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

You asked the Plan to provide a tiering exception for Trulicity. 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 Trulicity. The drug is requested to treat type 2 diabetes mellitus. The drug is on Tier 3 of the Plan's formulary. There are no available lower tier biologic drugs on the Plan's formulary to treat your 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 your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Trulicity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cathflo Activase. The Plan did not grant this request. We received this case to conduct an independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Cathflo Activase is used to clear a catheter. Cathflo Activase use in this instance is not therapeutic. Thus, Cathflo Activase does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Cathflo Activase.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Pregabalin. 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 Pregabalin 50 mg capsule. The drug is requested to treat neuropathic pain related to multiple sclerosis and fibromyalgia. The drug is a generic drug on tier three of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (amitriptyline) (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 Pregabalin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Posaconazole DR, 100 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Posaconazole DR, 100 mg tablet is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Posaconazole DR, 100 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ninlaro. 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 Ninlaro. The drug is requested to treat pyoderma gangrenosum, which is an off-label (non-FDA approved) use.The enrollee is a 79 year old man with pyoderma gangrenosum and an underlying monoclonal gammopathy and a history of chronic lymphocytic leukemia and lung cancer. He has had pyoderma gangrenosum since 2013. It has been treated with Doxycycline, Otezla, Tacrolimus, Rituximab, Revlimid, Prednisone, Cyclosporine, Infliximab, Clindamycin, Rifampin, and intralesional steroids. Revlimid caused a Stevens-Johnson syndrome like reaction. He was found to have an IgA monoclonal paraproteinemia. He has worsening of his skin lesions. His IgA level has increased from 691 to 1054. The office note ofApril 14, 2020 indicates he has MGUS (monoclonal gammopathy of unknown significance). You request Ninlaro to treat him in combination with Dexamethasone.This review was done as a non-cancer case as the treatment is requested for the pyoderma gangrenosum. However, this reviewer also searched all the CMS approved cancer compendia and found no supporting citations to use Ninlaro to treat MGUS. The articles submitted by you were also reviewed and a PubMed search found no supporting citations for use in MGUS.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 Ninlaro 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 Ninlaro. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan, 550 mg tablet. 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 Xifaxan, 550 mg tablet.The drug is requested to treat bacterial overgrowth from intestinal blind loop syndrome, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. A request for prescriberstatement and medical records was sent. The prescriber returned a statement with the above noted diagnosisand no medical records. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Xifaxan, 550 mg tablet 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 Xifaxan, 550 mg tablet.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 Gilotrif. 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 Gilotrif. The drug is requested to treat cholangiocarcinoma, which is an off-label (non-FDA approved) use.The enrollee is a 69-year-old man with metastatic cholangiocarcinoma involving the liver. He has been treated with surgery, Gemcitabine, Capecitabine, radiation, Cisplatin, PEGPH2O, Atezolizumab, 5FU, Leucovorin, and Oxaliplatin. Foundation One CDx testing identified an ERBB2 fusion mutation suggesting possible response to Gilotrif. The prescriber requests Gilotrif to treat him. Journal articles were submitted in support of the request and were reviewed.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 Gilotrif 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 Gilotrif. 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 cover Procrit. 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 Procrit 10,000 unit/ml solution. The drug is requested to treat anemia in chronic kidney disease. On05/08/2020 the enrollee's power of attorney sent updated medical records showing a decrease in theenrollee's hemoglobin level to 10.5 grams/dL as of 04/29/2020 (from a level of 12 grams/dL on04/13/2020) indicating a rate of hemoglobin decline likely to result in a red blood cell transfusion, thusaddressing the Plan's coverage criteria. The enrollee satisfies the Plan's coverage criteria. Our PhysicianReviewer's opinion is that prior authorization criteria are met.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 aremet. Therefore, our decision is the Plan is required to cover Procrit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Motegrity. 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 Motegrity is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Motegrity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Promethazine HCL, 25 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 Promethazine HCL 25 mg.The drug is requested to treat gastroenteritis with nausea, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Promethazine HCL, 25 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 Promethazine HCL, 25 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: Unfavorable

You asked the Plan to cover Testosterone 1.62% gel. 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 Testosterone 1.62% gel. Testosterone 1.62% gel is requested to treat male hypogonadism and N52.9 Male erectile dysfunction, unspecified. 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. Therefore, the requested drug is being prescribed for a medically accepted indication.However, 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 Testosterone 1.62% gel.
Appeal type: Prescription Drug
Decision: Unfavorable

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

You asked the Plan to cover Intron A Solution Ophthalmic compound. The Plan did not grant this request.We received this case to conduct an independent review.BSS Salt Solution, part of a compound:For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. If a drug is not used for a medically accepted indication of therapeutic value on the body, itcannot satisfy the definition of a Part D drug. BSS Salt Solution part of a compound is used as to irrigatetissues of the eye as a dilutant in the reconstitution of the Intron A Ophthalmic Solution. BSS Salt Solution,part of a compound use in this instance is not therapeutic. Thus, BSS Salt Solution part of a compound doesnot meet the definition of a Part D drug. Therefore, the Plan is not required to cover BSS Salt Solution partof a compound.Intron A Solution, part of a compound:We are dismissing the request for Intron A Solution, part of a compound. The Part D Plan provideddocumentation that the request for coverage or payment for Intron A Solution, part of a compound wasapproved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for areconsideration review.Contact the Part D Plan to learn more about how and when coverage or payment will be provided for IntronA Solution, part of a compound.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ketamine HCL Solution and Ketamine Powder Compound. The Plan did not grant this request. We received this case to conduct an independent review.Ketamine HCL Solution:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ketamine HCL 10 mg/ml solution. The drug is requested to treat chronic low back pain/neuropathic pain, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Ketamine HCL 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 Ketamine HCL Solution.Ketamine Powder Compound:Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Ketamine Powder Compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Ketamine Powder Compound. This decision does not concern the medical necessity of the requested drugs. It only establishes if payment can be made under the Medicare Part D benefit.