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

You asked the Plan to cover Fentanyl Citrate 400 mcg Buccal tablet. 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 Fentanyl Citrate 400 mcg Buccal tablet.The drug is requested to treat low back pain with radiculopathy, 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. Upon reconsideration request, the prescriber indicates the medication is being given for breakthrough cancer pain. While the enrollee does have a history of breast cancer, the medical records indicate the requested medication is being prescribed for the back pain and radiculopathy. 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 Fentanyl Citrate 400 mcg Buccal tablet 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 Fentanyl Citrate 400 mcg Buccal tablet. 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 Rizatriptan ODT 10 mg. 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 Rizatriptan 10 mg. The drug is requested to treat migraine. The Plan identified a safety issue with the requested medication due to current coverage of Sumatriptan, a medication in the same drug class as the requested drug. Upon reconsideration, you stated that both Sumatriptan along with Rizatriptan will be used for the treatment of the enrollee's migraines, and that you believe that the enrollee will significantly benefit from taking both Sumatriptan along with Rizatriptan. The product label, available at drugs@fda, states in the contraindication section that concurrent use of Rizatriptan and Sumatriptan may result in prolonged vasospastic reactions. DrugDex, a Medicare approved compendium, also states that concurrent use of Sumatriptan and Rizatriptan is contraindicated. The enrollee does not satisfy the Plan's coverage criteria. 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 Rizatriptan ODT.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Intuniv ER. 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 Intuniv ER 1 mg 24 hr tablet. The drug is requested to treat traumatic brain injury/attention deficit hyperactivity disorder, which is an off-label (non-FDA approved) use (in adults). 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 Intuniv ER 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 Intuniv ER. 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 Mycophenolate Mofetil. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. The case record indicates that Mycophenolate Mofetil is needed for a Kidney transplant performed March 12, 2007. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Mycophenolate Mofetil is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Mycophenolate Mofetil.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: Favorable

You asked the Plan to cover Cinacalcet HCL 30 mg. 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 Cinacalcet HCL 30 mg. The drug is requested to treat secondary hyperparathyroidism after kidney transplant. Upon reconsideration, the prescribing physician has submitted additional information indicating that the enrollee has had kidney transplant with secondary hyperparathyroidism and that the enrollee is not on dialysis. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of this drug for this condition. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Cinacalcet treatment significantly decreased the mean corrected total serum calcium to less than 10.2 mg/dL in 78.9% of patients compared with 3.5% with placebo in a 26-week, randomized study of renal transplant recipients with hypercalcemia and persistent hyperparathyroidism. Therefore, the requested drug is being prescribed for a medically accepted indication. The requested drug is not eligible for coverage under Medicare Part B. There are no applicable utilization management criteria identified for coverage of the requested drug. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Cinacalcet HCL 30 mg is on the Plan's formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover Cinacalcet HCL 30 mg.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 Denosumab. 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 Parts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to the service of a physician (or other practitioner). We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested confirmation of how and where this drug is supplied and billed. A response to our request was not received in the timeframe required for review of this case. Denosumab is a type of drug that is not usually self-administered. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Denosumab is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Denosumab. 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.
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 Tymlos, 80 mcg pen. 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 Tymlos, 80 mcg pen.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not 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 Tymlos 80 mcg pen.
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 Lidocaine 5% Patch. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Lidocaine 5% Patch 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 Lidocaine 5% Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Livalo 2 mg. 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 Livalo 2 mg tablet. The drug is requested to treat hyperlipidemia. 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 Livalo.Please note: the request for a tiering exception (lower copayment) for Livalo was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Famotidine 40 mg. 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 Famotidine 40 mg tablet. The drug is requested to treat gastroesophageal reflux disease. You have 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. On February 18, 2020 you sent additional information addressing formulary alternatives required by the plan. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are metA 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 Famotidine 40 mg.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

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 Duragesic. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Duragesic, 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 Cumulate Morphine Equivalent Dose (MED) was medically necessary and 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 Duragesic.
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 Telmisartan-HCTZ. 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 Telmisartan-HCTZ. Telmisartan-HCTZ is requested for treatment of the enrollee's condition. The prescriber has indicated that the enrollee has failed Losartan. Additional information was requested from the prescriber; however, no additional information was received. The prescriber has 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 nor 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, the Plan is not required to cover Telmisartan-HCTZ.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xarelto, 20 mg tablet. 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 Xarelto, 20 mg.Xarelto, 20 mg is requested to treat the enrollee's condition. The drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the 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.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 Xarelto, 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil 100 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Sildenafil 100 mg is one of those excluded drugs because it is a drug used to treat sexual dysfunction or sexual dysfunction drug used to treat a condition other than sexual dysfunction for which the drug has not been approved by the FDA. Sildenafil 100mg tablet is only approved for the treatment of erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Sildenafil 100 mg. Therefore, the Plan is not required to cover Sildenafil 100 mg. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.