CMS Proposes to Erode Up to 3 of the 6 Medicare Part D Protected Drug Classes

Sydney Abbott, JD

March 2014, Vol 4, No 2 - Patient and Provider Access


The Centers for Medicare & Medicaid Services (CMS) re­cently proposed a rule that would bring significant changes to the Medicare Part D and Medicare Advantage programs. Of all the changes proposed, oncology care providers and members of the Association of Community Cancer Centers (ACCC) are particularly concerned about the proposal to eliminate at least 2 of the 6 protected classes of drugs.

The Medicare prescription benefit program, known as Part D, is a re­sult of the Medicare Modernization Act of 2003 (MMA). Under MMA, CMS was tasked with ensuring that plans offered under Part D provided a robust formulary for patients. CMS issued regulations requiring insurance companies that offered plans through Medicare Part D to cover all, or substantially all, of the drugs in the following 6 classes of clinical concern (ie, protected classes): immunosuppressants, anticonvulsants, antineoplastics, antidepressants, antipsychotics, and antiretrovirals.

The Proposal
Now, citing authority provided by the Affordable Care Act (ACA), CMS states that the former rule regarding the 6 protected classes has served its purpose by addressing a learning curve for beneficiaries, and changes should now be made to ensure efficiencies in the program. CMS proposes to eliminate protected class status for antidepressants and immunosuppressants in 2015, with discussion of eliminating the antipsychotic class in 2016. CMS justifies this proposal by saying the policy has driven up the cost of Medicare Part D, and cites patient protection concerns due to the potential for overutilization. The agency estimates that this proposal, if finalized, will save $1.3 billion between 2015 and 2019.

The agency’s proposal interprets the ACA to limit protected class status to only those drugs for which access to all drugs in a category or class is required within 7 days for the average person requiring treatment. Upon consideration of the new criteria, CMS found that drugs in the antidepressant and immunosuppressant categories no longer need to be covered completely by Part D plans. While CMS notes that antipsychotics also fall outside of the new criteria, they will remain on protected class status through 2015 while CMS further evaluates the need to protect them for 2016.

The Problem

It is true that if plans are no longer required to cover all or substantially all of the drugs in a class, savings will be realized through Part D. However, this does not ensure a reduction in costs across the healthcare system, since decreased access to drugs could result in increased hospitalizations and emergency room visits. This would be a substantial concern for cancer care providers in the event that the policy on protected classes is further eroded through future rule-making.

In addition, this proposed change creates a slippery slope. While Part D plans are still required to cover all or substantially all antineoplastic drugs, and oncology providers and their patients are not facing an immediate threat, the proposal by CMS certainly creates apprehension about the future of this policy. In just 1 rule-making cycle, the CMS proposal would eliminate or directly threaten patient a­ccess to drugs in half of the protected classes that the agency once thought so important that it created a specific policy aimed at protecting patient access to them. For those with cancer, it is imperative that all drugs be available to patients; each patient reacts differently to medications, and changes in treatment regimens may be required as patients experience side effects or as their condition advances.

The Solution

CMS should listen to the public and not erode the coverage requirements for protected classes. Because of the large number of patients potentially affected by this policy change, many groups are outraged and are encouraging CMS to abandon its proposal. In fact, the US Senate Finance Committee wrote a letter to CMS Administrator Marilyn Tavenner stating, “We are very concerned this change will lead to decreased access to medication….Unfortunately, over the course of treatment, certain medications may cause undesired side effects or become ineffective. As a result, certain beneficiaries must have a wide range of treatment options available. By limiting the number and type of medications offered under a Part D plan, a beneficiary may be forced to rely, if only temporarily, on medication that simply does not work or results in adverse side effects.”

At the start of the Part D program, CMS recognized the importance of protecting vulnerable patients who may lose access to their drugs when transitioning into the Part D program; that is why policy was developed to protect the 6 drug classes. Erosion of this policy now will certainly have a chilling effect on Medicare Part D enrollment, and CMS should not implement this policy.

ACCC will be submitting comments on the proposed rule and will make them available to members on its website. We will keep members updated on this issue.