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

You asked the Plan to provide reimbursement for Prednisolone-Gatifloxacin-Bromfenac Compound purchased January 3, 2019 and February 28, 2019. 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 for both safety and effectiveness. We determined that Prednisolone-Gatifloxacin-Bromfenac Compound (NDC 70261-504-03) purchased January 3, 2019 and February 28, 2019 is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover or provide reimbursement for Prednisolone-Gatifloxacin-Bromfenac Compound purchased January 3, 2019 and February 28, 2019.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.Please note: the Reconsideration appeal request submitted to MAXIMUS Federal includes additional dates of service (January 7, 2019 and April 1, 2019). The Plan provided documentation that only January 3, 2019 and February 28, 2019 have been reviewed at the Plan level. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. If you would like the Plan review the January 7, 2019 and April 1, 2019 dates of purchase, you may wish to submit that request to the Plan at this time.
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 Prednisolone-Gatifloxacin-Bromfenac compound, purchased on November 22, 2019, from the 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. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. A representative of the pharmacy declined to clarify whether bulk powder was used or would be used when compounding the prescription for Prednisolone-Gatifloxacin-Bromfenac. There is insufficient documentation in the case record to establish that the requested compound drug or any of its ingredients are a Part D drug in this case. Therefore, the Plan is not required to cover or provide reimbursement for Prednisolone-Gatifloxacin-Bromfenac. This decision does not address the medical necessity or appropriateness of the requested compound 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 Torsemide, 10 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Torsemide, 10 mg tablet, which is not on the Plan's formulary. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Torsemide, 10 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Shingrix received on October 7, 2019, from your physician's office. 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. The record indicates that you received Shingrix, a Medicare-covered vaccine, from your physician's office on October 7, 2019. The case record includes proof of payment showing that you have paid the bill for vaccine and its administration in full. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to cover and provide any applicable reimbursement for Shingrix received on October 7, 2019, from your physician's office.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

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 Ranexa ER (Ranolazine). The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Ranexa ER (Ranolazine), which is not on the Plan's formulary. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Ranexa ER (Ranolazine).Please note: based on the available documentation it is unclear if brand Ranexa ER is being requested or generic Ranolazine. Brand Ranexa ER is not on the Plan's formulary. Generic Ranolazine is on the Plan's formulary without restriction.
Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Methadone HCL 10 mg, 120 per 30 days. 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 Methadone HCL 10 mg, 120 per 30 days. The drug is requested to treat pain from rheumatoid arthritis. The Plan has indicated that it intended to approve the requested drug but failed to meet the required time deadline. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules state that a Part D plan may exclude from coverage any Part D drug that is not medically reasonable and necessary to treat the enrollee's condition. The Part D Plan conducts drug use reviews for enrollees to help make sure that they are getting safe and appropriate care. During these reviews, the Plan looks for potential problems such as drugs that may not be necessary because the enrollee is taking another drug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's age or gender, or certain combinations of drugs that could harm the enrollee if taken at the same time. In this case, our Physician Reviewer determined that the safety concern raised by the Plan has been adequately addressed. Therefore, our Physician Reviewer determined that Methadone HCL is medically reasonable and necessary for the enrollee. 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 Gammagard. 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 Gammagard will be supplied from the home care center that will be also administering the home infusion, and will be billed as part of a physician service. Gammagard is a type of drug that is not usually self-administered. As a result, the drug as administered in this case appears to be eligible for coverage under Medicare Part B. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Gammagard. 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 Lidocaine 5% Patch. 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 Lidocaine 5% Patch. The drug is requested to treat M25.511, Pain in right shoulder, Persistent Pain From Posterior Closed Nondisplaced Fracture of the Acromion Process, Anterior Subluxation of Humeral Head, Rotator Cuff Arthropathy, and Post-Traumatic Arthritis of the Right Shoulder, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Lidocaine 5% Patch for the diagnosed conditions. 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 these conditions. 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 Lidocaine 5% Patch. 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 reimbursement for Amoxicillin 500 mg purchased January 16, 2020, Lidocaine 5% Ointment purchased January 30, 2020, Tramadol HCL 50 mg purchased February 1, 2020, and Doxycycline Hyclate 10 mg, Lidocaine 5% Ointment and Tramadol HCL 50 mg purchased February 4, 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 limited circumstances. In this case, you purchased Amoxicillin 500 mg, Lidocaine 5% Ointment, Tramadol HCL, Doxycycline Hyclate between January 16, 2020 and February 4, 2020. The Plan provided verification that the pharmacy used was an out of network pharmacy. There is no indication any of these purchases were due to an urgent care or emergency situation. The Plan's out-of-network coverage rules were not followed. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Amoxicillin 500 mg purchased January 16, 2020, Lidocaine 5% Ointment purchased January 30, 2020, Tramadol HCL 50 mg purchased February 1, 2020, and Doxycycline Hyclate 10 mg, Lidocaine 5% Ointment and Tramadol HCL 50 mg purchased February 4, 2020.This decision does not concern the medical 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 Hydrocodone-Acetaminophen 5-325 mg, 60 per 30 days. 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 Hydrocodone-Acetaminophen 5-325 mg, 60 per 30 days. The drug is requested to treat knee pain. A request for prescriber statement to address the plan's opioid drug utilization criteria was sent. A response was not received. The enrollee does not satisfy the Plan's coverage criteria. Based on the available documentation, the prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules state that a Part D plan may exclude from coverage any Part D drug that is not medically reasonable and necessary to treat the enrollee's condition. The Part D Plan conducts drug use reviews for enrollees to help make sure that they are getting safe and appropriate care. During these reviews, the Plan looks for potential problems such as drugs that may not be necessary because the enrollee is taking another drug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's age or gender, or certain combinations of drugs that could harm the enrollee if taken at the same time.We sent this case to our Physician Reviewer to determine whether the Part D Plan was correct in denying coverage for Hydrocodone-Acetaminophen 5-325 mg, 60 per 30 days. Based on the information available in the case record, our Physician Reviewer determined that the use of Hydrocodone-Acetaminophen 5-325 mg, 60 per 30 days in this case is not medically reasonable and necessary. Therefore, our decision is that the Part D Plan is not required to provide coverage for Hydrocodone-Acetaminophen 5-325 mg, 60 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gralise, 300 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 Gralise, 300 mg tablet.The drug is requested to treat chronic pain secondary to chronic degenerative arthritis and fibromyalgia, which is an off-label (non-FDA approved) use. Medical records from date of service 2/26/2020 were provided which substantiate these diagnoses. 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 Gralise, 300 mg tablet 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 Gralise, 300 mg tablet. 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 reimbursement for Phenylephrine 1% nasal spray received September 10, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Phenylephrine 1% nasal spray received September 10, 2019 is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for Phenylephrine for it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil Citrate, 20 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Sildenafil Citrate, 20 mg tablet which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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 Sildenafil Citrate, 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alrex 0.2%. 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 Alrex 0.2%. The drug is requested to treat allergic conjunctivitis. The initial request indicated diagnoses of dry eye syndrome and conjunctival cysts. Upon reconsideration, you submitted a diagnosis of allergic conjunctivitis. Additional medical information was requested by the Part D QIC. You were asked to address the formulary alternatives and to submit chart notes supporting a diagnosis of allergic conjunctivitis. The requested chart notes were submitted. 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: Loteprednol etabonate 0.2% (Alrex(R)) ophthalmic suspension is indicated for the treatment of seasonal allergic conjunctivitis. Therefore, the requested drug is being prescribed for a medically accepted indication. You have 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 Alrex 0.2%.