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

You asked the Plan to cover Testosterone 1.62%. 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%. The drug is requested to treat male hypogonadism in an enrollee with a pituitary microadenoma, hypopituitarism and hypothyroidism. You clarified the medical history in the request for reconsideration. Medical records were provided. Laboratory reports were also provided with the appeal.Free testosterone level from date of service was 44.6 (ref range 46.0-224.0 pg/mL) Total testosterone level from date of service was 194 (ref range 250-1100 ng/dL) Free testosterone level from date of service was 33.3 (ref range 46.0-224.0 pg/mL)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 Testosterone 1.62%.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 Orbactiv. 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. Orbactiv 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 Orbactiv.
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 Xifaxan, 550 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 Xifaxan, 550 mg tablet.The drug is requested to treat irritable bowel syndrome with diarrhea. The enrollee does not satisfy the Plan's coverage criteria; the Xifaxan, 550 mg tablet is being dosed at three tablets daily for 5 days each month as a maintenance or preventive regimen which is not supported by the Plan's prior authorization 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 Xifaxan, 550 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sensipar, 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 Sensipar, 30 mg tablet. Sensipar, 30 mg is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, 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.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 the prescriber to determine whether the enrollee is using Sensipar, 30 mg tablet 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 Sensipar, 30 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.Please note: the request for a tiering exception (lower copayment) for Sensipar, 30 mg tablet was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xadago, 100 mg tablet, 30 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 Xadago, 100 mg tablet.The drug is requested to treat Parkinson's disease (as monotherapy - without levodopa/carbidopa therapy), 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 Xadago 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 Xadago. 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 Altera nebulizer system. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Altera nebulizer system has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Altera nebulizer system. This decision does not address the medical necessity or appropriateness of the requested item. 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 Tyvaso Starter Kit. 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 Tyvaso Starter Kit for the management of secondary pulmonary arterial hypertension. In this case, the record shows that Tyvaso Starter Kit is administered through a nebulizer in the home for a diagnosis of I27.21 secondary pulmonary arterial hypertension. 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 Tyvaso Starter Kit. 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 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 G89.29-Other chronic pain and M79.18-Myalgia, other site, 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 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: 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 Diltiazem HCL Powder Compound (made of Diltiazem HCL Powder, Aquaphor 1% Healing Ointment and Glycerin Liquid). The Plan did not grant this request. We received this case to conduct an independent review.Diltiazem HCL Powder, part of a compound:Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Diltiazem HCL Powder Compound (made of Diltiazem HCL Powder, Aquaphor 1% Healing Ointment and Glycerin Liquid). Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Diltiazem HCL Powder Compound (made of Diltiazem HCL Powder, Aquaphor 1% Healing Ointment and Glycerin Liquid).Aquaphor 1% Healing Ointment and Glycerin Liquid, parts of a compound: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, Aquaphor 1% Healing Ointment and Glycerin Liquid, parts of a compound are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit. This decision does not address the medical necessity or appropriateness 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 Tylex CD (Tylenol with Codeine) purchased in Mexico on November 5, 2020. The Plan did not grant this request. We received this case to conduct an independent review.Tylex CD (Tylenol with Codeine) is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Tylex CD (Tylenol with Codeine). This decision does not concern the medical appropriateness 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 Sildenafil. 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 Sildenafil. The drug is requested to treat erectile dysfunction. You submitted an additional diagnosis of pulmonary hypertension; however, chart notes do not support a diagnosis of pulmonary hypertension. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions for which the drug is not FDA approved, are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Sildenafil is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Sildenafil. Therefore, the Plan is not required to cover Sildenafil. 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 Nuplazid. 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 Nuplazid. The drug is requested to treat Alzheimer's disease psychosis, 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 Nuplazid 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 Nuplazid. 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 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 to treat hyperlipidemia in a statin intolerant enrollee with clinical atherosclerotic cardiovascular disease. The request is for continuation of therapy. Medical records were provided with the request for reconsideration:LDL-C on December 11, 2019 was 171 mg/dL. Prior to starting Repatha: LDL-C on July 7, 2020 was 167 mg/dL. On Repatha: LDL-C on November 4, 2020 was 106 mg/dL. Documentation was provided which substantiated a reduction in LDL level while on Repatha. 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 Repatha Sureclick 140 mg/ml.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Autologous Serum Tears. The Plan did not grant this request. We received this case to conduct an independent review.The case record indicates that Autologous Serum Tears contains your blood and Sodium Chloride solution. Medicare Part D does not cover drugs that are not FDA approved. Medicare rules state that only costs for the Part D drug components in a compound may be covered under Medicare Part D. In this case, blood serum is not a Part D drug because it is not an FDA approved drug product or biological. For that reason, it is not eligible for coverage under Medicare Part D. An exception to the Plan's formulary cannot be made to grant coverage for a drug that does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover blood serum used in Autologous Serum Tears. For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Sodium Chloride solution is used to dilute the blood serum in compounded Autologous Serum Tears. Sodium Chloride solution's use in this instance is not therapeutic. Thus, Sodium Chloride solution does not, as used, meet the definition of a Part D drug. Therefore, the Plan is not required to cover Sodium Chloride solution used in Autologous Serum Tears. Since the components of Autologous Serum Tears do not meet the definition of a Part D drug, the Plan does not have to cover this compound drug. This decision does not address the medical necessity or appropriateness of the requested compound 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 Norvasc purchased outside of the United States on November 5, 2020. The Plan did not grant this request. We received this case to conduct an independent review.Norvasc is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Norvasc. This decision does not concern the medical appropriateness 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 Oxycodone HCL ER, 20 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, 20 mg tablet.The drug is requested to treat pain associated with C44.612 Basal cell carcinoma of skin of right upper limb, including shoulder. The prescriber states the enrollee has adverse effects with Fentanyl patch and Morphine ER. 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, 20 mg tablet.