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

You asked the Plan to cover Mycophenolate. 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 Mycophenolate Mofetil. Mycophenolate Mofetil is requested for ongoing treatment of autoimmune sensorineural hearing loss associated with a positive myeloperoxidase antibody in the past, which is an off-label (non-FDA approved) use. It is noted that the requested drug has stabilized the enrollee's hearing; 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 Mycophenolate 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 Mycophenolate. 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 Lantus SoloStar. 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Lantus SoloStar is a Tier 3 brand [biologic] 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 Lantus SoloStar.
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 Hydromorphone. 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 Hydromorphone, 500 mg per 50 ml solution. Hydromorphone, 500 mg per 50 ml solution for intravenous administration is requested for ongoing treatment of chronic severe pain associated with mitochondrial respiratory chain disorder. The prescriber states that the enrollee has been treated with intravenous Hydromorphone via a peripherally inserted central catheter (PICC line) for approximately 6-7 years, and that he has been prescribing the requested drug since 2019. The prescriber further states that the enrollee's current daily Hydromorphone dose is 192 mg maximum for a current Morphine Milligram Equivalent (MME) dose of 768 mg daily, and that a change in treatment to an alternative opioid regimen is beyond the prescriber's scope of practice in the outpatient setting. There are several several long and short acting opioids on the plan's formulary. The prescriber has not provided sufficient medical rationale that ongoing treatment with parenteral Hydromorphone is the most appropriate regimen for this enrollee, and 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 Hydromorphone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Depakote. 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Depakote is a Tier 2 brand [biologic] 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 Depakote.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Polyethyline Glycol powder. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Polyethyline Glycol powder is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.We also received your letter asking for an appeal of the Plan's unfavorable determination for Senna. We are dismissing this case. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time. Additionally, we received your letter asking for an appeal of the Plan's unfavorable determination for Dulcolax. We are dismissing this case. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.
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 Repatha SureClick 140 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 Repatha SureClick 140 mg/mL.Repatha SureClick 140 mg/mL is requested as a new start to treat this enrollee with hyperlipidemia and a history of multiple strokes. It is stated that the enrollee has had intolerance to statins as well as to Ezetimibe. The prescriber states that the enrollee requires a PCSK-9 inhibitor (protein convertase subtilisin/kexin type 9 (PCSK9). Praluent 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 Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tremfya 100 mg/mL syringe, 3 per 28 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 Tremfya, 100 mg/mL subcutaneous solution.The drug is requested to treat chronic plaque psoriasis. The prescriber has not indicated (with patient-specific, clinical rationale) 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 Tremfya 100 mg/mL syringe, 3 per 28 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cholesterol Powder. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Cholesterol Powder is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Cholesterol Powder. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Entresto. 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Entresto is a Tier 3 brand [biologic] 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 Entresto.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Fentanyl 12 mcg/hr 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 Fentanyl 12 mcg/hr Patch. The drug is requested to treat chronic pain. You clarified the medical history in the request for reconsideration. 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 Fentanyl 12 mcg/hr Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Auryxia. 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 Auryxia.Auryxia is requested for treatment of anemia and hyperphosphatemia/secondary hyperparathyroidism associated with chronic kidney disease (CKD), stage V, in this enrollee with a fistula in place who is not documented to be undergoing dialysis. For the diagnosis of anemia, Auryxia is excluded from coverage under Medicare Part D because the requested drug is being used as a prescription vitamin/mineral. The diagnosis of secondary hyperparathyroidism/hyperphosphatemia in this enrollee with CKD who is NOT DOCUMENTED to be on dialysis is an off-label (non-FDA approved) use for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of hyperphosphatemia related to CKD in patients not on dialysis. In summary, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law for the diagnosis of hyperphosphatemia related to CKD in an enrollee not on dialysis, and the requested drug is excluded from coverage for the diagnosis of anemia related to CKD.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 Auryxia 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 Auryxia. 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 Myrbetriq ER for 2021 Plan year. 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Myrbetriq ER is a Tier 3 brand drug on the Plan's 2021 formulary. 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 Myrbetriq ER for 2021 Plan year.
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 Chlorzoxazone, 500 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 Chlorzoxazone.Chlorzoxazone is requested for ongoing treatment of the enrollee's condition. Regarding the diagnosis being treated with the requested drug, the box on the prior authorization form is checked for acute musculoskeletal pain; however the diagnosis code is stated to be G89.4 which corresponds to a diagnosis of chronic pain syndrome. Additionally, the prescriber has indicated that the enrollee has been stable on the requested drug since August 11, 2018. The prescriber has also indicated that Baclofen has been or would likely be ineffective for this enrollee. Additional information requested from the prescriber was not received.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. Additionally, it is unclear if the requested drug is being prescribed for a medically accepted indication (there are some chronic medical conditions that are medically accepted indications for the use of the requested drug).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 Chlorzoxazone, 500 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xiidra. 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 Xiidra. Xiidra is requested for treatment of keratoconjunctivitis sicca. The plan's denial letters state that Restasis is their preferred formulary drug. 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 Xiidra.
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 Tretinoin. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Tretinoin is one of those excluded drugs because it is a drug used for cosmetic purposes or to promote hair growth. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tretinoin. Therefore, the Plan is not required to cover Tretinoin. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Nystop powder. 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 Nystop powder 100,000 u/gm, 180 gm per 30 days. Nystop powder 100,000 u/gm, 180 gm per 30 days is requested to treat candidiasis unspecified. The Plan limits the amount of Nystop powder 100,000 u/gm to 60 gram per 30 days. The prescriber was asked questions to clarify the diagnosis being treated and to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.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 Nystop powder 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 Nystop powder. 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 Methylphenidate. 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 Methylphenidate ER 20 mg tablet. The drug is requested to treat depression. Methylphenidate ER 20 mg tablet is a generic drug on tier 2 of the Plan's formulary. There are no available lower tier generic 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 Methylphenidate.