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

You asked the Plan to cover Diclofenac Sodium DR 75 mg tablet. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Diclofenac Sodium DR 75 mg tablet.Diclofenac Sodium DR 75 mg tablet is requested for treatment of osteoarthritis of the knees. The Plan'sdenial letter indicated that their formulary alternative was Diclofenac Potassium IR. You indicated at thetime of the initial request on April 6, 2020 that the enrollee had not tried the Plan's alternatives. Howeveryou report that the enrollee has now tried Diclofenac Potassium IR twice daily and the enrollee reportedthat it was ineffective. You have indicated why all alternatives required by the Plan would likely not be aseffective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. OurPhysician 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 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 Diclofenac Sodium DR 75 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Migranal 4 mg/mL spray. 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 Migranal 4 mg/mL spray. The drug is requested to treat migraine. You have 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 Migranal 4 mg/mL spray.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hizentra. 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 Hizentra 4 gm/20 ml solution. The drug is requested to treat primary immunodeficiency related to ataxia-telangiectasia. 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. Therefore, the requested drug is being prescribed for a medically accepted indication. You have not indicated why all alternatives required by the Plan (including Octagam, Privigen and Panzyga) 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 Hizentra.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica. 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 Lyrica. Lyrica is requested for treatment of the enrollee's condition; the diagnoses noted most recentlyon the request form submitted 4/27/20 are G63.0 (G63 = Polyneuropathy in diseases classified elsewhere)and M79.7 -fibromyalgia. The Plan's denial Redetermination denial letter dated April 10, 2020 states thatPregabalin and Duloxetine are on their formulary. The prescriber has indicated that the enrollee has triedand had adverse effects to generic Pregabalin and Gabapentin; however the prescriber has not indicatedwhy 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 not medically necessary. Our Physician Reviewer's opinion isthat 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 Lyrica.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Flector 1.3% patch. 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 Flector 1.3% patch. The drug is requested to treat chronic musculoskeletal pain, which is an off-label (non-FDA approved) use. You clarified the medical history in a letter dated April 29, 2020. You state the enrollee has had chronic musculoskeletal pain for over 30 years. 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 Flector 1.3% patch 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 Flector 1.3% patch. 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 Vascepa. 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 1 mg. The drug is requested to treat hyperlipidemia. The drug is on Tier 4 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 (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.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Zioptan 0.0015%, 30 vials per 30 days. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Zioptan 0.0015% ophthalmic solution.The drug is requested to treat glaucoma. On 04/26/2020 and 05/04/2020 the prescriber sent additionalinformation addressing the Plan's coverage criteria and formulary alternatives - the enrollee does nottolerate the preservatives in the formulary alternatives as they cause eye redness, irritation and discomfort.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as therequested 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.The Plan limits the amount of the drug to 30 vials per 30 days. On 05/04/2020 the prescriber sent additionalinformation indicating that 30 vials for 30 days was appropriate for the enrollee. The requested quantity iswithin the number of doses allowed by the Plan.Our Physician Reviewer's opinion is that quantity limit criteria are 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 met. Therefore,the Plan is required to cover Zioptan.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.Based on a review of the available documentation, our Physician Reviewer's opinion is that the doserequested is within the allowed quantity limit. Therefore, the Plan is required to cover the requestedquantity of Zioptan.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Testosterone 1.62% Gel. 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 Testosterone 1.62% Gel. The drug is requested to treat male hypogonadism in an enrollee withKlinefelter syndrome. You clarified the diagnosis in a statement dated April 24, 2020. Medical recordswere provided to support this diagnosis. For coverage under the prescription drug benefit, Medicarerequires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewerfound that the Medicare-approved resources do contain citations to support the use of the requested drugfor treatment of the noted condition. Therefore, the requested drug is being prescribed for a medicallyaccepted indication. The enrollee satisfies the Plan's coverage criteria. You state the enrollee has beenstable on Androgel for many years. Free testosterone level was 33.6 (ref range 35.0-255.0 pg/mL) and totaltestosterone 199 (ref range 250-1100 ng/dL) on 12/24/2019. Our Physician Reviewer's opinion is that priorauthorization criteria are 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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofTestosterone 1.62% Gel for the diagnosed condition. As a result, Testosterone 1.62% Gel is beingprescribed for a medically accepted indication as defined by Medicare law.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 Testosterone 1.62% Gel.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Levemir FlexTouch. The Plan did not grant thisrequest. 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 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. Levemir FlexTouch is a Tier 3brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decisionis the Plan is not required to provide a tiering exception for Levemir FlexTouch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha Sureclick. 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 Repatha Sureclick. Repatha Sureclick is requested for ongoing treatment of familial hyperlipidemia in this enrollee who is intolerant to statins. The Plan has indicated that Praluent is on their formulary. The prescriber's office states that the enrollee has been treated with Repatha for 1.5 years, and that the doc has seen better results with Repatha. You have provided sufficient documentation that 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 Repatha Sureclick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Promehazine 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 Promehazine HCL.Promehazine HCL is requested for treatment of nausea associated with gastroenteritis, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Promehazine 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, 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 Promehazine HCL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem Tartrate. 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 Tartrate. The drug is requested to treat chronic insomnia. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or have 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 Zolpidem Tartrate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR 11 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 Xeljanz XR 11 mg tablet. The drug is requested to treat rheumatoid arthritis, multiple sites. You statethe enrollee has tried and failed Humira, Infliximab, Azathioprine and Methotrexate in the past.Xeljanz XR 11 mg tablet is not on the Plan's formulary. Xeljanz 5 mg and 10 mg tablets are on the Plan'sformulary. You have 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 Xeljanz XR 11 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium-Albuterol neb sol. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium-Albuterol neb sol for the management of obstructive pulmonarydisease.In this case, the record shows that Ipratropium-Albuterol neb sol is administered through a nebulizer in thehome for a diagnosis of J43.2 - Centrilobular emphysema. There is no indication that it is not administeredthrough a small volume nebulizer. It appears that this medication is eligible for coverage under Part Brather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverageby Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium-Albuterol neb sol.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 Dronabinol . 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 Dronabinol. The drug is requested to treat anorexia in an enrollee with chronic obstructive pulmonary disease and respiratory failure, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Dronabinol 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 Dronabinol. 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.