Immunosuppressive Drugs

Affected Providers

Physicians and non-physician practitioners who write prescriptions for immunosuppressive drugs.

HCPCS & CPT Codes

Local Coverage Determination (LCD): Immunosuppressive Drugs (L33824) has the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for immunosuppressive drugs is 23.2%, with a projected improper payment amount of $45.4 million.

We limit immunosuppressive drug coverage to 36 months for patients with Medicare based solely on ESRD and for patients who are enrolled in other types of coverage (for example, a group health plan, TRICARE, or a Medicaid state plan that covers immunosuppressive drugs). Coverage continues beyond 36 months for eligible patients enrolled in the Medicare Part B immunosuppressive drug benefit.

We outline other policy requirements in LCD L33824 and Article: Immunosuppressive Drugs (A52474).

Denial Reasons

Insufficient documentation accounted for 40.3% of improper payments for immunosuppressive drugs during the 2024 reporting period, while no documentation (15.1%), medical necessity (10.9%), incorrect coding (0.6%), and other errors (33.1%) also caused improper payments. “Other” errors include duplicate payment, non-covered or unallowable service, or ineligible Medicare patient errors.

Preventing Denials

We cover prescription drugs for immunosuppressive therapy under the DMEPOS program benefit if all these criteria are met

• Health care providers prescribe immunosuppressive drugs after transplants for:
  • Kidney, heart, liver, bone marrow, stem cell, lung, or heart-lung transplant
  • Whole organ pancreas transplant done concurrently with or after a kidney transplant because of diabetic nephropathy (done on or after July 1, 1999)
  • Intestinal transplant (done on or after April 1, 2001)
  • Pancreatic islet cell transplant or partial pancreatic tissue transplantation done on or after October 1, 2004, as part of a National Institutes of Health-sponsored clinical trial
  • Pancreas transplants alone (done on or after April 26, 2006) that meet the 6 criteria listed in Article A52474
• The transplant met Medicare coverage criteria in effect at the time (for example, approved facility for kidney, heart, intestinal, liver, lung, or heart and lung transplant and national or local medical necessity criteria)
• The patient has Medicare Part A at the time of the transplant
• The patient has Part B at the time the drugs are dispensed
• The supplier delivers the drugs according to requirements outlined in Article A52474

Consider these factors when submitting immunosuppressive drug claims to Medicare:

• Immunosuppressive drug claims require dosage, frequency, and administration route. They must conform to generally accepted medical practice and meet medical necessity requirements to prevent or treat an organ transplant rejection.
• We limit the quantity of immunosuppressive drugs dispensed to a 90-day supply, effective January 1, 2025.

Refill Requirements

For DMEPOS items and supplies provided on a recurring basis, base your billing on prospective, not retrospective use.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.