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

At issue is coverage for Lokelma 10 gram packet to treat hyperkalemia, chronic kidney disease stage 3B. 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 available documentation.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 a tiering exception request for Dificid 200 milligram tablet to treat Clostridium difficile-associated diarrhea. 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 available documentation.Dificid is included on Tier 5 of the plans formulary. Tier 5 of the formulary is the tier reserved for specialty drugs. The Specialty tier is exempt from tiered cost-sharing expectations, per Medicare rules. Therefore, this drug is not eligible for a tiering exception.A physician reviewed the appeal and determined that the requested drug is not eligible for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Sandostatin LAR 10 milligram Kit to treat duodenal angiodysplasias with recurrent bleeding. 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 available documentation.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollees condition: Octreotide significantly decreased episodes of rebleeding in 3 trials of patients with small bowel angiodysplasias, and 1 trial of patients with small bowel angioectasias. The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements have not been met. Please note that Octreotide Acetate Injection Solution is on the plan's formulary. 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 Loteprednol Etabonate 0.5 percent suspension to prevent corneal transplant rejection. 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 available documentation. The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Dexlansoprazole DR (delayed release) 60 milligram capsule to treat gastroesophageal reflux disease. 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 available documentation. The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Wegovy 2.4 milligram per 0.75 milliliter solution auto-injector to treat obesity. 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 available documentation. Drugs prescribed to treat obesity and/or to promote weight loss are excluded from the Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage.  This decision does not address the medical necessity 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 Praluent 75 milligram per milliliter pen to treat dyslipidemia in an enrollee with atherosclerotic cardiovascular disease. 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 available documentation.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Proventil HFA (hydrofluoroalkane) 90 microgram inhaler to treat asthma. 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 available documentation.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Sildenafil 20 milligram tablet to treat pulmonary hypertension, WHO groups 2 and 3. 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 available documentation.The Part D plan is responsible for determining whether the requested drug has been prescribed for a medically accepted indication outlined in the Medicare approved compendia. The diagnosis initially provided to the plan for the requested drug was pulmonary hypertension, WHO groups 2 and 3. 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.At reconsideration, a new diagnosis of pulmonary hypertension, WHO group 1 has been noted. However, this diagnosis was not initially provided to the plan. Furthermore, no medical records have been submitted to validate this additional diagnosis. As such, due to the conflicting information provided and a lack of supporting medical records, it cannot be established that the requested drug has been prescribed for a 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 coverage for Nucynta ER (extended release) 50 milligram tablet to treat chronic pain syndrome. 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 available documentation.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not confirm that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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: Favorable

At issue is coverage for Budesonide 3 milligram capsules, 90 capsules per 30 days to treat graft versus host disease of the gut with abdominal pain, diarrhea and emesis in an enrollee with an allogeneic hematopoietic stem cell transplant and relapsed acute myeloid leukemia. 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 available documentation.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollees condition:Graft Versus Host Disease, Prophylaxis and Treatment: Clinical Practice Guideline: First-line Treatment of Acute GVHD [1] Budesonide, Gastrointestinal acute GVHD: 9 mg/day may be given in addition to systemic corticosteroids,Evidence Category: 1[1] Penack O, Marchetti M, Ruutu T, et al: Prophylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol 2020; 7(2):e157-e167. The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation supports that all of the plans requirements for coverage have been satisfied. Specifically, the plan requires a FDA approved or medically accepted indication supported in the Medicare approved compendia. Therefore, the plans prior authorization requirements have been met and 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 coverage for Ozempic 0.25 or 0.50 milligram pen injector for weight management and obesity treatment. 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 available documentation.  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 a tiering exception request for Invega Sustenna 234 milligram per 1.5 milliliter syringe to treat schizoaffective disorder, bipolar type. 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 available documentation. Invega Sustenna 234 milligram per 1.5 milliliter syringe is a brand drug on Tier 4 of the plans formulary. There are no brand drugs of the same type to treat the same condition on the lower tiers of the plans formulary. If there are no drugs of the same type on a lower tier, the drug is not eligible for a tiering exception.  A physician reviewed the appeal and determined that the requested drug is not eligible for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Mounjaro 2.5 milligram per 0.5 milliliter solution pen injector, 8 pens (4 milliliter) per 28 days to treat type 2 diabetes mellitus. 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 available documentation.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements have not been met. The prescriber is requesting 8 pens per 28 days which is above the dosage supported by the FDA label/manufacturer and the Medicare approved compendia. As the drug has not been approved for coverage, a quantity limit exception cannot be granted.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 Buprenorphine Hydrochloride (HCl) 2 milligram sublingual tablet to treat chronic pain. 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 available documentation. The product label, available at drugs@FDA, states: 'Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [23]. [23] Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.'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 coverage for Buprenorphine Hydrochloride 2 milligram sublingual tablet to treat chronic pain. 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 available documentation. The product label, available at drugs@FDA, states: 'Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [23]. [23] Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.'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 coverage for Metaxalone 800 milligram tablet to treat musculoskeletal pain in an enrollee with lumbar radiculopathy, status post spinal fusion and methylenetetrahydrofolate reductase deficiency and homocystinuria. 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 available documentation.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 coverage for Estring 7.5 microgram per 24 hour vaginal ring to treat unknown condition. The Part D plan denied the request for coverage and then 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 available documentation.During this review, we requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support a diagnosis and that all formulary alternatives were tried and failed or were deemed contraindicated. However, the prescriber did not respond to our request. The Part D plan is responsible for determining whether the requested drug has been prescribed for a medically accepted indication outlined in the Medicare approved compendia. The submitted documentation does not include medical records or evidence of a prescribed diagnosis. This information was requested by the Part D plan with no response from the prescriber/prescribers office. The documentation submitted at reconsideration also does not include medical records or evidence of a prescribed diagnosis. As such, there is insufficient documentation available to establish that the requested drug has been prescribed for a 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 coverage for Premarin Vaginal Cream with applicator to treat atrophic vaginitis. The Part D plan denied the request for coverage and then 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 available documentation.During this review, we requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support that all formulary alternatives were tried and failed or were deemed contraindicated. However, the prescriber did not respond to our request.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed or must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Dextroamphetamine/Amphetamine 10 milligram tablet, 180 per 30 days, to treat attention deficit disorder predominant inattentive type. The Part D plan denied the request for coverage and then 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 available documentation.During this review, we requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support that the quantity prescribed was medically necessary for the enrollee. However, the prescriber did not respond to our request.The plans quantity limit for the requested drug is 90 per 30 days. The prescriber has not provided patient-specific clinical rational as to why the amount allowed by the plan would be ineffective in treating the diagnosis and/or would be contraindicated. Furthermore, the submitted documentation does not support the medical necessity for an exception to the plans quantity limit for the drug. A physician reviewed the appeal and determined that the requested drug at the requested amount is not eligible for Part D coverage.