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

You asked the Plan to cover Mekinist. 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 Mekinist 2 mg; 30/30. The drug is requested to treat lung cancer without a BRAF mutation, which is an off-label (non-FDA approved) use.The enrollee is a 73 year old man with comorbidities including multiple myeloma treated with chemotherapy. He has squamous cell lung cancer with bilateral lung involvement. He has been treated with surgery, radiation, and Keytruda. He has progression of the cancer. Foundation One testing identified an NF1 mutation suggesting possible response to Mekinist. The prescriber requests Mekinist to treat him. Information about a clinical trial was submitted in support of the request and was reviewed. No published results were submitted and this reviewer did not find any supporting citations in a PubMed search. 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 Mekinist 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 Mekinist. 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 Corlanor. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Corlanor. Corlanor is requested for treatment of tachycardia, sinus vs atrial tachycardia, which is an offlabel(non-FDA approved) use. The prescriber has indicated that the enrollee had significant adverse effectswith beta blockers, heart rate was not controlled with Cardiazem, and that a trial of Corlanor has resulted inimproved heart rate and symptom control; however the Medicare-approved compendia do not contain anycitations 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Corlanor for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Corlanor.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Flector 1.3% Patch. 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 Flector 1.3% Patch. The drug is requested to treat chronic pain/chronic low back pain with intervertebral disc degeneration, 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 Flector 1.3% Patch 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 Flector 1.3% Patch. 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 Humira. 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 Humira which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was 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 Humira.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Humalog Kwikpen. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Humalog Kwikpen. The drug is requested to treat the enrollee's condition. A request for prescriberstatement was sent and not returned. You have not indicated why all alternatives required by the Planwould likely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. 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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Humalog Kwikpen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xarelto 20 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 requestfor a tiering exception for Xarelto 20 mg. The drug is requested to treat pulmonary embolism and deep veinthrombosis. The drug is on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs onthe Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tieringexception. 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Xarelto.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vitamin D (Ergocalciferol). The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Vitamin D 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 Vitamin D. Therefore, the Plan is not required to cover Vitamin D. 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

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 Praluent. 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 Praluent 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 Praluent
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Deferasirox. 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 Deferasirox 500 mg. The drug is requested to treat iron overload. Brand Exjade is available on the Plan's formulary. You have not indicated why this alternative 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 Deferasirox.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol nebulizer solution. 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 Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Albuterol nebulizer solution for the management of obstructive pulmonary disease. In this case, the record shows that Albuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of asthma. The pharmacy claims show the residence is a group home, which, for Medicare Part B versus Part D determinations, this is considered the enrollee's home. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Albuterol nebulizer solution. 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 Sildenafil Citrate. 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 Sildenafil Citrate. The drug is requested to treat secondary pulmonary hypertension, 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 Sildenafil Citrate 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 Sildenafil Citrate. 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

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 Apixaban, Digoxin, Empagliflozin, Rosuvastatin, Tamsulosin, Metformin, Metoprolol Succinate, Sacubitril-Valsartan and Spironolactone received November 23, 2019 through December 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. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee may 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 the enrollee was a patient at the hospital from November 22, 2019 through December 1, 2019. The enrollee received Apixaban, Digoxin, Empagliflozin, Rosuvastatin, Tamsulosin, Metformin, Metoprolol Succinate, Sacubitril-Valsartan and Spironolactone for a medical emergency or urgent care. A request for reimbursement was submitted to the Plan with an itemized statement from the hospital. However, the record does not include proof of payment in full of the self-administered drug portion of the bill. Additionally, on March 24, 2020, a representative from MAXIMUS Federal contacted the hospital's billing department and verified that as of March 24, 2020 the self-administered drug portion of the bill has not yet been paid. 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 Apixaban, Digoxin, Empagliflozin, Rosuvastatin, Tamsulosin, Metformin, Metoprolol Succinate, Sacubitril-Valsartan and Spironolactone received November 23, 2019 through December 1, 2019 at this time.Please note: once you have paid the remaining balance of the self-administered drug portion of the bill, 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

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 Jardiance. 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. Jardiance is a Tier 3 brand drug. The lower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Jardiance.
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 cover Azithromycin received November 18, 2019 while on a cruise ship. The Plan did not grant this request. We received this case to conduct an independent review.Azithromycin received November 18, 2019 while on a cruise ship 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 Azithromycin received November 18, 2019 while on a cruise ship. This decision does not concern the medical 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 provide a tiering exception for Travatan Z 0.004% drops. 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 Travatan Z 0.004% drops 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 Travatan Z 0.004% drops.
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 Heparin Lock Flush received November 16, 2019 while aboard a cruise ship. The Plan did not grant this request. We received this case to conduct an independent review.Heparin Lock Flush received November 16, 2019 while aboard a cruise ship 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 Heparin Lock Flush received November 16, 2019.This decision does not concern the medical appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.