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

You asked the Plan to cover Temazepam 15 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 Temazepam. The drug is requested to treat insomnia on a chronic basis. 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 cites the following guidelines in the FDA Uses section of the Temazepam monograph in the discussion about the use of Temazepam to treat insomnia: Sateia MJ, Buysse DJ, Krystal AD, et al: Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med 2017; 13(2):307-349 - which includes Temazepam as an option for treatment of chronic insomnia. Therefore, the requested drug is being prescribed for a medically accepted indication.Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. The prescriber states that the enrollee tried and failed treatment with Trazodone and Doxepin, which both caused dry mouth. 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 Temazepam 15 mg for the diagnosed condition. As a result, Temazepam 15 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 Temazepam 15 mg
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Uloric, 40 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 Uloric, 40 mg tablet.The drug is requested to treat gout. Upon reconsideration, the prescribing physician states that the enrollee has tried and failed treatment with Allopurinol and generic Febuxostat. 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 formulary exception criteria are 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 met. Therefore, the Plan is required to cover Uloric, 40 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nexium DR. 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 Nexium DR. The drug is requested to treat gastroesophageal reflux disease. The prescriber has not indicated why all alternatives required by the Plan (including generic equivalent Esomeprazole) 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 Nexium DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. 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. The drug is requested to treat hyperlipidemia in a patient with atherosclerotic cardiovascular disease (ASCVD), history of chest pain, bilateral carotid artery stenosis and occlusion, and statin intolerance. You have not indicated why all alternatives required by the Plan (Praluent) 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Eliquis. 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 Eliquis 5 mg. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Eliquis.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Venclexta 100 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 Venclexta100 mg. The drug is requested to treat myelodysplastic syndrome (MDS). The enrollee is a 65 year old man with high risk MDS diagnosed in 2019. He was treated with Decitabine followed by stem cell transplant followed by Azacitadine. He now has increasing marrow blasts to 7% and increased dysplasia. You request Venclexta to be given with Decitabine to treat him. Per Drug-dex, Venclexta has orphan drug designation: treatment of myelodysplastic syndromes. Per CMS, orphan drug status indicates a medically accepted indication.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. Therefore, the requested drug is being prescribed for a medically accepted indication. 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 Venclexta 100 mg tablet for the diagnosed condition. As a result, Venclexta 100 mg tablet 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 Venclexta 100 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron HCL. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ondansetron HCL Liquid 4 mg/5 mL. The drug is requested for the prevention of aspiration due to nausea/vomiting in a tracheostomy dependent patient with an anoxic brain injury, 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 Ondansetron HCL 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 HCL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Prolastin-C 100 mg/20 mL as prescribed. 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 Prolastin-C will not be supplied from physician and/or office stock supply nor will it be billed as part of a physician service. As a result, the drug in this case appears to be ineligible for coverage under Medicare Part B. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan was correct in denying the request for Prolastin-C 1000 mg/20 mL.The drug is requested to treat alpha-1 antitrypsin deficiency. Upon reconsideration, the prescribing physician has submitted additional documentation. The documentation submitted indicates that the enrollee acquires the requested medication directly from the pharmaceutical company and his infusion is provided by a nurse in his home. The requested drug is not eligible for coverage under Medicare Part B. 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 Prolastin-C.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 Xeljanz XR, 11 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 Xeljanz XR, 11 mg tablet.The drug is requested to treat rheumatoid arthritis. The prescriber has not indicated (with patient specific medical rationale) why all alternatives required by the Plan (including Enbrel, Humira, Kevzara, and Rinvoq ER tablet) 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 Xeljanz XR, 11 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Duloxetine HCL DR. 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 Duloxetine HCL DR 30 mg capsule. The drug is requested to treat depression. 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 of the same formulation type on the Plan's formulary to treat the enrollee's condition (Venlafaxine) (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 Duloxetine HCL DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide additional reimbursement for Fluoxetine HCL 10 mg purchased February16, 2020. 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 limitedcircumstances. The Plan submitted documentation showing that they approved coverage. They calculatedreimbursement based on the total cost of the drug, less your required copayment amount, and less thedifference 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 DPlan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provideany additional reimbursement for Fluoxetine HCL 10 mg purchased February 16, 2020.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Entresto 24-26 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 Entresto 24-26 mg. Entresto is requested for treatment of severe ischemic cardiomyopathy with a previous ejection fraction of 15-20% which improved to 30-34% recently, in this enrollee with coronary artery disease, status post coronary artery bypass grafting in January 2020, and hypertension. It is noted that the enrollee had NYHA (New York Heart Association) Class II heart failure symptoms when seen January 22, 2020. The enrollee was treated with continuation of Lasix and Coreg, and resumption of Lisinopril. When seen April 15, 2020, it was noted that dyspnea on exertion had improved, ejection fraction had improved on echocardiogram, but was still markedly depressed at 30-34%, and it was stated that further up titration of Lisinopril/Coreg was limited by blood pressure. As the enrollee still had severe cardiomyopathy on an ACE-I (angiotensin converting enzyme inhibitor), treatment with Entresto was prescribed.The Plan's denial notice indicates that their coverage criteria were not met as the enrollee did not have documentation of NYHA Class II heart failure. As noted, medical records provided indicate that the enrollee does indeed have NYHA Class II heart failure prior to starting an ACEI. Although NYHA class improved with ACEI, the patient has baseline NYHA Class II heart failure. As such, 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 Entresto 24-26 mg.
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 provide a tiering exception for Symbicort. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Symbicort. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Symbicort.
Appeal type: Prescription Drug
Decision: Favorable

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 chronic low back pain. OnApril 28, 2020 you sent additional information addressing the Plan's formulary alternative, fentanyl patch, indicating prior trial and failure due to lack of benefit and skin reaction. 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 formulary exception criteria are 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 met. Therefore, the Plan is required to cover Oxycodone HCL ER 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Morphine Sulfate ER. 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 Morphine Sulfate ER. The drug is requested to treat rheumatoid arthritis. You do not satisfy the Plan's coverage criteria (the prescriber answered No to: Is the requested drug being prescribed for pain severe enough to require daily, around-the-clock, long-term treatment in a patient who has been taking an opioid?). 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 you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you. 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 Morphine Sulfate ER.