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

You asked the Plan to provide a tiering exception for Azopt 1%. 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 a tiering exception for Azopt 1% ophthalmic suspension.The drug is requested to treat ocular hypertension. The drug is on tier 4 of the Plan's formulary. There areno available (branded, equivalent) 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 tieringexception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Azopt 1%.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Vaniqa 13.9% Cream received June 16, 2020. The Plandid not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Vaniqa 13.9% Cream. Vaniqa 13.9% Cream is requested to treat female facial hirsutism. For coverageunder the prescription drug benefit, Medicare requires that the drug prescribed be used for a medicallyaccepted indication. Our Physician Reviewer found that the Medicare-approved resources do containcitations to support the use of the requested drug for treatment of the noted condition. Therefore, therequested drug is being prescribed for a medically accepted indication.However, drugs prescribed for cosmetic purposes are excluded from coverage under Medicare Part D.Therefore, the requested drug is excluded from coverageMedicare law excludes certain drugs from Part D coverage. Vaniqa 13.9% Cream received June 16, 2020from the hospital is one of those excluded drugs because it is a drug used for cosmetic purposes or topromote hair growth. The record submitted by the Plan does not indicate that they provide supplementalcoverage for Vaniqa 13.9% Cream. Therefore, the Plan is not required to cover or provide reimbursementfor Vaniqa 13.9% Cream received June 16, 2020.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Otezla 30 mg tab. The drug is requested to treat atopic dermatitis, which is an off-label (non-FDAapproved) use. The prescriber sent a letter dated 6/24/2020 clarifying the medical history. Medical recordsfrom date of service 5/15/2020 were provided which support this diagnosis. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Otezla for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Otezla.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 reimbursement for Travatan Z 0.004% purchased March 25, 2020. The Plan did not grant this request. We received this case to conduct an independent review.In this case, Travatan Z is not on the Plan's 2020 Formulary. Drugs that are not on the Formulary but the Plan agrees to provide coverage (known as a Formulary Exception). The Plan's documentation shows that Travatan Z has been approved for coverage (as a Formulary Exception) from March 21, 2020 through April 20, 20021. The record shows that when Travatan Z 0.004% was purchased on March 25, 2020, the claim straddled both the deductible stage and the initial coverage stage of the Part D benefit. An enrollee is responsible for the full cost of covered drugs until the deductible amount $100 is satisfied. The initial coverage phase requires a 50% coinsurance amount for this drug and day supply purchased.The Plan documentation shows that there was $100 remaining in the deductible phase of coverage. This amount is subtracted from the total cost of the drug. This left a remaining total drug cost owed of $698.90. This remaining balance was subject to the initial coverage stage coinsurance amount (50%). 50% of the remaining balance is $349.45. The total of the two figures owed during each benefit phase (deductible and initial coverage) is $449.45. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Travatan Z 0.004% purchased March 25, 2020 was applied to your yearly true out-of-pocket (TrOOP) costs. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Travatan Z 0.004% purchased March 25, 2020.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for the Estradiol ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February 5, 2020. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy statedthe Estradiol ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February5, 2020 is a bulk powder. Bulk powders used in pharmacy compounding are not reviewed and approved forsafety and efficacy by the FDA. Therefore, the Plan is not required to cover or provide reimbursement forthe Estradiol ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February5, 2020.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil 100 mg. The Plan did not grant this request. We received this case to conduct an independent review.You requested that the Plan provide coverage for Sildenafil 100 mg. The Plan approved coverage of [drug] based on the enrollee's supplemental benefit. We received this case to conduct an independent review. Medicare law states that a Plan is permitted to use a number of different tools or approaches to manage the coverage of drugs, including quantity limits. Medicare law allows for exceptions to a Plan's quantity limit for Part D drugs only. Sildenafil is not covered by Medicare Part D because it is a drug used to treat sexual or erectile dysfunction. In this case, the Plan is providing coverage for Sildenafil under the enrollee's supplemental benefits. Although the Plan is providing coverage for Sildenafil as a supplemental benefit this does not make it a Part D drug. Since Sildenafil is not a Part D drug it is not subject to the Medicare exception process. As a result, there is nothing in the Medicare law or rules that require the Plan review or approve an exception to their quantity limit for Sildenafil. Therefore, it is our decision that the Plan is not required to provide a quantity limit exception for Sildenafil. 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 Ciclopirox Shampoo 1%. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ciclopirox Shampoo 1%.The drug is requested to treat psoriasis unspecified, which is an off-label (non-FDA approved) use. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Ciclopirox Shampoo 1% 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 Ciclopirox Shampoo 1%.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cinacalcet. 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 Cinacalcet HCL 30 mg. The drug is requested to treat secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) not on dialysis, which is an off-label (non-FDA approved) use. Medical records from date of service April 23, 2020 were provided which support this diagnosis. The following citation in DrugDex, a Medicare approved compendium, does not support the use of the requested drug for the enrollee's condition: Cinacalcet is not to be used in patients with chronic kidney disease who are not receiving dialysis, as hypocalcemia may occur [3] [3]. Product Information: SENSIPAR(R) oral tablets, cinacalcet oral tablets. Amgen Inc. (per FDA), Thousand Oaks, CA, 2014. 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 Cinacalcet 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 Cinacalcet.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 Acthar. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Acthar.Acthar is requested to treat inflammatory polyarthritis. There was insufficient documentation tosubstantiate that the requested drug is being used to treat the stated condition. The prescriber was askedquestions to clarify the diagnosis being treated and/or to provide documentation to support the noteddiagnosis. The prescriber was also asked questions to address the Plan's coverage/formulary exceptioncriteria. A response from the prescriber was not received. Therefore, based on the current record, there isinsufficient documentation to support an exception to the Plan's coverage criteria.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 Acthar for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Acthar.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Propantheline Bromide. 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 Propantheline Bromide. The drug is requested to treat irritable bowel disease with diarrhea. You were asked to clarify the enrollee's diagnosis, because the underlying etiology of the enrollee's condition was unclear from the case file. You were also asked to provide supporting medical records and to address the Plan's formulary alternatives. A response from you 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, formulary exception criteria are not 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 no citations in the Medicare approved compendia that support the use of Propantheline Bromide 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 Propantheline Bromide. 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 Budesonide neb sol. The Plan did not grant this request. We received this caseto conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Budesonide neb sol for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide neb sol is administered through a nebulizer in the home for adiagnosis of COPD. There is no indication that it is not administered through a small volume nebulizer. Itappears that this medication is eligible for coverage under Part B rather than Part D. Drugs which areeligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is ourdecision that the Part D Plan is not required to cover Budesonide neb sol.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes 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 Nexium, 40 mg capsule . The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Nexium, 40 mg capsule iscurrently being covered for the enrollee through a formulary exception. Therefore, our decision is the Planis not required to provide a tiering exception for Nexium, 40 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mesalamine 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 Mesalamine DR 1.2 gm.Mesalamine DR 1.2 gm is requested for treatment of Lymphocytic colitis, 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 Mesalamine DR 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 Mesalamine DR. 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.Please note: the request for a tiering exception (lower copayment) for Mesalamine DR was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.