CMS Corrects Course on Part D Medications


On January 6, 2014, the Centers for Medicare & Medicaid Services (CMS) Medicare Program proposed excluding immunosuppressive drugs from the six protected drug classes covered under Medicare Part D plans.

Although ASN understands the impetus to control health care spending in hard economic times, any cost-cutting approach that also jeopardizes patient safety is not acceptable. In 2013 alone 16,893 patients received a kidney transplant and approximately 121,000 patients were waiting for a kidney, according to the United Network for Organ Sharing. ASN was concerned that the CMS proposed rule as written could put transplant recipients at risk for adverse side effects as a result of restrictions to immunosuppressive drugs.

Protecting access to immunosuppressive drugs

Because patient tolerance for immunosuppressive medications varies widely it is common practice for physicians to try a combination of therapies, knowing that the first drug administered often needs to be adjusted or substituted altogether. Therefore, to provide optimal treatment for transplant patients physicians need all U.S. Food and Drug Administration–approved immunosuppressive drugs at their disposal.

Congress understood that patients with complex conditions need access to a wide variety of medications, which is why Section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA) was enacted in 2008. It established protection for immunosuppressive medications and five other classes of drugs—anticonvulsants, antineoplastics, antiretrovirals, antipsychotics, and antidepressants.

Since that time, there have been no scientifically justifiable reasons to eliminate protections for immunosuppressive drugs under Medicare Part D. This is why ASN was determined to work with Congress, in conjunction with its comments to CMS, to ensure the choice of immunosuppressive treatments is made by physicians and their patients and not dictated by CMS.

Good news for Part D

Through hard work, along with the overwhelming support of the health care community and powerful letters from Congress, CMS fully understood that the proposed rule would negatively impact transplant patients’ access to appropriate care and could affect overall patient safety.

On March 10, 2014, CMS Administrator Marilyn Tavenner sent a letter to Congress announcing that the “proposals to lift the protected class definition on three drug classes, to set standards on Medicare Part D plans’ requirements to participate in preferred pharmacy networks, to reduce the number of Part D plans a sponsor may offer, and clarifications to the non-interference provisions” would not be finalized at this time. CMS recognized that patients who require these types of therapies need a comprehensive set of options because of the unique sensitivities each patient can have for individual therapies.

ASN is committed to preserving equitable patient access to optimal care regardless of socioeconomic status, geographic location, complexity of comorbid illness, or demographic characteristics.