§290dd–3. Grants for reducing overdose deaths
(a) Establishment
(1) In general
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) Eligible entity
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) Subgrants
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) Prescribing
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) Application
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) Use of funds
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) Improving access to overdose treatment
(1) Information on best practices
(A) Health and Human Services
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) Defense
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) Veterans Affairs
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) Rule of construction
Nothing in this subsection shall be construed as establishing or contributing to a medical standard of care.
(e) Evaluations by recipients
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) Reports by the Secretary
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) Authorization of appropriations
There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2023 through 2027.
(July 1, 1944, ch. 373, title V, §544, as added
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,
Prior Provisions
A prior section 290dd–3, act July 1, 1944, ch. 373, title V, §544, formerly
Amendments
2022-
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4)(A).
Subsec. (a)(4)(D).
Subsec. (c)(5).
Subsecs. (d), (e).
Subsec. (f).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Funding for Community-Based Funding for Local Substance Use Disorder Services
"(a)
"(b)
"(1)
"(2)
Improving Access to Overdose Treatment