A change that began in January in the way pharmacies fill prescriptions for oral drugs that may be dialysis-related––and thus the responsibility of providers––has led to some confusion for patients, providers, and state kidney programs.

Previously, pharmacies filled the prescription and billed the patient’s Part D prescription plan. If it was determined later that the drug was ESRD-related and to be covered by the dialysis provider under Part B billing, the Part D plan would seek payment from the dialysis provider. Under the new approach, however, the pharmacy will turn down the patient if a prior review indicates the drug is ESRD-related and thus is the responsibility of the dialysis provider. if the drug is not considered for treatment that is ESRD-related, then Part D plans will continue to cover it. Likewise, if the drug is for a transplant patient, then Part D will continue to pay.

The oral drugs in question fit into seven categories that may, or may not be ESRD-related and account for 0.2% of the payments for separately billable drugs and biologics on ESRD facility claims, according to the Centers for Medicare & Medicaid Services.

In its Jan. 31 edition of Renal Watch, the National Renal Administrators Association said members have been reporting since the beginning of the year that some of their patients’ claims for Medicare Part D drugs have been rejected. “This is the result of the Centers for Medicare and Medicaid Services (CMS) Call Letter issued to Part D plans that instructs pharmacies that have the option for prior authorization to verify that a drug is not already covered by Part B before providing it to the customer,” Renal Watch said. “Previously, pharmacies would provide the drug and then verify it was covered by Part D after the fact, known as the ‘pay-and-chase’ system. If the drug was covered by Part B, then the plan would have to recover the money.”

But in an updated April 2013 call letter to providers, CMS said that system was “problematic” for Part D plans, as well as for pharmacies and beneficiaries.  “When we initially proposed the “pay-and-chase” approach, we thought that in the vast majority of situations, the respective parties would reliably follow Medicare rules and bill appropriately. For ESRD, the Medicare bundled payment to the dialysis facility includes all drugs and biologics used in the treatment of ESRD except ‘oral-only’ drugs…We now better understand that a hospice or ESRD dialysis facility may be uncertain about these definitions.”

The seven categories of drugs that may be considered ESRD-related and covered by dialysis providers include:

Antiemetic: Drugs used to prevent or treat nausea and vomiting secondary to dialysis

Anti-infectives: Drugs used to treat infections. These may include antibacterial and antifungal drugs.

Antipruritic: Drugs in this category have multiple clinical indications,but are included for their action to treat itching secondary to dialysis.

Anxiolytic: Drugs in this category have multiple actions, but are included for the treatment of restless leg syndrome secondary to dialysis.

Excess fluid management: drugs/fluids used to treat fluid excess/overload; fluid and electrolyte management including volume expanders.

Intravenous drugs/fluids: used to treat fluid and electrolyte needs.

Pain management: Drugs used to treat graft site pain and to treat pain medication overdose.

Some state kidney programs with pharmacies that work with Part D plans will continue to cover the medications through February to assist patients and clinics with a transition time.