[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74388-74390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

[CMS-4183-N]


Medicare Program; Listening Session Regarding the Implementation 
of Certain Medicare Part D Provisions in the Comprehensive Addiction 
and Recovery Act of 2016 (CARA)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

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SUMMARY: This document announces a listening session to solicit input 
from stakeholders regarding our implementation of section 704 of the 
Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes 
provisions to permit Part D sponsors to establish drug management 
programs for at-risk beneficiaries under which Part D sponsors may 
limit such beneficiaries' access to frequently abused drugs to certain 
prescribers and pharmacies.

[[Page 74389]]

    Medicare beneficiaries with Part A or Part B, advocacy groups 
representing Medicare beneficiaries, physicians, pharmacists, and other 
clinicians (particularly other lawful prescribers of controlled 
substances), retail pharmacies, plan sponsors, entities delegated by 
plan sponsors (such as pharmacy benefit managers), biopharmaceutical 
manufacturers, and other interested parties are invited to participate. 
The Listening Session will be held via teleconference and is open to 
the public.

DATES: 
    Meeting Date: The Listening Session announced in this document will 
be held via teleconference on Monday, November 14, 2016 from 1 p.m. to 
4 p.m., Eastern Standard Time (e.s.t.).
    Deadline for Submitting a Request for Special Accommodations: 
Individuals planning to participate in the teleconference who have a 
condition that requires special assistance or accommodations are asked 
to submit their requests as specified in the ADDRESSES section of this 
document no later than 5:00 p.m., e.s.t Tuesday, November 1, 2016.
    Deadline for Meeting Registration: Individuals may register online 
at https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html. or by phone by contacting the person 
listed in the FOR FURTHER INFORMATION CONTACT section of this document 
by 1 p.m. e.s.t., Monday, November 14, 2016.
    Deadline for Submission of Written Comments or Statements: Written 
comments or statements on the topics listed in section II.A. of this 
document may be sent via mail or electronically to the address 
specified in the ADDRESSES section of this document and must be 
received by 5 p.m. e.s.t., Friday, December 2, 2016.

ADDRESSES: 
    Meeting Location: The Listening Session will be held via 
teleconference only.
    Meeting Registration: Persons interested in participating in the 
teleconference must register by completing the online registration. 
Online registration is available via the CMS Compliance Training, 
Education & Outreach--Upcoming/Current Events Web site: https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html.
    Requests for Special Accommodations: Individuals who require 
special accommodations should send a request via email to 
[email protected].
    Written Comments or Statements: Any interested party may send 
written comments or statements by mail to Attn: Chad Buskirk, Centers 
for Medicare & Medicaid Services, Mail Stop C1-24-23, 7500 Security 
Boulevard, Baltimore, MD 21244-1850 or by email to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Chad Buskirk, 410-786-1630. News Media 
Representatives must contact our Public Affairs Office at (202) 690-
6145.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 704 of the Comprehensive Addiction and Recovery Act of 2016 
(CARA) (Pub. L. 114-198) includes provisions to permit Part D sponsors 
to establish drug management programs for at-risk beneficiaries under 
which Part D sponsors may limit such beneficiaries' access to 
frequently abused drugs to certain prescribers and pharmacies. Section 
704(g)(2)(A) of CARA requires the Secretary of Health and Human 
Services to convene stakeholders for input regarding specific topics in 
sufficient time for the Secretary to take such input into account in 
promulgating regulations to implement the relevant provisions. 
Stakeholders include Medicare beneficiaries with Part A or Part B, 
advocacy groups representing Medicare beneficiaries, physicians, 
pharmacists, and other clinicians (particularly other lawful 
prescribers of controlled substances), retail pharmacies, plan 
sponsors, entities delegated by plan sponsors (such as pharmacy benefit 
managers), and biopharmaceutical manufacturers.

II. Listening Session Topics and Format

A. Listening Session Topics

    Section 704 of CARA is the basis for the listening session and 
provides the information for which we are soliciting stakeholder input. 
The first topic is found in section 704(a) of CARA and the nine other 
topics are from the listing in section 704(g)(2)(B) of CARA. Therefore, 
we are soliciting feedback from stakeholders and other interested 
parties on the following 10 topics:
     The clinical guidelines that indicate misuse or abuse of 
frequently abused drugs. Section 704(a) of CARA refers to such clinical 
guidelines and requires the Secretary to develop such guidelines in 
consultation with Part D sponsors and other stakeholders.
     The anticipated impact of drug management programs for at-
risk beneficiaries under section 1860D-4(c)(5) of the Social Security 
Act (the Act) on cost-sharing and ensuring accessibility to 
prescription drugs for enrollees in prescription drug plans (PDPs), and 
MA-PD plans who are at-risk beneficiaries for prescription drug abuse 
(as defined in section 1860D-4(c)(5)(C) of the Act).
     The use of an expedited appeals process under which such 
an enrollee may appeal the enrollee's identification as an at-risk 
beneficiary for prescription drug abuse (similar to the processes 
established under the Medicare Advantage program that allow an 
automatic escalation to external review of claims submitted under Part 
C).
     The types of enrollees that should be treated as exempted 
individuals, as described in section 1860D-4(c)(5)(C)(ii) of the Act.
     The manner in which terms and definitions 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 section 1860D-4(c)(5)(C) of Act.
     The information to be included in the notices described in 
section 1860D-4(c)(5)(B) of Act and the standardization of such 
notices.
     The responsibility for the implementation of the program 
of the PDP sponsor (or Medicare Advantage organization) that 
establishes a drug management program for at-risk beneficiaries under 
section 1860D-4(c)(5) of the Act.
     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.
     Evidence-based prescribing guidelines for opiates.
     The sharing of claims data under Parts A and B of title 
XVIII of the Act with Part D sponsors.

B. Listening Session Format

    Stakeholders and other interested parties will be convened by 
teleconference for this listening session. The session will begin with 
teleconference logistics and an overview of objectives for the session. 
The remainder of the session will be devoted to receiving input on the 
10 topics specified in section II.A. of this document. Time allotted 
for each topic will be limited.

III. Registration Instructions

    Persons interested in participating the teleconference must 
register by completing the on-line registration via the CMS Compliance 
Training, Education & Outreach--Upcoming/Current Events Web site: 
https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html by the deadline specified in

[[Page 74390]]

the DATES section of this document. You will receive a registration 
confirmation with the dial-in information to participate in the 
listening session.
    Individuals requiring special accommodations should refer to the 
DATES and ADDRESSES section of this document.

    Dated: October 7, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-25806 Filed 10-21-16; 4:15 pm]
 BILLING CODE 4120-01-P