P.L. 114–198, Approved July 22, 2016 (130 Stat. 695)

SEC 1. [42U.S.C. 1305 note] Comprehensive Addiction and Recovery Act of 2016

An Act to authorize the Attorney General and Secretary of Health and Human Services to award grants to address the prescription opioid abuse and heroin use crisis, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. This Act may be cited as the “Comprehensive Addiction and Recovery Act of 2016”.

Approved July 22, 2016.

SEC. 704. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE PARTS C AND D.

(c)  Expanding Activities of Medicare Drug Integrity Contractors (MEDICs).—***

(2) OIG study and report on effectiveness of medics.—

(A)  Study.—The Inspector General of the Department of Health and Human Services shall conduct a study on the effectiveness of Medicare drug integrity contractors with which the Secretary of Health and Human Services has entered into a contract under section 1893 of the Social Security Act (42 U.S.C. 1395ddd) in identifying, combating, and preventing fraud under the Medicare program, including under the authority provided under section 1893(j) of the Social Security Act, added by paragraph (1).

Report.—Not later than 24 months after the date of the enactment of this Act, the Inspector General shall submit to Congress a report on the study conducted under subparagraph (A). Such report shall include such recommendations for improvements in the effectiveness of such contractors as the Inspector General determines appropriate.

(e)  Sense of Congress Regarding Use of Technology Tools To Combat Fraud.—It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under MA-PD plans and prescription drug plans under parts C and D of the Medicare program.

(f) Reports.—

(1) Report by secretary on appeals process.—

(A)  In general.—Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the appropriate committees of jurisdiction of Congress a report on ways to improve upon the appeals process for Medicare beneficiaries with respect to prescription drug coverage under part D of title XVIII of the Social Security Act. Such report shall include an analysis comparing appeals processes under parts C and D of such title XVIII.

(B)  Feedback.—In development of the report described in subparagraph (A), the Secretary of Health and Human Services shall solicit feedback on the current appeals process from stakeholders, such as beneficiaries, consumer advocates, plan sponsors, pharmacy benefit managers, pharmacists, providers, independent review entity evaluators, and pharmaceutical manufacturers.

(g) Effective Date; Rulemaking.—

(1)  In general.—The amendments made by this section shall apply to prescription drug plans (and MA-PD plans) for plan years beginning on or after January 1, 2019.

(2) Stakeholder meetings prior to effective date.—

(A)  In general.—Not later than January 1, 2017, the Secretary of Health and Human Services shall convene stakeholders, including individuals entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title, advocacy groups representing such individuals, physicians, pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers for input regarding the topics described in subparagraph (B). The input described in the preceding sentence shall be provided to the Secretary in sufficient time in order for the Secretary to take such input into account in promulgating the regulations pursuant to paragraph (3).

(B)  Topics described.—The topics described in this subparagraph are the topics of—

(i)  the anticipated impact of drug management programs for at-risk beneficiaries under paragraph (5) of section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of PDP sponsors, and enrollees in MA–PD plans, who are at-risk beneficiaries for prescription drug abuse (as defined in subparagraph (C) of such paragraph);

(ii)  the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph (similar to the processes established under the Medicare Advantage program under part C of title XVIII of the Social Security Act that allow an automatic escalation to external review of claims submitted under such part);

(iii)  the types of enrollees that should be treated as exempted individuals, as described in subparagraph (C)(ii) of such paragraph;

(iv)  the manner in which terms and definitions in such paragraph should be applied, such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph (C) of such paragraph;

(v)  the information to be included in the notices described in subparagraph (B) of such paragraph and the standardization of such notices;

(vi)  with respect to a PDP sponsor (or Medicare Advantage organization) that establishes a drug management program for at-risk beneficiaries under such paragraph, the responsibilities of such PDP sponsor (or organization) with respect to the implementation of such program;

(vii)  notices for plan enrollees at the point of sale that would explain why an at-risk beneficiary has been prohibited from receiving a prescription at a location outside of the designated pharmacy;

(viii)  evidence-based prescribing guidelines for opiates; and

(ix)  the sharing of claims data under parts A and B of title XVIII of the Social Security Act with PDP sponsors.

(3)  Rulemaking.—Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall, taking into account the input gathered pursuant to paragraph (2)(A) and after providing notice and an opportunity to comment, promulgate regulations to carry out the provisions of, and amendments made by this section.