CMS issued a final rule on May 16 that will continue to allow, at least for now, transplant physicians to prescribe most anti-rejection transplant drugs through the Medicare Part D drug formulary.
CMS had originally included provisions to include transplant drugs in a reform plan that would have limited access to certain brands, the NKF said. The regulation, CMS-4180-F, called the “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses” and which takes effect in 2020, will continue to cover most major pharmaceutical brands of transplant drugs, according to the NKF. Eventually, these would fit under the program’s “protected class policy” that allows patients to have more drug product choices among certain type of prescriptions.
“The National Kidney Foundation thanks the U.S. Department of Health and Human Services and specifically CMS for its decision to not finalize changes to its protected class policy that would have made it more challenging for some transplant recipients to access immunosuppressive drugs that they need to prevent organ rejection when they are covered under Medicare Part D,” the foundation said in a statement.
As initially proposed by CMS, the policies would have created broad exceptions to requirements that all immunosuppressive drugs be covered by Part D formularies.
“By maintaining its protected class coverage policy for immunosuppressives prescribed under Part D, CMS is putting patient safety at the forefront,” the NKF said. “We also appreciate that CMS will implement a complaints tracking module monitoring project in 2020 to monitor access to protected class Part D drugs and improvements in electronic prescribing through the use of a future real time benefit tool. These additional steps recognize the challenges that patients have accessing their medications, even under existing policy.
“We are hopeful these new tools will help provide additional information to CMS to improve access and reduce burden on health care professionals who work tirelessly on behalf of patients to ensure they can access the medications they need to preserve their transplanted organs.”
In a statement, AMA president Barbara L. McAneny, MD, said the changes to the final rule will benefit patients.
“Seriously ill patients who faced the prospect of new hurdles to accessing their medication can breathe a sigh of relief now that the Trump administration has discarded the proposal,” she said. “The American Medical Association commends the administration for recognizing its proposal to weaken coverage for six protected drug classes under Medicare Part D had potential dangers for patient health. The AMA and other patient champions detailed the potential effects of the policy, and we’re grateful the administration listened.”