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

At issue is Epclusa 400/100 milligram oral tablet to treat an enrollee with chronic hepatitis C, genotype 1b, treatment experienced without cirrhosis or with compensated cirrhosis. The enrollee has already received 12 weeks of treatment with Epclusa. 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. In the original appeal to the plan, the prescriber was asked if the patient had cirrhosis and the answer was no. Then, on December 22, 2022, the prescriber returned an Epclusa tablet prior authorization questionnaire to the plan, which indicated that the enrollee had cirrhosis, but that it was compensated cirrhosis. Finally, in the reconsideration appeal dated December 27, 2022, the prescriber indicated that the enrollee had decompensated cirrhoisis. However, no supporting medical records have been provided to confirm which information is correct.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 Gentamicin Sulfate powder for bladder washings for frequent urinary tract infections. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.The record shows the Gentamicin Sulfate powder is part of a compounded drug and each ingredient is reviewed individually. Medicare Part D does not cover drugs that do not meet the definition of a Part D drug. None of the ingredients within the compounded drug are eligible for Part D coverage. Therefore, we determined that the plan is not required to cover or reimburse for the Gentamicin Sulfate powder compounded drug.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Kerendia 10 milligram tablet to treat proteinuria and type 2 diabetes mellitus. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The documentation satisfies the plans coverage criteria. Laboratory studies provided support chronic kidney disease with type 2 diabetes mellitus. The submitted prescriber statement supports the use of maximally tolerated angiotensin converting enzyme (ACE) inhibitor, Enalopril. Neither spironolactone or eplerenone is noted. 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 tiering exception request for Breztri Aerosphere 160/9/4.8 microgram (mcg) per actuation aerosol to treat chronic obstructive pulmonary disease, 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.Breztri Aerosphere 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 Acthar 400 unit per 5 milliliter gel to treat sarcoidosis of lung. 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 Hydroxychloroquine Sulfate 200 milligram tablet to treat rheumatoid arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Hydroxychloroquine Sulfate 200 milligram tablet 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. Please note, this reconsideration decision was based on the plans 2023 coverage criteria. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Acthar 80 unit injector to treat ocular cicatricial pemphigoid. 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 Diclofenac Sodium 1 percent gel to treat cervicalgia. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Alrex 0.2 percent drops suspension to treat corneal edema. 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. To grant an exception for a drug that is 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 rationale as to why the formulary alternative drugs to treat the enrollee's condition 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 Ozempic (0.25 or 0.50 milligram per dose) 2 milligram per 5 milliliter pen injector, to promote weight los for an enrollee with the diagnosis of morbid obesity. 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.Drugs prescribed to treat weight gain (promote weight loss) 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 Orencia 250 milligram intravenous powder for solution to treat rheumatoid arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The 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 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 a tiering exception request for Mesalamine extended-release (ER) 0.375 gram capsule to treat ulcerative colitis. 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 extended-release (ER) 0.375 gram capsule is a generic drug on Tier 4 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is not eligible for a tiering exception. A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Ozempic 0.25/0.5 milligram pen injector to treat prediabetes/ diabetes prevention and weight loss. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Gralise 300 milligram tablet to treat restless legs 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 product label, available at drugs@ Food and Drug Administration (FDA), states, 'GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.' 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 2023 coverage year tiering exception request for Tenofovir Disoproxil Fumarate 300 milligram tablet to treat autoimmune encephalitis in an enrollee with a history of hepatitis B infection. 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.Tenofovir Disoproxil Fumarate 300 milligram tablet is a generic drug on Tier 4 of the plans 2023 formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Synjardy XR (extended release) 25/1000 milligram tablet to treat diabetes mellitus. 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.Synjardy XR (extended release) 25/1000 milligram 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 Lybalvi 10/10 milligram tablet to treat major depressive disorder, recurrent, 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 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. Therefore, the patient has not met the 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 Tadalafil 20 milligram tablet to treat pulmonary arterial hypertension, WHO group 1. 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.This drug is being provided by the plan at the cost sharing level of the Specialty tier. Specialty tier drugs are not available for a tiering exception per Medicare rules.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Nicotine 7 milligram (mg)/24 hour daily transdermal patch. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs prescribed that are available Over the Counter are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Sildenafil Citrate 20 milligram tablet to treat mixed hyperlipidemia and/or male erectile dysfunction. 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.The noted conditions are off-label uses for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of Sildenafil Citrate for the treatment of mixed hyperlipidemia. Additionally, the Medicare-approved compendia do not contain any citations to support the use of Sildenafil Citrate in the 20 milligram tablet form to treat male erectile dysfunction. Therefore, the drug is being prescribed for non-medically accepted indications. Furthermore, it should be noted that drugs used for the treatment of sexual or erectile dysfunction are excluded from 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 Taltz 80 milligram per milliliter injection 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.We requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support the enrollee has satisfied the plans prior authorization coverage criteria. We received additional documentation and included it in the review.At reconsideration, diagnoses of psoriatic arthritis and plaque psoriasis were given. However, no documentation was provided by the prescriber to support these diagnoses. We requested information from the prescriber but no medical records were 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 Diazepam 5 milligram tablet for an enrollee with a diagnosis of long term current use of opiate analgesic. The case was auto-forwarded by the plan. The plan stated that the drug was approved for 3 months but approval of the full length of therapy was not allowed.We received the submitted documentation to perform an independent and de novo review.We requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to clarify the diagnosis and address the length of time the drug is required. However, we did not receive the requested information.Without the additional information we cannot determine if the drug is medically necessary and if the duration allowed is appropriate. 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 Tenivac vaccine. 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

You requested compounded drug Prednisolone Sodium Phosphate/Moxifloxacin Hydrochloride/Bromfenac Sodium ophthalmic solution 1/0.5/0.075 percent eye drops prescribed to treat the enrollees condition. The Part D plan denied your 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.Drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drugs are considered a bulk powder or are consistent of bulk powder ingredients and are excluded from coverage under Part D. Furthermore, The National Drug Code numbers verified with the Food and Drug Administration confirm that the National Drug Code numbers submitted are not valid. Therefore, the drugs are not eligible for coverage under Medicare Part D. We determined the plan is not required to provide reimbursement for the Prednisolone Sodium Phosphate/Moxifloxacin Hydrochloride/Bromfenac Sodium ophthalmic solution 1/0.5/0.075 percent eye drops.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Forteo 600 microgram per 2.4 milliliter auto-injector to treat osteoporosis. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The documentation satisfies the plans coverage criteria. Medical records submitted support a T-score of -2.8 and a high fracture risk.  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 tiering exception request for Xarelto 10 milligram tablet prescribed for the 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.Xarelto 10 milligram 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 Diclofenac Sodium 3 percent gel to treat pain in left 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.