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

You asked the Plan to cover Ninlaro. 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 Ninlaro 4 mg. Ninlaro 4 mg is requested for use in combination with Dexamethasone for treatment of relapsed/progressive multiple myeloma in this 80 year old man who is not thought to be a candidate for bone marrow transplant, who has relapsed after Revlimid plus Dexamethasone, and had progressive disease with Velcade and Dexamethasone (10 cycles) and most recently with two cycles of Daratumumab, prior to moving and transferring care to the current prescriber. Detailed medical records have been submitted from the current treating oncologist which include medical records from the previous treating oncologist.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. NCCN (National Comprehensive Cancer Network) has a 2A recommendation for the use of Dexamethasone in combination with the requested drug for therapy of previously treated multiple myeloma with relapse/progressive disease. Additionally DRUGDEX has an orphan drug designation for the requested drug for the treatment of multiple myeloma without other requirements. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have 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 Ninlaro.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 reimbursement for the Naltrexone Compound. 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. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for the Naltrexone Compound. 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 or provide reimbursement for the Naltrexone CompoundThis 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 Zolpidem. 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 Zolpidem. The drug is requested to treat major depressive disorder, 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 Zolpidem 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 Zolpidem. 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 Zolpidem Tartrate. 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 Zolpidem Tartrate 5 mg. Zolpidem Tartrate 5 mg is requested to treat insomnia. There was insufficient documentation to substantiate that the requested drug is being used to treat the stated condition(s). The prescriber was asked questions to clarify the diagnosis being treated and/or to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. Supporting medical records were requested. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.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 Zolpidem Tartrate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Imbruvica 140 mg. 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. Imbruvica 140 mg 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 Imbruvica 140 mg.Your complaint regarding your confusion from the Plan in regards to reducing the dose is a grievance. A grievance is any complaint or dispute, other than one that involves a coverage determination or at-risk determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D plan. Grievance procedures are separate and distinct from appeal procedures. Medicare defines a coverage determination as (1) a decision not to provide or pay for a Part D drug, (2) failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee, (3) a decision concerning an exceptions request, or (4) a decision on the amount of cost-sharing for a drug. (42 CFR ??423.560, 423.564(b), 423.566(b)). Since your complaint involves a grievance, the Part D Plan must review this complaint under the Plan's grievance procedures. Each Part D Plan must provide meaningful procedures for timely hearing and resolving grievances between enrollees and the Part D Plan (or any other entity or individual through whom the Part D Plan provides covered benefits under any Part D Plan it offers). At this time, you should contact the Plan for information on how to proceed with having this complaint reviewed under the Plan's grievance procedures. 42 CFR Section 423.564(a).
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Harvoni. 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 Harvoni 90/400 mg. Harvoni 90/400 mg is requested for treatment of chronic hepatitis C, genotype 1a, in this enrollee without cirrhosis, who relapsed during an 8 week course of Mavyret (Glecaprevir/ Pibrentasvir), 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. Of note, you stated that Harvoni is the standard of care for this enrollee; however per the AASLD/IDSA (American Association for the Study of Liver Diseases/Infectious Disease Society of America) HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, Harvoni (Ledipasvir/ Sofosbuvir) is not a treatment option for Patients With Prior Glecaprevir/Pibrentasvir Treatment Failure (All Genotypes), With or Without Compensated Cirrhosis.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 Harvoni 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 Harvoni. 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 Paliperidone ER, 6 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 a tiering exception for Paliperidone ER 6 mg.The drug is requested to treat schizophrenia. The drug is a generic drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Paliperidone ER, 6 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Forteo 20 mcg/pen inj (2.4 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 Forteo 600 mcg/2.4 mL.The drug is requested to treat 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 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 Forteo 20 mcg/pen inj.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide neb sol. 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 Budesonide neb sol for the management of obstructive pulmonary disease. In this case, the record shows that Budesonide neb sol is administered through a nebulizer in the home for a diagnosis of J18.1 - Lobar pneuomonia. 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 Budesonide neb sol. 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 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%.Testosterone 1.62% is requested for ongoing treatment of hypogonadism of unstated cause in this 65 year old man. The medical records document two low free testosterone levels in the fall of 2018 (38.25, 39.34 - lower limit of normal 46.00) associated with erectile dysfunction, decreased libido and fatigue. Additional studies done at that time include normal LH (leutinizing hormone) and FSH (follicle stimulating hormone) levels consistent with secondary hypogonadism which can be seen with age related hypogonadism.The enrollee does not satisfy the Plan's coverage criteria as he does not have one of the Plan's approved diagnoses. 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 1.62%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica, 75 mg capsule. 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 Lyrica, 75 mg capsule.The drug is requested to treat brachial neuritis following vaccination, 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 Lyrica, 75 mg capsule 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 Lyrica, 75 mg capsule. 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 Dexamethasone Compound. 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. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Dexamethasone Compound. 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 Dexamethasone Compound. 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

You asked the Plan to cover Coenzyme Q10 Compound. 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 Coenzyme Q10 ingredient of the compound and determined from available resources that the drug is a non-prescription or OTC drug. Therefore, the Coenzyme Q10 ingredient of the compound is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that all other ingredients of the compound (Lipoic Acid, Alpha Lipoic Acid, L-Carnitine, 5-Methyltetr, D-Ribose and Acetylcysteine) are not FDA approved for both safety and effectiveness by checking FDA sources.Therefore, the Plan is not required to cover Coenzyme Q10 Compound. 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.