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

You asked the Plan to cover Solesta Gel. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover devices. Solesta Gel has been classified by the FDA as a device, not as adrug. Therefore, our decision is the Part D Plan is not required to cover Solesta Gel.This decision does not address the medical necessity or appropriateness of the requested item. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Remicade. The Plan did not grant this request. Wereceived this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Remicade is in the specialty tier. The record indicatesthe Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan isnot required to provide a tiering exception for Remicade.
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 Metformin ER osmotic 500 mg tablet. The Plan didnot 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 requestfor a tiering exception for Metformin ER osmotic 500 mg tablet. The drug is requested to treat theenrollee's condition. A request for prescriber statement was sent and not returned. The prescriber does notstate 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 forthe enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion isthat tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Metformin ERosmotic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Estriol Micronized Powder . 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. Bulkpowders used in pharmacy compounding are not reviewed and approved for safety and efficacy by theFDA. We determined that Estriol Micronized Powder is not FDA approved for both safety andeffectiveness by checking FDA sources. Therefore, the Plan is not required to cover Estriol MicronizedPowder.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 Cyclobenzaprine HCL. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cyclobenzaprine HCL. The drug is requested to treat migraine prophylaxis from teeth clenching, whichis an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 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 Cyclobenzaprine HCL 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forCyclobenzaprine HCL.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 Aubagio, 14 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Aubagio, 14 mg tablet.The drug is requested to treat relapsing form of multiple sclerosis. The prescriber has not indicated why allalternatives required by the Plan (Copaxone subcutaneous syringe, Glatiramer subcutaneous syringe, andGilenya capsule) would likely not be as effective for the enrollee as the requested drug; and/or would likelycause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coveragecriteria 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 Aubagio, 14 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Repatha SureClick 140 mg/ml.The drug is requested to treat severe hyperlipidemia/familial hypercholesterolemia. The enrollee does notsatisfy the Plan's coverage criteria (coronary artery calcium or calcification score greater than or equal to300 Agatston units). 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. 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 Otezla 30 mg tablet.Otezla 30 mg tablet is requested for treatment of psoriasis affecting 20% of the enrollee's body surface areaincluding extremities, trunk, and sensitive areas of the hands. The prescriber states that the enrollee hasfailed topical steroids, Methotrexate, and Enbrel, and that other systemic disease modifying anti-rheumaticdrugs are contraindicated due to the enrollee's age of 73. The plan has indicated in their denial letters thatCosentyx is on their formulary. The prescriber 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. Therefore, an exception to the Plan's coverage criteria is notsupported. 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 Otezla.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Livalo. 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 Livalo 1mg. Livalo 1mg is requested for treatment of hyperlipidemia in this enrollee with well documented coronary artery disease. The plan has indicated that Pravastatin and Ezetimibe are on their formulary. The prescriber has indicated that the enrollee's LDL (low density lipoprotein) was 168, goal LDL for this enrollee is less than 70, the enrollee had myalgias with prior trials of 3 high intensity statins, and the prescriber has highlighted the inferior LDL lowering potential of the plan's alternatives vs the requested drug. The prescriber has provided sufficient documentation as to 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 Livalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Baclofen 5 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Baclofen 5 mg tablet.Baclofen 5 mg tablet, 90 per 30 days, is requested to treat trigeminal neuralgia; it is noted that Baclofen isbeing used in combination with Tegretol. Baclofen 5 mg is not on the plan's formulary; however, Baclofen10 mg is on the plan's formulary. it was stated on November 24, 2020 that the prescriber prefers to use 5mg and not 10 mg as patient has been responding well with the 5 mg. However medical records fromDecember 2019 indicate that the enrollee was stable on the 10 mg size, three times daily in combinationwith Tegretol. Additionally, most of the generic Baclofen 10 mg tablets are scored, so can be cut in half.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'sopinion 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 Baclofen.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Hysingla ER, 40 mg tablet 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 requestfor Hysingla ER 40 mg tablet, 30/30.Hysingla ER, 40 mg tablet, 30/30 is requested for treatment of chronic pain. The prescriber indicates thatthe enrollee's pain is being treated with Hysingla ER, 40 mg tablet, 30/30 and Oxycodone, 5 mg every 6hours. The Plan denied coverage of Hysingla ER, 40 mg tablet, 30/30 because they indicate that their dailyMME (morphine milligram equivalent) limit of 90 has been exceeded. The Plan based their calculatedMME on previous fills of Oxycodone of 5 mg, #60 on February 6, 2020, and #40 per 10 days on February20. 2020. The Plan indicated that the #60 filled on February 6, 2020 was for 7 days thereby resulting in thehigher MME; however as noted, no additional Oxycodone was filled for #14 days (so the #60 lasted 14days). So the daily MME is 40 plus 30 to 32 for a total of 70 - 72 which is less than the Plans 90 mg/daylimit. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 Hysingla ER, 40 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lotemax 0.5% gel as prescribed. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lotemax 0.5%.Lotemax 0.5% is requested for ongoing treatment of chronic iridocyclitis of the right eye. The prescriber states that the enrollee is legally blind in her right eye and has a prosthetic left eye, the enrollee has failed other ocular corticosteroid preparations, the prescriber has indicated why stronger ocular corticosteroids are not medically appropriate for this enrollee, and the prescriber has indicated that the enrollee is stable on the requested drug and is at high risk for significant adverse clinical outcome, such as blindness with a medication change. The Plan denied coverage of the requested drug because they concluded that it is not being prescribed for a medically accepted indication. 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 ofthe noted condition. The FDA approved label for the requested drug states that it is indicated to treat steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitis conditions when the benefits of reduced edema and inflammation outweigh the inherent risks associated with steroid therapy Therefore, the requested drug is being prescribed for a medically accepted indication.It is unclear if the enrollee satisfies the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Lotemax 0.5% gel.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Acthar Gel 400 unit/5 mL 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 requestforActhar Gel.Acthar Gel is requested for ongoing treatment of chronic uveitis and scleritis. The prescriber states that theenrollee has failed multiple treatment options, he has been treated with Acthar Gel since April 2018 with apositive response, other treatment options will not be as effective as Acthar Gel, and that a change orinterruption in therapy will result in worsening of the enrollee's condition. The Plan denied coverage ofActhar Gel because they indicate that there is insufficient documentation of improvement with Acthar Gel.The medical records were reviewed; there is sufficient documentation that ongoing therapy is medicallynecessary. There are some specific notations that inflammation and/or symptoms have improved sincestarting Acthar (e.g. note of 6/3/2019 - problem has gradually worsening, Acthar provided moderate reliefof symptoms. It was stated in the medical record from an encounter November 11, 2019 that the enrolleewas having less pain on the noted treatment. It is also noted that the enrollee has poorly controlled steroidinduced diabetes mellitus, and that corticosteroids are being tapered, yet ocular condition has been stable onActhar and IVIG (intravenous immune globulin). The plan is for further tapering of corticosteroids.In summary, the prescriber has provided a sufficiently strong statement supported by medical records as towhy all alternatives required by the Plan would likely not be as effective as the requested drug for theenrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is thatprior 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 met. Therefore, our decision is the Planis required to cover Acthar Gel 400 unit/5 mL as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ofev, 100 mg 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 Ofev, 100 mg.Ofev, 100 mg is requested to treat worsening dyspnea related to pulmonary fibrosis which the prescriber states is likely idiopathic; however high resolution CT scan did not reveal the usual interstitial pneumonia pattern, and the enrollee did not undergo open lung biopsy. 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 Ofev, 100 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Torsemide . The Plan did not grant this request. We received this case toconduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limitedcircumstances. In this instance, the enrollee filled a 90 day prescription at an out-of-network pharmacy.According to the plan's Evidence of Coverage, drugs filled at an out-of-network pharmacy are limited to a30 day supply. The Plan's out-of-network coverage rules were not followed. Therefore, our decision is thePlan is not required to provide coverage for Torsemide.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Symbicort. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Symbicort is a Tier 3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Symbicort.