Highlights of the Final Rule

By March 5, 2021March 24th, 2021CMS, Medicare, PACE

Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly

starting to prepare for what is coming in 2022. On January 19, 2021, the Centers for Medicare & Medicaid Services (CMS) issued the second final rule referenced above (CMS-4190-F2) to amend regulations for the Medicare Advantage (MA) Part C program, Medicare Prescription Drug Benefit Part D program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE). This is the second final rule originating from the proposed rule (CMS-4190-P), which was issued on February 18, 2020.  The first final rule (CMS-4190-F1), which was issued on June 2, 2020, only addressed those provisions from the proposed rule that CMS deemed most helpful for bidding, that addressed the COVID-19 pandemic and public health emergency, or that advance the MA program.

Although the regulations are effective March 22, 2021, most of the rule’s requirements will be applicable to coverage beginning January 1, 2022.

If you have not received BluePeak’s complete summary of the Final Rule, please contact us.  Following are some noteworthy highlights that have operational impacts for Plans and PBMs to consider.

  • The Final Rule gives plans the option of introducing a second specialty tier.  If a Plan is considering implementing a second specialty tier, the Plan should first perform data analytics to determine how best to implement based on available rebates and other financial considerations.  The Pharmacy and Therapeutics teams will need to review product placement into this new tier.  Formulary management tools may require an update to accommodate the definition of an additional tier.  Internal team support will also be required to review the changes to the formulary to include with the bid submission and HPMS formulary uploads.  Once the second specialty tier benefit design is submitted, plans will need to communicate this new benefit offering to the teams who are programming the changes for contract year 2021.   Additionally, pre-go-live testing scenarios will need to be updated to confirm the additional tier has been implemented at the correct cost share and medications identified in the respective tier.  Member marketing materials and plan websites will also require an update to reflect the additional tier being implemented.  Training of call center teams will also be required to assure their understanding of the change so member inquiries can be appropriately addressed.  The department handling coverage determinations will also require training, especially because the introduction of the second specialty tier also requires a process for down tiering request from the higher tier to the lower tier when applicable.  Policies and procedures will need to be updated to reflect the change in processes.
  • There are operational considerations for plans and PBMs to think about as related to the member RTBT.  While Plans already are required to have the prescriber RTBT available, this new requirement is to implement a member-facing RTBT. If Plans leverage their existing prescriber RTBT to meet the member-facing RTBT requirements, the tool may require some updates to be member centric and meet the requirements of this Final Rule.  Member marketing materials and plan websites will also require updates to ensure members are aware of the tools available to them and how to access the tools.  The call center teams will require training surrounding this new technology, including its purpose, how it functions for members, and what common issues members may have while accessing the tool.  An escalation process will be required to handle technology related issues that may surface.  Lastly, CMS is allowing Plans to offer member incentives to increase member utilization of these RTBTs.  While member incentives is not a new concept to MAPD plans, this will be a new endeavor for some plans, particularly PDP plans who have not had incentives in place to date.
  • While many plans have already implemented a DMP for the members, it is not required by regulation until January 1, 2022.  In addition to the original requirements, CMS provided some additional considerations that all plans will need to address for 2022.  Plans will need to deploy additional analytics to identify a few additional members for inclusion in the DMP.  If a member has had an opioid related overdose, CMS has stated these individuals will need to be considered for the DMP.  Also, all identified at risk beneficiaries (ARBs) will need to be enrolled into the plan’s Medication Therapy Management Program (MTMP).   Once enrolled in MTMP, there is a new requirement for MTMP enrollees to be provided documentation on safe disposal of controlled substances.  Plans’ policy and procedures for the DMP will need to be updated to reflect these additional requirements.  Additional requirements from CMS will require member marketing materials and websites to be updated.  Members must receive information on the risks of prolonged opioid use, as well as non-pharmacological therapies, devices and non-opioid medication available to them under their Medicare benefit.  Lastly, Plans must automatically escalate upheld DMP decisions to the IRE for external review.  Appeals teams will need to update their policies and procedures to reflect this requirement, as well as provide training to the Appeals team for handling such requests.

Beyond the Part D requirements, the Final Rule also contains some operationally impactful new requirements for Special Needs Plans (SNP).  Previously, CMS issued new requirements that only applied only to Chronic Condition Special Needs Plans (CSNPs). But this Final Rule extends the requirements to include all SNPs.  The requirements are effective for coverage beginning in Contract Year (CY) 2023.  This means when Models of Care for CY 2023 are submitted for review and approval in early 2022, CMS will evaluate them against these rules because they will be effective in CY 2023.

The new requirements include:

  • The interdisciplinary care team (ICT) must include providers with demonstrated expertise, including training in an applicable specialty, in treating individuals similar to the targeted population of the Plan.
  • Face-to-face encounters for the delivery of health care, care management, or care coordination services, conducted in-person of via visual, real-time, interactive telehealth technology, are required between each enrollee and a member of the enrollee’s ICT or the Plan’s case management and coordination staff at least annually, beginning within the first 12 months of enrollment, as feasible and with the enrollee’s consent.
  • The results of the initial assessment and annual reassessment required for each enrollee must be addressed in the enrollee’s individualized care plan (ICP).
  • The evaluation and approval of the Model of Care must take into account whether the Plan fulfilled its previous Model of Care goals.
  • HHS will establish minimum benchmarks for each element of the Model of Care.  Each Model of Care can only be approved all benchmarks are met.