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

You asked the Plan to cover Icatibant 30 mg/3 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 Icatibant 30 mg/3 ml syringe. Icatibant 30 mg/3 ml syringe is requested for treatment of angioedema. You have discussed the enrollee's clinical history, the pathogenesis of the enrollee's condition, and why the requested drug is the best treatment option for this enrollee. 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 has the following notation in their monograph about the requested drug (Adult Dosing section - quick answers view only): Orphan drug designation: Treatment of angioedema. There is no stipulation that this orphan designation applies to hereditary or acquired angioedema. Therefore, the requested drug is being prescribed for a medically accepted indication. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 Icatibant 30 mg/3 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 Prasugrel HCL, 10 mg tablet. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forPrasugrel HCL, 10 mg tablet, which is not on the Plan's formulary. Our Physician Reviewer neededadditional information from the prescriber to make this determination. The prescriber was asked to addresswhether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug;and/or (2) have adverse effects. The requested information was not received. Based on a review of theavailable documentation, 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 Prasugrel HCL, 10 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Potassium Citrate-Citric Acid. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Potassium Citrate-Citric Acid is not FDA approved for both safety and effectiveness bychecking FDA sources. Therefore, the Plan is not required to cover Potassium Citrate-Citric Acid.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine-Naloxone SL 2-0.5 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 Buprenorphine-Naloxone SL 2-0.5 mg tablet.The drug is requested to treat opioid dependence. In the request for reconsideration dated 7/17/2020, the prescriber states that Zubsolv was inadequate for patient. He didn't like the effects of the medicine. Buprenorphine-Naloxone SL 2-0.5 mg tablet is not on the Plan's formulary. Buprenorphine-Naloxone 2-0.5 mg oral strip is on the Plan's 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 Buprenorphine-Naloxone SL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR ER 24 hr, 11 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 Xeljanz XR ER (24HR) 11 mg.The drug is requested to treat psoriatic arthritis. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not documented why the requested drug will not be used in combination with a non-biologic disease-modifying antirheumatic drug (DMARD) such as, Leflunomide, Sulfasalazine, etc. 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 Xeljanz XR ER 24 hr, 11 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Doptelet (10 tab pk) 20 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 Doptelet (10 tab pk) 20 mg tablet. The drug is requested to treat thrombocytopenia in an enrollee with chronic liver disease (CLD) scheduled to undergo a procedure. According to DrugDex, a Medicare compendium, the indication for use is not limited by platelet count. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 Doptelet (10 tab pk) 20 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Gattex 5 mg kit. 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 Gattex 5 mg kit.Gattex 5 mg kit is requested for ongoing treatment of short gut syndrome related to previous bowel resections due to Crohn's disease. The plan's denial letter states that they do not allow coverage of the requested medication based on your prescriber answering NO to the following question(s): Has the patient's requirement for parenteral support decreased from baseline while on therapy with the requested medication. The prescriber states that the answer should have been yes, and has provided additional documentation with the request for reconsideration which indicates that the enrollee required hyperalimentation to treat the noted condition when hospitalized and following discharge. It is noted that Gattex was started following discharge, and that subsequent to starting Gattex, hyperalimentation was no longer required. The enrollee satisfies the Plan's coverage 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 are met. Therefore, our decision is the Plan is required to cover Gattex.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 provide a tiering exception for Tobradex 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 a tiering exception for Tobradex Ointment 0.3%/0.1%. The drug is requested for the treatment of a right ocular inflammatory condition in a patient with a long history of bacterial ocular infections. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available similar 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 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 Tobradex Ointment.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Octagam 10% vial. 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 Octagam 10% vial.Octagam 10% vial is requested for treatment of systemic sclerosis/scleroderma, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical history and why the requested drug has been prescribed; 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 Octagam 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 Octagam. 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 provide a tiering exception for Oxycodone HCL ER. 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 Oxycodone HCL ER 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 Oxycodone HCL ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Midodrine HCL. 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 Midodrine HCL 2.5 mg. Midodrine HCL 2.5 mg is requested to treat the enrollee's condition. The requested drug is on tier 4 of the Plan's formulary. There are no similar lower tier drugs available 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 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 Midodrine HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Procrit. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Procrit is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Procrit is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Procrit. 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.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 Otezla. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Otezla is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Otezla.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Qbrexza. 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 Qbrexza 2.4%. Qbrexza 2.4% is requested for treatment of ICD-10-CM Diagnosis Code L74.510 - Primary focal hyperhidrosis, axilla. The plan has indicated Oxybutynin Hydrochloride is on their formulary. The prescriber initially stated that the requested drug is more patient friendly to use; the prescriber later stated that Qbrexza with less side effects than an oral Oxybutynin chloride tablet. The prescriber has not provided sufficient documentation as to why the 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 this particular enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are metA 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 Qbrexza.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 Xeljanz XR. 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 Xeljanz XR 11 mg. The drug is requested to treat rheumatoid arthritis. 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 Xeljanz XR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Timolol 0.5% eye drop. 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 Timolol 0.5%.Timolol 0.5% is requested for ongoing treatment of primary open angle glaucoma. The plan's denial letter lists the formulary alternatives which include, but are not limited to, Timolol Maleate (generic Timoptic). The prescriber states, may substitute with Betimol .5% which does not appear on the plan's formulary; the prescriber has not addressed the formulary alternatives noted in the plan's denial letter. 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 Timolol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Advair Diskus 250-50 mcg. 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 Advair Diskus, 250-50 mcg.The drug is requested to treat chronic obstructive pulmonary disease. The drug is a brand drug on Tier 3 of the Plan's formulary. The prescriber states the enrollee has tried and failed Albuterol nebulizer, Duoneb, and Wixela. 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 Advair Diskus 250-50 mcg.