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

Diagnosis:  Homocystinuria.
Treatment:  Cystadane.

The insurer denied coverage for Cystadane.  The denial is upheld.

This patient has a history of cobalamin C (methylmalonic aciduria with homocystinuria) disease and homocystinuria diagnosed by genetic testing.  The most recent homocysteine level was 77.2 and methylmalonic acid was 2.47, both of which are elevated and obtained while the patient was taking the drug, Cystadane.  The physician recommended continuing Cystadane to treat homocystinuria.

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

Cystadane is not considered medically necessary for this patient.  The documents provided by the treating provider do not document that there has been a clinical benefit. In fact, the request completed requesting a continuation of Cystadane note that there has NOT been a substantial decrease in homocysteine level.  It is also noted that no dose titration is planned and the current dose is to be continued.  Therefore, continuing the drug as requested would not be medically necessary under these circumstances.

Homocystinuria is an autosomal recessive disorder of homocysteine metabolism leading to increased plasma, urine and tissue accumulation of homocysteine and its metabolites. The clinical manifestations of classical homocystinuria include skeletal abnormalities, osteoporosis, ectopia lentis and/or severe myopia, cognitive impairment, developmental delay/intellectual disability, seizures, psychiatric disorders, atherosclerosis and thromboembolism.  If untreated, homocystinuria is a serious, life-threatening disease.  All clinical guidelines recommend the use of this medication for this indication.  However, since the patient has not had a reduction in homocysteine levels, the continuation of Cystadane would not be considered medically necessary.

The insurer's denial of coverage for Cystadane is upheld.  Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: subjective palpitations and lightheadedness

Treatment: inpatient admission

The insurer is denied coverage for inpatient admission

The denial is upheld. 

This female patient has a history of hypertension, asthma, and pancreatic pseudocysts.

Milliman Care Guidelines (MCG) recommends inpatient admission for patients with pulmonary embolism as evidenced by syncope, respiratory symptoms that are severe or persistent despite observation care, or positive cardiac biomarker. The patient was noted to have an elevated D-dimer. However, the patient had a perfusion study that noted a low probability for pulmonary embolism. There were no respiratory complaints. The patient had initial complaints that her blood pressure was going up and down. However, she was noted to be hemodynamically stable. CT scan of the head/brain was noted to reveal no new findings and additional work up to include an MRI could have been completed under observational care. There was a lack of significant findings to support inpatient admission.

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

The carrier's denial of coverage for the inpatient admission is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Respiratory System. 
Treatment: Inpatient Hospital. 
The insurer denied long term care facility. 
The denial is overturned.

The patient is a male with past medical history of anxiety, bipolar disorder, hepatitis C, major depressive disorder, tracheostomy tube with stenosis, chronic obstructive pulmonary disease (COPD), history of tobacco and alcohol abuse, and hypertension who had been admitted to rehabilitation facility. The patient underwent an assessment tool while at facility noting activity did not occur for tasks of meal preparation, ordinary housework, managing finances, managing medication, stairs, shopping, and transportation while noting capacity for all of these tasks was independent except for transportation which was total assistance. The patient was assessed at supervision with task of equipment management while independent with tasks of bathing, personal hygiene, dressing upper/lower body, walking, locomotion, transfer toilet, toilet use, bed mobility, and eating. Notes from the assessment stated per note the patient would be discharged to home as he remained independent with all care including self-suctioning. The assessment also noted the patient had no informal help.  The insurer sent initial adverse determination denial notice stating residential long-term care would be stopped because the patient's ability to care for himself had improved and he no longer required long-term residential services. The denial also stated the nursing assessment completed  indicated the patient was capable of caring for himself outside of a residential care facility. 

The health plan's determination is overturned. 

The patient was in a residential long-term care patient and initially the facility had noted the patient would be discharged with a discharge plan to home with home services. Subsequently, the facility realized the patient was homeless and had been incarcerated prior to his stay at the facility. The patient required assistance with activities of daily living (ADLs) of equipment management and transportation and did not have a safe discharge to a home setting. It was noted that the patient was fairly stable at the time of the assessment tool, but the patient still required some assistance with ADLs and Instrumental activities of daily living (IADLs) with no informal help. The assessment however did not take into account that the patient did not have a home and was homeless.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Gender Dysphoria. 
Treatment: Formulary exception for Estradiol Valerate 20mg/ml. 

The insurer denied the Formulary exception for Estradiol Valerate 20mg/ml. 
The denial is overturned. 

The patient is a female diagnosed with gender dysphoria (Transgender woman). This request is for Estradiol Valerate 20 mg/ml (milligrams per milliliter). As reported, she was transitioned from oral estradiol to injectable estradiol approximately three years ago and she has been on Estradiol Valerate since that time. She is a transgender woman and had insufficient feminization with oral estradiol. The physician would like to use injectable estradiol to avoid the hepatic first pass effect. The provider states that injectable estradiol has been studied to be more effective. 

Most recently, the patient's estradiol was 141.30. 

Yes, the health plan should cover the Formulary exception for Estradiol Valerate.
Treatment with estrogen is standard of care for adult and late adolescent male to female transgender patients [2-4]. Outcomes have been examined, and there is no increase in mortality in treating male to female transgender patients with estrogen [3, 4]. 

The physician reports that the patient has failed oral estradiol. Given the fact that the patient has failed the formulary alternative, the request is consistent with generally accepted standards of medical practice and is therefore medically necessary. The health plan should cover the Formulary exception for Estradiol Valerate.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder.
Treatment: Braces and treatment visit.
The insurer denied braces and treatment visit.
The determination is overturned.


The patient has an anterior crossbite on tooth 7. He presented with a skeletal Class I malocclusion with moderate crowding in the maxilla and mandible. Teeth 7 and 10 are undersized. He is treatment planned for 24-30 months of orthodontics to address the crowding and crossbite. At issue is the medical necessity of braces and treatment visit.
The treatment is medically necessary.
This patient presented with an anterior crossbite on tooth 7. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects. (1,2,3) If left untreated the damage that will likely occur to the patient's teeth will be much more time consuming to correct than the patient's existing orthodontic problem. For this reason, the treatment is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Problems.
Treatment: Dental/Orthodontic Procedure.
The insurer denied braces and monthly visits. 
The denial is overturned. 

The patient is a male with a Class III malocclusion. He has moderate spacing in the upper arch and minor crowding in the lower arch. He is missing tooth 4. Teeth 9 and 10 are in crossbite. He is treatment planned for 24-30 months of orthodontics to correct his malocclusion. The subject under review is the medical necessity for the treatment of braces and monthly visits.

The health plan's determination is overturned in whole. 

The treatment of braces and monthly visits are medically necessary for this patient. This patient presents with an anterior crossbite, maxillary spacing, and a skeletal jaw imbalance. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects. [1, 2, 3] These problems are much more time consuming to correct than the patient's current orthodontic problem.

The patient has significant spacing with teeth 9 and 10 in crossbite. These teeth have a high risk for restorative problems in the future, due to their traumatic occlusion with the mandibular teeth. He is already damaging his lower central incisors. Studies have shown that even the untreated dentition shows increased anterior irregularity with time, which will make treating this occlusion at a later time more difficult. [4] Orthodontic treatment now will likely prevent the need for future complicated periodontal and restorative procedures. For these reasons, orthodontic treatment is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders. 
Treatment: Pharmacy/Prescription Meds. 
The insurer denied Zeljanz. 
The denial is upheld.

The patient is a female with vitiligo. Her frontal hairline, antecubital fossa, and posterior neck are affected. She has failed tacrolimus ointment. The subject under review is the medical necessity for Xeljanz.

The requested health service/treatment of Xeljanz is not medically necessary for this patient. The patient has none of the diagnoses, such as rheumatoid arthritis, for which Xeljanz is a covered indication.
Xeljanz for the treatment of vitiligo would not be considered medically necessary, as it is to treat skin discoloration. According to the dermatologic literature, vitiligo is a pigmentary skin condition (1-2). Bolognia et al. writes in Disorders of Skin Pigmentation, that "The most common presentation of vitiligo is totally amelanotic (i.e., milk- or chalk-white) macules or patches surrounded by normal skin...Vitiligo is usually asymptomatic" (1). Therefore, treatment with Xeljanz is not medically necessary because vitiligo is considered a cosmetic skin condition.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis.
Treatment: Dupixent.
The insurer denied Dupixent.
The determination is upheld.

The patient has atopic dermatitis. The body surface area affected is 20%. She has tried and failed triamcinolone and tacrolimus. She has also failed mometasone, alcolometasone, and Aquaphor. The medication under review for medical necessity is Dupixent.

The requested health treatment of Dupixent is not medically necessary for this patient prior to a trial with the formulary alternative methotrexate.
Based on the evidence-based literature, the Dupixent is not medically necessary. According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the generic medicines such as methotrexate are effective treatments for the management of atopic dermatitis, including in pediatric patients (1, 2).
Within the peer-reviewed literature, in 2018, Gerbens et al writes "methotrexate (MTX) and azathioprine (AZA) seem to be effective and safe as maintenance treatments in moderate to severe AD up to 5 years" (3) Shah et al 2018 writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk" (4). There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis (5-8). The evidence-based literature is consistent. There are no unique clinical circumstances to this particular individual that would make Dupixent medically necessary. The patient has no true contraindications to the use of the preferred generic medications. The preferred agents, such as methotrexate, are appropriate agents for the treatment of the patient's atopic dermatitis including in pediatric patients. The formulary medications should be tried and failed prior to initiating Dupixent. Therefore, Dupixent is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chron's disease
Treatment: Stelara 90mg (milligrams) every 6weeks
The insurer denied Stelara 90mg every 6weeks. 
The health plan's determination is overturned. 

The patient is a male with Crohn's disease, as well as small bowel adenocarcinoma. He has failed Pentasa, Entocort, Remicade, Humira, and high-dose Entyvio. He started Stelara, with initial response. He has had abdominal pain, perianal pain, and fatigue starting 7 weeks after Stelara injections.

Stelara 90 mg every 6 weeks is medically necessary in this case. Stelara is Food and Drug Administration (FDA) -approved for the treatment of Crohn's disease, and a large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's disease. Guidelines for the treatment of Crohn's disease recommend the use of Stelara.
In this case, the patient had initial improvement, followed by symptoms and objective evidence of active disease. A study showed dosing intensification (90 mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response. One study showed that dose escalation was required and approximately half of patients, and successful in 61.1% of dose escalation attempts [5]. Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted. Additionally, the American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should...have their medication dose adjusted in order to attempt to optimize therapy".
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Problems. 
Treatment: Pharmacy/Prescription Drug. 

The insurer denied Tremfya. 
The denial is upheld.

The patient is a male with psoriasis. Body surface area involved is 15%. There are paid claims for methotrexate on file. The subject under review is the medical necessity for Tremfya 100 milligram per milliliter (MG/ML).

The requested health service/treatment of Tremfya 100 MG/ML is not medically necessary for this patient. Based on the evidence-based literature, the Tremfya 100 mg/ml is not medically necessary. There are no comparative, controlled studies showing that Tremfya has a superior efficacy and safety profile to all the formulary alternatives such as phototherapy. According to the "National Physician Specialty Society recommendations" for psoriasis - the American Academy of Dermatology Psoriasis Guidelines - and dermatology literature, phototherapy is an effective treatment for the management of psoriasis. (1, 2)
Within the peer-reviewed literature, Racz et al. writes "Phototherapy is a standard treatment option for psoriasis, generally applied if topical treatment modalities fail or are contraindicated...Phototherapy may lead to the clearance of psoriasis in 5 to 8 weeks." (3) Mehta et al writes "Ultraviolet (UV) B phototherapy is most appropriate for patients with greater than (>)10 % affected body surface area who have not responded to topical treatments...narrow band ultraviolet B (NB-UVB) ...effective treatment options for psoriasis...Long-term data on NB-UVB indicate that it has a good safety profile." (4)
Per the medical and scientific literature and/or evidence based clinical practice guidelines, and the information provided by the patient, the request for Tremfya is not necessary. The patient also has no true contraindications listed to a preferred treatment modality that would make the use of Tremfya medically more appropriate than phototherapy.
Therefore, the administration of Tremfya is not strongly supported for this patient, and Tremfya is not medically necessary for this patient based on the current evidence-based medical literature.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara 90MG/Ml. 
The denial was overturned.  

This is a male patient, who has severe Crohn's disease and has had a prior bowel resection. He previously tried and failed two anti-tumor necrosis factor (TNF) agents (infliximab and adalimumab) and two immunomodulators (6-Mercaptopurine and methotrexate). He was started on Stelara at standard dosing but did not achieve remission. He continues to have symptoms suggestive of a flare of his Crohn's disease and has low Stelara (ustekinumab) levels on therapeutic drug monitoring. Therefore, the attending gastroenterologist would like to escalate the dose of Stelara to 90 milligrams (MG)/milliliter (ML) every 4 weeks to treat the patient's severe Crohn's disease.
At issue is the medical necessity of Stelara 90MG/ML.

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

The requested health service/treatment of Stelara 90MG/ML is medically necessary for this patient.
Since this patient was not responding to a standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90MG every 28 days (4 weeks). Dose escalation in biologic therapy used in inflammatory bowel disease can be done based on clinical symptoms and signs or therapeutic drug monitoring by either increasing the dose or shortening the interval infusions or sometimes a combination of both.
Crohn's disease results from a pathological immune response to luminal antigens in genetically predisposed individuals. Since the causes of Crohn's disease are complex and only partially understood, treatment is based on the empiric use of anti-inflammatory drugs. Although multiple therapies for Crohn's disease currently exist, a substantial proportion of patients are unresponsive to conventional agents. Approximately a third of patients fail treatment with TNF antagonists, and up to 40% (percent) of patients who initially benefit subsequently lose response. Stelara (ustekinumab), a fully human IgG1-kappa monoclonal antibody, has emerged as a promising new treatment for both psoriasis and Crohn's disease. Clinical efficacy of ustekinumab in Crohn's disease was evaluated for the treatment of moderate to severe Crohn's disease in a randomized, placebo-controlled trial. The authors concluded that the ustekinumab response was more evident in patients who had previously received infliximab.
In a multi-center study, Fumery and colleagues found that two-thirds of patients recaptured response following treatment intensification with ustekinumab 90MG every 4 weeks. Similarly, Ollech and colleagues showed that shortening the ustekinumab 90MG dose interval to 4 weeks for patients with Chron's disease who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe.
Therefore, the requested health service/treatment of Stelara 90MG/ML is medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain. 
Treatment: Spine procedure (INTRACEPT) (C9752 & 22899). 

The insurer denied the Spine procedure (INTRACEPT) (C9752 & 22899).  The denial is upheld. 

The patient is a female with low back diagnosed with lumbar spondylosis. She has tried lumbar medial branch blocks with benefit and provider recommends lumbar radiofrequency ablation at L3-S1 (third lumbar spine vertebra-first sacral vertebra). The patient's physical examination is significant for painful flexion and extension, bilateral lumbar paraspinal tenderness, and palpable trigger points. The patient's pain medications include horizant, diclofenac, pensaid, hydromorphone, nucynta, percocet, and topamax. Her past medical history is significant for anxiety. 

The patient's provider also ordered Intracept procedure at L5-S1 (fifth lumbar spine vertebra-first sacral vertebra) on this date for low back pain. MRI (magnetic resonance imaging) from approximately two years prior, of the lumbar spine shows lumbar disc herniation and spondylosis without fracture. Modic changes were not noted on the report. 

The request for Intracept procedure was denied by the health plan as experimental/investigational.  No, the health plan should not cover the Intracept procedure. 

Review of literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on Type I or Type II Modic changes as well as other inclusion and exclusion criteria used in published literature to date. However, non-industry funded high-quality, large prospective studies are needed to confirm these findings. 

At this time there is not enough valid scientific evidence to show that the expected health benefits from the procedure, supply, equipment, or service are clinically significant and will have a greater chance of benefit, without a disproportionately greater risk of harm or complications, than other possible treatments; and that generally approved forms of treatment that are less invasive have been tried and did not work or are otherwise unsuitable. 

As such the Intracept procedure is considered experimental/investigational and should not be covered by the health plan. 

No, the Intracept procedure is not more beneficial than any standard treatment for the insured's condition or disease.