CMS Guidance 2018: Managing Part B Drugs (Part 2)

Donna Kerney Correia, PhDHealthcare Industry

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Part 1 of our 3 part series on the new CMS guidance for Part B drugs in Medicare Advantage plans highlighted the features of the guidance and specific areas that may be cause for concern. The guidance as written leaves room for interpretation and needs additional clarification – particularly in terms of implementation. Since last month, interviews with representatives from a variety of payer organizations have been conducted to get their impressions of the guidance. Here’s what they had to say.

Payers are starting to examine options

While there is still much to be sorted out, payers have started to look at their MA plans and drug formularies to determine where they may want to begin. Some payers have suggested their initial approach is to examine categories with many treatment options, including mentions of lipid-lowering therapies, HIV treatments, asthma medications and even multiple sclerosis drugs. While categories like oncology might be controversial, payers didn’t indicate that any category was truly off-limits from potential management. Again, all are in the early stages of determining what is feasible and appropriate for their organizations and beneficiaries.

BUT… It’s a wait and see approach for actual implementation

Payers are still deciphering the CMS guidance. MA plan sponsors are sorting through their approach to implementation and actual changes are unlikely to occur until 2020 – at the earliest. One payer commented, “I think it is even optimistic to think we’d see any real impact even in 2020.”

They noted that formularies for 2019 are already set. Formularies for 2020 are under development and plans are focused on the work involved in submitting those to CMS. Payers remarked that the timing of the guidance release was not ideal – there just isn’t enough time to sort through all the nuances and the implications of implementation for their plans to make decisions in the near term.

Several aspects in the guidance, including the use of gift cards to encourage enrollee participation and the data collection and monitoring requirements of CMS, are unclear. One payer noted specifically that the biggest concern is the CMS oversight, auditing and reporting requirements. They are looking to CMS to release more specific information about the implementation – or at least provide feedback on questions that payers have raised regarding the practical implications of this guidance.

Payers need pharma to participate

Payers certainly welcome the ability to manage Part B drugs per the new guidance. But they feel that pharma needs to come to the table and work with them. And they are skeptical.

  • There is interest among payers in meeting with pharma, but none have been approached.
  • “Unless this becomes mandatory, I’m not sure how much impact it will have. Pharma doesn’t tend to do anything until they have to.”
  • Another suggested that the dynamic of the payer and the PBM could be challenging as PBMs don’t manage Part B drugs.

Communication across the board is important

The implementation of ST edits for Part B drugs has implications for payers, but also beneficiaries and providers. The impact of any decisions made by payers needs to be communicated to those parties:

  • Providers should be made aware of changes and implications for them
    • Medical exception processes
    • Impact on their reimbursement
  • Patients need to understand what any changes mean for their access to treatments
    • Payers felt they held some responsibility in this regard as there is concern over the possibility of patient confusion about:
      • Cost increases for medications
      • Alternative medication options
      • Appeal processes to continue coverage

Don’t expect any real impact any time soon

Payers are still deciphering the CMS guidance. Their focus now is on 2020 formularies. So much of the new guidance is unresolved. MA plan sponsors agree that there is much to do before any real impact will be felt.

The story will continue…

Stay connected with us and keep an eye out for Part 3 of our series on this guidance as we track the industry buzz, see more from CMS, and hear from payers about their progress in implementing any changes. Share your insights and comments by contacting us at

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