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

You asked the Plan to cover Tacrolimus 1 mg. 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 Tacrolimus 1 mg. The drug is requested to treat Renal transplant rejection; prophylaxis. The enrolleesatisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteriaare met.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. In thiscase, the Plan denied the request for coverage under Medicare Part D because the Plan states it is eligiblefor coverage under Medicare Part B. We requested evidence from the Plan that Medicare performed thetransplant performed September 7, 2011. The Plan responded to our request, however the Plan failed toprovide sufficient evidence that supports that Medicare paid for the transplant in question. Based on theavailable information we cannot verify that coverage would be available for the requested drug underMedicare Part B. Therefore, it is not eligible for coverage under Medicare Part B and we sent the request toour physician reviewer to review for coverage under Medicare Part D.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria aremet. Therefore, our decision is the Plan is required to cover Tacrolimus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tradjenta. 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 Tradjenta 5 mg tablet.The drug is requested to treat diabetes mellitus. Tradjenta 5 mg tablet is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type 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 Tradjenta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ursodiol 300 mg capsule. 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 Ursodiol 300 mg capsule. The drug is requested to treat primary biliary cirrhosis, which is an off-label(non-FDA approved) use. This is the diagnosis submitted by the prescriber in an appeal letter dated2/6/2020. 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.A written request for Reconsideration must be filed within 60 days from the date of the Plan'sRedetermination Letter. This request was not filed within the required 60-day time limit. However, the caserecord reflects there is good cause for the late filing. Therefore, the Reconsideration request is beingprocessed.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 Ursodiol for the diagnosed condition. As a result, the drug isnot being 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 Ursodiol.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.Please note: the request for a tiering exception (lower copayment) for Ursodiol was not reviewed. Wecannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine. 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 Azathioprine 50 mg. The drug is requested to treat bilateral scleritis, 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 Azathioprine 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 Azathioprine.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 Samsca, 15 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 Samsca, 15 mg tablet, 30/30.The drug is requested to treat hyponatremia due to syndrome of inappropriate antidiuretic hormone. Theenrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan'scoverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be aseffective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exceptioncriteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Samsca, 15 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover and process applicable reimbursement for Hydrocodone/Acetaminophen 5/325 mg and Ondansetron 4 mg received at the hospital on December 11, 2019. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, the record indicates you were a patient in the hospital on December 11, 2019 and received Hydrocodone/Acetaminophen 5/325 mg and Ondansetron 4 mg for a medical emergency or urgent care. You then submitted a request for reimbursement showing proof of payment with itemized statement. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and process applicable reimbursement for Hydrocodone/Acetaminophen 5/325 mg and Ondansetron 4 mg received at the hospital on December 11, 2019.Information in the case record indicates that the enrollee was an outpatient when they received these drugs. As such, the enrollee was not in a position to obtain the drugs that had been previously filled at a network pharmacy, nor were they able to obtain prior authorization or off-formulary exception review. Since this was a one-time emergency stay, the Plan should provide an exception to their normal coverage rules.
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 additional reimbursement for Boostrix Vaccine and administration feereceived August 27, 2019 at your provider's office. The Plan did not grant this request. We received thiscase to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limitedcircumstances. The Plan submitted documentation showing that they approved coverage. They calculatedreimbursement based on the total cost of the drug, less your required copayment amount, and less thedifference between what the Plan normally pays for the drug and what the out-of-network pharmacy (i.e.,hospital or provider's office) charged you.The case record indicates that the Plan provided coverage and reimbursement in accordance with the Part DPlan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provideany additional reimbursement for Boostrix Vaccine and administration fee received August 27, 2019 atyour provider's office.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Entresto. 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 Entresto.Entresto is requested to treat Non-Ischemic cardiomyopathy. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or have 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'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 Entresto.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xyrem 500 mg/mL solution. 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 Xyrem 500 mg/mL solution. The drug is requested to treat narcolepsy with symptoms of excessive daytime sleepiness. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. OnJune 30, 2020 you (a sleep specialist) sent additional information and medical records documenting narcolepsy with excessive daytime sleepiness confirmed with a sleep study with a multiple sleep latency test. Also past trial and failure of dextroamphetamine, methylphenidate and modafinil (among others) was documented. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Xyrem 500 mg/mL solution for the diagnosed condition. As a result, Xyrem 500 mg/mL solution is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Xyrem 500 mg/mL solution.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Bosentan, 62.5 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 Bosentan, 62.5 mg tablet.The drug is requested to treat pulmonary hypertension. Medical records were provided. The enrollee doesnot satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coveragecriteria and/or has not indicated why all alternatives required by the Plan would likely not be as effectivefor the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to theenrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exceptioncriteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Bosentan, 62.5 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Welchol, 625 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 Welchol, 625 mg tablet.The drug is requested to treat diarrhea associated with bile acid malabsorption in an enrollee with multiplemyeloma, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Welchol, 625 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Welchol, 625 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

You asked the Plan to cover Sublocade Soler Syringe. The Plan did not grant this request. We received thiscase to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the MedicareCoverage Gap discount agreement. Sublocade Soler Syringe is a brand name drug, and its manufacturer isnot on this list. Therefore, the Part D Plan is not required to cover Sublocade Soler Syringe.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz, 5 mg tablet. 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 Xeljanz, 5 mg.The drug is requested to treat dermatomyositis, which is an off-label (non-FDA approved) use. TheMedicare-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 Xeljanz, 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 forXeljanz, 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

You asked the Plan to cover Sodium Chloride. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drug is a non-prescription or OTC drug.Therefore, Sodium Chloride is not eligible for Part D coverage, and the Plan is not required to cover itunder the Part D benefit.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 Xiidra 5%. 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 Xiidra 5% ophthalmic solution.The drug is requested to treat dry eye syndrome. The prescriber has not indicated why all alternatives required by the Plan (Restasis) 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 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 requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Xiidra 5%.