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

You asked the Plan to cover Viberzi. 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 Viberzi. The drug is requested to treat irritable bowel syndrome with diarrhea. Upon reconsideration, the prescribing physician states that the enrollee tried and failed treatment with Imodium (Loperamide). Dicyclomine and Xifaxan are available on the Plan's formulary and were not addressed. 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 Viberzi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Praluent. 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 Praluent. The drug is requested to treat hyperlipidemia in a patient with coronary artery disease (CAD), without clinical atherosclerotic cardiovascular disease (ASCVD), and statin intolerance. The prescriber has not indicated why all alternatives required by the Plan (Repatha Pushtronex, Repatha SureClick, and Repatha Syringe) 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 Praluent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Repatha SureClick. The drug is requested to treat hyperlipidemia. The enrollee does not satisfy thePlan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria(requirement for coronary artery calcium or calcification score of 300 Agatston units or higher) and/or hasnot indicated why all alternatives required by the Plan would likely not be as effective for the enrollee asthe requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician'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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Copper Chloride. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Copper Chloride is one of those excluded drugsbecause it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicatethat they provide supplemental coverage for Copper Chloride. Therefore, the Plan is not required to coverCopper Chloride.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Breo Ellipta. 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 Breo Ellipta. The drug is requested to treat asthma. The drug is on tier three of the Plan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the 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 Breo Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lasix. 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 Lasix 40 mg tablet. The drug is requested to treat congestive heart failure/edema. The prescriber has not indicated why all alternatives required by the Plan (including torsemide) 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 Lasix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dexcom G6 Sensor. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Dexcom G6 Sensor 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 Dexcom G6 Sensor. 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.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 Gabapentin 800mg, 180 per 30 days. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Gabapentin 800 mg, 180 per 30 days. The drug is requested to treat meralgia paresthetica. For coverageunder the prescription drug benefit, Medicare requires that the drug prescribed be used for a medicallyaccepted indication. Our Physician Reviewer found that the Medicare-approved resources do containcitations to support the use of the requested drug for treatment of the noted condition. American HospitalFormulary Service Drug Information (AHFS DI) cites the following reference in their discussion about theuse of Gabapentin for treatment of Other Types of Neuropathic Pain: Serpell MG. Gabapentin inneuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Pain. 2002; 99:557-66.[PubMed 12406532]. This double-blind, randomized, placebo-controlled 8-week study was conducted toevaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain, using doses up to 2400mg/day. The study used a novel design that was symptom- rather than syndrome-based; an approach thataimed to reflect the realities of clinical practice. Participants had a wide range of neuropathic painsyndromes, with at least two of the following symptoms: allodynia, burning pain, shooting pain, orhyperalgesia. The study concluded that gabapentin reduces pain and improves some quality-of-lifemeasures in patients with a wide range of neuropathic pain syndromes. This study supports the use ofGabapentin for treatment of neuropathic pain irrespective of the etiology of the symptoms. Therefore, therequested drug is being prescribed for a medically accepted indication. The Plan limits the amount of thedrug to 120 per 30 days. Upon reconsideration, the prescribing physician states that the number of dosesavailable under the quantity limit rules has not been effective. You have indicated that the number of dosesof the requested drug allowed by the Plan has been ineffective in treating the enrollee's condition.Therefore, an exception to the Plan's coverage criteria is medically necessary.Our Physician Reviewer's opinion is that quantity limit exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.A Plan must grant an exception if it determines that the requested dosage is medically reasonable andnecessary, consistent with the prescriber's statement. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to the quantity limit criteria is met. Therefore, thePlan is required to cover the requested quantity of Gabapentin 800mg, 180 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare PartA at the time of the organ transplant.The case record indicates that Tacrolimus is needed for a liver transplant performed February 28, 2003.According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part Acoverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant andTacrolimus is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverageare excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is notrequired to cover Tacrolimus.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes 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

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 the enrollee's condition. The diagnosis being treated with the requested drug has changed over the course of the request/appeal process. The initial diagnosis was polyneuropathy, unspecified. Medical records indicate that the enrollee has a history of small fiber neuropathy in the context of Crohn's disease and IgG kappa monoclonal gammopathy with possible meralgia paresthetica involving the left thigh. The medical record indicates that the enrollee was informed that he could use Lidocaine patches for the noted left thigh pain. Of note, the enrollee does not have a previous history of diabetes mellitus, however the medical record indicates the enrollee has a diagnosis of pre-diabetes, likely based on a glycosylated hemoglobin of 5.9. There was no documentation in the medical record that the enrollee has diabetic neuropathy. Based on the information provided, there is insufficient documentation that the enrollee has a medically accepted indication for the use of the requested drug. 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 Lidocaine 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 Lidocaine 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 brand Lyrica, 200 mg capsule. 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 brand Lyrica, 200 mg capsule, which is not on the Plan's formulary. 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 would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 brand Lyrica, 200 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Dexilant DR. 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 Dexilant DR. The drug is requested to treat gastroesophageal reflux disease. The drug is on tier four of the Plan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the 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 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 Dexilant DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover ZTLido 1.8% patch. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor ZTLido 1.8% patch. The drug is requested to treat chronic pain, cervicalgia, radiculopathy, rheumatoidarthritis, and disc degeneration, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of ZTLido 1.8% 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forZTLido 1.8% patch.This decision does not concern the medical
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Propranolol 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 requestfor a tiering exception for Propranolol HCL. The drug is requested to treat atrial fibrillation. The drug is ageneric drug on Tier 2 of the Plan's formulary. You do not state why all available lower tier alternatives onthe Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as therequested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to thesecriteria 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 thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Propranolol HCL
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Spravato. The Plan did not grant this request. We received this case to conductan independent review.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to theservice of a physician (or other practitioner).In this case, we requested additional information from the prescribing physician. We requested evidence ofhow the requested drug was shipped and evidence of how the requested drug was billed. The prescriber'sresponse indicated that the office had not yet ordered the drug. Spravato is a type of drug that is not usuallyself-administered. Based on the record we are unable to verify if Spravato will be supplied from physicianand/or office stock supply, and billed as part of a physician service. As a result, the drug may be eligible forcoverage under Medicare Part B. Drugs which are eligible for coverage under Part B are excluded fromPart D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to coverSpravato.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to contact the enrollee's Part B servicer to see if Spravato can be covered under theenrollee's Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prevymis. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Prevymis. The drug is requested to treat cytomegalovirus viremia related to kidney transplant, which isan off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Prevymis for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Prevymis.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.