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

You asked the Plan to cover Lidocaine 5% Patch as prescribed. 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.Lidocaine 5% Patch is requested for ongoing treatment of chronic back and knee pain related to degenerative disc disease and degenerative joint disease. The prescriber states that the enrollee has failed Acetaminophen, and that she is not a candidate for oral non-steroidal anti-inflammatory drugs, oral opioids/Tramadol. 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. Drugdex cites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. The study demonstrated that among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than nonopioid medications. The noted reference states that topical Lidocaine was included in the nonopioid prescribing strategy. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. The Plan's coverage criteria require that the requested drug is being prescribed for a medically accepted indication. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Lidocaine 5% Patch as prescribed for the diagnosed condition. As a result, Lidocaine 5% Patch as prescribed is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Lidocaine 5% Patch as prescribed.
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 Desmopressin Acetate 0.01% Solution (non-refrigerated). 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 Desmopressin Acetate 0.01% Solution (non-refrigerated), 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 Desmopressin Acetate 0.01% Solution (non-refrigerated).Please note: Desmopressin Acetate 0.01% Solution (refrigerated) is on the Plan's 2020 formulary without restriction.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Livalo, 4 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 Livalo, 4 mg tablet.The drug is requested to treat hypercholesterolemia. 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 Livalo, 4 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Verzenio, 150 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 Verzenio 150 mg; 56/28.The drug is requested to treat breast cancer previously treated with Ibrance. The enrollee is a 97 year old man with hormone receptor positive, HER2 negative breast cancer. He had bone pain. PET scan was negative for metastases. He has been treated with Ibrance and Anastrozole. His CA 27-29 has risen from 87.5 on 11/11/19 to 105.3 on 2/5/20. The prescriber states the enrollee started Verzenio on 2/28/20. The prescriber requests Verzenio to be given with Fulvestrant, Lupron, and Anastrozole. The plan requires no disease progression on Ibrance. The enrollee has had progression of his cancer, as indicated by the rising CA 27-29, while on Ibrance.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 Verzenio, 150 mg tablet.
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 the Adacel Vaccine and its administration fee received March 22, 2018. 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 Adacel vaccine from your prescriber's office. The Adacel vaccine is a Part D eligible vaccine. You requested reimbursement from the Part D Plan. The request includes an itemized statement from the prescriber's office, for this vaccine. The request also includes proof of payment for the vaccine and its administration fee. The Plan's out-of-network coverage rules were followed. The Plan does not provide any reason why the claim should not be paid at this time. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the Adacel Vaccine and its administration fee received March 22, 2018.
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 Retacrit purchased January 30, 2020. 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 purchased January 30, 2020 is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Retacrit purchased January 30, 2020 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 or provide reimbursement for Retacrit purchased January 30, 2020. 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 and reimbursement of Retacrit purchased January 30, 2020 under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nubeqa. 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 Nubeqa. The drug is requested to treat metastatic castration resistant prostate cancer, 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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Nubeqa 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 Nubeqa.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 Azithromycin 500 mg, Loratadine 10 mg, Beclometasone Dipropionate Nasal Spray, Ondansetron ODT and Loperaide 2 mg purchased November 2, 2019 and November 11, 2019 while on a cruise ship. The Plan did not grant this request. We received this case to conduct an independent review.Azithromycin 500 mg, Loratadine 10 mg, Beclometasone Dipropionate Nasal Spray, Ondansetron ODT and Loperaide 2 mg purchased November 2, 2019 and November 11, 2019 while on a cruise ship 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 Azithromycin 500 mg, Loratadine 10 mg, Beclometasone Dipropionate Nasal Spray, Ondansetron ODT and Loperaide 2 mg purchased November 2, 2019 and November 11, 2019 while on a cruise ship. 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: 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 Methyldopa 250 mg 60/30 purchased November 25, 2019. 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. Methyldopa 250 mg is not on the Plan's 2019 Formulary. However, the Plan provided documentation that a formulary exception was approved. The Plan verified the enrollee used an in-network pharmacy and the claim has not yet been processed. The Plan has not provided any reason why the claim should be denied at this time. The case record includes proof of payment for the November 25, 2019 purchase. The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is required to process and provide any applicable reimbursement for Methyldopa 250 mg purchased November 25, 2019.
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 Testosterone. 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 Testosterone 1.62% Gel Pump. The drug is requested to treat hypogonadism. The drug is on tier three 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.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type 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 Testosterone.
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 Methocarbamol, 750 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 Methocarbamol 750 mg tablets, 180/30.The drug is requested to treat cervical neck spasms and chronic pain syndrome, 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 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 Methocarbamol 750 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 Methocarbamol 750 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: Partially Favorable

You asked the Plan to provide reimbursement (or additional reimbursement) for Finasteride, Famotidine, Amlodipine, Olmesartan Medoxomil, Hydrocodone-Acetaminophen, Oxybutynin and Senna Lax received July 20, 2019 and July 21, 2019. The Plan did not grant this request. We received this case to conduct an independent review.OxybutyninThe Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received Oxybutynin 5 mg while at the hospital. This was an emergency or urgent care. You requested reimbursement from the Part D Plan. The Plan denied the request on the basis that the National Drug Code (NDC) provided (68084-0400-01) is an invalid NDC and therefore, not eligible for Part D coverage. The NDC provided for Oxybutynin is a repackaged NDC. We verified that Oxybutynin, NDC 68084-0400-01, was at one time an active, FDA approved prescription drug, eligible for Part D coverage. It is reasonable that a hospital would provide self-administered drugs that have been re-packaged. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide reimbursement Oxybutynin 5 mg received July 20, 2019 and July 21, 2019.Finasteride, Famotidine, Amlodipine, Olmesartan Medoxomil, Hydrocodone-AcetaminophenThe 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. 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. Although reimbursement might not have been provided, the Plan did apply the amount paid to your True Out of Pocket (TrOOP) expenses for the year.The case record indicates that the Plan provided coverage and reimbursement in accordance with the Part D Plan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provide any additional reimbursement for Finasteride, Famotidine, Amlodipine, Olmesartan Medoxomil and Hydrocodone-Acetaminophen received July 20, 2019 and July 21, 2019.Senna LaxMedicare 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, Senna Lax received July 20, 2019 and July 21, 2019 is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement 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 Corlanor, 5 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 Corlanor, 5 mg tablet.The drug is requested to treat chronic heart failure. 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 Corlanor, 5 mg tablet.