Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3; 117th Congress)/Title V/Subtitle C

by Frank Pallone

SEC. 521. OVERDOSE 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 overdose 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 $2,000,000,000 for each of fiscal years 2022 through 2026.

(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 2022 through 2026, 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 522, $1,500,000,000 for each of fiscal years 2022 through 2026.

(2) CDC.—For the Centers for Disease Control and Prevention to carry out programs and activities pursuant to section 523, $120,000,000 for each of fiscal years 2022 through 2026.

(3) FDA.—For the Food and Drug Administration to carry out programs and activities pursuant to section 524, $10,000,000 for each of fiscal years 2022 through 2026.

(4) NIH.—For the National Institutes of Health to carry out programs and activities pursuant to section 525, $240,000,000 for each of fiscal years 2022 through 2026.

(5) HRSA.—For the Health Resources and Services Administration to carry out programs and activities pursuant to section 526, $90,000,000 for each of fiscal years 2022 through 2026.

(6) ACF.—For the Administration for Children and Families to carry out programs and activities pursuant to section 527, $40,000,000 for each of fiscal years 2022 through 2026.

(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 2022 through 2026 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 2023 through 2027, 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. 522. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.

(a) In General.—The entirety of the funds made available pursuant to section 521(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 521(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. 523. CENTERS FOR DISEASE CONTROL AND PREVENTION.

(a) Addressing Opioid Use Disorder.—The entirety of the funds made available pursuant to section 521(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 521(c)(2) for carrying out this section, not more than 20 percent may be used for intramural purposes.

SEC. 524. FOOD AND DRUG ADMINISTRATION.

The entirety of the funds made available pursuant to section 521(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. 525. NATIONAL INSTITUTES OF HEALTH.

The entirety of the funds made available pursuant to section 521(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. 526. HEALTH RESOURCES AND SERVICES ADMINISTRATION.

The entirety of the funds made available pursuant to section 521(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. 527. ADMINISTRATION FOR CHILDREN AND FAMILIES.

Of the funds made available pursuant to section 521(c)(6) for each of fiscal years 2022 through 2026, $40,000,000 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.).