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

You asked the Plan to cover Modafinil. 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. The drug is requested to treat cognitive dysfunction (including issues with executive functioning, memory and concentration) due to an astrocytoma, 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 Modafinil 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 Modafinil.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 Xifaxan. 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 Xifaxan 550 mg tablet. The drug is requested to treat small intestine bacterial overgrowth, 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 Xifaxan 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 Xifaxan. 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 Orencia. 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 Orencia 125 mg/mL subcutaneous solution. The drug is requested to treat seronegative rheumatoid arthritis. 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. You have argued that the formulary alternatives Kevzara and Kineret carry an increased risk of infections. According to the Medicare-approved compendium Micromedex DrugDex, Orencia is not without this same risk. Orencia carries a high risk of infections - as high as 37.6%-54% risk of infection. 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 Orencia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vyndaqel. 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. Vyndaqel 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 Vyndaqel.
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 Retacrit. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Retacrit is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Retacrit is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Retacrit. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of Retacrit under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prevymis. 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 Prevymis 480 mg tablet. The drug is requested for Prophylaxis in a Cytomegalovirus positive enrollee status post allogeneic hematopoietic stem cell transplant. 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 Prevymis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tremfya. 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 Tremfya 100 mg/mL. The drug is requested to treat plaque psoriasis, moderate to severe disease. In a statement, the prescriber indicates that Humira and Enbrel have been tried in the past. In a letter sent with the request for reconsideration, the prescriber states the enrollee has tried and failed Methotrexate, Otezla and several topical treatments. Phototherapy is contraindicated due to sensitive areas. Tremfya 100 mg/mL is not on the Plan's formulary. Cosentyx and Skyrizi are on the Plan's formulary. 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 Tremfya.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Pregabalin. The Plan did not grant this request. We received this case to conduct an independent review.Our decision is the Plan is not required to provide monetary reimbursement for Pregabalin.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If you pay the full cost of a prescription drug out-of-pocket or if you find you have paid more than you expected to pay under the Plan's coverage rules, you can ask the Plan to pay you back. When submitting a request for reimbursement, the Plan requires that you submit your receipt documenting the payment you have made along with your reimbursement request.In this case, you submitted a request for reimbursement to the Plan for Pregabalin and indicated on the date of the purchase the insurance company had not yet approved coverage for Pregabalin. It appears the Plan processed reimbursement for this fill once they completed and approved your request for coverage, however reimbursement was provided based on the Plan's negotiated contract rate and deductible requirements. As indicated by the enrollee's appeal request it appears this claim was run by the pharmacy on the date of purchase and it was rejected because coverage had not yet been approved by the Plan.For cash purchases made at in-network pharmacies, the enrollee is responsible for the difference between the cash price and the Plan's negotiated price, except for circumstances in which a pharmacy's or payer's system is offline at the time of purchase, or in which there is evidence of an enrollment-related error or other a sponsor error that limited the enrollee's access to the negotiated price.Since the claim was rejected because coverage had not yet been approved at the time of the purchase it appears that this is a situation in which the Plan's policy of charging the enrollee the difference between the cash price paid and the Plan's contracted negotiated rate for the drug is applicable. Therefore, it is our decision that the Plan is not required to provide monetary reimbursement for Pregabalin, and the claim was processed correctly by the Plan.Please note, whether the Plan should provide a one-time exception to their reimbursement rules given the circumstances of this case is a grievance. A grievance is any complaint or dispute, other than one that involves a coverage 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.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). Since your complaint involves a grievance, the Part D Plan must review this part of your complaint under the Plan's grievance procedures. At this time, you should contact the Plan for information on how to proceed with having this part of your complaint reviewed under the Plan's grievance procedures.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xtampza 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 Xtampza ER 27 mg capsule. The drug is requested to treat chronic pain. 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 Xtampza ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epclusa. 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 Epclusa - 400/100 mg, 28 per 28 days. The drug is requested to treat chronic hepatitis C in a ribavirin ineligible enrollee with decompensated cirrhosis. The enrollee does not satisfy the Plan's coverage criteria. The Plan's paid claims records indicate that the enrollee has received the total 24 weeks indicated for the enrollee's condition. In the request for reconsideration, the prescriber states the enrollee lost 1 bottle of the requested drug. 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 Epclusa.
Appeal type: Prescription Drug
Decision: Unfavorable

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

You asked the Plan to cover Vemlidy. 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 Vemlidy 25 mg tablet. The drug is requested to treat chronic hepatitis B with liver transplant status. 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. The prescriber argues that the formulary alternative entecavir is not appropriate due to high levels of drug resistance. The American Association for the Study of Liver Diseases lists entecavir as a preferred, first line therapy for chronic hepatitis B with no warnings with regard to high resistance rates. 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 Vemlidy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR. 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 Xeljanz XR. The drug is requested to treat ankylosing spondylitis, 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 Xeljanz XR 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 Xeljanz XR. 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 cover Lidocaine 5% Ointment. 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 5% Ointment 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 5% Ointment.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Inbrija. 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 Inbrija 42 mg inhalation cap. The drug is requested to treat Parkinson's disease. The prescriber states the enrollee has tried and failed or had adverse effects with Requip and Mirapex. Inbrija is not on the Plan's formulary. 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 Inbrija.