Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature
Treatment: Nutropin Aq Inj 10mg/2ml
The insurer denied the Nutropin Aq Inj 10mg/2ml
The denial is overturned

The patient is a male diagnosed with ISS (idiopathic short stature). This request is for Nutropin Starting dose of 0.9mg (milligrams) (0.34mg/kg/wk [milligrams per kilogram per week]). His GH (growth hormone) stimulation test with arginine and clonidine peaked at 16.40. His IGF1 (insulin-like growth factor 1) was 82 (62-347). His Z-score was -1.4 SD (standard deviation). His height velocity is reported to be 8 cm/yr (centimeters per year). Earlier in the year, his IGF1 (insulin-like growth factor 1) was 99 (62-347); IGFBP3 (insulin-like growth factor binding protein 3) was 3818. Approximately two years prior, his IGF1 (insulin-like growth factor 1) was 82 (62-347). He is at tanner 1.

The patient's weight was 18.6 kg (kilograms).

The patient's height approximately two years prior was 104.1 cm (centimeters) (- [minus] 2.27 SDS [standard deviation score]) and most recent was was 115.5 cm (centimeters) (- [minus] 2.62 SDS [standard deviation score]) with height velocity over 2 years 5 months of 4.7 cm/yr (centimeters per year).

The patient's mother's height is 149.86 cm (centimeters), and his father's height is 170.18 cm (centimeters). His mid-parental height is 166.52 cm (centimeters) (- [minus] 1.44 SDS [standard deviation score]).

Yes, the requested Nutropin is medically necessary.
The patient had a pretreatment height less than or equal to - [minus] 2.25 SD (standard deviation). The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria.

The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient, as the request is medically necessary as described above.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain and Vomiting. 
Treatment: Inpatient Admission. 

The insurer denied the inpatient admission. 
The denial is upheld. 

The patient is a male with no past medical history who presented to the emergency room with abdominal pain, watery diarrhea, and vomiting x 6 days. 

The patient had a temperature of 102. In the emergency room, he had diarrhea x 6 episodes over 3 hours. He had poor oral intake. He had tachycardia to 116 / min. The sodium was 132, bicarbonate was 19. The patient received IV (intravenous) fluids, Zofran. He was placed on a clear liquid diet and advanced as tolerated. The patient was discharged. 

No, the Inpatient admission was not medically necessary. 

The medical records do not support that the acute inpatient admission was medically necessary. The patient did not require services of such intensity that could have been safely and effectively provided only on an inpatient level of service. The health, safety, and medical condition of the patient would not have been threatened by providing the care given in a lower level of care setting. 

An inpatient level of care was not medically. The patient did not require any procedural or surgical intervention, did not require to be nothing by mouth for a prolonged duration of time, did not require prolonged treatment with intravenous hydration or intravenous medications, did not have acute kidney injury, did not have electrolyte derangement needing intravenous replacement, and did not have any complications such as intra-abdominal abscess or a surgical abdomen. 

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient. 

Based on review of the submitted medical records, the requested inpatient level of care was not medically necessary for the dates of service in question, as it exceeded in scope and intensity the level of care necessary to provide safe, adequate and effective treatment for this patient's condition.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Missing teeth. 
Treatment: Endosteal Implant (D6010). 

The insurer denied the Endosteal Implant (D6010). 
The denial is overturned. 

This female patient is under the care of an oral and maxillofacial surgeon (OMS) for the replacement of missing teeth # (number) 3 and #4 with dental implants. The patient was treatment planned for a sinus augmentation and dental implant placement. The sinus augmentation treatment plan was denied, but the request was approved on appeal. The patient has already undergone sinus grafting and is ready for the implants. The implants in the #3 and #4 areas at this time have been denied. 

Yes, the two dental implants are medically necessary. 

The patient is missing the right posterior molar and second premolar. To replace these teeth for functionality is medically necessary. The replacement of the teeth in question allows for the best function for this patient. This is further corroborated by the approval of the sinus graft. The replacement of the teeth from a fixed standpoint allows for better mastication and incising capability. The implants will prevent atrophy of the underlying alveolus where the partial allows for continual bony resorption. The implants will act like natural teeth where the partials are removable and are not like natural teeth. 

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient. 

The best approach to replace the missing teeth and allow for proper function is with the dental implants.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Problems. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Dupixent. 
The denial is upheld.

The patient is a female with request for Dupixent for atopic dermatitis. She has tried hydrocortisone 2.5%, and tacrolimus. She has nasal polyps and has tried triamcinolone and fluticasone over the counter (OTC). The subject under review is the medical necessity for the Dupixent.

The health plan's determination is upheld.

No, Dupixent is not medically necessary. For polyps, age is off label. For atopic dermatitis, the patient has not tried an oral systemic therapy or phototherapy.
Per Gerbens et al. "Methotrexate (MTX) and Azathioprine (A2A) seem to be effective and safe as maintenance treatments in moderate to severe atopic dermatitis (AD) up to five years".
Per Musters et al., "Compared to placebo or no treatment, narrow band ultraviolet B (NB-UVB) may improve physician-rated signs, patient-reported symptoms, and Investigators Global Assessment (IGA) after 12 weeks, without a difference in withdrawal due to adverse events"
The plan offered alternatives are also indicated for atopic dermatitis and can be tried.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Remicade 100mg (milligram) vial every 4 weeks.
The health plan's determination of medical necessity is overturned in whole.

This patient is a female. She has a history of very early onset inflammatory bowel disease (VEO-IBD), ulcerative colitis phenotype. She previously tried and failed corticosteroids. She was then started on infliximab however, she required dose escalation. Her drug level remains low. She has been recommended for dose escalation of infliximab to 15mg (milligram) per kg (kilogram) every 4 weeks.
At issue is the medical necessity of Remicade 100mg vial every 4 weeks (wks).

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Remicade 100mg vial every 4 wks is medically necessary for this patient.
Remicade (infliximab) dose escalation is medically necessary. The management of inflammatory bowel disease is very complicated, and the available treatments are limited. It is common for patients with inflammatory bowel disease to lose response to their biologic over time or to require higher than standard dosing to maintain adequate drug levels.
There are many peer-reviewed literature reports showing that low infliximab levels were associated with poor clinical response. The experience with dose escalation of infliximab has been extensive in both adult and pediatric patients. The available scientific evidence strongly supports the safety and efficacy of this approach. The use of higher doses and/or more frequent infusions is indicated and appropriate in this patient in order to maintain an adequate drug level and clinical remission. The requested dose of 15 mg per kg every 4 weeks is an acceptable dose when escalation of treatment is indicated.
According to the clinical practice guidelines "In ambulatory patients with ulcerative colitis (UC), infliximab (IFX) should be administered initially at 5 mg/kg per dose (at weeks 0, 2, and 6 followed by 5 mg/kg every 8 weeks for maintenance). Higher initial dosing should be considered in children with low body weight (less than [<] 30 kg) or high body mass index (BMI), and in the presence of higher inflammatory burden and hypoalbuminemia." (1) According to Taxonera, Carlos, et al, "In UC patients who lost response to infliximab during maintenance, infliximab dose escalation enabled recovery of short-term response in nearly 70% of patients. In the long term, 58% of patients maintained sustained clinical benefit, and 9 of 10 avoided colectomy. Short-term response was associated with an 86% reduction in the relative risk of colectomy." This patient has already tried and failed the standard dose of infliximab. Her drug level is very low, and she is at risk of antibody formation and treatment failure. There are no better treatment alternatives for this child. Therefore, dose escalation is recommended.
Therefore, the requested health service/treatment of Remicade 100mg vial every 4 wks is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Left frontal anaplastic oligodendroglioma. 
Treatment: New Century Health Regimen Zejula (niraparib). 

The insurer denied coverage for New Century Health Regimen Zejula (niraparib). 

The denial is upheld. 

The patient is a female with a history of left frontal anaplastic oligodendroglioma, radiation, and chemotherapy. The patient has completed 12 cycles of TMZ (Temozolomide). The treating provider is requesting treatment with Zejula which is under review. 

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. The proposed treatment is based on the presence of BRCA (breast cancer gene) mutation in this cancer. Among various strategies of inducing death in cancer cells, inhibition of poly (ADP (adenosine diphosphate) -ribose) polymerase (PARP) has emerged as a beneficial therapy when combined with other anticancer agents. There are a few publications recently, mostly exploring the further study of PARP inhibitors and a few small series. It is not recommended by any guidelines. 

New Century Health Regimen Zejula (niraparib) is not considered medically necessary for this patient. The patient has a history of left frontal anaplastic oligodendroglioma, radiation, and chemotherapy. The patient had Temozolomide (TMZ), Lomustine (CCNU), Procarbazine Hydrochloride + Lomustine + Vincristine Sulfate (PCV), Avastin and new leptomeningeal spread. Her cancer is BRCA positive. The patient has completed 12 cycles of TMZ. This is a multiple treated brain cancer patient, and the proposed therapy, while promising is still considered experimental/investigational at this time. 

Per Lal & Snape, (2021), "Central nervous system (CNS) cancers are among the most aggressive and devastating. Further, due to unavailability of neuro-oncologists and neurosurgeons, the specialized treatment options of CNS cancers are still not completely available in most parts of the world. Among various strategies of inducing death in cancer cells, inhibition of poly (ADP-ribose) polymerase (PARP) has emerged as a beneficial therapy when combined with other anticancer agents". 
Therefore, the request is not considered medically necessary. The health plan acted reasonably with sound medical judgment in the best interest of the patient. The insurer's denial of coverage for New Century Health Regimen Zejula (niraparib) is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Left frontal anaplastic oligodendroglioma

Treatment is New Century Health Regimen Zejula (niraparib)

The insurer denied coverage for New Century Health Regimen Zejula (niraparib)

The denial is upheld 

The patient is a female, with a history of left frontal anaplastic oligodendroglioma, radiation, and chemotherapy. The patient has completed 12 cycles of TMZ (Temozolomide). The treating provider is requesting treatment with Zejula which is under review.

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. The proposed treatment is based on the presence of BRCA mutation in this cancer. Among various strategies of inducing death in cancer cells, inhibition of poly (ADP-ribose) polymerase (PARP) has emerged as a beneficial therapy when combined with other anticancer agents. There are a few publications recently, mostly exploring the further study of PARP inhibitors and a few small series. It is not recommended by any guidelines.  

New Century Health Regimen Zejula (niraparib) is not considered medically necessary for this patient. The patient has a history of left frontal anaplastic oligodendroglioma, radiation, and chemotherapy. The patient had Temozolomide (TMZ), Lomustine (CCNU), Procarbazine Hydrochloride + Lomustine + Vincristine Sulfate (PCV), Avastin and new leptomeningeal spread. Her cancer is BRCA positive. The patient has completed 12 cycles of TMZ. This is a multiple treated brain cancer patient, and the proposed therapy, while promising is still considered experimental/investigational at this time.

Per Lal & Snape, (2021), "Central nervous system (CNS) cancers are among the most aggressive and devastating. Further, due to unavailability of neuro-oncologists and neurosurgeons, the specialized treatment options of CNS cancers are still not completely available in most parts of the world. Among various strategies of inducing death in cancer cells, inhibition of poly (ADP-ribose) polymerase (PARP) has emerged as a beneficial therapy when combined with other anticancer agents".
Therefore, the request is not considered medically necessary. The health plan acted reasonably with sound medical judgment in the best interest of the patient. The insurer's denial of coverage for New Century Health Regimen Zejula (niraparib) is upheld. Medical Necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Asthma
Treatment: Dulera
The insurer denied the Dulera.
The determination is overturned.

This is a patient with late preterm gestational status, severe persistent asthma, bronchiectasis, thick secretions, growth failure, and a concern for genetic syndrome, who was on Dulera and wants to continue Dulera.
At issue is whether the formulary drug [Advair Diskus, Advair Hydrofluoroalkane (HFA), Breo Ellipta, Symbicort] will be or has been ineffective, would not be as effective as the non-formulary drug Dulera, or would have adverse effects.
Advair, Breo Ellipta, Symbicort will have adverse effects. These agents have steroids that can be absorbed more than the Mometasone in the Dulera. Mometasone, as shown in multiple studies have a favorable absorption profile compared to other inhaled corticosteroids absorption profile through the lungs
The patient is also having growth hormone injections regularly for her short stature. Inhaled corticosteroids if absorbed at large quantities through lung lining, will have an adverse effect on patient's growth and ultimate height. Therefore, Dulera is medically indicated and is also indicated from a severe persistent asthma standpoint.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Deep vein thrombosis (DVT).
Treatment Eliquis (apixaban).

The insurer denied coverage for Eliquis (apixaban).
The denial is upheld.

According to the medical records, the patient is a female with history of cancer and Deep vein thrombosis (DVT), being treated with Eliquis.  The formulary drugs are warfarin and Xarelto. These drugs are Food and Drug Administration (FDA)-approved and not likely to cause adverse reactions. The incidence of adverse reactions from these drugs is much lower than "likely". These drugs had not been tried by this patient.     

There is no literature that Eliquis is more effective than the formulary alternatives. The appeal includes two articles, one with a lower rate of recurrence and higher intracranial and gastrointestinal (GI) bleeding. This was a retroactive study, which does not change the standard of care, and the absolute reduction in the probability of recurrent DVT was 0.006. This study has limitations, see references 1. The study in the appeal is not for DVT, which is the issue in this case.

Hellfritzsch, M. et al., "Venous thromboembolism (VTE) may affect all parts of the venous circulation, but frequently manifests as deep vein thrombosis or pulmonary embolism. Annually, around 10 million cases are diagnosed worldwide, and VTE constitutes a growing global health burden with increasing incidence and prevalence. VTE is associated with substantial morbidity and mortality, and about 30% (percent) of all patients with VTE experience a recurrent event within 10 years. Traditionally, vitamin K antagonists (VKA) have been the cornerstone in the treatment of patients with VTE, but the emergence of direct oral anticoagulants [DOAC] (dabigatran, rivaroxaban, apixaban, and edoxaban) has led to a substantial shift in the pharmacological management of VTE during recent years. All four DOACs are non-inferior to VKA in the prevention of recurrent VTE events and superior to VKA with regard to bleeding events. Therefore, international guidelines recommend DOAC therapy over VKA therapy following acute VTE." (3)

Budovich, A. et al., "Apixaban is a potent, direct, selective factor Xa (anticoagulant) inhibitor that was approved. This article reviews the pharmacology, pharmacodynamics, pharmacokinetics, clinical efficacy, and safety data for this agent." (1)

ELIQUIS HIGHLIGHTS OF PRESCRIBING INFORMATION, "ELIQUIS is a factor Xa inhibitor indicated: 1) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2) 3) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy." (2)                                                       

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Formulary Exception for Eliquis (apixaban) is upheld. Medical Necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atrial Fibrillation. 
Treatment: Apixaban. 

The health plan denied the prescription Drug of Apixaban as it does not meet the health plan criteria for a formulary exception. The reviewer has overturned in whole the health plan's determination. 

This case involves a patient with a history of paroxysmal atrial fibrillation, prior cardioversion and atrial fibrillation ablations 2 years apart. The patient has been anticoagulated with apixaban to prevent stroke and continues to do well on this medical therapy. The patient's health plan has denied a prescription benefit exception request for apixaban on the grounds that the patient does not meet the health plan criteria demonstrating treatment failure, intolerance and anticipated adverse effects to the formulary anticoagulants warfarin and Xarelto. The patient's treating provider is appealing this denial. 

Based on the documentation provided for his case, the formulary anticoagulants warfarin and Xarelto are inappropriate for this patient for the following reasons. This patient has a well documented history of significant bleeding due to her varicose veins making the formulary anticoagulants Xarelto and warfarin poor choices for anticoagulation given their higher bleeding risk compared to the non-formulary anticoagulant apixaban (1). Furthermore, based on published clinical trial data evaluating the safety and efficacy of the novel oral anticoagulants (NOACs) compared to warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation, NOACs are favored over warfarin given a lower risk of serious bleeding (2). For these reasons, apixaban is the best choice of anticoagulant therapy to prevent stroke due to atrial fibrillation and is safest for this patient given her history of bleeding.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atrial Fibrillation.
Treatment: Formulary exception for Eliquis.
The insurer denied the Formulary exception for Eliquis.
The denial is overturned.

The patient is a female with chronic atrial fibrillation. She has been on anti-coagulation for non valvular atrial fibrillation. She has been prescribed a DOAC (directly acting oral anticoagulants), Eliquis. Her present Plan's formulary allows warfarin or Xarelto.

Therefore, coverage for Eliquis was denied by the health plan due to another DOAC (directly acting oral anticoagulants) being on the formulary.

Yes, the health plan should cover the Formulary exception for Eliquis.
The non-formulary drug, Eliquis, has been shown to have superior outcomes with regard to stroke prevention in chronic atrial fibrillation. While Xarelto is an effective anti-coagulant for chronic atrial fibrillation, recent evidence does suggest superiority of Eliquis.

Apixaban (Eliquis) users had significantly lower rates of ischemic stroke or systemic embolism than those on rivaroxaban (Xarelto, 6.6 vs 8.0 per 1,000 person-years, HR [hazard ratio] 0.82, 95% (percent) CI [confidence interval] 0.68-0.98), according to researchers.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atopic dermatitis
Treatment: Opzelura Cream 1.5%
The insurer denied Opzelura Cream 1.5%.
The determination is overturned.

The patient has atopic dermatitis. She has tried and failed Dupixent, clobetasol ointment, triamcinolone ointment, and tacrolimus ointment. She has also failed prednisone. The medication under review is Opzelura Cream 1.5%.

The formulary drug triamcinolone has been ineffective, and the formulary drugs amcinonide, betamethasone, clobetasol, and desonide will be ineffective. The formulary drugs would not have adverse effects, more so than the non-formulary drug, Opzelura Cream 1.5%. The patient has already tried and failed triamcinolone, and therefore it is unlikely that any other topical steroid would be effective in managing her atopic dermatitis.
The patient has tried and failed all the conventional therapies for atopic dermatitis, including Dupixent, tacrolimus, prednisone and triamcinolone. Opzelura has been shown to be very effective for atopic dermatitis. Papp et al writes in "Efficacy and safety of ruxolitinib (RUX) cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies" that "RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated" (1). Baluvelt et al writes "Ruxolitinib cream rapidly decreases pruritus in atopic dermatitis: Pooled results from two phase 3 studies" (2). Simpson et al writes "In summary, ruxolitinib cream brought about substantial and clinically meaningful improvements in multiple patient reported outcomes (PROs)" (3). Given that the patient has failed the potent topical steroid triamcinolone, the other formulary topical steroids are unlikely to be effective.  

Therefore, the non-formulary drug Opzelura, which works through a different inflammatory pathway, is likely to be more effective than the formulary drugs for this particular patient in this particular scenario.