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

You asked the Plan to cover Coreg CR ER. 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 Coreg CR ER. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Coreg CR ER.
Appeal type: Prescription Drug
Decision: Partially 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 Twinrix vaccine received November 27, 2019 and June 30, 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 Twinrix vaccine at the clinic on November 27, 2019 and June 30, 2020. The Twinrix vaccine is a Part D eligible vaccine on Tier 3 of the Plan's 2019 and 2020 Formulary. You requested reimbursement from the Part D Plan. The request includes a statement for the November 27, 2019 date of service. The statement shows proof of payment for the vaccine. The record does not include proof of payment for the June 30, 2020 date of service. Additionally, a representative from Maximus Federal contacted the clinic in an attempt to verify proof of payment for the June 30, 2020 date of service but the information could not be verified.   The Plan's out-of-network coverage rules were followed for the November 27, 2019 date of service for Twinrix. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Twinrix received November 27, 2019. However, the Plan's criteria for out-of-network coverage and reimbursement have not been met for the June 30, 2020 date of service. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Twinrix received June 30, 2020.  Please note: once you have paid the remaining balance of the June 30, 2020 date of service 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

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 Hydroquinone Cream 4%. 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 Hydroquinone 4% topical cream. The drug is requested to treat brown spots on face/ hyperpigmentation of skin (ICD-10 L81.4). Additional medical information was requested by the Part D QIC. You were asked to address the diagnosis and formulary alternatives. The prescriber statement was not returned. Drugs prescribed for cosmetic purposes 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. Hydroquinone Cream 4% is one of those excluded drugs because it is a drug used for cosmetic purposes or to promote hair growth. The record submitted by the Plan does not indicate that they provide supplemental coverage for Hydroquinone Cream 4%. Therefore, the Plan is not required to cover Hydroquinone Cream 4%.   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 cover Contrave ER. 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. Contrave ER is one of those excluded drugs because it is a drug used for anorexia, weight loss or weight gain. The record submitted by the Plan does not indicate that they provide supplemental coverage for Contrave ER. Therefore, the Plan is not required to cover Contrave ER.   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 Promacta. 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 Promacta 75 mg. The drug is requested to treat thrombocytopenia secondary to chemotherapy, which is an off-label (non-FDA approved) use.  The enrollee is a 76 year old man with gall bladder cancer. He has been treated with surgery and chemotherapy including Gemcitabine, Abraxane, Cisplatin. He had treatment delays due to thrombocytopenia. He now has progression of the cancer and you plan to use Capecitabine and Gemcitabine. His platelet count was 89,000 (normal >150,000) on August 7, 2020. You request Promacta 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. 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 Promacta 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 Promacta.  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 Linzess, 145 mcg capsule, 30 per 30 days. 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 Linzess, 145 mcg capsule.   The drug is requested to treat constipation. The enrollee does not satisfy the Plan's coverage criteria - records do not indicate that the enrollee has tried and had an inadequate response to lactulose or that the enrollee has a documented intolerance, FDA labeled contraindication, or hypersensitivity to lactulose. 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 Linzess, 145 mcg capsule, 30 per 30 days.
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Hydromorphone HCL ER & Exalgo ER. The Plan did not grant this request. We received this case to conduct an independent review.   You asked the Plan to cover Hydromorphone HCL ER.  We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Hydromorphone HCL ER 32 mg 30/30. The drug is requested to treat chronic pain syndrome. Upon reconsideration, the prescribing physician has submitted a sufficiently strong statement supported by medical records as to why the formulary alternatives are inappropriate for the enrollee. The enrollee tried and failed treatment with Morphine Sulfate ER from March 1, 2017 to November 1, 2017, Xtampza ER from September 23, 2020 to October 8, 2002, and Fentanyl Patch from October 8, 2020 to October 20, 2020. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Elmiron, 100 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 a tiering exception for Elmiron, 100 mg capsule.  The drug is requested to treat chronic interstitial cystitis. The drug is a brand drug 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 Elmiron, 100 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tadalafil 5 mg. The drug is requested to treat erectile dysfunction and hypertension. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions for which the drug is not FDA approved, are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Tadalafil is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tadalafil. Therefore, the Plan is not required to cover Tadalafil. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Guanfacine. 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 Guanfacine. The drug is requested to treat obsessive compulsive disorder, unspecified tic disorder, in an adult enrollee with autism spectrum disorder and unspecified intellectual disability, 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 Guanfacine 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 Guanfacine.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 conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Corlanor 5 mg & 7.5 mg tablets. The drug is requested to treat heart failure with inappropriate sinus tachycardia. The enrollee does not satisfy the Plan's coverage criteria (no documentation of left ventricular ejection fraction of 35% or less). 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. A tiering exception cannot be considered as the enrollee does not meet prior authorization criteria.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 Corlanor.
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 tablet.The drug is requested to treat GAD65-antibody associated cerebellar ataxia, 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 Xifaxan, 550 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 Xifaxan, 550 mg tablet.The drug is requested to treat irritable bowel syndrome with diarrhea. The enrollee does not satisfy the Plan's coverage criteria - the enrollee has already received an initial 14-day course of treatment AND two additional 14-day courses of treatment with the requested drug. 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.In addition, the prescriber has stated in the appeal request that the drug is requested to treat intestinal bacterial overgrowth due to amyloid and motility 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.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 Xifaxan, 550 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyzulta. 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 Vyzulta 0.024% ophthalmic solution. The drug is requested to treat glaucoma. The prescriber has not indicated why one (1) additional formulary alternative required by the Plan (Latanoprost, Travatan, or Travoprost) 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 Vyzulta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nurtec ODT. 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 Nurtec ODT 75 mg tablet. The drug is requested to treat migraine headaches. The prescriber documented that the requested medication will be used in combination with another CGRP inhibitor (Aimovig). 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 Nurtec ODT.