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

At issue is coverage for Evenity 105 milligram per 1.17 milliliter syringe to treat osteoporosis in a male. 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 Albuterol Sulfate 2.5 milligrams per 3 milliliters solution to treat mild intermittent asthma, uncomplicated. 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 documentation indicates that the requested drug is going to be used with a nebulizer in the enrollees home or home-like setting. Medicare classifies nebulizers as durable medical equipment. Medicare rules state that Medicare Part B pays for the rental and purchase of durable medical equipment. Additionally, payment will be made under Medicare Part B for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals, which must be put directly into the equipment. Any drug available for coverage under Medicare Part B cannot be covered under Part D, per Medicare rules. Therefore, the requested nebulizer drug is not eligible for 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. Please submit the request for coverage through Medicare Part B.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Silodosin 8 milligram capsule to treat benign prostatic hyperplasia without lower urinary tract symptoms. 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. The prescriber has 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. Specifically, in their denial the plan stated that the enrollee needed to try and fail one of the following drugs: Alfuzosin extended-release, Doxazosin, Prazosin, or Terazosin. In the reconsideration appeal the prescriber provided medical records documenting that the enrollee did try and fail Doxazosin. Therefore, a formulary exception is supported in this case.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 Mounjaro 7.5 milligram per 0.5 milliliter pen to treat type 2 diabetes. 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.Mounjaro is a brand drug on Tier 3 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 Dalfampridine ER (extended release) tablet 12 hour to treat multiple sclerosis. 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: Unfavorable

At issue is a tiering exception request for Trulicity 1.5 milligram per 0.5 milliliter injection to treat diabetes. 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.Trulicity is a biologic drug on Tier 3 of the plans formulary. There are no biologic 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 a tiering exception request for Oxcarbazepine 600 milligram (mg) tablet to treat the enrollees condition. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Oxcarbazepine is a generic drug on Tier 3 of the plans formulary. The prescriber has not provided patient-specific clinical rationale as to why all of the lower-tiered alternative drugs on the plans formulary to treat the enrollees condition are contraindicated. Therefore, the tiering exception requirements have not been met. 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 a tiering exception request for Advair hydrofluoroalkane (HFA) 230-21 microgram aerosol to treat asthma. 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.Advair HFA is a brand drug on Tier 3 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 Farxiga 10 milligram tablet to treat type 2 diabetes mellitus. 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 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 Zolpidem Tartrate 10 milligram tablet to treat insomnia. 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 plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not support that all of the plans requirements for coverage have been satisfied. Furthermore, the documentation does not support the medical necessity for an exception to the plans prior authorization requirements. 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 Levemir 100 units per milliliter solution to treat 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 plan provided information indicating that the enrollee is under a Pharmaceutical Manufacturer Patient Assistance Program (PAP) for the purchases of the requested drug. Medicare rules state that PAPs operate outside of Medicare Part D. Therefore, we determined the drug is not eligible for coverage under the Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Novolog 100 units per milliliter solution to treat 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 plan provided information indicating that the enrollee is under a Pharmaceutical Manufacturer Patient Assistance Program (PAP) for the purchases of the requested drug. Medicare rules state that PAPs operate outside of Medicare Part D. Therefore, we determined the drug is not eligible for coverage under the Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Xepi 1 percent cream. 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.For the drug at issue to be covered under Medicare Part D, the manufacturer of the drug must participate in the Medicare Coverage Gap Discount Program. The manufacturer of this drug is not participating in the program. 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 Pregabalin 50 milligram capsule to treat multiple sclerosis. 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 Hydrocortisone Acetate 25 milligram suppository. 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.Hydrocortisone Acetate 25 milligram suppository is currently classified by the Food and Drug Administration (FDA) Drug Efficacy Study Implementation (DESI) program as less than effective for its labeled indication. Some drugs currently on the market are FDA approved for safety only. These drugs were approved prior to the passing of current FDA law. The FDA reviews these drugs to determine which are less than effective for their labeled indications. This review process is known as the DESI program. This program has resulted in the FDA classifying some of these drugs as less than effective DESI program drugs. Medicare Part D does not pay for prescription drug products classified by the FDAs DESI program as less than effective for their labeled indications. Therefore, the requested drug is excluded from Medicare Part D coverage. This decision does not address the medical necessity of the requested 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 Entresto 24/26 milligram tablet to treat grade 3 diastolic dysfunction. 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.Entresto is a brand drug on Tier 3 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 Fasenra 30 milligram per milliliter solution prefilled syringe to treat severe persistent 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 valid patient-specific clinical rationale as to why both alternative drugs on the plans formulary, Dupixent and Xolair, 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 either 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 Xifaxan 550 milligram tablet to treat hepatic encephalopathy due to liver cirrhosis. 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 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 enrollee has had previous treatment with Lactulose. Medical records were provided with the request for reconsideration. These records document prior treatment with Lactulose. 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 Procrit 10,000 unit per milliliter injection solution to treat anemia of chronic kidney 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 plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not support that all of the plans requirements for coverage have been satisfied, as the enrollees does not currently have adequate iron stores as demonstrated by a transferrin saturation of at least 20 percent. The enrollees current transferrin saturation is 16 percent. Furthermore, the documentation does not support the medical necessity for an exception to the plans prior authorization requirements.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 Ramelteon 8 milligram tablet to treat insomnia. 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 Acuicyn Antimicrobial Eyelid and Eyelash Hygiene 0.01 percent solution. 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.Acuicyn Antimicrobial Eyelid and Eyelash Hygiene 0.01 percent solution has not been approved by the United States Food and Drug Administration (FDA). Drugs that are not FDA-approved do not meet the definition of a Part D drug and are excluded from Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage.This decision does not address the medical necessity of the requested 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 Oxycodone Hydrochloride ER (extended release) 10 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 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 Vyzulta 0.024 percent ophthalmic solution to treat primary open-angle glaucoma, bilateral, severe stage. 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.Vyzulta 0.024 percent ophthalmic solution is a brand drug on Tier 3 of the plans formulary. The prescriber has not provided patient-specific clinical rationale as to why all of the lower-tiered alternative drugs on the plans formulary to treat the enrollees condition are contraindicated. Therefore, the tiering exception requirements have not been met. 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 Praluent 75 milligram per milliliter pen to treat mixed hyperlipidemia with coronary artery 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 Nuju 0.1 percent cream to treat atopic dermatitis. 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.Nuju 0.1 percent cream has not been found by the Food and Drug Administration (FDA) to be safe and effective, and the drug product labeling has not been approved by the FDA. Drugs that are not FDA-approved do not meet the definition of a Part D drug and are excluded from Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage.This decision does not address the medical necessity of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.