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

You asked the Plan to cover Compounded Medication (Hydrocortisone Powder, Levofloxacin Powder, Clotrimazole Powder and Acetic Acid Liquid). 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. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Compounded Medication (Hydrocortisone Powder, Levofloxacin Powder, Clotrimazole Powder and Acetic Acid Liquid). 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 Compounded Medication (Hydrocortisone Powder, Levofloxacin Powder, Clotrimazole Powder and Acetic Acid Liquid).  This decision does not address the medical necessity or appropriateness 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 Tagrisso, 80 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 Tagrisso, 80 mg tablet; 30/30.The drug is requested to treat non-small cell lung cancer (NSCLC). The enrollee is a 78 year old woman with NSCLC involving pleural effusions. She has been treated with Carboplatin/Taxol and Keytruda. The prescriber requests Tagrisso to treat her. The prior authorization request indicates yes to EGFR exon19 deletion or exon 21 substitution but no to detected by an approved test. The visit note states next generation sequencing is pending and if EGFR mutation present can switch to Tagrisso. No mutation testing results were submitted for review. In response to inquiry the prescriber submitted Caris testing results indicating the tumor has an EGFR exon 21 L858R mutation. Per the FDA website, Caris testing is not one of the FDA approved tests. The prescriber did not explain whether or why testing could not be done by an FDA approved test. Therefore, the requested use does not meet the Plan's prior authorization criteria nor exception criteria.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 Tagrisso, 80 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcitriol. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.   In this case, Calcitriol is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Calcitriol is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Calcitriol.  This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.  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 Engerix B. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Medicare law states that Medicare Part B pays for the Hepatitis B vaccine for the prevention of illness for those individuals who are at high or intermediate risk of contracting Hepatitis B.   In this case, documentation in the record indicates that the enrollee is at high or intermediate risk of contracting Hepatitis B. Thus, it appears Engerix B would be eligible for coverage under Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Engerix B.   This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.  Please contact the Plan for more information regarding coverage of Engerix B under the Part B benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Repatha SureClick. 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 Repatha SureClick 140 mg/mL.  Repatha SureClick 140 mg/mL is requested for treatment of hyperlipidemia in this enrollee with known coronary artery disease, history of cardiomyopathy, type II diabetes mellitus, chronic kidney disease, and essential hypertension.  The enrollee does not satisfy the Plan's coverage criteria as there has only been documented failure of one statin. The prescriber indicates that the enrollee had previously been on Atorvastatin 20 and 40; however did not reach LDL goal.  The records indicate that on a combination of Lipitor 40 mg and Ezetimibe 10 mg daily, LDL (low density lipoprotein) was 157 in March 2019. As such a PCSK9 inhibitor was started.   The prescriber clarifies that the recent LDL of only 77 represents the impact of the PCSK9 inhibitor which the enrollee had already been on.  Based on the information noted, the prescriber asks for an exception to the plan's requirement regarding the trial of two statins.  In summary, the enrollee had marked elevation of LDL on maximal doses of Atorvastatin plus Ezetimibe, and has had significant LDL reduction with a PCSK9 inhibitor.  It is unlikely that other statins will provide sufficient LDL lowering. The prescriber has 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine/Prilocaine. 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-Prilocaine 2.5%- 2.5% cream. The drug is requested to treat pain related to multiple sclerosis, 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 Lidocaine/Prilocaine 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 Lidocaine/Prilocaine. 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 Pomalyst 2 mg capsule. 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 Pomalyst 2 mg capsule; 28 capsules per 28 days. The drug is requested to treat multiple myeloma. The enrollee is a 70 year old woman with multiple myeloma. She has been treated with Revlimid (Lenalidomide), Dexamethasone, stem cell transplant, Velcade, Kyprolis, and Daratumumab. She is currently on Daratumumab (Darzalex) and Dexamethasone.  MRI in July of 2020 showed new bone lesions and marrow biopsy showed minimal residual involvement by lambda light chain myeloma. You request Pomalyst to be given with Darzalex and Dexamethasone.   Per the NCCN compendium, Pomalyst is indicated for previously treated multiple myeloma with progressive disease &#61623; In combination with dexamethasone and daratumumab in patients who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor.The enrollee has received more than two prior therapies. She had Revlimid, an immunomodulatory agent and both Kyprolis and Velcade, proteasome inhibitors. Therefore she meets the NCCN recommended use. 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. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.   For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Pomalyst 2 mg capsule for the diagnosed condition. As a result, Pomalyst 2 mg capsule is being prescribed for a medically accepted indication as defined by Medicare law.  Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Pomalyst 2 mg capsule.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Sofosbuvir-Velpatasvir (Epclusa) 400 mg/100 mg. 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 Sofosbuvir-Velpatasvir 400-100 mg. The drug is requested to treat chronic hepatitis C, genotype 3, treatment-naive, without cirrhosis. Upon reconsideration, you have submitted an additional statement, chart notes, and diagnostic reports. The enrollee does not have cirrhosis based on September 1, 2020 FibroScan results. The drug and regimen requested are consistent with the American Association for the Study of Liver Diseases (AASLD) guidelines for the treatment of Hepatitis C. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer'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 are met. Therefore, our decision is the Plan is required to cover Sofosbuvir-Velpatasvir (Epclusa) 400 mg/100 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Afinitor, 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 Afinitor, 5 mg; 30/30.The drug is requested to treat cholangiocarcinoma, which is an off-label (non-FDA approved) use. The enrollee is a 70 year old woman with cholangiocarcinoma involving liver, bones and retroperitoneum Biopsy showed metastatic poorly differentiated adenocarcinoma. She has been treated with TACE (transarterial chemoembolization), Gemcitabine, Cisplatin, 5FU, Leucovorin, Oxaliplatin, Lenvatinib, Pembrolizumab and on a clinical trial with Nivolumab and Surufatinib. Foundation One testing revealed an NF2 alteration suggesting response to Afinitor (Everolimus.) The prescriber requests Afinitor to treat her. Medical literature was submitted in support of the request and was 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 Afinitor, 5 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 Afinitor, 5 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: Favorable

You asked the Plan to cover Icatibant Acetate 30 mg/3 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 Icatibant Acetate 30 mg/3 ml. Icatibant Acetate 30 mg/3 ml is requested for ongoing use to treat acute attacks related to the diagnosis of acquired angioedema. You state that the enrollee has effectively used the requested drug the last three years to abort life-threatening acute attacks. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Drugdex states the following in their Adult Dosing section for the requested drug (Quick Answers view only):  Orphan drug designation: Treatment of angioedema. The designation is not limited to hereditary angioedema. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have 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 Icatibant Acetate 30 mg/3 ml.
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 Femring. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Femring is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Femring.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 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 Diclofenac Sodium 1%.  Diclofenac Sodium 1% is requested for ongoing treatment of chronic back 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 Diclofenac Gel 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 Diclofenac Gel.  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.