42 U.S.C. § 290ee–3 (THE PUBLIC HEALTH AND WELFARE)
§ 290ee–3. State demonstration grants for comprehensive opioid abuse response
(a) Definitions
In this section:
(1) Dispenser
The term “dispenser” has the meaning given the term in section 802 of title 21.
(2) Prescriber
The term “prescriber” means a dispenser who prescribes a controlled substance, or the agent of such a dispenser.
(3) Prescriber of a schedule II, III, or IV controlled substance
The term “prescriber of a schedule II, III, or IV controlled substance” does not include a prescriber of a schedule II, III, or IV controlled substance that dispenses the substance—
(A) for use on the premises on which the substance is dispensed;
(B) in a hospital emergency room, when the substance is in short supply;
(C) for a certified opioid treatment program; or
(D) in other situations as the Secretary may reasonably determine.
(4) Schedule II, III, or IV controlled substance
The term “schedule II, III, or IV controlled substance” means a controlled substance that is listed on schedule II, schedule III, or schedule IV of section 812(c) of title 21.
(b) Grants for comprehensive opioid abuse response
(1) In general
The Secretary shall award grants to States, and combinations of States, to implement an integrated opioid abuse response initiative.
(2) Purposes
A State receiving a grant under this section shall establish a comprehensive response plan to opioid abuse, which may include—
(A) education efforts around opioid use, treatment, and addiction recovery, including education of residents, medical students, and physicians and other prescribers of schedule II, III, or IV controlled substances on relevant prescribing guidelines, the prescription drug monitoring program of the State described in subparagraph (B), and overdose prevention methods;
(B) establishing, maintaining, or improving a comprehensive prescription drug monitoring program to track dispensing of schedule II, III, or IV controlled substances, which may—
(i) provide for data sharing with other States; and
(ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled substances to access the prescription drug monitoring program of the State;
(C) developing, implementing, or expanding prescription drug and opioid addiction treatment programs by—
(i) expanding the availability of treatment for prescription drug and opioid addiction, including medication-assisted treatment and behavioral health therapy, as appropriate;
(ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically appropriate; or
(iii) developing, implementing, or expanding recovery support services and programs at high schools or institutions of higher education;
(D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to prescription medications and opioids; and
(E) advancing the education and awareness of the public, providers, patients, consumers, and other appropriate entities regarding the dangers of opioid abuse, safe disposal of prescription medications, and detection of early warning signs of opioid use disorders.
(3) Application
A State seeking a grant under this section shall submit to the Secretary an application in such form, and containing such information, as the Secretary may reasonably require.
(4) Use of funds
A State that receives a grant under this section shall use the grant for the cost, including the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established under paragraph (2).
(5) Priority considerations
In awarding grants under this section, the Secretary shall, as appropriate, give priority to a State that—
(A)
(i) provides civil liability protection for first responders, health professionals, and family members who have received appropriate training in administering 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; and
(ii) submits to the Secretary a certification by the attorney general of the State that the attorney general has—
(I) reviewed any applicable civil liability protection law to determine the applicability of the law with respect to first responders, health care professionals, family members, and other individuals who—
(aa) have received appropriate training in 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; and
(bb) may administer a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
(II) concluded that the law described in subclause (I) provides adequate civil liability protection applicable to such persons;
(B) has a process for enrollment in services and benefits necessary by criminal justice agencies to initiate or continue treatment in the community, under which an individual who is incarcerated may, while incarcerated, enroll in services and benefits that are necessary for the individual to continue treatment upon release from incarceration;
(C) ensures the capability of data sharing with other States, where applicable, such as by making data available to a prescription monitoring hub;
(D) ensures that data recorded in the prescription drug monitoring program database of the State are regularly updated, to the extent possible;
(E) ensures that the prescription drug monitoring program of the State notifies prescribers and dispensers of schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients is suspected; and
(F) has in effect one or more statutes or implements policies that maximize use of prescription drug monitoring programs by individuals authorized by the State to prescribe schedule II, III, or IV controlled substances.
(6) Evaluation
In conducting an evaluation of the program under this section pursuant to section 701 of the Comprehensive Addiction and Recovery Act of 2016, with respect to a State, the Secretary shall report on State legislation or policies related to maximizing the use of prescription drug monitoring programs and the incidence of opioid use disorders and overdose deaths in such State.
(7) States with local prescription drug monitoring programs
(A) In general
In the case of a State that does not have a prescription drug monitoring program, a county or other unit of local government within the State that has a prescription drug monitoring program shall be treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1).
(B) Plan for interoperability
In submitting an application to the Secretary under paragraph (3), a county or other unit of local government shall submit a plan outlining the methods such county or unit of local government shall use to ensure the capability of data sharing with other counties and units of local government within the state 1 and with other States, as applicable.
(c) Authorization of funding
For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2017 through 2021.
(July 1, 1944, ch. 373, title V, § 548, as added Pub. L. 114–198, title VI, § 601, July 22, 2016, 130 Stat. 732.)
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(5)(A)(i), (ii)(I), 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.
Section 701 of the Comprehensive Addiction and Recovery Act of 2016, referred to in subsec. (b)(6), is section 701 of Pub. L. 114–198, which enacted sections 290aa–15 and 290aa–16 of this title, sections 10706 and 10707 of Title 34, Crime Control and Law Enforcement, and provisions set out as a note under section 290aa–15 of this title.
heading: Prior Provisions
text: A prior section 290ee–3, act July 1, 1944, ch. 373, title V, § 548, formerly Pub. L. 92–255, title IV, § 408, Mar. 21, 1972, 86 Stat. 79, as amended Pub. L. 93–282, title III, § 303(a), (b), May 14, 1974, 88 Stat. 137, 138; Pub. L. 94–237, § 4(c)(5)(A), Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I, § 111(c)(3), Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97–35, title IX, § 973(d), Aug. 13, 1981, 95 Stat. 598; renumbered § 527 of act July 1, 1944, and amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(16)(B), 97 Stat. 182; Aug. 27, 1986, Pub. L. 99–401, title I, § 106(b), 100 Stat. 907; renumbered § 548, 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)(iii), (B)(ii), 105 Stat. 278, which related to confidentiality of patient records for drug abuse programs, was omitted in the general revision of this part by Pub. L. 102–321. See section 290dd–2 of this title.
heading: Grant Program for the State and Tribal Response to the Opioid Abuse Crisis
text: Pub. L. 114–255, div. A, title I, § 1003, Dec. 13, 2016, 130 Stat. 1044, as amended by Pub. L. 115–271, title VII, § 7181(a), Oct. 24, 2018, 132 Stat. 4068, provided that:
“(a) In General.—
The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall use any funds appropriated pursuant to subsection (h) to carry out the grant program described in subsection (b) for purposes of addressing the opioid abuse crisis within the States and Indian Tribes.
“(b) Opioid Grant Program.—
“(1) State and tribal response to the opioid abuse crisis.—
Subject to the availability of appropriations, the Secretary shall award grants to States and Indian Tribes for the purpose of addressing the opioid abuse crisis within such States and Indian Tribes, in accordance with subparagraph (B) [sic, probably should be “paragraph (2)”]. In awarding such grants, the Secretary shall give preference to States or Indian Tribes with an incidence or prevalence of opioid use disorders that is substantially higher relative to other States or other Indian Tribes, as applicable.
“(2) Opioid grants.—
Grants awarded under this subsection shall be used for carrying out activities that supplement activities pertaining to opioids undertaken by the State agency responsible for administering the substance abuse prevention and treatment block grant under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.), which may include public health-related activities such as the following:
“(A) Establishing or improving prescription drug monitoring programs.
“(B) Implementing prevention activities, and evaluating such activities to identify effective strategies to prevent opioid abuse.
“(C) Training for health care practitioners, such as best practices for prescribing opioids, pain management, recognizing potential cases of substance abuse, referral of patients to treatment programs, preventing diversion of controlled substances, and overdose prevention.
“(D) Supporting access to health care services, including those services provided by Federally certified opioid treatment programs or other appropriate health care providers to treat substance use disorders.
“(E) Other public health-related activities, as the State or Indian Tribe determines appropriate, related to addressing the opioid abuse crisis within the State or Indian Tribe, including directing resources in accordance with local needs related to substance use disorders.
“(c) Accountability and Oversight.—
A State receiving a grant under subsection (b) shall include in a report related to substance abuse submitted to the Secretary pursuant to section 1942 of the Public Health Service Act (42 U.S.C. 300x–52), a description of—
“(1) the purposes for which the grant funds received by the State under such subsection for the preceding fiscal year were expended and a description of the activities of the State under the program; and
“(2) the ultimate recipients of amounts provided to the State in the grant.
“(d) Limitations.—
Any funds made available pursuant to subsection (h)—
“(1) notwithstanding any transfer authority in any appropriations Act, shall not be used for any purpose other than the grant program in subsection (b); and
“(2) shall be subject to the same requirements as substance abuse prevention and treatment programs under titles V and XIX of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w et seq.).
“(e) Indian Tribes.—
“(1) Definition.—
For purposes of this section, the term ‘Indian Tribe’ has the meaning given the term ‘Indian tribe’ in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).
“(2) Appropriate mechanisms.—
The Secretary, in consultation with Indian Tribes, shall identify and establish appropriate mechanisms for Tribes to demonstrate or report the information as required under subsections (b), (c), and (d).
“(f) Report to Congress.—
Not later than 1 year after the date on which amounts are first awarded after the date of enactment of this subsection [Oct. 24, 2018], pursuant to subsection (b), and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the information provided to the Secretary in reports made pursuant to subsection (c), including the purposes for which grant funds are awarded under this section and the activities of such grant recipients.
“(g) Technical Assistance.—
The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide State agencies and Indian Tribes, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing the opioid crisis.
“(h) Authorization of Appropriations.—
For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $500,000,000 for each of fiscal years 2019 through 2021, to remain available until expended.
“(i) Set Aside.—
Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, 5 percent of such amount for such fiscal year shall be made available to Indian Tribes, and up to 15 percent of such amount for such fiscal year may be set aside for States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention.
“(j) Sunset.—
This section shall expire on September 30, 2026.”