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

You asked the Plan to cover Pimecrolimus 1% Cream. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Pimecrolimus 1% Cream. The drug is requested to treat cutaneous lupus of the scalp, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions 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 Pimecrolimus 1% Cream for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Pimecrolimus 1% Cream.This decision does not concern the medical necessity of the requested drug. It only establishes i f paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Repatha SureClick 140 mg/mL. The Plan did notgrant 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 Repatha SureClick.Repatha SureClick is requested to treat the enrollee's condition. The requested drug is a biologic drug ontier 3 of the Plan's formulary. There are no available lower tier biologic drugs on the Plan's formulary totreat the enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception. OurPhysician 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Repatha SureClick 140mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Asacol HD 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 requestfor a tiering exception for Asacol HD DR 800 mg tab. The drug is requested to treat inflammatory boweldisease. The prescriber sent a letter dated 3/25/2020 clarifying the diagnosis. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition. Therefore, the requested drug isbeing prescribed for a medically accepted indication. Asacol HD DR 800 mg tab is a brand drug on tier 4 ofthe Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan's formularyto treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer's opinion is that tiering exception criteria are not metMedicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharingtiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are notmet because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee'scondition. Therefore, our decision is the Plan is not required to provide a tiering exception for Asacol HDDR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Livalo. 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 (Fenofibrate, Fenofibric Acid, Gemfibrozil, Atorvastatin, Fluvastatin ER, Lovastatin, Simvastatin, Cholestyramine, Colestipol, Colesevelam, Niacin ER, and Omega-3-Ethyl Esters) 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq. 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 Myrbetriq 25 mg tablet.The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 4 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 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 Myrbetriq.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tymlos 3120 mcg/1.56 mL. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Tymlos 3120 mcg/1.56 mL.The drug is requested to treat osteoporosis. The enrollee does not satisfy the Plan's coverage criteria - use ofparathyroid hormone analog therapy (e.g., abaloparatide or teriparatide) for more than 2 years during thepatient's lifetime. The prescriber has not sufficiently addressed the Plan's coverage criter ia and/or has notindicated why all alternatives required by the Plan would likely not be as effective for the enrollee as therequested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician'sopinion 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 Tymlos 3120 mcg/1.56 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Armodafinil. The Plan did not grant this request. We received this case toconduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forArmodafinil which is subject to prior approval. Our Physician Reviewer needed additional informationfrom the prescriber to make this determination. The prescriber was asked to address whether the drugsoffered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as therequested drug; and/or (2) have adverse effects. The requested information was not received. Based on areview of the available documentation, neither prior authorization criteria nor prior authorization exceptioncriteria 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 Armodafinil.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Morphine ER 15 mg, #60 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 Morphine ER 15 mg tablet 60/30.The drug is requested to treat chronic pain in an enrollee with spinal stenosis. The prescriber sent astatement dated 3/31/2020, stating that the enrollee requires Morphine Sulfate ER 15 mg CR 60/30 andMorphine Sulfate ER 60 mg CR 90/30 for chronic pain secondary to spinal stenosis. The prescriber stateshe is requesting 210 oral morphine equivalents every day. The prescriber states the daily MED dose of 210is medically necessary. The prescriber also states that a lower total daily MED dose would be insufficientto control the enrollee's pain and that the enrollee has been on a stable regimen for years. Therefore, anexception 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 Morphine ER 15 mg, #60 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Capecitabine. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. 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 coverage includes oral anti -cancer drugs that are prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti-cancer chemotherapeutic agents which would be covered if they were not self-administered and they were furnished incident to a physician's service as drugs and biologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancerdrug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or offlabel uses, as the non-self-administrable form of the drug. A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that are Covered, will receive a statutory denial as non-covered, but may be covered at appeal if used for a medically accepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents.In this case the record shows that Capecitabine is being prescribed for a diagnosis of colon cancer. Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancer chemotherapeutic agents. It appears Capecitabine may be eligible for coverage under Medicare Part B for the diagnosis provided in this case. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part Bbut that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part Bcoverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Therefore, our decision is the Part D Plan is not required to coverCapecitabine.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

You asked the Plan to cover Monurol. 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 Monurol 3 gram packet.The drug is requested to treat Pseudomonas aeruginosa urinary tract infection (with history of recurrent urinary tract infections), 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 Monurol 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 Monurol. 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 Guanfacine ER. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Guanfacine ER 2 mg.The drug is requested to treat autism, anxiety, and irritability associated with possible bipolar disorder,which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain anycitations to support the use of the requested drug, as prescribed, for treatment of the noted conditions.Therefore, the requested drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested drug is not eligible for coverage under Medicare Part D for the noted conditions.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 Guanfacine ER for the diagnosed conditions. As a result, thedrug 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 these conditions. 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 forGuanfacine ER.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ocusoft EyeLid Scrub. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drug is a non-prescription or OTC drug.Therefore, Ocusoft EyeLid Scrub is not eligible for Part D coverage, and the Plan is not required to cover itunder the Part D benefit.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 cover Gleevec. 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 Gleevec 400mg. The drug is requested to treat chronic myelogenous leukemia. The case file indicatesthat the enrollee requires brand name drug for patient assistance program reasons. Upon reconsiderationrequest, you have not provided a sufficient medical rationale why the plan's generic formulary alternative isnot appropriate for the enrollee. You have not indicated why all alternatives required by the Plan wouldlikely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported.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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Gleevec.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat. 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 a tiering exception for Vimpat 200mg Tab. The drug is requested to treat intractable focal epilepsy.Vimpat 200mg Tab is a brand drug on Tier 4 of the Plan's formulary. There are no available lower tierbrand drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug isnot eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria arenot met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Vimpat.