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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Dicyclomine HCL 10 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Dicyclomine HCL 10 mg capsule. The drug is requested to treat irritable bowel syndrome with diarrhea. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. You have indicated in the supplied documentation that the benefits of the drug outweigh the risks and that you have discussed the risks and potential side effects with the enrollee. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Dicyclomine HCL 10 mg capsule for the diagnosed condition. As a result, Dicyclomine HCL 10 mg capsule is being prescribed for a medically accepted indication as defined by Medicare law.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 Dicyclomine HCL 10 mg capsule.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levalbuterol nebulizer solution. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Levalbuterol nebulizer solution for the management of obstructive pulmonary disease.In this case, the record shows that Levalbuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of asthma. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Levalbuterol nebulizer solution. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Zolpidem. Our Physician Reviewer determined that prior authorization criteria was 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 Zolpidem Tartrate. Zolpidem Tartrate is requested for the ongoing treatment of insomnia. Upon the reopening of this case, the prescriber submitted additional medical records. The prescriber has not documented that the enrollee has a contraindication to two non-HRM alternative drugs: Doxepin (3 mg or 6 mg) and Trazodone, or that one non-HRM alternative drug Doxepin (3 mg or 6 mg) or Trazodone has been tried and the patient experienced an inadequate treatment response, or an intolerance to one of those non-HRM drugs. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Zolpidem.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Orencia Clickject. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Orencia Clickject 125 mg/mL. Orencia Clickject 125 mg/mL is requested for treatment of seropositive rheumatoid arthritis. The enrollee has a complex medical history: she developed pancytopenia with Imuran, Methotrexate was discontinued when the enrollee was diagnosed with a cryptococcal lung infection, the enrollee did not tolerate Plaquenil due to pruritis, she is allergic to Sulfa, and she is still quite symptomatic with her rheumatoid arthritis despite Arava. The plan has indicated that their preferred drugs are Humira, Enbrel, Kevzara, and Rinvoq ER. The prescriber states that the enrollee's infectious disease doctor approved the use of Orencia for this patient, and that based on the enrollee's medical history, the prescriber feels that requested drug is the safest option for the enrollee. Of note, it is stated in the medical record that the enrollee is 75 years of age, she has type II diabetes mellitus, and is on chronic low dose corticosteroids. Additionally, it is noted that all of the Plan's alternatives all have black box warnings today related to the risk of infectious complications while the requested drug does not. The prescriber has provided a sufficient statement as to why the requested drug is a safer option than the plan's alternatives. 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 Orencia Clickject.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
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 Epolamine 1.3% Patch. 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 Epolamine 1.3% Patch. Diclofenac Epolamine 1.3% Patch is requested to treat tendonitis, arthropathy, knee pain, rheumatoid arthritis, metatarsalgia, and joint pain, which is are off-label (non-FDA approved) uses. Upon reopening, the prescriber submitted additional information. The prescriber stated, patient has severe juvenile-onset rheumatoid arthritis. The patch is applied by a caregiver and stays on for 12 hours. She is unable to use her hands to apply gel, and stomach issues prevent oral medication. 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 condition(s).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 Epolamine 1.3% Patch 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 Epolamine 1.3% PatchThis 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 Nucynta. Our Physician Reviewer determined that formulary exception criteria was 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 Nucynta (IR) 100 mg tablet. Nucynta (IR) 100 mg tablet is requested to treat chronic pain of right upper extremity due to complex regional pain syndrome type 1(CRPS1). Upon reopening, the prescriber submitted additional information. The prescriber documented that the enrollee has not responded to Hydrocodone, Oxycodone, or Morphine (all short-acting opiates). The prescriber has not indicated why additional alternatives (short-acting opiates) required by the Plan (Hydromorphone, Tramadol and long-acting/extended-release opiates) 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.The prescriber also stated that given her pain has a neuropathic component, Nucynta is a treatment of choice for symptom control. However, according to DrugDex, a Medicare-approved compendium, Tapentadol extended-release (Nucynta ER) is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 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 Nucynta.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 Talzenna. 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 a Physician Reviewer to determine whether the Plan was correct in denying the request for Talzenna which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Talzenna.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 Gralise. Our Physician Reviewer determined that it is 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 Gralise. Gralise is requested to treat diabetic neuropathy in an individual with type 2 diabetes mellitus, which is an off-label (non-FDA approved) use. Upon reopening, the prescriber submitted additional information. 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 Gralise 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 Gralise.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 requested additional information from the prescriber to determine whether the Plan's formulary exception criteria for Febuxostat 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 Febuxostat 40 mg. Febuxostat 40 mg tablet is requested to treat gout/gouty arthritis in an individual with stage 4 chronic renal disease. Upon reopening, the prescriber statement was returned. The prescriber documented that the enrollee has an allergy to Allopurinol, Colchicine was ineffective, and cannot take Probenecid due to renal failure. 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 Febuxostat.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 step therapy criteria for Levalbuterol HFA 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 Levalbuterol HFA 45 mcg. Levalbuterol HFA 45 mcg is requested to treat chronic obstructive pulmonary disease (COPD). Upon reopening, the prescriber statement was received. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The prescriber documented that the enrollee has a history of atrial fibrillation/ paroxysmal supraventricular tachycardia. The prescriber has indicated why all alternatives required by the Plan (generic Albuterol HFA and Ventolin HFA) would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reactions 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 step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception to step therapy rules 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 an exception to step therapy criteria is met. Therefore, the Plan is required to cover Levalbuterol HFA.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 Onpattro 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 Onpattro 10 mg/5 mL. Onpattro 10 mg/5 mL is requested to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. A reopening of this case has been requested as the Plan had initially denied the requested drug as a non-approved FDA drug. The requested drug, Onpattro, is FDA approved to treat the enrollee's condition. Additional information was submitted by the prescriber. The prescriber documented that the enrollee has biopsy-proven hereditary cardiac amyloidosis associated with hereditary polyneuropathy. The prescriber has indicated that there are no other drugs available on the Plan's formulary (Patisiran, Tafamidis (Vyndaqel), or Inotersen (Tegsedi) to treat the enrollee's condition. 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 Onpattro.This decision reverses our previous unfavorable decision.