Oral-Only ESRD Drugs Removed from Medicare Part D Coverage in 2025
Starting January 1, 2025, Medicare Part D no longer covers “oral-only” medications used for patients with end-stage renal disease (ESRD) undergoing dialysis treatment. This mainly impacts payment of phosphate binders such as PhosLo® (calcium acetate) and Renvela® (sevelamer carbonate), as well as Xphozah® (tenapor).
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When used for ESRD patients, these oral-only medications will now be covered by Medicare Part B under the ESRD Prospective Payment System (PPS) bundled payment to dialysis facilities and should NOT be billed by pharmacies to a Medicare patient’s Part D plan (pharmacies will also not be able to bill Medicare B). If pharmacies are looking to continuing dispensing these medications, advanced coordination with dialysis facilities will be required to ensure pharmacies receive reimbursement.
Part D claims may reject with the following NCPDP reject codes:
- 75>Prior Authorization Required
- 569>Provide Notice: Medicare Prescription Drug Coverage and Your Rights
- A4>This product may be covered under the Medicare-B Bundled Payment to an ESRD Dialysis Facility
If Part D claims do not reject and pharmacy bills Part D incorrectly, then there will likely be future coordination of benefit (COB) “audits” where the Part D plan recoups the pharmacy payment, leaving the pharmacy to reconcile with the dialysis facility after the fact. PAAS National® already sees these types of retroactive, COB audits when claims were billed to Part D but “should have” been billed to Part A for patients residing in a nursing home on a covered stay.
Phosphate binders remain coverable under Part D for other medically accepted indications for patients not on dialysis for ESRD. Pharmacies may want to obtain (and document) diagnosis codes to support these claims.
Numerous organizations, including NCPA, the American Society of Consultant Pharmacists (ASCP), and the American Society of Nephrology (ASN) provided feedback to CMS that this change in payment policy will negatively affect patients as many dialysis facilities do not have an in-house pharmacy and may supply these medications without the expertise of a pharmacist.
PAAS Tips:
- Educate billing staff about the likely rejects for phosphate binder medications for Part D patients
- Coordinate with dialysis facilities to ensure continuity of patient care and payment for pharmacy services
I obtained my PharmD from the University of Wisconsin-Madison School of Pharmacy and worked for a major chain as well as various LTC and independent pharmacies, before coming to PAAS.
I am passionate about learning and teaching. I strive to learn something new about PBM audits every day, so that PAAS can be more knowledgeable to better serve our members! In 2018, I started traveling to state pharmacy conferences to present audit seminars and meet our wonderful members in person.
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