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Title VII — NIH, FDA, and Opioids Funding

H.R. 3 · 116th Congress · Dec 16, 2019 · Lineage

VII NIH, FDA, and Opioids Funding

A Biomedical Innovation Expansion

Sec. 701 NIH Innovation Initiatives

(a)
NIH Innovation account—
(1)
In general— Section 1001(b) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following:

“(5) Supplemental funding and additional activities

“(A) In general—In addition to the funds made available under paragraph (2), there are authorized to be appropriated, and are hereby appropriated, to the Account, out of any monies in the Treasury not otherwise appropriated, to be available until expended without further appropriation, the following:

“(i) For fiscal year 2021, $255,400,000.

“(ii) For fiscal year 2022, $260,400,000.

“(iii) For fiscal year 2023, $163,400,000.

“(iv) For fiscal year 2024, $547,000,000.

“(v) For fiscal year 2025, $848,000,000.

“(vi) For fiscal year 2026, $842,400,000.

“(vii) For fiscal year 2027, $1,089,600,000.

“(viii) For fiscal year 2028, $1,115,600,000.

“(ix) For fiscal year 2029, $1,170,600,000.

“(x) For fiscal year 2030, $1,207,600,000.

“(B) Supplemental funding for certain projects—Of the total amounts made available under subparagraph (A) for each of fiscal years 2021 through 2030, a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:

“(i) For projects described in paragraph (4)(A), an amount not to exceed a total of $2,070,600,000 as follows:

“(I) For each of fiscal years 2021 and 2022, $50,000,000.

“(II) For fiscal year 2024, $100,000,000.

“(III) For each of fiscal years 2025 and 2026, $300,000,000.

“(IV) For each of fiscal years 2027 through 2029, $317,000,000.

“(V) For fiscal year 2030, $319,600,000.

“(ii) For projects described in paragraph (4)(B), an amount not to exceed a total of $2,041,900,000 as follows:

“(I) For each of fiscal years 2021 and 2022, $50,000,000.

“(II) For fiscal year 2024, $128,000,000.

“(III) For fiscal year 2025, $209,000,000.

“(IV) For fiscal year 2026, $100,000,000.

“(V) For fiscal year 2027, $325,000,000.

“(VI) For fiscal year 2028, $350,000,000.

“(VII) For fiscal year 2029, $400,000,000.

“(VIII) For fiscal year 2030, $429,900,000.

“(iii) For projects described in paragraph (4)(C), an amount not to exceed a total of $1,558,400,000 as follows:

“(I) For each of fiscal years 2024 and 2025, $151,200,000.

“(II) For each of fiscal years 2026 through 2030, $251,200,000.

“(iv) For projects described in paragraph (4)(D), an amount not to exceed $15,400,000 for each of fiscal years 2021 through 2030.

“(C) Additional NIH Innovation Projects—In addition to funding NIH Innovation Projects pursuant to subparagraph (B), of the total amounts made available under subparagraph (A), a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:

“(i) To support research related to combating antimicrobial resistance and antibiotic resistant bacteria, including research into new treatments, diagnostics, and vaccines, research, in consultation with the Centers for Disease Control and Prevention, into stewardship, and the development of strategies, in coordination with the Biomedical Advanced Research and Development Authority under section 319L of the Public Health Service Act, to support commercialization of new antibiotics, not to exceed a total of 1,144,500,000, as follows:

“(I) For each of fiscal years 2021 through 2024, $100,000,000.

“(II) For each of fiscal years 2025 and 2026, $120,000,000.

“(III) For each of fiscal years 2027 through 2029, $125,000,000.

“(IV) For fiscal year 2030, $129,500,000.

“(ii) To support research and research activities related to rare diseases or conditions, including studies or analyses that help to better understand the natural history of a rare disease or condition and translational studies related to rare diseases or conditions, not to exceed a total of $530,600,000, as follows:

“(I) For fiscal year 2021, $40,000,000.

“(II) For fiscal year 2022, $45,000,000.

“(III) For fiscal year 2023, $48,000,000.

“(IV) For each of fiscal years 2024 and 2025, $52,400,000.

“(V) For fiscal year 2026, $55,800,000.

“(VI) For fiscal year 2027, $56,000,000.

“(VII) For fiscal year 2028, $57,000,000.

“(VIII) For each of fiscal years 2029 and 2030, $62,000,000.”

(2)
Conforming amendments— Section 1001 of the 21st Century Cures Act (Public Law 114–255) is amended—
(A)
in subsection (a), by striking “subsection (b)(4)” and inserting “subsections (b)(4) and (b)(5)”;
(B)
in subsection (b)(1), by striking “paragraph (4)” and inserting “paragraphs (4) and (5)”; and
(C)
in subsection (c)(2)(A)(ii), by inserting “or pursuant to subsection (b)(5)” after “subsection (b)(3)”; and
(D)
in subsection (d), by inserting “or pursuant to subsection (b)(5)” after “subsection (b)(3)”.
(b)
Workplan— Section 1001(c)(1) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following:

“(D) Updates—The Director of NIH shall , after seeking recommendations in accordance with the process described in subparagraph (C), update the work plan submitted under this subsection for each of fiscal years 2021 through 2030 to reflect the amendments made to this section by the Elijah E. Cummings Lower Drug Costs Now Act.”

(c)
Annual reports— Section 1001(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “2027” and inserting “2030”.
(d)
Sunset— Section 1001(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “September 30, 2026” and inserting “September 30, 2030”.

Sec. 702 NIH clinical trial

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:

“404O. Clinical Trial Acceleration Pilot Initiative

“(a) Establishment of pilot program—The Secretary, acting through the Director of the National Institutes of Health, shall, not later than 2 years after the date of enactment of this Act, establish and implement a pilot program to award multi-year contracts to eligible entities to support phase II clinical trials and phase III clinical trials—

“(1) to promote innovation in treatments and technologies supporting the advanced research and development and production of high need cures; and

“(2) to provide support for the development of medical products and therapies.

“(b) Eligible entities—To be eligible to receive assistance under the pilot program established under subsection (a), an entity shall—

“(1) be seeking to market a medical product or therapy that is the subject of clinical trial or trials to be supported using such assistance;

“(2) be a public or private entity, which may include a private or public research institution, a contract research organization, an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), a medical center, a biotechnology company, or an academic research institution; and

“(3) comply with requirements of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.

“(c) Duties—The Secretary, acting through the Director of National Institutes of Health, shall—

“(1) in establishing the pilot program under subsection (a), consult with—

“(A) the Director of the National Center for Advancing Translational Sciences and the other national research institutes in considering their requests for new or expanded clinical trial support efforts; and

“(B) the Commissioner of Food and Drugs and any other head of a Federal agency as the Secretary determines to be appropriate to ensure coordination and efficiently advance clinical trial activities;

“(2) in implementing the pilot program under subsection (a), consider consulting with patients and patient advocates; and

“(3) in awarding contracts under the pilot program under subsection (a), consider—

“(A) the expected health impacts of the clinical trial or trials to be supported under the contract; and

“(B) the degree to which the medical product or therapy that is the subject of such clinical trial or trials is a high need cure.

“(d) Exclusion—A contract may not be awarded under the pilot program under subsection (a) if the drug that is the subject of the clinical trial or trials to be supported under the contract is a drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act as a drug for a rare disease or condition.

“(e) NIH Clinical Trial Accelerator Account

“(1) Establishment—There is established in the Treasury an account, to be known as the “NIH Clinical Trial Accelerator Account” (referred to in this section as the “Account”), for purposes of carrying out this section.

“(2) Transfer of direct spending savings—There shall be transferred to the Account from the general fund of the Treasury, $680,000,000 for each of fiscal years 2021 through 2025, to be available until expended without further appropriation.

“(3) Work plan—Not later than 180 days after the date of enactment of this Act, 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 work plan that includes the proposed implementation of this section and the proposed allocation of funds in the Account.

“(f) Reports to Congress—Not later than October 1 of each fiscal year, 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—

“(1) the implementation of this section;

“(2) any available results on phase II clinical trials and phase III clinical trials supported under this section during such fiscal year; and

“(3) the extent to which Federal funds are obligated to support such clinical trials, including the specific amount of such support and awards pursuant to an allocation from the Account under subsection (e).

“(g) Definitions—In this section:

“(1) Phase II clinical trial—The term “phase II clinical trial” means a phase II clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

“(2) Phase III clinical trials—The term “phase III clinical trial” means a phase III clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

“(3) High need cure—The term “high need cure” has the meaning given such term in section 480(a)(3).”

Sec. 703 Innovation Network

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.), as amended by section 702, is further amended by adding at the end the following:

“404P. Innovation Network

“(a) Funds—The Director of NIH shall award grants or contracts to eligible entities to develop, expand, and enhance the commercialization of biomedical products.

“(b) Eligible entity—In this section, the term eligible entity means an entity receiving funding under—

“(1) the Small Business Innovation Research program of the National Institutes of Health; or

“(2) the Small Business Technology Transfer program of the National Institutes of Health.

“(c) Use of funds—An eligible entity shall use the funds received through such grant or contract to support—

“(1) the Commercialization Readiness Pilot program of the National Institutes of Health;

“(2) the Innovation Corps program of the National Institutes of Health;

“(3) the Commercialization Accelerator program of the National Institutes of Health;

“(4) the Commercialization Assistance program of the National Institutes of Health; and

“(5) such other programs and activities as the Director of NIH determines to be appropriate, to support the commercialization stage of research, later stage research and development, technology transfer, and commercialization technical assistance.

“(d) Authorization of appropriations—There are authorized to be appropriated to carry out this section $100,000,000 for each of fiscal years 2021 through 2025, to be available until expended.”

B Investing in Safety and Innovation

Sec. 711 Food and Drug Administration

(a)
FDA Innovation account—
(1)
In general— Section 1002(b) of the 21st Century Cures Act (Public Law 114–255) is amended—
(A)
in paragraph (1), by striking “paragraph (4)” and inserting “paragraphs (4) and (5)”; and
(B)
by adding at the end the following new paragraph:

“(5) Supplemental funding and additional activities

“(A) In general—In addition to the funds made available under paragraph (2), there are authorized to be appropriated, and are hereby appropriated, to the Account, out of any monies in the Treasury not otherwise appropriated, to be available until expended without further appropriation, the following:

“(i) For fiscal year 2020, $417,500,000.

“(ii) For each of fiscal years 2021 and 2022, $157,500,000.

“(iii) For each of fiscal years 2023 through 2025, $152,500,000.

“(iv) For each of fiscal years 2026 through 2029, $202,500,000.

“(B) Supplemental funding for certain activities—Of the total amounts made available under subparagraph (A) for each of fiscal years 2026 through 2029, a total amount not to exceed $50,000,000 for each such fiscal year, shall be made available for the activities under subtitles A through F (including the amendments made by such subtitles) of title III of this Act and section 1014 of the Federal Food, Drug, and Cosmetic Act, as added by section 3073 of this Act.

“(C) Additional FDA activities—In addition to funding activities pursuant to subparagraph (B), of the total amounts made available under subparagraph (A), a total amount not to exceed the following shall be made available for the following categories of activities:

“(i) For modernization of the technical infrastructure of the Food and Drug Administration, including enhancements such as interoperability across the agency, and additional capabilities to develop an advanced information technology infrastructure to support the agency’s regulatory mission:

“(I) For fiscal year 2020, $180,000,000.

“(II) For each of fiscal years 2021 through 2029, $60,000.

“(ii) For support for continuous manufacturing of drugs and biological products, including complex biological products such as regenerative medicine therapies, through grants to institutions of higher education and nonprofit organizations and other appropriate mechanisms, for each of fiscal years 2020 through 2029, $20,000,000.

“(iii) For support for the Commissioner of Food and Drugs to engage experts, such as through the formation and operation of public-private partnerships or other appropriate collaborative efforts, to advance the development and delivery of individualized human gene therapy products:

“(I) For fiscal year 2020, $50,000,000.

“(II) For each of fiscal years 2021 through 2029, $10,000,000.

“(iv) For support for inspections, enforcement, and quality surveillance activities across the Food and Drug Administration, including foreign and domestic inspections across products, for each of fiscal years 2020 through 2029, $20,000,000.

“(v) For support for activities of the Food and Drug Administration related to customs and border protection to provide improvements to technologies, inspection capacity, and sites of import (including international mail facilities) in which the Food and Drug Administration operates, for each of fiscal years 2020 through 2029, $10,000,000.

“(vi) To further advance the development of a coordinated postmarket surveillance system for all medical products, including drugs, biological products, and devices, linked to electronic health records in furtherance of the Food and Drug Administration’s postmarket surveillance capabilities:

“(I) For fiscal year 2020, $112,500,000.

“(II) For each of fiscal years 2021 through 2029, $12,500,000.

“(vii) For support for Food and Drug Administration activities to keep pace with the projected product development of regenerative therapies, including cellular and somatic cell gene therapy products:

“(I) For each of fiscal years 2020 through 2022, $10,000,000.

“(II) For each of fiscal years 2023 through 2029, $5,000,000.

“(viii) For carrying out section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3a; relating to hiring authority for scientific, technical, and professional personnel), for each of fiscal years 2020 through 2029, $2,500,000.

“(ix) For the Food and Drug Administration to support improvements to the technological infrastructure for reporting and analysis of adverse events associated with the use of drugs and biological products, for each of fiscal years 2020 through 2029, $12,500,000.”

(2)
Conforming amendments— Section 1002 of the 21st Century Cures Act (Public Law 114–255) is amended—
(A)
in subsection (a), by inserting before the period at the end the following: “or pursuant to subparagraph (A) of subsection (b)(5) to carry out the activities described in subparagraphs (B) and (C) of such subsection”; and
(B)
in subsection (d)—
(i)
by inserting “or pursuant to subparagraph (A) of subsection (b)(5)” after “subsection (b)(3)”; and
(ii)
by striking “subsection (b)(4)” and inserting “subsections (b)(4) and (b)(5)”.
(b)
Annual Report— Section 1002(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended, in the matter preceding clause (i), by striking “2026” and inserting “2030”.
(c)
Sunset— Section 1002(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “September 30, 2025” and inserting “September 30, 2030”.

Sec. 712 Study on high-risk, high-reward drugs

(a)
In general— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall conduct a study to identify—
(1)
diseases or conditions that lack a treatment approved by the Food and Drug Administration and instances in which development of a treatment for such diseases or conditions could fill an unmet medical need for the treatment of a serious or life-threatening disease or condition or a rare disease or condition; and
(2)
appropriate incentives that would lead to the development, approval, and marketing of such treatments.
(b)
Report to Congress; recommendations— Not later than one year after the date of enactment of this Act, the Secretary shall submit to the Congress a report that includes—
(1)
findings from the study under subsection (a); and
(2)
recommendations regarding legislation necessary to create appropriate incentives identified pursuant to subsection (a)(2).

C Opioid Epidemic Response

Sec. 721 Opioid Epidemic Response Fund

(a)
In general— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall use any funds made available pursuant to subsection (b) to carry out the programs and activities described in subsection (c) to address the opioid and substance use disorder epidemic. Such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities.
(b)
Opioid Epidemic Response Fund—
(1)
Establishment of account— There is established in the Treasury an account, to be known as the Opioid Epidemic Response Fund (referred to in this section as the “Fund”), for purposes of funding the programs and activities described in subsection (c).
(2)
Funding— There is authorized to be appropriated, and there is appropriated, to the Fund, out of any monies in the Treasury not otherwise appropriated $1,980,000,000 for each of fiscal years 2021 through 2025.
(3)
Availability— Amounts made available by paragraph (2) shall be made available to the agencies specified in subsection (c) in accordance with such subsection. Amounts made available to an agency pursuant to the preceding sentence for a fiscal year shall remain available until expended.
(c)
Programs and activities— Of the total amount in the Fund for each of fiscal years 2021 through 2025, such amount shall be allocated as follows:
(1)
SAMHSA— For the Substance Abuse and Mental Health Services Administration to carry out programs and activities pursuant to section 722, $1,500,000,000 for each of fiscal years 2021 through 2025.
(2)
CDC— For the Centers for Disease Control and Prevention to carry out programs and activities pursuant to section 723, $120,000,000 for each of fiscal years 2021 through 2025.
(3)
FDA— For the Food and Drug Administration to carry out programs and activities pursuant to section 724, $10,000,000 for each of fiscal years 2021 through 2025.
(4)
NIH— For the National Institutes of Health to carry out programs and activities pursuant to section 725, $240,000,000 for each of fiscal years 2021 through 2025.
(5)
HRSA— For the Health Resources and Services Administration to carry out programs and activities pursuant to section 726, $90,000,000 for each of fiscal years 2021 through 2025.
(6)
ACF— For the Administration for Children and Families to carry out programs and activities pursuant to section 727, $20,000,000 for each of fiscal years 2021 through 2025.
(d)
Accountability and oversight—
(1)
Work plan—
(A)
In general— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Appropriations, and the Committee on Education and Labor of the House of Representatives, a work plan including the proposed allocation of funds made available pursuant to subsection (b) for each of fiscal years 2021 through 2025 and the contents described in subparagraph (B).
(B)
Contents— The work plan submitted under subparagraph (A) shall include—
(i)
the amount of money to be obligated or expended out of the Fund in each fiscal year for each program and activity described in subsection (c); and
(ii)
a description and justification of each such program and activity.
(2)
Annual reports— Not later than October 1 of each of fiscal years 2022 through 2026, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Appropriations, and the Committee on Education and Labor of the House of Representatives, a report including—
(A)
the amount of money obligated or expended out of the Fund in the prior fiscal year for each program and activity described in subsection (c);
(B)
a description of all programs and activities using funds made available pursuant to subsection (b); and
(C)
how the programs and activities are responding to the opioid and substance use disorder epidemic.
(e)
Limitations— Notwithstanding any authority in this subtitle or any appropriations Act, any funds made available pursuant to subsection (b) may not be used for any purpose other than the programs and activities described in subsection (c).

Sec. 722 Substance Abuse and Mental Health Services Administration

(a)
In general— The entirety of the funds made available pursuant to section 721(c)(1) shall be for the Assistant Secretary for Mental Health and Substance Use to continue to award the State Opioid Response Grants funded by the heading “Substance Abuse And Mental Health Services Administration—Substance Abuse Treatment” in title II of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018 (Public Law 115–141). Subject to subsections (b) and (c), such grants shall be awarded in the same manner and subject to the same conditions as were applicable to such grants for fiscal year 2018.
(b)
Requirement that treatment be evidence-based— As a condition on receipt of a grant pursuant to subsection (a), a grantee shall agree that—
(1)
treatments, practices, or interventions funded through the grant will be evidence-based; and
(2)
such treatments, practices, and interventions will include medication-assisted treatment for individuals diagnosed with opioid use disorder, using drugs only if the drugs have been approved or licensed by the Food and Drug Administration 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)
Reservations— Of the amount made available pursuant to section 731(c)(1) for a fiscal year—
(1)
not less than $75,000,000 shall be reserved to make grants under subsection (a) to Indian Tribes or Tribal organizations; and
(2)
not less than $50,000,000 shall be reserved to make grants under subsection (a) to political subdivisions of States, such as counties, cities, or towns.

Sec. 723 Centers for Disease Control and Prevention

(a)
Addressing opioid use disorder— The entirety of the funds made available pursuant to section 721(c)(2) shall be for the Director of the Centers for Disease Control and Prevention, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), to continue and expand programs of the Centers for Disease Control and Prevention to address opioid and substance use disorder, including by—
(1)
improving the timeliness and quality of data on the opioid use disorder epidemic, including improvement of—
(A)
data on fatal and nonfatal overdoses;
(B)
syndromic surveillance;
(C)
data on long-term sequelae (including neonatal abstinence syndrome); and
(D)
cause of death reporting related to substance abuse or opioid overdose;
(2)
expanding and strengthening evidence-based prevention and education strategies;
(3)
supporting responsible prescribing practices, including through development and dissemination of prescriber guidelines;
(4)
improving access to and use of effective prevention, treatment, and recovery support, including through grants and the provision of technical assistance to States and localities;
(5)
strengthening partnerships with first responders, including to protect their safety;
(6)
considering the needs of vulnerable populations;
(7)
addressing infectious diseases linked to the opioid crisis;
(8)
strengthening prescription drug monitoring programs; and
(9)
providing financial and technical assistance to State and local health department efforts to treat and prevent substance use disorder.
(b)
Limitation— Of the funds made available pursuant to section 721(c)(2) for carrying out this section, not more than 20 percent may be used for intramural purposes.

Sec. 724 Food and Drug Administration

The entirety of the funds made available pursuant to section 721(c)(3) shall be for the Commissioner of Food and Drugs, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.) or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other applicable law, to support widespread innovation in non-opioid and non-addictive medical products for pain treatment, access to opioid addiction treatments, appropriate use of approved opioids, and efforts to reduce illicit importation of opioids. Such support may include the following:
(1)
Facilitating the development of non-opioid and non-addictive pain treatments.
(2)
Advancing guidance documents for sponsors of non-opioid pain products.
(3)
Developing evidence to inform the potential for nonprescription overdose therapies.
(4)
Examining expanded labeling indications for medication-assisted treatment.
(5)
Conducting public education and outreach, including public workshops or public meetings, regarding the benefits of medication-assisted treatment, including all drugs approved by the Food and Drug Administration, and device treatment options approved or cleared by the Food and Drug Administration.
(6)
Exploring the expansion and possible mandatory nature of prescriber education regarding pain management and appropriate opioid prescribing through authorities under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1).
(7)
Examining options to limit the duration of opioid prescriptions for acute pain, including through packaging options.
(8)
Increasing staff and infrastructure capacity to inspect and analyze packages at international mail facilities and pursue criminal investigations.

Sec. 725 National Institutes of Health

The entirety of the funds made available pursuant to section 721(c)(4) shall be for the Director of the National Institutes of Health, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), to carry out activities related to—
(1)
accelerating research for addressing the opioid use disorder epidemic, including developing non-opioid medications and interventions, including non-addictive medications, to manage pain, as well as developing medications and interventions to treat and to prevent substance use disorders;
(2)
conducting and supporting research on which treatments (in terms of pain management as well as treating and preventing substance use disorders) are optimal for which patients; and
(3)
conducting and supporting research on creating longer-lasting or faster-acting antidotes for opioid overdose, particularly in response to the prevalence of fentanyl and carfentanyl overdoses.

Sec. 726 Health Resources and Services Administration

The entirety of the funds made available pursuant to section 721(c)(5) shall be for the Administrator of the Health Resources and Services Administration, pursuant to applicable authorities in titles III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et seq.), to carry out activities that increase the availability and capacity of the behavioral health workforce. Such activities shall include providing loan repayment assistance for substance use disorder treatment providers.

Sec. 727 Administration for Children and Families

Of the funds made available pursuant to section 721(c)(6) for each of fiscal years 2021 through 2025, $20,000,000 for each such fiscal year shall be for the Secretary of Health and Human Services to carry out title I of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5101 et seq.).

D Reducing Administrative Costs and Burdens in Health Care

Sec. 731 Reducing administrative costs and burdens in health care

Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:

“E Reducing administrative costs and burdens in health care

“281. Eliminating unnecessary administrative burdens and costs

“(a) Reducing administrative burdens and costs—The Secretary, in consultation with providers of health services, health care suppliers of services, health care payers, health professional societies, health vendors and developers, health care standard development organizations and operating rule entities, health care quality organizations, health care accreditation organizations, public health entities, States, patients, and other appropriate entities, shall, in accordance with subsection (b)—

“(1) establish a goal of reducing unnecessary costs and administrative burdens across the health care system, including the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and the private health insurance market, by at least half over a period of 10 years from the date of enactment of this section;

“(2) develop strategies and benchmarks for meeting the goal established under paragraph (1);

“(3) develop recommendations for meeting the goal established under paragraph (1); and

“(4) take action to reduce unnecessary costs and administrative burdens based on recommendations identified in this subsection.

“(b) Strategies, recommendations, and actions

“(1) In general—To achieve the goal established under subsection (a)(1), the Secretary, in consultation with the entities described in such subsection, shall not later than 1 year after the date of enactment of this section, develop strategies and recommendations and take actions to meet such goal in accordance with this subsection. No strategies, recommendation, or action shall undermine the quality of patient care or patient health outcomes.

“(2) Strategies—The strategies developed under paragraph (1) shall address unnecessary costs and administrative burdens. Such strategies shall include broad public comment and shall prioritize—

“(A) recommendations identified as a result of efforts undertaken to implement section 3001;

“(B) recommendations and best practices identified as a result of efforts undertaken under this part;

“(C) a review of regulations, rules, and requirements of the Department of Health and Human Services that could be modified or eliminated to reduce unnecessary costs and administrative burden imposed on patients, providers, payers, and other stakeholders across the health care system; and

“(D) feedback from stakeholders in rural or frontier areas on how to reduce unnecessary costs and administrative burdens on the health care system in those areas.

“(3) Recommendations—The recommendations developed under paragraph (1) shall include—

“(A) actions that improve the standardization and automation of administrative transactions;

“(B) actions that integrate clinical and administrative functions;

“(C) actions that improve patient care and reduce unnecessary costs and administrative burdens borne by patients, their families, and other caretakers;

“(D) actions that advance the development and adoption of open application programming interfaces and other emerging technologies to increase transparency and interoperability, empower patients, and facilitate better integration of clinical and administrative functions;

“(E) actions to be taken by the Secretary and actions that need to be taken by other entities; and

“(F) other areas, as the Secretary determines appropriate, to reduce unnecessary costs and administrative burdens required of health care providers.

“(4) Consistency—Any improvements in electronic processes proposed by the Secretary under this section should leverage existing information technology definitions under Federal Law. Specifically, any electronic processes should not be construed to include a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form image.

“(5) Actions—The Secretary shall take action to achieve the goal established under subsection (a)(1), and, not later than 1 year after the date of enactment of this section, and biennially thereafter, submit to Congress and make publically available, a report describing the actions taken by the Secretary pursuant to goals, strategies, and recommendations described in this subsection.

“(6) FACA—The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the development of the goal, strategies, recommendations, or actions described in this section.

“(7) Rule of construction—Nothing in this subsection shall be construed to authorize, or be used by, the Federal Government to inhibit or otherwise restrain efforts made to reduce waste, fraud, and abuse across the health care system.

“282. Grants to States to develop and implement recommendations to accelerate State innovation to reduce health care administrative costs

“(a) Grants

“(1) In general—Not later than 6 months after the date of enactment of this section, the Secretary shall award grants to at least 15 States, and one coordinating entity designated as provided for under subsection (e), to enable such States to establish and administer private-public multi-stakeholder commissions for the purpose of reducing health care administrative costs and burden within and across States. Not less than 3 of such grants shall be awarded to States that are primarily rural, frontier, or a combination thereof, in nature.

“(2) Entities—For purposes of this section, the term State means a State, a State designated entity, or a multi-State collaborative (as defined by the Secretary).

“(3) Priority—In awarding grants under this section, the Secretary shall give priority to applications submitted by States that propose to carry out a pilot program or support the adoption of electronic health care transactions and operating rules.

“(b) Application

“(1) In general—To be eligible to receive a grant under subsection (a) a State shall submit to the Secretary an application in such a manner and containing such information as the Secretary may reasonably require, including the information described in paragraph (2).

“(2) Required information—In addition to any additional information required by the Secretary under this subsection, an application shall include a description of—

“(A) the size and composition of the commission to be established under the grant, including the stakeholders represented and the degree to which the commission reflects important geographic and population characteristics of the State;

“(B) the relationship of the commission to the State official responsible for coordinating and implementing the recommendations resulting from the commission, and the role and responsibilities of the State with respect to the commission, including any participation, review, oversight, implementation or other related functions;

“(C) the history and experience of the State in addressing health care administrative costs, and any experience similar to the purpose of the commission to improve health care administrative processes and the exchange of health care administrative data;

“(D) the resources and expertise that will be made available to the commission by commission members or other possible sources, and how Federal funds will be used to leverage and complement these resources;

“(E) the governance structure and procedures that the commission will follow to make, implement, and pilot recommendations;

“(F) the proposed objectives relating to the simplification of administrative transactions and operating rules, increased standardization, and the efficiency and effectiveness of the transmission of health information;

“(G) potential cost savings and other improvements in meeting the objectives described in subparagraph (F); and

“(H) the method or methods by which the recommendations described in subsection (c) will be reviewed, tested, adopted, implemented, and updated as needed.

“(c) Multi-Stakeholder commission

“(1) In general—Not later than 90 days after the date on which a grant is awarded to a State under this section, the State official described in subsection (b)(2)(B), the State insurance commissioner, or other appropriate State official shall convene a multi-stakeholder commission, in accordance with this subsection.

“(2) Membership—The commission convened under paragraph (1) shall include representatives from health plans, health care providers, health vendors, relevant State agencies, health care standard development organizations, and operating rule entities, relevant professional and trade associations, patients, and other entities determined appropriate by the State.

“(3) Recommendations—Not later than one year after the date on which a grant is awarded to a State under this section, the commission shall make recommendations and plans, consistent with the application submitted by the State under subsection (b), and intended to meet the objectives defined in the application. Such recommendations shall comply with, and build upon, all relevant Federal requirements and regulations, and may include—

“(A) common, uniform specifications, best practices, and conventions, for the efficient, effective exchange of administrative transactions adopted pursuant to the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191);

“(B) the development of streamlined business processes for the exchange and use of health care administrative data; and

“(C) specifications, incentives, requirements, tools, mechanisms, and resources to improve—

“(i) the access, exchange, and use of health care administrative information through electronic means;

“(ii) the implementation of utilization management protocols; and

“(iii) compliance with Federal and State laws.

“(d) Use of funds for implementation—A State may use amounts received under a grant under this section for one or more of the following:

“(1) The development, implementation, and best use of shared data infrastructure that supports the electronic transmission of administrative data.

“(2) The development and provision of training and educational materials, forums, and activities as well as technical assistance to effectively implement, use, and benefit from electronic health care transactions and operating rules.

“(3) To accelerate the early adoption and implementation of administrative transactions and operating rules designated by the Secretary and that have been adopted pursuant to the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191), including transactions and operating rules described in section 1173(a)(2) of the Social Security Act.

“(4) To accelerate the early adoption and implementation of additional or updated administrative transactions, operating rules, and related data exchange standards that are being considered for adoption under the Health Insurance Portability and Accountability Act of 1996 or are adopted pursuant to such Act, or as designated by the Secretary, including the electronic claim attachment.

“(5) To conduct pilot projects to test approaches to implement and use the electronic health care transactions and operating rules in practice under a variety of different settings. With respect to the electronic attachment transaction, priority shall be given to pilot projects that test and evaluate methods and mechanisms to most effectively incorporate patient health data from electronic health records and other electronic sources with the electronic attachment transaction.

“(6) To assess barriers to the adoption, implementation, and effective use of electronic health care transactions and operating rules, as well as to explore, identify, and plan options, approaches, and resources to address barriers and make improvements.

“(7) The facilitation of public and private initiatives to reduce administrative costs and accelerate the adoption, implementation, and effective use of electronic health care transactions and operating rules for State programs.

“(8) Developing, testing, implementing, and assessing additional data exchange specifications, operating rules, incentives, requirements, tools, mechanisms, and resources to accelerate the adoption and effective use of the transactions and operating rules.

“(9) Ongoing needs assessments and planning related to the development and implementation of administrative simplification initiatives.

“(e) Coordinating entity

“(1) Functions—Not later than 6 months after the date of enactment of this section, the Secretary shall designate a coordinating entity under this subsection for the purpose of—

“(A) providing technical assistance to States relating to the simplification of administrative transactions and operating rules, increased standardization, and the efficiency and effectiveness of the transmission of health care information;

“(B) evaluating pilot projects and other efforts conducted under this section for impact and best practices to inform broader national use;

“(C) using consistent evaluation methodologies to compare return on investment across efforts conducted under this section;

“(D) compiling, synthesizing, disseminating, and adopting lessons learned to promote the adoption of electronic health care transactions and operating rules across the health care system; and

“(E) making recommendations to the Secretary and the National Committee on Vital and Health Statistics regarding the national adoption of efforts conducted under this section.

“(2) Eligibility—The entity designated under paragraph (1) shall be a qualified nonprofit entity that—

“(A) focuses its mission on administrative simplification;

“(B) has demonstrated experience using a multi-stakeholder and consensus-based process for the development of common, uniform specifications, operating rules, best practices, and conventions, for the efficient, effective exchange of administrative transactions that includes representation by or participation from health plans, health care providers, vendors, States, relevant Federal agencies, and other health care standard development organizations;

“(C) has demonstrated experience providing technical assistance to health plans, health care providers, vendors, and States relating to the simplification of administrative transactions and operating rules, increased standardization, and the efficiency and effectiveness of the transmission of health care information;

“(D) has demonstrated experience evaluating and measuring the adoption and return on investment of administrative transactions and operating rules;

“(E) has demonstrated experience gathering, synthesizing, and adopting common, uniform specifications, operating rules, best practices, and conventions for national use based on lessons learned to promote the adoption of electronic health care transactions and operating rules across the health care system;

“(F) has a public set of guiding principles that ensure processes are open and transparent, and supports nondiscrimination and conflict of interest policies that demonstrate a commitment to open, fair, and nondiscriminatory practices;

“(G) builds on the transaction standards issued under Health Insurance Portability and Accountability Act of 1996; and

“(H) allows for public review and updates of common, uniform specifications, operating rules, best practices, and conventions to support administrative simplification.

“(f) Period and amount—A grant awarded to a State under this section shall be for a period of 5 years and shall not exceed $50,000,000 for such 5-year period. A grant awarded to the coordinating entity designated by the Secretary under subsection (e) shall be for a period of 5 years and shall not exceed $15,000,000 for such 5-year period.

“(g) Reports

“(1) States—Not later than 1 year after receiving a grant under this section, and biennially thereafter, a State shall submit to the Secretary a report on the outcomes experienced by the State under the grant.

“(2) Coordinating entity—Not later than 1 year after receiving a grant under this section, and at least biennially thereafter, the coordinating entity shall submit to the Secretary and the National Committee on Vital and Health Statistics a report of evaluations conducted under the grant under this section and recommendations regarding the national adoption of efforts conducted under this section.

“(3) Secretary—Not later than 6 months after the date on which the States and coordinating entity submit the report required under paragraphs (1) and (2), the Secretary, in consultation with National Committee on Vital and Health Statistics, 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 outcomes achieved under the grants under this section.

“(4) GAO—Not later than 6 months after the date on which the Secretary submits the final report under paragraph (3), the Comptroller General of the United States shall conduct a study, 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, a report on the outcomes of the activities carried out under this section which shall contain a list of best practices and recommendations to States concerning administrative simplification.

“(h) Authorization of appropriations—There is authorized to be appropriated to carry out this section, $250,000,000 for the 5-fiscal-year period beginning with fiscal year 2020.”