For any item to be covered, it must

1. be eligible for a defined benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered, a written signed and dated order must be received by the supplier. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Prescription drugs used in immunosuppressive therapy are covered if all of the following criteria (1-5) are met:

1. Immunosuppressive drugs are prescribed for transplant patients following either:
   
   
   1. Kidney, heart, liver, bone marrow/stem cell, lung, or heart/lung transplant; or,
   2. Whole organ pancreas transplant performed concurrent with or subsequent to a kidney transplant because of diabetic nephropathy; or,
   3. Intestinal transplant; or,
   4. Pancreatic islet cell transplant or partial pancreatic tissue transplantation that is conducted as part of a National Institutes of Health (NIH)-sponsored clinical trial; or
   5. Pancreas transplants alone that meet the following criteria:
      • The transplant is performed in a facility that is Medicare-approved for kidney transplantation; and
      • Patient must have a diagnosis of type I diabetes and:
        1. Must be beta cell autoantibody positive; or
        2. Must 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
      • 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 patient is unaware, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks; and
      • 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
      • 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,
      • Must otherwise be a suitable candidate for transplantation.
        and,
        
2. 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,
   
3. The patient was enrolled in Medicare Advantage at the time of the transplant; and,
   
4. The patient is enrolled in Medicare Part B at the time that the drugs are dispensed; and,
   
5. The drugs are furnished on or after the date of discharge from the hospital following a covered organ transplant.

If criteria 1-5 are not met, the drug(s) will be denied as not medically necessary.

If criteria 1, 2, and 3 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 islet cell transplants or partial pancreatic tissue transplants conducted as part of an NIH-sponsored clinical trial, Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services. The term "routine costs" means reasonable and necessary routine patient care costs, including immunosuppressive drugs and other follow-up care. In addition, Medicare will cover transplantation of pancreatic islet cells. Coverage includes the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.

Immunosuppressive drugs used following partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial or performed before October 1, 2004, will continue to be non-covered.

NOTE:

Claims for islet cell transplantation or partial pancreatic tissue transplants for Medicare Advantage members who are participating in a clinical trial should be submitted to the appropriate Medicare carrier or intermediary. See www.cms.hhs.gov/clinicaltrialpolicies for the appropriate billing guidelines.

Immunosuppressive drug coverage is limited to 36 months for beneficiaries whose entitlement is based solely on end-stage renal disease (ESRD).

Immunosuppressive drugs are denied when used for the treatment of patients with non-transplant related diagnoses (e.g., rheumatoid arthritis, connective tissue diseases, vasculitis).

Immunosuppressive drugs are denied if they are used following a whole organ pancreas transplant that was not simultaneous with or preceded by a kidney transplant for diabetic nephropathy unless the patient meets the criteria for PA listed above in 1(E). Coverage of immunosuppressive drugs already exists and will continue for patients who have had a pancreas transplant simultaneous with a kidney transplant because in these situations, coverage is based on the kidney transplant.

There is no coverage under the immunosuppressive drug benefit for supplies used in conjunction with the administration of parenteral immunosuppressive drugs.

If an immunosuppressive drug is billed without a KX modifier (See Documentation Requirement section of the policy), it will be denied as not medically necessary.

NOTE:

This policy addresses prescription drug coverage for immunosuppressive drugs for transplant patients. It is not intended to address injectable immunosuppressive drugs administered by a physician.

Supply Fee Information
Payment may be determined by contractual arrangements with providers. Home infusion therapists and DME suppliers are not eligible for reimbursement for pharmacy supply fees (Q0511, Q0512).

Reasons for Noncoverage

Payment for services will be denied as not medically necessary when used for indications or in circumstances other than those listed in this policy. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

There is no separate coding or payment for a compounding fee.

For immunosuppressive drugs covered under this policy, the dosage, frequency and route of administration must conform to generally accepted medical practice and must be medically necessary to prevent or treat the rejection of an organ transplant.

Coverage of parenteral azathioprine (J7501) or methylprednisolone (J2920, J2930) is limited to those situations in which the medication cannot be tolerated or absorbed if taken orally and is self-administered by the patient. Claims for parenteral azathioprine or methylprednisolone that do not meet this criterion will be denied as not medically necessary.

Parenteral cyclosporine (J7516), antithymocyte globulin (J7504, J7511), muromonab-CD3 (J7505), tacrolimus (J7525) and daclizumab (J7513) are not proven to be safe when administered in the home setting and therefore they will be denied as not medically necessary when provided in that setting.

Drugs may be covered only if dispensed and billed by the entity that actually dispenses the drug to the member, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs.

Documentation Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider" (42 U.S.C. section 1395l(e)). It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for the drug(s) must be signed and dated by the treating physician, kept on file by the supplier and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

A new order is required if a new drug(s) is added to the patient’s immunosuppressive regimen or if there is a change in dose or frequency of administration of an already allowed drug.

Suppliers must add modifier GY to a code if any of criteria 1-5 in the "Indications and Limitations of Coverage" section have not been met.

The KX modifier must be added to the claim line(s) for the immunosuppressive drug(s) only if:

1. The supplier obtains from the ordering physician the date of the organ transplant; and
2. The member was enrolled in Medicare Advantage at the time of the organ transplant (whether or not Medicare paid for the transplant); and
3. The transplant date precedes the date of service on the claim.

If these three requirements are not met, the KX modifier may not be added to the claim.

If code J7599 is billed, the claim must list the name of the drug, the dosage strength, number dispensed and administration instructions.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Code J7599 should be used for immunosuppressive drugs that do not have a specific J or K code.

For all immunosuppressive drugs, the number of units billed must accurately reflect the definition of one unit of service in each code narrative. For example, if fifty 10 mg prednisone tablets are dispensed, bill J7506, 100 units (1 unit of J7506 = 5 mg). If fifty 2.5 mg prednisone tablets are dispensed, bill J7506, 25 units.

EY – No physician or other licensed health care provider order for this item or service.

GY – Item or service statutorily excluded or does not meet the definition of any Medicare benefit.

KX – Requirements specified in the medical policy have been met.

The presence of a diagnosis code listed in this section is not sufficient by itself to assure coverage. Refer to the "Indications and Limitations of Coverage" section for other coverage criteria and payment information.