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

You asked the Plan to cover Testosterone. 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 Testosterone 1.62% gel. The drug is requested to treat primary hypogonadism/testicular failure due to cryptorchidism. The prescriber has not documented two morning serum testosterone levels (total or free) that are less than the reference range for the lab. 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 Testosterone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclophosphamide and Prednisone. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cyclophosphamide 25 mg capsule. The drug is requested to treat acquired factor VIII inhibitiondisorder in a non-hemophilic enrollee, which is an off-label (non-FDA approved) use. You stated that therequested drug is NOT being used after administration of IV Cyclophosphamide and IV Vincristine.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted condition.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Everolimus. 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 Everolimus. The drug is requested to treat kidney (renal) cancer. The enrollee is a 62 year old woman with metastatic renal cell cancer involving adrenal gland, nodes and retroperitoneum. She has been treated with surgery, radiation, Sunitinib, Nivolumab, Ipilumumab, and Pazopanib. She has progressive cancer in lymph nodes and is not eligible for a clinical trial. You request Everolimus to be given with Lenvatinib to treat her. The Plan has approved the brand name equivalent, Afinitor.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 Everolimus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mekinist. 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 Mekinist 0.5 mg, 120 per 30 days. The drug is requested to treat ovarian cancer, which is an off-label (non-FDA approved) use. The enrollee is a 64 year old woman with metastatic ovarian cancer involving pleura, peritoneum, nodes and soft tissue. She has been treated with pleurodesis, Carboplatin, Taxol, Doxil, Niraparib, Gemcitabine, Avastin, Topotecan and Pemetrexed. Her CA 125 has risen from 149 on 6/1/20 to 243 on 6/23/20. Her tumor has a BRCA2 mutation and and NF1 mutation. The prescriber requests Mekinist to be given with Lynparza to treat her. Journal articles were submitted and reviewed.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 Mekinist 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 Mekinist. 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 Prolia 60 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 a tiering exception for Prolia 60 mg/mL.The drug is requested to treat the enrollee's condition. The drug is a biologic drug on tier 4 of the Plan's formulary. There are no available lower tier biologic 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 Prolia 60 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Megestrol Acetate. 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 Megestrol Acetate 400 mg/10 mL oral solution. The drug is requested to treat failure to thrive/weight loss/protein calorie malnutrition (not related to cancer or AIDS), 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 Megestrol Acetate 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 Megestrol Acetate. 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 Estradiol. 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 Estradiol 10 mcg vaginal insert. The drug is requested to treat abnormal hormone levels and menopausal symptoms. 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 Estradiol.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Dificid 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 Plan was correct in denying the request for Dificid 200 mg tablet. Dificid 200 mg tablet is requested to treat Clostridium difficile (C. difficile) colitis with associated diarrhea. Additional medical information was requested by the Part D QIC. You were asked to clarify the diagnosis and address Step Therapy (ST) coverage criteria. The prescriber statement was returned. You documented a history of anaphylaxis to IV Vancomycin (possibly x2). You documented that we do not want to put patient's health at risk by trying Vancomycin again. Although oral administration of Vancomycin in patients with C. difficile infections do not usually result in systemic absorption, you have indicated why the Step 1 alternative required by the Plan (oral Vancomycin) would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reactions 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 step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception to step therapy rules 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 step therapy criteria are met. Therefore, the Plan is required to cover Dificid 200 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lenvima 10 mg daily dose, 60 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 Lenvima 10 mg daily dose (10mgx2); 60 per 30 days. The drug is requested to treat endometrial cancer.The enrollee is a 65 year old woman with metastatic endometrial cancer involving her peritoneum and lungs. She has been treated for metastatic disease with surgery, paracentesis, thoracentesis, Carboplatin/Paclitaxel, HIPEC (hyperthermic intraperitoneal chemotherapy), Doxil, Gemcitabine, and Avastin. Her recent CT scan showed progression in the lungs. In response to inquiry, the prescriber submitted the MMR report. Her tumor is not MMR deficient. The prescriber requests Lenvima to be given with Pembrolizumab to treat her.Per the FDA website, Lenvima in combination with Pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. The enrollee's cancer meets those criteria.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Lenvima for the diagnosed condition. As a result, Lenvima is being prescribed for a medically accepted indication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Lenvima.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycodone HCL ER, 30 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 Oxycodone HCL ER, 30 mg tablet.The drug is requested to treat chronic pain syndrome in an enrollee with osteoarthritis, low back pain and cervicalgia. The prescriber sent a statement on 8/6/2020 clarifying the medical history. Oxycodone HCL ER 30 mg is not on the Plan's formulary. Xtampza ER is on the Plan's formulary. The prescriber states Xtampza worked well, but he had an extremely high out of pocket cost even though it was covered. 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 Oxycodone HCL ER, 30 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prednisone. 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 Prednisone is needed for a Kidney transplant performed November 5, 2004. 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 Prednisone 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 Prednisone. 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

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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Prolia. The Plan did not grant this request. We received this case to conduct anindependent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Prolia. The drug is requested to treat postmenopausal osteoporosis (T-score -2.6). The enrollee does notsatisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/orhave not indicated why all alternatives required by the Plan would likely not be as effective for the enrolleeas the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician'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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Prolia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyvanse. 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 Vyvanse 10 mg capsule. The drug is requested to treat attention deficit hyperactivity disorder. Theenrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan'scoverage criteria and/or has not indicated why all alternatives required by the Plan (methylphenidate ER)would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adversereaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor priorauthorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Vyvanse.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Emgality, 120 mg/mL pen. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Emgality, 120 mg/mL pen.The drug is requested to treat chronic intermittent migraine headaches. The prescriber has not indicatedwhy all alternatives required by the Plan (Aimovig) would likely not be as effective for the enrollee as therequested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Emgality 120 mg/mL pen.