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

You asked the Plan to cover Isosorbide Dinitrate. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Isosorbide Dinitrate. The drug is requested to treat angina. The prescriber has not indicated why allalternatives required by the Plan would likely not be as effective for you as the requested drug; and/orwould likely cause adverse reaction(s) or other harm to you. Therefore, an exception to the Plan's coveragecriteria 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 Isosorbide Dinitrate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rytary ER. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Rytary ER. The drug is requested to treat Parkinson's disease. The drug is onTier 4 of the Plan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Rytary ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolic Acid DR and Sirolimus. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the transplant was paid for by Medicare. The case record indicates that Mycophenolic Acid DR and Sirolimus is needed for a kidney transplant performed 2015. According to the case record, it was determined that Medicare Part A paid for the transplant in question. Thus, the transplant is considered a Medicare covered transplant and Mycophenolic Acid DR and Sirolimus are eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part B coverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Thus, Mycophenolic Acid DR and Sirolimus are not considered a Part D drug in this case. Therefore, our decision is the Part D Plan is not required to cover Mycophenolic Acid DR and Sirolimus. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes 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 Tadalafil, 20 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Tadalafil, 20 mg tablet is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction or sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tadalafil, 20 mg tablet. Therefore, the Plan is not required to cover Tadalafil, 20 mg tablet. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone Cypionate. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Testosterone Cypionate 200 mg/mL solution.The drug is requested to treat unspecified hypogonadism, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Testosterone Cypionate 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, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Testosterone Cypionate. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Estriol 10% Cream. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Estriol 10% Cream is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Estriol 10% Cream. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolastin-C. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Prolastin-C 1000 mg injection.The drug is requested to treat alpha-1 antitrypsin (AAT) deficiency with deficient genotype of MZ. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all 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.Our Physician Reviewer's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Prolastin-C.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Apriso ER. 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 Apriso ER. The drug is requested to treat Ulcerative colitis, Maintenance of Remission. In theReconsideration appeal you stated that the enrollee also tried and failed Balsalazide in 2014 due to anincrease in loose stools and abdominal discomfort. You have indicated why all alternatives required by thePlan would likely not be as effective as the requested drug for the enrollee, and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria ismedically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore,the Plan is required to cover Apriso ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Saphris. 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 Saphris.Saphris is requested for ongoing treatment of psychosis, unspecified type (reportedly a continuation sincehospitalized in 2015), in this enrollee with major depressive disorder, recurrent, moderate, generalizedanxiety disorder, panic disorder, post-traumatic stress disorder, chronic, borderline personality disorder,irritability and anger, and history of traumatic brain injury, which is an off-label (non-FDA approved) use.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 Saphris for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered 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 Saphris.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 Lyrica CR ER. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lyrica CR ER. The drug is requested to treat Fibromyalgia, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Lyrica CR ER 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, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Lyrica CR ER. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Megestrol Acetate 625 mg/5 mL suspension. The Plan did not grant thisrequest. We received 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 Megestrol Acetate 625 mg/5 mL.The drug is requested to treat loss of appetite in an enrollee with end stage renal disease, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible for coverage under 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 Megestrol Acetate 625 mg/5 mL suspension for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Megestrol Acetate 625 mg/5 mL suspension.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 Accu-Chek Guide Test Strip. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that the definition of a Part D drug includes medical supplies directly associated with the injection of insulin. Test strips, lancets and needle disposal systems are not considered medical supplies directly associated with the delivery of insulin for purposes of coverage under Part D. You asked the Part D Plan to provide coverage for test strips. Diabetic test strips are a medical supply that is specifically excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Accu-Chek Guide Test Strip. This decision does not concern the medical necessity or appropriateness of the requested item. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gebauer's Pain Ease spray. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Gebauer's Pain Ease spray is not FDA approved for both safety and effectiveness bychecking FDA sources. Therefore, the Plan is not required to cover Gebauer's Pain Ease spray.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 Clinolipid 20% . 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 underParts A or B of Medicare for that individual. Medicare Part B rules state that parenteral nutrition is coveredfor a beneficiary who has a permanent, severe pathology of the alimentary tract which does not allowabsorption of sufficient nutrients to maintain weight and strength commensurate with the beneficiary'sgeneral condition. If the coverage requirements for parenteral nutrition are met, medically necessarynutrients, administration supplies, and equipment are covered.In this case, we requested additional information whether Clinolipid 20% is requested to treat an enrolleewith a permanent, severe pathology of the alimentary tract which does not allow absorption of sufficientnutrients to maintain weight and strength commensurate with the beneficiary's general condition. It is notedthat at various times the prescriber has indicated that the enrollee does have a functioning GI tract and theenrollee does not have a functioning GI tract. Based on the lack of a response, we do not have enoughinformation to determine if the enrollee does or does not have a functioning GI tract. Clinolipid 20% willbe administered through an intravenous/pump in the enrollee's home. It appears the drug as prescribed andadministered would be eligible for coverage under Medicare Part B parenteral nutrition coverage. Drugswhich are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, ourdecision is the Part D Plan is not required to cover Clinolipid 20%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mexiletine HCL . The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mexiletine HCL 200 mg capsule.Mexiletine HCL 200 mg capsule is requested for ongoing treatment of hypertension and migraine headaches, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Mexiletine 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, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Mexiletine HCL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.