The Centers for Medicare & Medicaid Services (CMS) released detailed and specific requirements on November 20, 2018, in the “Part D Drug Management Program Policy Guidance.” The release includes the “how to” for implementation of Drug Management Programs (DMPs), which are required beginning January 1, 2022. CMS expects all Part D sponsors to implement DMPs in 2019, including Programs of All-Inclusive Care for the Elderly (PACE) plans and Employer Group Waiver Plans (EGWPs). CMS describes programming that intends to strike a balance between beneficiary access and beneficiary risk due to use of frequently abused drugs (FADs). Of particular interest are the following:
- Standard beneficiary notice of intent to limit access of FADs is being finalized through the Office of Management and Budget (OMB), and Part D sponsors are required to use these notices when available.
- Beneficiaries must meet criteria in the quarterly Overutilization Monitoring System (OMS) reports to be potential at-risk beneficiaries (PARBs), however, plans can institute more frequent monitoring (monthly).
- Part D sponsors must review all beneficiaries meeting minimum OMS criteria and respond to CMS.
- Members identified as meeting criteria will be enrolled in case management with prescriber engagement to determine if the member is indeed at risk.
- Members’ access can only be limited after notification.
- Options available include beneficiary-specific point of sale edits, limitation to network prescriber, and/or limitation to network pharmacy.
- Members generally may select the prescriber and pharmacy.
- Case management must be conducted by a licensed professional – “generally a physician or other health care professional with expertise to conduct medical necessity reviews related to potential opioid overutilization.”
- Having a cancer diagnosis does not exempt a beneficiary from DMP enrollment only “active cancer-related pain.” Only cancer survivors with chronic pain, in active remission, or under cancer surveillance would not be exempt.
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