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

You asked the Plan to cover Mekinist. 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. The drug is requested to treat melanoma without a BRAF mutation, which is an off-label (non-FDA approved) use.The enrollee is a 64-year-old man with metastatic melanoma that involves bones, brain, abdomen/retroperitoneum, and kidney. He has been treated with surgery, including nephrectomy for the kidney metastasis and resection of a brain lesion, radiation, Keytruda, Yervoy (Ipilumumab), and Nivolumab. He has enlarging mesenteric mass in the abdomen by PET scan on 1/6/2020. Foundation One testing identified an NF1 mutation suggesting possible response to Mekinist. The prescriber requests Mekinist to treat him.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. 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 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 Mekinist. 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 provide a tiering exception for Amabelz. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Amabelz is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Amabelz.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Norpace CR 100 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 Norpace CR 100 mg. The drug is requested to treat atrial fibrillation. You have not indicated why all alternatives required by the Plan (including Quinidine) 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 Norpace CR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Budesonide EC. 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 Budesonide EC. The drug is requested to treat collagenous colitis. The drug is a generic drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier 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. 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 Budesonide EC.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Forteo. 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 Forteo 600 mcg/2.4 ml pen.The drug is requested to treat Q78.0 - Osteogenesis imperfecta, which is an off-label (non-FDA approved)use. The Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Forteo for the diagnosed condition. As a result, the drug is notbeing 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 Forteo.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 Zolpidem. 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 Zolpidem. The drug is requested to treat sleep disorder/insomnia. The enrollee does not satisfy thePlan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria 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 Zolpidem.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Wixela Inhub Inhalation Disk. 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 Wixela Inhub Inhalation Disk.The drug is requested to treat severe asthma. The prescriber has not indicated why all alternatives requiredby the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likelycause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coveragecriteria 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 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 Wixela Inhub Inhalation Disk.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Altabax 1% ointment. 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 Altabax 1% ointment.The drug is requested to treat impetigo. The prescriber has not indicated why all alternatives required by the Plan (including Mupirocin 2% ointment) 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.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. In this case, the Plan denied coverage for Altabax because Altabax is a brand name drug, and its manufacturer was not on this list at the time of the Plan's review. However, the manufacturer has been added to the list effective February 2020. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been 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 Altabax.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Repatha SureClick 140 mg/mL, 2 for 28 days. The Plan did not grant thisrequest. 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 Repatha 140 mg/mL, 2 for 28 days. Repatha 140 mg/mL is requested to treat hyperlipidemia andcoronary artery disease with coronary artery bypass graft surgery and stents. Upon reconsideration, youhave submitted an additional statement and chart notes. The enrollee is intolerant of statins. The enrolleedoes not satisfy the Plan's coverage criteria. You have indicated why all alternatives required by the Planwould likely not be as effective as the requested drug for the enrollee, and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medicallynecessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. 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 met. Therefore, our decision is the Planis required to cover Repatha SureClick 140 mg/mL, 2 for 28 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Temozolomide. The Plan did not grant this request. We received this case to conduct 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 under Parts 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-cancer drug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label 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 Temozolomide is being prescribed for a diagnosis of glioblastoma multiforme, a cancer. Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancer chemotherapeutic agents. It appears Temozolomide 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. Therefore, our decision is that the Part D Plan is not required to cover Temozolomide. 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: 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, post laminectomy syndrome,spondylosis, and sacroiliac joint pain and dysfunction, which are off-label (non-FDA approved) uses. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 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 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 Stendra. 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. Stendra is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Stendra. Therefore, the Plan is not required to cover Stendra. 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.
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 caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lidocaine 5% Patch. The drug is requested to treat chronic pain due to ankylosing spondylitis,unspecified sites, and neuropathic pain due to chronic injury-related wounds, which are off-label (non-FDAapproved) uses. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 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, 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 forLidocaine 5% Patch.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 provide a tiering exception for Lenvima. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Lenvima is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Lenvima.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydrocortisone-Iodoquinol 1.9%/1% cream. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Hydrocortisone-Iodoquinol 1.9%/1% cream is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Hydrocortisone-Iodoquinol 1.9%/1% cream. 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.