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

You asked the Plan to cover Nubeqa. 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 Nubeqa. The drug is requested to treat metastatic prostate cancer, which is an off-label (non-FDA approved) use.The enrollee is a 74-year-old man with metastatic prostate cancer involving bones. He has had bone biopsy confirming the diagnosis. He has been treated with Lupron, Abiraterone/Prednisone, and Xtandi. He has neurocognitive side effects of fatigue and mental changes from Xtandi so the drug was stopped. The prescriber requests Nubeqa to treat him. The prescriber states the drug does not cross the blood-brain barrier and would cause less neurological side effects than Xtandi and would be better tolerated.Nubeqa is indicated in non-metastatic castration resistant prostate cancer. The enrollee has metastatic castration resistant prostate cancer. Therefore, he does not meet a medically accepted indication.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Nubeqa 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 Nubeqa. 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 Otezla 28 day starter pack. 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 Otezla 28 day starter pack.The drug is requested to treat psoriasis vulgaris. 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 Otezla 28 day starter pack.
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 Budesonide . The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Budesonide for the management of obstructive pulmonary disease. We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Budesonide has been prescribed, and confirmation of where this drug is being administered. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Budesonide is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Budesonide. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ursodiol 500 mg tablets. 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 Urosodiol 500 mg tablet. The drug is requested to treat primary biliary cirrhosis. The drug is on Tier 4 of the Plan's formulary. There are no available lower tier 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 Ursodiol 500 mg tablets. Please note, you may wish to request a tiering exception for Urosodiol capsules from the Medicare Part D Plan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Temazepam 15 mg, 90 per 90 days. 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 quantity of Temazepam requested. Our Physician Reviewer needed additional information from you to make this determination. We asked you to address why it is medically necessary for the enrollee to have a greater quantity than that allowed by the Plan. The requested information was not received. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria for Temazepam is 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 Temazepam 15 mg, 90 per 90 days.
Appeal type: Prescription Drug
Decision: Favorable

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 is requested for ongoing treatment of hypercholesterolemia, well documented coronary artery disease, and hypertension. The prescriber stated that the enrollee had a history of intolerance to most statins and Ezetimibe. The prescriber has provided documentation in the medical records that the patient had separate trials of Atorvastatin and Rosuvastatin, which resulted in myalgias that resolved with discontinuation of the statin. Additionally, the prescriber has provided documentation that the enrollee has responded to Repatha with decreased LDL to goal. 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 Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT. The drug is requested to treat nausea due to cardiac medication, 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 Ondansetron ODT 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 Ondansetron ODT. 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 Hydrocortisone compound. 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 Hydrocortisone compound is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Hydrocortisone compound. 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 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. The drug is requested to treat hyperlipidemia and coronary artery disease. Praluent is available on the Plan's formulary. The prescriber has not indicated why this alternative 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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified time frame. 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 Mycophenolate . The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. The case record indicates that Mycophenolate is needed for a Kidney transplant performed June 8, 1998. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Mycophenolate is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Mycophenolate. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified time frame. 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 provide reimbursement for the Shingrix vaccine received August 16, 2019 from the clinic. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers certain vaccines purchased and/or administered out-of-network. If an enrollee receives a vaccine from an out-of-network provider, the enrollee will generally have to pay the full cost for the vaccine. The enrollee may then submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. In this case, the record shows that you were administered the Shingrix vaccine received August 16, 2019 from the clinic. You submitted a request for reimbursement however, the record does not include proof of payment in full for the vaccine. Additionally, a representative verified that the cost of the vaccine has not yet been paid for as of January 15, 2020. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for the Shingrix vaccine received August 16, 2019 from the clinic at this time.Please note: once you have paid the remaining balance of the vaccine and its administration fee, you may wish to obtain a statement showing a zero balance and submit that to the Plan as proof of payment. Until proof of payment is established, the Plan will not process the claims or provide reimbursement.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Avonex. The Plan did not grant this request. We received 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 the specialty tier are not eligible for a tiering exception. Avonex is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Avonex.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for the Shingrix vaccine received September 30, 2019 from the health department. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. In this case, documentation in the record shows that the enrollee was in the deductible stage when the Shingrix vaccine was purchased on September 30, 2019 from the health department. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2019 before the Plan would pay a share of the cost. The Shingrix vaccine was on the Plan's 2019 formulary and was classified as a Tier 4 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of the coverage determination, and that the full cost of the purchase in dispute was applied to the required deductible amount. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for the Shingrix vaccine received September 30, 2019 from the health department.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dextroamphetamine-Amphetamine 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 Dextroamphetamine-Amphetamine ER. The drug is requested to treat attention deficit hyperactivity disorder. 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 Dextroamphetamine-Amphetamine ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gralise. 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 Gralise. The drug is requested to treat unspecified neuropathic pain, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. You state the requested drug is notbeing prescribed for the treatment of postherpetic neuralgia. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Gralise for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Gralise.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 Sildenafil 25 mg. 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. Sildenafil 25 mg is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction or it is a sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. The record submitted by the Plan does not indicate that they provide supplemental coverage for Sildenafil 25 mg. Therefore, the Plan is not required to cover Sildenafil 25 mg. 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.