The Centers for Medicare & Medicaid Services released a memo to Medicare Part D payers on Nov. 14, revising guidance regarding payment for non-dialysis-related drugs for Medicare patients.

Earlier this year, CMS issued rules for Medicare Part D prescription drug plans that provided limited information on identifying drugs outside the dialysis payment bundle that can be separately billable. As a result, dialysis patients in some cases had to get prior authorization for their medications if the payers believed the drugs should be covered under the ESRD bundled payment rate. This resulted in delays as some dialysis patients had to wait for authorization before accessing medications to fight infections, nausea, pain, and anxiety, among other ailments.

After discussions with patient and professional groups like the National Kidney Foundation, the Renal Physicians Association, and others, CMS revised its guidance in the Nov. 14 memo and is now encouraging Part D plans to change their policies so that patients no longer have delays getting medications that are not specifically linked to kidney disease.

Part D plans should review the purpose of the prescription before assuming it is covered under the bundled rate, advocacy groups said. For example, antibiotics could be used to treat a dialysis catheter related infection (dialysis related) or they can be prescribed to treat an infected foot wound (not dialysis related), the NKF noted in its statement on the CMS memo.

“Since it wasn’t always clear to the pharmacist or to the Part D plan whether the drug prescribed was used to treat something dialysis related, Part D plans required the prescribing health care practitioner to submit documentation as to why the drug was being prescribed," the NKF wrote. "It could take anywhere from a few hours to a few days for a health care practitioner to receive the request for documentation, complete it and get it back to the pharmacist. This meant patients had to wait to get their medications, leaving many confused and worried about their health.”

RPA’s Public Policy Director Rob Blaser told members that the CMS directive issued last January “created substantial barriers for ESRD patients who were receiving the drugs for purposes unrelated to the treatment of their ESRD.”

The RPA helped to lead the community-wide effort to inform CMS about the ramifications of the guidance and its impact on patients. The revised guidance says CMS "strongly encourages" Part D sponsors, such as pharmacy chains, to remove the "beneficiary level prior authorization edits on these drugs."