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, Section 1860D-2(e)(2)(B).Effective January 1, 2011, Medicare law requires that all drugs and biologicals used in the treatment of endstage renal disease (ESRD) be included in the ESRD prospective payment system (PPS) payment bundle,including drugs formerly paid under Medicare Part D. The law identifies categories of drugs that either are,or may be, ESRD-related. Drugs that are always considered ESRD-related include access managementdrugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineralmetabolism drugs and cellular management drugs. Social Security Act, Section 1881(b)(14); 42 CFRSection 413.171; Medicare Benefit Policy Manual, Chapter 11, Section 20.3; and 75 Federal Register No.155, issued August 12, 2010 (Preamble to Final Rule).Effective February 20, 2018, Medicare law also provides coverage of related drugs under the PPS bundlefor treatment of acute kidney injury (AKI). Medicare Benefit Policy Manual, Chapter 11, Section 100.6.For drugs that are always considered ESRD-related, it is important to note that the ESRD bundle includesall ESRD-related drugs and biologicals, regardless of whether or not these are furnished by a dialysisfacility. Thus, effective January 1, 2011, any claims for a drug included in the five categories of drugs thatare always considered renal dialysis drugs when furnished to an ESRD patient and used as specified inTable 4 of the Preamble to the Final Rule would not be payable under Part D when the beneficiary is anESRD patient in dialysis, regardless of why the drug is being furnished. Medicare Program; End-StageRenal Disease Prospective Payment System, 75 Fed. Reg. 49030, 49050 (August 12, 2010); CMS memo:Clarification of Exclusion of Part D Payment for Drugs included in the End-Stage Renal DiseaseProspective Payment dated February 17, 2011.Part D specifies that a drug prescribed to a Part D eligible individual cannot be considered a covered Part Ddrug if payment for such drug ...is available (or would be available but for the application of a deductible)under part A or B for that individual. CMS interprets this to mean that if payment could be available underPart A or Part B to the individual for such drug, then it will not be covered under Part D. Consequently,drugs covered under Parts A and B are considered available (and excluded from Part D) even if abeneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has notyet taken effect. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.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. Please refer to the Plan's Evidence of Coverage.