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 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 thedrug was enrolled in Medicare Part A at the time of the organ transplant. 42 CFR ?410.30; MedicareBenefit Policy 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. CGS Administrators, LLC, Policy Articlefor Immunosuppressive Drugs (A52474).Medicare Part B local policy states that immunosuppressive drugs are covered only for the specificlabeled indications 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 asnot medically necessary when provided in that setting. CGS Administrators, LLC, Local CoverageDetermination for Immunosuppressive Drugs (L33824).A Part D plan is permitted to use a number of different tools to manage its formulary. One of these toolsis known as prior authorization. This process requires an enrollee to obtain coverage approval for a drugbefore the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005(Preamble to Final Rule).The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be coveredunder Medicare Part A or Part B. The Plan requires prior approval (also called prior authorization) beforecovering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. Pleaserefer to the Plan's Evidence of Coverage.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 Sections 423.578(b) and423.578(b)(5)(i).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).