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

You asked the Plan to cover Norvasc. 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 Norvasc 10 mg. The drug is requested to treat hypertension. 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 Norvasc.
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 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 myofascial pain. The prescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file if the underlying etiology of the enrollee's pain is a medically accepted indication for the requested drug. The prescriber was also asked to address the appropriateness other analgesics for the enrollee's condition. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorization exception criteria are not 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 Sildenafil, 20 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 Sildenafil, 20 mg tablet.The drug is requested to treat benign prostatic hypertrophy, 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 at the requested dose, 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 Sildenafil, 20 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 Sildenafil, 20 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

You asked the Plan to cover Privigen. 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 Privigen 10 gm/100 mL. The drug is requested to treat chronic relapsing inflammatory optic neuropathy, 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 Privigen 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 Privigen. 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 Imbruvica. 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 Imbruvica. The drug is requested to treat Waldenstrom's macroglobulinemia. The enrollee is a 79 year old man with Waldenstrom's macroglobulinemia. He has been treated with Bendamustine/Rituxan with a very good partial response. He started Imbruvica (Ibrutinib). Due to neutropenia the dose was reduced to 280 mg per day. He has been taking two 140 mg daily. The prescriber requests 280 mg tablets which are non-formulary.Per the FDA website, Imbruvica is indicated for the treatment of adult patients with Waldenstr?m's macroglobulinemia (WM). Therefore, the drug is requested for an FDA approved, medically accepted indication. 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. However, 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 Imbruvica.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dupixent. 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 Dupixent. The drug is requested to treat asthma. The enrollee does not satisfy the Plan's coverage criteria. You note the requested Dupixent will be prescribed with Xolair. 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.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 Dupixent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Guanfacine HCL. 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 Guanfacine HCL. The drug is requested to treat attention deficit hyperactivity disorder (ADHD) in this 20 year old enrollee, 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 Guanfacine HCL 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 Guanfacine HCL. 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 Diclofenac Epolamine 1.3% 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 Diclofenac Epolamine 1.3% Patch.The drug is requested to treat chronic thoracic and lumbar pain, 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 Diclofenac Epolamine 1.3% 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 Diclofenac Epolamine 1.3% 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 Scopolamine 1 mg/3 day Patch. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that for prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions for which hospice coverage is being provided. In this case, the prescribing physician has indicated the enrollee is receiving hospice benefits and Scopolamine 1 mg/3 day Patch is being used for treatment of a condition that is related to the terminal condition(s). Thus, Scopolamine 1 mg/3 day Patch appears to be eligible for Part A coverage in this case. Drugs which are eligible for Part A coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to provide coverage for Scopolamine 1 mg/3 day Patch. 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 hospice 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 Paroxetine HCL ER 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. 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. The Plan required a 37% for up to a 90 days day supply of a Tier 4 drug purchased from a preferred pharmacy in 2020. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at the time of purchase. The record shows that Paroxetine HCL ER was purchased for an amount that is less than or equal to the required copayment amount. The case record indicates that the Plan provided coverage in accordance with the Part D contract. Therefore, our decision is the Plan is not required to provide reimbursement for Paroxetine HCL ER purchased from the pharmacy.
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 Vaqta vaccine received August 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. The Plan submitted documentation showing that they approved coverage. This claim paid under the deductible stage of coverage. They calculated reimbursement based on the total cost of the drug, less your required copayment amount, and less the difference between what the Plan normally pays for the drug and what the out-of-network pharmacy (i.e., hospital or provider's office) charged you.Therefore, our decision is the Plan is not required to provide reimbursement for Vaqta vaccine received August 4, 2020. For detailed information on how vaccines are reimbursed, please refer to the Plan's Evidence of Coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Synthroid. 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 Synthroid 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 or additional reimbursement for Synthroid.In addition, your complaint regarding how the Plan has been handling your request with no response 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 cover Testosterone 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 Testosterone 1% gel. The drug is requested to treat male hypogonadism. 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 Testosterone 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 provide a tiering exception for Myrbetriq. 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. Myrbetriq is a Tier 3 brand 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 Myrbetriq.