RETIRED - Documentation Reminders: Immunosuppressive Drugs

IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.Content Provided on this page contains outdated information and instruction and should not be considered current. Noridian is providing this archived information for research purposes only. This archived article contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

Article retired due to content incorporation into the applicable Local Coverage Determination or related Policy Article.

Posted June 28, 2013

Claims review by both the DME MACs and the Comprehensive Error Rate Testing (CERT) Review Contractor show a high percentage of documentation errors involving claims for immunosuppressive drugs. As a result many of the DME MACS are, or will be, conducting a review of immunosuppressive drug claims. Some of the most common errors identified by claim reviewers relate to physician records including:

Detailed Written Orders:

  • Copy of detailed written order was not provided;
  • Detailed written order was illegible (blackened and/or blurred)
  • The order was invalid because it was missing required elements. Required elements for orders include:
    • Beneficiary's name
    • Name of drug
    • Dosage
    • Quantity to be dispensed
    • Route of administration
    • Frequency of administration
    • Physician's name
    • Refill instructions
    • Physician signature and date
    • The start date of the order - only required if the start date is different than the signature date
  • Physician did not personally date his/her signature; and
  • Items were delivered prior to obtaining a detailed written order and no written documentation of a dispensing order was provided.

Medical Records:

  • Copy of pertinent medical records was not provided;
  • Medical records did not document that the drug was included in the physician's plan of care for the beneficiary;
  • Records failed to document continued use and/or medical need for the drug;
  • The name of the transplant center was not provided;
  • Records are missing a signature or it is illegible; and
  • Records provided did not document a transplant.

Physicians are reminded that while immunosuppressive drugs are often prescribed for various medical indications, Medicare's coverage of immunosuppressive drugs is narrowly defined and closely regulated by Medicare statute and benefit category language. Title XVIII of the Social Security Act, §1861(s)(2)(J) provides for coverage of immunosuppressive drugs; however, coverage is limited solely to usage following specific organ transplants. Regulations regarding coverage and payment of immunosuppressive drugs are found in 42 CFR 410.30 and the Centers for Medicare & Medicaid Services (CMS) Benefit Policy Manual (Internet-Only Manual, Publication 100-2), Chapter 15, Section 50.5.1 and Claims Processing Manual (Internet-Only Manual, Publication 100-4), Chapter 17, Section 80.3.

As a result of the statutory and benefit language, immunosuppressive drugs are eligible for reimbursement only when all of the following criteria are met:

I. Immunosuppressive drugs are prescribed following either:

A. Kidney (V42.0), heart (V42.1), liver (V42.7), bone marrow (V42.81)/stem cell (V42.82), lung (V42.6), or heart/lung (V42.1 and V42.6) transplant; or,

B. Whole organ pancreas (V42.83) transplant performed concurrent with or subsequent to a kidney transplant (V42.0) because of diabetic nephropathy (performed on or after July 1, 1999); or,

C. Intestinal transplant (V42.84) (performed on or after April 1, 2001); or,

D. Pancreatic islet cell transplant (V42.89) or partial pancreatic tissue transplantation (V42.89) performed on or after October 1, 2004 that is conducted as part of a National Institutes of Health (NIH)-sponsored clinical trial; or,

E. Pancreas transplants alone (performed on or after April 26, 2006) that meet the following criteria:

1. The transplant is performed in a facility that is Medicare-approved for kidney transplantation; and

2. Beneficiary must have a diagnosis of type I diabetes and:

a. Mst be beta cell autoantibody positive; or,

b. Mst demonstrate insulinopenia, (fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method). A fasting glucose must be obtained when performing a fasting C-peptide determination. Fasting C-peptide levels are considered valid when a concurrently obtained fasting glucose is <225 mg/dL; and,

3. Must have a history of labile (brittle or medically-uncontrollable) insulin-dependent diabetes mellitus resulting in documented recurrent, severe, acutely life-threatening metabolic complications requiring hospitalization(s). Complications may include frequent hypoglycemia where the beneficiary is unaware, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks; and,

4. Must have been under the care of an endocrinologist and have clinical documentation denoting optimal and intensive management was provided for at least 12 months, having received the most medically-recognized advanced insulin formulations and delivery systems; and,

5. Must demonstrate being able to emotionally and mentally understand the significant risks associated with surgery and be able to effectively manage the lifelong need for immunosuppression; and,

6. Must otherwise be a suitable candidate for transplantation; and

II. The transplant met Medicare coverage criteria in effect at the time (e.g., approved facility for kidney, heart, intestinal, liver, lung, or heart/lung transplant; national and/or local medical necessity criteria; etc.); and,

III. The beneficiary was enrolled in Medicare Part A at the time of the transplant; and,

IV. The beneficiary is enrolled in Medicare Part B at the time that the drugs are dispensed; and,

V. The drugs are furnished on or after the date of discharge from the hospital following a covered organ transplant.

If criteria I-V are not met, the drug(s) will be denied as noncovered.

If criteria I, II, and III are met, the transplant is considered a "covered transplant" for purposes of this policy whether payment for the transplant was made by Medicare or by another insurer.

For questions regarding documentation requirements for Immunosuppressive Drug claims, physicians and suppliers should refer to the Immunosuppressive Drugs LCD and related Policy Article for their respective DME MAC.

            Last Updated Thu, 10 Jan 2019 12:21:45 +0000