Decision Alleviates Concerns Over Potential for Organ Rejections, Preserves Physician Discretion Over Patient Care

Washington, DC – Kidney Care Partners (KCP) voiced strong support for Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner’s announcement that CMS would not finalize proposals to lift the protected class definition on three drug classes, including life-sustaining immunosuppressive drugs, that transplant patients must take to help prevent their bodies from rejecting the transplanted organ. KCP is a broad-based alliance that includes patient advocates, dialysis care professionals, providers, and manufacturers organized to advance policies that improve the quality of care for individuals with chronic kidney disease (CKD) and irreversible kidney failure, known as end?stage renal disease (ESRD).

The decision was heralded by the kidney community as essential to preserving the doctor-patient relationship by ensuring that Part D prescription drug plans do not restrict the immunosuppressive drugs they cover. Retaining the protected class status of these drugs will allow physicians to prescribe the most appropriate medicine tailored to each transplant patient.

In January, CMS issued a proposed rule that would have permitted Part D plans to stop including all immunosuppressive drugs in their plans. Individuals who receive a transplant must take immunosuppressive drugs indefinitely, which help prevent their bodies from rejecting the kidney. The decision of which combination of drugs to take is a complex medical choice that requires physicians to balance multiple factors and tailor the treatment to each individual patient.

“Individuals who receive life-saving kidney transplants rely upon immunosuppressive drugs to sustain their lives,” said Dr. Edward Jones, Chair of KCP and a practicing nephrologist. “To minimize or avoid rejection, patients and their doctors work closely together to find the right combination of drugs to reduce myriad side effects, while carefully accounting for changes in the patient’s body that require adjusting the drugs over time to prevent organ rejection.”

In response to the proposed rule, KCP said that, if finalized, the revised policies would have contradicted the intent of the Congress, which was to protect access to certain drugs and biologicals for which restricted access would have major or life-threatening consequences. Specifically, Congress authorized the Secretary to make exceptions that would prohibit Part D sponsors from limiting access for such drugs.

KCP maintained that Medicare ESRD beneficiaries should not have their lives put at risk by a Part D sponsor’s decision not to place all or substantially all necessary immunosuppressive drugs on its formulary, thus disrupting the delicate balancing act reached between the patient and his/her physician with regard to these life-sustaining drugs. Getting it wrong could mean losing the transplanted kidney or even death.
“All along, our concern with the proposed rule had nothing to do with favoring one drug over another, but rather the importance of protecting the doctor-patient relationship and the ability of physicians to prescribe the most appropriate medication for each individual patient based on their case,” concluded Dr. Jones. “We commend CMS Administrator Tavenner for listening to KCP’s concerns and their thoughtful response. KCP looks forward to working with them on this issue and other issues important to kidney patients.”