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

At issue is Tacrolimus 0.5-milligram capsules prescribed daily for liver and 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 liver and 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 Diclofenac Epolamine 1.3-percent patch to treat chronic cancer 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 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 1-percent gel to treat arthralgia, unspecified joint and chronic pain in knee. 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: Favorable

At issue is coverage for Esbriet 267-milligram tablet to treat idiopathic pulmonary fibrosis. The Part D plan denied the request because there was insufficient documentation to determine if the plans prior authorization requirements were 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 documentation satisfies the plans coverage criteria. The documentation indicates the drug is being prescribed for the treatment of idiopathic pulmonary fibrosis, which is a medically accepted indication for the drug, as outlined in the Medicare approved compendia. The documentation supports that the drug is being prescribed by, or in consultation, with a pulmonary specialist. Finally, the high-resolution computed tomography (CT) scan results from July 13, 2020, which have been submitted at reconsideration, show a usual interstitial pneumonia (UIP) pattern. As such, the plans requirements for coverage for the requested drug have been satisfied.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 a request for coverage of Cinacalcet Hydrochloride 30-milligram tablets. 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 diagnosis provided to the plan numerous times by the prescriber/prescribers office for the requested drug is secondary hyperparathyroidism associated with chronic kidney disease in an enrollee who is not currently receiving dialysis. However, as outlined in the Food and Drug Administration (FDA) product label and the Medicare approved compendia, Cinacalcet Hydrochloride is indicated for the treatment of secondary hyperparathyroidism associated with chronic renal disease in patients who are undergoing dialysis. The safety and efficacy in patients who are not undergoing dialysis have not been established. The use of Cinacalcet Hydrochloride in these patients is not recommended because of an increased risk of hypocalcemia. At reconsideration, it has now been noted that the requested drug is being prescribed to treat primary hyperparathyroidism. However, no medical records have been submitted to confirm this change in diagnosis. Furthermore, as outlined in the FDA product label and the Medicare approved compendia, Cinacalcet Hydrochloride is indicated for the treatment of primary hyperparathyroidism in patients with serum calcium levels indicating parathyroidectomy, but who are unable to undergo surgery. No documentation has been submitted to support the enrollee has serum calcium levels indicating parathyroidectomy, but is unable to undergo surgery. As such, there is not sufficient documentation available to determine if the requested drug is being 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 Calcitriol 0.25 mcg capsule prescribed for hypocalcemia. 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 furnished Incident To a physicians service are excluded from Medicare Part D coverage. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Droxidopa 100-milligram capsule to treat symptomatic neurogenic orthostatic hypotension. The Part D plan denied the request because the plans prior authorization requirements for coverage 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 medical records submitted at reconsideration support that the plans coverage criteria have been met. The medical records indicate the drug has been prescribed for the treatment of symptomatic neurogenic orthostatic hypotension secondary to the presence of Parkinsons disease, which is a medically accepted indication for the drug, as outlined in the Medicare approved compendia. The plans prior authorization requirement for coverage of this drug is that the enrollee has a diagnosis of neurogenic orthostatic hypotension that is being caused by one of the following: primary autonomic failure due to Parkinsons disease, multiple system atrophy, or pure autonomic failure; dopamine beta-hydroxylase deficiency; or non-diabetic autonomic neuropathy. As noted previously, the medical records submitted at reconsideration confirm that the enrollees symptomatic neurogenic orthostatic hypotension is due to primary autonomic failure because of the presence of Parkinsons disease. As such, the plans requirement for coverage for the requested drug have been satisfied.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 a request for coverage of Budesonide ER 9-milligram extended release 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 prescriber/prescribers office initially indicated the requested drug has been prescribed for the treatment of ulcerative colitis currently in remission. However, as outlined in the Food and Drug Administration (FDA) product label and the Medicare approved compendia, Budesonide ER 9-milligram tablet is indicated for the treatment of active ulcerative colitis. At reconsideration, it has now been noted that the requested drug is being prescribed for the induction of remission for the enrollee's active, moderate ulcerative colitis. However, the submitted medical records indicate the enrollees ulcerative colitis is in remission, as it is noted that the enrollee has a Lichtiger score of 3. The Lichtiger score is a 21-point ulcerative colitis disease activity index in which a Lichtiger score of 3 or less is traditionally defined as remission, 4 to 8 as mildly active disease, 9 to 14 as moderately active disease, and 14 or greater as severely active disease. No medical records have been submitted to validate the enrollees ulcerative colitis is now active. As such, there is insufficient documentation to support the drug is being 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 a tiering exception request for Lubiprostone 24-microgram capsules to treat chronic idiopathic constipation. 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.Lubiprostone is a generic drug on Tier 4 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 Cinacalcet Hydrochloride 60-milligram tablets to treat primary hyperparathyroidism in an enrollee who is able to undero a parathyroidectomy. 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 a tiering exception request for Livalo 1 milligram to treat hypercholesterolemia. 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.This drug is being provided by the plan under a formulary exception. It 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 are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Anoro Ellipta 62.5/25-microgram inhaler 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.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 2.5-milligram/3-milliliter nebuilzer 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 Deferasirox 500-milligram tablets for suspension to treat iron overload in an enrollee not dependent on red blood cell transfusions and without thalassemia 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 Testosterone Cypionate solution 200-milligrams/milliliter to treat a condition that was not submitted. 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 Eliquis 5-milligram tablets as anti-coagulation therapy for prophylaxis of deep vein thromboses. 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.This drug is being provided by the plan under a formulary exception. It 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 are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Sucraid 8500-unit/milliliter solution to treat Sucrase-Isomaltase deficiency; acquired. 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 Memantine Hydrochloride 5-milligram tablets to treat dementia due to radiation for brain mets. 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 Weligreg 40-milligram tablets to treat metastatic clear cell renal cell carcinoma. 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. Medicare-approved compendia do not contain any citations to support the use of the requested drug as prescribed, for treatment of the noted diagnosis. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare.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 0.25 microgram capsule prescribed for the treatment of end stage renal 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. This includes the case file from the plan, and any information submitted at the reconsideration level. According to Medicare rules, the requested drug cannot be approved for separate payment under Part D when it's for treatment on a patient who is receiving dialysis. Medicare records show the enrollee is actively receiving dialysis. Therefore, the requested drug must be billed by the renal dialysis facility.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Pregabalin 200-milligram capsules to treat an unknown condition. The Part D plan denied the request for coverage because there was insufficient documentation from the prescriber to determine if the plans coverage requirements were 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 submitted documentation does not include medical records or evidence of a prescribed diagnosis. Therefore, it cannot be determined if the 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 Fentanyl 50-microgram/hour patch 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 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 Methylphenidate HCL ER 36 milligram tablet to treat attention-deficit hyperactivity disorder. 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 Posaconazole DR 100-milligram delayed release tablets to treat invasive aspergillosis infection of the lungs. 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 Food and Drug Administration (FDA) product label and the Medicare approved compendia, the use of  Posaconazole DR  is indicated for use as salvage therapy in patients with invasive aspergillosis refractory to or intolerant of previous antifungal therapy with Voriconazole, Isuvaconazole, or lipid formulations of Amphotericin B. The submitted documentation does not support that the requested drug is being used as salvage therapy and/or that other antifungals were ineffective or could not be used. As such, the submitted documentation supports that the requested 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.