Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program, 16440-16757 [2018-07179]

Agencies

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

[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Rules and Regulations]
[Pages 16440-16757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07179]



[[Page 16439]]

Vol. 83

Monday,

No. 73

April 16, 2018

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 417, 422, et al.





Medicare Program; Contract Year 2019 Policy and Technical Changes to 
the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, 
the Medicare Prescription Drug Benefit Programs, and the PACE Program; 
Final Rule

Federal Register / Vol. 83 , No. 73 / Monday, April 16, 2018 / Rules 
and Regulations

[[Page 16440]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 417, 422, 423, 460, and 498

[CMS-4182-F]
RIN 0938-AT08


Medicare Program; Contract Year 2019 Policy and Technical Changes 
to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-
Service, the Medicare Prescription Drug Benefit Programs, and the PACE 
Program

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

ACTION: Final rule.

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

SUMMARY: This final rule will revise the Medicare Advantage (MA) 
program (Part C) regulations and Prescription Drug Benefit program 
(Part D) regulations to implement certain provisions of the 
Comprehensive Addiction and Recovery Act (CARA) to further reduce the 
number of beneficiaries who may potentially misuse or overdose on 
opioids while still having access to important treatment options; 
implement certain provisions of the 21st Century Cures Act; support 
innovative approaches to improve program quality, accessibility, and 
affordability; offer beneficiaries more choices and better care; 
improve the CMS customer experience and maintain high beneficiary 
satisfaction; address program integrity policies related to payments 
based on prescriber, provider and supplier status in MA, Medicare cost 
plan, Medicare Part D and the PACE programs; provide an update to the 
official Medicare Part D electronic prescribing standards; and clarify 
program requirements and certain technical changes regarding treatment 
of Medicare Part A and Part B appeal rights related to premiums 
adjustments.

DATES: 
    Effective Date: This rule is effective June 15, 2018.
    The incorporation by reference of certain publications listed in 
the rule is approved by the Director of the Federal Register as of June 
15, 2018.
    Applicability Dates: The applicability date of the provisions of 
this rule is January 1, 2019 except for the provisions in Sec. Sec.  
422.100(f)(4) and (5) and 422.101(d) (discussed in section II.A.4. of 
this final rule (Maximum Out-of-Pocket Limit for Medicare Parts A and B 
Services)) and Sec.  422.100(f)(6) (discussed in section II.A.5. of 
this final rule (Cost Sharing Limits for Medicare Parts A and B 
Services)). Those provisions are applicable for contract year 2020 
(January 1, 2020). E-Prescribing and the Part D Prescription Drug 
Program; Updating Part D E Prescribing Standards discussed in section 
II.D.8. of this final rule is applicable January 1, 2020 conditioned on 
The Office of the National Coordinator for Health Information 
Technology (ONC) adopting the same standard for use in its Electronic 
Health Record Certification Program by that date.

FOR FURTHER INFORMATION CONTACT: 
    Theresa Wachter, (410) 786-1157, Part C Issues.
    Marie Manteuffel, (410) 786-3447, Part D Issues.
    Kristy Nishimoto, (206) 615-2367, Beneficiary Enrollment and 
Appeals Issues.
    Raghav Aggarwal, (410) 786-0097, Part C and D Payment Issues.
    Vernisha Robinson-Savoy, (443) 826-9925, Compliance Program 
Training Issues.
    Frank Whelan, (410) 786-1302, Preclusion List Issues.
    Shelly Winston, (410) 786-3694, Part D E-Prescribing Program.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary and Background

A. Executive Summary

1. Purpose
    The primary purpose of this final rule is to make revisions to the 
Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit 
Program (Part D) regulations based on our continued experience in the 
administration of the Part C and Part D programs and to implement 
certain provisions of the Comprehensive Addiction and Recovery Act and 
the 21st Century Cures Act. The changes are necessary to--
     Support Innovative Approaches to Improving Quality, 
Accessibility, and Affordability;
     Improve the CMS Customer Experience; and
     Implement Other Changes.
    In addition, this final rule makes technical changes related to 
treatment of Part A and Part B premium adjustments and updates the 
NCPDP SCRIPT standard used for Part D electronic prescribing. While the 
Part C and Part D programs have high satisfaction among enrollees, we 
continually evaluate program policies and regulations to remain 
responsive to current trends and newer technologies, and provide 
increased flexibility to serve patients. Specifically, this regulation 
meets the Administration's priorities to reduce burden and provide the 
regulatory framework to develop MA and Part D products that better meet 
the individual patient's health care needs. These changes being 
finalized will empower MA and Part D plans to meet the needs of 
enrollees at the local level, and should result in more enrollee choice 
and more affordable options. Additionally, this regulation includes a 
number of provisions that will help address the opioid epidemic and 
mitigate the impact of increasing drug prices in the Part D program.
2. Summary of the Major Provisions
a. Implementation of the Comprehensive Addiction and Recovery Act of 
2016 (CARA) Provisions
    In line with the agency's response to the President's call to end 
the scourge of the opioid epidemic, this final rule implements 
statutory provisions of the Comprehensive Addiction and Recovery Act of 
2016 (CARA), which amended the Social Security Act and was enacted into 
law on July 22, 2016. CARA includes new authority for Medicare Part D 
plans to establish drug management programs effective on or after 
January 1, 2019. Through this final rule, CMS has established a 
framework under which Part D plan sponsors may establish a drug 
management program for beneficiaries at risk for prescription drug 
abuse or misuse, or ``at-risk beneficiaries.'' Specifically, under drug 
management programs, Part D plans will engage in case management of 
potential at-risk beneficiaries, through contact with their 
prescribers, when such beneficiary is found to be taking a specific 
dosage of opioids and/or obtaining them from multiple prescribers and 
multiple pharmacies who may not know about each other. Sponsors may 
then limit at-risk beneficiaries' access to coverage of controlled 
substances that CMS determines are ``frequently abused drugs'' to a 
selected prescriber(s) and/or network pharmacy(ies) after case 
management with the prescribers for the safety of the enrollee. CMS 
also limits the use of the special enrollment period (SEP) for dually- 
or other low income subsidy (LIS)-eligible beneficiaries by those LIS-
eligible beneficiaries who are identified as at-risk or potentially at-
risk for prescription drug abuse under such a drug management program. 
Finally, these provisions will codify the current Part D Opioid Drug 
Utilization Review (DUR) Policy and Overutilization Monitoring System 
(OMS) by integrating this current policy with drug management program 
provisions.

[[Page 16441]]

Through the adoption of this policy, from 2011 through 2017, there was 
a 76 percent decrease (almost 22,500 beneficiaries) in the number of 
Part D beneficiaries identified as potential very high risk opioid 
overutilizers. Thus, drug management programs will expand upon an 
existing, innovative, successful approach to reduce opioid 
overutilization in the Part D program by improving quality of care 
through coordination while maintaining access to necessary pain 
medications, and will be an important next step in addressing the 
opioid epidemic and safeguarding the health and safety of our nation's 
seniors.
b. Revisions to Timing and Method of Disclosure Requirements
    Consistent with agency efforts supporting innovative approaches to 
improve quality, accessibility, and affordability and reduce burden, we 
are finalizing changes to align the MA and Part D regulations in 
authorizing CMS to set the manner of delivery for mandatory disclosures 
in both the MA and Part D programs. CMS will use this authority to 
allow MA plans to meet the disclosure and delivery requirements for 
certain documents by relying on notice of electronic posting and 
provision of the documents in hard copy when requested, when previously 
the documents, such as the Evidence of Coverage (EOC), had to be 
provided in hard copy. Additionally, we are changing the timeframe for 
delivery of the MA and Part D EOC to the first day of the Annual 
Election Period (AEP), rather than 15 days prior to that date. Allowing 
Part C and Part D plans to provide the EOC electronically will 
alleviate plan burden related to printing and mailing and reduce the 
number of paper documents that enrollees receive from plans. Changing 
the date by which plans must provide the EOC to enrollees will allow 
plans more time to finalize the formatting and ensure the accuracy of 
the information in the EOC. Changing the date will also separate the 
mailing and receipt of the EOC from the Annual Notice of Change (ANOC), 
which describes the important changes in a patient's plan from one year 
to the next. The ANOC must be delivered 15 days prior to the AEP and 
will be received by enrollees ahead of the EOC, thus allowing enrollees 
to focus on materials that drive decision-making during the AEP. We see 
this final change as an overall reduction of burden that our 
regulations have on plans and enrollees. In aggregate, we estimate a 
savings (to plans for not producing and mailing hardcopy EOCs) of 
approximately $54.7 million each year, 2019 through 2023.
c. Preclusion List Requirements for Prescribers in Part D and 
Individuals and Entities in MA, Cost Plans, and PACE
    This final rule will rescind current regulatory provisions that 
require prescribers of Part D drugs and providers of MA services and 
items to enroll in Medicare in order for the Part D drug or MA service 
or item to be covered. As a replacement, a Part D plan sponsor will be 
required to reject, or require its pharmacy benefit manager to reject, 
a pharmacy claim for a Part D drug if the individual who prescribed the 
drug is included on the ``preclusion list.'' Similarly, an MA service 
or item will not be covered if the provider that furnished the service 
or item is on the preclusion list. The preclusion list will consist of 
certain individuals and entities that are currently revoked from the 
Medicare program under 42 CFR 424.535 and are under an active 
reenrollment bar, or have engaged in behavior for which CMS could have 
revoked the individual or entity to the extent applicable if they had 
been enrolled in Medicare, and CMS determines that the underlying 
conduct that led, or would have led, to the revocation is detrimental 
to the best interests of the Medicare program. We believe that this 
change from an enrollment requirement to a preclusion list requirement 
will reduce the burden on Part D prescribers and MA providers without 
compromising our program integrity efforts.
3. Summary of Costs, Savings and Benefits of the Major Provisions

------------------------------------------------------------------------
          Provision           Savings and benefits          Costs
------------------------------------------------------------------------
Implementation of the         The purpose of this   The creation of lock
 Comprehensive Addiction and   provision is to       in-status is a
 Recovery Act of 2016.         create a lock-in      burden to plans.
                               status for certain    The cost to
                               at-risk               industry is
                               beneficiaries. In     estimated at about
                               addition to the       $2.8 million per
                               benefits of           year. This $2.8
                               preventing opioid     million cost arises
                               and benzodiazepine    from (i) the
                               dependency in         uploading and
                               beneficiaries, we     preparing of
                               estimate, in 2019,    additional notices
                               a reduction of $19    to enrollees
                               million in Trust      ($101,721), (ii)
                               Fund expenditures     the re-negotiation
                               because of reduced    of contracts
                               opioid scripts.       between Part D
                               This $19 million      sponsors and
                               reduction modestly    pharmacies
                               increases to a $20    ($547,415), (iii)
                               million reduction     the programming of
                               in 2023.              edits about lock-
                                                     ins into the
                                                     systems of Part D
                                                     sponsors
                                                     ($2,152,332), and
                                                     (iv) the right of
                                                     enrollees to appeal
                                                     a status of lock-in
                                                     ($35,183).
Revisions to Timing and       We estimate 67% of    ....................
 Method of Disclosure          the current 47.8
 Requirements.                 million
                               beneficiaries will
                               prefer use of the
                               internet versus
                               hard copies. This
                               will result in a
                               savings to the
                               industry of $54.7
                               million each year,
                               2019 through 2023.
                               This is due to a
                               reduction in
                               printing and
                               mailing costs.
Preclusion List Requirements  For 2019, this        For 2019, this
 for Prescribers in Part D     provision saves       provision costs
 and Individuals and           providers $34.4       Part D sponsors or
 Entities in MA, Cost Plans,   million. For 2020     their PBMs $9.3
 and PACE.                     and future years,     million. For 2020
                               there are no          and future years,
                               savings. The $34.4    costs are
                               million in savings    negligible (below
                               to providers arises   $50,000). The $9.3
                               because of removal    million cost arises
                               of the requirement    because of
                               of MA providers and   programming and
                               suppliers and Part    staff resources
                               D prescribers to      needed to produce
                               enroll in Medicare    and send required
                               as a prerequisite     notifications to
                               for furnishing        enrollees and
                               health care items     prescribers.
                               and services. Part
                               C providers and
                               suppliers save
                               $24.1 million in
                               reduced costs while
                               Part D providers
                               save $10.3 million
                               in reduced costs.

[[Page 16442]]

 
Physician Incentive Plans--   For 2019, this        ....................
 Update Stop-Loss Protection   provision reduces
 Requirements.                 required
                               reinsurance
                               resources by $204.6
                               million. The $204.6
                               million savings
                               increases yearly
                               because of expected
                               enrollment
                               increases and
                               medical inflation;
                               the savings is
                               $281.8 million in
                               2023. The savings
                               arise because we
                               are replacing the
                               current insurance
                               schedule in the
                               regulation with
                               updated stop-loss
                               insurance
                               requirements that
                               will allow
                               insurance with
                               higher deductibles.
                               This updated
                               schedule will
                               result in a
                               significant
                               reduction to the
                               cost of obtaining
                               stop-loss
                               insurance. The
                               higher deductibles
                               are consistent with
                               the increase in
                               medical costs due
                               to inflation.
                               Through transfers,
                               the 2019 $204.6
                               million savings
                               results in $71.6
                               savings to the
                               Medicare Trust Fund
                               and $133 million
                               savings (in the
                               form of rebates) to
                               Medicare Advantage
                               (MA) organizations.
                               It is likely that
                               some of the savings
                               to MA organizations
                               will result in
                               increased health
                               care benefits to MA
                               enrollees.
------------------------------------------------------------------------

B. Background

    In the proposed rule titled ``Medicare Program; Contract Year 2019 
Policy and Technical Changes to the Medicare Advantage, Medicare Cost 
Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit 
Programs, and the PACE Program'' which appeared in the November 28, 
2017 Federal Register (82 FR 56336), we proposed to revise the Medicare 
Advantage program (Part C) regulations and Prescription Drug Benefit 
program (Part D) regulations to implement certain provisions of the 
Comprehensive Addiction and Recovery Act (CARA) and the 21st Century 
Cures Act; improve program quality, accessibility, and affordability; 
improve the CMS customer experience; address program integrity policies 
related to payments based on prescriber, provider and supplier status 
in Medicare Advantage, Medicare cost plan, Medicare Part D and the PACE 
programs; provide a proposed update to the official Medicare Part D 
electronic prescribing standards; clarify program requirements; and 
make certain technical changes regarding treatment of Medicare Part A 
and Part B appeal rights related to premium adjustments.
    We received approximately 1,669 timely pieces of correspondence 
containing multiple comments on the CY 2019 proposed rule. While we are 
finalizing several of the provisions from the proposed rule, there are 
a number of provisions from the proposed rule that we intend to address 
later and a few that we do not intend to finalize. We also note that 
some of the public comments were outside of the scope of the proposed 
rule. These out-of-scope public comments are not addressed in this 
final rule. Summaries of the public comments that are within the scope 
of the proposed rule and our responses to those public comments are set 
forth in the various sections of this final rule under the appropriate 
heading. However, we note that in this final rule we are not addressing 
comments received with respect to the provisions of the proposed rule 
that we are not finalizing at this time. Rather, we will address them 
at a later time, in a subsequent rulemaking document, as appropriate.

II. Provisions of the Proposed Rule and Analysis of and Responses to 
Public Comments

A. Supporting Innovative Approaches to Improving Quality, 
Accessibility, and Affordability

1. Implementation of the Comprehensive Addiction and Recovery Act of 
2016 (CARA) Provisions
a. Medicare Part D Drug Management Programs
    The Comprehensive Addiction and Recovery Act of 2016 (CARA), 
enacted into law on July 22, 2016, amended the Social Security Act and 
includes new authority for the establishment of drug management 
programs in Medicare Part D, effective on or after January 1, 2019. In 
accordance with section 704(g)(3) of CARA and revised section 1860D-
4(c) of the Act, CMS must establish through notice and comment 
rulemaking a framework under which Part D plan sponsors may establish a 
drug management program for beneficiaries at-risk for prescription drug 
abuse, or ``at-risk beneficiaries.'' Under such a Part D drug 
management program, sponsors may limit at-risk beneficiaries' access to 
coverage of controlled substances that CMS determines are ``frequently 
abused drugs'' to a selected prescriber(s) and/or pharmacy(ies). While 
such programs, commonly referred to as ``lock-in programs,'' have been 
a feature of many state Medicaid programs for some time, prior to the 
enactment of CARA, there was no statutory authority to allow Part D 
plan sponsors to require beneficiaries to obtain controlled substances 
from a certain pharmacy or prescriber in the Medicare Part D program. 
Thus, although drug management programs are voluntary, this rule 
codifies a framework that will place requirements upon such programs 
when established by Part D sponsors.
    This final rule implements the CARA Part D drug management program 
provisions by integrating them with the current Part D Opioid Drug 
Utilization Review (DUR) Policy and Overutilization Monitoring System 
(OMS) (``current policy'').\1\ This integration will mean that Part D 
plan sponsors implementing a drug management program could limit an at-
risk beneficiary's access to coverage of frequently abused drugs 
beginning 2019 through a beneficiary-specific point-of-sale (POS) claim 
edit and/or by requiring the beneficiary to obtain frequently abused 
drugs from a selected

[[Page 16443]]

pharmacy(ies) and/or prescriber(s) after case management and notice to 
the beneficiary. To do so, the beneficiary will have to meet clinical 
guidelines that factor in that the beneficiary is taking opioids over a 
sustained time period and that the beneficiary is obtaining them from 
multiple prescribers and/or multiple pharmacies. This final rule also 
implements a limitation on the use of the special enrollment period 
(SEP) for low income subsidy (LIS)-eligible beneficiaries who are 
identified as potential at-risk beneficiaries or at-risk beneficiaries.
---------------------------------------------------------------------------

    \1\ In using the term ``current policy'', we refer to the aspect 
of our current Part D opioid overutilization policy that is based on 
retrospective DUR and case management. Please refer to the CMS 
website, ``Improving Drug Utilization Review Controls in Part D'' at 
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html which contains CMS 
communications regarding the current policy.
---------------------------------------------------------------------------

    We received the following general comments and our responses 
follow:
    Comment: Commenters were overall supportive of our proposal. Some 
commenters found it to be a conservative and uniform approach to 
implementing the CARA drug management program provisions. Other 
commenters included specific suggestions for improvements with their 
overall supportive or neutral comments.
    Response: We thank the commenters for their comments. We summarize 
and respond to specific recommendations later in this preamble.
    Comment: We received a request that we confirm that nothing in the 
final rule impacts PACE organizations' waivers of Part D requirements 
in Sec.  423.153. This commenter also asked that existing waivers of 
Sec.  423.153 be extended to include Sec.  423.153(f) unless such a 
waiver is not needed due to the voluntary nature of drug management 
programs.
    Response: PACE organizations are not excluded from OMS reporting 
under the current policy. Additionally, because of the voluntary nature 
of the provisions under Sec.  423.153(f), a waiver is not necessary for 
PACE organizations. However, to the extent that PACE organizations 
commence drug utilization management activities covered under Sec.  
423.153(f), PACE organizations must comply with the requirements of 
423.153(f).
    Comment: We received comments that expressed concern about the time 
needed for Part D plan sponsors to make the necessary systems changes 
to implement compliant drug management programs.
    Response: Section 704(g)(1) of CARA states that 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. However, 
given the current national opioid epidemic, we expect that Part D 
sponsors will diligently implement fully-functional drug management 
programs in 2019. Moreover, as the new requirements for drug management 
programs build from and are integrated with existing policy, we expect 
sponsors will be able to implement them expeditiously.
    Comment: We received one suggestion that CMS pilot different 
approaches for implementing the CARA drug management program 
provisions, specifically the ``lock-in'' provisions, as we did before 
implementing our current policy.
    Response: Because the CARA drug management provisions will be 
integrated with our current policy, albeit with some modifications to 
that policy, we are not persuaded that an additional pilot is necessary 
since plan sponsors already have experience with addressing potential 
opioid overutilization.
    Comment: A commenter requested that CMS acknowledge the work it 
will take for Standard Development Organizations (SDOs) to implement 
the finalized CARA provisions. In particular, the commenter noted that 
development of any codes and messaging associated with the new CARA-
related requirements will take time to implement.
    Response: We understand that any modifications to existing 
standards to accurately achieve the desired functionalities to further 
the electronic exchange of information between healthcare stakeholders 
about the final CARA provisions may require time. We rely on SDOs to 
coordinate these efforts, and CMS is committed to working with the SDOs 
during this process, if needed.
    Comment: A commenter requested clarification on how to handle 
concurrent DUR edits, such as formulary-level cumulative opioid MME 
safety edits, and the drug management program. Specifically, the 
comment sought clarification on whether the drug management program 
beneficiary-specific POS claim edits or lock-in limitations would take 
precedence over an approved exception to a cumulative opioid MME safety 
edit.
    Response: A plan sponsor may implement formulary-level coverage 
rules for opioids (that is, prior authorization, quantity limits or 
step therapy) or safety edits, and implement a drug management program. 
The formulary and coverage rules would apply to all enrollees (unless 
they obtain an exception), and the drug management program would apply 
to potential at-risk and at-risk beneficiaries. A Part D sponsor's 
concurrent and retrospective DUR programs should be closely 
coordinated. In certain circumstances, it may be appropriate for a 
sponsor to make an at-risk determination through the drug management 
program for a beneficiary who received an approved exception to a 
cumulative opioid MME safety edit, and as part of the at-risk 
determination, may determine that continuing the approved exception is 
no longer appropriate.
    For example, a plan implemented a hard formulary-level cumulative 
MME opioid edit at 200 MME with 2 or more opioid prescribers. A 
beneficiary received their opioids from 2 prescribers and has a 
cumulative MME that exceeds 200 MME. They trigger the edit and request 
a coverage determination. The prescriber attests to medical necessity 
and the exception request is approved. At a later time, the beneficiary 
seeks opioids from 3 additional prescribers, and meets the CARA/OMS 
criteria. Through case management, the prescriber verifies the 
beneficiary is at-risk and agrees to prescriber lock-in due to care 
coordination issues.
b. Integration of CARA and the Current Part D Opioid DUR Policy and OMS
    Our proposal was to integrate the CARA Part D drug management 
program provisions with our current policy and codify them both. 
Specifically, under this regulatory framework, we proposed that Part D 
plan sponsors may voluntarily adopt drug management programs through 
which they address potential overutilization of frequently abused drugs 
identified retrospectively through the application of clinical 
guidelines/OMS criteria that identify potential at-risk beneficiaries 
and conduct case management which incorporates clinical contact and 
prescriber verification that a beneficiary is an at-risk beneficiary. 
If deemed necessary, a sponsor could limit at-risk beneficiaries' 
access to coverage for such drugs through pharmacy lock-in, prescriber 
lock-in, and/or a beneficiary-specific point-of-sale (POS) claim edit. 
Finally, sponsors would report to CMS the status and results of their 
case management through OMS and any beneficiary coverage limitations 
they have implemented through MARx, CMS' system for payment and 
enrollment transactions. Thus, although drug management programs are 
voluntary, our proposal was to codify a framework that will place 
requirements upon such programs when established by Part D sponsors.
    We stated that we foresee that all plan sponsors will implement 
such drug management programs based on our experience that all plan 
sponsors are complying with the current policy; the fact that our 
proposal largely incorporates the CARA drug management provisions into 
existing

[[Page 16444]]

CMS and sponsor operations; and especially, in light of the national 
opioid epidemic and the declaration that the opioid crisis is a 
nationwide Public Health Emergency.
    Comment: Commenters expressed strong support for integrating the 
drug management program provisions of CARA with the current policy. 
Commenters expressed that our proposal is reasonable, thoughtful, 
thorough, practical, and comprehensive; that it builds on a successful 
existing Medicare Part D program; that it will involve a common set of 
procedures and help ensure a streamlined and efficient process rather 
than creating a separate one that would require additional oversight 
and add administrative burden. We did not receive comments that opposed 
integrating the drug management program provisions of CARA with the 
current policy.
    Response: We thank the commenters for their supportive comments and 
are finalizing this integration approach to our proposal.
(1) Requirements for Part D Drug Management Programs (Sec. Sec.  
423.100 and 423.153)
    We proposed the following definitions in establishing requirements 
for Part D drug management programs.
(i) Definitions (Sec.  423.100)
(A) Definition of ``Potential At-Risk Beneficiary'' and ``At-Risk 
Beneficiary'' (Sec.  423.100)
    Section 1860D-4(c)(5)(C) of the Act contains a definition for ``at-
risk beneficiary'' that we proposed to codify at Sec.  423.100. In 
addition, although the section 1860D-4(c)(5) of the Act does not 
explicitly define a ``potential at-risk beneficiary,'' it refers to a 
beneficiary who is potentially at-risk in several subsections.
    Accordingly, we proposed to define these two terms at Sec.  423.100 
as follows: Potential at-risk beneficiary means a Part D eligible 
individual--(1) Who is identified using clinical guidelines (as defined 
in Sec.  423.100); or (2) With respect to whom a Part D plan sponsor 
receives a notice upon the beneficiary's enrollment in such sponsor's 
plan that the beneficiary was identified as a potential at-risk 
beneficiary (as defined in paragraph (1) of this definition) under the 
prescription drug plan in which the beneficiary was most recently 
enrolled, such identification had not been terminated upon 
disenrollment, and the new plan has adopted the identification.
    At-risk beneficiary means a Part D eligible individual--(1) who 
is--(i) Identified using clinical guidelines (as defined in Sec.  
423.100); (ii) Not an exempted beneficiary; and (iii) Determined to be 
at-risk for misuse or abuse of such frequently abused drugs under a 
Part D plan sponsor's drug management program in accordance with the 
requirements of Sec.  423.153(f); or (2) With respect to whom a Part D 
plan sponsor receives a notice upon the beneficiary's enrollment in 
such sponsor's plan that the beneficiary was identified as an at-risk 
beneficiary (as defined in paragraph (1) of this definition) under the 
prescription drug plan in which the beneficiary was most recently 
enrolled, such identification had not been terminated upon 
disenrollment, and the new plan has adopted the identification. We 
noted that we included the phrase, ``and the new plan has adopted the 
identification'' to both definitions for cases where a beneficiary has 
been identified as a potential at-risk or at-risk beneficiary by the 
immediately prior plan to indicate that the beneficiary's status in the 
subsequent plan is not automatic.
    We received the following comments and our response follows:
    Comment: A commenter did not believe that a definition for a 
``potential at-risk beneficiary'' was needed, nor the additional 
prescriber verification the commenter associated with the definition.
    Response: We disagree. Although as we noted above, section 1860D-
4(c)(5) of the Act does not explicitly define a ``potential at-risk 
beneficiary,'' it refers to a beneficiary who is potentially at-risk in 
section 1860D-4(c)(5)(B)(ii), which addresses initial notices; in 
1860D-4(c)(5)(H)(i) which addresses data disclosures; and in section 
1860D-4(c)(5)(I) which addresses the sharing of information for 
subsequent plan enrollments. Therefore, we proposed to define a 
potential at-risk beneficiary in Sec.  423.100, as the CARA drug 
management program provisions clearly contemplate this status for a 
beneficiary.
    With respect to additional prescriber verification of a potential 
at-risk beneficiary, we believe this comment is based on a 
misunderstanding of our proposal, as we did not propose that a 
beneficiary's status as a potential at-risk beneficiary must be 
verified. Rather, we proposed and are finalizing a requirement, as we 
discuss later in this preamble, that a prescriber must verify that a 
beneficiary is at-risk, which serves as his or her professional opinion 
that a Part D plan sponsor takes into account during case management.
    Comment: We received a question whether an individual who is 
subject to lock-in under his or her Medicaid program and then becomes 
dually-eligible constitutes a potential or at-risk beneficiary under 
our proposed definitions.
    Response: Such a beneficiary would not automatically be considered 
to be a potential at-risk or an at-risk beneficiary under a Part D 
sponsor's drug management program. Rather, whether such a beneficiary 
is a potential at-risk or at-risk beneficiary would depend upon whether 
he or she meets the clinical guidelines and is determined to be an at-
risk beneficiary under the process set forth in this rule. An automatic 
determination based on a beneficiary's inclusion and status in a 
Medicaid drug management program would not be appropriate because each 
Medicaid drug management program has its own criteria and requirements 
for reviewing and addressing recipients who may be at-risk for 
prescription drug abuse or misuse and its own interventions. We also 
note that Medicaid programs are not required to comply with section 
1860D-4(c)(5) as Part D drug management programs are.
    To the extent a Part D sponsor is aware or discovers based on 
reliable information that a beneficiary who meets the clinical 
guidelines was locked-in under a Medicaid drug management program, that 
sponsor may consider that information in deciding whether to determine 
that a beneficiary is an at-risk beneficiary under the requirements of 
this final rule. Also, any beneficiary entering the Part D program will 
be immediately subject to their plan's formulary-level controls to 
address opioid overutilization before they may be identified as 
potentially at-risk, so any opioid overutilization by the beneficiary 
in his or her new Part D plan may be addressed by these controls.
    Comment: We received a comment requesting clarification with regard 
to a person who is locked-in under an employer plan and then becomes 
eligible for a Part D EGWP, if the EGWP can continue the lock-in in the 
Part D plan or at least consider the prior lock-in as part of a new 
determination.
    Response: Beginning with plan year 2019, Part D sponsors, including 
sponsors of EGWPs, may adopt drug management programs that meet the 
requirements we are finalizing in this rule. Under a Part D 
prescription drug management program, sponsors may implement a 
prescriber and/or pharmacy lock-in or beneficiary-specific POS claim 
edit for frequently abused drugs with respect to an at-risk 
beneficiary. Similar to a Medicaid beneficiary who becomes newly 
eligible for Medicare and enrolls in Part D, a person who is locked-in 
under a

[[Page 16445]]

commercial plan does not automatically meet the definition of an at-
risk beneficiary we are finalizing in Sec.  423.100. Rather, such a 
person first must be determined to be an at-risk beneficiary in 
accordance with the requirements we are finalizing at Sec.  423.153(f).
    In other words, in order for a beneficiary to be eligible to be 
immediately locked-in to a prescriber or pharmacy in a Part D plan in 
which they are newly enrolled, the plan from which they most recently 
disenrolled must be a Part D plan in which he or she was determined to 
be an at-risk beneficiary under that plan's drug management program. 
When a new enrollee comes from a non-Part D plan in which the 
beneficiary was subject to lock-in, however, the sponsor can consider 
the prior lock-in if it learns or knows of it based upon reliable 
information which is legally available to the sponsor in conjunction 
with the information it gathers from the case management process, the 
beneficiary, and the sponsor's other relevant internal sources and 
data.
    Comment: A commenter asked if a Part D sponsor may consider opioid 
utilization information from external sources during case management, 
such as a state prescription drug monitoring program (PDMP) in making 
the determination if a beneficiary is at-risk.
    Response: As noted above with respect to beneficiaries who were 
locked-in under an employer or Medicaid plan before enrolling in 
Medicare Part D, we encourage sponsors to use all reliable sources 
legally available to them to obtain an accurate account of a potential 
at-risk or at-risk beneficiary's utilization of frequently abused 
drugs.
    After considering the comments, we are finalizing the definition of 
potential at-risk beneficiary and at-risk beneficiary with minor 
modifications for clarity. First, we are removing the phrase ``and the 
new plan adopted the identification'' from paragraph (2) of both 
definitions. As we noted above, the purpose of this language was to 
indicate that the beneficiary's at-risk status in the subsequent plan 
is not automatic, which we meant for purposes of the limitation on the 
special enrollment period (SEP) for LIS beneficiaries with an at-risk 
status. However, as we discuss later in this preamble, this limitation 
will be triggered or continued by Part D sponsors sending the initial 
and second notices to such beneficiaries, as applicable, so we no 
longer believe this phrase is necessary in these definitions.
    Second, we also are making a minor clarifying change in the 
definition of at-risk beneficiary to explicitly acknowledge that it is 
the Part D sponsor that determines which beneficiaries are at-risk 
beneficiaries under its drug management program.
    The definition of potential at-risk beneficiary will read: A Part D 
eligible individual--(1) Who is identified using clinical guidelines 
(as defined in Sec.  423.100); or (2) With respect to whom a Part D 
plan sponsor receives a notice upon the beneficiary's enrollment in 
such sponsor's plan that the beneficiary was identified as a potential 
at-risk beneficiary (as defined in paragraph (1) of this definition) 
under the prescription drug plan in which the beneficiary was most 
recently enrolled and such identification had not been terminated upon 
disenrollment. The definition of at-risk beneficiary will read: At-risk 
beneficiary means a Part D eligible individual--(1) Who is--(i) 
Identified using clinical guidelines (as defined in Sec.  423.100); 
(ii) Not an exempted beneficiary; and (iii) Determined to be at-risk 
for misuse or abuse of such frequently abused drugs by a Part D plan 
sponsor under its drug management program in accordance with the 
requirements of Sec.  423.153(f); or (2) With respect to whom a Part D 
plan sponsor receives a notice upon the beneficiary's enrollment in 
such sponsor's plan that the beneficiary was identified as an at-risk 
beneficiary (as defined in the paragraph (1) of this definition) under 
the prescription drug plan in which the beneficiary was most recently 
enrolled and such identification had not been terminated upon 
disenrollment.
(B) Definition of ``Frequently Abused Drug'', ``Clinical Guidelines'', 
``Program Size'', and ``Exempted Beneficiary'' (Sec.  423.100)
    Because we use these terms in the proposed definitions of 
``potential at-risk beneficiary'' and ``at-risk beneficiary,'' we 
proposed to define ``frequently abused drug'', ``clinical guidelines'', 
``program size'', and ``exempted beneficiary'' at Sec.  423.100 as 
follows:
 Frequently Abused Drug
    Section 1860D-4(c)(5)(G) of the Act defines ``frequently abused 
drug'' as a drug that is a controlled substance that the Secretary 
determines to be frequently abused or diverted. Consistent with the 
statutory definition, we proposed to define ``Frequently abused drug'' 
at Sec.  423.100 to mean a controlled substance under the Federal 
Controlled Substances Act that the Secretary determines is frequently 
abused or diverted, taking into account the following factors: (1) The 
drug's schedule designation by the Drug Enforcement Administration; (2) 
Government or professional guidelines that address that a drug is 
frequently abused or misused; and (3) An analysis of Medicare or other 
drug utilization or scientific data. This definition is intended to 
provide enough specificity for stakeholders to know how the Secretary 
will determine a frequently abused drug, while preserving flexibility 
to update which drugs CMS considers to be frequently abused drugs based 
on relevant factors, such as actions by the Drug Enforcement 
Administration and/or trends observed in Medicare or scientific data. 
Since we did not receive any specific comments to change this 
definition, we are finalizing it as proposed.
    Comment: A commenter requested that CMS include the criteria, 
resources, and the evidence basis upon which it will rely to determine 
that a drug is a frequently abused drug for purposes of a drug 
management program.
    Response: The definition of frequently abused drug that we are 
finalizing indicates that criteria, resources, and evidence basis will 
be the DEA schedule designation, government, and professional drug 
guidelines, and analyses of drug utilization or scientific data.
    We did not receive any further comment on the definition of 
``frequently abused drug'' and are therefore finalizing it as proposed.
    Consistent with current policy, we proposed that opioids are 
frequently abused drugs, except buprenorphine for medication-assisted 
treatment (MAT) and injectables. As we stated in the preamble to the 
proposed rule, we plan to publish and update a list of frequently 
abused drugs for purposes of Part D drug management programs.
    Comment: All commenters agreed that the Secretary should determine 
that opioids are frequently abused drugs, many referencing the national 
opioid overuse epidemic.
    Response: We appreciate that stakeholders are focused on the opioid 
public health emergency.
    Comment: Some of these commenters agreed with our proposal to 
determine only opioids, except buprenorphine for medication-assisted 
treatment (MAT) and injectables, as frequently abused drugs, at least 
in the initial implementation of Part D drug management programs, in 
order to allow CMS and stakeholders to focus on opioid overuse and gain 
experience with the use of lock-in as a tool to address overutilization 
in the Part D program, before potentially determining other controlled 
substances as

[[Page 16446]]

frequently abused drugs. These commenters urged CMS to wait until drug 
management programs were established, and testing and monitoring 
indicate that the program can be administered in a manner that does not 
limit beneficiary access to needed medications before expanding the 
programs further. Some of these commenters were concerned that an at-
risk beneficiary would have to obtain all frequently abused drugs from 
one pharmacy or one prescriber and that this could disrupt patient care 
if the pharmacy did not carry all frequently abused drugs.
    However, some commenters urged us to determine that all controlled 
substances are frequently abused drugs. These commenters were 
particularly focused on a determination as to benzodiazepines, and to a 
lesser extent, muscle relaxants. Due to this focus, these commenters 
referred to the CDC Guideline that specifically recommends that 
clinicians avoid prescribing opioid pain medication and benzodiazepines 
concurrently whenever possible due to increased risk for overdose. They 
also referred to CMS work in this area: (1) The fact that CMS added a 
concurrent benzodiazepine-opioid flag to OMS in October 2016 in 
response to the CDC Guideline and after our own research on the use of 
benzodiazepines among Medicare beneficiaries \2\ to alert Part D 
sponsors that concurrent use may be an issue that should be addressed 
during case management; \3\ and (2) the fact that we have stated that a 
sponsor may implement a beneficiary-specific claim edit at POS for non-
opioid medications under the current policy.\4\ They further referred 
to a statistic from the National Institute on Drug Abuse that 30 
percent of overdoses involving opioids also involve benzodiazepines.\5\ 
Finally, these commenters pointed out that the FDA has found that the 
growing combined use of opioid medicines with benzodiazepines or other 
drugs that depress the central nervous system has resulted in serious 
side effects, including slowed or difficult breathing and deaths. These 
commenters further noted that in an effort to decrease the use of 
opioids and benzodiazepines, and opioids and other such depressants, 
the FDA added Boxed Warnings--its strongest warnings--to the drug 
labeling of prescription opioid pain and cough medicines, and 
benzodiazepines.\6\ Given these developments, these commenters stressed 
the importance of Part D plan sponsors being able to use the tools that 
will be available to them under drug management programs to address the 
dangers of concurrent opioid and benzodiazepine use.
---------------------------------------------------------------------------

    \2\ https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Concurrent-Use-of-Opioids-and-Benzodiazepines-in-a-Medicare-Part-D-Population-CY-2015.pdf.
    \3\ Please refer to the memo, ``Medicare Part D Overutilization 
Monitoring System (OMS) Update: Addition of the Concurrent Opioid-
Benzodiazepine Use Flag'' dated October 21, 2016.
    \4\ Supplemental Guidance Related to Improving Drug Utilization 
Review Controls in Part D'' September 6, 2012.
    \5\ https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids.
    \6\ https://www.fda.gov/Drugs/DrugSafety/ucm518473.htm.
---------------------------------------------------------------------------

    Response: In light of these comments, we are persuaded that it is 
appropriate that drug management programs are able to address 
concurrent opioid and benzodiazepine use. Such a determination is 
consistent with the definition of frequently abused drugs that we are 
finalizing. First, the Secretary determines benzodiazepines are 
frequently abused or diverted, taking into account that they are 
controlled substances under the Controlled Substances Act (CSA) and 
that prescription benzodiazepines are on Schedule IV, where the DEA 
places substances that have a potential for abuse. In addition, the 
Secretary takes into account that the FDA has issued a warning about 
the risks associated with using opioids and benzodiazepines 
concurrently. Further, the CDC included in its evidence-based opioid 
prescribing guideline a caution to co-prescribe opioids and 
benzodiazepines. Finally, CMS' own statistics reveal that 51 percent of 
Part D beneficiaries that will be identified as potentially at-risk 
under the 2019 clinical guidelines we are finalizing are using opioids 
and benzodiazepines concurrently compared to 24 percent across all Part 
D opioid users. This statistic is indicative that concurrent use is 
even more of a danger among potential at-risk beneficiaries than 
Medicare Part D beneficiaries generally. Therefore, the Secretary 
determines that benzodiazepines are a frequently abused drug for 
purposes of Part D drug management programs beginning in 2019. However, 
the clinical guidelines will still only consider a beneficiary's opioid 
use, as we explain just below.
    Comment: A commenter agreed with our statement in the proposed rule 
that there is difficulty in establishing overuse guidelines for non-
opioid substances. The commenter stated that this underscores the need 
for a robust evidence base to support determining that additional types 
of drugs are frequently abused drugs.
    Response: We agree with the commenter's concern, and for this 
reason we are not modifying the clinical guidelines for 2019 to include 
benzodiazepine use, even though benzodiazepines will be considered a 
frequently abused drug for 2019. This means that a beneficiary who is 
determined to be at-risk based on clinical guidelines that look at the 
beneficiary's opioid use could have a coverage limitation applied under 
a drug management program to both opioids and benzodiazepines to manage 
current and future concurrent use. For example, a sponsor could require 
an at-risk beneficiary to obtain both opioids and benzodiazepines from 
one selected pharmacy.
    We believe that this is appropriate based on the robust evidence 
that concurrent benzodiazepine use with opioids results in an even 
higher risk of an adverse health event than use of opioids alone. We 
will expect to rarely see a sponsor apply a limitation only to an at-
risk beneficiary's access to coverage for benzodiazepines, since to do 
so, the beneficiary would have to have met the clinical guidelines 
which look at opioid use that is potentially risky. However, we 
acknowledge that prescriber agreement during case management could 
rarely lead to such an outcome. For example, no opioid prescriber 
agrees to a beneficiary-specific POS claim edit for opioids, but 
rather, all but one states they will no longer prescriber opioids to 
coordinate the beneficiary's use. However, the benzodiazepine 
prescriber agrees to such an edit for benzodiazepines. We discuss 
prescriber agreement in more detail later in this preamble.
    Given that we are finalizing two categories of drugs as frequently 
abused drugs for 2019, depending upon what a plan sponsor learns during 
case management, we reiterate that the sponsor may have to permit a 
beneficiary to obtain frequently abused drugs from more than one 
pharmacy and/or more than one prescriber in order to provide reasonable 
access, if the sponsor applies lock-in as a coverage limitation, which 
we discuss later in this preamble.
    Comment: A few commenters suggested that Part D sponsors be able to 
expand their drug management programs to include additional frequently 
abused drugs based on their experience with their enrollees. One 
suggested that a sponsor be required to submit such an expansion to CMS 
for approval.
    Response: We disagree with this comment. Section 1860D-4(c)(5)(G) 
of the Act defines ``frequently abused

[[Page 16447]]

drug'' as a drug that is a controlled substance that the Secretary 
determines to be frequently abused or diverted. Consistent with this 
statutory provision, we believe it is appropriate that the 
determination of frequently abused drugs not be plan-specific, but 
rather be consistent across Part D plans, as this will permit better 
oversight and promote consistency across all Part D drug management 
programs.
    We proposed that future determinations of frequently abused drugs 
by the Secretary primarily be included in the annual Medicare Parts C&D 
Call Letter or in similar guidance, if necessary, to address midyear 
entries to the drug market or evolving government or professional 
guidelines or relevant data analysis, which will be subject to public 
comment. We proposed that this approach would be consistent with our 
approach under the current policy and necessary for Part D drug 
management programs to be responsive to changing public health issues 
over time.
    Comment: We received comments supportive of our proposal to apply 
the standards we are establishing in rulemaking to future 
determinations of frequently abused drugs through the annual Medicare 
Parts C&D Call Letter, or in similar guidance. We did not receive any 
comments that opposed this proposed approach.
    Response: We appreciate the comments.
    Comment: A commenter asked us to confirm that we would use the same 
process to determine that a drug is no longer a frequently abused drug.
    Response: We will apply the same regulatory standards and use the 
same process that we use to determine that a drug is a frequently 
abused drug when determining that a drug no longer is a frequently 
abused drug for purposes of Part D drug management programs.
    Comment: A few commenters urged CMS to exclude abuse-deterrent (AD) 
opioids from this definition of ``frequently abused drug'' as there is 
no evidentiary data to support the thesis that AD opioids are 
frequently abused and existing observation data supports their 
exclusion from this broad standard.
    Response: The FDA requires a boxed warning on opioid abuse-
deterrent formulations (ADFs), because even with these formulations 
there is still potential for addiction, abuse, misuse, and diversion. 
The FDA has also noted \7\ that ``abuse-deterrent technologies have not 
yet proven successful at deterring the most common form of abuse--
swallowing a number of intact capsules or tablets to achieve a feeling 
of euphoria. Moreover, the fact that a product has abuse-deterrent 
properties does not mean that there is no risk of abuse. It means, 
rather, that the risk of abuse is lower than it would be without such 
properties.'' Also, ADFs do not prevent patients who may be using 
opioids for therapeutic reasons from taking higher doses than 
prescribed or diverting the opioid. For these reasons, we disagree that 
abuse-deterrent formulations should be excluded from the determination 
of frequently abused drugs.
---------------------------------------------------------------------------

    \7\ ``Abuse-Deterrent Opioids--Evaluation and Labeling Guidance 
for Industry'', U.S. Department of Health and Human Services, Food 
and Drug Administration, Center for Drug Evaluation and Research 
(CDER), Clinical Medical, April 2015.
---------------------------------------------------------------------------

    Comment: A few commenters asked CMS to clarify whether methadone, a 
Part D drug when indicated for pain, would be included in the 
definition of a frequently abused drug under the drug management 
program. Other commenters agreed with excluding buprenorphine for MAT 
from the definition of frequently abused drug as not to limit patient 
access to treatment and noted that removing buprenorphine as a 
frequently abused drug is consistent with the CDC's approach to exclude 
buprenorphine from the determination of a person's daily opioid MME.
    Response: Yes, methadone for pain is included in the definition of 
a frequently abused drug for purposes of Part D drug management 
programs, consistent with current policy/OMS. Although buprenorphine is 
recognized by the DEA as a drug of abuse, we thank the commenters that 
agreed with excluding buprenorphine for MAT from the definition of 
frequently abused drug so that access to MAT, such as buprenorphine, is 
not impacted. However, the commenters' reference to the CDC's exclusion 
of buprenorphine from the determination of a person's daily opioid MME 
made us believe that commenters may be conflating the definition of a 
frequently abused drug with the clinical guidelines and associated 
opioid dosage thresholds. Therefore, we realize that we need to be more 
specific about what opioid use, opioid prescribers, and opioid 
dispensing pharmacies means in the clinical guidelines, which we also 
discuss later.
    Since the publication of the proposed rule, the CDC removed the 
conversion factors for all formulations of buprenorphine, for pain and 
for MAT, from the most recent CDC MME conversion factor file (https://www.cdc.gov/drugoverdose/data-files/CDC_Oral_Morphine_Milligram_Equivalents_Sept_2017.xlsx). Therefore, CMS 
cannot determine the MME. As such, buprenorphine products are not used 
to determine the beneficiary's average daily MME. However, we will 
still use prescription opioids, including all formulations of 
buprenorphine for pain and MAT, to determine opioid prescribers and 
opioid dispensing pharmacies in the clinical guidelines.
 Clinical Guidelines & Program Size
    Section 1860D-4(c)(5)(C)(i)(I) of the Act requires at-risk 
beneficiaries to be identified using clinical guidelines that indicate 
misuse or abuse of frequently abused drugs and that are developed by 
the Secretary in consultation with stakeholders. We proposed to include 
a definition of ``clinical guidelines'' that cross references standards 
that we proposed at Sec.  423.153(f) for how the guidelines will be 
established and updated. Specifically, we proposed to define clinical 
guidelines for purposes of a Part D drug management program in Sec.  
423.100 as criteria to identify potential at-risk beneficiaries who may 
be determined to be at-risk beneficiaries under such programs, and that 
are developed in accordance with the standards in Sec.  423.153(f)(16) 
and beginning with contract year 2020, will be published in guidance 
annually.
    We also proposed to add Sec.  423.153(f)(16) to state that 
potential at-risk beneficiaries and at-risk beneficiaries are 
identified by CMS or a Part D sponsor using clinical guidelines that: 
(1) Are developed with stakeholder consultation; (2) Are based on the 
acquisition of frequently abused drugs from multiple prescribers, 
multiple pharmacies, the level of frequently abused drugs, or any 
combination of these factors; (3) Are derived from expert opinion and 
an analysis of Medicare data; and (4) Include a program size estimate. 
This proposed approach to developing and updating the clinical 
guidelines is intended to provide enough specificity for stakeholders 
to know how CMS will determine the guidelines by identifying the 
standards we will apply in determining them.
    This proposed approach also indicated that the program size will be 
determined as part of the process to develop the clinical guidelines--a 
process into which stakeholders will provide input. Section 1860D-
4(c)(5)(C)(iii) of the Act states that the Secretary shall establish 
policies, including the guidelines and exemptions, to ensure that the 
population of enrollees in drug management programs could be 
effectively managed by plans. We proposed to define ``program size'' in

[[Page 16448]]

Sec.  423.100 to mean the estimated population of potential at-risk 
beneficiaries in drug management programs (described in Sec.  
423.153(f)) operated by Part D plan sponsors that the Secretary 
determines, as part of the process to develop clinical guidelines, can 
be effectively managed by such sponsors.
    Comment: We did not receive any specific comments about the 
definition we proposed for clinical guidelines in Sec.  423.100, nor 
the standards we proposed in Sec.  423.153(f)(16).
    Response: We are therefore finalizing the definition and standards 
as proposed, with one modification adding language so that the 
guidelines will be published in guidance annually beginning with 
contract year 2020 guidance, since we are publishing the 2019 clinical 
guidelines in this final rule.
    Comment: We received comments supportive of our proposal to apply 
the standards we are establishing in rulemaking for clinical guidelines 
in Sec.  423.153(f)(16) to develop future OMS criteria through the 
annual Medicare Parts C&D Call Letter process beginning with plan year 
2020.
    We did not receive comments that specifically opposed this proposed 
approach.
    Response: We appreciate these comments.
    Because Part D drug management programs will be integrated with the 
current policy/OMS beginning in 2019, there will be no separate OMS 
criteria in 2019 and beyond. For plan year 2019, we proposed the 
clinical guidelines to be the OMS criteria established for plan year 
2018. The clinical guidelines for use in drug management programs we 
proposed for 2019 are: Use of opioids with an average daily MME greater 
than or equal to 90 mg for any duration during the most recent 6 months 
and either: 4 or more opioid prescribers and 4 or more opioid 
dispensing pharmacies OR 6 or more opioid prescribers, regardless of 
the number of opioid dispensing pharmacies.
    We estimated that these criteria would identify approximately 
33,053 potential at-risk beneficiaries in the Part D program based on 
2015 data, whom we believe are at the highest risk of death or overdose 
due to their opioid use. Also, under our proposal, we stated that Part 
D plan sponsors will not be able to vary the criteri