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

You asked the Plan to cover Milrinone Lactate . The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Milrinone Lactate 1 mg/ml. The drug is requested to treat NYHA Class III congestive heart failure. Theenrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria 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 aremet. Therefore, our decision is the Plan is required to cover Milrinone Lactate.Please note that the Plan denied coverage for Milrinone Lactate stating it was covered under Medicare B.However, the diagnosis, to treat NYHA Class III congestive heart failure is not in the Medicare B rules,therefore we had our Physician Reviewer review coverage under Medicare Part D.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide a tiering exception for Budesonide EC 3 mg capsule. The Plan did not grantthis 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 requestfor a tiering exception for Budesonide EC 3 mg capsule.The drug is requested to treat Collagenous colitis. The drug is a generic drug on tier 4 of the Plan'sformulary. In the Reconsideration appeal the prescriber stated that the enrollee is allergic to sulfa and istherefore unable to take Sulfasalazine. (a tier 2 drug) The prescriber has therefore indicated why all eligiblelower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effectivefor the enrollee as the requested drug; and/or (2) would have adverse effects for the enrollee. Our PhysicianReviewer's opinion is that tiering exception criteria are met.Medicare rules permit a Plan to grant an exception to its tiering structure whenever it determines that thenon-preferred or higher cost-sharing drug for treatment of the enrollee's condition is medically necessaryconsistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exceptioncriteria are met. Therefore, our decision is the Plan is required to provide a tiering exception and anyapplicable reimbursement for Budesonide EC from the date of the Plan's initial denial.Important: This request was based on your 2019 benefits. If you would like a review for 2020 you willneed to reach out to your 2020 Medicare Part D Plan.
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 Aimovig. 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 Aimovig. Aimovig is requested for the prophylaxis of migraine headache. There was insufficient documentation to substantiate that the requested drug is being used to treat the stated condition(s). The prescriber was asked questions to clarify the diagnosis being treated and/or to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Aimovig.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Modafinil 100 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 Modafinil 100 mg. The drug is requested to treat bipolar depression. On 1/15/2020 the prescriber sent in additional information indicating the drug was being used for treatment of bipolar depression. 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 Modafinil 100 mg for the diagnosed condition. As a result, Modafinil 100 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 Modafinil 100 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xifaxan. 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. Xifaxan 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 Xifaxan.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for DOK Plus 50-8.6 mg and Aspercreme Lidocaine 4%Patch purchased November 24, 2019 at a hospital pharmacy upon discharge. The Plan did not grant thisrequest. 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. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to paythe full cost when the prescription is filled. The enrollee may submit a request for reimbursement withproof of payment to ask the Plan to pay its share of the cost.In this case, the record shows that you purchased DOK Plus 50-8.6 mg and Aspercreme Lidocaine 4%Patch on November 24, 2019 from a hospital pharmacy upon discharge. You received DOK Plus 50-8.6 mgand Aspercreme Lidocaine 4% Patch for a medical emergency or urgent care. You submitted a request forreimbursement with an itemized statement from the pharmacy. However, the record does not include proofof payment in full. The Plan's criteria for out-of-network coverage and reimbursement have not been met.Therefore, our decision is the Plan is not required provide reimbursement for DOK Plus 50-8.6 mg andAspercreme Lidocaine 4% Patch purchased November 24, 2019 at a hospital pharmacy upon discharge.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide reimbursement for the Shingrix vaccine and its administration fee received November 15, 2019 from the health department. 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, you received the Shingrix vaccine at the health department. You requested reimbursement from the Part D Plan. The Plan denied the request on the basis that the National Drug Code (NDC) and the prescriber's NPI number were missing from your request. The record shows you provided the NDC 58160-823-11, which is a valid, Part D eligible vaccine. The record also includes proof of payment in full for the vaccine. Medicare rules state that when a plan sponsor could acquire missing information, such as the NDC or NPI number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. The Plan may utilize the remainder of the 30-day payment period after approval is granted to obtain missing information in order to determine the amount of reimbursement to be provided. Thus, the Plans reimbursement rules as stated in the Evidence of Coverage have been met, and the Plan should obtain missing NPI information in order to process reimbursement.The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to process and provide reimbursement for the Shingrix vaccine and its administration fee received November 15, 2019 from the health department.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide reimbursement for the Shingrix vaccine and its administration fee received October 3, 2019. 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, you received the vaccine at your provider's office. You requested reimbursement from the Part D Plan. The Plan denied reimbursement on the basis that that National Drug Code (NDC) is missing and/or invalid. However, the NDC provided (58160-828-03) is a valid, Part D eligible vaccine. Additionally, on January 15, 2020 a representative from MAXIMUS Federal verified with the prescriber's office that the vaccine and its administration fee have been paid for in full. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to process and provide reimbursement for the Shingrix vaccine and its administration fee received October 3, 2019 from Palo Alto Medical Foundation.Please note: the Reconsideration appeal request indicates you also requested reimbursement for a vaccine administered on July 12, 2019. The Plan's file does not include any indication a request for reimbursement for a July 12, 2019 date of service has been reviewed. You may wish to submit your request for reimbursement for the July 12, 2019 date of service to the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cotellic. 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 Cotellic. The drug is requested to treat prostate cancer, which is an off-label (non-FDA approved) use.The enrollee is a 71-year-old man with stage IV prostate cancer. The prescriber states he has exhausted all treatment options offered. Guardant360 testing identified BRAF amplification suggesting possible response to Cotellic (Cobimetinib.) The prescriber requests Cotellic to treat him. The enrollee's daughter indicates the drug would be used in combination with Bicalutamide.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. This reviewer did a PubMed search and found no supporting citations. 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 Cotellic 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 Cotellic. 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 provide a tiering exception for Vyzulta. The Plan did not grant this request. We received this case to conduct an independent review.The Plan provided documentation that coverage (as a formulary exception) was approved by the Plan. Therefore, we are dismissing the request for coverage for Vyzulta. You should contact te Plan for more information regarding how and when coverage for Vyzulta will be provided.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 Vyzulta 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 Vyzulta.
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 Mycopenolate Mofetil. 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 Mycopenolate Mofetil. The drug is requested to treat J84.9, Interstitial pulmonary disease, unspecified, 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 Mycopenolate Mofetil 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 Mycopenolate Mofetil. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol Sulfate 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 Albuterol Sulfate neb sol for the management of obstructive pulmonary disease.In this case, the record shows that Albuterol Sulfate neb sol is administered through a nebulizer in the home for a diagnosis of J43.2 - centrilobular emphysema. 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 Albuterol Sulfate neb sol. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier
Appeal type: Prescription Drug
Decision: Unfavorable

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 Progesterone Compound purchased March 26, 2019, April 23, 2019, August 6, 2019, November 11, 2019 and December 16, 2019 from a compounding pharmacy. 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 Progesterone Compound purchased March 26, 2019, April 23, 2019, August 6, 2019, November 11, 2019 and December 16, 2019 from a compounding pharmacy. 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 Progesterone Compound purchased March 26, 2019, April 23, 2019, August 6, 2019, November 11, 2019 and December 16, 2019 from a compound pharmacy. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil, 500 mg.The drug is requested to treat eosinophilic fasciitis, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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.