The year 2020 was unprecedented in many ways and that included the CMS rulemaking process for contract year 2021 (CY2021). Instead of issuing a Proposed Rule and a single, related Final Rule, CMS released multiple documents and Final Rules. While CMS finalized the most immediate regulatory actions in June 2020 in order to implement certain changes before CY2021, there were delays in implementing portions of the proposed rules due to the pandemic that are now being finalized.
In the next phase of finalizing the 2021 proposed rules, CMS released the CY2022 Medicare Advantage and Part D Final Rule (Final Rule) on January 19, 2021, which clarifies and implements some of these changes. The Final Rule also codifies existing Part C and D program policy with respect to supplemental benefits and Programs of All-Inclusive Care for the Elderly (PACE).
Elixir has reviewed the CY2022 Final Rule to assess its impact on Part D plans. Following are key provisions for CY2022:
New “Preferred” Specialty Tier in Part D – Beginning in CY2022, CMS allows Part D plans to establish a second specialty tier, splitting specialty drugs between non-preferred and preferred specialty tiers, with the preferred tier carrying lower cost-sharing obligations. The Final Rule also updates the methodologies for calculating the specialty tier cost threshold and determining whether a drug meets the specialty tier cost threshold.
According to the Pharmacy Benefit Management Institute (PBMI), the majority of employers have multiple tiers for traditional drugs to help manage costs. Applying this same tactic to the costly and growing specialty drug class could provide cost savings opportunities for Part D plans and beneficiaries.
SUPPORT Act Opioid Provisions – The Final Rule implements several provisions outlined in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Beginning in CY2022, the following SUPPORT Act initiatives will be implemented:
- CMS is adding to the existing clinical guidelines used to identify potential at-risk beneficiaries (PARBs) to include individuals who have a history of opioid-related overdose and at least one recent opioid claim.
- Those defined as at-risk beneficiaries (ARBs) will now be targeted for enrollment in Medication Therapy Management (MTM) programs.
- Part D sponsors must disclose to each enrollee information about the risks of prolonged opioid use, as well as coverage of non-pharmacological therapies, devices and non-opioid medications available for treatment of pain under their plans. Sponsors of standalone PDPs must disclose coverage under Medicare Parts A and B.
- Plan sponsors are permitted to meet the safe-disposal educational requirements through the use of comprehensive medication reviews (CMRs), targeted medication reviews (TMRs) or other MTM correspondence.
- Drug management programs (DMPs) will be mandatory for all Part D sponsors, and sponsors are required to auto-forward to the independent review entity (IRE) redeterminations where the denial is related to an at-risk determination.
Pharmacy Performance Measures Reporting Requirements – CMS will require Part D plan sponsors to report the pharmacy performance measures they use to evaluate network pharmacy performance under their network agreements. This will help CMS to better understand how such measures are applied and to report pharmacy performance measures publicly to improve transparency and work toward a standard set of pharmacy performance measures.
Beneficiary Real Time Benefit Tool (RTBT) – Following on to the Prescriber RTBT requirement that was effective for CY2021, the Final Rule requires Part D plans to offer a beneficiary real-time benefit tool that allows enrollees to access patient-specific, real-time formulary and benefit information, such as cost, formulary alternatives and utilization management requirements. The original effective date for the beneficiary RTBT was CY2022, but CMS has moved the effective date of this requirement to CY2023.
Elixir’s comprehensive Member Portal provides real-time benefit information, as well as cost-saving, clinically effective alternatives.
Elixir is ready to support all of our impacted clients with these provisions and will continue to provide guidance throughout CY2022 implementation, including any additional rulemaking CMS may release to address the two remaining proposals from 2020. Clients can contact their designated Elixir account manager or compliance officer with any additional questions.
2018 Trends in Drug Benefit Design. PBMI