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

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil. Mycophenolate Mofetil is requested for ongoing prophylaxis of lung transplant rejection, which is an off-label (non-FDA approved) use. You state that the enrollee has done well on the requested drug. Additionally, you have indicated that a three drug immunosuppressive regimen utilizing Mycophenolate for prophylaxis following lung transplant is standard of care, and have highlighted studies that support the use of the requested drug as part of an immunosuppressive regimen following lung transplant; 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Kineret. 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 Kineret.Kineret is requested to treat the enrollee's condition. The Plan concluded that the stated diagnosis of chronic recurrent multifocal osteomyelitis (CRMO) is not a medically accepted indication for the use of the requested drug. You now state that Kineret is requested for treatment of CRMO as well as for seropositive rheumatoid arthritis. It was noted in the records provided to the Plan from a patient encounter dated November 12, 2020 that the enrollee had a positive rheumatoid factor IgM of 100 and a negative CCP; however the records indicated that Kineret was requested to treat the enrollee's CRMO/autoinflammatory bone disorder. Additional medical records from a telemedicine visit on December 9, 2020 were included with the request for reconsideration. The records indicate that the enrollee has been treated with Methotrexate sinceAugust 5, 2020 - initially orally, then switched to injectable, and that the enrollee received a single dose of Simponi on October 15, 2020 which was held due to a flare of symptoms two weeks after receiving the dose of Simponi. It is noted in the records that the enrollee's rheumatoid arthritis is manifested by pain/swelling mainly in the left ulnar styloid with evidence of ECU (extensor carpi ulnaris) tendinitis on ultrasound. It is noted that bone/joint symptoms of CRMO have improved on Celebrex and Methotrexate; however the enrollee continues to have episodic rash that you feel it is related to CRMO. It is also noted that sedimentation rate and C reactive protein were increasing as of November 13, 2020.There are several biologics on the Plan's formulary for treatment of rheumatoid arthritis, which is a medically accepted indication for the use of Kineret. The optimal treatment for CRMO is not clear. You have 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 Kineret.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium-Albuterol. 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 Ipratropium-Albuterol. The drug is requested to treat cough, history of bronchitis and wheezing, which is an off-label (non-FDA approved) use. 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 Ipratropium-Albuterol 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 Ipratropium-Albuterol. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Megestrol Acetate. 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 Megestrol 40 mg/ml. The drug is requested to treat Cachexia secondary to Alzheimer's disease, which is an off-label (non-FDA approved) use. 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 Megestrol Acetate 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 Megestrol Acetate. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alprazolam. 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 Alprazolam. Alprazolam is requested to treat an unknown diagnosis. The prescriber was asked to state your diagnosis, because there was no prescriber statement of your diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.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 needed additional information from the prescriber to determine whether the enrollee is using Alprazolam for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Alprazolam. 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.
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 Prolia 60 mg/mL as prescribed. 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 Prolia.Prolia is requested for treatment of age related osteoporosis in this 80 year old woman. The Plan's notes indicate that they have information regarding a trial of bisphosphonates. It is noted that the enrollee's bone mineral density T-score was -4.4 in the spine, and that she has a history of a vertebral compression fracture. Additionally, medical records indicate that the enrollee's diagnoses include hiatal hernia, gastroesophageal disease treated with Pantoprazole, and gastroparesis with current bothersome symptoms related to gastroparesis. 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 Prolia 60 mg/mL as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Nucynta. 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 Plan was correct in denying the request for Nucynta.Nucynta is requested to treat pain. You have not indicated that the enrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy or 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 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 not met. Therefore, for the 2021 Plan year, the Plan is not required to cover Nucynta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Acetazolamide, 250 mg tablet, 30 per 30 days. 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 a tiering exception for Acetazolamide, 250 mg.Acetazolamide, 250 mg tablet (.5 tablet - 125 mg twice daily per the appeal request) is prescribed for treatment of severe bilateral primary open angle glaucoma. Acetazolamide, 250 mg is on tier 4 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat this enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Of note, the prescriber mentioned the lower tier alternative Acetazolamide, 500 mg (which is an extended release oral capsule) in his response to the request for additional information. Please note that Acetazolamide, 250 mg and 125 mg tablets are on tier 4 of the Plan's formulary. Acetazolamide 500 mg extended release oral capsule is on tier 3 of the Plan's formulary; however this lower tier capsule is not an appropriate lower tier alternative for this particular enrollee given that the dose of this capsule is more than the daily dose required for this enrollee, and the formulation is an extended release capsule formulation which is not meant to be cut in half. As such, there are no appropriate lower tier alternatives for this particular enrollee; therefore Acetazolamide, 250 mg tablet is not eligible for a tiering exception for this enrollee.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Acetazolamide, 250 mg tablet, 30 per 30 days.
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 provide reimbursement for Carbidopa-Levodopa ODT 25-100 mg purchased October 19, 2020. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Carbidopa-Levodopa ODT 25-100 mg is on Tier 2 of the Plan's 2020 Formulary. In this case, you purchased Carbidopa-Levodopa ODT 25-100 mg on October 19, 2020 from a standard in-network pharmacy. The Plan verified the claim did not pay at point of sale due to an error regarding eligibility which has since been resolved, the claim has not yet been paid and there is currently no reason why the claim should not be paid at this time.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is required to process and provide reimbursement for Carbidopa-Levodopa ODT 25-100 mg purchased October 19, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Risedronate. 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 Risedronate. The drug is requested to treat age related osteoporosis. You have 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 Risedronate.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Clobazam, 10 mg tablet as prescribed. 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 Clobazam, 10 mg.Clobazam, 10 mg is requested for ongoing treatment of focal epilepsy. It is noted that the enrollee takes the requested drug in combination with Neurontin, the patient has failed other medication for the noted diagnosis, and that the enrollee is stable on the noted drug combination. The Plan indicated in their denial letter that coverage of Clobazam was denied because the enrollee does not have seizures associated with Lennox-Gastaut syndrome. 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 this drug for the enrollee's condition. Both of the Medicare approved compendia support the use of the requested drug for treatment ofseizures other than those associated with Lennox-Gastaut syndrome. The following is stated in the non-FDA uses section of DRUGDEX under the discussion of epilepsy:Clobazam is indicated as adjunctive treatment of refractory focal seizures (partial seizure and localization-related seizure) as well as generalized tonic-clonic seizures in children, young adults, and adults if first-line treatment is ineffective or not tolerated.Therefore, this drug is being prescribed for a medically accepted indication.The Plan's coverage rules do not apply to current users of this drug. The enrollee has been taking the requested drug. Our Physician Reviewer's opinion is that the coverage rule for this drug does not apply because the enrollee is a current user. However, a review of the documentation indicates that 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 met. Therefore, our decision is the Plan is required to cover Clobazam, 10 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% Patch. 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 Lidocaine 5% Patch.Lidocaine 5% Patch is requested for treatment of neuralgia/neuritis unspecified. You have clarified that the enrollee has chronic cancer related neuropathic pain following mastectomy. Medical records submitted from a patient encounter in December 26, 2018 for follow up of chest wall pain document the prior diagnosis of left breast cancer, status post lumpectomy in 2017, and an emergency room visit for left chest wall pain which was effectively treated with Lidocaine patch. 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 Lidocaine 5% Patch.