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

You asked the Plan to cover Yupelri 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 Yupelri neb sol for the management of obstructive pulmonary disease. We noted that at this time Yupelri (Revefenacin) is not listed in the Medicare Part B local policy as a covered drug. Medicare Part B would thus not provide coverage for Yupelri at this time. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Yupelri 175 mcg/3 ml neb sol. The drug is requested to treat chronic obstructive pulmonary disease. In a statement dated 1/16/2020, the prescriber states the enrollee has tried and failed ipratropium and albuterol. Yupelri is not on the Plan's formulary. 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 Yupelri.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Novolog. 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 Novolog. The drug is requested to treat Type 2 diabetes. The drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type 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 Novolog.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amphotericin B Compound. The Plan did not grant this request. We received this case to conduct an independent review.Amphotericin BWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Amphotericin B 50 mg.Amphotericin B 50 mg, to be instilled 1 drop on the right eye every 2 hours, is requested to treat infectious keratitis, 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 Amphotericin B Compound 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 Amphotericin B Compound. 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.Sterile WaterFor 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. Sterile Water is used as a dilutant in the reconstitution of the Amphotericin B Compound. Sterile Water use in this instance is not therapeutic. Thus, Sterile Water does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Sterile Water.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amitiza. 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 Amitiza. The drug is requested to treat opioid induced constipation. The prescriber clarified the alternatives tried in the request for reconsideration dated 1/15/2020. The prescriber states that the enrollee has tried and failed Miralax, Exlax, and Senokot. Amitiza is not on the Plan's formulary. 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 Amitiza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Votrient. 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 Votrient. The drug is requested to treat glioblastoma multiforme, which is an off-label (non-FDA approved) use.The enrollee is a 68 year old man with newly diagnosed glioblastoma multiforme. He has had surgery. He did not start radiation and chemotherapy that was recommended. You request Votrient to be given with Sprycel, Avastin and Afinitor to treat him. You submitted several journal articles and a list of references in support of the request which were reviewed. 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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Votrient 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 Votrient. 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 additional reimbursement for Tenivac Vaccine and its administration received March 22, 2017 by your physician. The Plan did not grant this request. We received this case to conduct an independent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed.The Part D Plan covers certain vaccines purchased and/or administered out-of-network. The enrollee will be responsible for the difference in cost between the Plan's allowed charge for the vaccine and its administration, and the amount charged by the out-of-network provider. In 2017, the Plan required a $141 deductible for Tier 2, Tier 3, Tier 4 and Tier 5 drugs and up to a $95 copayment amount during the initial coverage stage for Tier 4 drugs. Tenivac Vaccine was classified as a Tier 4 drug on the Plan's 2017 formulary.The Plan submitted documentation showing that coverage and payment for the vaccine and its administration was processed and determined that no reimbursement was due. The reimbursement provided was the total cost of the vaccine, minus your required copayment amount for an out-of-network purchase, and minus the difference between the Plan's allowable charge for vaccine administration and the out-of-network provider's charge for vaccine administration.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolic Acid 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 Mycophenolic Acid DR.Mycophenolic Acid DR is requested for ongoing prophylaxis of cardiac transplant rejection, which is an off-label (non-FDA approved) use. The prescriber has indicated that you have been treated with the requested drug since your heart transplant in January 2014, and that continuation of the requested drug is in your best interest to prevent cardiac rejection, graft loss, and death; 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 Mycophenolic Acid DR 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 Mycophenolic Acid 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.
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 Digoxin. 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 Digoxin 125 mcg (90/30). The drug is requested to treat Supraventricular tachycardia. The following citation in AHFS-DI, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Digoxin also is used in the management of paroxysmal supraventricular tachycardia (PSVT) due to AV nodal reentry tachycardia (AVNRT) or AV reentry tachycardia (AVRT). Some experts state that oral digoxin may be reasonable for ongoing management of PSVT in patients who are not candidates for, or prefer not to undergo, catheter ablation. 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 Plan limits the amount of the drug to 30 tablets per 30 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met. Also note that the prescriber wrote the prescription as Sig 1 po qHS (sic). This is the same as writing for one 0.125 mg tablet per day or 30 tablets per 30 days.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Digoxin .
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 Novolog FlexPen. 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 Plan was correct in denying the request for Novolog FlexPen.Novolog FlexPen is requested to treat Type 2 Diabetes Mellitus. You were asked to provide dates of drug trials and supporting medical records. Medical records and drug trial dates were not provided. Therefore, you have not indicated that the enrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy or step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception 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 an exception to step therapy criteria is not met. Therefore, the Plan is not required to cover Novolog FlexPen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Cholestyramine. The Plan did not grant this request. We received this case to conduct an independent review. You also requested that we consider a tiering exception for Creon.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Cholestyramine 4 gm powder.The drug is requested to be used as a Bile Acid Sequestrant. The Plan denied the initial appeal since when the prescriber was asked to list the diagnosis specific to the medication the prescriber wrote, metastatic Neuroendocrine tumor, metastatic to liver. In the Reconsideration appeal the prescriber clarified that the requested drug is being used as a bile acid sequestrant in the setting of a metastatic Neuroendocrine tumor.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.The following citation in AHFS-DI, a Medicare-approved compendium, supports the use of the requested drug for the enrollee's condition: Cholestyramine has been used with some success in the management of diarrhea associated with excess fecal bile acids.Therefore, the requested drug is being prescribed for a medically accepted indication.The drug is a generic drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs of the same type 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 Cholestyramine.We are dismissing the request for Creon. We received your letter asking for an appeal of the Plan's unfavorable determination for Creon. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination for Creon. You may wish to submit this request to the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide. 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 Budesonide 0.5 mg/2ml ampule nebulizer solution is requested to treat the enrollee's condition. The Plan has documented that the requested drug is administered at home. The diagnosis and route of administration has changed over the course of the request/appeal process. Most recently, the prescriber has clarified that the diagnosis is asthma, and has indicated that the drug is administered via nebulizer. Based on the information provided, the drug would be eligible for coverage under Part B for the enrollee's condition. Our Physician Reviewer's opinion is that the requested drug is not eligible for Part D coverage in this case.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 for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered through a nebulizer in the home for a diagnosis of Asthma. 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. 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.