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

At issue is a formulary exception request for Amitiza 24 microgram capsules prescribed to treat an enrollee with the diagnosis of other constipation.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 documentation shows the doctor prescribed Amitiza 24 microgram capsules to treat the diagnosis of other constipation. Amitiza 24 microgram capsules is off formulary. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of the noted condition. Therefore, the drug is being prescribed for a non-medically accepted indication and is not eligible for coverage under Medicare Part D.  Note that lubiprostone 8 mcg and 24 mcg oral capsules are on the formulary.A physician reviewed the appeal and determined that the plan is not required to cover Amitiza 24 microgram capsules.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Esbriet 267 milligram capsule prescribed for idiopathic pulmonary fibrosis. 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 your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any records submitted at the reconsideration level. The medical records show that Esbriet was prescribed to treat idiopathic pulmonary fibrosis. The plan has prior authorization requirements for this drug that must be met before they will cover the requested drug. The documentation provided does not show the enrollee has satisfied the plan's coverage criteria.A physician reviewed your appeal and determined that the plan is not required to cover Esbriet. The physician reviewer also determined that an exception to the plans prior authorization requirements cannot be granted at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Lidocaine 5% topical patches. 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 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 documentation indicates that Lidocaine 5% topical patches have been prescribed for the treatment of bilateral chronic knee pain. However, the Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of the noted condition. Therefore, the drug is being prescribed for a non-medically accepted indication and is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Linzess 145 microgram capsules prescribed daily. The Part D plan denied your request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. Linzess is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower cost sharing tiers. Therefore, this drug is not eligible for a tiering exception.A physician reviewed your appeal and determined that the plan is not required to grant your request for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a formulary exception request for Vumerity 231 milligram delayed-release capsules prescribed to treat an enrollee with multiple sclerosis. The Part D plan denied the appeal 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.Vumerity 231 milligram delayed-release capsules is not included in the plans formulary (list of covered drugs). 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. The prescriber has not provided patient specific clinical rationale, supported by medical records, as to why the formulary alternatives included in the plan to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the plan is not required to cover Vumerity 231 milligram delayed-release capsules.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Testosterone Gel to treat hypogonadism secondary to panhypopituitarism. The Part D plan denied the request. We performed 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 prescriber clarified the medical history in a letter dated 8/27/2021.  Medical records were provided which support this diagnosis. The documentation satisfies the plans coverage criteria. 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 Viibryd 20 milligram tablets prescribed as directed. The Part D plan denied your request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. Viibryd is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower cost sharing tiers. Therefore, this drug is not eligible for a tiering exception.A physician reviewed your appeal and determined that the plan is not required to grant your request for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Colchicine 0.6 milligram tablet prescribed for calcium pyrophosphate deposition 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 read your 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 documentation shows Colchicine was prescribed to treat calcium pyrophosphate deposition disease. However, the Medicare approved compendia do not support the use of this drug for the enrollees condition. A physician reviewed your appeal and determined that the plan is not required to cover Colchicine.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Ondansetron 8 milligram orally disintegrating 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 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 documentation indicates that Ondansetron has been prescribed for the treatment of chronic daily nausea due to the presence of chronic pancreatitis in an enrollee with porphyria.  . However, the Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of the noted conditions. Therefore, the drug is being prescribed for non-medically accepted indications and is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Buprenorphine Hydrochloride 2 milligram sublingual tablets, 120 tablets per 30 days. The Part D plan denied the request for coverage because the amount requested exceeded the plans quantity limit. Additionally, the drug was being prescribed for a non-medically accepted indication.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 documentation indicates that Buprenorphine Hydrochloride sublingual tablets have been prescribed for the treatment of chronic pain associated with osteoarthritis of the hip. However, the Medicare approved compendia do not contain any citations to support the use of Buprenorphine Hydrochloride in sublingual tablet form for the treatment of the noted condition.   The Medicare approved compendium DrugDex states, 'Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [21].   21. Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.'  Therefore, the drug is being prescribed for a non-medically accepted indication and is not eligible for coverage under Medicare Part D. Since the drug is not eligible for coverage under Medicare Part D, the plans quantity limit for the drug is not relevant to this review. A physician reviewed the appeal and determined that the plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

You requested Cyclobenzaprine Hydrochloride 10 milligram tablets prescribed as directed for radiculopathy, lumbar region. The Part D plan denied your request. We received the case to perform an independent and de novo review. To make our decision, we read your 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 documentation shows your doctor prescribed Cyclobenzaprine Hydrochloride to treat your radiculopathy, lumbar region. Medical records were requested and were not provided.  However, the Medicare approved compendia do not support the use of this drug for your condition. A physician reviewed your appeal and determined that the plan is not required to cover Cyclobenzaprine Hydrochloride.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Mesalamine 4 gram enema prescribed for ulcerative colitis. The Part D plan denied your request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. We requested additional information from your prescriber but did not receive a response. Mesalamine 4 gram enema is a generic drug on Tier 4 of the plans formulary. The documentation does not address why the drugs available on the lower tiers of the plans formulary would not work. Therefore, this drug is not eligible for a tiering exception.A physician reviewed your appeal and determined that the plan is not required to grant your request for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Mesalamine 1.2 gram delayed release tablet prescribed for ulcerative colitis. The Part D plan denied your request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. We requested additional information from your prescriber but did not receive a response. Mesalamine 1.2 gram delayed release tablet is a generic drug on Tier 4 of the plans formulary. The documentation does not address why the drugs available on the lower tiers of the plans formulary would not work. Therefore, this drug is not eligible for a tiering exception.A physician reviewed your appeal and determined that the plan is not required to grant your request for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Oxybutynin Chloride ER 5 milligram tablet. The Part D plan denied your request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. Oxybutynin Chloride ER 5 milligram tablet is a generic drug on Tier 3 of the plans formulary. The prescribers statement does not address why the drugs available on the lower tiers of your plans formulary would not work for the enrollee. Therefore, Oxybutynin Chloride ER is not eligible for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

The enrollee requested Folic Acid 1 milligram tablet prescribed for unknown diagnosis. We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. 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, drugs that fall into the category of vitamins and minerals are excluded from coverage under Part D. Therefore, we determined that the plan is not required to cover the Folic Acid. The plan does not indicate that supplemental coverage for the Folic Acid is offered. 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: Unfavorable

At issue is Viberzi 100 milligram tablets prescribed as directed for irritable bowel syndrome with diarrhea. The Part D plan denied your request.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. 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 medical records do not support why other drugs on the plans formulary would not work for you. A physician reviewed your appeal and determined that the plan is not required to cover Viberzi.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Ruconest 2100 unit solution prescribed for acute attacks of hereditary angioedema. The Part D plan denied your request.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan and any information submitted at the reconsideration level. 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. The prescriber indicates Cinryze is not for acute attacks but for prophylaxis use and would not work for the enrollee.  The prescriber also states that Firazyr caused lip and tongue tingling and did not work as well as Ruconest. The records also show that the enrollee had tried a low dose of Firazyr but had lip tingling and swelling. Cinryze is only indicated for prophylaxis use and not acute attacks. There are no other drugs on the plans formulary to treat acute attacks of hereditary angioedema. The documentation supports why the other drugs on the plans formulary would not work. A physician reviewed your appeal and determined that the plan is required to cover Ruconest.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Lidocaine-Prilocaine 2.5-2.5% cream prescribed for neuropathic 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 read your 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 documentation shows Lidocaine-Prilocaine was prescribed to treat neuropathic pain. However, the Medicare approved compendia do not support the use of this drug for the enrollees condition. A physician reviewed your appeal and determined that the plan is not required to cover Lidocaine-Prilocaine.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Synthroid 125-microgram tablet to treat hypothyroidism in an enrollee status post total thyroidectomy for thyroid cancer. The Part D plan denied the request. We performed 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.Synthroid is a brand drug on Tier 3 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug.  Therefore, this drug is not eligible for a tiering exception.Our physician reviewer's opinion is that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Doxepin Hydrochloride 10 milligram capsule prescribed for pruritus in an enrollee with actinic keratosis and psoriasis vulgaris. 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. Themedical records support that Doxepin Hydrochloride is prescribed to treat pruritus in an enrollee with actinic keratosis and psoriasis vulgaris. However, the Medicare approved compendia do not support the use of this drug for this condition. A physician reviewed your appeal and determined that the plan is not required to cover Doxepin Hydrochloride.
Appeal type: Prescription Drug
Decision: Unfavorable

The enrollee requested Contrave ER 12 HR 8/90/milligram tablet prescribed to treat morbid severe obesity. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we read your case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined the plan is not required to cover Contrave because it is excluded from coverage under Part D. The record shows the enrollee was prescribed Contrave for the treatment of weight gain. Medicare rules state that drugs used for treatment of weight loss or weight gain are statutorily excluded from coverage under the Part D benefit. If you purchased drugs/products that are excluded, you must pay for them yourself. This decision does not address the medical necessity or appropriateness of the drug/product. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Xtandi 80 milligram tablet prescribed for adenocarcinoma of the prostate. 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 your 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 documentation shows Xtandi was prescribed to treat adenocarcinoma of the prostate. However, the Medicare approved compendia do not support the use of this drug for the enrollees condition. A physician reviewed your appeal and determined that the plan is not required to cover Xtandi.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Berinert 500 unit kit for intravenous infusion. 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 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 medical records indicates that Berinert is being infused weekly as prophylaxis against hereditary angioedema attacks.  The use of Berinert for prophylaxis against hereditary angioedema attacks is not a medically accepted indication.  The product label available at drugs@fda.gov states:  'The safety and efficacy of Berinert for prophylactic therapy have not been established .'  As such, the drug is being prescribed for a non-medically accepted indication and is not eligible for coverage under Medicare Part D.  A physician reviewed the appeal and determined that the plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Alosetron Hydrochloride 0.5 milligram tablet prescribed for chronic uncontrolled diarrhea related to diarrhea-predominant irritable bowel 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 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 prescriber indicates that Alosetron Hydrochloride 0.5 tablet is prescribed to treat chronic uncontrolled diarrhea related to diarrhea-predominant irritable bowel syndrome. However, the Medicare approved compendia do not support the use of this drug for this condition in male patients but only in women. A physician reviewed your appeal and determined that the plan is not required to cover Alosetron Hydrochloride.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Zioptan Solution 0.0015%. The Part D plan denied your request for a tiering exception.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. This drug is 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 reviewed your appeal and determined that the plan is not required to grant your request for a tiering exception.