Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act ?1860D-2(e)(2)(b) and 42 CFR ?423.100.Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapyfurnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drugwas enrolled in Medicare Part A at the time of the organ transplant. 42 CFR ?410.30; Medicare BenefitPolicy Manual, Chapter 15, ?50.5.1.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are coveredif I) they are prescribed following a transplant, II) the transplant met Medicare coverage criteria in effectwith respect to the facility being approved for transplant, III) the patient was enrolled in Medicare Part A atthe time of the transplant, IV) the patient is enrolled in Medicare Part B at the time the drugs are dispensedand V) the drugs are furnished on or after the date of discharge. Assuming criteria I, II and III are met, atransplant is considered a covered transplant for purposes of this Medicare policy whether payment for thetransplant was made by Medicare or another insurer. You can find this rule at Noridian HealthcareSolutions, LLC, Policy Article for Immunosuppressive Drugs (A52474) or CGS Administrators, LLC,Policy Article for Immunosuppressive Drugs (A52474).Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeledindications and approval for marketing by the FDA (bp 102 c15, ?50.5.1). Parenteral Belatacept (Nulojix)is not proven to be safe when administered in the home setting and therefore will be denied as notmedically necessary when provided in that setting. CGS Administrators, LLC, Local CoverageDetermination for Immunosuppressive Drugs (L33824).Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines thatthe drug is medically necessary, consistent with the prescriber's statement, and that the drug would becovered but for the fact that it is not on the formulary. The statement must show that all of the covereddrugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effectiveas the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Section 423.578(b).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover thedrug. The Plan will make an exception for coverage if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage(EOC).