Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium-Albuterol 0.5-3 mg per 3mlL nebulizer solution. The Plan did notgrant this request. We received this case to conduct an independent review.We sent the case file to a Physician Reviewer. We asked this doctor to determine whether the Plan wascorrect in denying the request for Ipratropium-Albuterol.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 Ipratropium-Albuterol for the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium-Albuterol is administered for a diagnosis of R06.02,Shortness of breath, J90, Pleural effusion, not elsewhere classified and C34.90, Malignant neoplasm ofunspecified part of unspecified bronchus or lung. Medicare Part B does not provide coverage forIpratropium-Albuterol for this diagnosis. Thus, Ipratropium-Albuterol would not be eligible for Part Bcoverage in this case. We therefore asked our Physician Reviewer to determine if Part D coverage criteriahave been met.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.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ipratropium/Albuterol 0.5-3 mg per 3mlL nebulizer solution. The drug is requested to treat R06.02,Shortness of breath, J90, Pleural effusion, not elsewhere classified and C34.90, Malignant neoplasm ofunspecified part of unspecified bronchus or lung, which are off-label (non-FDA approved) uses. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted conditions.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Ipratropium-Albuterol for the diagnosed condition. As a result,the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forIpratropium-Albuterol 0.5-3 mg per 3mlL nebulizer solution.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.