished
at the facility under the Program in a case where
communication with the resident is not possible.
``(D) The facility ensures that individuals to be
furnished such items and services under the Program at
such facility have the opportunity, at their request,
to instead be transported to a hospital emergency
department.
``(E) The facility is not part of the Special Focus
Facility program of the Centers for Medicare & Medicaid
Services (although the facility may, at the discretion
of the Secretary, be a candidate for selection under
such program).
Nothing in this paragraph shall affect the requirements under
section 1819(b)(4).
``(2) Qualified group practices.--For purposes of this
section, the Secretary shall certify a group practice as a
qualified group practice for a period of 3 years if the group
practice submits an application in a time and manner specified
by the Secretary and meets the following requirements:
``(A) The group practice offers to furnish all
minimum required items and services identified under
subsection (b)(3) under the Program.
``(B) The group practice submits a notification to
the Secretary annually specifying which (if any)
additional items and services identified under
subsection (b)(4) for a year the group practice will
offer to furnish for such year under the Program.
``(C) The group practice ensures that only
individuals who meet the qualifications established
under subsection (b)(5) or a physician who is part of
such group practice may furnish such minimum required
items and services and such additional items and
services.
``(D) The group practice ensures that, in the case
where such minimum required items and services or such
additional items and services are furnished by such an
individual, such individual furnishes such minimum
required items and services or additional items and
services under the supervision, either in-person or
through the use of telehealth (not including store-and-
forward technologies), of--
``(i) a physician--
``(I) who is board certified or
board eligible in emergency medicine,
family medicine, geriatrics, or
internal medicine; or
``(II) who has been certified by a
nationally recognized specialty board
of certification or equivalent
certification board in basic life
support;
``(ii) a nurse practitioner who has been
certified by a nationally recognized specialty
board of certification or equivalent
certification board in basic life support; or
``(iii) a physician assistant who has been
certified by a nationally recognized specialty
board of certification or equivalent
certification board in basic life support.
``(E) With respect to any year in which the
qualified group practice would participate in the
Program, the Chief Actuary for the Centers for Medicare
& Medicaid Services determines that such participation
during such year will not result in total estimated
expenditures under this title for such year being
greater than total estimated expenditures under such
title for such year without such participation.
``(d) Payments.--
``(1) In general.--For 2022 and each subsequent year, the
Secretary shall develop a schedule of payments to apply for
items and services identified under paragraph (3) or paragraph
(4) of subsection (b) furnished during such year under the
Program. Such payments shall be in lieu of any other payments
that may be made under this title for such items and services.
``(2) Shared savings.--In the case of a year for which the
Secretary determines that participation in the Program resulted
in a reduction in expenditures under this title compared to
what such expenditures would have been without such
participation, the Secretary shall--
``(A) pay to such qualified group practice an
amount equal to 37.5 percent of the estimated amount of
such reduction; and
``(B) in the case of each qualified skilled nursing
facility where such qualified group practice furnished
items and services under the Program during such year--
``(i) if the qualified skilled nursing
facility has at least a three-star rating under
the Five Star Quality Rating System (or a
successor system), pay to the facility an
amount that bears the same ratio to 12.5
percent of the estimated amount of such
reduction as the amount of expenditures under
the Program for such items and services
furnished with respect to individuals at such
facility by such qualified group practice
during such year bears to the total amount of
expenditures under the Program for such items
and services furnished with respect to all
individuals by such qualified group practice
during such year; and
``(ii) in the case of a qualified skilled
nursing facility that is not described in
clause (i), retain in the Federal Hospital
Insurance Trust Fund under section 1817 the
amount that the facility would have been paid
pursuant to clause (i) if the facility were
described in such clause until such time as the
facility has at least a three-star rating under
the Five Star Quality Rating System (or a
successor system), at which point the Secretary
shall pay such amount to the facility.
``(3) Advanced alternative payment models.--Paragraph (2)
shall not apply to items and services furnished to an
individual entitled to benefits under part A and enrolled under
part B for whom shared savings would otherwise be attributed
through an advanced alternative payment model as authorized
under section 1115A or section 1899.
``(e) Evaluation.--
``(1) In general.--With respect to a qualified group
practice and a qualified skilled nursing facility, not later
than 6 months after such group practice begins furnishing items
and services under the Program (or, in the case of a qualified
skilled nursing facility, not less than 6 months after a
qualified group practice first furnishes such items and
services at such facility), and not less than once every 2
years thereafter, the Secretary shall evaluate such qualified
group practice and such qualified facility using information
received under paragraph (2) on such criteria as determined
appropriate by the Secretary.
``(2) Reporting of information.--In a time and manner
specified by the Secretary, a qualified group practice and a
qualified skilled nursing facility shall submit to the
Secretary a report containing the following information with
respect to items and services furnished under the Program
during a reporting period (as specified by the Secretary):
``(A) The number of individuals with respect to
whom such group practice furnished such items and
services in such period (or, in the case of a qualified
skilled nursing facility, the number of individuals
with respect to whom such a group practice furnished
such items and services at such facility in such
period).
``(B) The number of such individuals who were
admitted to a hospital or treated in the emergency
department of a hospital within 24 hours of being
furnished such items and services.
``(C) Other information determined appropriate by
the Secretary.
``(3) Loss of qualified certification.--
``(A) In general.--Not later than 3 months after a
determination described in this sentence is made, the
Secretary may revoke the certification of a qualified
skilled nursing facility or a qualified group practice
made under subsection (c) if--
``(i) the Chief Actuary of the Centers for
Medicare & Medicaid Services determines that
the participation of such skilled nursing
facility or such group practice in the Program
during a year resulted in total expenditures
under this title for such period being greater
than total expenditures under such title would
have been during such period without such
participation; or
``(ii) a facility is selected for the
Special Focus Facility program or, if the
facility is a candidate for the Special Focus
Facility program, the Secretary determines that
the participation of such facility in the
Program should be terminated.
``(B) Exclusion from certification.--
``(i) In general.--In the case that the
Secretary revokes the certification of a
qualified skilled nursing facility or a
qualified group practice under subparagraph
(A), such skilled nursing facility or such
group practice shall be ineligible for
certification as a qualified skilled nursing
facility or a qualified group practice (as
applicable) under subsection (c) for the
applicable period (as defined under clause
(ii)).
``(ii) Applicable period defined.--In this
subparagraph, the term `applicable period'
means--
``(I) if the revocation of a
facility or group practice under
subparagraph (A) is due to the
application of clause (i) of such
subparagraph, a 1-year period beginning
on the date of such revocation; and
``(II) in the revocation of a
facility under subparagraph (A) is due
to the application of clause (ii) of
such subparagraph, the period beginning
on the date of such revocation and
ending on the date on which the
facility graduates from the Special
Focus Facility program (or, in the case
of a facility that is a candidate for
such program, the date on which the
facility is no longer such a candidate,
as determined by the Secretary).
``(f) Determination of Budget Neutrality; Termination of Program.--
``(1) Determination.--Not later than July 1, 2027, the
Chief Actuary of the Centers for Medicare & Medicaid Services
shall determine whether the Program has resulted in an increase
in total expenditures under this title with respect to the
period beginning on January 1, 2022, and ending on December 31,
2026, compared to what such expenditures would have been during
such period had the Program not been in operation.
``(2) Termination.--If the Chief Actuary makes a
determination under paragraph (1) that the Program has resulted
in an increase in total expenditures under this title, the
Secretary shall terminate the Program as of January 1 of the
first year beginning after such determination.''.
TITLE X--APPROPRIATIONS
appropriations
Sec. 10001. The following sums are hereby appropriated, out of any
money in the Treasury not otherwise appropriated, for the fiscal year
ending September 30, 2021, and for other purposes, namely:
Subtitle A--Health Programs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF THE SECRETARY
public health and social services emergency fund
(including transfer of funds)
For an additional amount for ``Public Health and Social Services
Emergency Fund'', $31,000,000,000, to remain available until September
30, 2025, to prevent, prepare for, and respond to coronavirus,
domestically or internationally, including the development of necessary
countermeasures and vaccines, prioritizing platform-based technologies
with United States-based manufacturing capabilities, the purchase of
vaccines, therapeutics, diagnostics, necessary medical supplies, as
well as medical surge capacity, addressing blood supply chain,
workforce modernization, telehealth access and infrastructure, initial
advanced manufacturing, novel dispensing, enhancements to the United
States Commissioned Corps, and other preparedness and response
activities: Provided, That funds appropriated under this paragraph in
this title may be used to develop and demonstrate innovations and
enhancements to manufacturing platforms to support such capabilities:
Provided further, That the Secretary of Health and Human Services shall
purchase vaccines developed using funds made available under this
paragraph in this title to respond to an outbreak or pandemic related
to coronavirus in quantities determined by the Secretary to be adequate
to address the public health need: Provided further, That products
purchased by the Federal Government with funds made available under
this paragraph in this title, including vaccines, therapeutics, and
diagnostics, shall be purchased in accordance with Federal Acquisition
Regulation guidance on fair and reasonable pricing: Provided further,
That the Secretary may take such measures authorized under current law
to ensure that vaccines, therapeutics, and diagnostics developed from
funds provided in this title will be affordable in the commercial
market: Provided further, That in carrying out the previous proviso,
the Secretary shall not take actions that delay the development of such
products: Provided further, That the Secretary shall ensure that
protections remain for individuals enrolled in group or individual
health care coverage with pre-existing conditions, including those
linked to coronavirus: Provided further, That products purchased with
funds appropriated under this paragraph in this title may, at the
discretion of the Secretary of Health and Human Services, be deposited
in the Strategic National Stockpile under section 319F-2 of the Public
Health Service Act: Provided further, That of the amount appropriated
under this paragraph in this title, not more than $2,000,000,000 shall
be for the Strategic National Stockpile under section 319F-2(a) of such
Act: Provided further, That funds appropriated under this paragraph in
this title may be transferred to, and merged with, the fund authorized
by section 319F-4, the Covered Counter measure Process Fund, of the
Public Health Service Act: Provided further, That of the amount
appropriated under this paragraph in this title, not more than
$2,000,000,000, to remain available until September 30, 2023, shall be
for activities to improve and sustain State medical stockpiles:
Provided further, That of the amount appropriated under this paragraph
in this title, $20,000,000,000 shall be available to the Biomedical
Advanced Research and Development Authority for necessary expenses of
manufacturing, production, and purchase, at the discretion of the
Secretary, of vaccines, therapeutics, diagnostics, and small molecule
active pharmaceutical ingredients, including the development,
translation, and demonstration at scale of innovations in manufacturing
platforms: Provided further, That funds in the previous proviso may be
used for the construction or renovation of United States-based next
generation manufacturing facilities, other than facilities owned by the
United States Government: Provided further, That amounts provided in
the eleventh proviso may be for necessary expenses related to the
sustained on-shore manufacturing capacity for public health
emergencies: Provided further, That of the amount appropriated under
this paragraph in this title, $6,000,000,000 shall be for activities to
plan, prepare for, promote, distribute, administer, monitor, and track
coronavirus vaccines to ensure broad-based distribution, access, and
vaccine coverage: Provided further, That the Secretary shall coordinate
funding and activities outlined in the previous proviso through the
Director of the Centers for Disease Control and Prevention: Provided
further, That the Secretary, through the Director of the Centers for
Disease Control and Prevention, shall report to the Committees on
Appropriations of the House of Representatives and the Senate within 60
days of the date of enactment of this title on a comprehensive
coronavirus vaccine distribution strategy and spend plan that includes
how existing infrastructure will be leveraged, enhancements or new
infrastructure that may be built, considerations for moving and storing
vaccines, guidance for how States and health care providers should
prepare for, store, and administer vaccines, nationwide vaccination
targets, funding that will be distributed to States, how an
informational campaign to both the public and health care providers
will be executed, and how the vaccine distribution plan will focus
efforts on high risk, underserved, and minority populations: Provided
further, That such plan shall be updated and provided to the Committees
on Appropriations of the House of Representatives and the Senate 90
days after submission of the first plan: Provided further, That the
Secretary shall notify the Committees on Appropriations of the House of
Representatives and the Senate 2 days in advance of any obligation in
excess of $50,000,000, including contracts and interagency agreements,
from funds provided in this paragraph in this title: Provided further,
That funds appropriated under this paragraph in this title may be used
for the construction, alteration, or renovation of nonfederally owned
facilities for the production of vaccines, therapeutics, diagnostics,
and medical supplies where the Secretary determines that such a
contract is necessary to secure sufficient amounts of such supplies:
Provided further, That not later than 30 days after enactment of this
title, and every 30 days thereafter until funds are expended, the
Secretary shall report to the Committees on Appropriations of the House
of Representatives and the Senate on uses of funding for Operation Warp
Speed, detailing current obligations by Department or Agency, or
component thereof broken out by the coronavirus supplemental
appropriations Act that provided the source of funds: Provided further,
That the plan outlined in the previous proviso shall include funding by
contract, grant, or other transaction in excess of $20,000,000 with a
notation of which Department or Agency, and component thereof is
managing the contract: Provided further, That such amount is designated
by the Congress as being for an emergency requirement pursuant to
section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit
Control Act of 1985.
For an additional amount for ``Public Health and Social Services
Emergency Fund'', $16,000,000,000, to remain available until September
30, 2023, to prevent, prepare for, and respond to coronavirus,
domestically or internationally, which shall be for necessary expenses
for testing, contact tracing, surveillance, containment, and mitigation
to monitor and suppress COVID-19, including tests for both active
infection and prior exposure, including molecular, antigen, and
serological tests, the manufacturing, procurement and distribution of
tests, testing equipment and testing supplies, including personal
protective equipment needed for administering tests, the development
and validation of rapid, molecular point-of-care tests, and other
tests, support for workforce, epidemiology, to scale up academic,
commercial, public health, and hospital laboratories, to conduct
surveillance and contact tracing, support development of COVID-19
testing plans, and other related activities related to COVID-19
testing: Provided, That of the amount appropriated under this paragraph
in this title, not less than $15,000,000,000 shall be for States,
localities, territories, Tribes, Tribal organizations, urban Indian
health organizations, or health service providers to Tribes for
necessary expenses for testing, contact tracing, surveillance,
containment, and mitigation, including support for workforce,
epidemiology, use by employers, elementary and secondary schools, child
care facilities, institutions of higher education, long-term care
facilities, or in other settings, scale up of testing by public health,
academic, commercial, and hospital laboratories, and community-based
testing sites, health care facilities, and other entities engaged in
COVID-19 testing, and other related activities related to COVID-19
testing, contact tracing, surveillance, containment, and mitigation:
Provided further, That the amount provided in the preceding proviso
shall be made available within 30 days of the date of enactment of this
title: Provided further, That the amount identified in the first
proviso under this paragraph in this title shall be allocated to
States, localities, and territories according to the formula that
applied to the Public Health Emergency Preparedness cooperative
agreement in fiscal year 2019: Provided further, That not less than
$500,000,000 shall be allocated in coordination with the Director of
the Indian Health Service, to Tribes, Tribal organizations, urban
Indian health organizations, or health service providers to Tribes:
Provided further, That the Secretary of Health and Human Services
(referred to in this paragraph as the ``Secretary'') may satisfy the
funding thresholds outlined in the first and fourth provisos under this
paragraph in this title by making awards through other grant or
cooperative agreement mechanisms: Provided further, That the Governor
or designee of each State, locality, territory, Tribe, or Tribal
organization receiving funds pursuant to this title shall update their
plans, as applicable, for COVID-19 testing and contact tracing
submitted to the Secretary pursuant to the Paycheck Protection Program
and Health Care Enhancement Act (Public Law 116-139) and submit such
updates to the Secretary not later than 60 days after funds
appropriated in this paragraph in this title have been awarded to such
recipient: Provided further, That not later than 60 days after the date
of enactment, and every quarter thereafter until funds are expended,
the Governor or designee of each State, locality, territory, Tribe, or
Tribal organization receiving funds shall report to the Secretary on
uses of funding, detailing current commitments and obligations broken
out by the coronavirus supplemental appropriations Act that provided
the source of funds: Provided further, That not later than 15 days
after receipt of such reports, the Secretary shall summarize and report
to the Committees on Appropriations of the House of Representatives and
the Senate on States' commitments and obligations of funding: Provided
further, That funds an entity receives from amounts described in the
first proviso in this paragraph may also be used for the rent, lease,
purchase, acquisition, construction, alteration, renovation, or
equipping of nonfederally owned facilities to improve coronavirus
preparedness and response capability at the State and local level:
Provided further, That such amount is designated by the Congress as
being for an emergency requirement pursuant to section 251(b)(2)(A)(i)
of the Balanced Budget and Emergency Deficit Control Act of 1985.
Subtitle B--General Provisions-This Title
Sec. 10101. Each amount appropriated or made available by this
title is in addition to amounts otherwise appropriated for the fiscal
year involved.
Sec. 10102. No part of any appropriation contained in this title
shall remain available for obligation beyond the current fiscal year
unless expressly so provided herein.
Sec. 10103. Unless otherwise provided for by this title, the
additional amounts appropriated by this title to appropriations
accounts shall be available under the authorities and conditions
applicable to such appropriations accounts for fiscal year 2020.
Sec. 10104. In this title, the term ``coronavirus'' means SARS-
CoV-2 or another coronavirus with pandemic potential.
Sec. 10105. Each amount designated in this title by the Congress
as being for an emergency requirement pursuant to section
251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control
Act of 1985 shall be available (or rescinded or transferred, if
applicable) only if the President subsequently so designates all such
amounts and transmits such designations to the Congress.
Sec. 10106. Any amount appropriated by this title, designated by
the Congress as an emergency requirement pursuant to section
251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control
Act of 1985 and subsequently so designated by the President, and
transferred pursuant to transfer authorities provided by this title
shall retain such designation.
Sec. 10107. (a) Statutory Paygo Scorecards.--The budgetary effects
of this title 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 this title
shall not be entered on any PAYGO scorecard maintained for purposes of
section 4106 of H. Con. Res. 71 (115th Congress).
(c) Classification of Budgetary Effects.--Notwithstanding Rule 3 of
the Budget Scorekeeping Guidelines set forth in the joint explanatory
statement of the committee of conference accompanying Conference Report
105-217 and section 250(c)(7) and (c)(8) of the Balanced Budget and
Emergency Deficit Control Act of 1985, the budgetary effects of this
title shall be estimated for purposes of section 251 of such Act.
(d) Ensuring No Within-Session Sequestration.--Solely for the
purpose of calculating a breach within a category for fiscal year 2020
pursuant to section 251(a)(6) or section 254(g) of the Balanced Budget
and Emergency Deficit Control Act of 1985, and notwithstanding any
other provision of this title, the budgetary effects from this title
shall be counted as amounts designated as being for an emergency
requirement pursuant to section 251(b)(2)(A) of such Act.
This title may be cited as the ``Coronavirus Response Additional
Supplemental Appropriations Act, 2020''.
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