Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Tyvaso. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Tyvaso 1.74mg/2.9 ampul- neb. The drug is requested to treat pulmonary arterial hypertension, WHOGroup I. Local Coverage Determination (LCD): Nebulizers (L33370) states that in order for this drug to becovered under Part B the following needs to be satisfied:1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in theLCD-related Policy Article for applicable diagnoses, Local Coverage Article: Nebulizers - Policy Article(A52466); and2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial orventriculardisease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g., chronicobstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disorderedbreathing, alveolar hypoventilation disorders, etc.); and3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary toone of the following conditions: connective tissue disease, thromboembolic disease of the pulmonaryarteries, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to rightshunts. If these conditions are present, the following criteria (a-d) must be met:a. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of theidentified condition; andb. The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; andc. The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea onexertion, and either fatigability, angina, or syncope); andd. Treatment with oral calcium channel blocking agents has been tried and failed, or has been consideredand ruled out.You were asked the above questions. You stated that the enrollee has a Pulmonary artery pressure of 20mm Hg. This has been confirmed by right heart catheterization. Based on the information provided and theabove LCD requirements, the drug would NOT be eligible for coverage under Part B for the enrollee'scondition. Therefore, the enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion isthat prior authorization criteria are met.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Tyvaso for the management of obstructive pulmonary disease.In this case, the record shows that Tyvaso is administered for a diagnosis of pulmonary arterialhypertension. Medicare Part B does not provide coverage for Tyvaso for this diagnosis. Thus, Tyvasowould not be eligible for Part B coverage in this case. We therefore asked our Physician Reviewer todetermine if Part D coverage criteria have been met.Please note that if the Plan does not agree with our decision, they can ask usto open a case again. We only open a case again if we believe there was a mistake or if there is newinformation to review. The health plan has to show us the mistake and/or send us the new information. Thisdoes not happen often. If we decide to open the case again, we will notify you in writing that the case isbeing reviewed again and the outcome of the reopening.