Persius/hicric huggingface dataset:
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 Imiquimod 5% cream. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forImiquimod 5% cream which is subject to prior approval. Our Physician Reviewer needed additionalinformation from the prescriber to make this determination. The prescriber was asked to address whetherthe drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective asthe requested drug; and/or (2) have adverse effects. The requested information was not received. Based ona review of the available documentation, neither prior authorization criteria nor prior authorizationexception criteria 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 Imiquimod 5% cream.Please note: the request for a tiering exception (lower copayment) for Imiquimod 5% cream was notreviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to providecoverage.
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 Gamunex-C . 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 Gamunex-C Solution 20 gram/200 mL. The drug is requested to treat primary immunodeficiency/nonfamilialhypogammaglobulinemia. For coverage under the prescription drug benefit, Medicare requires thatthe drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that theMedicare-approved resources do contain citations to support the use of the requested drug for treatment ofthe noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.You have not indicated why all alternatives required by the Plan (including Gammaplex, Privigen,Panzyga, others) would likely not be as effective for the enrollee as the requested drug; and/or would likelycause adverse reaction(s) or other harm to the enrollee. 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 Gamunex-C.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus. The Plan did not grant this request. We received this case toconduct 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 the beneficiary receiving the drug was enrolled in Medicare PartA at the time of the organ transplant.The case record indicates that Tacrolimus is needed for a Kidney transplant performed July 28, 2012.According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part Acoverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant andTacrolimus is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverageare excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is notrequired to cover Tacrolimus.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

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 Nutren. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Nutren is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. 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: Favorable

You asked the Plan to cover Dorzolamide 2%. The Plan did not grant this request. We received this case toconduct an 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 Dorzolamide 2%.Please note: while the NDC (national drug code) to identify the specific drug in this case is not FDAapproved, there may be other NDCs for Dorzolamide 2% that are eligible for coverage under the Part DPlan. You may contact the Plan or pharmacy for more information on Part D eligible NDCs forDorzolamide 2%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq. 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. Myrbetriq is a Tier 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 Myrbetriq.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide nebulizer solution. 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 a small volume nebulizer and related compressor are covered when medically necessary to administer Budesonide nebulizer solution for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide nebulizer solution is administered through a nebulizer in the home for a diagnosis of chronic obstructive pulmonary disease. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. 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 Budesonide nebulizer solution. 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 Sildenafil. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Sildenafil is one of those excluded drugsbecause it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does notindicate that they provide supplemental coverage for Sildenafil. Therefore, the Plan is not required to coverSildenafil.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: Favorable

You asked the Plan to cover Metopirone 250 mg, two tablets three times daily. 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. The Plan denied the request for Metopirone on the basis that it is excluded from Medicare Part D coverage. The case file and Redetermination letter provided by the Plan did not give any specific reason why Metopirone is excluded from coverage. Additionally, a representative from MAXIMUS Federal verified using Medicare approved resources that Metopirone 250 mg is available by prescription, is FDA approved and not excluded for another reason. Therefore, we sent the request to our physician reviewer to review for Part D coverage.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Metopirone 250 mg, two tablets three times daily. The drug is requested to treat persistent pituitary Cushing's disease related to pituitary adenoma. 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. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Effective for managing the clinical features of Cushing's disease. Therefore, the requested drug is being prescribed for a medically accepted indication.Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the formulary alternatives. The prescriber has indicated why all alternatives 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 the Plan's coverage criteria is medically 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 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 met. Therefore, the Plan is required to cover Metopirone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epidiolex. 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 Epidiolex. The drug is requested to treat G40.311 Generalized idiopathic epilepsy and epileptic syndromes, intractable, with status epilepticus, 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 Epidiolex 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 Epidiolex. 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 provide a tiering exception for Combigan. 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Combigan is a Tier 3 brand drug. The lower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Combigan.
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 Emgality, 120 mg/mL inj. 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 Emgality 120 mg/mL.The drug is requested for Migraine Prophylaxis. 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'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 Emgality, 120 mg/mL inj.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vraylar 1.5 and 3 mg - Capsule Therapy Pack. 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 Vraylar 1.5 mg and 3 mg - Capsule Therapy Pack. The drug is requested to treat major depressivedisorder, recurrent severe without psychotic features, 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 Vraylar 1.5 and 3 mg - Capsule Therapy Pack for thediagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for thiscondition. An exceptions request based on medical necessity cannot be considered because this drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Planis not required to provide coverage for Vraylar 1.5 and 3 mg - Capsule Therapy Pack.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 Buprenorphine. 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 Buprenorphine 2 mg SL tab.The drug is requested to treat chronic pain syndrome, 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 Buprenorphine for the diagnosed condition. As a result, thedrug 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.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 Utira-C tablet. 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 Utira-C tablet is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Utira-C 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 Methylphenidate. 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 Methylphenidate 20 mg tab.The drug is requested to treat fatigue and cognitive impairment due to major depressive disorder, 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 Methylphenidate 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 Methylphenidate. 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.