Persius/hicric huggingface dataset:
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Corlanor, 5 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Corlanor, 5 mg tablet.The drug is requested to treat postural orthostatic tachycardia syndrome, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare 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 Corlanor, 5 mg tablet 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 forCorlanor, 5 mg tablet.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.
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 Cyancobalamin. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Cyancobalamin is one of those excluded drugsbecause it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicatethat they provide supplemental coverage for Cyancobalamin. Therefore, the Plan is not required to coverCyancobalamin.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Spiriva HandiHaler, 18 mcg capsule. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Spiriva HandiHaler, 18 mcg capsule.The drug is requested to treat chronic obstructive pulmonary disease. The prescriber has not indicated whyall alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug;and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Spiriva HandiHaler 18 mcg capsule.
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 Testosterone 1.62% gel pump . The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Testosterone 1.62% gel pump.Testosterone 1.62% gel pump is requested to treat, low Testosterone. The prescriber was asked questionsto clarify the diagnosis being treated and to provide documentation to support the noted diagnosis. Theprescriber was also asked questions to address the Plan's coverage/tiering exception criteria. A responsefrom the prescriber was not received. Therefore, based on the current record, there is insufficientdocumentation to support an exception to the Plan's coverage criteria.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 needed additional information from the prescriber to determine whether theenrollee is using Testosterone 1.62% gel pump for an FDA-approved use, or a use listed in the Medicareapprovedcompendia. The requested information was not received. As a result, we could not confirm thatthe drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessitycannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare PartD drug. Therefore, our decision is that the Plan is not required to provide coverage for Testosterone 1.62%gel pump.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Perforomist. 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 Perforomist for the management of obstructive pulmonary disease.In this case, the record shows that Perforomist is administered through a nebulizer in the home for adiagnosis of Chronic obstructive pulmonary disease. There is no indication that it is not administeredthrough a small volume nebulizer. It appears that this medication is eligible for coverage under Part Brather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverageby Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Perforomist.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cyclobenzaprine.Cyclobenzaprine is requested to treat an unclear diagnosis. The prescriber was asked to clarify theenrollee's diagnosis, because there was a change of the enrollee's diagnosis in the case file. The prescriberwas also asked to address medical necessity for the requested drug. A response from the prescriber was notreceived. Therefore, based on the current record, there is insufficient documentation that the requestedmedication is being prescribed for a medically accepted indication as defined by Medicare law. In addition,an exceptions request based on medical necessity cannot be considered because it cannot be confirmed thatthe drug meets the definition of a Medicare Part D drug.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 i ssupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether theenrollee is using Cyclobenzaprine for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Therefore, our decision is that the Plan is not required to provide coverage for Cyclobenzaprine.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Donnatal. The Plan did not grant this request. We received this case to conductan independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Donnatal is not FDA approved for both safety and effectiveness by checking FDA sources.Therefore, the Plan is not required to cover Donnatal.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine HCL. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Buprenorphine HCL 2 mg sublingual tablet. The drug is requested to treat chronic pain, which is an offlabel(non-FDA approved) use. The following citation was referenced in DrugDex, a Medicare approvedcompendium which states: Buprenorphine hydrochloride sublingual tablets are not appropriate as ananalgesic (off-label usage) [17]. 17. Product Information: buprenorphine HCl sublingual tablets,buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. 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 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 Buprenorphine HCL 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 forBuprenorphine HCL.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lantus. 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 Lantus 100unit/ml. Lantus 100 unit/ml is requested to treat an unknown diagnosis. You were asked tostate the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in thecase file. You were also asked to address medical necessity for the requested drug. A response from youwas not received. Therefore, based on the current record, there is insufficient documentation that therequested medication is being prescribed for a medically accepted indication as defined by Medicare law.In addition, an exceptions request based on medical necessity cannot be considered because it cannot beconfirmed that the drug meets the definition of a Medicare Part D drug.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 Lantus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Sodium DR. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided that Medicare Part A paid for the transplant in question.The case record indicates that Mycophenolate Sodium DR is needed for a kidney transplant performed July25, 2011. According to the case record, the transplant in question was paid for by Medicare Part A. Thus,the transplant is considered a Medicare covered transplant and Mycophenolate Sodium DR is eligible forcoverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part Dcoverage by Medicare law. Therefore, our decision is that Part D Plan is not required to coverMycophenolate Sodium DR.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ozempic. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Ozempic is a Tier 3 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Ozempic.You also asked the Plan to provide a tiering exception for Delestrogen. The Plan did not grant this request.We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Delestrogen is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Delestrogen
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trulicity. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Trulicity is a Tier 3 brandbiologic drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Trulicity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin. The Plan did not grant this request. We received this case toconduct an independent review.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 needed additional information from the prescriber to determine whether you areusing Pregabalin for an FDA-approved use, or a use listed in the Medicare-approved compendia. Therequested information was not received. As a result, we could not confirm that the drug is being prescribedfor a medically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit. An exceptions request based on medical necessity cannot be considered because itcannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decisionis that the Plan is not required to provide coverage for Pregabalin.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.
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 provide a tiering exception for Trelegy Ellipta. The Plan did not grant this request.We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Trelegy Ellipta is a Tier 3 branddrug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is thePlan is not required to provide a tiering exception for Trelegy Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover and provide reimbursement for Rivastigmine 1.5 mg capsule, purchased onApril 14, 2020, from the pharmacy. The Plan did not grant this request. We received this case to conduct anindependent review. You also requested we consider reimbursement for Rivastigmine purchased on May27, 2020.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Rivastigmine 1.5 mg capsule.The drug is requested to treat dementia. The prescriber has not indicated why all alternatives required bythe Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot 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 Rivastigmine 1.5 mg capsule,purchased on April 12, 2020, from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gammagard. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Gammagard 10% liquid. The drug is requested to suppress/eliminate anti-HLA antibodies in an enrolleeawaiting lung transplant, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Gammagard 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 Gammagard.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.