Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated 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 under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Medicare Part B pays for the rental or purchase of durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38; Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B covers an external infusion pump for the administration of other drugs if either of the following sets of criteria (1) or (2) are met:Criteria set 1:- Parenteral administration of the drug in the home is reasonable and necessary. - An infusion pump is necessary to safely administer the drug - The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy - The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hoursCriteria set 2:- Parenteral administration of the drug in the home is reasonable and necessary - An infusion pump is necessary to safely administer the drug - The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours) which does not require the beneficiary to return to the physician's office prior to the beginning of each infusion - Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information Administration of parenteral inotropic therapy using the drugs dobutamine (J1250), milrinone (J2260) ordopamine (J1265) for beneficiaries with American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) or New York Heart Association (NYHA) Class IV HF, if a beneficiary meets all of the following criteria:1. Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,2. As Bridge therapy for patients eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for patients not eligible for either MCS/cardiac transplantation; and,3. Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,4. There has been a documented improvement in beneficiary symptoms of heart failure while on theselected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility; and,5. An evaluation every three months by the prescribing provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the beneficiary's cardiac symptoms and the continuing response and need for therapy. The heart failure team or physician.Medicare National Coverage Determinations Manual (CMS Pub. 100-03), Chapter 1, ?280.14. CGS or Noridian Local Coverage Determination (LCD) for External Infusion Pumps (L33794).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).