42 U.S.C. § 290ee — Opioid overdose reversal medication ac-

Page 934 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 290ee 1 So in original. Probably should be capitalized. or a hospital that receives disproportionate share hospital payments under section 1395ww(d)(5)(F) of this title. (B) The eligible entity is located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Direc- tor of the Centers for Disease Control and Prevention, or under the jurisdiction of an Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the na- tional overdose mortality rate, as deter- mined through appropriate mechanisms as determined by the Secretary in consultation with Indian Tribes. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community set- tings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Indian Tribe; tribal organization The terms ‘‘Indian Tribe’’ and ‘‘tribal orga- nization’’ have the meanings given the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ in section 5304 of title 25. (2) Recovery coach the 1 term ‘‘recovery coach’’ means an indi- vidual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (3) Recovery community organization The term ‘‘recovery community organiza- tion’’ has the meaning given such term in sec- tion 290ee–2(a) of this title. (d) Reporting Requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the enti- ty has received such grant that includes infor- mation on— (A) the number of individuals treated by the entity for non-fatal overdoses, including the number of non-fatal overdoses where overdose reversal medication was adminis- tered; (B) the number of individuals administered medication-assisted treatment by the enti- ty; (C) the number of individuals referred by the entity to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individ- uals admitted to such other facilities pursu- ant to such referrals; and (D) the frequency and number of patients with reoccurrences, including readmissions for non-fatal overdoses and evidence of re- lapse related to substance use disorder. (2) Report by Secretary Not later than 5 years after October 24, 2018, the Secretary shall submit to Congress a re- port that includes an evaluation of the effec- tiveness of the grant program carried out under this section with respect to long term health outcomes of the population of individ- uals who have experienced a drug overdose, the percentage of patients treated or referred to treatment by grantees, and the frequency and number of patients who experienced re- lapse, were readmitted for treatment, or expe- rienced another overdose. (e) Privacy The requirements of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Fed- eral and State privacy laws. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $10,000,000 for each of fis- cal years 2019 through 2023. (Pub. L. 115–271, title VII, § 7081, Oct. 24, 2018, 132 Stat. 4032.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(4)(B), (5)(A), 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. CODIFICATION Section was enacted as part of the Substance Use–Disorder Prevention that Promotes Opioid Recov- ery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Commu- nities Act, and not as part of the Public Health Service Act which comprises this chapter. § 290ee. Opioid overdose reversal medication ac- cess, education, and co-prescribing grant programs (a) Grants The Secretary shall make grants to States, lo- calities, Indian Tribes, and Tribal organizations (as those terms are defined in section 5304 of title 25) to— (1) implement strategies that increase access to drugs or devices approved, cleared, or other- wise legally marketed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or sus- pected opioid overdose, as appropriate, pursu- ant to a standing order; (2) encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) encourage health care providers to co- prescribe, as appropriate, drugs or devices ap- proved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Page 935 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 290ee Act for emergency treatment of known or sus- pected opioid overdose; (4) develop or provide training materials that persons authorized to prescribe or dis- pense 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 over- dose may use to educate the public con- cerning— (A) when and how to safely administer such drug or device; and (B) steps to be taken after administering such drug or device; and (5) educate the public concerning the avail- ability of drugs or devices approved, cleared, or otherwise legally marketed under the Fed- eral Food, Drug, and Cosmetic Act for emer- gency treatment of known or suspected opioid overdose without a person-specific prescrip- tion. (b) Certain requirement A grant may be made under this section only if the State involved has authorized standing or- ders to be issued for drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emer- gency treatment of known or suspected opioid overdose. (c) Preference in making grants In making grants under this section, the Sec- retary may give preference to States that have a significantly higher rate of opioid overdoses than the national average, and that— (1) have not implemented standing orders re- garding 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 over- dose; (2) authorize standing orders to be issued that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved, cleared, or other- wise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treat- ment of known or suspected opioid overdose; or (3) authorize standing orders to be issued that permit police, fire, or emergency medical services agencies to acquire and administer drugs or devices approved, cleared, or other- wise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treat- ment of known or suspected opioid overdose. (d) Grant terms (1) Number A State may not receive more than one grant under this section at a time. (2) Period A grant under this section shall be for a pe- riod of 5 years. (3) Limitations A State may— (A) use not more than 10 percent of a grant under this section for educating the public pursuant to subsection (a)(5); and (B) use not less than 20 percent of a grant under this section to offset cost-sharing for distribution and dispensing of drugs or de- vices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. (e) Applications To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and con- taining such information as the Secretary may reasonably require, including detailed proposed expenditures of grant funds. (f) Reporting A State that receives a grant under this sec- tion shall, at least annually for the duration of the grant, submit a report to the Secretary eval- uating the progress of the activities supported through the grant. Such reports shall include in- formation on the number of pharmacies in the State that dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emer- gency treatment of known or suspected opioid overdose under a standing order, and other in- formation as the Secretary determines appro- priate to evaluate the use of grant funds. (g) Definitions In this section the term ‘‘standing order’’ means a document prepared by a person author- ized to prescribe medication that permits an- other person to acquire, dispense, or administer medication without a person-specific prescrip- tion. (h) Authorization of appropriations (1) In general To carry out this section, there are author- ized to be appropriated $5,000,000 for the period of fiscal years 2023 through 2027. (2) Administrative costs Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. (July 1, 1944, ch. 373, title V, § 545, as added Pub. L. 114–198, title I, § 110(a), July 22, 2016, 130 Stat. 709; amended Pub. L. 117–328, div. FF, title I, § 1220, Dec. 29, 2022, 136 Stat. 5672.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in text, 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 290ee, act July 1, 1944, ch. 373, title V, § 545, formerly Pub. L. 92–255, title V, § 502, as added Pub. L. 94–237, § 12(b)(1), Mar. 19, 1976, 90 Stat. 247, and amended Pub. L. 95–461, § 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96–181, § 11, Jan. 2, 1980, 93 Stat. 1315; renum- bered § 524 of act July 1, 1944, and amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(15), 97 Stat. 181; renumbered § 545, Page 936 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 290ee–1 July 22, 1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat. 516; Nov. 4, 1988, Pub. L. 100–607, title VIII, § 813(3), 102 Stat. 3170; Nov. 7, 1988, Pub. L. 100–628, title VI, § 613(3), 102 Stat. 3243; Aug. 16, 1989, Pub. L. 101–93, § 5(t)(1), 103 Stat. 615, which related to technical assistance to State and local agencies by the National Institute on Drug Abuse, was omitted in the general revision of this part by Pub. L. 102–321. AMENDMENTS 2022—Pub. L. 117–328, § 1220(e), substituted ‘‘approved, cleared, or otherwise legally marketed’’ for ‘‘approved or cleared’’ wherever appearing. Pub. L. 117–328, § 1220(a)(1), substituted ‘‘access, edu- cation, and co-prescribing grant programs’’ for ‘‘access and education grant programs’’ in section catchline. Subsec. (a). Pub. L. 117–328, § 1220(a)(2), (3), sub- stituted ‘‘Grants’’ for ‘‘Grants to States’’ in heading and ‘‘shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are de- fined in section 5304 of title 25)’’ for ‘‘shall make grants to States’’ in introductory provisions. Subsec. (a)(1). Pub. L. 117–328, § 1220(a)(4), substituted ‘‘implement strategies that increase access to drugs or devices’’ for ‘‘implement strategies for pharmacists to dispense a drug or device’’. Subsec. (a)(3) to (5). Pub. L. 117–328, § 1220(a)(5), (6), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. Subsec. (d)(2). Pub. L. 117–328, § 1220(b), substituted ‘‘5 years’’ for ‘‘3 years’’. Subsec. (d)(3). Pub. L. 117–328, § 1220(c), amended par. (3) generally. Prior to amendment, text read as follows: ‘‘A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(4).’’ Subsec. (h)(1). Pub. L. 117–328, § 1220(d), substituted ‘‘fiscal years 2023 through 2027’’ for ‘‘fiscal years 2017 through 2019’’. § 290ee–1. First responder training (a) Program authorized The Secretary shall make grants to States, local governmental entities, and Indian tribes and tribal organizations (as defined in section 5304 of title 25) to allow first responders and members of other key community sectors to ad- minister 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. (b) Application (1) In general An entity seeking a grant under this section shall submit an application to the Secretary— (A) that meets the criteria under para- graph (2); and (B) at such time, in such manner, and ac- companied by such information as the Sec- retary may require. (2) Criteria An entity, in submitting an application under paragraph (1), shall— (A) describe the evidence-based method- ology and outcome measurements that will be used to evaluate the program funded with a grant under this section, and specifically explain how such measurements will provide valid measures of the impact of the program; (B) describe how the program could be broadly replicated if demonstrated to be ef- fective; (C) identify the governmental and commu- nity agencies with which the entity will co- ordinate to implement the program; and (D) describe how the entity will ensure that law enforcement agencies will coordi- nate with their corresponding State sub- stance abuse and mental health agencies to identify protocols and resources that are available to overdose victims and families, including information on treatment and re- covery resources. (c) Use of funds An entity shall use a grant received under this section to— (1) make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose available to be carried and administered by first re- sponders and members of other key commu- nity sectors; (2) train and provide resources for first re- sponders and members of other key commu- nity sectors on carrying and administering a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; (3) establish processes, protocols, and mech- anisms for referral to appropriate treatment, which may include an outreach coordinator or team to connect individuals receiving opioid overdose reversal drugs to followup services; and (4) train and provide resources for first re- sponders and members of other key commu- nity sectors on safety around fentanyl, carfentanil, and other dangerous licit and il- licit drugs to protect themselves from expo- sure to such drugs and respond appropriately when exposure occurs. (d) Technical assistance grants The Secretary shall make a grant for the pur- pose of providing technical assistance and train- ing on the use of a drug or device approved or cleared under the Federal Food, Drug, and Cos- metic Act for emergency treatment of known or suspected opioid overdose, mechanisms for refer- ral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs. (e) Geographic distribution In making grants under this section, the Sec- retary shall ensure that not less than 20 percent of grant funds are awarded to eligible entities that are not located in metropolitan statistical areas (as defined by the Office of Management and Budget). The Secretary shall take into ac- count the unique needs of rural communities, including communities with an incidence of in- dividuals with opioid use disorder that is above the national average and communities with a shortage of prevention and treatment services. (f) Evaluation The Secretary shall conduct an evaluation of grants made under this section to determine— (1) the number of first responders and mem- bers of other key community sectors equipped with a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treat- ment of known or suspected opioid overdose;