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

You asked the Plan to cover Dicyclomine HCL. 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 Dicyclomine HCL. The drug is requested to treat diverticulitis, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Additional medical information wasrequested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorizationcriteria and to clarify your diagnosis. A response from the prescribing physician was not received.Therefore, based on the current record, 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 Dicyclomine HCL for the diagnosed condition. 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 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 forDicyclomine HCL.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 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 left knee pain due to meniscal injury, which is anoff-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 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 cover Tacrolimus Ointment 0.1%. 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 Tacrolimus Ointment 0.1%.The drug is requested to treat perioral dermatitis, which is an off-label (non-FDA approved) use. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. 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 Tacrolimus Ointment 0.1% 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 Tacrolimus Ointment 0.1%.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: Favorable

You asked the Plan to cover Ingrezza, 40 mg capsule as prescribed. 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 Ingrezza, 40 mg capsule.The drug is requested to treat moderate tardive dyskinesia. The prescriber sent a statement dated 6/22/2020clarifying the medical history. The prescriber states the enrollee has a baseline AIMS score of 11. Theenrollee has a current AIMS score of 3 on item 8. The requested drug will not be used in combination withtetrabenazine or Austedo. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer'sopinion 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 aremet. Therefore, our decision is the Plan is required to cover Ingrezza, 40 mg capsule as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 50 mg/5 gm pkt. 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 Testosterone 50 mg/5 gm pkt.Testosterone 50 mg/5 gm is requested to treat testicular hypofunction in this 72 year old male which theprescriber has indicated represents late onset (age related) hypogonadism, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. 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 Testosterone 50 mg/5 gm pkt 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 Testosterone 50 mg/5 gm pkt.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 Buprenorphine. 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 Buprenorphine 10 mcg/hr Patch. The drug is requested to treat chronic pain syndrome. Buprenorphine10 mcg/hr Patch is not on the Plan's formulary. Belbuca film is on the Plan's formulary. The prescriber 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. Therefore,an exception 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 Buprenorphine.
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 Estradiol Compound, Progesterone Compound, Women's Testosterone GelCompound and Nature Throid. The Plan did not grant this request. We received this case to conduct anindependent review.Estradiol Compound, Progesterone Compound, and Women's Testosterone Gel CompoundMedicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy statedthat bulk powder was used or would be used when compounding the prescription for Estradiol Compound,Progesterone Compound, and Women's Testosterone Gel Compound. Bulk powders used in pharmacycompounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is notrequired to cover Estradiol Compound, Progesterone Compound, and Women's Testosterone GelCompound.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.Nature ThroidMedicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Nature Throid is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover Nature ThroidThis 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: Favorable

You asked the Plan to cover Pregabalin 50 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 Pregabalin 50 mg.Pregabalin 50 mg is requested for treatment of idiopathic progressive neuropathy (painful). The enrollee did not tolerate Horizant (Gabapentin enacarbil), and has failed Botox. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. DRUGDEX cites results from the following reference in the FDA USE section Neuropathic pain - spinal cord injury: Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14(2):162-173 which concluded that the requested drug is one of several drugs proposed as first line treatment of neuropathic pain. It is noted that the enrollee's condition is included in the patient population of studies cited. Therefore, this drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. 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. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Pregabalin 50 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyndamax. 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 Vyndamax 61 mg cap. The drug is requested to treat cardiomyopathy of hereditary transthyretinmediatedamyloidosis in conjunction with Onpattro. The enrollee does not satisfy the Plan's coveragecriteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicatedwhy all alternatives required by the Plan would likely not be as effective for the enrollee as the requesteddrug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion isthat 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 Vyndamax.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxymorphone HCL 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 Oxymorphone HCL ER.Oxymorphone HCL ER is requested for treatment of chronic pain. Per the Plan's notes, you informed thePlan by telephone that a prior authorization for Morphine sulfate ER was sent in as that is the drug theywant the member to have. The following day, your office contact person submitted a request forreconsideration stating that the patient has tried and failed Percocet and Oxycodone. A medication list wasincluded which showed that most recently the enrollee's long acting opioid has been Morphine sulfate ER.You have not provided sufficient documentation that all alternatives required by the Plan would likely notbe as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or otherharm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 Oxymorphone HCL ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Pregabalin 75 mg capsule. 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 Pregabalin 75 mg capsule. The drug is requested to treat cervical radiculopathy/neuropathic pain. Forcoverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. DRUGDEXcites results from the following reference in the FDA USE section Neuropathic pain - spinal cord injury:Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy for neuropathic pain in adults: a systematicreview and meta-analysis. Lancet Neurol 2015; 14(2):162-173 which concluded that the requested drug isone of several drugs proposed as first line treatment of neuropathic pain in general. It is noted that theenrollee's condition is included in the patient population of studies cited. Therefore, this drug is beingprescribed for a medically accepted indication. You documented that the enrollee had tried and failedGabapentin. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is thatprior authorization 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 ofPregabalin 75 mg capsule for the diagnosed condition. As a result, Pregabalin 75 mg capsule is beingprescribed 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 Pregabalin 75 mg capsule.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Shingrix Vaccine and admin fee received February 4, 2020 at your physician'soffice. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances.The case record shows that you received Shingrix vaccine, a Medicare covered vaccine, at your physician'soffice on February 4, 2020. On June 30, 2020 a representative from MAXIMUS Federal Services contactedyour physician's office. A representative of the physician's office stated that payment has been made in fullfor Shingrix vaccine and its administration. The Plan's out-of-network coverage rules were followed.Therefore, our decision is the Plan is required to cover and provide any applicable reimbursement forShingrix vaccine and its administration received February 4, 2020 at your physician's office, minus anyapplicable co-payment amounts.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sensipar. 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 Sensipar 60 mg.The drug is requested to treat hypercalcemia due to primary hyperparathyroidism. Cinacalcet is availableon the Plan's formulary. The prescriber has not indicated why this alternative 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 Sensipar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Stelara. The Plan did not grant this request. Wereceived this case to conduct an independent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan'sRedetermination Letter. This request was not filed within the required 60-day time limit. However, the caserecord reflects there is good cause for the late filing. Therefore the Reconsideration request is beingprocessed.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Stelara is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Stelara.