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

You asked the Plan to cover Armodafinil, 250 mg tablet. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Armodafinil, 250 mg.The drug is requested to treat fatigue in an enrollee with multiple sclerosis, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 Armodafinil, 250 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Armodafinil, 250 mg tablet.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 provide a tiering exception for Trulance. The Plan did not grant this request. Wereceived 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs.Trulance 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 Trulance.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Humira Pen 40 mg/0.4 mL. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Humira Pen 40 mg/0.4 mL 2/28.The drug is requested to treat seronegative rheumatoid arthritis. Upon reconsideration, the prescribingphysician has submitted additional documentation supported by chart notes which indicate that the enrolleehas a diagnosis of seronegative rheumatoid arthritis and that the enrollee has failed treatment withMethotrexate and Arava. For coverage under the prescription drug benefit, Medicare requires that the drugprescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicareapprovedresources do contain citations to support the use of the requested drug for treatment of the notedcondition. The product label, available at drugs@fda, states that Humira is indicated for the treatment ofrheumatoid arthritis. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofHumira Pen 40 mg/0.4 mL for the diagnosed condition. As a result, Humira Pen 40 mg/0.4 mL is beingprescribed for a medically accepted indication as defined by Medicare law.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 aremet. Therefore, our decision is the Plan is required to cover Humira Pen 40 mg/0.4 mL.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Gamunex-C 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 Gamunex-C.The drug is requested to treat chronic inflammatory demyelinating polyradiculoneuropathy. On 03/02/2020 the prescriber sent additional information and medical records indicating the enrollee was trialed on prednisone for the condition with no improvement. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria 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 Gamunex-C as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nexium 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 Nexium DR. The drug is requested to treat gastroesophageal reflux. Upon reconsideration request, the prescriber has not provided a sufficient medical rationale why all of the plan's formulary alternatives are not appropriate for the enrollee. 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 Nexium DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Fentanyl. 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 Fentanyl 50 mcg/hr. patch. The drug is requested to treat the enrollee's condition. Fentanyl 50 mcg/hr. patch is a generic drug on tier 4 of the Plan's formulary. There are no available lower tier generic drugs of the same type 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 metMedicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type 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 Fentanyl.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Albuterol. 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 Ipratropium Albuterol for the management of obstructive pulmonary disease. In this case, the record shows that Ipratropium Albuterol is administered through a nebulizer in the home for a diagnosis of J43.9 Emphysema, unspecified and J43.1 Panlobular emphysema. 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 Ipratropium Albuterol.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 provide a tiering exception for Budesonide ER, 9 mg tablet. 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 Budesonide ER, 9 mg tablet 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 Budesonide ER, 9 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Adult Depends. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Adult Depends is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. 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 Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 mg.The drug is requested to treat IgG4-related disease, 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 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. 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 Cayston. 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 Cayston. Cayston is requested for ongoing treatment of this enrollee with bronchiectasis and history of Pseudomonas, Achromobacter and Nocardia, and also a past history of Mycobacterium avium complex pulmonary disease, 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 Cayston 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 Cayston. 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 Zolpidem Tartrate. 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 Zolpidem Tartrate. The drug is requested to treat insomnia. Zolpidem Tartrate is a generic drug on Tier 4 of the Plan's formulary. In the request for reconsideration dated 2/26/2020, the prescriber states the enrollee has tried and failed Temazepam 15 mg, Temazepam 22.5 mg, and Sonata 5 mg. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Zolpidem Tartrate.
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 the enrollee's condition. The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier 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 cover Tacrolimus, Prednisone and Mycophenolic Acid DR . The Plan did not grantthis request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare PartA at the time of the organ transplant.The case record indicates that Tacrolimus, Prednisone and Mycophenolic Acid DR are needed for a Kidneytransplant performed July 23, 2010. According to Medicare enrollment records, the enrollee wasdetermined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant isconsidered a Medicare covered transplant and Tacrolimus, Prednisone and Mycophenolic Acid DR areeligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excludedfrom Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to coverTacrolimus, Prednisone and Mycophenolic Acid DR.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 Livalo. 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 Livalo 2 mg tablet. The drug is requested to treat hyperlipidemia. The prescriber has not indicated why all alternatives required by the Plan (Atorvastatin and Pravastatin) 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 Livalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gelclair gel. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Gelclair gel has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Gelclair gel. This decision does not address the medical necessity or appropriateness of the requested item. 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 provide a tiering exception for Dupixent. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Dupixent is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Dupixent.