March 17, 2014
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CMS scraps plans to lift protected class status of transplant drugs

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The Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner said the agency does not plan to finalize certain elements of its proposed rule for Medicare Part D prescription drug plans. Tavenner said in a letter to lawmakers that the agency received numerous concerns about the proposed rule released in January that would include changes to the Medicare Part D Drug Benefit Program.

The kidney care community was particularly concerned about the proposal to lift the protected class definition on immunosuppressant drugs, which would mean part D plans would not be required to provide access to all immunosuppressant drugs.

"Retaining the protected class status of these drugs will allow physicians to prescribe the most appropriate medicine tailored to each transplant patient," Kidney Care Partners, an alliance that includes patient advocates, dialysis care professionals, providers, and manufacturers, said in a new release.

(Related: New organ transplant strategy aims to better prevent rejection)

"Individuals who receive life-saving kidney transplants rely upon immunosuppressive drugs to sustain their lives," said Dr. Edward Jones, chair of Kidney Care Partners 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."

More controversial measures within the proposed rule included lifting the protected class status from antidepressants and antipsychotics, changing the requirements to participate in preferred pharmacy networks, and reducing the number of Part D plans a sponsor may offer.

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