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

You asked the Plan to cover Buprenorphine-Naloxone sublingual 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-Naloxone sublingual tablet. The drug is requested to treat chronic pain syndrome, 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 Buprenorphine-Naloxone sublingual 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-Naloxone sublingual 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 Epidiolex. 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 Epidiolex. The drug is requested to treat localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus, 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 Epidiolex 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 Epidiolex.  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 Dexilant DR. 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 Dexilant DR. The drug is requested to treat gastroesophageal reflux disease. The drug is on Tier 4 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 Dexilant DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Prolia. 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 Prolia. The drug is requested to treat osteoporosis. The drug is on Tier 2 of the Plan's formulary. There are no available lower tier biologic drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the 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 Prolia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Livalo. 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. Livalo is a Tier 3 brand 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 Livalo.
Appeal type: Prescription Drug
Decision: Favorable

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 BCG vaccine received April 7, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received the the BCG vaccine from your prescriber's office. You requested reimbursement from the Part D Plan. The Plan did not process the request. The BCG vaccine is a Part D eligible vaccine that is on the Plan's 2020 Formulary with no prior authorization and no quantity limit restrictions. Proof of payment for the vaccine has been provided. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the BCG vaccine received April 7, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica. 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 Lyrica. The drug is requested to treat polyneuropathy. The prescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file. The prescriber was also asked to address the request for tiering exception. 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, tiering exception criteria are not 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 no citations in the Medicare approved compendia that support the use of Lyrica 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 Lyrica.  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 request for a tiering exception (lower copayment) for Lyrica was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Clinpro 5000 Toothpaste purchased February 28, 2020. 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 for both safety and effectiveness. We determined that Clinpro 5000 Toothpaste is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover or provide reimbursement for Clinpro 5000 Toothpaste purchased February 28, 2020.  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: Favorable

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 Vaqta vaccine and its administration fee received June 8, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received the Vaqta vaccine from your prescriber's office. You requested reimbursement from the Part D Plan. The Plan did not process the request. The Vaqta vaccine is a Part D eligible vaccine on the Plan's 2020 Formulary. The request includes proof of payment for the vaccine and its administration fee. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the Vaqta vaccine and its administration fee received June 8, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha. 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 140 mg/mL.  The drug is requested to treat hyperlipidemia. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan?s prior authorization 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 Repatha.
Appeal type: Prescription Drug
Decision: Favorable

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 Oxycodone HCL 15 mg and Morphine Sulfate ER 15 mg purchased February 10, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare rules state that an individual that meets requirements under Medicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. According to enrollment records from CMS, you were determined to be entitled to an LIS, copay level 3, effective February 1, 2020 through December 31, 2020. For copay level 3, an enrollee is required to pay no monthly premium for benchmark plans, no deductible, and no copayments on Medicare Part D covered drugs. In this case, you purchased Oxycodone HCL 15 mg and Morphine Sulfate ER 15 mg on February 10, 2020 for more than the LIS copayment to which you are entitled.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract and with the LIS benefit to which you were entitled. Therefore, our decision is the Plan is required to provide reimbursement for Oxycodone HCL 15 mg and Morphine Sulfate ER 15 mg purchased February 10, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 mg.   The drug is requested to treat discoid lupus, 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 Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 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 Capecitabine. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. 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 coverage includes oral anti-cancer drugs that are prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti-cancer chemotherapeutic agents which would be covered if they were not self-administered and they were furnished incident to a physician's service as drugs and biologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancer drug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug. A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that are Covered, will receive a statutory denial as non-covered, but may be covered at appeal if used for a medically accepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents.  In this case the record shows that Capecitabine is being prescribed for a diagnosis of C44.92 Squamous cell carcinoma of skin, unspecified. Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancer chemotherapeutic agents. It appears Capecitabine may be eligible for coverage under Medicare Part B for the diagnosis provided in this case. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part D Plan is not required to cover Capecitabine.  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 Lynparza. 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 Lynparza 100 mg tablet.   The drug is requested to treat squamous cell carcinoma of left lung; clinical stage IIIA; pathologic stage IVB, which is an off-label (non-FDA approved) use. The enrollee is a 70 year old man with squamous cell carcinoma of left lung with CNS metastases. He was treated with Cisplatin/Etoposide (9/2019) and was maintained on Durvalumab (10/2019). The enrollee had progression after 3 months of therapy.  On 2/7/2020 resected CNS metastases showed squamous cell carcinoma of the lung confirmed.  The 2nd palliative treatment of Carboplatin/Paclitaxel/Pembrolizumab was started in 3/2020.  Foundation 1 mutation testing showed ATM mutation which could benefit from Niraparib, Olaparib, Rucaparib, or Talazoparib. The prescriber requests Lynparza to treat him.   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 Lynparza 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 Lynparza.  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.