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 InformationI. Levodopa-Carbidopa enteral suspension (J7340) is only covered for treatment of motor fluctuations in beneficiaries with Parkinson's disease (PD), who meet all of the following criteria (See Diagnosis Codes Group 4 that Support Medical Necessity section below):1. The beneficiary has been evaluated by a neurologist, who prescribes and manages treatment with the drug; and, 2. Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD features (tremor, rigidity, postural instability); and, 3. L-dopa responsive with clearly defined On periods; and, 4. Persistent motor complications with disabling Off periods for a minimum of 3 hours/day, despite medical therapy with levodopa-carbidopa, and at least one other class of anti-PD therapy i.e. COMT inhibitor or MAO-B inhibitor. CGS Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and Local Coverage Article (LCA) for External Infusion Pumps (A52507).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).