PRIA, Government Policy, Made Personal

Summary

The Secretary of Health and Human Services must give grants to states, territories, local governments, and Indian tribes to help more people get drugs or devices that are legally approved for emergency treatment of opioid overdose. Grant recipients can make subgrants to community health centers, opioid treatment programs, certain clinicians who dispense drugs for maintenance or detox, and eligible nonprofits (including Urban Indian organizations). “Prescribing” here means giving or co-prescribing the overdose treatment in certain high‑risk situations, such as with opioid prescriptions, during opioid‑use disorder treatment, to a caregiver or close relative, or whenever a provider sees a patient at high risk of overdose. To get a grant, an entity must explain how bad the overdose problem is in the area, how it will pick patients for the program, and how it will keep the program going after federal money ends. Grant funds may be used to set up prescribing programs, train providers and pharmacists, buy overdose treatments for distribution, pay patient copays, and connect overdose survivors to further care. No more than 20 percent of funds may be used for buying products and covering copays. Grantees must send yearly evaluations. The Secretary may share best practices and consult with the Department of Defense and Veterans Affairs, but that guidance does not create a medical standard. The Secretary must report results to Congress within 5 years after the first grant. Up to $5,000,000 is authorized for fiscal years 2023 through 2027.

Title 42, §290dd–3

The Public Health and Welfare, Source: USLM XML via OLRC

(a)(1)The Secretary shall award grants to eligible entities to expand access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or suspected opioid overdose.

(2)For purposes of this section, the term “eligible entity” means a State, Territory, locality, or Indian Tribe or Tribal organization (as those terms are defined in section 5304 of title 25).

(3)For the purposes for which a grant is awarded under this section, the eligible entity receiving the grant may award subgrants to a Federally qualified health center (as defined in section 1395x(aa) of this title), an opioid treatment program (as defined in section 8.2 of title 42, Code of Federal Regulations (or any successor regulations)), any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment, or any nonprofit organization that the Secretary deems appropriate, which may include Urban Indian organizations (as defined in section 1603 of title 25).

(4)For purposes of this section, the term “prescribing” means, with respect to a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, the practice of prescribing such drug or device—

(A)in conjunction with an opioid prescription for patients at an elevated risk of overdose, including patients prescribed both an opioid and a benzodiazepine;

(B)in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] for the treatment of opioid use disorder;

(C)to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or

(D)in other circumstances in which a provider identifies a patient is at an elevated risk for an intentional or unintentional overdose from heroin or prescription opioid therapies.

(b)To be eligible to receive a grant under this section, an eligible entity shall submit to the Secretary, in such form and manner as specified by the Secretary, an application that describes—

(1)the extent to which the area to which the entity will furnish services through use of the grant is experiencing significant morbidity and mortality caused by opioid abuse;

(2)the criteria that will be used to identify eligible patients to participate in such program; and

(3)a plan for sustaining the program after Federal support for the program has ended.

(c)An eligible entity receiving a grant under this section may use amounts under the grant for any of the following activities, but may use not more than 20 percent of the grant funds for activities described in paragraphs (3) and (4):

(1)To establish a program for prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or suspected opioid overdose.

(2)To train and provide resources for health care providers and pharmacists on the prescribing of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

(3)To purchase drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, for distribution under the program described in paragraph (1).

(4)To offset the co-payments and other cost sharing associated with drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

(5)To establish protocols to connect patients who have experienced an overdose with appropriate treatment, including overdose reversal medications, medication assisted treatment, and appropriate counseling and behavioral therapies.

(d)(1)(A)The Secretary of Health and Human Services may provide information to States, localities, Indian Tribes, Tribal organizations, and Urban Indian organizations on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

(B)The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Defense regarding the provision of information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

(C)The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Veterans Affairs regarding the provision of information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.

(2)Nothing in this subsection shall be construed as establishing or contributing to a medical standard of care.

(e)As a condition of receipt of a grant under this section, an eligible entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities funded by the grant which contains such information as the Secretary may reasonably require.

(f)Not later than 5 years after the date on which the first grant under this section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of the Senate a report aggregating the information received from the grant recipients for such year under subsection (e) and evaluating the outcomes achieved by the programs funded by grants awarded under this section.

(g)There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2023 through 2027.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (c)(1) to (4), and (d)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Prior Provisions

A prior section 290dd–3, act

July 1, 1944, ch. 373, title V, § 544, formerly Pub. L. 91–616, title III, § 333, Dec. 31, 1970, 84 Stat. 1853, as amended Pub. L. 93–282, title I, § 122(a),

May 14, 1974, 88 Stat. 131; Pub. L. 94–581, title I, § 111(c)(4), Oct. 21, 1976, 90 Stat. 2852; renumbered § 523 of act

July 1, 1944, Apr. 26, 1983, Pub. L. 98–24, § 2(b)(13), 97 Stat. 181; Aug. 27, 1986, Pub. L. 99–401, title I, § 106(a), 100 Stat. 907; renumbered § 544,

July 22, 1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat. 516;

June 13, 1991, Pub. L. 102–54, § 13(q)(1)(A)(ii), 105 Stat. 278, which related to confidentiality of patient records for alcohol abuse and alcoholism programs, was omitted in the general revision of this part by Pub. L. 102–321. See section 290dd–2 of this title.

Amendments

2022—Pub. L. 117–328, § 1219(a)(7)(A), substituted “approved, cleared, or otherwise legally marketed” for “approved or cleared” wherever appearing. Subsec. (a)(2). Pub. L. 117–328, § 1219(a)(1), (2), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: “A grant awarded under this section may not be for more than $200,000 per grant year.” Subsec. (a)(3). Pub. L. 117–328, § 1262(b)(4), substituted “any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment” for “any practitioner dispensing narcotic drugs pursuant to section 823(g) of title 21”. Pub. L. 117–328, § 1219(a)(2), added par. (3) and struck out former par. (3). Prior to amendment, text read as follows: “For purposes of this section, the term ‘eligible entity’ means a Federally qualified health center (as defined in section 1395x(aa) of this title), an opioid treatment program under part 8 of title 42, Code of Federal

Regulations

, any practitioner dispensing narcotic drugs pursuant to section 823(h) of title 21, or any other entity that the Secretary deems appropriate.” Pub. L. 117–215 substituted “823(h)” for “823(g)”. Subsec. (a)(4)(A). Pub. L. 117–328, § 1219(a)(3)(A), inserted “, including patients prescribed both an opioid and a benzodiazepine” after “overdose”. Subsec. (a)(4)(D). Pub. L. 117–328, § 1219(a)(3)(B), substituted “overdose” for “drug overdose”. Subsec. (c)(5). Pub. L. 117–328, § 1219(a)(4), amended par. (5) generally. Prior to amendment, par. (5) read as follows: “To establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medication-assisted treatment and appropriate counseling and behavioral therapies.” Subsecs. (d), (e). Pub. L. 117–328, § 1219(a)(5)(A), (C), added subsec. (d) and redesignated former subsec. (d) as (e). Former subsec. (e) redesignated (f). Subsec. (f). Pub. L. 117–328, § 1219(a)(5)(A), (B), redesignated subsec. (e) as (f) and substituted “subsection (e)” for “subsection (d)”. Former subsec. (f) redesignated (g). Subsec. (g). Pub. L. 117–328, § 1219(a)(5)(A), (6), redesignated subsec. (f) as (g) and substituted “fiscal years 2023 through 2027” for “fiscal years 2017 through 2021”.

Statutory Notes and Related Subsidiaries

Funding for Community-Based Funding for Local Substance Use Disorder Services Pub. L. 117–2, title II, § 2706, Mar. 11, 2021, 135 Stat. 47, provided that: “(a) In General.—In addition to amounts otherwise available, there is appropriated to the Secretary [of Health and Human Services] for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $30,000,000, to remain available until expended, to carry out the purpose described in subsection (b). “(b) Use of Funds.—“(1) In general.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use and in consultation with the Director of the Centers for Disease Control and Prevention, shall award grants to support States; local, Tribal, and territorial governments; Tribal organizations; nonprofit community-based organizations; and primary and behavioral health organizations to support community-based overdose prevention programs, syringe services programs, and other harm reduction services. “(2) Use of grant funds.—Grant funds awarded under this section to eligible entities shall be used for preventing and controlling the spread of infectious diseases and the consequences of such diseases for individuals with substance use disorder, distributing opioid overdose reversal medication to individuals at risk of overdose, connecting individuals at risk for, or with, a substance use disorder to overdose education, counseling, and health education, and encouraging such individuals to take steps to reduce the negative personal and public health impacts of substance use or misuse.” Improving Access to Overdose Treatment Pub. L. 114–198, title I, § 107(b), July 22, 2016, 130 Stat. 705, authorized Secretary of Health and Human Services to provide information to prescribers within certain Federal health facilities on best practices for prescribing or co-prescribing drugs or devices for emergency treatment of opioid overdose, prior to repeal by Pub. L. 117–328, div. FF, title I, § 1219(a)(7)(B), Dec. 29, 2022, 136 Stat. 5672. See subsec. (d) of this section.

§290dd–3 Grants for Reducing Overdose Deaths