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

You asked the Plan to cover Albuterol Sulfate Solution. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Albuterol Sulfate Solution for the management of obstructive pulmonary disease. In this case, the record shows that Albuterol Sulfate Solution is administered through a nebulizer in the home for a diagnosis of J44.0 Chronic obstructive pulmonary disease with acute lower respiratory infection. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Albuterol Sulfate Solution.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 Vraylar. The Plan did not grant this request. Wereceived 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 thespecialty tier are not eligible for a tiering exception. Vraylar is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Vraylar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Metaxalone. 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 Metaxalone. The drug is requested to treat chronic cervical and lumbar intervertebral disc degeneration (ICD-10 M51.36), 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 Metaxalone 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 Metaxalone. 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 Mycophenolate Mofetil. 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 Mycophenolate Mofetil. The drug is requested to treat retinal vasculitis, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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 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 Symbicort. The drug is requested to treat chronic respiratory failure due to interstitial lung disease and sarcoidosis of the lung, 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 Symbicort 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 Symbicort. 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 Corlanor 5 mg. 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 Corlanor 5 mg. The drug is requested to treat chronic heart failure (NYHA Class II) in an enrollee with an ejection fraction of 20-25% and heart rate of 97 beats per minute (sinus rhythm).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. Please note that in the Reconsideration appeal the prescriber corrected their earlier answers and stated that the enrollee does NOT have acute decompensated heart failure and that the enrollee is NOT exclusively pacemaker dependent. Supporting medical records were also provided. Therefore, the requested drug is being prescribed for a medically accepted indication and 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 Corlanor 5 mg for the diagnosed condition. As a result, Corlanor 5 mg 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 Corlanor 5 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 newinformation 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 Ipratropium Albuterol Solution. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Ipratropium Albuterol Solution for the management of obstructive pulmonary disease. In this case, the record shows that Ipratropium Albuterol Solution is administered through a nebulizer in the home for a diagnosis of J44.9 Chronic obstructive pulmonary disease, unspecified. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium Albuterol Solution.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 Cyclosporine. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare PartA at the time of the organ transplant.The case record indicates that Cyclosporine is needed for a Kidney transplant performed January 22, 1999.According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part Acoverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant andCyclosporine is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverageare excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is notrequired to cover Cyclosporine.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes 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 Lidocaine 5% 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 Lidocaine 5% Patch. The drug is requested to treat osteoarthritis of the left ankle and foot, complex regional pain syndrome with reflex sympathetic dystrophy of the lower limb and paresthesias of the skin, which are all off-label (non-FDA approved) uses. Relevant medical records were requested and not provided. 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 Lidocaine 5% Patch 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 Lidocaine 5% Patch. 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 Nulojix . 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 Nulojix 250 mg. The drug is requested for the prophylaxis of organ rejection in an enrollee with a renal transplant. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA. The Medicare Part B rules state thatparenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting, and therefore will be denied under Medicare Part B as not medically necessary when provided in that setting. The case record indicates that Nulojix will be administered in the home. Nulojix would therefore not be eligible for coverage under Medicare Part B in this case. Thus, Nulojix may be eligible for coverage under Medicare Part D. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met, including addressing safety concerns.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, as detailed above. Therefore, our decision is the Plan is required to cover Nulojix 250 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 provide additional reimbursement for Menactra Vaccine and its administration fee received 8/2/19 and 9/17/19 at your provider's office. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. The Plan submitted documentation showing that they approved coverage. They calculated reimbursement based on the total cost of the drug, less your required copayment amount, and less the difference between what the Plan normally pays for the drug and what the out-of-network pharmacy (i.e., hospital or provider's office) charged you. The case record indicates that the Plan provided coverage and reimbursement in accordance with the Part D Plan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provide an additional reimbursement for Menactra Vaccine and its administration fee received 8/2/19 and 9/17/19 at your provider's office.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover NP Thyroid. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that NP Thyroid is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover NP Thyroid. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Nicotine 14 mg/24 hr patch. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Nicotine 14 mg/24 hr patch is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hizentra. 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 the rental or purchase of DME if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. Medicare Part B local policy states that an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. In this case, Hizentra is being administered via external infusion pump in the home, and is being used for ICD-10 diagnosis code D80.5 Immunodeficiency with increased immunoglobulin M [IgM]. This diagnosis is eligible for coverage under Medicare Part B. Thus, Hizentra as prescribed and administered in this case appears to be eligible for Part B coverage. 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 coverHizentra. 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.