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

You asked the Plan to cover Pennsaid. 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 Pennsaid 2% solution. The drug is requested to treat pain from degenerative joint disease of the hands, 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 Pennsaid 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 Pennsaid.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: Favorable

You asked the Plan to cover Humulin R U 500. 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 Humulin R U-500. Humulin R U-500 is requested for treatment of type II diabetes mellitus. Althoughyou initially indicated that Humulin R U-500 was being administered via an insulin pump, you haveclarified that the enrollee is no longer using a pump; you stated that the enrollee is now injecting theHumulin through pen needles. As such the requested drug is not eligible for coverage under Medicare PartB. The enrollee satisfies the Plan's coverage criteria which only requires Medicare B vs D determination.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 Humulin R U 500.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Novolin. 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 Novolin. The drug is requested to treat the enrollee's condition. The drug is abrand drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Novolin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydrocortisone Pramoxine 2.5% 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 Pramoxine 2.5% Cream is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Hydrocortisone Pramoxine 2.5% 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone. 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 Testosterone 1% Gel (25 mg/2.5 gm) (90 packets/30 days). The drug is requested to treathypogonadism. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Planwould likely not be as effective for the enrollee as the requested drug, and/or would likely cause adversereaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor priorauthorization 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 Testosterone.
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 Olopatadine. 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 Olopatadine 0.1%.The drug is requested to treat allergic conjunctivitis. The case file indicates that this is a new diagnosis andno other drugs have been considered. The prescriber has not indicated why all alternatives required by thePlan 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 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 Olopatadine.
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 Edarbi. 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 Edarbi 40 mg.Edarbi 40 mg is requested for treatment of essential hypertension. The prescriber has indicated that theenrollee has failed Irbesartan and Amlodipine. Olmesartan, Telmisartan, and Valsartan are on the Plan'sformulary. The Plan has documented that per a phone call to the prescriber's office, the enrollee has nottried nor does he have contraindications to the Plan's formulary alternatives.The prescriber has not indicated why all alternatives required by the Plan would likely not be as effectivefor the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to theenrollee. 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 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 Edarbi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Omega-3-Acid Ethyl Esters. The Plan did not grant this request. We receivedthis case to conduct 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 reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Omega-3-Acid Ethyl Esters 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 Omega-3-Acid Ethyl Esters.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 Lyrica 50 mg 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 fo Lyrica 50 mg.Lyrica 50 mg is requested for ongoing treatment of neuropathic pain related to lumbar radiculopathy, post-laminectomy syndrome, and spondylosis of the lumbar region. The prescriber states that the enrollee has tried and failed Gabapentin, Lyrica has provided good relief of the enrollee's neuropathic pain since August 6, 2019, and that Duloxetine is not an option. 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, a Medicare-approved compendium, 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. 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 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 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 met. Therefore, the Plan is required to cover Lyrica.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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 Cresemba. The drug is requested to treat prophylaxis of fungal infections, which is an off-label (non-FDA approved) use.The enrollee is a 70-year-old woman with acute myelogenous leukemia (AML) who is being treated with chemotherapy including Rydapt. She is expected to have prolonged neutropenia requiring prophylactic antifungal therapy. The prescriber requests Cresemba to treat her prophylactically. The prescriber states other antifungals are CYP3A4 inhibitors and cause QTc prolongation. The requested drug is preferred as it has less interaction with Rydapt.The submitted documentation does not indicate the enrollee has an invasive fungal infection. The prescriber submitted journal articles in support of the request. The drug is not being used to treat her AML. Therefore, cancer drug review rules do not apply, and journal articles cannot be used to determine medically accepted 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 Cresemba 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 Cresemba. 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 and provide reimbursement for Oseltamivir Phosphate (Tamiflu) purchased at an out of network pharmacy on February 6, 2020. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you purchased Oseltamivir Phosphate (Tamiflu) on February 6, 2020 at an out of network pharmacy. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. The record indicates that you have not provided a reason for filling this prescription at an out of network pharmacy in accordance to the Plan's Evidence of Coverage (EOC). The Plan's out-of-network coverage rules were not followed. Therefore, our decision is the Plan is not required to provide coverage or reimbursement for Oseltamivir Phosphate (Tamiflu) purchased at an out of network pharmacy on February 6, 2020.
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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Estradiol. 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 Estradiol 1 mg tablet. The drug is requested to treat the enrollee's condition. The drug is a generic drug on Tier 4 of the Plan's formulary. A request for prescriber statement was sent and not returned. 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 Estradiol.
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 Myrbetriq . 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 Myrbetriq. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 4 of the Plan's formulary. There are no available lower tier drugs on the Plan's formularyto treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharingtiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are notmet because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee'scondition. Therefore, our decision is the Plan is not required to provide a tiering exception for Myrbetriq.
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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Carisoprodol. 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 Carisoprodol. The drug is requested to treat chronic sciatica with chronic muscle spasms. 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. Per DrugDex: Carisoprodol was superior to propoxyphene in improving range of movement, but approximately equivalent to propoxyphene in improving sleep in a placebo-controlled study involving 94 patients with pain due to muscle spasm and/or stiffness associated with acute or chronic low-back syndrome. Therefore, the requested drug is being prescribed for a medically accepted indication. The prescriber has not indicated why all alternatives required by the Plan Carisoprodol 350 mg tablet) would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 Carisoprodol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil 20 mg. 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. Tadalafil is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction and/or sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tadalafil. Therefore, the Plan is not required to cover Tadalafil. 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.