NKF Statement on CMS Final Rule on Protected Drug Class

Washington, DC – May 17, 2019 – All quotes for attribution to the National Kidney Foundation - “May 16, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses (CMS-4180-F).”
The National Kidney Foundation (NKF) thanks the U.S. Department of Health and Human Services (HHS) 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. 
As initially proposed by CMS, the policies would have created broad exceptions to requirements that all immunosuppressive drugs be covered by Part D formularies. Since 2008, this requirement has ensured the safety of transplant recipients, nearly every one of whom depends on a tailored combination of immunosuppressive medications that must be taken every day to prevent organ rejection.
By maintaining its protected class coverage policy for immunosuppressives prescribed under Part D, CMS is putting patient safety at the forefront. 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 healthcare professionals who work tirelessly on behalf of patients to ensure they can access the medications they need to preserve their transplanted organs.
NKF thanks the hundreds of patients, families and healthcare professionals who contacted CMS, shared their personal experiences, and advocated to maintain the protected class policy for immunosuppressive drugs. We applaud CMS for listening to these advocates and preserving the patient safety protections inherent in the protected class coverage policy.
NKF is a longstanding champion for the comprehensive immunosuppressive coverage needed to maintain the health of transplant recipients. With today’s announcement, the U.S. Department of Health and Human Services continues to show its commitment to advancing policies that improve the lives of kidney patients."
Kidney Disease Facts
In the United States 30 million adults are estimated to have chronic kidney disease—and most aren’t aware of it.  1 in 3 American adults are at risk for chronic kidney disease.  Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history.  People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease.  African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).
The National Kidney Foundation (NKF) is the largest, most comprehensive and longstanding organization dedicated to the awareness, prevention and treatment of kidney disease. For more information about NKF visit www.kidney.org.