The Secretary shall award grants to eligible entities to expand access to drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or suspected opioid overdose.
A grant awarded under this section may not be for more than $200,000 per grant year.
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(g) of title 21, or any other entity that the Secretary deems appropriate.
For purposes of this section, the term "prescribing" means, with respect to a drug or device approved or cleared 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;
(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 drug overdose from heroin or prescription opioid therapies.
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.
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 or cleared 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 or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.
(3) To purchase drugs or devices approved or cleared 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 or cleared 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 a drug overdose with appropriate treatment, including medication-assisted treatment and appropriate counseling and behavioral therapies.
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.
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 (d) and evaluating the outcomes achieved by the programs funded by grants awarded under this section.
There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2017 through 2021.
(July 1, 1944, ch. 373, title V, §544, as added Pub. L. 114–198, title I, §107(a), July 22, 2016, 130 Stat. 703.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1) and (c)(1) to (4), 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.
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.
Pub. L. 114–198, title I, §107(b), July 22, 2016, 130 Stat. 705, provided that:
"(1)
"(A) The Secretary of Health and Human Services may provide information to prescribers within Federally qualified health centers (as defined in paragraph (4) of section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa))), and the health care facilities of the Indian Health Service, on best practices for prescribing or co-prescribing a drug or device approved or cleared 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 Defense may provide information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a drug or device approved or cleared 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.
"(C) The Secretary of Veterans Affairs may provide information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing a drug or device approved or cleared 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.
"(2)