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

You asked the Plan to cover Mektovi. 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 Mektovi 15 mg; 180/30. The drug is requested to treat pancreatic cancer, which is an off-label (non-FDA approved) use.The enrollee is an 85-year-old woman with metastatic pancreatic cancer involving bones and possiblylungs. She has been treated with surgery. Radiation is planned. She is expected to start chemotherapy with5FU and Onivyde in April. Her tumor has a BRAF V600 mutation suggesting possible response toMektovi. The prescriber requests Mektovi to be given with Braftovi to treat her. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. There was no peer-reviewed, clinically relevant, medical literature from anapproved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed fora medically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Mektovi for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Mektovi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. 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 Otezla.Otezla is requested for treatment of psoriasis involving the face, scalp and trunk in this 77 year old womanwho has not responded to topical therapy. The Plan has indicated that several biologic drugs are on theirformulary. You have not indicated why all alternatives required by the Plan would likely not be as effectivefor the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to theenrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer'sopinion 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 Otezla.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil 500 mg.Mycophenolate Mofetil 500 mg is requested for treatment of interstitial lung disease associated with autoimmune polymyositis, which is an off-label (non-FDA approved) use. The prescriber has discussed the rationale for prescribing the requested drug; however 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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 provide a tiering exception for Dyrenium. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Dyrenium is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Dyrenium.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Humira (CF) Pen. 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 Humira Pen 80 mg- 40 mg. The drug is requested to treat psoriasis. 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 Humira (CF) Pen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover OneTouch Ultra Blue Strip. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that the definition of a Part D drug includes medical supplies directly associated with the injection of insulin. Test strips, lancets and needle disposal systems are not considered medical supplies directly associated with the delivery of insulin for purposes of coverage under Part D. You asked the Part D Plan to provide coverage for test strips. Diabetic test strips are a medical supply that is specifically excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover OneTouch Ultra Blue Strip. This decision does not concern the medical necessity or appropriateness of the requested item. It only establishes if payment can be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of OneTouch Ultra Blue Strip under the Part B 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 a tiering exception for Repatha Sureclick 140 mg/mL. 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 Repatha Sureclick 140 mg/mL..Repatha Sureclick 140 mg/mL is requested to treat the enrollee's condition. The requested drug is a biologic drug on tier 3 of the Plan's formulary. There are no available lower tier biologic drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested 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 Repatha Sureclick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover and provide a tiering exception for Sirolimus 1 mg. The Plan did not grant thisrequest. We received this case to conduct an independent review.The case record indicates that Sirolimus is needed for a kidney transplant performed August 7, 2009. In thiscase, we sent a request for additional information to the Part D Plan. We requested the evidence that thePlan used to determine that Medicare paid for the transplant performed August 7, 2009. The Planresponded to our request, however the Plan failed to provide claims data that supports that Medicare paidfor the transplant in question. Based on the available information we cannot verify that coverage would beavailable for the requested drug under Medicare Part B. Therefore we asked our Physician Reviewer todetermine if other Medicare Part D coverage criteria are met.Coverage:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Sirolimus 1 mg. Sirolimus 1 mg is requested to treat kidney transplant. There is no evidence thatMedicare paid for your transplant; therefore the requested drug is not eligible for coverage under Part B.You satisfy the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria are met.Tiering:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Sirolimus 1 mg. The drug is requested to treat kidney transplant. The drug is onTier 4 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat yourcondition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion isthat tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sodium Ferric Gluconate Complex. 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. Sodium Ferric Gluconate Complex is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Sodium Ferric Gluconate Complex. Therefore, the Plan is not required to cover Sodium Ferric Gluconate Complex. 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 Tramadol HCL ER 100 mg, 60 per 30 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 Tramadol HCL ER 100 mg, 60 per 30 days. Tramadol HCL ER 100 mg twice daily is requested for ongoing treatment of chronic non-cancer pain. The Plan has a quantity limit for the requested drug of 30 per 23 days. The prescriber states that the enrollee is stable on this medication since 2014, and that the requested drug is not currently being titrated; however, the prescriber has not indicated that once daily Tramadol ER 100 mg or 200 mg have been failed. The prescriber has not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. 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 (60 per 30 days) of Tramadol HCL ER 100 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Euflexxa. The Plan did not grant this request. We received this case to conductan independent review.Medicare Part D does not cover devices. Euflexxa has been classified by the FDA as a device, not as adrug. Therefore, our decision is the Part D Plan is not required to cover Euflexxa.This decision does not address the medical necessity or appropriateness of the requested item. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
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 11 mg.The drug is requested to treat rheumatoid arthritis. 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 Xeljanz XR.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Ingrezza 80 mg. 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 Ingrezza 80 mg. Ingrezza is requested for ongoing treatment of tardive dyskinesia. The case file fromthe Plan is not available for this medical review. The Plan's denial letter indicates that Tetrabenazine andAustedo are on their formulary.The prescriber states that the enrollee has been stable on the requested drug since May 2018, and that achange in therapy is not in the best interest of the patient especially when Ingrezza is effectively controllinghis symptoms. Medical records submitted with the request for reconsideration support the prescriber's claimthat a change in therapy is not in the best interest of this enrollee. The records indicate that the enrollee hasa history of schizophrenia, tardive dyskinesia, substance abuse disorder, seizure disorder, and posttraumaticstress disorder and is on multiple medications including, but not limited to Prolixin Decanoate,Olanzapine, Ingrezza, Benztropine, and Keppra. The records support that a change in therapy will put theenrollee at risk for significant adverse clinical outcome.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as therequested 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'sopinion is that formulary exception criteria are metA 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 met. Therefore,the Plan is required to cover Ingrezza 80 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Topiramate. 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 Topiramate. Topiramate is requested for ongoing treatment of back pain associated with lumbarspondylosis, which is an off-label (non-FDA approved) use. The prescriber has indicated that the enrollee isstable on the requested drug, opioids are contraindicated for this enrollee, and that a change in treatmentwill result in sub-optimal control of the enrollee's pain; however the Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Topiramate 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 Topiramate.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 provide a tiering exception for Brilinta, 60 mg tablet. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of 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. Brilinta, 60 mg tablet is a Tier 3brand [biologic] drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore,our decision is the Plan is not required to provide a tiering exception for Brilinta, 60 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tradjenta. 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 Tradjenta 5 mg tablet. The drug is requested to treat diabetes. The drug is on tier three of the Plan's formulary. There are no available (branded) 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 Tradjenta.