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The U.S. Centers for Medicare and Medicaid Services (CMS) released a final rule yesterday on drug pricing in the Medicare Advantage and Medicare Part D programs.

In its final rule, CMS chose not to implement a harmful change that it had initially put forward – a change strongly opposed by HFA and numerous other patient groups.

Longstanding federal policy requires Medicare Part D plan sponsors to cover all available drugs in six “protected classes.” Two of those classes are of particular interest to the bleeding disorders community: antiretrovirals and immunosuppressants for treatment of transplant rejection.

CMS in late 2018 had proposed to abandon that longstanding policy, and to allow Medicare plan sponsors to limit coverage of drugs in the protected classes. The proposed rule would have permitted Part D plans to impose prior authorization and step therapy requirements; to exclude new formulations of drugs; and to exclude drugs with price increases above a specified rate.

HFA and many other patient advocacy groups strongly opposed this proposed rule. HFA and NHF filed joint comments with CMS, pointing out that restricting patient access to antiretrovirals and/or immunosuppressants would:

  • reduce treatment options for especially vulnerable Medicare beneficiaries,
  • disrupt care and worsen health outcomes, for example:
    • increasing the risk of developing resistance to available antiretroviral drugs,
    • endangering individuals at risk for organ transplant rejection, and
  • give health plans a potent new way to discriminate against people with costly health needs via formulary design.

HFA is very pleased to note that CMS chose not to finalize the Part D limits. Instead, CMS decided to maintain its previous policy requiring plans to include on their formularies all drugs in the six protected classes.

CMS’ final rule also codified a year-old policy allowing Medicare Advantage plans to implement step therapy for Part B drugs (a category that includes clotting factor and other hemophilia treatments). HFA and NHF opposed this portion of the proposed rule, too, voicing our shared concern that step therapy is always inappropriate in the context of treatments for bleeding disorders. While the final rule continues to permit the use of step therapy for Part B drugs, it does include some safeguards to protect Medicare beneficiaries. Medicare Advantage plans:

  • will be permitted to apply step therapy requirements only to new starts of medication (i.e., patients on an existing drug therapy must be allowed to continue using that medication),
  • will have to ensure that any step therapy protocols are reviewed and approved by the plan’s pharmacy and therapeutics committee, and
  • will have to adjudicate patient requests for exceptions and appeals from denials within strict timeframes.
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