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

You asked the Plan to provide a tiering exception for Yuvafem. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Yuvafem is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Yuvafem.We are dismissing the request for Vivelle-Dot. You requested an appeal of the Plan's unfavorable determination for coverage of Vivelle-Dot. Medicare rules do not allow us to review this case until you have completed all levels of appeal with the Plan.Medicare rules set forth the steps you must take when appealing a Part D Plan's denial of coverage. If you do not agree with a coverage decision from the Plan, you must request that the Plan review this decision, and the Plan must issue a Coverage Determination. If you do not agree with the Plan's Coverage Determination, the next step is for you to request a Redetermination appeal from the Plan. The request for a Redetermination asks the Plan to reconsider the initial Coverage Determination. Both levels of appeal with the Plan must be completed before you can appeal to us. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination for Vivelle-Dot.
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 Humira Pen 40 mg/0.8 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 Humira Pen 40 mg/0.8 ml. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Humira Pen 40 mg/0.8 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover the Silver Sulfa-Aquaphor-Hydrocortisone 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 Aquaphor and Hydrocortisone classification or determined from other available resources that the drugs are non-prescription or OTC drugs. Therefore, the Aquaphor and Hydrocortisone ingredients of the Silver Sulfa-Aquaphor-Hydrocortisone 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 that payment cannot be made under the Medicare Part D benefit.Please note: the Plan provided documentation that the Silver Sulfadiazine ingredients of the compound has been approved. The decision above does not affect the Plan's approval of the Silver Sulfadiazine ingredient. You may wish to contact the Plan to verify how and when the Silver Sulfadiazine ingredient of the compound will be covered.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover GenTeal Severe Gel. 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, GenTeal Severe Gel 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 Lidoderm . 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 the prescriber to determine whether the enrollee is using Lidoderm 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 Lidoderm. 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 reimbursement for Symbicort 80-4.5 mcg. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Symbicort 80-4.5 mcg was purchased, the claim straddled both the deductible stage and the initial coverage stage of the Part D benefit. An enrollee is responsible for the full cost of covered drugs until the deductible amount $435 is satisfied. The initial coverage phase requires a $141 amount for this drug and day supply purchased. The Plan documentation also shows that there was $435 remaining in the deductible phase of coverage. This amount is subtracted from the total cost of the drug. This left a remaining total drug cost owed of $549.97. This remaining balance was subject to the initial coverage stage copayment amount of $141. The total of the two figures owed during each benefit phase (deductible and initial coverage) is $576. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Symbicort 80-4.5 mcg was applied to your yearly true out-of-pocket (TrOOP) costs. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Symbicort 80-4.5 mcg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dexcom G6 Transmitter and Receiver. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Dexcom G6 Transmitter and Receiver have 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 Dexcom G6 Transmitter and Receiver. 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.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 Restasis 0.05% Droperette. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Restasis 0.05% Droperette is a Tier 2 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Restasis 0.05% Droperette.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT 4 mg.Ondansetron ODT 4 mg is requested for treatment of nausea and vomiting associated with gastroesophageal reflux disease, which is an off-label (non-FDA approved) use. The prescriber states that alternative treatment was ineffective or not tolerated; however 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 Ondansetron ODT 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 Ondansetron ODT. 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

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 and provide reimbursement for Hydrocodone Acetaminophen 5/325 mg received while you were a patient at the hospital. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, the record shows you were a patient at the hospital. You received Hydrocodone Acetaminophen 5/325 mg for a medical emergency or urgent care. You submitted a request for reimbursement with a copy of the hospital bill and proof of payment. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to process applicable reimbursement for Hydrocodone Acetaminophen 5/325 mg received while you were a patient at the hospital.Information in the case record indicates that you were an outpatient at Cone Health when you received this drug. As such, you were not in a position to obtain the drug that had been previously filled at a network pharmacy, nor were you able to obtain prior authorization or off-formulary exception review. Since this was a one-time emergency stay, the Plan should provide an exception to their normal coverage rules.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 Budesonide Suspension. 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 Suspension for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide Suspension is administered through a nebulizer in the home for a diagnosis of J44.9 Chronic obstructive pulmonary disease. 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 Suspension. 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

You asked the Plan to cover Carisoprodol, 350 mg tablet 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 Carisoprodol, 350 mg.Carisoprodol, 350 mg is requested for ongoing use for treatment of ICD 10 code M62.838 - Other muscle spasm which is associated with chronic neck and low back pain due to disc degeneration, and chronic knee pain. It is noted that the enrollee has been maintained on a combination of opioids and the requested drug. 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. Drugdex has the following citations in the comparative efficacy section their Carisoprodol monograph: 1) Carisoprodol and chlorphenesin carbamate were superior to methocarbamol in the relief of chronic moderate to severe pain for 50 elderly patients, 2) Carisoprodol was superior to propoxyphene in improving range of movement, but approximately equivalent to propoxyphene in improving sleep in a placebo-controlled study involving 94 patients with pain due to muscle spasm and/or stiffness associated with acute or chronic low-back syndrome. This study concluded that Both drugs were superior to placebo. Therefore, the requested drug is being prescribed for a medically accepted indication. 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 Carisoprodol, 350 mg tablet as prescribed.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: Favorable

You asked the Plan to cover Sirturo. 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 Sirturo.Sirturo is requested for treatment of a persistent, drug-resistant, Mycobacterium avium complex (MAC) lung infection. You have indicated that aggressive treatment with multiple drugs have been unsuccessful, and that the enrollee is clinically deteriorating. You have included medical references that support the use of the requested drug for treatment of the enrollee's condition, and have discussed why Sirturo is likely to be helpful for this enrollee. 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. Drugdex states the following in the Adult Dosing Section of the monograph for the requested drug (Quick Answers view only): Orphan drug designation: Treatment of Nontuberculosis Mycobacteria infection. Therefore therequested drug is being prescribed for a medically accepted indication as defined by Medicare. 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 Sirturo.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 Rituxan. 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 services and supplies incident to the service of a physician (or other practitioner). In this case, the record reflects that Rituxan will be supplied from physician and/or office stock supply, and will be billed as part of a physician service. Rituxan is a type of drug that is not usually self-administered. As a result, the drug as administered in this case appears to be eligible for coverage under Medicare Part B. 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 Rituxan. 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.Please contact the Plan for more information regarding coverage of Rituxan under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Esomeprazole Magnesium DR. 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 the prescriber to determine whether the enrollee is using Esomeprazole Magnesium DR 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 Esomeprazole Magnesium DR. 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.