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

You asked the Plan to cover Sildenafil. 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 Sildenafil. The drug is requested to treat pulmonary hypertension due to heart failure WHO Group 2, 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 Sildenafil 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 Sildenafil.  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 Dronabinol. 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 Dronabinol. The drug is requested to treat chronic pain and nausea related to lumbosacral radiculopathy, interstitial cystitis, idiopathic progressive neuropathy, and pelvic pain/vulvodynia, 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 Dronabinol for the diagnosed conditions. 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 these conditions. 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 Dronabinol.  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 Tremfya. 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 Tremfya. The drug is requested to treat plaque psoriasis. You 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. 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 Tremfya.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Fluticasone-Salmeterol. 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 Fluticasone-Salmeterol. The drug is requested to treat asthma. You 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. 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 Fluticasone-Salmeterol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Norlyda. 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 Norlyda. The drug is requested to treat menorrhagia, 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 Norlyda 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 Norlyda.  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 Tretinoin 0.025% Cream . 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 Tretinoin 0.025% cream. Tretinoin 0.025% cream is requested to treat L70.8 - other acne, which you have indicated is a cosmetic condition. Drugs prescribed for cosmetic purposes are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage  Medicare law excludes certain drugs from Part D coverage. Tretinoin 0.025% Cream is one of those excluded drugs because it is a drug used for cosmetic purposes or to promote hair growth. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tretinoin 0.025% Cream. Therefore, the Plan is not required to cover Tretinoin 0.025% 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: 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 Humira 40 mg/0.4 ml. 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 Humira 40 mg/0.4 mL.  The drug is requested to treat rheumatoid arthritis. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.  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 Humira 40 mg/0.4 ml.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin. The Plan did not grant this request. We received this case to conduct an independent review.   We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Oxycontin which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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 Oxycontin.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide applicable reimbursement for Motegrity 1 mg purchased June 30, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. Motegrity 1 mg is not on the Plan's 2020 Formulary. However, the Plan provided documentation that a formulary exception was approved. Per the 2020 Evidence of Coverage, if the Plan makes an exception and covers a drug that is not on the formulary, it will be covered at a Tier 4 copayment level. The Plan verified the enrollee used an in-network pharmacy and the claim has not yet been processed. The Plan also indicated there is no reason the claim should be denied at this time. The case record includes proof of payment for the June 30, 2020 purchase.  The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is required to process and provide any applicable reimbursement for Motegrity 1 mg tab purchased June 30, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol 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 Albuterol nebulizer solution for the management of obstructive pulmonary disease.  In this case, the record shows that Albuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of ICD-10 J45.909 (Unspecified asthma, uncomplicated). 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 Albuterol 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 Intralipid. 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 Parts A or B of Medicare for that individual. Medicare Part B rules state that parenteral nutrition is covered for a beneficiary who has a permanent, severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the beneficiary's general condition. If the coverage requirements for parenteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.   In this case, we requested additional medical information to determine if criteria for Medicare part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Intralipid has been prescribed, confirmation if the enrollee has a permanent dysfunction of the GI tract, is receiving dialysis and how the Intralipid will be supplied. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Intralipid is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Intralipid.  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 Travasol. 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 Parts A or B of Medicare for that individual. Medicare Part B rules state that parenteral nutrition is covered for a beneficiary who has a permanent, severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the beneficiary's general condition. If the coverage requirements for parenteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.  In this case, we requested additional medical information to determine if criteria for Medicare part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Travasol has been prescribed, confirmation if the enrollee has a permanent dysfunction of the GI tract, is receiving dialysis and how the Travasol will be supplied. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Travasol is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Travasol.  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 Ipratropium-Albuterol 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 Ipratropium-Albuterol nebulizer solution for the management of obstructive pulmonary disease.  In this case, the record shows that Ipratropium-Albuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of ICD-10 J44.1 (Chronic obstructive pulmonary disease with (acute) exacerbation). 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 Ipratropium-Albuterol 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

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 Indomethacin. 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 Indomethacin. The drug is requested to treat the enrollee's condition.  A request for prescriber statement was sent and not returned. You 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. 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 Indomethacin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcitriol. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.  In this case, Calcitriol is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Calcitriol is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Calcitriol.  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 provide reimbursement the Dexamethasone-Microcrystalline Compound. 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 the Dexamethasone-Microcrystalline Compound purchased from the Pharmacy is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover or provide reimbursement the Dexamethasone-Microcrystalline Compound. 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.