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

At issue is coverage for Tukysa 150 milligram tablet, 120 tablets per 30 days. The Part D plan denied the request for coverage because all of the plans prior authorization requirements were not met. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The plans prior authorization requirements for the requested drug are as follows: the enrollee has metastatic or advanced unresectable HER 2 positive breast cancer (inclusive of brain metastases); the enrollee has received one or more prior anti-HER2 based regimens in the metastatic setting; and the Tukysa is to be given in combination with a trastuzumab product and Capecitabine as subsequent therapy. The submitted medical records indicate the enrollee has advanced metastatic HER 2 positive breast cancer with brain metastases. The records indicate that the enrollees breast cancer was originally treated with Abraxane and Tecentriq chemotherapy. Additionally, it is indicated in the progress notes submitted at reconsideration that if the prior authorization for Tukysa is approved, the enrollee will start therapy with Herceptin [trastuzumab product], Xeloda [Capecitabine], and Tucatinib [Tukysa]. As such, the submitted medical records support the enrollee metastatic HER 2 positive breast cancer (inclusive of brain metastases) and the Tukysa is to be given in combination with a trastuzumab product and Capecitabine as subsequent therapy. Yet, there is no indication the enrollee has received one or more prior anti-HER2 based regimens.However, as outlined in the National Comprehensive Cancer Network (NCCN) guidelines, it is 2A recommendation that Tukysa may be given in the second-line setting in combination with Capecitabine and Trastuzumab for patients with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) human epidermal growth factor receptor 2 (HER2)-positive disease that is hormone receptor-negative, or hormone receptor-positive with or without endocrine therapy. It should be noted that the NCCN does not indicate that previous treatment has to contain previous anti-HER2 regimen; it just states second line treatment. In this case, the Tukysa will be given as second line treatment, as the enrollee already had immunotherapy/chemotherapy. The medical records support that the NCCN guideline requirements for coverage of the drug have been met. As such, an exception to the plans prior authorization requirement that the enrollee must have received one or more prior anti-HER2 based regimens is supported. Furthermore, the amount requested does not exceed the plans quantity limit for the drug. Therefore, coverage can be allowed.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Corlanor 7.5-milligram tablets prescribed for baroreflex dysfunction, sick sinus syndrome with pacemaker, possible postural orthostatic tachycardia syndrome. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Cyanocobalamin 1000 microgram per milliliter solution to treat Vitamin B-12 deficiency. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs prescribed for use as vitamins and minerals are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Propranolol extended release 80 milligram tablet to treat essential tremor. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Propranolol extended release 80 milligram tablet is a generic drug on Tier 4 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Otezla 30 milligram tablet to treat psoriasis vulgaris.  The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Tizanidine hydrochloride 2 milligram capsules to treat cervicalgia and radiculopathy, lumbar region. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The prescriber has not indicated that all alternatives required by the plan have been tried and failed, or why the plans required step therapy drugs would likely not be as effective as the requested drug. A physician reviewer determined that neither step therapy nor step therapy exception criteria are met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Zelnorm 6 milligram tablet to treat slow transit constipation. The Part D plan denied the request as an excluded drug in the Medicare Part D program. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. For the drug at issue to be covered under Medicare Part D, the manufacturer must participate in the Medicare Coverage Gap Discount Program. This manufacturer is not participating in the program; therefore, the drug is excluded from Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Voriconazole 200 milligram tablet to treat Paecilomyces, infective myositis, and tenosynovitis. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Breo Ellipta 200/25 microgram per actuation inhaler. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Breo Ellipta is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Xifaxan 550 milligram tablet for the prophylaxis of hepatic encephalopathy in an enrollee with cirrhosis. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The documentation satisfies the plans coverage criteria. The prescriber clarified the medical history in the request for reconsideration. Medical records were provided. The prescriber states the enrollee has tried and failed lactulose and neomycin in the past 12 months.   A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Orphenadrine ER (extended release) 100 milligram tablet to treat chronic back pain. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Repatha sureclick 140 milligram per milliliter auto-injector to treat familial hyperlipidemia. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Enbrel Sureclick 50 milligram per milliliter pen injector to treat rheumatoid arthritis. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a direct member reimbursement request for Keppra 1000 milligram tablet. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The submitted documentation supports the drug at issue was refilled more than once in too short of a timeframe. Therefore, payment cannot be issued for this drug.In conclusion, the decision of the Qualified Independent Contractor (QIC) is unfavorable.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a reimbursement request for Budesonide-Formoterol inhalation powder. The Part D plan denied the request.We received a case to perform an independent and de novo review of this request for coverage. We reviewed all documentation submitted for review, including the case file from the plan, and any information submitted at the reconsideration level. The the submitted documentation does not include a valid proof of purchase for the drug at issue. Therefore, the request for reimbursement cannot be granted.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Simponi aria 50 milligram per 4 milliliter injection solution to treat rheumatoid arthritis. The case was auto-forwarded by the plan. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is tocilizumab 162 milligrams per 0.9 milliliter to treat polymyalgia rheumatica. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Octreotide 100 microgram per milliliter injection solution for prophylaxis of gastrointesinal fistula following a Whipple procedure. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Rybelsus 7 milligram tablet to treat the enrollee's condition. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Rybelsus is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is reimbursement for Estradiol 10 microgram vaginal tablet. The Part D plan denied the request.We performed an independent and de novo review. To make our decision, we reviewed all documentation submitted.The plan submitted documentation that shows the claim for Estradiol was approved and copayment was charged correctly to the enrollee at the point of sale. The plans Evidence of Coverage indicates reimbursement is calculated based on the total cost of the drug, minus the required copayment/coinsurance amount, and minus the difference between what the plan normally pays for the drug and what the pharmacy charges. We determined this drug was paid correctly and no further reimbursement is required by the plan.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Cyclosporine modified 25 milligram prescribed for transplant status. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. We also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received an organ transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Mycophenolate 50 milligram tablet prescribed for transplant status. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. We also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received an organ transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Prednisone 5 milligram tablet prescribed for transplant status. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. We also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received an organ transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Risaquad 8 billion colony forming units capsule. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs prescribed that are available Over the Counter are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Botox 100 unit vial to treat urinary frequency and urgency in an enrollee with detrusor overactivity.  The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Sildenafil 20 milligram tablet to treat male erectile dysfunction and benign prostatic hyperplasia. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other diagnoses for which the drug is not Food and Drug Administration (FDA) approved, are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.  Also note that the use of the requested drug to treat benign prostatic hyperplasia is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis.  A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Bimatoprost 0.03 percent powder to treat hair loss. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs that are not approved by the Food and Drug Administration (FDA) are excluded from Medicare Part D coverage. According to the compendia, This drug has not been found by the FDA to be safe and effective, and the drug product labeling has not been approved by the FDA. Therefore, the requested drug is excluded from coverage.