Thanks to the efforts of patient, provider, and research organizations, a proposed policy change to Medicaid part D coverage that could have limited or restricted patients’ access to therapies was rescinded.  

Background

 In 2003, Congress passed the Medicare Modernization Act, which created an outpatient prescription drug benefit in the Medicare program called Part D. Part D requires Medicare cover at least two drugs in each therapeutic class of drug.

Patients with certain illnesses and diseases, such as mental illness, Parkinson’s Disease, or cancer, need access to a full range of effective medications because patients react differently to different drugs. Because of this, Congress established the six protected classes of drugs, which required Part D plans to cover “all or substantially all drugs” within each of the classes. These six protected classes include: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. This policy is essential, because it guarantees patients access to all available medications, ensuring optimal care.

In January 2020, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) launched the Part D Payment Modernization Model (PDM), a five-year model that affects part D prescription drug spending and out-of-pocket costs. The Model creates new incentives for plans, patients, and providers to choose drugs with lower list prices to address rising costs in Part D.

Proposal Threatened Patient Access to Medication

 Earlier this year, proposed changes to the PDM threatened patient access to their lifesaving therapies. If implemented, the proposed changes would allow Medicaid insurers to limit the drugs they cover, including denying patient access to medications in the six protected classes. Specifically, the changes would permit Part D insurers to treat five of the six protected classes – anticonvulsants, immunosuppressants, antidepressants, antipsychotics, and antineoplastics – as any other drug class, eliminating their protected classes status.

LUNGevity stood firmly opposed to these proposed changes. Lung cancer patients often require combination therapies involving several drugs or a range of different drugs over the course of their treatment. Covering only one drug per class (which is all that is required in this proposal) would have dramatic consequences for patients and effectively end the era of personalized medicine. Cancer patients need access to “all or substantially all” treatments available in their disease.

Read more about our concerns about this proposal.

Conclusion

CMMI heard patient, provider, and research organizations’ concerns and have decided not to move forward with the proposed changes to limit coverage of drugs within the six protected drug classes. However, it’s important to stay vigilant against alterations to the six protected classes policy; changes could result in drastically reduced set of drugs options and limit patients’ access to the most appropriate, most innovative, and most clinically indicated medication selected by their provider. The six protected classes are necessary to preserve critical patient access to innovative treatments.

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