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The Center for Medicare Advocacy recently submitted comments to a Notice of Proposed Rulemaking issued by the Centers for Medicare & Medicaid Services (CMS) entitled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (CMS-4180-P).  The Center’s comments are available at:  

Currently, Part D prescription drug plans (PDPs) and Medicare Advantage prescription drug plans (MA-PDs) are required to include on their formularies all of the available drugs in six categories known as the “protected classes”: anti-depressants, antipsychotics, anticonvulsants, immunosuppressants for transplant rejection, antiretrovirals and antineoplastics. The proposed rule would allow plans to limit coverage of these drugs through new utilization management (UM) strategies, such as requiring certain patients to undergo step therapy (ST, aka “fail first”) or obtain prior authorization (PA).  The proposal would also allow plans to completely exclude protected class drugs from their formularies and add additional hoops for beneficiaries to jump through absent adequate existing safeguards (e.g., effective exceptions, appeals, transition fills and formulary requirements).

The Center opposes these proposed changes because they would create barriers to life-saving medication.  There is insufficient evidence of potential cost savings generated by the proposals, particularly in light of the serious access problems likely to be faced by beneficiaries.  Beneficiary protections are not currently robust enough to ensure beneficiary access, and would be even less sufficient under diminished protected class safeguards proposed under the rule; both our experience and external evidence demonstrate that current protections fall short.   As discussed in our comments, one area in which we do support the use of some utilization management within the protected classes concerns the inappropriate prescribing of anti-psychotics in the long-term care setting.

The Center also opposes CMS’ policy changes allowing Medicare Advantage (MA) plans to utilize step therapy on Part B drugs (first presented in 2018 sub-regulatory guidance, and now to be codified in this proposed rule).  This policy will limit beneficiaries’ access to Part B drugs, including in the treatment of life-threatening conditions like cancer. 

We agree with CMS that the problem of high and rising drug prices must be addressed, however we disagree with the agency’s approach in this proposed rule, since it would likely impede access to vital medications.

January 2019 – D. Lipschutz

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