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

You asked the Plan to cover Cyproheptadine HCL. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Cyproheptadine HCL is one of those excluded drugs because it is a drug used for anorexia, weight loss or weight gain. The record submitted by the Plan does not indicate that they provide supplemental coverage for Cyproheptadine HCL. Therefore, the Plan is not required to cover Cyproheptadine HCL. 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 provide a tiering exception for Corlanor. 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 Corlanor. The drug is requested to treat chronic congestive heart failure. The drug is on Tier 4 of the Plan's formulary. There are no available lower tier brand 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 Corlanor.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tobramycin. 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 Tobramycin 300 mg/5 mL ampule-nebulizing solution for inhalation. The drug is requested to treat chronic respiratory infection with Pseudomonas related to tracheostomy and chronic respiratory failure. 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 DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Nebulized (inhaled) tobramycin has been used in patients with non-cystic fibrosis bronchiectasis and chronic bronchial infection with pseudomonas aeruginosa. Therefore, the requested drug is being prescribed for a medically accepted indication. 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.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 Tobramycin for the diagnosed condition. As a result, Tobramycin 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 Tobramycin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cinacalcet. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs. In this case, Cinacalcet is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Cinacalcet is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Cinacalcet. 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 Zemaira. 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 Zemaira. Zemaira is requested to treat Alpha-1-antitrypsin deficiency. 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 does not satisfy the Plan's coverage criteria. Laboratory reports and medical records were provided which document that the enrollee's phenotype is MS and the serum alpha-1-antitrypsin level is 115 mg/dL (ref range 90-200 mg/dL) from date of service September 15th, 2020. 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 theenrollee 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 Zemaira.
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 Humira CF Pen. 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. Humira CF Pen 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 Humira CF Pen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Seroquel XR. 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 Seroquel XR 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 Seroquel XR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq ER. The Plan did not grant this request. We received this case to conduct an independent review.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 Myrbetriq ER. Please note, this decision applies to both 2020 and 2021 plan years.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ongentys. 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 Ongentys 50 mg. The drug is requested to treat Parkinson's disease. 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 Ongentys.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Cresemba. Our Physician Reviewer determined that the requested drug is not being prescribed to treat a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Cresemba (Isavuconazonium Sulfate) 186 mg capsule. Cresemba is requested to treat coccidioidal meningitis, which is an off-label (non-FDA approved) use. Upon the reopening request, the prescriber submitted additional information. 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(s).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 Cresemba 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 Cresemba.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.This decision affirms our previous unfavorable decision.
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 reimbursement for Estradiol 0.01% Cream purchased from the Pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. In this case, documentation in the record shows that the enrollee was in the deductible stage when Estradiol 0.01% Cream purchased from the Pharmacy. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased before the Plan would pay a share of the cost. Estradiol 0.01% Cream purchased was on the Plan's 2020 formulary and was classified as a Tier 3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, and that the full cost of the purchase in dispute was applied to the required deductible amount.The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for Estradiol 0.01% Cream purchased from the Pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for the Boostrix TDAP vaccine and the Shingrix vaccine and their administration fees. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers certain vaccines purchased and/or administered out-of-network. If an enrollee receives a vaccine from an out-of-network provider, the enrollee will generally have to pay the full cost for the vaccine. The enrollee may then submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost.In this case, the record shows that you were administered the Boostrix TDAP vaccine (58160-842-43) and the Shingrix vaccine (58160-829-01) and their administration fees. You submitted a request for reimbursement however, the record does not include proof of payment in full for the vaccine. Additionally, outreach to the clinic in order to verify proof of payment was unsuccessful. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for the Boostrix TDAP vaccine and the Shingrix vaccine and their administration fees received at this time. Once you have paid the remaining balance of the vaccine and its administration fee, you may wish to obtain a statement showing a zero balance and submit that to the Plan as proof of payment. Until proof of payment is established, the Plan will not process the claims or provide reimbursement.Please note: Your complaint regarding incomplete and/or misleading information regarding where to receive the vaccine 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 provide a tiering exception for Aimovig. The Plan did not grant this request. We received this case to conduct an independent review.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 Aimovig.
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 reimbursement for Estriol Cream 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 Estriol Cream 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 Estriol Cream 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

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 Duopa. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be covered under Medicare Part A or Part B. Medicare Part B pays for the rental or purchase of DME if the equipment is used in the patient's home or in an institution that is used as a home. Medicare Part B covers an external infusion pump and the supplies necessary for the effective use of DME, including Levodopa-Carbidopa enteral suspension when used for the treatment of motor fluctuations in beneficiaries with PD, if certain criteria, detailed above, are met. In this case, additional information was required in order to determine if Duopa in this case, is eligible for coverage under Medicare Part D. A response to our request was not received. Therefore, there is insufficient information to determine that Duopa is not eligible for Part B coverage. Drugs that are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part D Plan is not required to cover Duopa.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 Duopa under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Megestrol Acetate. 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 Megestrol Acetate. The drug is requested to treat abnormal weight loss with chronic kidney disease and dementia, 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 Megestrol Acetate 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 Megestrol Acetate. 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.