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

You asked the Plan to cover Fluticasone-Salmeterol. 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 Fluticasone-Salmeterol. The drug is requested to treat asthma. The prescriber has not indicated why allalternatives 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. Review of the FDA drugshortages database does not show any shortage of brand name Advair. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot 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 Fluticasone-Salmeterol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epclusa. 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 Epclusa. The drug is requested to treat liver cirrhosis with chronic hepatitis C infection, 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. The enrollee does havecardiac history, but this is not noted as a contra-indication of the recommended treatment plan usingRibavirin in combination of Epclusa for a 12 week regimen. Reviewed records do not indicate the enrolleeis taking amiodarone. 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 Epclusa 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 Epclusa.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 Lidocaine 5% patch. 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 Lidocaine 5% patch. The drug is requested to treat degenerative disc disease and spondylolisthesis,which is an off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain anycitations 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 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 Lidocaine 5% patch 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 forLidocaine 5% patch.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: Favorable

You asked the Plan to cover Cosentyx Sensoready (300 mg) Sol Auto inj as prescribed. The Plan did notgrant 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 requestfor Cosentyx Sensoready (300 mg) Sol Auto inj.Cosentyx Sensoready (300 mg) Sol Auto inj is requested to treat moderate to severe Plaque psoriasis in this65 year old enrollee who has failed multiple high dose topical steroids, Methotrexate, and Otezla. Theenrollee's family history is notable for melanoma in the enrollee's mother. The prescriber has discussed theenrollee's clinical history, and potential treatment options including Humira and Stelara, the alternativesnoted in the Plan's denial letter. Additionally the prescriber has cited several clinical trials documenting thesuperior efficacy of Cosentyx. The prescriber has provided a sufficiently strong statement as to why allalternatives required by the Plan would likely not be as effective as the requested drug for the enrollee,and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to thePlan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formularyexception 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 Cosentyx Sensoready (300 mg) Sol Auto inj as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha solution prefilled syringe. 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 Repatha solution prefilled syringe. The drug is requested to treat other hyperlipidemia. 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.However, the prescriber has not indicated why all alternatives required by the Plan (including Praluent) 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 Repatha solution prefilled syringe.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Austedo. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Austedo is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Austedo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xiidra 5% ophthalmic drops. 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 drops. The drug is requested to treat keratoconjunctivitis sicca. You have not indicated why all alternatives required by the Plan (Restasis ophthalmic drops) 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% ophthalmic drops.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tymlos, 80 mcg. 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 Tymlos, 80 mcg.The drug is requested to treat osteoporosis. The prescriber has not indicated (with patient specific rationale) why all alternatives required by the Plan (Forteo and Prolia) 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 Tymlos, 80 mcg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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 Cresemba. The drug is requested to treat Paecilomyces lilacinus, 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 Cresemba 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 Cresemba. 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

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 Insulin Aspart. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that insulin is covered if certain criteria, detailed above, are met. In this case, documentation in the file shows that Insulin Aspart is being administered through an infusion pump in the home for treatment of diabetes. Insulin Aspart appears eligible for Part B coverage in this case. Drugs that are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part D Plan is not required to cover Insulin Aspart. 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.Please contact the Plan for more information regarding coverage of Insulin Aspart under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. 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 Otezla 30 mg. Otezla 30 mg is requested to treat moderate to severe plaque psoriasis affecting 15-20% of the enrollee's body surface area including involvement of the hands, arms and feet. The prescriber states that the enrollee has failed phototherapy, Triamcinolone, Dovonex, and Betamethasone. There are multiple biologics on the plan's formulary. The plan has indicated in their denial letters that coverage of Otezla requires trial/contraindication to at least of two of their formulary biologic drugs. The prescriber states that the enrollee is not comfortable with needles; however, the prescriber states that the enrollee does not have a needle phobia. The prescriber has discussed some of the benefits of Otezla; however, 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'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 Otezla.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla . 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 Otezla 30 mg. Otezla 30 mg is requested to treat hidradenitis suppurativa, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical history, and has provided medical literature to support the request; however, 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 Otezla 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 Otezla. 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 Orilissa. The Plan did not grant this request. We received this case to conductan independent review.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 Orilissa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Methylphenidate HCL. 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 a tiering exception for Methylphenidate HCL 10 mg. The drug is requested to treat attention deficithyperactivity disorder. Methylphenidate HCL 10 mg is a generic drug on Tier 3 of the Plan's formulary.There are no available lower tier generic drugs of the same type on the Plan's formulary to treat theenrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Methylphenidate HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Spravato. The Plan did not grant this request. We received this case to conductan 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 pays for services and supplies incident to theservice of a physician (or other practitioner).Spravato is a type of drug that must be administered under direct observation of a health care provider andmonitored for at least two hours after administration. The Food and Drug Administration (FDA) hasmandated a Risk Evaluation and Mitigation Strategy (REMS) for Spravato. The Spravato REMS requiresthat Spravato be only dispensed and administered to patients in a medically supervised healthcare settingthat monitors the enrollee.As a result, the drug as administered in this case appears to be eligible for coverage under Medicare Part B.Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law.Therefore, it is our decision that the Part D Plan is not required to cover Spravato.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.