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

You asked the Plan to cover Vyvanse. 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 Vyvanse. The drug is requested to treat idiopathic hypersomnia, 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 Vyvanse 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 Vyvanse. 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

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Clinolipid. We determined there was insufficient information to determine whether the requested drug is covered under Medicare Part B. After we issued our decision, we received new information. We reopened this appeal to conduct a second 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 Part B rules state that parenteral nutrition is covered for a beneficiary who has a permanent, severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the beneficiary's general condition. If the coverage requirements for parenteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.We previously issued an unfavorable decision finding that we did not have sufficient information to determine if the enrollee does or does not have a functioning GI tract and therefore were unable to verify whether Clinopid is eligible for a coverage review under Medicare Part D. Upon reopening the prescriber submitted additional information clarifying that the enrollee does not a have a permanent dysfunction of the GI tract. 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 Part B pays for services and supplies incident to the service of a physician (or other practitioner).We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested confirmation of how and where this drug is supplied and billed. A response to our request was not received in the timeframe required for review of this case. Clinolipid is a type of drug that is not usually self-administered. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage.As a result, the record does not establish that Clinolipid is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Clinolipid. 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 note, Prosol 20% and Dextrose 70% were previously dismissed in the original appeal because the Plan had not completed a Redetermination review. These drugs were not included in the reopening and therefore a review has not been completed. You may submit a request for a Reconsideration appeal with us if needed after the Plan issues an unfavorable Redetermination.This decision affirms our previous unfavorable decision, but on different grounds.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Pennsaid (Diclofenac Sodium). Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the requested drug is not being prescribed to treat a medically accepted indication. We reopened this case to address the Plan's argument.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Pennsaid (Diclofenac Sodium) 2% solution. Pennsaid (Diclofenac Sodium) 2% solution is requested to treat polyosteoarthritis (ICD-10 M15) and osteoarthritis of the hand (M19.049), which are off-label (non-FDA approved) uses. A reopening of this case is being requested by the Plan. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the diagnoses and formulary alternatives tried and failed. The prescriber submitted additional information along with the prescriber statement. The prescriber indicated a new diagnosis of osteoarthritis of the knee (ICD-10 M17.9). However, progress notes originally submitted do not support that the requested drug is being used to treat osteoarthritis of the knee. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for medically accepted indications 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 Pennsaid (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, 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 Pennsaid (Diclofenac Sodium).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.This decision reverses our previous favorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Cialis. Our Physician Reviewer determined that the requested drug is not covered because it was purchased outside of the United States. After we issued our decision, we received additional information. We reopened this appeal to conduct a second review.Cialis purchased from the clinic is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Cialis.Additionally, Medicare law excludes certain drugs from Part D coverage. Cialis is one of those excluded drugs because it is a drug used to treat erectile dysfunction. Therefore, the Plan is not required to cover Cialis.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.Please note, although the Plan may provide coverage for Cialis as a supplemental benefit and may provide coverage for drugs purchased outside of the United States in certain circumstances, this does not make it a Part D drug. Since Cialis is not a Part D drug it is not subject to the Medicare exception process. As a result, Maximus is unable to review or approve an exception to cover an erectile dysfunction medication purchased outside of the United States.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Alvesco. We determined that the requested drug met criteria for reimbursement. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that since coverage was previously denied under a separate appeal, reimbursement could not be authorized. We reopened this case to address the Plan's argument.Maximus reviewed and issued an unfavorable decision for coverage of Alvesco. Our Physician Reviewer determined that there are no citations in the Medicare approved compendia that support the use of Alvesco 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 was that the Plan is not required to provide coverage for Alvesco.After we issued our coverage decision, the Plan forwarded an appeal for reimbursement for Alvesco because they did not make a timely decision. We issued a favorable decision finding that no reason was provided by the Plan to explain why reimbursement should be denied. The Plan subsequently submitted a reopening request explaining that reimbursement was denied because the requested drug is not on the Plan's formulary and coverage has not been approved. The Plan is correct. Since coverage for Alvesco has been denied, reimbursement cannot be issued. Therefore, our decision is that the Plan is not required to cover or provide reimbursement for Alvesco.This decision reverses our previous favorable decision.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Tacrolimus. Our Physician Reviewer determined that criteria for coverage under Medicare Part D were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that since the enrollee was entitled to Medicare Part A at the time of the transplant, coverage for the requested drug is available under Medicare Part B, not Part D. We reopened this case to address the Plan's argument.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant.The case record indicates that Tacrolimus is needed for a kidney transplant. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage. Since the enrollee was entitled to Medicare Part A at the time of the transplant, the transplant is considered a Medicare covered transplant and Tacrolimus is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Tacrolimus.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.This decision reverses our previous favorable decision.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Aptiom. 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 Aptiom 400 mg tablet 60/30. The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 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 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 Aptiom.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dupixent 300 mg/2 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 Dupixent 300 mg/2 mL solution.The drug is requested to treat pruritus related to immunotherapy, 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 Dupixent 300 mg/2 mL 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 Dupixent 300 mg/2 mL. 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 Clomiphene Citrate, 50 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 Clomiphene Citrate, 50 mg tablet.The drug is requested to treat Male hypogonadism. 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. The following citation was referenced in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition:Testosterone levels and quality of life scores significantly improved in hypogonadal men treated with clomiPHENE in 2 prospective, open-label cohort trials (n=125 and n=86).Therefore, the requested drug is being prescribed for a medically accepted indication.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 Clomiphene Citrate, 50 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil. 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 Tadalafil 5 mg. The drug is requested to treat erectile dysfunction. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions for which the drug is not FDA approved, are excluded from coverage under Medicare Part D. Chart notes submitted do not support that the requested drug is being used to treat benign prostatic hypertrophy. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Tadalafil is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tadalafil. Therefore, the Plan is not required to cover Tadalafil. 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 Venclexta. 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 Venclexta. The drug is requested to treat light chain amyloidosis, which is an off-label (non-FDA approved) use.The enrollee is a 67-year-old man with light chain amyloidosis affecting his heart. He has 20% plasma cells in his marrow. FISH analysis showed 50% 13q14 deletion, p53 and 3 copies of 5p. He has been treated with Cytoxan/Bortezomib/Dexamethasone and Daratumumab. He has increasing free light chains. The prescriber requests Venclexta to be given with Ixazomib to treat him. A letter to the editor and an article from a non-CMS approved journal with 2 case reports were submitted in support 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. This reviewer did not find any supportive citations in a PubMed search. 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 Venclexta 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 Venclexta. 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 Gamastan. 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 Part B provides coverage of IVIG for the treatment of primary immune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, D83.9, G11.3) in the home.The case record indicates that Gamastan is prescribed for the treatment of a primary immune deficiency disease, ICD-10 D83.8 Other common variable immunodeficiencies and D83.9 Common variable immunodeficiency, unspecified and will be administered in the home. It appears that this medication qualifies for coverage under Part B rather than Part D. As a result, the record does not establish that Gamastan is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to provide coverage for Gamastan {under the Part D benefit.} 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.You may wish to submit this request to the Medicare Part B carrier.