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General Memorandum 16-048

General Memorandum 16-048
Opioid Legislation Approved by Congress

The House and the Senate have approved legislation aimed at addressing the urgent national issue of opioid abuse. This includes both the misuse of a certain class of pain medicines and the use of heroin. The skyrocketing death rates and the number of infants born affected by opioids around the nation prompted many congressional committees to hold hearings on this issue, including the Senate Committee on Indian Affairs. The legislation, the Comprehensive Addiction and Recovery Act of 2016 (CARA) (S. 524; conference report – H. Rept. 114-669) was approved by the House on July 8 by a vote of 407-5 and by the Senate on July 13 by a margin of 92-2. CARA contains tribal eligibility for a number of competitive grant programs; but there is no tribal-specific allocation of funds. An early effort to include a tribal allocation in the Senate's version of the legislation did not succeed.

The vote margins belie the strong differences of opinion over this legislation. The Administration and congressional Democrats strongly supported mandatory emergency funding to address the opioid crisis while congressional Republicans stood firm for discretionary funding provided through appropriations bills. The Republicans prevailed. Up until the time of the floor votes it was not certain whether Democrats would vote for the bill. Efforts by Democrats in both Houses to provide additional emergency mandatory funding failed. House Republicans point out correctly that in the pending FY 2017 appropriations bills there is recommended funding for efforts to address opioid abuse, notably the Health and Human Services (HHS) and the Department of Justice (DOJ) bills. The prospects of enacting any FY 2017 appropriations bills is problematic and we expect a FY 2017 Continuing Resolution (CR) of some indeterminate length of time, possibly into December or even longer. Funding could be provided in a CR under the relatively rare addition of an "anomaly".

As of this writing CARA has not yet been transmitted to the White House for signature. President Obama, while disappointed with the bill, has said that he will sign it.

CARA covers a wide range of issues including prescribing practices; pain management and research; access to opioid overdose reversal drugs; medication-assisted treatment; prescription electronic reporting; HHS opioid education campaigns, including one geared to youth injured in sports; codification of several existing federal agency practices regarding opioid abuse; a DOJ new Comprehensive Opioid Abuse Grant Program; allowance under some circumstances for partial refill of prescriptions for controlled substances; and prescription and pain management provisions specific to prevention of prescription drug abuse under Medicare and Medicaid. It also has provisions specific to drug-addicted infants, residential treatment grants for pregnant and postpartum women, and the Veterans Health Administration.

Below is information on sections of CARA which specifically mention tribes:

Section 107. Improving Access to Overdose Treatment. No later than 180 days after the enactment the Secretary of HHS may provide information to 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." Similar provisions are included for the Secretaries of Defense and Veterans Administration for their health facilities. Section 107 also authorizes $5 million in grants for Federally Qualified Health Centers and others from FY 2017 through 2021 for expansion of access to drugs or devices for emergency treatment of known or suspected opioid overdose.

Section 201. Comprehensive Opioid Abuse Grant Program. The Attorney General is authorized to make grants to Indian tribes and state and local governments to provide services primarily relating to opioid abuse; developing, implementing, or expanding a treatment alternative to incarceration programs; training criminal justice agency personnel on substance use disorders and co-occurring mental illness and substance use disorders; the development of a mental health court; the development of a drug court; the development of a veterans treatment court program; creating programs focused on parents whose incarceration could result in their children entering the child welfare system; and the development of community-based substance use diversion programs sponsored by a law enforcement agency.

Tribes, state and local governments that are awarded a grant from this program may use all or a portion of that grant to contract with, or make one or more sub-awards to, one or more of the following (1) local or regional organizations that are private and nonprofit, including faith-based organizations; (2) units of local government; or (3) tribal organizations.

To request a grant the chief executive officer of a tribe, state or local government must submit an application to the Attorney General and include the following:

" (1) A certification that Federal funds made available under this part will not be used to supplant State, local, or tribal funds, but will be used to increase the amounts of such funds that would, in the absence of Federal funds, be made available for the activities described in section 3021(a).
(2) An assurance that, for each fiscal year covered by an application, the applicant shall maintain and report such data, records, and information (programmatic and financial) as the Attorney General may reasonably require.
(3) A certification, made in a form acceptable to the Attorney General and executed by the chief executive officer of the applicant (or by another officer of the applicant, if qualified under regulations promulgated by the Attorney General),
(A) the activities or services to be funded by the grant meet all the requirements of this part;
(B) all the information contained in the application is correct;
(C) there has been appropriate coordination with affected agencies; and
(D) the applicant will comply with all provisions of this part and all other applicable Federal laws.
(4) An assurance that the applicant will work with the Drug Enforcement Administration to develop an integrated and comprehensive strategy to address opioid abuse."

Included is a provision to ensure that services may be provided to pregnant women who are eligible for grants under the Family-Based Substance Abuse Grant Program. (Section 501 of the bill also reauthorizes a grant program for residential treatment of pregnant and postpartum women who have an opioid use order, including assistance for their children).

The CARA authorizes $103 million in each of fiscal years 2017 through 2021 for this grant program. The Attorney General is to distribute funds that "equitably address the needs of underserved populations, including rural and tribal communities; and focuses on communities that have been disproportionately impacted by opioid abuse…"

Section 202. First Responder Training. CARA codifies an existing grant program whereby HHS provides grants to tribes, tribal organizations, states and local governments that will allow "first responders and other key community sectors to 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." Grantees are also to use funds for training and to establish processes and protocols for referral to proper treatment. At least 20 percent of funds are to be awarded to entities that are not located in metropolitan statistical areas.

CARA authorizes $12 million annually for this grant program for each of fiscal years 2017 through 2021.

Section 301. Evidence-Based Prescription Opioid and Heroin Treatment and Interventions Demonstration. CARA codifies an existing Substance Abuse and Mental Health Services Administration program for grants, contracts, or cooperative agreements with tribes, tribal organizations, state substance abuse agencies, local governments and nonprofit organizations to expand the availability of medication-assisted treatment and other clinically-appropriate services. Funds are for use in areas where there is a high rate or rapid increase in the use of heroin or other opioids.

CARA authorizes $25 million in each of fiscal years 2017 through 2012 for this program.

Pain Management Task Force. We also point out that Section 101 would establish a Pain Management Best Practices Inter-Agency Task Force which would have a large number of representatives including HHS, relevant HHS agencies (presumably the Indian Health Service) and experts in the field of minority health. The Secretary of HHS is to ensure that the Task Force membership includes individuals representing rural and underserved areas. The Task Force is to study whether there are gaps or inconsistencies among federal agencies in their pain management best practices and to propose updates and recommendations regarding the same. The Task Force does not have rulemaking authority.

The Conference Report on CARA is available: https://www.congress.gov/114/crpt/hrpt669/CRPT-114hrpt669.pdf

Please let us know if we may provide additional information or assistance regarding the Comprehensive Addiction and Recovery Act of 2016.

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Inquiries may be directed to:
Karen Funk (kfunk@hobbsstraus.com)

Available Documents for Download ( any referenced attachments are included in download )


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