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

You asked the Plan to provide a tiering exception for Tagrisso. 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 Tagrisso. The drug is requested to treat non-small cell lung cancer (NSCLC).The enrollee is an 86 year old woman with NSCLC with an EGFR exon 21 L858R mutation by FoundationOne testing. There is a left upper lobe lung mass, possible lymphadenopathy and a thoracic compressionfracture concerning for metastasis. She does not want intravenous chemotherapy. She has not had anytreatment. You request Tagrisso to treat her.Per the FDA website, Tagrisso is a kinase inhibitor indicated for the first-line treatment of patients withmetastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon21 L858R mutations, as detected by an FDA-approved test. The requested use is first line treatment. Hertumor has the required mutation done by an FDA approved test. Therefore she meets the FDA approveduse for the drug.For coverage 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. Therefore,the requested drug is being prescribed for a medically accepted indication. Therefore, the requested drug isbeing prescribed for a medically accepted indication. The drug is on Tier 3 of the Plan's formulary. There isno lower tier alternative. 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 Tagrisso.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil. 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 Tadalafil. The drug is requested to treat pulmonary hypertension, 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 Tadalafil 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 Tadalafil.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 Fasenra 30 mg/mL syringe. 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 Fasenra 30 mg/mL syringe. The drug is requested to treat severe asthma with an eosinophilicphenotype. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed beused 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.On 04/01/2020 the prescriber sent additional information addressing the diagnosis and Plan's formularyalternatives. The prescriber has indicated why all alternatives required by the Plan would likely not be aseffective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. OurPhysician Reviewer's opinion is that formulary exception 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 Fasenra 30 mg/mL syringe.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Clotrimazole 1% cream purchased on February 3, 2020, from the pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Plan required a $10 copayment for a Tier 1 drug purchased from a retail pharmacy in 2020. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at the time of purchase. The record shows that Clotrimazole was purchased for an amount that is less than or equal to the required copayment amount. The case record indicates that the Plan provided coverage in accordance with the Part D contract. Therefore, our decision is the Plan is not required to provide reimbursement for Clotrimazole 1% cream purchased on February 3, 2020, from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alosetron HCL, 1 mg tablet. 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 Alosetron HCL, 1 mg tablet.The drug is requested to treat diarrhea due to radiation proctitis in a male, 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 Alosetron HCL, 1 mg tablet 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 Alosetron HCL, 1 mg tablet.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 Digoxin 250 mcg. 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 Digoxin 250 mcg tablet. The drug is requested to treat atrial fibrillation. On 04/01/2020 the prescribersent additional information addressing the Plan's coverage criteria. The enrollee satisfies the Plan'scoverage 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 aremet. Therefore, our decision is the Plan is required to cover Digoxin 250 mcg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide ER. 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 Budesonide ER 9. Budesonide ER is requested for treatment of K52.9 - Noninfective gastroenteritis and colitis, unspecified, which the prescriber has clarified is due to Cronkhite-Canada Syndrome, which is an off-label (non-FDA approved) use. The prescriber states that the enrollee has failed multiple drugs, there are no FDA approved medications for treatment of the noted rare condition, and that case reports indicate that the requested drug has been used successfully for treatment of the noted condition; however 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 Budesonide ER 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 Budesonide ER. 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 Tetrabenazine. 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 Tetrabenazine 25 mg tablet (120/30). The drug is requested to treat Tardive dyskinesia. The submittedoffice notes from date of service 3/3/2020, document that the prescriber is requesting Tetrabenazine 25 mgtablet, 120 tablets per 30 days, with 3 refills. In a statement dated 4/1/2020, the prescriber states that theenrollee is only taking Tetrabenazine 50 mg per day. Relevant medical records were requested but notprovided to substantiate the revised dosing schedule. Medical records were not provided which documentthat Tetrabenazine 25 mg tablet is being prescribed in a quantity of 60 tablets per 30 days. The enrolleedoes not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan'scoverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be aseffective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Our Physician's opinion is that neither prior authorization 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 Tetrabenazine.
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 FreeStyle Libre 14 Day Sensor. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare Part D does not cover devices. FreeStyle Libre 14 Day Sensor has been classified by the FDA asa device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover FreeStyle Libre14 Day Sensor.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.You may wish to submit this request to the Medicare Part B carrier
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Combivent Respimat. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Combivent Respimat is a Tier 3brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decisionis the Plan is not required to provide a tiering exception for Combivent Respimat.
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 Ondansetron 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 Ondansetron HCL. The drug is requested to treat nausea. The prescriber was asked to clarify yourdiagnosis, because it was unclear from the case file if the underlying etiology of your nausea is a medicallyaccepted indication. The prescriber was also asked if you were taking other medications concurrently withthe requested drug for the noted diagnosis. A response from the prescriber was not received. Therefore,based on the current record, there is insufficient documentation that the requested medication is beingprescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorizationexception criteria are not 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 Ondansetron HCL.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% 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 Lidocaine 5% ointment. Lidocaine 5% ointment is requested to treat chronic low back pain. 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 - Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. On 03/302020 the prescriber sent additional information addressing the Plan's coverage criteria. The prescriber has 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 Lidocaine 5% ointment.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Patch . 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 Lidocaine 5% Patch. The drug is requested to treat the enrollee's condition. A request for prescriberstatement was sent and not returned. The enrollee does not satisfy the Plan's coverage criteria. You have notsufficiently addressed the Plan's coverage criteria and/or have not indicated why all alternatives required bythe Plan 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. Our Physician's opinion is that neither prior authorizationnor 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 Lidocaine 5% Patch.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% patch as prescribed. 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 to treat lumbago (chronic back pain) and osteoarthritis of the knees. 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 - Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has 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 Lidocaine 5% patch as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Prolia. 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 Prolia. The drug is requested to treat oteoporosis. The drug is a biologic drug 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 Prolia.