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

You asked the Plan to cover AndroGel 1.62% Gel packet. 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 Androgel 1.62% (2.5g) gel packet.   The drug is requested to treat male hypogonadism/testicular hypofunction/low testosterone. 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 AndroGel 1.62% Gel packet.  Please note that the appeal request refers to AndroGel 1.62% Gel pump, and the Plan did not provide any documentation that a coverage determination/redetermination was reviewed for AndroGel 1.62% Gel pump, only AndroGel 1.62% Gel packet was reviewed. This review is for AndroGel 1.62% Gel packet only. If coverage for AndroGel 1.62% Gel pump is needed, a request should be sent to the Plan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine 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 Cyclobenzaprine HCL 10 mg tab 45/15. The drug is requested to treat muscle spasms in an enrollee with lumbar spondylosis, sacroiliitis, lumbar radicular pain and lumbar degenerative disc disease, which is an off-label (non-FDA approved) use. Medical records from date of service October 8, 2020 were provided which support these diagnoses.  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 Cyclobenzaprine HCL 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 Cyclobenzaprine HCL.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Amitiza. 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 Amitiza 24 mcg. The drug is requested to treat opioid induced constipation.  Upon reconsideration, the prescribing physician has submitted chart notes which support that the enrollee does not have known or suspected mechanical gastrointestinal obstruction. 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 Amitiza.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Auryxia, 210 mg tablet 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 Auryxia, 210 mg tablet.   The drug is requested to treat uncontrolled hyperphosphatemia in an enrollee with chronic kidney disease receiving hemodialysis. The prescriber sent a letter dated October 16, 2020, clarifying the medical history. The prescriber states the enrollee receives hemodialysis three times weekly. Her current labs include Phoshorus of 7.4, Calcium 7.5 and PTH 406. 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 Auryxia, 210 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Favorable

 You asked the Plan to cover Procrit . The Plan did not grant this request. We received this case to conduct an independent review.   In this case, the Plan denied Procrit on the basis that it is eligible for Medicare Part B. The case record indicates that the enrollee is no longer on dialysis. Therefore, we asked our Physician Reviewer to determine whether coverage criteria are met under Part D. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Procrit 40,000 units/mL 3 per 90 days. The drug is requested to treat anemia in chronic kidney disease not on dialysis. Upon reconsideration, you submitted an additional statement, chart notes, and laboratory reports. The enrollee has been off dialysis since July of 2020 and has had removal of Permacath. The enrollee had a hemoglobin of 8.8 g/dL on October 8, 2020. The enrollee has not been treated with erythropoietin in the previous month.  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 Procrit.
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 Ozempic. 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 Ozempic 2mg/1.5 ml. The drug is requested to treat type 2 diabetes mellitus. You have not indicated why all alternatives required by the Plan (such as, Trulicity, Symlin, Victoza) 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 Ozempic.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Latuda in a 90 day supply. 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 Latuda 120 mg 90 per 90 days. The drug is requested to treat bipolar disorder. The Plan limits the amount of the drug to 30 per 30 days as a recurring 30 day supply. Per guidance from the  Centers for Medicare & Medicaid Services (CMS) regarding the coronavirus disease 2019 (COVID-19) public health emergency, Part D sponsors must suspend all quantity and days? supply limits under 90 days for all covered Part D drugs (as defined in 42 CFR ? 423.100) other than such limits resulting from safety edits. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are 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 met. Therefore, the Plan is required to cover the requested quantity of Latuda in a 90 day supply.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcipotriene 0.005% Cream. 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 Calcipotriene 0.005% Cream.  The drug is requested to treat plantar pustulosis, 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 Calcipotriene 0.005% Cream 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 Calcipotriene 0.005% Cream.  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 Cyclosporine Modified. 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 B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant.  The case record indicates that Cyclosporine Modified is needed for a kidney transplant performed July 5, 1997. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Cyclosporine Modified is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Cyclosporine Modified.  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 Samsca. 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 Samsca. The drug is requested to treat hyponatremia. You do 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 you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you. 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 Samsca.
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 Aspirin DR. 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, Aspirin DR 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

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 Anucort HC. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare Part D does not cover LTE DESI drugs. Anucort HC is identified as an LTE DESI drug on the Centers for Medicare & Medicaid Services (CMS) website. Therefore, the Plan is not required to cover Anucort HC.   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: Favorable

You asked the Plan to cover Trokendi XR. 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 Trokendi XR 200 mg capsule. The drug is requested to treat migraine headache and epilepsy, unspecified, not intractable. The prescriber sent additional information and medical records on 10/16/2020 addressing the diagnosis and coverage criteria. The prescriber argues that Depakote/divalproex (sodium valproate and valproic acid in a 1:1 molar relationship) is unsafe as the enrollee is of childbearing age (28 years old). Per AHFS DI: Because of the risk of major congenital malformations and other adverse pregnancy outcomes (e.g., decreased IQ in offspring) which may occur very early in pregnancy, use of valproic acid should be avoided whenever possible in women of childbearing potential. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are met.  A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber?s statement. Based on a review of the available documentation, our Physician Reviewer?s opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Trokendi XR.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Northera 100 mg, 270 capsules per 90 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 Northera 100 mg capsule 270 capsules per 90 days. The drug is requested to treat hypotension with Parkinson's disease. The Plan limits the amount of the drug to 90 capsules for 30 days. Based on the CMS memorandum of April 21, 2020 due to the COVID-19 public health emergency Part D sponsors must permit enrollees to obtain the total days supply prescribed for a covered Part D drug (as defined in 42 CFR - 423.100) up to a 90-day supply in one fill (or one refill) if:  ? Requested by the enrollee,  ? PA or ST requirements have been satisfied; and No safety edits otherwise limit the quantity or days supply. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are 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 met. Therefore, the Plan is required to cover the requested quantity of Northera.
Appeal type: Prescription Drug
Decision: Partially Favorable

We previously issued a partially favorable reconsideration decision. In this decision we found that the Plan was required to process and provide any applicable reimbursement for Clonazepam 0.5 mg tablet and Donepezil HCL 10 mg tablet received January 16, 2020. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the specific National Drug Codes (NDCs) provided for Clonazepam and Donepezil had marketing end dates and are therefore not eligible for coverage under Medicare Part D. We reopened this case to address the Plan's argument.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances.In this case, you were a patient at the hospital on January 16, 2020 for an emergency or urgent care. You received several self-administered drugs during your stay and submitted a request for reimbursement to your Part D Plan.Clonazepam and Donepezil HCL:While a patient on January 16, 2020, you received Clonazepam 0.5 mg tablet, NDC 51079-881-20 and Donepezil HCL 10 mg tablet, NDC 0904-6409-61. Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We checked FDA sources and determined that Clonazepam, NDC 51079-881-20, had a marketing end date of April 30, 2017 and Donepezil HCL, NDC 0904-6409-61, had a marketing end date of April 30, 2019. Since the NDCs provided by the hospital both had marketing end dates prior to the date they were received; Clonazepam 0.5 mg tablet, NDC 51079-881-20 and Donepezil HCL 10 mg tablet, NDC 0904-6409-61 are not eligible for coverage or reimbursement under Medicare Part D. Therefore, the Plan is not required to cover or provide reimbursement for Clonazepam or Donepezil HCL received January 16, 2020.Our review for the remaining drugs at issue has not changed and is included below.Fish Oil, Lactobacillus (Floranex), Aspirin and Acetaminophen 325 mg: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, Fish Oil, Lactobacillus (Florauex), Aspirin and Acetaminophen 325 mg received January 16, 2020 while you were a patient at the hospital are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit.Multi Minerals and Calcium Plus Vitamin D3:Medicare law excludes certain drugs from Part D coverage. Multi Minerals and Calcium Plus Vitamin D3 are those excluded drugs because they are a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Multi Minerals and Calcium Plus Vitamin D3. Therefore, the Plan is not required to cover Multi Minerals and Calcium Plus Vitamin D3 received January 16, 2020 while you were a patient at the hospital. These unfavorable decisions do not address the medical necessity or appropriateness of the requested drugs. It only establishes that payment cannot be made under the Medicare Part D benefit.