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

You asked the Plan to cover Skyrizi. 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 Skyrizi 150 mg.Skyrizi 150 mg is requested for treatment of moderate to severe plaque psoriasis. The prescriber states that the enrollee has tried numerous topical corticosteroids and vitamin D, and that Methotrexate resulted in liver function abnormalities. It is noted that Humira, Enbrel and Cosentyx are on the plan's formulary. The prescriber states that because of liver function abnormalities, tumor necrosis inhibitors like Humira and Enbrel are contraindicated. The prescriber also states that the enrollee was in a one year clinical study of the requested drug that was reportedly beneficial. Although not initially stated, the prescriber added at the time of the request for reconsideration that the enrollee has IBD so Cosentyx is contraindicated.Medical records previously submitted to the plan were reviewed - it is noted that the enrollee had intermittent, transient mild elevated liver function tests on Methotrexate, and that the enrollee was still on Methotrexate at the time of a visit on September 11, 2019, there is no mention that the enrollee has a history of inflammatory bowel disease and no gastrointestinal symptoms were noted, and there was no documentation of the clinical trial mentioned by the prescriber. Of note, there is a precaution regarding the use of Cosentyx in patients with (active) inflammatory bowel disease, however the drug is not contraindicated for this indication, and as noted, there is insufficient documentation that the enrollee has active inflammatory bowel disease.The prescriber has not provided sufficient documentation as to 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 Skyrizi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Xifaxan 550 mg tablet.Xifaxan 550 mg tablet is requested for treatment of irritable bowel with constipation in this enrollee with dypspesia and a positive hydrogen breath test, 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 Xifaxan 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 Xifaxan. 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

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 cover Alvesco HFA. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Alvesco HFA. Alvesco HFA is requested to treat an unknown diagnosis. The prescriber was asked tostate the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in thecase file. The prescriber was also asked to address medical necessity for the requested drug. A responsefrom the prescriber was not received. Therefore, based on the current record, there is insufficientdocumentation that the requested medication is being prescribed for a medically accepted indication asdefined by Medicare law. In addition, an exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.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 needed additional information from the prescriber to determine whether theenrollee is using Alvesco HFA for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Therefore, our decision is that the Plan is not required to provide coverage for Alvesco HFA.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: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Tacrolimus 1 mg. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Tacrolimus 1 mg. The drug is requested for the prophylaxis of renal transplant rejection. 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. The enrollee satisfies the Plan'scoverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 that Medicare Part A paid for the transplant in question. In thiscase, we requested evidence from the Plan that Medicare performed the kidney transplant. The Plan did notrespond to our request. Because the Plan failed to provide claims data that supports that Medicare paid forthe transplant in question, based on the available information, we cannot verify that coverage would beavailable for the requested drug under Medicare Part B. Therefore, it is not eligible for coverage underMedicare Part B and we sent the request to our physician reviewer to review for coverage under MedicarePart D.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 ofTacrolimus for the diagnosed condition. As a result, Tacrolimus is being prescribed for a medicallyaccepted 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 Tacrolimus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rytary. 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 Rytary. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs of the same typeon the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tieringexception. 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 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 Rytary.
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 provide reimbursement for Levothyroxine 88 mcg purchased on March 13, 2020 at your pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Plan required an $8.00 copayment for up to a 30 days day supply of a Tier 1 drug purchased from a standard retail in 2020. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at the time of purchase. The record shows that Levothyroxine 88 mcg purchased on March 13, 2020 at your pharmacy was purchased for an amount that is less than or equal to the required copayment amount. The case record indicates that the Plan provided coverage in accordance with the Part D contract. Therefore, our decision is the Plan is not required to provide reimbursement for Levothyroxine 88 mcg purchased on March 13, 2020 at your pharmacy.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Carbinoxamine maleate 4 mg as prescribed. The Plan did not grant thisrequest. 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 Carbinoxamine maleate 4 mg tablet.The drug is requested to treat allergic sinusitis. On 06/08/2020 the prescriber sent additional informationand medical records addressing the Plan's formulary alternatives indicating past trial and failure of allalternatives. The prescriber has indicated why all alternatives required by the Plan would likely not be aseffective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harmto 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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore,the Plan is required to cover Carbinoxamine maleate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levbid (Hyoscyamine Sulfate ER). The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Levbid (Hyoscyamine Sulfate ER) is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Levbid (Hyoscyamine Sulfate ER). This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover and provide reimbursement for Rosuvastatin 10 mg received December 7, 2019 while you were a patient at the hospital. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the documentation shows you were at the hospital on December 7, 2019. This was a medical emergency or urgent care. During this stay Rosuvastatin 10 mg, a self-administered drug was administered. A request for reimbursement was submitted to the Plan. The record includes proof of payment in full for the Rosuvastatin received December 7, 2019 while you were a patient at the hospital. The Plan denied Rosuvastatin on the basis that it was repackaged into smaller sizes from bulk packaging. The hospital provided the National Drug Code (NDC) you received while in the hospital (NDC 50268-709-15). Information on the FDA National Drug Code Directory (NDC) website indicates that NDC 50268-709-15 is a valid, Part D eligible NDC. This NDC shows Rosuvastatin 10 mg is packaged in a blister package. The Plan may process the claim using this NDC. Therefore, our decision is the Plan is required to process and provide any applicable reimbursement for Rosuvastatin 10 mg received December 7, 2019 while you were a patient at the hospital.
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 Budesonide inhalation sol. 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 inhalation sol for the management of obstructive pulmonary disease.We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Budesonide inhalation sol has been prescribed, and confirmation of where this drug is being administered. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Budesonide inhalation sol is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Budesonide inhalation sol. 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: Partially Favorable

You asked the Plan to cover Fentanyl 25 mcg patch. 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 Fentanyl 25 mcg patch. The drug is requested to treat chronic cervical pain. On June 6, 2020 you sent additional information and medical records addressing the Plan's coverage criteria. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.You also asked the Plan to provide a tiering exception for Fentanyl 25 mcg patch. The Plan did not grant this request.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Fentanyl 25 mcg patch. The drug is requested to treat chronic cervical pain. The drug is a generic drug on Tier 4 of the Plan's formulary. You do 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 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 Fentanyl 25 mcg patch.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 Fentanyl 25 mcg patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xarelto 20 mg. The Plan did not grant this request. We received this case to conduct an independent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug if the lower tiers on the formulary only contain generic alternative drugs. Xarelto 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 Xarelto.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Otezla. 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. Otezla 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 Otezla. Please note that coverage of the drug has been approved by the Plan.
Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover and provide reimbursement for Zostavax (Zoster) Vaccine and its administration received at your prescribers office on February 28, 2020 . The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. The record indicates that you received Zostavax (Zoster) Vaccine, a Medicare covered vaccine at your physician's office on February 28, 2020. The case record includes proof of payment showing that you have paid the bill for the vaccine and its administration in full. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide applicable reimbursement for Zostavax (Zoster) Vaccine and its administration received at your prescribers office on February 28, 2020 .The Plan also denied the request on the basis that the National Drug Code (NDC) was not provided. Medicare rules state that when a plan sponsor could acquire missing information, such as the NDC number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. The Plan may utilize the remainder of the 30-day payment period after approval is granted to obtain missing information in order to determine the amount of reimbursement to be provided. Thus, the Plans reimbursement rules as stated in the Evidence of Coverage have been met, and the Plan should obtain missing NDC information in order to process applicable reimbursement.