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

You asked the Plan to cover Topamax. 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 Topamax 100 mg. The drug is requested to treat bipolar II disorder, 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 Topamax 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 Topamax.  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.  Please note, the Plan has indicated that Topamax 100 mg is currently being covered under the enrollee?s enhanced benefit. You may wish to contact the Plan regarding this.  Also, please note this appeal only addresses the request for Topamax. A representative of MAXIMUS contacted the prescriber's office to confirm which drug was actually being requested and were told that Topamax is the only drug being appealed at this time.
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 reimbursement for the Zoster vaccine received August 27, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   The Part D Plan covers certain vaccines purchased and/or administered out-of-network. If an enrollee receives a vaccine from an out-of-network provider, the enrollee will generally have to pay the full cost for the vaccine. The enrollee may then submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost.  In this case, the record shows that you were administered the Zoster vaccine on August 27, 2020. You submitted a request for reimbursement however, the record does not include proof of payment in full for the vaccine. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for the Zoster vaccine received August 27, 2020.  Please note: once you have paid the remaining balance for the vaccine and its administration fee, you may wish to obtain a statement showing a zero balance and submit that to the Plan as proof of payment. Until proof of payment is established, the Plan will not process the claims or provide reimbursement.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% ointment. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine 5% ointment. Lidocaine 5% ointment is requested to treat arthritic pain. The prescriber was asked to clarify the enrollee's diagnosis, because there was no prescriber statement or records of the enrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. 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 5% ointment 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 5% ointment.  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 Uceris Rectal Foam. 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 Uceris 2 mg Rectal Foam. The drug is requested to treat ulcerative colitis. Upon reconsideration, you submitted chart notes supporting the diagnosis of ulcerative colitis/ulcerative proctitis. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of this drug for this condition. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Budesonide rectal foam is indicated for induction of remission of active mild to moderate distal ulcerative colitis that extends up to 40 cm from the anal verge. There are no applicable utilization management criteria identified for coverage of the requested drug. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met.  Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Uceris Rectal Foam is on the Plan?s formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover Uceris Rectal Foam.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Cequa 0.09% Solution. 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 Cequa 0.09% Solution 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 Cequa 0.09% Solution.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Auryxia. 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 Auryxia 210 mg. The drug is requested to treat iron deficiency anemia related to chronic kidney disease not on dialysis. Vitamin and mineral products are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.  Medicare law excludes certain drugs from Part D coverage. Auryxia 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 Auryxia. Therefore, the Plan is not required to cover Auryxia.   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 Buprenorphine HCL, 2 mg SL 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 Buprenorphine HCL, 2 mg sublingual tablet.   The drug is requested to treat chronic pain, which is an off-label (non-FDA approved) use. The following citation was referenced in DrugDex, a Medicare approved compendium states;   Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [17].  17. Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.    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 Buprenorphine HCL, 2 mg SL 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 Buprenorphine HCL, 2 mg SL 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 provide a tiering exception for Micardis. 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 Micardis 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 Micardis.
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 Tresiba. The Plan did not grant this request. 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Tresiba is a Tier 3 brand 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 Tresiba.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tremfya . 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 Tremfya 100 mg/mL. The drug is requested to treat Plaque psoriasis. You have 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 Tremfya.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Megestrol Acetate. 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 Megestrol Acetate 40 mg/ml. Megestrol Acetate 40 mg/ml is requested to treat cachexia in an enrollee with neuroendocrine carcinoma and new liver lesions. The prescriber clarified the medical history in the request for reconsideration. Medical records from date of service September 28, 2020 were provided. These medical records document that you have a history of neuroendocrine carcinoma in the stomach. You have a recent loss of 30 pounds in the past two months with loss of appetite. The results of an abdomen and pelvis CT scan from date of service September 4, 2020 were provided. The CT scan documents that the liver is replaced by innumerable ill-defined rounded hypodense lesions. The largest liver lesion measures 8.6 x 5.0 cm in the right hepatic lobe. These are in favor of metastatic disease. 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 does not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for you, and/or would likely cause adverse reaction(s) or other harm to you. 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 Megestrol Acetate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62%. The Plan did not grant this request. We received this case to conduct an independent review.   We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Testosterone 1.62% which is subject to prior approval. Our Physician Reviewer needed additional information from you to make this determination. You were asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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%.
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 reimbursement for the Tenivac vaccine and its administration fee received October 1, 2019. The Plan did not grant this request. We received this case to conduct an independent review.   The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received the Tenivac vaccine at your prescriber's office on October 1, 2019. You then requested coverage and reimbursement from the Part D Plan. The Plan provided documentation that the claim has been processed and reimbursement was provided to the prescribers' office. Thus, the Plan does not owe any reimbursement to you as they have processed the claims. If you are owed money, the prescriber would be responsible for issuing your reimbursement. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is not required to provide reimbursement for the Tenivac vaccine and its administration fee received October 1, 2019.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Spravato. 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 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. Spravato 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 Spravato is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Spravato.  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 Spravato 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 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 1.5 mg/0.5 ml. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Trulicity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Febuxostat, 40 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 Febuxostat, 40 mg tablet.   The drug is requested to treat gout in an enrollee who had an adverse effect with allopurinol. 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 Febuxostat, 40 mg tablet.