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

You asked the Plan to cover Polyethylene Glycol Powder. 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 Polyethylene Glycol Powder - NDC 38779028908. The drug is requested to treat constipation. Our Physician Reviewer's opinion is that Polyethylene Glycol Powder - NDC 38779028908 is not FDA approved.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Polyethylene Glycol Powder is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Polyethylene Glycol Powder. 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 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. The drug is requested to treat cardiomyopathy with ejection fraction not less than 35%, coronary artery disease, and inappropriate sinus tachycardia, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Corlanor for the diagnosed conditions. 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 these conditions. 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 Corlanor. 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 Rexulti . 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. Rexulti 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 Rexulti.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Savella. 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 Savella 100 mg. The drug is requested to treat fibromyalgia. You have not indicated why all alternatives required by the Plan (Duloxetine, Lyrica capsule, Lyrica oral solution, Pregabalin capsule, Pregabalin oral solution) 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 Savella.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide Nebulizer. 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 Budesonide Nebulizer for the management of obstructive pulmonary disease. In this case, the record shows that Budesonide Nebulizer is administered through a nebulizer in the home for a diagnosis of ICD-10-CM Diagnosis Code J44.9 - Chronic obstructive pulmonary disease, unspecified. 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 Budesonide Nebulizer.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: Favorable

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for cover Nulojix (Belatacept).We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nulojix (Belatacept) 5 mg. The drug is requested for prophylaxis of organ rejection in this kidney transplant recipient. The requested drug is subject to B versus D prior authorization criteria. The enrollee received a kidney transplant on October 27, 2017, which was covered under Medicare. However, the enrollee will be receiving the requested medication by home infusion. The requested drug is not eligible for coverage under Part B rules. The enrollee satisfies the Plan's coverage criteria.Our Physician Reviewer's opinion is that prior authorization criteria are met.Our decision is the Plan is required to cover Nulojix (Belatacept) .The Plan was asked to cover cover Nulojix (Belatacept). The Plan did not grant this 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 payment would be available under Parts A or Part B of Medicare for that individual. Medicare coverage rules specific to Nulojix (Belatacept) state that parenteral belatacept is not proven to be safe when administered in the home setting and therefore will be denied under Medicare Part B as not medically necessary when provided in that setting. In this case the record shows that Nulojix (Belatacept) will be administered at home. It appears this drug is not eligible for coverage under Medicare Part B as administered. Thus, Nulojix (Belatacept) is eligible for Part D coverage.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. The Plan's prior approval criteria for enrollees who are not newly started on this drug require a Medicare Part B versus Part D coverage review only. 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 Nulojix (Belatacept).
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Imatinib Mesylate 100mg. 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 Imatinib Mesylate (Gleevec) 100mg tablet.Imatinib Mesylate 100mg tablet is requested for the treatment of graft-versus-host disease (GVHD). The enrollee is a 62 year old male with a past medical history of myelodysplastic (MDS)/myeloproliferative neoplasms (MPN), who is status post allogenic haplo-identical stem cell transplant. Subsequent workup was concerning for disease recurrence. He was hospitalized for FLAG chemotherapy followed by DLI. His course is complicated by GVHD. The patient has been treated with Tacrolimus, Mycophenolate, Prednisone, and Cyclosporine. In December of 2019, the enrollee was placed on a Prednisone burst with some improvement, but soon began reporting recurring symptoms at lower doses, concerning for steroid-refractory GVHD. 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 NCCN compendium states the drug is indicated for chronic graft-versus-host disease (GVHD) as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options. 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 prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Imatinib Mesylate 100mg for the diagnosed condition. As a result, Imatinib Mesylate 100mg is being prescribed 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 are met. Therefore, our decision is the Plan is required to cover Imatinib Mesylate 100mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Propranolol HCL 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 a tiering exception for Propranolol HCL ER. The drug is requested to treat hypertension. The drug is a generic drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier beta-blocker alternatives on the Plan's formulary to treat the enrollee's condition (such as, Bisoprolol, Carvedilol, Metoprolol) (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 Propranolol HCL ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat and Briviact. 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 Vimpat 10mg/mL and Briviact 10mg/mL. The drugs are requested to treat the enrollee's condition. The drugs are brand drugs 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 drugs are 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 Vimpat and Briviact.
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.Medicare law excludes certain drugs from Part D coverage. Sildenafil Citrate 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 Sildenafil Citrate. Therefore, the Plan is not required to cover Sildenafil Citrate. 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 provide a tiering exception for Acitretin. 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 Acitretin 10mg capsule. The drug is requested to treat the enrollee's condition. The drug is a generic drug on Tier 3 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 Acitretin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Thyrogen. 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 Thyrogen. The drug is requested for a patient with papillary thyroid carcinoma (PTC), s/p total thyroidectomy (11/2018), s/p radioactive iodine (1/2019). The prescriber documented that the enrollee would undergo another whole body scan in 1/2020 after Thyrogen and annual ultrasound for surveillance of thyroid cancer. Based on the information provided, the drug would be eligible for coverage under Part B for the enrollee's condition. Thyrogen is covered under the Medicare Part B benefit when it is an integral part of a procedure that is a diagnostic service, and is therefore not covered under the Medicare Part D benefit. The enrollee does not satisfy the Plan's coverage criteria. Our Physician Reviewer's opinion is that the requested drug is not eligible for Part D coverage in this case.Medicare law specifically excludes coverage under Part D for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B pays for drugs and biologicals integral to diagnostic tests and which are not being prescribed for a therapeutic use. Medicare rules state diagnostic testing supply drugs are a category of drug that are not eligible for coverage under the Part D benefit and should not be included on a Part D sponsor's formulary. Thyrogen is being prescribed as integral to a diagnostic test. 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, our decision is that the Part D Plan is not required to cover Thyrogen. 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 Lidocaine 5% Ointment. 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% Ointment. The drug is requested to treat chronic pain, hip pain, degenerative joint disorder, and chronic low back pain, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 5% Ointment for the diagnosed conditions. 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 these conditions. 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 5% Ointment. 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 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. The drug is requested to treat interstitial lung disease due to sarcoidosis and hypersensitivity pneumonitis, 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

You asked the Plan to cover Pioglitazone HCL. 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 Pioglitazone (Actos) 15 mg tablet, 90 per 30 days. The drug is requested to treat type 2 diabetes mellitus. The Plan limits the amount of the drug to 30 tabs per 30 days. You are requesting a total daily dosage of 45 mg. You state that the 45 mg oral tablet is on backorder from the Pharmacy and other pharmacies. However, there is no shortage listed on the FDA website. You have not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported.Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Pioglitazone HCL.