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

You asked the Plan to cover Lidocaine 5% 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 Lidocaine 5% patch. Lidocaine 5% patch is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement 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 needed additional information from the prescriber to determine whether the enrollee is using Lidocaine 5% patch for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. 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. Therefore, our decision is that the Plan is not required to provide coverage for Lidocaine 5% 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 Relpax, 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 Relpax, 40 mg tablet.The drug is requested to treat migraine. 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 Relpax, 40 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Synthroid 75 mcg. 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 Synthroid 75 mcg tablet.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 Synthroid.
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 Buprenorphine 5 mcg patch. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that for prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions for which hospice coverage is being provided. In this case, the prescribing physician has indicated the enrollee is receiving hospice benefits and Buprenorphine 5 mcg patch is being used for treatment of a condition that is related to the terminal condition(s). Thus, Buprenorphine 5 mcg patch appears to be eligible for Part A coverage in this case. Drugs which are eligible for Part A coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to provide coverage for Buprenorphine 5 mcg patch. 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 enrollee's hospice benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% 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 Lidocaine 5% patch. Lidocaine 5% patch is requested to treat chronic back pain. 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 in the comparative section of DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Opioids did not significantly improve pain-related function compared with nonopioids (3.4 vs 3.3 points on the 11-point Brief Pain Inventory (BPI) interference scale), nonopioids significantly improved pain intensity (mean BPI, 4 vs 3.5), and opioids were associated with significantly more adverse effects (mean symptoms, 1.8 vs 0.9) over 12 months in a randomized trial in patients with either chronic back (65%) or hip or knee osteoarthritis (35%) pain despite analgesic use (N=240). In addition, the reference cited in DrugDex states: Among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioid medications did not result in significantly better pain related function over 12 months. Nonopioid treatment was associated with significantly better pain intensity. Therefore, the requested drug is being prescribed for a medically accepted indication.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. However, the prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Lidocaine 5% patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 2% gel. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine 2% gel.The drug is requested to treat chronic leg ulcer related to chronic inflammation, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Lidocaine 2% gel for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Lidocaine 2% gel. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Afrezza 90-4 unit inhaler as prescribed. 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 Afrezza 90-4 unit inhaler.The drug is requested to treat Type 2 diabetes mellitus. The Plan stated that the enrollee must have tried and failed at least two of the formulary alternatives of the requested drug prior to approval of a non-formulary request. In the Reconsideration appeal the prescriber stated that the enrollee tried and failed Novolog, Fiasp, Humalog and Apidra. Therefore, the prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore, the Plan is required to cover Afrezza 90-4 unit inhaler as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ferrlecit. 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. Ferrlecit 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 Ferrlecit. Therefore, the Plan is not required to cover Ferrlecit. 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 Zolpidem, 10 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 Zolpidem, 10 mg tablet.The drug is requested to treat insomnia. 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 Zolpidem, 10 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tacrolimus 1 mg and 0.5 mg capsules. The Plan did not grant this request. Wereceived 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 Tacrolimus 1 mg and 0.5 mg capsules. Tacrolimus is requested for the prophylaxis of organ rejection inthis kidney transplant recipient. The requested drug is subject to B versus D prior authorization criteria. Theenrollee received a kidney transplant on 4/20/2007. However, the enrollee did not have Medicare A or Bcoverage until 5/1/2013. Therefore, the requested drug is not eligible for coverage under Part B rules. Theenrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Tacrolimus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin ER 60 mg. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Oxycontin 60 mg ER. Oxycontin 60 mg ER is requested for ongoing treatment of severe pain related to polyneuropathy of unknown etiology. The Plan has indicated that Hysingla ER and Xtampza ER are on their formulary. You stated that the enrollee has failed and/or had adverse effects to Tramadol, Nucynta, Lyrica, Gabapentin, Cymbalta, and various non-medication treatments, and that the enrollee is stable on the requested drug. You stated that the enrollee's job entails that he is on his feet all day, and the enrollee reports that he is unable to function without his pain medication which have allowed him to continue to work, and care for his kids and himself. It sounds as if the enrollee has significant disability when his pain is not sufficiently treated; however Xtampza ER has the same active ingredient as the requested drug. 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 Oxycontin ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Metopirone 250 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Metopirone 250 mg capsule. Metopirone 250 mg capsule is requested for ongoing treatment of ACTH-dependent Cushing's syndrome. 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 is noted in DRUGDEX in the Adult Dosing section (Quick Answers view only): Orphan drug designation: Treatment of Cushing syndrome. Therefore, the requested drug is being prescribed for a medically accepted indication. You have discussed why other treatment options are not medically appropriate for this enrollee. You indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore, the Plan is required to cover Metopirone 250 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 tablet. The drug is requested to treat dermatomyositis, 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 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. 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 a tiering exception for Jardiance. The Plan did not grant this request. We received this case to conduct an independent review.The Plan provided documentation that coverage (reviewed as a step therapy review) was approved by the Plan. Therefore, we are dismissing the request for coverage for Jardiance. You should contact the Plan for more information regarding how and when coverage for Jardiance will be provided.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 tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Jardiance.