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

You asked the Plan to provide a tiering exception for Synthroid. 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 Synthroid 88 mcg tablet. The drug is requested to treat hypothyroidism. The drug is a brand drug on Tier two of the Plan's formulary. The prescriber does not state why all available lower tier brand alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee - lower tier brand alternatives include Levo-T, Euthyrox, Unithroid and Levoxyl. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Synthroid.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mekinist, 2 mg tablet and Tafinlar, 75 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 Mekinist, 2 mg tablet; 30/30 and Tafinlar, 75 mg capsule; 120/30.The drugs are requested to treat ovarian cancer, which is an off-label (non-FDA approved) use. The enrollee is a 75 year old woman with recurrent high grade serous ovarian cancer involving lungs and peritoneum. She has been treated for recurrence with surgery, Carboplatin/Taxol, Cytoxan, and Avastin. Foundation One testing identified a BRAF V600E mutation suggesting possible response to the two drugs. The prescriber requests Mekinist and Tafinlar to treat her. Journal articles and case reports were submitted in support of the request and were reviewed.The Medicare-approved compendia do not contain any citations to support the use of the requested drugs, as prescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drugs are 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 drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, the requested drugs are 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Mekinist, 2 mg tablet and Tafinlar, 75 mg capsule for the diagnosed condition. As a result, the drugs are not being prescribed for a medically accepted indication as defined by Medicare law. As such, they cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because these drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Mekinist, 2 mg tablet and Tafinlar, 75 mg capsule. This decision does not concern the medical necessity of the requested drugs. 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 Lidoderm 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 Lidoderm 5% patch. The drug is requested to treat muscle spasms, 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 Lidoderm 5% 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 Lidoderm 5% Patch.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 Rinvoq. 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 Rinvoq. The drug is requested to treat atopic dermatitis, which is an off-label (non-FDA approved) use. You clarified the diagnosis in a letter. 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 Rinvoq 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 Rinvoq.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

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 Oxycontin 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 Oxycontin ER 10mg Tablet, 60 per 30 days. The drug is requested to treat chronic pain. Oxycontin ER 10mg Tablet is not on the Plan's formulary. 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 Oxycontin ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lotemax 0.5% Ophthalmic Gel. 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 Lotemax 0.5% Ophthalmic Gel. The drug is requested to treat uveitic glaucoma. You have not indicated why all alternatives required by the Plan (fluorometholone, which is also low risk for raising intraocular pressure) 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 Lotemax 0.5% Ophthalmic Gel.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Guanfacine HCl . 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 Guanfacine HCl 2 mg tablet. The drug is requested to treat Attention Deficit Hyperactivity Disorder in an adult, 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 Guanfacine HCl 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 HCl.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

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 Freestyle Libre 2 sensor system. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Freestyle Libre 2 sensor system has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Freestyle Libre 2 sensor system. This decision does not address the medical necessity or appropriateness of the requested item. It only establishes that payment cannot be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of Freestyle Libre 2 sensor system under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gabapentin. 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 Gabapentin 100 mg capsule. The drug is requested to treat spondylosis without myelopathy or radiculopathy, lumbar region, 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 Gabapentin 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 Gabapentin.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 Gammagard 10 gm/100 mL. 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 Gammagard 10 gm/100 mL.The drug is requested to treat radiculopathy, idiopathic sacral polyradiculitis, which is an off-label (non-FDA approved) use. The prescriber sent a letter stating that the enrollee has a diagnosis of atypical chronic inflammatory demyelinating polyneuropathy (CIDP). The most recent medical records submitted are from date of service. These medical records do not document a diagnosis of atypical chronic inflammatory demyelinating polyneuropathy (CIDP). The diagnosis of sacral polyradiculopathy or polyradiculitis with persistent saddle distribution pain-uncertain etiology is documented in the medical records.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 Gammagard 10 gm/100 mL 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 Gammagard 10 gm/100 mL.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 Zioptan. 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 Zioptan 0.0015% ophthalmic solution. The drug is requested to treat glaucoma. The prescriber documented that the enrollee needs to stay on Zioptan because it is preservative-free and gives her no discomfort. The prescriber has not indicated why all preservative-free formulary alternatives required by the Plan (Dorzolamide/Timolol ophthalmic solution) 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 documented that the enrollee has a trial with Timolol, however, had not taken along with Dorzolamide at that time. 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 Zioptan.
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. The drug is requested to treat chronic low back pain with left-sided sciatica. 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. Drugdex cites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. The study demonstrated that among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than nonopioid medications. The noted reference states that topical Lidocaine was included in the nonopioid prescribing strategy. Therefore, the requested drug is being prescribed for a medically accepted indication. 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 Lidocaine 5% Patch for the diagnosed condition. As a result, Lidocaine 5% Patch 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 Lidocaine 5% Patch.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.