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

You asked the Plan to cover Diclofenac 1% Gel. 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 Diclofenac 1% Gel. Diclofenac 1% Gel is requested for treatment of pain in the feet/ankles related to osteoarthritis. You have stated that the enrollee is in a lot of pain, she has diabetes mellitus, and that over the counter medications did not help. The Plan's coverage requirement for generic Diclofenac gel requires that the requested drug is necessary due to intolerance or contraindication to oral nonsteroidal anti-inflammatory drugs (NSAIDs). The Plan states that you indicated that the enrollee does not have intolerance/contraindication to NSAIDs. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met. Of note, per the Plan's Evidence of Coverage and HPMS (Health Plan Management System - CMS's official database for Plan formularies), brand Voltaren gel is also on Tier 3 of the Plan's formulary, and does not have prior authorization requirements.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 Diclofenac 1% Gel.
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 Zohydro ER. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Zohydro ER 20 mg capsule.Zohydro ER 20 mg capsule is requested for treatment of chronic pain syndrome associated with lumbar degenerative disc disease. The prescriber has indicated that the enrollee has tried Xtampza and Percocet; the medical record indicates that Xtampza was only partially effective. 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 Zohydro ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tymlos. 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 Tymlos. The drug is requested for the treatment of postmenopausal osteoporosis with current pathological fracture. You have not indicated why all alternatives required by the Plan (Forteo) 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 Tymlos.
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 provide reimbursement for the Shingrix vaccine and its administration fee. 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 from your prescriber's office. You requested reimbursement from the Part D Plan. The Plan did not process the request. The Shingrix vaccine is a Part D eligible vaccine on the Plan's 2020 Formulary. You provided proof of payment for the vaccine and its administration fee. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the Shingrix vaccine and its administration fee.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 Visbiome. 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, Visbiome is not eligible for Part D coverage, and the Plan is not required to cover 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 Synbio, Pharolit, Buscopan Plus and Tocet purchased January 2, 2020 while inBali, Indonesia. The Plan did not grant this request. We received this case to conduct an independentreview.Synbio, Pharolit, Buscopan Plus and Tocet purchased January 2, 2020 while in Bali, Indonesia are notcovered by Medicare because they were purchased outside the United States. Therefore, our decision is thatthe Part D Plan is not required to pay for Synbio, Pharolit, Buscopan Plus and Tocet purchased January 2,2020 while in Bali, Indonesia.This decision does not concern the medical appropriateness of the requested drug. It only establishes ifpayment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lokelma . 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 Lokelma (Sodium Zirconium Cyclosilicate) 10 g pkt for oral suspension.The drug is requested to treat hyperkalemia in a patient status post kidney transplant. The prescriber has not indicated why all alternatives required by the Plan (Sodium Polystyrene Sulfonate powder for oral suspension, Sodium Polystyrene Sulfonate oral suspension, SPS oral suspension, Kionex oral suspension) 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 Lokelma.
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 SMZ-TMP DS, Raloxifene, Sertraline, Ciprofloxacin, Levothyroxine and Omeprazole. 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. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. You purchased SMZ-TMP DS, Raloxifene, Sertraline, Ciprofloxacin, Levothyroxine and Omeprazole, which were covered by another insurance. You then requested reimbursement from the Part D Plan. The Plan did not process the request due to proof of payment and the Explanation of Benefits from the other insurance carrier not being provided. The Plan is not required to provide reimbursement without proof of payment and the Explanation of Benefits from the other insurance carrier.Therefore, it is our decision the Plan is not required to provide reimbursement for SMZ-TMP DS, Raloxifene, Sertraline, Ciprofloxacin, Levothyroxine and Omeprazole.Please note: you may wish to contact the pharmacy where these purchases were made to request proof of payment which includes the drug name, dose, quantity and price of each drug. You may wish to provide that information as well as the Explanation of Benefits to the Part D Plan in order for them to process these claims.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Losartan 50 mg, Eliquis 5 mg and Lipitor 20 mg purchased while you were outside the United States. The Plan did not grant this request. We received this case to conduct an independent review.Losartan 50 mg, Eliquis 5 mg and Lipitor 20 mg purchased while you were in Israel are not covered by Medicare because they were purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Losartan 50 mg, Eliquis 5 mg and Lipitor 20 mg purchased while you were outside the United States. 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

You asked the Plan to provide a tiering exception for Clopidogrel Bisulfate and Repatha Pushtronex. 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 Clopidogrel Bisulfate 75 mg tablet.The drug is requested to treat the enrollee's condition. The drug is a generic drug on tier 2 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Repatha Pushtronex 420 mg/3.5 ml.The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier 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 Clopidogrel Bisulfate and Repatha Pushtronex.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ofev. 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 Ofev 100 mg.The drug is requested to treat idiopathic pulmonary fibrosis (IPF). The prescriber documented that the enrollee has a forced vital capacity (FVC) of 45% of predicted value (required to have greater than or equal to 50% of predicted value). The enrollee does not satisfy the Plan's coverage criteria. 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 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 Ofev.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine Patch. 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 Lidocaine Patch 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 Lidocaine Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cromolyn Sodium 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 Cromolyn Sodium 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 Cromolyn Sodium 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

You asked the Plan to cover Lidocaine Patch. The Plan did not grant this request. We received this case to conduct an independent review.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 Patch 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 Lidocaine 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

You asked the Plan to cover 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 Corlanor.Corlanor is requested to treat inappropriate sinus tachycardia, 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 Corlanor 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 Corlanor. 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 reimbursement for Cyanocobalamin and TB syringes. The Plan did not grant this request. We received this case to conduct an independent review.TB syringesMedicare rules state that the definition of a Part D drug includes medical supplies associated with the injection of insulin, including syringes, needles, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle-free syringes. In this case, TB syringes were requested for injection of Cyanocobalamin. Part D does not cover syringes when used to inject Cyanocobalamin. Medicare Part D only covers syringes when they are used to administer insulin. Therefore, our decision is the Part D Plan is not required to cover syringes for injection of Cyanocobalamin. This decision does not concern the medical necessity or appropriateness of the requested item. It only establishes if payment can be made under the Medicare Part D benefit.CyanocobalaminThe Plan provided documentation that the request for reimbursement for Cyanocobalamin was approved under Part B. Since the Plan has agreed to provide coverage or payment under Part B, we do not have jurisdiction to provide a decision regarding coverage under Part D. You may wish to appeal the decision made to the Part B coverage department of your Plan.Contact the Plan to learn more about how and when coverage or payment will be provided for Cyanocobalamin under the Part B portion of the benefit.Please contact the Plan for more information regarding coverage of syringes for injection of under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lantus Solostar . The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Lantus Solostar is a Tier 2 biologic drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Lantus Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dronabinol. 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 Dronabinol 5mg capsule.The drug is requested to treat abnormal weight loss associated nausea and vomiting due to chemo-radiation. The enrollee does not satisfy the Plan's coverage criteria. 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 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 Dronabinol.