81 FR 74388 - Medicare Program; Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range		74388-74390
FR Document		2016-25806

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. 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.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74388-74390]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

74388 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules

§ 36.4500 Applicability and qualified (c) In no event may the total fee (7) Any other fee the Secretary
mortgage status. agreed upon between the Secretary and determines reasonably necessary for the
* * * * * the borrower result in an amount that protection of the Secretary’s investment.
(c) * * * will cause the loan to be designated as (d) Any fee included in the loan
(2) Applicability of safe harbor a high-cost mortgage as defined in 15 instrument and permitted under
qualified mortgage. Any VA direct loan U.S.C. 1602(bb) and 12 CFR part 1026. paragraph (c) of this section would be
made by the Secretary pursuant to (Authority: 38 U.S.C. 2041, 3720, 3733) based on the amount customarily
chapter 20 or 37 of title 38, U.S.C., is a charged in the industry for the
safe harbor qualified mortgage. § 36.4529 Vendee loan post-origination performance of the service in the
fees. particular area, the status of the loan,
(Authority: 15 U.S.C. 1639C(b)(3)(B)(ii), 38
U.S.C. 2041, 3710, 3711, 3720, 3733, and (a) The Secretary may charge a and the characteristics of the affected
3761) borrower the following reasonable fees, property.
* * * * * per use, following origination, in (Authority: 38 U.S.C. 2041, 3720, 3733)
(e) Sections 36.4528, 36.4529, and connection with the servicing of any
36.4530, which concern vendee loans, vendee loan: § 36.4530 Vendee loan other fees.
shall be applicable to all vendee loans. (1) Processing assumption fee for the (a) In addition to the fees that may be
■ 3. Amend § 36.4501 by adding in transfer of legal liability of repaying the charged pursuant to 38 CFR 36.4528 and
alphabetical order a definition for ‘‘Safe mortgage when the individual assuming 36.4529 and the statutory loan fee
harbor qualified mortgage’’ and revising the loan is approved. Such fee will not charged pursuant to 38 U.S.C. 3729, the
the definition ‘‘Vendee Loan’’ to read as exceed $300, plus the actual cost of the borrower may be required to pay third-
follows: credit report. If the assumption is party fees for services performed in
denied, the fee will not exceed the connection with a vendee loan.
§ 36.4501 Definitions. actual cost of the credit report. (b) Examples of the third party fees
* * * * * (2) Processing subordination fee, not that may be charged in connection with
Safe harbor qualified mortgage means to exceed $350, to ensure that a a vendee loan include, but are not
a mortgage that meets the Ability-to- modified vendee loan retains its first limited to:
Repay requirements of sections 129B lien position; (1) Termite inspections;
and 129C of the Truth-in-Lending Act (3) Processing partial release fee, not (2) Hazard insurance premiums;
(TILA) regardless of whether the loan to exceed $350, to exclude collateral (3) Force-placed insurance premiums;
might be considered a high cost from the mortgage contract once a (4) Courier fees;
mortgage transaction as defined by certain amount of the mortgage loan has (5) Tax certificates; and
section 103bb of TILA (15 U.S.C. been paid; (6) Recorder’s fees.
1602bb). (4) Processing release of lien fee, not
(Authority: 38 U.S.C. 2041, 3720, 3733)
* * * * * to exceed $15, for the release of an
obligor from a mortgage loan in [FR Doc. 2016–25738 Filed 10–25–16; 8:45 am]
Vendee loan means a loan made by
the Secretary for the purpose of connection with a division of real BILLING CODE 8320–01–P

financing the purchase of a property property;
acquired pursuant to chapter 37 of title (5) Processing payoff statement fee,
38, United States Code. The terms of a not to exceed $30, for a payoff statement DEPARTMENT OF HEALTH AND
vendee loan (e.g., amount of down showing the itemized amount due to HUMAN SERVICES
payment; amortization term; whether to satisfy a mortgage loan as of a specific
date; Centers for Medicare & Medicaid
escrow taxes, insurance premiums, or Services
homeowners’ association dues; fees, (6) Processing payment by phone fee,
etc.) are negotiated between the not to exceed $12, when a payment is
made by phone and handled by a 42 CFR Chapter IV
Secretary and the borrower on a case-by-
case basis, subject to the requirements of servicing representative; [CMS–4183–N]
38 U.S.C. 2041 or 3733. Terms related (7) Processing payment by phone fee,
to allowable fees are also subject to not to exceed $10, when a payment is Medicare Program; Listening Session
§§ 36.4528 through 36.4530 of this part. made by phone and handled through an Regarding the Implementation of
interactive voice response system, Certain Medicare Part D Provisions in
(Authority: 38 U.S.C. 2041, 3720, 3733) without contacting a servicing the Comprehensive Addiction and
* * * * * representative. Recovery Act of 2016 (CARA)
■ 4. Add §§ 36.4528, 36.4529, and (b) The specific fees to be charged on
36.4530 to read as follows: each account may be negotiated AGENCY: Centers for Medicare &
between the Secretary and the borrower. Medicaid Services (CMS), HHS.
§ 36.4528 Vendee loan origination fee.
The Secretary will review the maximum ACTION: Notice of meeting.
(a) In addition to the loan fee required fees under paragraph (a) of this section
pursuant to 38 U.S.C. 3729, the bi-annually to determine that they SUMMARY: This document announces a
Secretary may, in connection with the remain reasonable. listening session to solicit input from
origination of a vendee loan, charge a (c) The Secretary may charge a stakeholders regarding our
borrower a loan origination fee not to borrower reasonable fees established in implementation of section 704 of the
exceed one-and-a-half percent of the Comprehensive Addiction and Recovery
Lhorne on DSK30JT082PROD with PROPOSALS

the loan instrument, including but not
loan amount. limited to the following: Act of 2016 (CARA), which includes
(b) All or part of such fee may be paid (1) Property inspection fees; provisions to permit Part D sponsors to
in cash at loan closing or all or part may (2) Property preservation fees; establish drug management programs for
be included in the loan. The Secretary (3) Appraisal fees; at-risk beneficiaries under which Part D
will not increase the loan origination fee (4) Attorneys’ fees; sponsors may limit such beneficiaries’
because the borrower chooses to include (5) Returned-check fees; access to frequently abused drugs to
such fee in the loan amount financed. (6) Late fees; and certain prescribers and pharmacies.

VerDate Sep<11>2014 15:05 Oct 25, 2016 Jkt 241001 PO 00000 Frm 00074 Fmt 4702 Sfmt 4702 E:\FR\FM\26OCP1.SGM 26OCP1

$74390 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules the DATES section of this document. You Individuals requiring special Dated: October 7, 2016. will receive a registration confirmation accommodations should refer to the Andrew M. Slavitt, with the dial-in information to DATES and ADDRESSES section of this Acting Administrator, Centers for Medicare participate in the listening session. document. & Medicaid Services. [FR Doc. 2016–25806 Filed 10–21–16; 4:15 pm] BILLING CODE 4120–01–P Lhorne on DSK30JT082PROD with PROPOSALS VerDate Sep<11>2014 15:05 Oct 25, 2016 Jkt 241001 PO 00000 Frm 00076 Fmt 4702 Sfmt 9990 E:\FR\FM\26OCP1.SGM 26OCP1$

Document Created: 2016-10-26 02:17:36
Document Modified: 2016-10-26 02:17:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of meeting.
Contact		Chad Buskirk, 410-786-1630. News Media Representatives must contact our Public Affairs Office at (202) 690- 6145.
FR Citation		81 FR 74388

81 FR 74388 - Medicare Program; Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA)

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 207 (October 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services