2024 DMEPOS Series #6: Immunosuppressive Drugs for Transplant

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

Specifically, you need to demonstrate the following in case of an audit regarding immunosuppressive drugs for transplant:

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  • Standard Written Order (SWO)
  • Medical Records
    • Type of transplant must be documented (see documentation checklists in PAAS tips for full list)
    • The drugs prescribed following the transplant
    • Date and location where transplant was performed (in a Medicare approved facility)
  • Proof of Delivery
  • Proof of Refill Request and Affirmative Response
    • Required if delivered or mailed

Coverage criteria for immunosuppressive therapy:

  • The beneficiary was enrolled in Medicare Part A at the time of the transplant.
  • The beneficiary was enrolled in Medicare Part B at the time the drugs are dispensed.
  • The drugs were furnished on or after the date of discharge from the hospital following a covered organ transplant.
    • For date of service (DOS) on or after April 3, 2019 mail-order deliveries of immunosuppressive drugs may be mailed one or two days prior to a beneficiary’s anticipated date of discharge from an inpatient facility to a qualified place of service or alternate address, such as the inpatient hospital that performed the transplant or alternative location where the beneficiary is temporarily staying (such as temporary housing). The DOS on the claim must be the date of discharge.
  • The transplant was performed at a Medicare-approved facility.
  • The dosage, frequency and route of administration conform to generally accepted medical practice and is medically necessary to prevent or treat the rejection of an organ transplant.
  • If the prescribed drug is parenteral azathioprine (J7501) or methylprednisolone (J2920, J2930), medical records confirm that the medication cannot be tolerated or absorbed if taken orally and is being self-administered by the beneficiary.

PAAS Tips:

  • Immunosuppressive drugs are only covered under Part B to maintain an organ transplant that was Medicare eligible
  • The quantity of immunosuppressive drugs dispensed is limited to a 30-day supply
  • The KX modifier must be added to the claim line(s) for the immunosuppressive drug(s) only if all of the following four requirements are met:
    • The supplier has obtained from the ordering treating practitioner the specific date of the organ transplant, and
    • The supplier is retaining this documentation of the transplant in its files, and
    • The beneficiary was enrolled in Medicare Part A, at the time of the organ transplant (whether or not Medicare paid for the transplant), and
    • The transplant date precedes the date of service on the claim
  • If all coverage criteria are not met, the GY modifier must be added to the claim line(s)
  • The diagnosis code(s) that justify the need for these items must be included on the claim
  • Download PAAS’ Proof of Refill Request and Affirmative Response form under Proactive Tips on the Member Portal where you can document the required information from the beneficiary or their caregiver if the prescription is being mailed or delivered
  • Review documentation checklist for Jurisdiction A and D
  • Review documentation checklist for Jurisdiction B and C
  • Review the Immunosuppressive Drugs LCD and Policy Article
  • Review the following Newsline articles for additional information:

PAAS Audit Assistance members can search the Newsline archive for keyword “DMEPOS series” to read previous articles in this series. If you have any questions on accessing the Member Portal, or need help adding employees so they have access, please contact us at (608) 873-1342 or info@paasnational.com and our staff can assist you.

Jenevra Azzopardi, CPhT