Persius/hicric huggingface dataset:
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 Albuterol HFA. 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 Albuterol HFA.Albuterol HFA is requested to treat an unknown diagnosis. You were asked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. You were also asked to address medical necessity for the requested drug and to provide relevant medical records. 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, an exceptions request based on medical necessity cannot be considered 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 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 Albuterol HFA 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 Albuterol HFA. 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 Diclofenac Sodium 3% Gel. 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 Diclofenac Sodium 3% Gel. The drug is requested to treat myalgia, chronic pain, cervicalgia and 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 Diclofenac Sodium 3% Gel 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 Diclofenac Sodium 3% Gel. 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Caplyta. 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 Caplyta. The drug is requested to treat F31.9, Bipolar disorder, unspecified, 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 Caplyta 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 Caplyta. 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

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 the Shingrix vaccine. 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. In this case, you received the Shingrix vaccine at your prescriber's office. You requested reimbursement form the Part D Plan. The request includes an itemized statement from the prescriber's office and proof of payment for the vaccine. The Shingrix vaccine is a Part D eligible vaccine on Tier 4 of the Plan's 2020 Formulary.The Plan indicates your request does not include the NDC (National Drug Code) number for the Shingrix vaccine. However, the Plan's file includes NDC 58160081912 which is a valid, Part D eligible NDC for the Shingrix vaccine. Medicare rules state that when a Plan sponsor could acquire missing information, such as the National Drug Code (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. If the NDC included in the file by the Plan is not the NDC verified with the prescriber's office, 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 reimbursement.The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the Shingrix vaccine.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epidiolex, 100 mg/mLsolution. 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 Epidiolex, 100 mg/mL solution.The drug is requested to treat Lennox-Gastaut syndrome. The enrollee does not satisfy the Plan's coverage criteria. In the Reconsideration appeal the prescriber addressed the Plan's requirement that the enrollee have, an EEG which has shown a pattern of slow (less than 2.5 Hz) spike-and wave complexes. The prescriber wrote, EEG was not seen by the health plan. EEG does show slowing as needed to be covered. The prescriber submitted medical records. The records state in the EEG summary that the EEG did show generalized background slowing, however, the prescriber did not address the plan's requirement that the EEG, has shown a pattern of slow (less than 2.5 Hz) spike-and wave complexes. In addition, the prescriber was asked on October 30, 2020, Does the patient have an EEG which has shown a pattern of slow (less than 2.5 Hz) spike-and wave complexes? The prescriber answered, No. 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 the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. 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 Epidiolex 100 mg/mL solution.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Finasteride. Our Physician Reviewer determined that formulary exception criteria were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that Finasteride was not prescribed for a medically accepted indication. We reopened this case to address the Plan's argument.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Finasteride 1 mg tablet. Finasteride 1 mg has been prescribed for ongoing treatment of benign prostatic hyperplasia in this 92 year old male. The prescriber has indicated that the enrollee failed Tamsulosin, developed side effects to Finasteride 5 mg, and has been successfully treated with Finasteride 1 mg since 2012. The prescriber's statement sufficiently addressed the formulary alternatives. The Part D QIC (qualified independent contractor) issued a favorable formulary exception decision for coverage of Finasteride 1 mg.The Plan has requested a reopening because they argue that benign prostatic hypertrophy is not a medically accepted indication for the use of Finasteride 1 mg. However, 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. AHFS DI (American Hospital Formulary Services Drug Information), a Medicare approved compendium, states the following: Finasteride is used to reduce prostatic size, urinary obstruction and associated manifestations (e.g., urinary hesitancy and/or urgency, nocturia), the risk of acute urinary retention, and the risk of the need for surgery (including transurethral resection of the prostate [TURP] and prostatectomy) in patients with symptomatic benign prostatic hyperplasia (BPH, benign prostatic hypertrophy). The list of references includes citations which report some beneficial effects with the 1 mg dose to increase maximal urinary flow rate and decrease prostatic volume. Therefore, the requested drug is being prescribed for a medically accepted indication.As noted, 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 Finasteride.This decision affirms our previous favorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously requested additional information from the prescriber to determine whether the Plan's prior authorization for Ninlaro were satisfied. We did not receive the information from the prescriber. As a result, we issued an unfavorable reconsideration decision. We subsequently received the additional information previously requested from the prescriber. We reopened this appeal to conduct a second review with the additional information.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ninlaro 2.3 mg. Ninlaro 2.3 mg is requested to treat multiple myeloma. This review is a reopening requested by the prescriber. Medical records were provided with the reopening that were not available at the time of the original review.The enrollee is an 80 year old man with multiple myeloma. He has been treated with Revlimid/Velcade/Dexamethasone, Revlimid/Dexamethasone and with Darzalex. His free lambda light chain level has been rising from 28.8 in 6/2020 to 58.4 on 10/29/20. Normal is 5.7 to 26.3. The prescriber requests Ninlaro to treat him in combination with Revlimid (Lenalidomide) and Dexamethasone. Per the FDA website, Ninlaro is indicated in combination with Lenalidomide and Dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.The enrollee has had more than one prior therapy and the drug will be used with Lenalidomide and Dexamethasone. Therefore, the enrollee meets the plan's prior authorization criteria.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. 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 Ninlaro for the diagnosed condition. As a result, Ninlaro 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 Ninlaro.This decision reverses our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Verzenio. Our Physician Reviewer determined that it was not prescribed for a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Verzenio. Verzenio is requested to treat recurrent grade 1 atypical meningioma with an NF2mutation, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical history and has detailed the rationale for prescribing the requested drug for treatment of this enrollee's condition; however, 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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Verzenio 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 Verzenio. 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.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Rytary ER. Our Physician Reviewer determined that formulary exception criteria were not met. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Rytary ER 36.25-145 mg capsule. Rytary ER 36.25-145 mg is requested for ongoing treatment of Parkinson's disease. The medical record indicates that this 88 year old woman was evaluated for worsening in freezing impacting gait and activities of daily living associated with poor balance, despite dosing of regular release Levodopa-Carbidopa every 3 hours. It is noted in the records that the enrollee experienced wearing off up to a half hour early. Rytary was initiated to bridge the doses of immediate release Levodopa; the prescriber states that Rytary has improved the enrollee's function and has reduced the enrollee's freezing episodes.The Plan has indicated that Levodopa-Carbidopa extended-release tablet is on the Plan's formulary. The prescriber has indicated that Sinemet CR tablet (Levodopa-Carbidopa ER tablet) is erratically absorbed, generally not effective in management of the enrollee's condition, and will not provide the function that Rytary has provided. The prescriber has provided a sufficiently strong statement indicating 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 Rytary ER.This decision reverses our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Granix. Our Physician Reviewer determined that it was not prescribed for a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.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 Granix 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 Granix. 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.This decision affirms our previous unfavorable decision.