CY2019 Plan Benefit Package (PBP) Software and Formulary Submission (CMS-R-262)

Opioid Strategy Layout

Required File Format = Microsoft® Word
Filename extension should be “.doc” or “.docx”
This submission document should contain a summary of your organization’s comprehensive strategy to
combat the opioid crisis. Provide information on your current strategy and note changes or new strategy
to be implemented for the upcoming contract year. If the same strategy applies to multiple contracts,
only one document needs to be uploaded and the applicable contracts may be associated to the
document during the upload process. This applies to all organizations offering a Part D benefit, including
PACE and Employer Groups. CMS will utilize information submitted through this process to assist in the
modification of existing Part D policy and/or development of new policy to help combat the opioid crisis.
We may also synthesize information and publish “best practices.” Any information made publicly
available will be summarized and not attributed to a specific organization.
The strategy document should be divided into sections as outlined below. Examples of information to be
included in the sections are recommendations only. Sponsors are not required to address each example
and should include any additional information related to these areas. The submissions will not be
subject to an approval process and modifications or resubmissions will not be requested by CMS.
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P&T Opioid Formulary Design Approach – What formulary placement strategies are utilized? For
example, placing certain opioids in non-preferred versus preferred tiers, inclusion of alternatives
to treat pain in preferred tiers, and formulary considerations of abuse-deterrent opioids. What
utilization management techniques are applied to opioids, and are there differences in how
these are applied based on the specific opioid? How are quantity limits determined? Do prior
authorization or step therapy requirements result in preferring certain opioids over others, or
non-opioids versus opioids? What clinical guidelines or other sources are utilized in the
formulary development process?
Concurrent Drug Utilization Review (DUR) – How are the morphine milligram equivalents (MME)
hard and/or soft edits developed? How is the effectiveness of these edits monitored and what
adjustments are made as a result? What additional concurrent DUR editing is performed on
opioids? Are the edits hard or soft edits? Are opioid prescriptions limited to days supplies or unit
restrictions, and if so, what is utilized and how are they developed? What challenges have you
encountered in implementing concurrent DUR?
Medication Therapy Management (MTM) Program – Are opioids explicitly addressed in your
MTM program? Do you offer MTM services to at-risk beneficiaries, who do not otherwise qualify
for MTM? If so, what kind of MTM services or interventions do you offer?
Retrospective DUR Strategies – Do you have a drug management program? If not, why not and
what program do you have instead to address opioid overutilization? (Please describe in detail
and include the impacted beneficiary population size). If so, please describe the overall
approach of your drug management program. Please include in your description 1) how you
apply the clinical guidelines/OMS criteria to your beneficiary population; 2) whether you use a
wait and see approach to case management, and if so, do you always use it or do you address
certain cases more immediately by contacting the prescribers telephonically?; 3) how you

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handle at-risk beneficiaries who continue to meet the clinical guidelines/OMS criteria; 4) your
experience with making exceptions to at-risk beneficiary preferences and providing reasonable
access to beneficiaries, and beneficiary appeals; 5) how you approach potential and at-risk
beneficiaries who change plans; and 6) how you have addressed your program with your
pharmacy and provider (if applicable) network.
Fraud, Waste, and Abuse (FWA) Programs – Please describe any FWA programs or activities
specific to opioids and the effectiveness of these programs.
Medication-Assisted Treatment (MAT) Access Initiatives – What formulary and benefit designs
are incorporated to promote appropriate access to Part D MAT? What activities does your
organization perform to promote and/or monitor adherence to MAT? What types of edits are
drugs indicated for MAT subject to at point-of-sale?
Overuse Prevention – Describe what strategies, if any, your organization has in place with
respect to overdose prevention, outside of formulary placement. For example, to increase
access to overdose reversal drugs; conduct education with doctors, pharmacies, and
beneficiaries; use of pain treatment plans; promote the use of prescription drug monitoring
program (PDMP) databases; and/or medication disposal.
Use of Medicare Advantage (MA) Data to Support Opioid Crisis Efforts (MA Plans) – How is MA
data utilized in the identification of opioid utilization? How is data utilized in the outreach and
management of overutilization? What coordination is done between the health and drug
benefits to address overutilization? What care management interventions are provided to
enrollees using high dosage opioids?
Commercial Efforts to Combat the Opioid Crisis – Please describe any programs, initiatives, or
other efforts that you have in place for your commercial lines of business. Have these efforts
been successful? Please describe any Part D policy barriers that are in place that would prevent
you from implementing these programs in Part D.
Lessons Learned or Outcomes Data – Describe outcomes of your strategy, lessons learned, or
best practices.
Other

PRA Disclosure Statement According to the Paperwork Reduction Act of 1995, no persons are required to respond
to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-0763. The time required to complete this information collection is estimated to average
6 hours per response, including the time to review instructions, search existing data resources, and gather the data
needed, and complete and review the information collection. If you have any comments, concerning the accuracy of
the time estimate(s) or suggestions for improving this form, please write to CMS, Attn: Reports Clearance Officer,
7500 Security Boulevard, Baltimore, Maryland 21244-1850.