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

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Diclofenac 3% Gel. Our Physician Reviewer determined that it was not prescribed for a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Diclofenac 3% Gel. Diclofenac 3% Gel is requested to treat chronic low back and neck pain related to spondylosis without myelopathy or radiculopathy, which is an off-label (non-FDA approved) use. The prescriber has indicated that the enrollee has failed Diclofenac sodium 1% gel, and that caution is exercised regarding the use of non-steroidal anti-inflammatory drugs due to Crohn's colitis; however the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Diclofenac 3% Gel for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law.As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Diclofenac 3% Gel. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Linzess. Our Physician Reviewer determined that prior authorization criteria were not met. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Linzess 145 mcg capsule. Linzess 145 mcg is requested to treat chronic constipation. Upon the reopening request, the prescriber submitted additional information. The prescriber documented that the enrollee has tried Lactulose and had constant bloating, stomach rumbling, loose stools and incontinence. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Linzess.This decision reverses our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously requested additional information from the prescriber to determine whether the Plan's formulary exception criteria for Nifedipine were satisfied. We did not receive the information from the prescriber. As a result, we issued an unfavorable reconsideration decision. We subsequently received the additional information previously requested from the prescriber. We reopened this appeal to conduct a second review with the additional information.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nifedipine. Nifedipine is requested to treat Raynaud's phenomenon in an individual with multiple sclerosis. Upon the reopening request, the prescriber statement was returned. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Nifedipine.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Repatha SureClick. Our Physician Reviewer determined that formulary exception criteria were not met. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Repatha SureClick 140 mg/mL. Repatha SureClick 140 mg/mL is requested to treat mixed hyperlipidemia in this enrollee with atherosclerotic cardiovascular disease, and previous failure and/or intolerance to multiple drugs including, but not limited to, Pravastatin and Rosuvastatin. The prescriber had noted that the enrollee's lipids were well controlled with Repatha; however, coverage of Repatha was denied by the plan because Praluent is on their formulary. Subsequent to the denial of Rosuvastatin, the prescriber states that the enrollee was switched Praluent with resultant severe diarrhea, dehydration and heart palpitations. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Repatha SureClick.This decision reverses our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Soliris. Our Physician Reviewer determined that prior authorization coverage criteria were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that this request is eligible for coverage under Medicare Part B. We reopened this case to address the Plan's argument.The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be covered under Medicare Part A or Part B. Medicare Part B pays for the rental or purchase of durable medical equipment if the equipment is used in the patient's home or in an institution that is used as a home. Soliris (Eculizumab) is not a drug that is address in the Medicare Part B rules. Therefore, it is not a Medicare Part B covered drug when administered via infusion pump in the enrollee's home and we sent the request to our physician reviewer to review for coverage under Medicare Part D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Soliris 300 mg/30 mL. Soliris 300 mg/30 mL is requested for treatment of anti-acetylcholine receptor antibody positive generalized myasthenia gravis (MG) without acute exacerbation. A reopening has been requested by the Plan. The enrollee's MG has been refractory to many prior treatments including, but not limited to, Mestinon, Imuran, and intravenous immune globulin. The prescriber states that the enrollee has been receiving Soliris with significant improvement in symptoms and has indicated that a change in treatment will result in a high risk for significant adverse outcome. The prescriber has provided a comprehensive appeal letter and supporting medical records. The plan denied coverage of Soliris; their denial letter indicates that the drug may be covered under Medicare Part A or B. However, a review of the Medicare regulations indicates that the although the requested drug is administered via an infusion pump at home, the requested drug is not eligible for coverage under Medicare Part B. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Soliris.This decision affirms our previous favorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Cresemba. Our Physician Reviewer determined that it was not prescribed for a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Cresemba. Cresemba is requested as anti-fungal prophylaxis in this enrollee with acute myelogenous leukemia, status post allogenic stem cell transplant and donor leukocyte infusion, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical history and the medical necessity for the requested drug; however, the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Cresemba for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law.As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Cresemba. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Guanfacine. Our Physician Reviewer determined that it was not prescribed for a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Guanfacine 1 mg. Guanfacine 1 mg is requested to treat the following conditions: autism spectrum disorder, obsessive compulsive disorder, intellectual disability, and vocal/motor tics, which are off-label (non-FDA approved) uses. It is noted that the enrollee has been stable on the requested drug for years; however, the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.Of note, the enrollee's legal guardian states that the requested drug also helps keep the enrollee's blood pressure in check; however there has been no documentation by the prescriber that Guanfacine is being used to treat hypertension.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Guanfacine for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Guanfacine. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Lasix 40 milligram tablets prescribed once daily for essential hypertension (high blood pressure). The Part D plan denied your request because the documentation did not support an off-formulary exception. We received an expedited reconsideration request. We performed 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.Your physician submitted a supporting statement. The record shows the physician had prescribed Lasix to treat your high blood pressure. The Medicare approved compendium, DrugDex, supports the use of the requested drug for your condition.The records do not show why you cannot take other drugs on your plans formulary for your condition. Specifically, your physician indicated you were allergic to furosemide and could not take this drug. However, your physician did not indicate why you could not take all of the other formulary alternatives to treat your condition. A formulary exception request could not be granted.A physician reviewed your appeal and determined that the plan is not required to cover Lasix.
Appeal type: Prescription Drug
Decision: Favorable

At issue is tacrolimus 0.5 milligram capsules prescribed twice daily following a lung transplant. The Part D plan denied the request because drugs that could be covered under Medicare Part B are not eligible to be covered under the Medicare Part D Prescription Drug benefit. We received an expedited reconsideration request. We performed 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 also researched Medicare systems and reviewed the enrollment data available. We determined that the drug is not eligible for Part B coverage. Medicare enrollment records show the enrollee was entitled to Medicare Part A coverage on June 1, 2002. The documentation submitted states the enrollee received a lung transplant on June 23, 2013, at The Florida Hospital Transplant Center. This hospital was not a Medicare-approved lung transplant facility at the time of the procedure. Medicare system records do not show that Medicare provided coverage for the enrollees lung transplant. Therefore, the drug can be considered for payment under the Part D benefit. The medical records show the doctor prescribed tacrolimus to provide immunosuppression following a lung transplant. A citation in DrugDex, a Medicare approved compendia, supports the use of this drug following a lung transplant to prevent rejection.A physician reviewed your appeal and determined that the plan is required to cover tacrolimus. Tacrolimus is eligible for Part D coverage and is being utilized for a medically accepted indication.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Levemir 100 units/milliliter prescribed at 30 units subcutaneously twice daily. The Part D plan denied your request for a tiering exception because Levemir 100 units/milliliter is a Tier 3 medication with no alternate drugs on a lower tier. We received an expedited auto-forwarded reconsideration request from the plan. We performed and 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 Levemir 100 units/milliliter is a biologic drug on Tier 3 of the plans formulary. There are no biologic  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 cover Levemir 100 units/milliliter.
Appeal type: Prescription Drug
Decision: Unfavorable

You requested Saxenda 18 milligrams/3 milliliter pen prescribed for morbid obesity. The Part D plan denied your request because the drug did not meet the definition of a Part D drug. We received an expedited reconsideration request. We performed and 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 that the plan is not required to cover Saxenda because it it was used to treat obesity. Drugs prescribed to treat weight gain (promote weight loss) are excluded from coverage. Your plan does not offer supplemental (additional) coverage for this drug. If you purchased drugs that are excluded, you must pay for them yourself. 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 Diclofenac Sodium gel 3% prescribed two times a day as needed for arthritic shoulder pain. The Part D plan denied your request because your condition is not a medically accepted indication for arthritic shoulder pain. We received an auto-forwarded reconsideration request from the plan. We performed 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. Your medical records show your doctor prescribed Diclofenac Sodium gel 3% to treat shoulder pain. 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 Diclofenac Sodium gel 3% because your condition is not a medically accepted indication for the drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Hetlioz 90 milligrams prescribed daily for circadian rhythm sleep disorder, free running type. The Part D plan denied coverage because medical necessity was not established. The plan requires prior authorization before covering some prescription drugs. If prior approval is not obtained, the plan may not cover the drug. We received an expedited reconsideration request.We performed 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. We also researched Medicare systems and reviewed the enrollment data available.Your medical records show your doctor prescribed Hetlioz 90 milligrams daily for circadian rhythm sleep disorder, free running type. The plan requires prior authorization criteria for this drug be met before they will cover the requested drug. The records provided do not show that the enrollee has satisfied the plan's coverage criteria.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Xifaxan 550 milligram tablets prescribed twice daily for the prevention of hepatic encephalopathy. The Part D plan denied your request for a tiering exception because the drug you requested is in the specialty tier; drugs placed in the specialty tier are not eligible for tiering exceptions. We received an expedited reconsideration request. We performed 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. Xifaxan is a brand drug on Tier 5, also known as the specialty tier, of the plans formulary. If a plan maintains a specialty tier, the plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. The record indicates the plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, this drug is not eligible for a tiering exception.A physician reviewed your appeal and determined that the plan is not required to cover Xifaxan. A tiering exception cannot be granted for a drug on the specialty tier of this plan.