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Renal Physicians Association voices concern about impact of Part D changes for transplant patients
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The Renal Physicians Association has joined the National Kidney Foundation in voicing concern about how changes to the Medicare Part D drug benefit program may limit access to certain immunosuppressive drugs for kidney transplant patients.
Under its Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses proposal, which would take effect in 2020, CMS has said that Medicare Advantage and Part D plans would have more tools to negotiate lower drug prices.
“President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice,” HHS Secretary Alex Azar said in a press release last November. “By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need and expand their choice of plans.”
However, in a letter to CMS Administrator Seema Verma, MPH, last month, Michael D. Shapiro, MD, MBA, FACP, CPE, president of the RPA, said the agency’s plan to remove drugs used by transplant patients from a group of protected classes could limit access and “allow Part D sponsors to: (1) implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications; (2) exclude a protected class drug from a formulary if the drug is a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look back period,” Shapiro wrote. “RPA believes that these additional exceptions if implemented would create barriers to the availability of immunosuppressive drugs to end-stage renal disease (ESRD) beneficiaries with kidney transplants.”
While the association is “sensitive to CMS’ fiduciary responsibilities, and we understand the rationale for the agency’s efforts to provide plan flexibility in order to manage the protected classes of drugs,” the exceptions for transplant drugs have the potential to “both unnecessarily threaten the health outcomes of kidney transplant patients and heighten the possibility that Medicare will incur the additional expense of a kidney patient returning to dialysis,” Shapiro wrote. “This proposed policy is neither in the best interest of patient-centered quality kidney care nor the financial viability of the Medicare program,” he wrote.
Last November, the NKF also raised concerns about leaving immunosuppressive drugs unprotected outside the classes, saying the proposal could remove “key protections for transplant patients that allow them to access the immunosuppressive drug regimen that best meets their individual needs and would leave the government in the position of deciding what is clinically appropriate when reviewing Part D plan formularies.”
Shapiro said CMS needs to consider the “potential long-term health policy ramifications” of the proposal as it applies to the agency’s goal to promote value over volume in Medicare. He wrote, “RPA believes that any action that complicates the ability of patients to acquire these medications increases the potential for transplant failure, with the inability to pay for these medications being a frequent cause of such failure. Given that CMS has invested considerably in the initial transplant, RPA urges CMS to rescind the proposal to create additional exceptions related to the protected classes of drugs.” – by Mark E. Neumann
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