Appeal type: Prescription Drug
Decision: Unfavorable

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 and provide reimbursement for Heplisav-B and Travelan received on March 3,2020, from the provider. The Plan did not grant this request. We received this case to conduct anindependent review. This case also involves a request for reimbursement for Boostrix, Havrix, IPOL, andTyphim VI received on March 3, 2020.Regarding the request for Heplisav-B: Medicare law specifically excludes coverage for any drug for whichpayment would be available under Parts A or B of Medicare for that individual. Medicare law states thatMedicare Part B pays for the Hepatitis B vaccine for the prevention of illness for those individuals who areat high or intermediate risk of contracting Hepatitis B.In this case, documentation in the record indicates that the enrollee was administered Heplisav-B, aHepatitis B vaccine, due to imminent international travel, not due to being a member of a group at high orintermediate risk of contracting Hepatitis B. Thus, it appears Heplisav-B would be eligible for coverageunder Part D. We therefore asked our Physician Reviewer to determine if Part D coverage criteria havebeen met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan wascorrect in denying the request for Heplisav-B.The drug is requested for the prophylaxis of Hepatitis B prior to travel. Heplisav-B is not on the Plan'sformulary. Recombivax HB and Engerix-B are on the Plan's formulary. The prescriber has not indicatedwhy all alternatives required by the Plan would likely not be as effective for the enrollee as the requesteddrug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exceptionto the Plan's coverage criteria is not supported.Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover or provide reimbursement for Heplisav-B received on March 3,2020, from the provider.Regarding the request for Travelan: Medicare Part D does not cover non-prescription drugs. We checkedFDA approved sources for the drug's classification or determined from other available resources that thedrug is a non-prescription or OTC drug. Therefore, Travelan is not eligible for Part D coverage, and thePlan is not required to cover or provide reimbursement for it under the Part D benefit.This decision does not address the medical necessity or appropriateness of Travelan received on March 3,2020, from the provider. It only establishes that payment cannot be made under the Medicare Part Dbenefit.