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

You asked the Plan to cover Rubraca, 300 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 Rubraca, 300 mg tablet; 120/30.   The drug is requested to treat uterine cancer, which is an off-label (non-FDA approved) use. The enrollee is a 72 year old woman with metastatic endometrioid uterine cancer involving the peritoneum and abdominal wall. She has had multiple surgeries, radiation, Carboplatin/Paclitaxel, Tamoxifen, and Doxil. The October 13, 2020 office note indicates she has had progression of the cancer on CT scan. Foundation One CDx testing identified an ATM mutation suggesting possible response to Rubraca (Rucaparib.) Options including weekly Taxotere and Keytruda with Lenvima were discussed. The prescriber requests Rubraca to treat her.  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 Rubraca, 300 mg tablet for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Rubraca, 300 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Paricalcitol. The Plan did not grant this request. We received this case to conduct an independent review.   In this case, the Plan denied coverage of Paricalcitol as covered under Medicare Part B. Research and records provided on request show the enrollee is not on dialysis. Therefore, Paricalcitol is determined to be a Medicare Part D drug. We sent this to our Physician Reviewer to determine if criteria was met for coverage under Medicare Part D. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Paricalcitol 1 mcg capsule. The drug is requested to treat secondary hyperparathyroidism related to stage 3 chronic kidney disease. Research shows that the enrollee is not on dialysis. 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 Paricalcitol.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Prolia 60 mg/mL as prescribed. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Prolia 60 mg/mL.   Prolia 60 mg/mL is requested to treat male osteoporosis/steroid induced osteoporosis. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan?s prior authorization criteria.   The prescriber states that the enrollee cannot take bisphosphonates due to chronic kidney disease and need for concomitant nephrotoxic medications including Tacrolimus for a lung transplant. The enrollee does not satisfy the Plan's coverage criteria.   The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Prolia 60 mg/mL as prescribed.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Tacrolimus. Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the enrollee was entitled to Medicare Part A at the time of the transplant and therefore the requested drug is eligible for coverage under Medicare Part B, not Part D. We reopened this case to address the Plan's argument.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 Tacrolimus is needed for a kidney transplant performed October 16, 1993. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage from January 1, 1993 through October 31, 1996, August 1, 1999 through February 29, 2008, and again from October 1 2014 through the present. Since the enrollee was entitled to Medicare Part A at the time of the transplant, the transplant is considered a Medicare covered transplant and Tacrolimus 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 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.This decision reverses our previous favorable decision.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Azathioprine and Astagraf XL. Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the enrollee was entitled to Medicare Part A at the time of the transplant and therefore the requested drug is eligible for coverage under Medicare Part B, not Part D. We reopened this case to address the Plan's argument.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 Azathioprine and Astagraf XL is needed for a kidney transplant performed February 10, 2014. 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 Azathioprine and Astagraf XL 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 Azathioprine and Astagraf XL.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.This decision reverses our previous favorable decision.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Tacrolimus. Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the enrollee was entitled to Medicare Part A at the time of the transplant and therefore the requested drug is eligible for coverage under Medicare Part B, not Part D. We reopened this case to address the Plan's argument.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 Tacrolimus is needed for a kidney transplant performed October 3, 2012. 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 Tacrolimus 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 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.This decision reverses our previous favorable decision.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Venclexta Starting pack as prescribed. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Venclexta starting pack.   Venclexta is requested to treat mantle cell lymphoma. The enrollee is a 70 year old man with mantle cell lymphoma. He has been treated with R-hyperCVAD/M/ara-C (Rituxan, Cytoxan, Vincristine, Doxorubicin, Dexamethasone, Methotrexate, Ara-C) and had complete remission. He had biopsy confirmed relapse in September 24, 2020. The prescriber requests Venclexta to be given with Acalabrutininb on a clinical trial: NCT03946878. The trial is sponsored by the M. D. Anderson Cancer Center, an NCCN institution with the collaboration of the NCI. The enrollee has signed consent on October 19, 2020. Per DrugDex, Venclexta has Orphan drug designation: Treatment of mantle cell lymphoma. The information does not specify monotherapy or any specific combination. Because the drug is part of an NCI sponsored trial it is covered by Medicare Part D. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Venclexta Starting pack as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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 Cresemba 186 mg capsule. The drug is requested to treat cryptococcus infection, 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 Cresemba 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 Cresemba. 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

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 Invokana, 300 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 Invokana, 300 mg tablet.  The drug is requested to treat diabetes mellitus type 2. The prescriber has not indicated why at least 2 formulary alternatives required by the Plan (Farxiga 5 mg,10 mg; Jardiance 10 mg,25 mg) 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 Invokana, 300 mg tablet.
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 Sirolimus, 2 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 Sirolimus, 2 mg tablet.   The drug is requested to treat coronary artery disease/stent closure, 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 Sirolimus, 2 mg tablet for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Sirolimus, 2 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nuedexta, 20-10 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.   We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Nuedexta, 20-10 mg capsule which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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 Nuedexta, 20-10 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Atovaquone. 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. Atovaquone 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 Atovaquone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem Tartrate. The Plan did not grant this request. We received this case to conduct an independent review.   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 needed additional information from you to determine whether the enrollee is using Zolpidem Tartrate for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Zolpidem Tartrate.  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.