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 InformationRemodulin (Treprostinil):Administration of epoprostenol (J1325) or treprostinil (J3285) for beneficiaries with pulmonary hypertension if they meet the following disease criteria:1. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g. chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.); and 2. The beneficiary has primary pulmonary hypertension or pulmonary hypertension, which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, diet drugs, congenital left to right shunts, etc. If these conditions are present, the following criteria must be met:a. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and, b. The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and c. The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and d. Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.e. Epoprostenol/treprostinil is administered using ambulatory infusion pump K0455. Claims for usage Local Coverage Determination for External Infusion Pumps (L33794) https://www.cms.gov/medicare-coverage-database/details/lcd-details.as...of infusion pumps other than K0455 will be denied as not reasonable and necessary.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).