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

You asked the Plan to cover Tymlos. 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 Tymlos 80 mcg.The drug is requested to treat Postmenopausal osteoporosis. The provided medical records document that the enrollee has previously tried and failed Fosamax, Prolia, Boniva and Reclast. 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 Tymlos.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolastin-C. 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 Prolastin-C Solution 1000 mg/20 ml. The drug is requested to treat alpha-1 antitrypsin deficiency. Theenrollee does not satisfy the Plan's coverage criteria (pretreatment serum alpha-1 proteinase inhibitor level).You have not sufficiently addressed the Plan's coverage criteria and/or have not indicated why allalternatives 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. Our Physician's opinion is thatneither 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 Prolastin-C.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Toujeo Solostar. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Toujeo Solostar is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Toujeo Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xtampza ER . The Plan did not grant this request. Wereceived 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. Xtampza ER is a Tier 3 branddrug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is thePlan is not required to provide a tiering exception for Xtampza ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ursodiol, 500 mg tablet. 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 Ursodiol, 500 mg tablet.The drug is requested to treat primary biliary cirrhosis. The drug is a Generic drug on Tier 4 of the Plan's formulary. Please note that the formulary has 250 mg tablets available. The prescriber's appeal letter dated 3/30/2020 addressed 300 mg capsules, but did not address the 250 mg tablets. The 250 mg tablets are tier 3. The 300 mg capsules are non-formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Ursodiol, 500 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pravastatin. 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 Pravastatin 20 mg tab, 45 tablets per 30 days.The drug is requested to treat hyperlipidemia. The prescriber had clarified the diagnosis as hyperlipidemiain the request for reconsideration. Relevant medical records were requested but not provided. Theprescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file if theunderlying etiology of the enrollee's condition was lichen sclerosus or hyperlipidemia. The Plan limits theamount of the drug to 30 tablets per 30 days. The prescriber was also asked to clarify the quantityrequested. The prescriber was asked if the number of doses of the requested drug allowed by the Planwould likely be ineffective in treating the enrollee's condition and/or would likely cause harm to theenrollee. A response from the prescriber was not received. Therefore, based on the current record, there isinsufficient documentation that the requested medication is being prescribed for a medically acceptedindication as defined by Medicare law. In addition, quantity limit exception criteria are not 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 needed additional information from the prescriber to determine whether theenrollee is using Pravastatin for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Therefore, our decision is that the Plan is not required to provide coverage for Pravastatin.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 Zolmitriptan ODT 5 mg, 27 tablets 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 request for Zolmitriptan ODT 5 mg (27 tablets/30 days).The drug is requested to treat acute migraine headaches. The Plan limits the amount of Zolmitriptan ODT 5 mg tablets to 9 tablets per 30 days. The following citation in DrugDex, a Medicare approved compendium states: Maximum dosage: 5 mg as a single dose; 10 mg in 24 hours [3]. The safety of treating, on average, more than 3 migraines in a 30-day period has not been established with oral tablets [2]. 2. Product Information: ZOMIG(R) oral tablets, zolmitriptan oral tablets. Impax Pharmaceuticals (per FDA), Hayward, CA, 2012. 3. Product Information: ZOMIG-ZMT(R) oral disintegrating tablets, zolmitriptan oral disintegrating tablets. Impax Pharmaceuticals (per FDA), Hayward, CA, 2012. The Medicare-approved compendia do not support the use of this drug for treatment of the noted condition due to safety concerns. The prescriber has not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Zolmitriptan ODT 5 mg, 27 tablets per 30 days .
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ursodiol. 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 Ursodiol 300 mg capsule. The drug is requested to treat chemodissolution of bile duct stone/gallstones. The drug is on tier three of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician 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 the same type in a lower cost-sharing tier approved for treating the same condition that the higher cost sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Ursodiol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Topiramate. 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 Topiramate. The drug is requested to treat major depressive disorder and impulse control disorder, which are off-label (non-FDA approved) uses. 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 Topiramate 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 Topiramate. 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: Partially Favorable

You asked the Plan to provide reimbursement for Ventolin HFA 90 mcg, Breo Ellipta 200-25 mcg and Acetaminophen 500 mg received November 14, 2019 and November 15, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within the specified timeframes. If the Plan does not make a timely decision, this is considered a denial. In these circumstances, the Plan is required to forward the coverage request or the redetermination request to the Part D QIC. In this case, the case record indicates Acetaminophen was submitted with each request submitted to the Plan. The Plan did not properly process Acetaminophen to move the case forward to the next appeal level. Therefore, the applicable time frames have been exceeded, and the Part D QIC has jurisdiction to process the request for reimbursement for Acetaminophen.Ventolin HFA and Breo ElliptaThe Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you were a patient at the medical center on November 14, 2019 and November 15, 2019. During this stay you were given several self-administered drugs. The Plan did not approve the request for reimbursement for Ventolin HFA and Breo Ellipta on the basis that the National Drug Code (NDC) for each drug was missing and/or invalid. The Reconsideration appeal request included valid and Part D eligible NDCs for both drugs (Ventolin HFA - 00173-0682-24 and Breo Ellipta - 00173-0882-14). The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to process and provide reimbursement for Ventolin HFA 90 mcg and Breo Ellipta 200-25 mcg received November 14, 2019.AcetaminophenMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Acetaminophen received November 14, 2019 and November 15, 2019is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it under the Part D benefit.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 provide a tiering exception for Amitiza. 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 Amitiza. The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Amitiza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Loteprednol. 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 Loteprednol. The drug is requested to treat corneal melt. Brand Lotemax is available on the Plan's formulary. You have not indicated why this alternative 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 Loteprednol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for 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 a tiering exception for Vascepa, 1gm capsule.Vascepa, 1gm capsule is requested to treat the enrollee's condition. The requested drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception. Our Physician 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Vascepa, 1 gm capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Entacapone. 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 Entacapone 200 mg tablet.Entacapone 200 mg tablet is requested to treat Parkinson's disease. Entacapone 200 mg tablet is a generic drug on tier 3 of the plan's formulary. There are no similar drugs on the lower tiers of the plan's formulary to treat the enrollee's condition; therefore Entacapone 200 mg tablet is not eligible for a tiering exception. Our Physician 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Entacapone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolastin-C 1,000 mg/20 mL. 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 Prolastin-C 1,000 mg/20 mL.Prolastin-C 1,000 mg/20 mL is requested for ongoing use in this enrollee with emphysema and reportedalpha-1-antitrpsin deficiency. The records indicated that this enrollee has a previous history of tobaccoabuse, severe chronic obstructive lung disease/asthma with CT scan notable for centrilobular emphysemawith upper lobe predominance. Pre-treatment alpha one antitrypsin level was 81 mg/ml in December 2017,and 93.6 mg/ml (18.0 uM) on February 14, 2018 with an MZ genotype. The enrollee does not satisfy thePlan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or hasnot indicated why all alternatives required by the Plan would likely not be as effective for the enrollee asthe requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Prolastin-C 1,000 mg/20 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil (Cialis) 20 mg. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Tadalafil (Cialis) 20 mg is one of thoseexcluded drugs because it is a sexual or erectile dysfunction drug used to treat a condition other than sexualor erectile dysfunction for which the drug has not been approved by the FDA. The record submitted by thePlan does not indicate that they provide supplemental coverage for Tadalafil (Cialis) 20 mg. Therefore, thePlan is not required to cover Tadalafil (Cialis) 20 mg.This 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.