42 U.S.C. § 290ee–3: State demonstration…

Summary

The Secretary must give grants to States, or groups of States, to run a broad program to fight opioid abuse. Definitions used include: dispenser (who gives out medicine); prescriber (a dispenser who writes prescriptions or their agent); prescriber of a schedule II, III, or IV controlled substance (with some listed exceptions, like on-site use, emergency rooms, certified opioid treatment programs, or other situations the Secretary allows); and schedule II, III, or IV controlled substance (drugs listed on those federal schedules). States that get grants must make a single, detailed plan. The plan can cover public and professional education, building or improving a prescription drug monitoring program (PDMP) that can share data with other States and let prescribers access it, expanding treatment (including medication-assisted treatment and counseling), screening and care for hepatitis C and HIV when appropriate, recovery supports in schools, and overdose prevention. States must apply in the form the Secretary asks for and must use grant money to pay for the plan’s costs, including technical help, training, and administration. The Secretary should give priority to States that meet certain criteria. These include laws that protect trained first responders, health workers, and family members from civil liability when they use an FDA-approved drug or device to treat an overdose, plus a certification from the State attorney general that the protection has been reviewed and is adequate; a process that lets people who are incarcerated enroll in services so treatment can continue after release; the ability to share PDMP data with other States; keeping PDMP data up to date; notifying prescribers and dispensers when patient overuse or misuse is suspected; and laws or policies that encourage PDMP use. The Secretary must report on State PDMP laws and on rates of opioid use disorders and overdose deaths. If a State does not have a PDMP, a county or local government with a PDMP can apply like a State, but must show how it will share data with other areas. The program had authorization for $5,000,000 for each of fiscal years 2017 through 2021.

Title 42, §290ee–3

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

(a)Definitions

In this section: (1) Dispenser

(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 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.

Notes & Related Subsidiaries

Editorial Notes

References in 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 section 290aa–15 and 290aa–16 of this title, section 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.

Prior Provisions

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.

Statutory Notes and Related Subsidiaries

Grant Program for the State and Tribal Response to the Opioid Abuse Crisis 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, which related to grant program to address opioid abuse crisis within States and Indian Tribes, was amended generally by Pub. L. 117–328, div. FF, title I, § 1273, Dec. 29, 2022, 136 Stat. 5688, and transferred to section 290ee–3a of this title.

§290ee–3 State Demonstration Grants for Comprehensive Opioid Abuse Response