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

At issue is Desmopressin Acetate 1.5 milligram per milliliter nasal solution to treat von willebrand's disease. 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 requested Desmopressin nasal solution 1.5 milligram per milliliter at the plans coverage determination level, which the plan denied on grounds that the drug is not listed in the NSDE file, or the NDC listed on the NSDE has a marketing end date prior to the date of service, and therefore is not payable under Medicare Part D. The Prescriber requested a redetermination from the plan but changed the request to Desmopressin 0.01 percent nasal spray. The plan did not identify the changed request and issued an unfavorable redetermination for Desmopressin Acetate nasal solution 1.5 milligram per milliliter, denying for the same reason as noted at the coverage determinationlevel. The plan should have processed the changed drug request as a new coverage determination request. The prescriber appealed to the Part D Qualified Independent Contractor (QIC) for a reconsideration. The QIC does not have jurisdiction to review the changed request for Desmopressin 0.01 percent nasal spray since the plan has not issued a coverage determination or redetermination for this particular drug. Accordingly, the QICs reconsideration reviews the prescribers original request for Desmopressin nasal solution.Desmopressin nasal solution is not coverable under Medicare Part D as there are no available NDCs for this particular concentration that are listed on the NSDE list within the current marketing date. As such, Desmopressin nasal solution is not a Part D drug under the Medicare rules, and there is not eligible to be covered. The Prescriber should return to the plan to request a coverage determination for Desmopressin 0.01 percent nasal spray. This drug is listed on the NSDE and therefore is eligible to be evaluated for coverage as a Part D drug. Drugs that are not approved by the Food and Drug Administration (FDA) are excluded from Medicare Part D coverage. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Wixela Inhub 250-50 microgram inhaler to treat obstructive lung disease. 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.Wixela Inhub is a generic drug on Tier 3 of the plans formulary. There are no generic 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 Progesterone Wettable powder, Polyethylene Glycol powder, Silica gel, Acesulfame Potassium powder, Acacia powder, Stevia Extract powder compounded drug prescribed to treat an unspecified diagnosis. We received the 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. Drugs that are not approved by the Food and Drug Administration (FDA) are excluded from Medicare Part D coverage. According to the compendia, The individual ingredients within the compounded drug have 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 compounded drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Ozempic 0.25 milligram or 0.5 milligram pen injector to treat enrollees condtion. 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.Ozempic 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 a tiering exception request for Repatha Pushtronex 420 milligram per 3.5 milliliter wearable injector to treat mixed 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.Repatha Pushtronex is a biologic on Tier 3 of the plans formulary. There are no biologics of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this biologic 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 coverage for Diclofenac Epolamine 1.3 percent patch to treat unspecified pain in the right and left shoulders. The Part D plan denied the request for coverage. 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 noted condition 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 condition. Therefore, the drug is being prescribed for a non-medically accepted indication.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 Butalbital - Aspirin - Caffeine - Codeine 50/325/40/30 milligrams for unknown diagnosis, the diagnosis provided at initial determinations. 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. At reconsideration, diagnosis of tension headaches was given. However, no documentation by the prescriber to support this new diagnosis is provided in the form of medical records. We requested information but no information was received. We are not able to determine whether the requested drug was prescribed for a medically accepted indication. Therefore, the 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 Diclofenac Sodium gel 1 percent prescribed for other enthesopathies, not elsewhere classified (tendonitis of shoulder); strain of muscle and tendon of back wall of thorax, initial encounter and dorsalgia, unspecified. 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. This decision does not speak to the medical necessity of this drug; it speaks to whether the Part D drug plan is responsible for payment under CMS rules. 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 Cyclobenzaprine Hydrochloride 10 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.At reconsideration a diagnosis of fibromyalgia was given. However, no documentation was provided by the prescriber to support this diagnosis. We requested information from the prescriber but no information was received. We are not able to determine whether the requested drug(s) was prescribed for a medically accepted indication. Therefore, the 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 Botox 100 unit vial to treat neurogenic bladder (N31.9). 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.Botox is a biologic drug on Tier 2 of the plans formulary. There are no biologic drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this biologic 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 Lamotrigine (orange) 25 milligram (42)-100 milligram (7) tablet dose pack to treat depression. 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 coverage for Spravato 28 milligram per 0.2 milliliter (56 milligram per dose) nasal spray prescribed as an adjunct therapy for recurrent treatment-resistant depression. The Part D plan denied the request for coverage. 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.As outlined in the drugs product labeling, SPRAVATO is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO must never be dispensed directly to a patient for home use. Drugs that cannot be dispensed directly to a patient for home use and require physician supervision with administration are excluded from Part D coverage. However, the drug may be available for coverage under Medicare Part B. 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 Vitamin D2 1.25 milligram (50,000 units) to treat Vitamin D 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 Albuterol Sulfate 0.63 milligram per 3 milliliter vial for nebulization prescribed for the treatment of chronic pansinusitis, nasal polyps, and wheezing. The Part D plan denied the request.We received the 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 submitted documentation shows the requested drug is being administered through a nebulizer in the home setting. Therefore, we determined the drug may be eligible for coverage under Part B under Medicare rules.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Lynparza 150 milligram tablet to treat metastatic castrate resistant prostate cancer. 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 indicates the prescriber ordered the drug at issue for the enrollees diagnosis. The Medicare approved compendia contain a citation to support the use of the drug for the noted diagnosis. The documentation supports homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer. In addition, there is evidence of progress disease following prior treatment with Abiraterone.The plan has prior authorization coverage criteria that must be met prior to approval. The enrollee satisfies the Plans coverage criteria.  A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Tadalafil 20 milligram tablet, 30 tablets per 30 days, to treat pulmonary arterial hypertension, World Health Organization (WHO) group 1. The Part D plan denied the request for coverage stating that the requested drug was an excluded Part D drug. 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.As outlined in the Medicare Prescription Drug Benefit Manual (MPDBM), Chapter 6, Section 20.1, erectile dysfunction (ED) drugs will not meet the definition of a Part D drug when used off-label, even when the off label use is listed in one of the compendia. However, while Tadalafil is used to treat erectile dysfunction, it is also Food and Drug Administration (FDA)-approved to treat pulmonary arterial hypertension, WHO Group 1. As such, the drug is not being used for an off-label use and is a covered Part D drug for the treatment of pulmonary arterial hypertension, WHO Group 1. It should be noted that the requested drug is listed in the plans formulary as a pulmonary arterial hypertension drug. Additionally, the plan has prior authorization requirements for the drug that have to be met in order for coverage to be approved. During this review, we requested additional documentation from the prescriber. Specifically, we requested medical records and a prescriber statement to address the plans coverage requirements for the drug and to provide supporting medical records. We received additional documentation and included it in the review. The newly submitted documentation confirms that the plans prior authorization requirements for coverage of the requested drug have been met. The submitted medical records validate that the requested drug is being prescribed to treat pulmonary arterial hypertension, WHO Group 1, which is a medically accepted indication for the drug outlined in the Medicare approved compendia. Additionally, the prescriber has submitted right heart catheterization results obtained on July 7, 2022, which confirm the diagnosis of pulmonary arterial hypertension, WHO Group 1. Finally, the drug has been prescribed by a cardiologist. Therefore, the newly submitted documentation supports the plans prior authorization requirements for coverage of the requested drug have been satisfied. In addition, the amount requested does not exceed the plans quantity limit for the drug. As such, coverage for the drug is supported.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 Olumiant 2 milligram tablet to treat alopecia areata. 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 Tadalafil 20 milligram tablet to treat male erectile dysfunction. The Part D plan auto-forwarded 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Diazepam 5 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 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 tiering exception request for Myrbetriq extended release 50 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.Mybetriq extended release 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 coverage for Wegovy 1.7 milligram per 0.75 milliliter subcutaneous auto injection pen prescribed for chronic weight management. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted.Drugs prescribed to treat/promote weight loss (even if used for a non-cosmetic purpose, such as morbid obesity) are excluded from the Part D coverage. Therefore, the requested drug is excluded from coverage.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 coverage for Otezla 30 milligram tablet to treat severe plaque psoriasis. The Part D plan denied the request for coverage. 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 and failed, or deemed contraindicated. In this case, the prescriber has not provided patient specific clinical/medical rationale as to why each formulary alternative drug required by the plan would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Therefore, the formulary exception criteria have not been met.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 Budesonide 0.5 milligrams per 2 milliliter nebulized solution to treat chronic obstructive pulmonary disease. 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.  Based on the information provided, we determined the drug may be eligible for coverage under Part B under Medicare rules. The plan does not offer supplemental (additional) coverage for this drug. If the enrollee purchased drugs that are excluded, the enrollee must pay for them. 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 a tiering exception request for Eliquis 5 milligram tablet to be used for prophylaxis of thromboembolism in an enrollee with atrial fibrillation. 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.Eliquis 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 condition. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.