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

You asked the Plan to cover Samsca, 15 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 request for Samsca, 15 mg tablet.Samsca, 15 mg tablet is requested for treatment of euvolemic hyponatremia. The Plan's denial letter states that coverage of Samsca has been denied because their coverage criteria require that treatment with the requested drug is initiated/re-initiated in the hospital prior to discharge within the past 30 days. The prescriber has provided medical record documentation that the enrollee was admitted to the hospital on November 21, 2020 to re-initiate treatment with Samsa. 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 Samsca, 15 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz. 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. The drug is requested to treat alopecia areata, 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 Xeljanz 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 Xeljanz.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 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 a tiering exception for Livalo. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 4 of the Plan's formulary. There are no available lower tier brand drugs 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 Livalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin, 150 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 Pregabalin.Pregabalin is requested for ongoing treatment of chronic low back pain which is felt to be due to severe lumbar facet arthropathy with medial branch nerve irritation, which is an off-label (non-FDA approved) use. The prescriber states that Pregabalin has been effective to treat the neuropathic pain which disturbs sleep; 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 Pregabalin, 150 mg capsule 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 Pregabalin, 150 mg capsule. 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 Modafinil, 200 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 Modafinil, 200 mg, two each morning.Modafinil, 200 mg, two each morning, is requested for ongoing treatment of this 81 year old woman with daytime somnolence (R40.0) which the prescriber has indicated in the medical record is primary/chronic and associated with acute/chronic fatigue. Medical records were submitted from a patient encounter December 2, 2020; there is no evidence of evaluation with sleep studies or consultation with a neurologist/sleep specialist; however it is noted that fatigue and somnolence have improved with Modafinil. It is also noted that the enrollee also has insomnia and anxiety, she reported difficulty getting to sleep (on the requested dose of Modafinil) at the time of the noted recent visit, and she is prescribed Alprazolam as needed for treatment of insomnia/anxiety. Based on the information provided, there is insufficient documentation that the enrollee is being prescribed Modafinil for treatment of a medically accepted indication as defined by Medicare. 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 Modafinil, 200 mg tablet 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 Modafinil, 200 mg tablet.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 ER. 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 ER. The drug is requested to treat 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 ER.
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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Xtampza ER, 13.5 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Xtampza ER, 13.5 mg capsule, which is not on the Plan's formulary. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether 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 the available 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 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 Xtampza ER, 13.5 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Glucagon 1 mg emergency 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 Glucagon 1 mg emergency kit. The drug is requested to treat hypoglycemia related to diabetes, chronic renal disease, gastroparesis, and widely fluctuating blood sugars. 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 Glucagon 1 mg emergency kit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ursodiol 300 mg. The Plan did not grant this request. We received this case to conduct an independent review.A Part D Plan may establish tiered cost-sharing for drugs on its formulary of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug). Ursodiol 300 mg is classified as a Tier 4 drug on the Plan's 2020 formulary. However, the Plan provided documentation that Ursodiol 300 mg was previously approved for coverage at a Tier 1 copay for the 2020 Plan year. Tier 1 drugs are not eligible for a tiering exception because they are already classified as the lowest tier on the Plan's formulary. Therefore, our decision is the Part D Plan is not required to provide any additional tiering exception for Ursodiol 300 mg.Please note: If you are looking for a tiering exception for the 2021 Plan year, you may wish to submit that request to the Plan at this time.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Digoxin. 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 Digoxin 250 mcg tablet. The drug is requested to treat atrial fibrillation. The prescriber was asked to address the prior authorization requirements. 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 Digoxin.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Forteo, 600 mcg 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 Forteo, 600 mcg.Forteo, 600 mcg is requested for treatment of post-menopausal osteoporosis in this enrollee who has had a osteoporotic/fragility fracture. It is noted that the enrollee has previously tried one oral bisphosphonate, she will not be taking Forteo with other medications to treat osteoporosis, and she has not previously taken any Forteo. 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 Forteo, 600 mcg as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Humira CF Pen, 40 mg/0.4 mL. 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 Humira Pen, 40 mg/0.4 mL.Humira Pen, 40 mg/0.4 mL is requested for treatment of granuloma annulare, 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 Humira CF Pen, 40 mg/0.4 mL 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 Humira CF Pen, 40 mg/0.4 mL. 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 Alprazolam 2 mg tablet, 180 tablets per 30 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Alprazolam 2 mg tablet 180 tablets per 30 days. You are requesting a total of 12mg per day. The drug is requested to treat anxiety. The Plan limits the amount of Alprazolam 2 mg tablet to 150 tablets per 30 days. The following citation in DrugDex, a Medicare approved compendium states:for Anxiety: a) Usual dosage: 0.25 to 0.5 mg orally 3 times daily; the lowest effective dose should be used [15][16]. b) Dose titration: Titrate upward every 3 to 4 days [15][16]. c) Maximum dose: 4 mg daily [15][16] 15. Product Information: NIRAVAM(TM) orally disintegrating tablet, alprazolam orally disintegrating tablet. Schwarz Pharma, Milwaukee, WI, 2003. 16. Product Information: Xanax(R), alprazolam. Pharmacia & Upjohn Company, Kalamazoo, MI, USA, 1999.You are requesting an amount greater than the maximum dose noted above. You have not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Alprazolam.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Premarin vaginal cream applicator 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 Premarin cream.Premarin cream is requested for ongoing treatment of vaginal dryness/menopausal symptoms. Additional information was requested from the prescriber; the prescriber has indicated that the enrollee had tried failed and/or had adverse effects to other estrogen preparations and Osphena. 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 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 Premarin vaginal cream applicator as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Taltz 80 mg/mL. 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 Taltz 80 mg/ mL.The drug is requested to treat psoriasis. The prescriber has not indicated why all alternatives required by the Plan (Cosentyx and Skyrizi) 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 Taltz 80 mg/mL.