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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only
Manual, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1.
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.
You can find this information in Local Coverage Determination (LCD): Immunosuppressive Drugs (L33824).
Presciption drugs used in immunosuppressive therapy are covered only if all of the following criteria (I-V) are met:
Immunosuppressive drugs are prescribed following transplants either:
A. Kidney, heart, liver, bone marrow/stem cell, lung, or heart/lung transplant; or,
B. Whole organ pancreas transplant performed concurrent with or subsequent to a kidney transplant because of diabetic nephropathy (performed on or after July 1, 1999); or
C. Intestinal transplant (performed on or after April 1, 2001); or
D. Pancreatic islet cell transplant or partial pancreatic tissue transplantation 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. Must be beta cell autoantibody positive; or
b. 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
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. Delivery requirements:
a. For DOS prior to August 1, 2016 the drugs are furnished on or after the date of discharge from the hospital
following a covered organ transplant.
b. For DOS on or after August 1, 2016 through April 2, 2019, mail-order deliveries may be mailed one or two days prior to a beneficiary's discharge from an inpatient facility to a qualified place of service (such as home or custodial facility). The DOS on the claim must be the date of discharge.
c. For DOS on or after April 3, 2019 mail-order deliveries 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.
If criteria I-V are not met, the drug(s) will be denied as noncovered. You can find this information in Local Coverage Article: Immunosuppressive Drugs - Policy Article (A52474).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rule