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

You asked the Plan to cover Dronabinol. 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 Dronabinol 5 mg. The drug is requested to treat refractory nausea secondary to severe gastroparesis,which is an off-label (non-FDA approved) use. Medical records which support this diagnosis wereprovided. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 Dronabinol 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 Dronabinol.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 Levalbuterol inhalation solution. 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 Levalbuterol inhalation solution. The drug is requested to treat wheezing and allergic rhinitis due to pollen, which are off-label (non-FDA approved) uses. 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 Levalbuterol inhalation solution 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 Levalbuterol inhalation solution. 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: Favorable

You asked the Plan to provide a tiering exception for Isosorbide Dinitrate 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 a tiering exception for Isosorbide Dinitrate 5 mg tablet. The drug is requested to treat angina. The drug is on Tier 3 of the Plan's formulary. Upon reconsideration, the prescriber states that you failed treatment with Isosorbide Mononitrate which caused rapid heart rate, stomach burning, and headache. The prescriber has indicated why all eligible lower tier alternatives on the Plan's formulary to treat your condition (1) would not be as effective for you as the requested drug; and/or (2) would have adverse effects for you. Our Physician Reviewer's opinion is that tiering exception criteria are met.Medicare rules permit a Plan to grant an exception to its tiering structure whenever it determines that the non-preferred or higher cost-sharing 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 met. Therefore, our decision is the Plan is required to provide a tiering exception for Isosorbide Dinitrate 5 mg tablet from the date of the Plan's initial denial.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Forteo. 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. Forteo is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Forteo.
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 Trintellix. 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 Trintellix 20 mg. The drug is requested to treat major depressive disorder. The drug is on Tier 4 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Trintellix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tradjenta. The Plan did not grant this request. Wereceived 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Tradjenta is a Tier 3 branddrug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is thePlan is not required to provide a tiering exception for Tradjenta.
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 Nalocet. 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 Nalocet, 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 Nalocet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Multaq. The Plan did not grant this request. Wereceived 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 Multaq 400 mg tablet. The drug is requested to treat atrial fibrillation. The drugis on Tier 4 of the Plan's formulary. There are no available (branded) lower tier drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 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 Multaq.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nuedexta 20-10 mg, 180 per 90 days. 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 Nuedexta 20-10 mg, 180 per 90 days. Nuedexta 20-10 mg, 180 per 90 days is requested for ongoing treatment of pseudobulbar affect. The Plan's Redetermination denial letter states that the Plan has approved prior authorization for the requested drug; however the Plan states that Nuedexta is limited to a recurring 30 day supply. Per correspondence dated April 21, 2020, CMS (The Centers for Medicare and Medicaid Services) has issued the following guidance in response to the public health emergency posed by COVID-19: Part D sponsors must suspend all quantity and days' supply limits under 90 days for all covered Part D drugs (as defined in 42 CFR 423.100) other than such limits resulting from safety edits. As such, an exception to the Plan's 30 day supply limit is warranted. Our Physician Reviewer's opinion is that criteria for an exception to the plan's maximum day supply limit are 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 met. Therefore, the Plan is required to cover the requested quantity of Nuedexta 20-10 mg, 180 per 90 days.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Valtrex, 1 gm capsule. 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 Valtrex, 1 gram capsule.The drug is requested to treat herpes zoster. The prescriber has not indicated why all alternatives requiredby the Plan (including acyclovir and famciclovir) would likely not be as effective for the enrollee as therequested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 Valtrex, 1 gm capsule.
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 conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Privigen 40 gram/400 ml intravenous solution. The drug is requested to treat non-familialhypogammaglobulinemia with non-Hodgkin lymphoma. You have not indicated (with patient-specificmedical rationale) why all alternatives required by the Plan would likely not be as effective for the enrolleeas 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 opinionis 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 Privigen.Please note: the request for a tiering exception (lower copayment) for Privigen was not reviewed. Wecannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover PS-UV-AHS Humira (CF) Pen. The Plan did not grant this request. Wereceived 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 PS-UV-AHS Humira (CF) Pen. The drug is requested for treatment of psoriasis. The prescriber hasindicated that the enrollee has failed topical therapy, Enbrel, and Stelara, and that the enrollee previouslyresponded to Humira. The Plan's denial letter states that their coverage criteria for Humuira requires priortherapy with a conventional oral systemic treatment, or contraindication to all conventional oral systemictreatments. The prescriber's Letter of Medical Necessity (not dated) states that the enrollee has diseaseaffecting her scalp, groin, nails, with a body surface area greater than 40%, and that DMARDs such asMethotrexate has been avoided due to their associated risks and side effects. The prescriber further statesthat the enrollee is currently suffering and that her quality of life is being negatively impacted by herpsoriasis. Medical records submitted with the request for reconsideration include a note from a patientencounter dated March 11, 2020. It is noted that at that visit, the enrollee was being treated with topicalagents only, she was in no apparent distress, and exam was notable for patches of psoriasis on the left upperabdomen, left upper back, and forearms. It is stated in the records that the enrollee would like to restartHumira. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Planwould likely not be as effective as the requested drug. Our Physician's opinion is that neither priorauthorization nor prior authorization exception criteria are met.Of note, although the enrollee has had more extensive involvement in the past, the prescriber's statementregarding areas of involvement and impact of disease do not reflect the enrollee's current status, based onthe medical records submitted.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover PS-UV-AHS Humira (CF) Pen.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% 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. Lidocaine 5% Patch is requested to treat chronic back pain related to lumbar radiculopathy and postlaminectomy syndrome. 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 - 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. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. On 05/08/2020 you sent additional information and medical records addressing the Plan's coverage criteria. You indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Lidocaine 5% Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cellcept. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cellcept 500 mg. The drug is requested to treat cardiac sarcoidosis, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 Cellcept 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 Cellcept.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.