Title: Commitment to Defeat the Virus and Keep America Healthy Act
Policy area: Health

Summary:
Commitment to Defeat the Virus and Keep America Healthy Act
This bill provides funding for various public health programs and activities and revises multiple provisions, including within the tax code, to respond to COVID-19 (i.e., coronavirus disease 2019) and otherwise address health outcomes.
The bill specifically makes changes to support pharmaceutical manufacturing and supply chains; prevent diversion of controlled substances; increase access to telehealth services under Medicare; and expand various public health programs to address health disparities, maternal and infant health, and behavioral health.

[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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