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

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

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 the BSS-Vancomycin Compound. The Plan did not grant this request. We received this case to conduct an independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. The BSS ingredient of the BSS-Vancomycin Compound is used as a filler, vehicle and/or excipient in the reconstitution of the BSS-Vancomycin Compound. The BSS ingredient use in this instance is not therapeutic. Thus, the BSS ingredient of the BSS-Vancomycin Compound does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover the BSS ingredient of the BSS-Vancomycin Compound.Please note: the Plan provided documentation that the Vancomycin ingredient of the BSS-Vancomycin Compound has been approved. The Plan is still required to provide coverage of the Vancomycin ingredient of the BSS-Vancomycin Compound and the decision above does not affect the Plan's approval of the Vancomycin ingredient of the BSS-Vancomycin Compound.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Clobazam, 10 mg tablet as prescribed. 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 Clobazam, 10 mg tablet.Clobazam, 10 mg tablet is requested to treat refractory epilepsy and juvenile myoclonic epilepsy. The prescriber clarified the diagnoses in a letter. Medical records were provided which documents that the enrollee is taking Klonopin, Keppra and Zonegran concurrently. 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:Adjunctive therapy with clobazam has been effective in the treatment of uncontrolled or refractory epilepsy in adults and children (Robertson, 1986; Scott & Moffett, 1986; Tinuper et al, 1986; Aucamp, 1985; Allen et al, 1983; Franceschi et al, 1983; Shimizu et al, 1982). Effective doses have been 20 to 30 mg/day (Aucamp, 1985). Unfortunately, tolerance to the drug has been reported (Schmidt et al, 1986). A comprehensive review of the open and controlled studies of clobazam in the treatment of epilepsy is available (Robertson, 1986).Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. 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 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 met. Therefore, our decision is the Plan is required to cover Clobazam, 10 mg tablet as prescribed.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Kisqali. 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 Kisqali. The drug is requested to treat metastatic breast cancer. The enrollee is a 74 year old man with metastatic breast cancer involving bones and liver. He has been treated with Tamoxifen, Lupron/Ibrance/Letrozole. Pet scanning showed new bone and liver lesions. He started Kisqali. You request Kisqali to be given with Faslodex. You state Kisqali is different from Ibrance by binding to cyclin D not CDK4/6. Per the NCCN compendium, Kisqali is indicated if CDK4/6 inhibitor not previously used. Ibrance is a CDK4/6 inhibitor. The enrollee has had progression of his cancer on Ibrance and therefore does not meet the Plan's prior authorization criteria.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 Kisqali.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tremfya 100 mg/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 Tremfya 100 mg/mL subcutaneous solution.The drug is requested to treat psoriasis. The prescriber 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. 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 100 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin, 75 mg capsule. 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 Pregabalin, 75 mg capsule, 90/30.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Pregabalin, 75 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Fasenra, 30 mg/mL. 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 Fasenra, 30 mg/mL 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 Fasenra, 30 mg/mL.Please note: the request for a tiering exception (lower copayment) for Fasenra, 30 mg/mL was not reviewed. We cannot 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 Desoxyn, 5 mg tablet. 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 Desoxyn, 5 mg tablet.The drug is requested to treat the enrollee's condition. The prescriber 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. 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 Desoxyn, 5 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 Inlyta. 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 Inlyta 5 mg; 60/30. The drug is requested to treat metastatic kidney cancer. The enrollee is a 69 year old man with metastatic kidney (renal cell) cancer involving bones and lungs. No other clinical information was submitted for review. The prescriber requests Inlyta to be given with Pembrolizumab to treat him. Per the NCCN Compendium, Inlyta is indicated for: therapy for relapse or stage IV disease with clear cell histology in combination with - pembrolizumab (preferred) or avelumab as first-line therapy for favorable risk - pembrolizumab (preferred) or avelumab as first-line therapy for poor/intermediate risk - pembrolizumab or avelumab as subsequent therapy.The requested combination is therefore a medically accepted use. 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 satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met. Inlyta is on the T5 specialty tier.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 Inlyta.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Enbrel Mini. 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 Enbrel Mini 50 mg. The drug is requested to treat M13.80 Other specified arthritis, unspecified site, 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 Enbrel Mini 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 Enbrel Mini. 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 Yonsa. 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 Yonsa 125 mg; 120 per 30 days. The drug is requested to treat the enrollee's condition. The enrollee is a 65-year-old man with metastatic castration resistant prostate cancer. The prescriber states he cannot take Zytiga due to not being compliant with dietary restrictions. No other clinical information was submitted for review. The prescriber requests Yonsa to treat him.The prescriber 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. 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 Yonsa.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tacrolimus. 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 Tacrolimus 1 mg capsule. The drug is requested to treat kidney and pancreas transplant rejection. Records available to the Part D QIC show the enrollee was not Medicare-entitled at the time of the transplant. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the transplant was paid for by Medicare Part A.The case record indicates that Tacrolimus is needed for a kidney and pancreas transplant. In this case, we researched the Medicare Data Base and found that the enrollee was not enrolled in Medicare at the time of the transplant. Therefore, it appears that Tacrolimus is eligible for Part D coverage. We asked our Physician Reviewer to determine if other Part D coverage criteria are met.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Northera 100mg capsule. Northera 100mg capsule is requested to treat orthostatic hypotension symptoms NOT associated with primary autonomic failure (eg, Parkinson disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, or nondiabetic autonomic neuropathy, in a patient with paroxysmal atrial fibrillation, AV node dysfunction, s/p pacemaker insertion, which is an off-label (non-FDA approved) use. Upon reopening of this case, you submitted additional information. 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(s).We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Northera. Our Physician Reviewer determined that the requested drug is not eligible for coverage under Medicare Part D for the noted condition. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.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 Northera 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 Northera.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.This decision affirms our previous unfavorable decision.