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

You asked the Plan to cover Methocarbamol, 500 mg tablet as prescribed. 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 Methocarbamol, 500 mg tablet.The drug is requested to treat chronic musculoskeletal pain. For coverage under the prescription drugbenefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Drugdexhas the following citations in the comparative efficacy section of the DRUGDEX monograph forMethnocrabamol: Feinberg I, Carey J, Hussussian J, et al: Treatment of painful skeletal muscle disorders: areport of a double blind study of methocarbamol, aspirin and placebo. Am J Orthopedics 1962; 4:280-282.In this study, Oral methocarbamol 500 mg was superior to aspirin 300 mg in patients (n=139) presentingwith severe, painful muscle spasm or myositis following laminectomy, osteotomy, fracture, multipl etrauma, cervical contusions, prosthesis application, osteoarthritis of the spine, post -traumatic arthritis,bursitis, and sciatica. Stern FH: A controlled comparison of three muscle relaxant agents. Clin Med 1964;71:367-372. In this study, Carisoprodol and chlorphenesin carbamate were superior to methocarbamol inthe relief of chronic moderate to severe pain for 50 elderly patients; however it was noted in this study that19 patients treated with Methocarbamol vs one with placebo had a good response. Therefore, the requesteddrug is being prescribed for a medically accepted indication. Therefore, the requested drug is beingprescribed for a medically accepted indication. Our Physician Reviewer found that the Medicare-approvedresources do contain citations to support the use of the requested drug for treatment of the noted condition.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 priorauthorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofMethocarbamol, 500 mg tablet as prescribed for the diagnosed condition. As a result, Methocarbamol, 500mg tablet as prescribed 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 aremet. Therefore, our decision is the Plan is required to cover Methocarbamol, 500 mg tablet as prescribed.
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 provide a tiering exception for Toviaz ER. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Toviaz ER is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Toviaz ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tacrolimus 0.1% Ointment. The Plan did not grantthis 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 Tacrolimus 0.1% Ointment. The drug is requested to treat eczema. The drug is onTier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat theenrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion 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 Tacrolimus 0.1%Ointment.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover QVAR Redihaler. The Plan did not grant this request. We received this case toconduct an independent review.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 needed additional information from the prescriber to determine whether you areusing QVAR Redihaler for an FDA-approved use, or a use listed in the Medicare-approved compendia. Therequested information was not received. As a result, we could not confirm that the drug is being prescribedfor a medically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit. An exceptions request based on medical necessity cannot be considered because itcannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decisionis that the Plan is not required to provide coverage for QVAR Redihaler.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 Symbicort. 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 Symbicort.Symbicort is requested to treat worsening shortness of breath in this enrollee with Sjogren's syndrome, which is an off-label (non-FDA approved) use. Medical records indicate that the enrollee is also diagnosed with nonspecific interstitial pneumonia, obstructive sleep apnea, seasonal allergies and sinusitis, which are also not medically accepted indications for the use of the requested drug. The Medicare-approved compendia do not contain any citations 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 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 conditions.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 Symbicort for the diagnosed conditions. 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 these conditions. 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 Symbicort. 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 Cambia. 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 Cambia. The drug is requested to treat migraine headaches. You have not indicated why all alternativesrequired by the Plan would likely not be as effective for the enrollee as the requested drug; and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot 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 Cambia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Butalbital-Acetaminophen-Caffeine-Codeine. 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 Butalbital-Acetaminophen-Caffeine-Codeine 50-325-40-30 mg capsule. The drug is requested to treatmigraine headaches. For coverage under the prescription drug benefit, Medicare requires that the drugprescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicareapprovedresources do contain citations to support the use of the requested drug for treatment of the notedcondition. DRUGDEX has listed acute migraine in their non-FDA uses section in the monograph for therequested drug which includes a link to their Drug Consult reference: Migraine Prophylaxis and Treatmentin Adults - Clinical Practice Guidelines. The practice guidelines include the requested drug as a treatmentoption for acute migraine management. Therefore, the requested drug is being prescribed for a medicallyaccepted indication.The appeal request also noted a diagnosis of tension/migraine headaches. However, the documentation doesnot support this additional diagnosis. However, for the diagnosis of migraine headache, the prescriber hasnot indicated why all alternatives required by the Plan (Rizatriptan, Ibuprofen, Naproxen, additional betablockers) would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot 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 citeria are not met.Therefore, the Plan is not required to cover Butalbital-Acetaminophen-Caffeine-Codeine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem Tartrate ER. 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 Zolpidem Tartrate ER 6.25 mg tablet. The drug is requested to treat insomnia. The prescriber has notindicated why all alternatives required by the Plan (Belsomra) would likely not be as effective for theenrollee 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 opinionis 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 Zolpidem Tartrate ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Vascepa 1 gm 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 Vascepa 1 gram capsule. The drug is requested to treat hypertriglyceridemia. On June 22, 2020 you sent additional information and medical records addressing the Plan's coverage criteria and documenting past trial and failure of generic omega-3 ethyl esters fish oil supplement with persistent triglyceride levels greater than 500mg/dL. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 Vascepa 1 gm capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Corlanor. 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 Corlanor. The drug is requested to treat Postural orthostatic tachycardia syndrome, 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 Corlanor 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 Corlanor. 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 Erythromycin. 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 Erythromycin. The drug is requested to treat gastroesophageal reflux disease with esophagitis in a20 year old enrollee, which is an off-label (non-FDA approved) use. You sent a letter dated May 29, 2020clarifying the medical history. 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 Erythromycin for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered 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 Erythromycin.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

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 Nucynta ER, 50 mg tablet, 60 per 30 days. 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 Nucynta ER, 50 mg tablet, 60 tablets per 30 days.The drug is requested to treat G89.4 - chronic pain syndrome. The prescriber states the enrollee has triedand failed Oxycodone. Medical records were provided which document that the enrollee has triedHydrocodone, Methadone and Fentanyl. Nucynta ER is not on the Plan's formulary. The prescriber 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. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 Nucynta ER, 50 mg tablet, 60 per 30 days.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Solifenacin 10 mg tablet. 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 Solifenacin 10 mg tablet. The drug is requested to treat benign prostatic hyperplasia with urinary urgeincontinence. You have indicated why all alternatives required by the Plan would likely not be as effectiveas the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to theenrollee. On June 18, 2020 you sent additional information and medical records addressing the Plan'scoverage criteria and detailing trial and failure of oxybutynin and tolterodine. Therefore, an exception tothe Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formularyexception criteria are 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 met. Therefore,the Plan is required to cover Solifenacin 10 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Adderall XR. 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 Adderall XR 20 mg. Adderall XR 20 mg is requested to treat attention deficit disorder. The prescriber states that immediate release Adderall wore off too quickly, Methylphenidate was tried and failed, and the enrollee had an idiosyncratic reaction to generic formulations of Adderall where it was less efficacious than brand name. The plan has indicated that METHYLPHENIDATE ER 20 mg, and Modafinil are on the plan's formulary. Although the prescriber and the enrollee state that Ritalin was tried and not effective, there is insufficient documentation that extended release Methylphenidate has been trialed. 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 Adderall XR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Euflexxa. The Plan did not grant this request. We received this case to conductan independent review.Medicare Part D does not cover devices. Euflexxa has been classified by the FDA as a device, not as adrug. Therefore, our decision is the Part D Plan is not required to cover Euflexxa.This decision does not address the medical necessity or appropriateness of the requested item. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.