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

At issue is Gamunex-C 10 grams per 100 milliliter vial to treat chronic inflammatory demyelinating polyneuropathy (CIDP). We received the submitted documentation to perform an independent and de novo review. The submitted documentation includes a case file from the plan, medical records and a prescriber statement showing evidence of a prescribed diagnosis. The appellant submitted the plan's Notice of Dismissal of Appeal Request at the redetermination level (dated May 2, 2022) referring to the dismissal of Gamunex-C. The appellant submitted the redetermination appeal to the plan on April 19, 2022. The Centers for Medicare & Medicaid Services (CMS) states any request for appeal must be filed within 60 days of the initial coverage determination. Because the redetermination request was received more than 60 days after the initial coverage determination denial (dated February 10, 2022), and the appellant did not provide evidence of good cause for being untimely, we agree with the plan's dismissal decision.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Flector 1.3 percent patch to treat sprain of other parts of lumbar spine and pelvis, low back pain, other spondylosis with radiculopathy, unilateral primary osteoarthritis, and chronic pain 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 diagnoses 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 these diagnoses. 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 Synthroid 88 microgram tablet to treat hypothyroidism. 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. Synthroid 88 microgram tablet 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 Cinacalcet Hydrochloride 60 milligram tablets. 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

Mesalamine delayed release 1.2 gram tablet was requested to treat the enrollees condition. 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.A request was submitted to the prescriber to provide a diagnosis, to address the nonformulary exception criteria and to provide supporting medical records. A reply from the prescriber was not received. Without a diagnosis, it cannot be established that the requested drug is being prescribed for a medically accepted indication. As such, the requested drug does not satisfy the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D. A physician reviewed your appeal and determined that the plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Timolol Maleate 0.5 percent solution to treat open-angle glaucoma. 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.Timolol is a generic drug on Tier 3 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: Favorable

At issue is Botox 200 units per milliliter injection solution to treat migraine headaches. 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 drug at issue is not on the plans formulary. The prescriber provided patient specific clinical rationale supported by documentation, indicating why the formulary alternatives, required by the plan, would likely not be as effective as the requested drug for this diagnosis, and/or would likely cause adverse reaction(s) or other harm. Specifically, the prescriber statement and/or medical records indicate the enrollee has tried and failed samples of Nurtec. Therefore, an exception to the plans formulary coverage criteria is medically necessary.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 Repatha Sureclick 140 milligram per milliliter injection solution to treat pure hypercholesterolemia and atherosclerotic heart 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 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 Taltz 80 milligram per milliliter injection solution to treat psoriasis. 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 Albuterol Sulfate 0.083 percent nebulizer solution. 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 Fluocinonide 0.1 percent cream to treat atopic dermatitis. 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 Pentamidine 300 milligram nebulizer solution. 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: Favorable

At issue is coverage for Rydapt 25 milligram capsule, 120 capsules per 30 days. The Part D plan denied the request for coverage because the drug was not prescribed for a medically accepted indication. 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 statement and medical records submitted at reconsideration clarify that the enrollee has a history of chronic myelomonocytic leukemia (CMML), which has now progressed to acute myeloid leukemia (AML), as evidenced by the presence of increased blast cells. The records show that the enrollee is currently is on chemotherapy with Dacogen and Venetoclax, and that Rydapt has been requested because of the presence of an FLT3 mutation. As outlined in the National Comprehensive Cancer Network (NCCN) guidelines, it is a 2A recommendation for Rydapt to be used as treatment in combination with AML-type induction chemotherapy for lymphoid, myeloid or mixed lineage neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements in blast phase. The documentation supports that the enrollee meets this criteria, as the enrollee is already on an AML-type induction chemotherapy (Dacogen/Venetoclax,) for the treatment of FLT3-mutated AML in blast phase. As such, the drug is being requested for a medically accepted indication as outlined in the NCCN guidelines. Since the drug is being used for a medically accepted indication, an exception to the plans prior authorization requirements 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 Ozempic 0.25 milligram-0.5 milligram pen injector to treat prediabetes and obesity. 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 Oxymorphone Hydrochloride 10 milligram tablets to treat chronic 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 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 Gemtesa 75 milligram tablets to treat urinary incontinence. 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 Xywav 500 milligram per milliliter solution to treat insomnia. 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 Reclast 5 milligram per 100 milliliter intravenous solution to treat osteoporosis. 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 addressed the formulary alternatives required by the plan to treat the enrollees condition and provided patient specific clinical rationale as to why each formulary alternative 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. It should be noted that the generic formulation of Reclast, which is Zoledronic Acid, is one of the plans formulary alternative drugs.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 Calcitriol 0.5 microgram capsules. 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 Tirosint 88 microgram capsules to treat autoimmune thyroiditis. 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 Armodafinil 250 milligram tablet. 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 submitted medical records indicate the requested drug has been prescribed to manage fatigue associated with multiple sclerosis. However, 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 Cyclosporine Modified 25 milligram tablets prescribed daily for kidney transplant. 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 a kidney 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 a tiering exception request for Mesalamine ER 0.375 milligram extended-release capsule to treat ulcerative proctocolitis. 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.Mesalamine ER 0.375 milligram extended-release capsule is being provided by the plan under a formulary exception. This drug is not on the plans formulary but they have agreed to provide it at a cost sharing level assigned to all formulary exceptions. Per Medicare rules, non-formulary drugs are not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Diclofenac Epolamine 1.3 percent patch to treat chronic pain and polyarthralgia. 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 Testosterone 1 percent gel. 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.On original appeal, a diagnosis of other abnormal findings of blood chemistry was submitted. The prescriber submitted a prescriber statement that indicated the enrollee did not have primary or hypogonadotrophic hypogonadism. At reconsideration, a diagnosis of primary hypogonadism was given. However, the submitted documentation does not support this diagnosis. No documentation was submitted in support of a change in diagnosis. 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.