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

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Hydroxychloroquine Sulfate. Our Physician Reviewer determined that criteria for coverage were not met. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Hydroxychloroquine Sulfate 200 mg tablet. Hydroxychloroquine Sulfate is requested to treat polymyalgia rheumatica, which is an off-label (non-FDA approved) use. The Plan asked the prescriber to state the diagnosis for which the drug was prescriber. The prescriber wrote, Polymyalgia rheumatica.  With the appeal to the Plan the prescriber submitted the additional diagnosis of M06.4, Inflammatory polyarthropathy. In the Reconsideration appeal the prescriber changed the diagnosis and stated that the enrollee has Rheumatoid arthritis and changed the diagnosis to M06.09 - Rheumatoid arthritis without rheumatoid factor, multiple sites. The submitted medical records state, I do not see a prominent link at this stage with any inflammatory arthritis. She certainly seems to have a generalized hypertrophic osteoarthritis picture. The submitted medical record also states that the reason for the enrollee's visit was, Follow up of Polymyalgia Rheumatica. 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(s). 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(s).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 Hydroxychloroquine 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 Hydroxychloroquine 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.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously requested additional information from the prescriber to determine whether the Plan's criteria for coverage for Stelara were satisfied. We did not receive all the necessary information from the prescriber. As a result, we issued an unfavorable reconsideration decision. We subsequently received the additional information previously requested from the prescriber. We reopened this appeal to conduct a second review with the additional information.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Stelara 45 mg/0.5 ml injection. Stelara 45 mg/0.5 ml injection is requested to treat psoriatic arthritis. Upon the reopening request, the prescriber statement was returned. The prescriber stated that the enrollee has tried and failed Remicade. However, the prescriber stated that the enrollee has not had a trial and failure, or had a contraindication or intolerance to, Cosentyx (secukinumab) and Humira (adalimumab). 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 Stelara.This decision affirms our previous unfavorable decision.
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. The drug is requested for continued treatment of hyperlipidemia in this enrollee with atherosclerotic cardiovascular disease (ASCVD), peripheral arterial disease, s/p cerebrovascular accident (CVA), hypertrophic cardiomyopathy, and statin intolerance. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address cholesterol levels and prior authorization coverage criteria. The prescriber statement was returned. The enrollee satisfies the Plan's coverage criteria. The physician prescribed the requested drug. The LDL-C of 48 mg/dl was documented.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.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Symbicort. 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 Symbicort. The drug is requested to treat asthma. The drug is 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 Symbicort.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Northera. 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 Northera. The drug is requested to treat orthostatic hypotension in the absence of confirmed primary autonomic failure, dopamine beta-hydroxylase deficiency, or nondiabetic autonomic neuropathy, 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 Northera 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 Northera.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 Testosterone 1.62% Gel. 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. Testosterone 1.62% Gel is requested to treat hypogonadism in this 81 year old male who has a free testosterone level of 42, just below the lower limit of normal of 45 for the testing laboratory. You initially stated that the enrollee has testicular hypogonadism of unstated cause; however has changed the diagnosis to acquired secondary hypogonadism, when notified that the LH/FSH values were not consistent with the diagnosis of primary hypogonadism. You were asked additional information; however you have not provided a statement in response to the questions asked. The etiology of the enrollee's hypogonadism is not stated, and there is insufficient documentation that the enrollee does not simply have age related hypogonadism. Based on the information provided, there is insufficient documentation that testosterone is 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 Testosterone 1.62% Gel 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 Testosterone 1.62% Gel. 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 Calcitriol. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs. In this case, Calcitriol is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. In the appeal request, the prescriber indicated that the enrollee is not on dialysis, however, the official CMS (Centers for Medicare & Medicaid Services) record shows that the enrollee is currently receiving dialysis. Calcitriol is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Calcitriol. 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: 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 Mycophenolate 250 mg and Tacrolimus 1 mg. 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 250 mg and Tacrolimus 1 mg are needed for a kidney transplant. According to Medicare enrollment records, the enrollee was not determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is not considered a Medicare covered transplant and Mycophenolate 250 mg and Tacrolimus 1 mg are eligible 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 Mycophenolate 250 mg and Tacrolimus 1 mg. The drugs are requested to treat kidney transplant. There is no evidence that the enrollee was entitled to Medicare at the time of the transplant; therefore, the requested drugs are not eligible for coverage under Part B. There are no applicable utilization management criteria identified for coverage of the drugs. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drugs have been met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Mycophenolate 250 mg and Tacrolimus 1 mg are on the Plan's formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover Mycophenolate 250 mg and Tacrolimus 1 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover 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 Tacrolimus is needed for a kidney transplant. 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. 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, Tacrolimus is not considered a Part D drug in this case. Therefore, our decision is the 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.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine HCL. 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 Cyclobenzaprine HCL The drug is requested to treat chronic pain and spasms in lumbar spine due to low bone mass and osteoporosis, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Cyclobenzaprine HCL for the diagnosed conditions. 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 these conditions. 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 Cyclobenzaprine HCL. 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.