Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tobramycin. The Plan did not grant this request. We received this case toconduct an independent review.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 Tobramycin for the management of cystic fibrosis or bronchiectasis.In this case, the record shows that Tobramycin is administered for a diagnosis of recurrent pneumonia.Medicare Part B does not provide coverage for Tobramycin for this diagnosis. Thus, Tobramycin would notbe eligible for Part B coverage in this case. We therefore asked our Physician Reviewer to determine if PartD coverage criteria have been met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan wascorrect in denying the request for Tobramycin 300 mg/5 mL nebulizer solution.Tobramycin 300 mg/5 mL nebulizer solution is requested for use in this patient without a diagnosis ofcystic fibrosis or bronchiectasis, who has a history of recurrent pneumonia, which is an off-label (non-FDAapproved) use. The prescriber states that this enrollee has benefited from the requested drug in the past;however, the Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Tobramycin for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Tobramycin.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.