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

You asked the Plan to cover Ibandronate. 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 Ibandronate 3 mg/3 mL. Ibandronate 3 mg/3 mL is requested for treatment of osteoporosis. The plan's redetermination denial letter states that that Calcitonin nasal spray and Forteo are on their formulary. The prescriber has indicated that the enrollee had gastrointestinal problems with oral bisphosphonates, and an allergic reaction to Prolia. 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 Ibandronate.
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 provide a tiering exception for Levothyroxine. 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 Levothyroxine. Levothyroxine is requested to treat the enrollee's condition. Levothyroxine is on tier 2 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 Levothyroxine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Shingrix. 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 Shingrix. The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand 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 Shingrix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine, 5 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 Buprenorphine, 5 mcg patch.The drug is requested to treat lumbago with sciatica unspecified side/chronic pain. 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 Buprenorphine, 5 mcg/hr patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tymlos, 80 mcg dose pen injector. 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 Tymlos, 80 mcg dose pen.Tymlos, 80 mcg dose pen is requested for treatment of age related osteoporosis; bone mineral density T-score is extremely low at -5.6. The Plan's denial letters state that Forteo is on their formulary. The prescriber states that the enrollee is unable to tolerate oral bisphosphonates due to GERD (gastroesophageal reflux disease), she has tried and failed Prolia in the past, and that the enrollee has been treated with Tymlos since July 23, 2020. 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 Tymlos, 80 mcg dose pen injector.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imatinib Mesylate. 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 Imatinib mesylate 100 mg; 180/30. The drug is requested to treat chronic myelogenous leukemia (CML). The enrollee is a 77 year old woman with CML since 2009.She was treated with Gleevec (Imatinib mesylate) with varying doses from 2009 to 2018. The doses were adjusted down initially due to pancytopenia then increased to 600 mg/day as her bcr-abl levels rose. In 2018 due to headaches, swelling, anorexia and aspiration, she was switched to Dasatinib. Her bcr-abl was 12.5% and CBC normal except for mild anemia so she remained on Dasatinib until 8/2019 when her bcr-abl rose to 17.5% and she was anemic, hemoglobin 10.4. She was switched to Nilotinib. Her hemoglobin normalized at 12.1 but the bcr-abl rose to 22.5%. The dose of Nilotinib was increased and her bcr-abl rose to 32.5 and hemoglobin 11.5.The prescriber requests Imatinib mesylate to treat her now.The documentation indicates the enrollee had progression of her CML on Dasatinib and Nilotinib, both tyrosine kinase inhibitors (TKIs). Therefore the requested use does not meet the plan's prior authorization criteria. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met. .Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Imatinib Mesylate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem 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 ER. Zolpidem ER is requested to treat insomnia, which the prescriber states is required for treatment of both sleep onset as well as sleep maintenance insomnia. The prescriber has indicated that the enrollee has failed immediate release Zolpidem. The Plan has indicated in their denial letter that Belsomra is on their 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 Zolpidem ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil and Tacrolimus. 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 Mofetil and Tacrolimus are needed for a kidney transplant performed September 19, 2001. 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 Mofetil and Tacrolimus are eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part B coverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Thus, Mycophenolate Mofetil and Tacrolimus are not considered a Part D drug in this case. Therefore, our decision is the Part D Plan is not required to cover Mycophenolate Mofetil and Tacrolimus. 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 Zestril. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Zestril is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Zestril.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Codeine Sulfate. 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 Codeine Sulfate 30 mg tablet. The drug is requested to treat postsurgical malabsorption/short bowel syndrome/diarrhea, 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 Codeine Sulfate 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 Codeine Sulfate. 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 Tabrecta, 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 Tabrecta, 200 mg; 112/28.The drug is requested to treat lung cancer. The enrollee is a 72 year old woman with metastatic non-small cell lung cancer (NSCLC) involving bones, adrenal gland,and pleural effusion. She has been treated with radiation, Keytruda, Crizotinib, and Taxotere/Carboplatin, Tempus next generation sequencing (NGS) showed MET p.T006fs exon 14 deletion.Genpath Onkosight NGS showed MET p.7 alteration.The prescriber requests Tabrecta to treat her.The prescriber states that FoundationOne CDx can be ordered.The prior authorization criteria require FDA approved use which requires the FDA approved test to determine MET exon 14 skipping alteration.Per the FDA website the FDA approved test is FoundationOne CDx.Neither of the tests performed on the enrollee's tumor was that test. Therefore the requested use does not meet the Plan's prior authorization criteria.The prescriber indicates that the FDA test can be ordered.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Tabrecta, 200 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Clonazepam 2 mg, 90 per 90 days. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within the specified timeframes. If the Plan does not make a timely decision, this is considered a denial. In these circumstances, the Plan is required to forward the coverage request or the redetermination request to the Part D QIC. The case record indicates multiple requests were submitted to the Plan for a 90 day supply (not a 180 day supply). The Plan did not properly process these requests to move the case forward to the next appeal level. Therefore, the applicable time frames have been exceeded, and the Part D QIC has jurisdiction to process this case.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Clonazepam 2 mg, 90 per 90 days. Clonazepam 2 mg, 90 tablets per 90 days is requested for ongoing treatment of the enrollee's sleep disorder. The Plan has indicated that they have a 30 day dispensing limit for the requested drug. Per correspondence dated April 21, 2020, CMS (The Centers for Medicare and Medicaid Services) has issued the following guidance in response to the public health emergency posed by COVID-19: Part D sponsors must suspend all quantity and days' supply limits under 90 days for all covered Part D drugs (as defined in 42 CFR 423.100) other than such limits resulting from safety edits. Although it is reasonable to implement a dispensing limit for safety reasons for benzodiazepines, it is noted that the enrollee is stable on the requested medication, and the prescriber has specifically stated that because the enrollee is on so many medications, it is difficult for her to keep track of her medications and call each month for a refill. As such, an exception to the plan's 30 day supply limit is warranted. Our Physician Reviewer's opinion is that quantity limit exception criteria are 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 met. Therefore, the Plan is required to cover the requested quantity of Clonazepam 2 mg, 90 per 90 days.
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 a tiering exception for Trelegy Ellipta. The Plan did not grant this request. We received this case to conduct an independent review.However, according to the documentation provided by the Plan, the enrollee is in the Coverage Gap Stage of the enrollee's benefit. It is noted that the tiering exception process is limited to the Initial Coverage Stage and since the enrollee is in the Coverage Gap Stage, the enrollee's covered drugs are not eligible for tiering exceptions. Therefore, our decision is the Plan is not required to provide a tiering exception for Trelegy Ellipta while the enrollee is in the Coverage Gap Stage of the enrollee's benefit. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if an exception 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 Methazolamide. 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 Methazolamide. The drug is requested to treat the enrollee's condition. The drug is a generic drug on tier 3 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 Methazolamide.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Spravato. 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 Parts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to the service of a physician (or other practitioner). We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested confirmation of how and where this drug is supplied and billed. A response to our request was received. However, Spravato is a type of drug that is not usually self-administered. 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 Spravato is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Spravato. 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.Please contact the Plan for more information regarding coverage of Spravato under the Part B benefit.