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

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 Vumerity 231 mg capsule DR as prescribed. The Plan did not grant thisrequest. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Vumerity 231 mg capsule DR.Vumerity 231 mg capsule DR is requested for treatment of multiple sclerosis. The enrollee has tried andfailed and/or had adverse effects to Rebif and Tecfidera. The Plan has indicated that their formularyexception coverage criteria require the trial of at least two formulary alternatives that treat the samecondition or diagnosis first. Per HPMS (Health Plan Management System - CMS's official database forPlan formularies), both Rebif and Tecfidera are on the Plan's formulary. The prescriber has indicated whyall 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 thePlan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formularyexception criteria are met.Of note, although Rebif (interferon beta 1a) is not specifically listed in the Plan's denial letter, it is listed asa formulary drug on HPMS. Additionally Avonex, a different brand formulation of interferon beta 1a isspecifically listed in the Plan's denial letter.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 Vumerity 231 mg capsule DR as prescribed.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tegsedi 284 mg/1.5 ml syringe. 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 Tegsedi 284 mg/1.5 ml syringe. The drug is requested to treat neuropathic hereditary amyloidosis. Upon reconsideration, the prescribing physician has submitted laboratory report dated 9/6/19 with genetic testing showing pathologic mutation p.V50M detected in the TTR gene, consistent with a diagnosis of transthyretin (TTR) amyloidosis. There are no formulary alternates available for the treatment of the enrollee's condition. 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 Tegsedi 284 mg/1.5 ml syringe.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 Cinacalcet. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included inthe ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless ofwhether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD andAKI-related include access management drugs, anemia management drugs, anti-infectives to treat siteaccess infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Cinacalcet is being prescribed to an enrollee who has ESRD or AKI and is on dialysis.Cinacalcet is a class of medication which is always considered ESRD or AKI-related for purposes of thePart B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRDpayment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or notthe drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excludedfrom Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to coverCinacalcet.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can 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 cover Augmentin. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. The Plan provided documentation that the pharmacy is attempting to fill Augmentin (National Drug Code (NDC) 72508-004-15). This NDC of Augmentin is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover Augmentin. The Plan also provided documentation that the pharmacy has also previously used NDC 43598-004-53. There is no indication the Plan will reject payment for NDC 43598-004-53. You may wish to discuss this option with the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Thrombin-JMI received July 3, 2019. The Plan did notgrant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage under Part D for any drug for which payment would beavailable under Part A or Part B of Medicare for that individual. Medicare Part B pays for hemophiliaclotting factors. Medicare rules state the blood clotting factors are a category of drug that are not eligiblefor coverage under the Part D benefit and should not be included on a Part D sponsor's formulary.Thrombin-JMI received July 3, 2019 is a blood clotting factor drug product. It appears that this medicationis eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part Bare excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part D Plan is notrequired to cover or provide reimbursement for Thrombin-JMI received July 3, 2019.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.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 Dexilant DR. 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 Dexilant DR. The drug is requested to treat gastroesophageal reflux disease. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs of the same type 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 Dexilant DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ensure Plus. The Plan did not grant this request. We received this case to conduct an independent review.Medicare 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, Ensure Plus is not eligible for Part D coverage, and the Plan is not required to cover 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 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. The drug is requested to treat the enrollee's condition. The drug is generic drug on tier 3 of the Plan's formulary. For the 2020 plan year, eligibility for a tiering exception requires the presence of at least one similar lower tier drug on the Plan's formulary to treat the enrollee's condition. There are no similar drugs on the lower tiers of the Plan's formulary. 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 Estradiol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolia. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to the service of a physician (or other practitioner). In this case, the record reflects that Prolia will be supplied from physician and/or office stock supply, and will be billed as part of a physician service. Prolia is a type of drug that is not usually self-administered. As a result, the drug as administered in this case appears to be eligible for coverage under Medicare Part B. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Prolia. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of Prolia under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified time frame. 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 Megestrol Acetate. 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 Megestrol Acetate 400 mg/10 mL.The drug is requested to treat anorexia. Drugs prescribed for the treatment of weight loss are excluded from coverage. Therefore, this drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Megestrol Acetate is one of those excluded drugs because it is a drug used for anorexia, weight loss or weight gain. The record submitted by the Plan does not indicate that they provide supplemental coverage for Megestrol Acetate. Therefore, the Plan is not required to cover Megestrol Acetate. 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 Triazolam. 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 Triazolam. Triazolam is requested for ongoing treatment of insomnia in this 82-year-old man with known severe chronic obstructive pulmonary disease. The prescriber indicated that a formulary exception was approved for coverage of the requested drug last year; however, the Plan has new formulary alternatives this year which include Temazepam and Belsomra. It is documented that the patient tried Temazepam subsequent to the initial denial of Triazolam; however, the prescriber has not addressed the appropriateness of Belsomra for this enrollee. 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 Triazolam.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Qsymia. 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. Qsymia is one of those excluded drugs because it is a drug used for anorexia, weight loss or weight gain. The record submitted by the Plan does not indicate that they provide supplemental coverage for Qsymia. Therefore, the Plan is not required to cover Qsymia. 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 Dupixent. 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 Dupixent. The drug is requested to treat atopic dermatitis. The redetermination request noted symptoms of intractable pruritis. However, the original progress notes submitted documented that the enrollee did not have intractable pruritis, or cracking, oozing, or bleeding of affected skin. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician'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. 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 not met. Therefore, the Plan is not required to cover Dupixent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Estradiol 0.01% Cream. 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 Estradiol 0.01% Cream. The drug is requested to treat lichen sclerosus, which is an off-label (non-FDA approved) use. Medical records provided document that Estradiol 0.01% Cream is being used for the treatment of lichen sclerosus. 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 Estradiol 0.01% Cream 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 Estradiol 0.01% Cream. 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.Please note: the request for a tiering exception (lower copayment) for Estradiol 0.01% Cream was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Pentasa. 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 Pentasa. The drug is requested to treat Crohn's disease. The drug is a brand drug on tier 3 of the Plan's formulary. Eligibility for a tiering exception requires the presence of at least one similar lower tier brand drug on the Plan's formulary to treat the enrollee's condition. There are no similar brand drugs on the lower tiers of the Plan's formulary. 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 Pentasa
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem 10 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 Zolpidem 10 mg tablet.The drug is requested to treat insomnia. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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.Our Physician Reviewer'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. 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 not met. Therefore, the Plan is not required to cover Zolpidem.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Orenitram ER, 0.125 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 Orenitram ER 0.125 mg.Orenitram ER 0.125 mg is requested for treatment of WHO group I pulmonary arterial hypertension. The prescriber has indicated that the enrollee has had bad experiences to other drugs such as Sildenafil, and Tadalafil, and that the enrollee has improved on Opsumit with significant improvement in functional status - medical record indicates no shortness of breath despite remaining reasonably active, and ongoing improvement in 6 minute walk test documented in November 11, 2019. The prescriber states that additional therapy is required for worsening RVSP (right ventricular systolic pressure) although there is insufficient documentation of recent worsening of RVSP. The Plan has indicated that Adempas is on their formulary; 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 Orenitram ER, 0.125 mg tablet.