CMS backs off from Part D and Medicare Advantage step therapy proposals

CMS modified its proposal to expand prior authorization and step therapy to protected classes of drugs for Part D and Medicare Advantage beneficiaries, according to a final rule released May 16.

In December 2018, CMS released a proposed rule that would have created three exceptions to the current protected classes of drugs. Medicare Advantage plans are required to include on their formularies all drugs in the following six classes except in certain limited circumstances:

• Anticonvulsants
• Antidepressants
• Antineoplastics
• Antipsychotics
• Antiretrovirals
• Immunosuppressants for treatment of transplant rejection

The proposed rule would have allowed plans to introduce prior authorization and step therapy requirements. Although the proposal was widely supported by insurers, patient and provider groups raised concerns that such a proposal could negatively impact beneficiaries’ health and ultimately drive up costs.

The final rule takes a step back by distinguishing between new and existing therapies. Beneficiaries starting on new therapies may be required to undergo prior authorization and step therapy. Beneficiaries on existing therapies will not be subject to these requirements. In addition, the final rule also dropped proposals that would have allowed plans to exclude a protected class drug from the formulary if it exceeded a certain threshold or was a new formulation of an existing single-source drug or biologic.