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

You asked the Plan to provide a tiering exception for Nuedexta. The Plan did not grant this request. Wereceived 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 thespecialty tier are not eligible for a tiering exception. Nuedexta is in the specialty tier. The record indicatesthe Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan isnot required to provide a tiering exception for Nuedexta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trelegy Ellipta. 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 requestfor a tiering exception for Trelegy Ellipta. The drug is requested to treat chronic obstructive pulmonarydisease. Trelegy Ellipta is a brand drug on tier 3 of the Plan's formulary. There are no available lower tierbrand drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug isnot eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria arenot met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Trelegy Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tresiba FlexTouch. 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 Tresiba FlexTouch 100 unit/ml.The drug is requested to treat E11.9 - Type 2 diabetes mellitus without complications. Tresiba FlexTouch is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type 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 Tresiba FlexTouch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Jardiance and Creon DR. The Plan did not grant this request. We received this case to conduct an independent review. You also requested we consider Incruse Ellipta.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for tiering exceptions for Jardiance 10 mg tablet and Creon DR 36,000 unit capsule.The drugs are requested to treat type II diabetes mellitus and pancreatic insufficiency in an enrollee with chronic pancreatitis. Jardiance 10 mg tablet is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan's formulary to treat the enrollee's condition. Creon DR 36,000 unit capsule is a biologic drug on Tier 3 of the Plan's formulary. There are no available lower tier biologic drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drugs are not eligible for tiering exceptions.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 Jardiance and Creon DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Amantadine. 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 Amantadine. The drug is requested to treat Paralysis agitans. The drug is a GENERIC drug on Tier 4 of the Plan's formulary. You do not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Amantadine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha. The Plan did not grant this request. We received this case to conductan independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether you areusing Repatha for an FDA-approved use, or a use listed in the Medicare-approved compendia. Therequested information was not received. As a result, we could not confirm that the drug is being prescribedfor a medically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit. An exceptions request based on medical necessity cannot be considered because itcannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decisionis that the Plan is not required to provide coverage for Repatha.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Pregabalin. The drug is requested to treat M54.5, low back pain, spinal stenosis and sciatica, which areoff-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Pregabalin for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Pregabalin.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover AndroGel. 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 AndroGel. The drug is requested for ongoing treatment of hypogonadism. Additional medical information was requested by the Part D QIC. You were asked to clarify the diagnosis and address prior authorization coverage criteria. The enrollee does not satisfy the Plan's coverage criteria. The prescriber statement was returned. You have not sufficiently addressed the Plan's coverage criteria (have not provided at least two confirmed low testosterone levels according to current practice guidelines) 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 AndroGel.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tresiba Flextouch. 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 if the lower tiers on the formulary only contain generic alternative drugs. Tresiba Flextouch is a Tier 3 biologic drug. The lower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Tresiba Flextouch.
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 NP Thyroid purchased January 9, 2020. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that NP Thyroid is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover or provide reimbursement for NP Thyroid purchased January 9, 2020. 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 Fentanyl. 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 Fentanyl 100 mcg/hr Patch 10 patches per 30 days. The drug is requested to treat short bowel syndrome in an enrollee with a history of arthritis and abdominal pain. The Plan limits the amount of opioids to 200 mg morphine milligram equivalents (MME) per day. The calculated MME is indicative of the amount of opioid the enrollee could potentially have on-hand (at their disposal) and may not be indicative of the actual daily dose of opioid the enrollee is currently taking (e.g., discontinued medication, switching opioid therapies). The accumulated morphine milligram equivalent dose per day, including the requested medication, is 270 mg/day. The prescriber was asked to indicate the morphine milligram equivalent dose warranted to adequately manage the patient's condition. The prescriber replied N/A. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Fentanyl.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for the Shingrix vaccine received October 22, 2019 andDecember 21, 2019. The Plan did not grant this request. We received this case to conduct an independentreview.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a $47 for up to a 30 day supply of aTier 3 drug purchased from a standard retail pharmacy in 2019. A request for reimbursement was submittedto the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Planat the time of purchase. The record shows that the Shingrix vaccine received October 22, 2019 andDecember 21, 2019 were purchased for an amount that is less than or equal to the required copaymentamount.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 the Shingrix vaccinereceived October 22, 2019 and December 21, 2019.
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 received September 25, 2019. 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 on September 25, 2019. You requested reimbursement from the Part D Plan. The Plan did not process the request. The request includes proof of payment in full for the vaccine and its administration fee. The itemized statement did not include the vaccine name; however, a representative from MAXIMUS Federal verified with the clinic that the vaccine provided was the Shingrix vaccine. The Shignrix vaccine is a Part D eligible vaccine that was on Tier 3 of the Plan's 2019 Formulary. 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 received September 25, 2019 from Park Nicollet Clinic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac Sodium. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Diclofenac Sodium 3% gel. The drug is requested to treat unspecified osteoarthritis and cervicalgia,which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain anycitations 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Diclofenac Sodium 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forDiclofenac Sodium.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Benzonatate purchased November 6, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Benzonatate is one of those excluded drugs because it is a drug used for the symptomatic relief of coughs and colds. The record submitted by the Plan does not indicate that they provide supplemental coverage for Benzonatate. Therefore, the Plan is not required to cover or provide reimbursement for Benzonatate purchased November 6, 2019. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil Citrate 20 mg. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Sildenafil Citrate 20 mg. The drug is requested to treat pulmonary hypertension (I27.20), WHO group2/3, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain anycitations 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Sildenafil Citrate 20 mg for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Sildenafil Citrate 20 mg.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mesalamine 400 mg. The Plan did not grant this request. We received this caseto conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forMesalamine, which is not on the Plan's formulary. Our Physician Reviewer needed additional informationfrom the prescriber to make this determination. The prescriber was asked to address whether the drugsoffered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) haveadverse effects. The requested information was not received. Based on a review of the availabledocumentation, 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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Mesalamine.