Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Stage IV sacral pressure ulceration. 
Treatment: Grafix prime tissue engineered skin substitute. 

The insurer denied coverage for Grafix prime tissue engineered skin substitute. 

The denial is upheld. 

The scientific evidence does not support improvement in health outcomes. 

Grafix is Food and Drug Administration (FDA) approved. 

A multicenter, single-blinded, randomized controlled clinical trial conducted by Lavery et al. compared Grafix with standard of care treatments for diabetic ulcers.  A large, retrospective single-center study conducted by Regulski et al consisted of 66 patients with 67 chronic wounds and demonstrated a 76.1% wound closure rate for all types of wounds. This study had only six patients with non-diabetic, non-venous ulcers.  As noted by the auhors: "However, the absence of a control group is a limitation of the study due to its retrospective nature."  Thus, the data on the efficacy of Grafix for non-diabetic, non-venous ulcers is quite limited.  The published data is not sufficient to establish Grafix as an appropriate treatment for a non-diabetic, non-venous wound such as this patient's pressure sore wound. The patient is not a good candidate for Grafix engineered tissue. 

There are no adverse risks over standard treatments. 

There is insufficient scientific evidence to conclude that Grafix is more likely than standard treatments to improve this patient's pressure ulcer. 

In summary, the denial of Grafix prime tissue engineered skin substitute and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Class I occlusion 
Treatment: Braces
The insurer denied braces. The health plan's determination is upheld. 

The patient in question is a male with a Class I occlusion with 2 (two) millimeter (mm) overbite and 2(two) mm (millimeter) overjet. He has maxillary and mandibular crowing. He is treatment planned for orthodontics (braces) to correct his malocclusion. 

Full braces are not medically necessary.
There is no medical reason to correct his malocclusion with braces. While the patient has crowding, there is no anterior or posterior crossbite. There is no evidence of wear or periodontal recession. There are functional problems that may occur in the dentition that become more difficult, if not impossible, to correct if not addressed in adolescence. However, this patient presents with none of those conditions. Aligning his teeth will likely not increase chewing efficiency since masticatory efficiency is already highest in patients with a Class I occlusion.
The patient's overjet is within normal limits (2 [two] mm [millimeter]). His overjet would not affect oral health related quality of life unless it was greater than 6 (six) mm (millimeter). If his teeth were aligned, it would provide a minor esthetic improvement, but it would not create a medically significant improvement to the patient's health. Braces are not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Rheumatoid Arthritis
Treatment: Olumiant 2 milligrams (mg)
The insurer denied the Olumiant 2 milligrams (mg).
The health plan's determination is upheld.

The patient is a female with Mixed connective tissue disease (MCTD) with rheumatoid arthritis (RA) features (rash, arthritis, myalgias, pos Sjogren's syndrome A (SSA), RNP and cyclic citrullinated peptide (CCP)). The patient was previously on Cellcept and Plaquenil (stopped due to hyperpigmentation) and is currently on Olumiant only for treatment of MCTD and RA overlap. The issue in this case is Olumiant 2 mg is being denied by the health plan. The reason for the denial is the plan does not allow coverage of requested drug if it will be used in combination with another biologic, targeted synthetic drug or potent immunosuppressant, such as Imuran or Cyclocporine. Moreover, the plan does not allow coverage unless the patient has had an inadequate response or intolerable adverse events to all preferred products indicated for RA, including Enbrel, Humira, Kevzara, Rinvoq and Xeljanz.

The patient has not tried the formulary alternatives, which has similar adverse effects and would be equally effective to the non-formulary drug (Olumiant). There is no medical reason the patient cannot try one of the formulary medications. The patient is on Olumiant for treatment of her MCTD with RA overlap. Olumiant is a Janus kinase (JAK) inhibitor. Both Rinvoq and Xeljanz (other JAK inhibitors) are on the health plan's formulary and are effective for the treatment of her disease. For example, as published in Ann Rheum Dis in 2016, 'Tofacitinib demonstrated efficacy in both biological disease-modifying antirheumatic drug (bDMARD)-naive and bDMARD inadequate responder (IR) patients with RA. Clinical response to tofacitinib was generally numerically greater in bDMARD-naive than bDMARD-IR patients. The safety profile appeared similar between subpopulations'. Likewise, there is no medical reason the patient cannot try Enbrel, Humira or Kevzara, which are all indicated for RA as well.

The health plan's determination is upheld in whole. There is no reason the patient cannot try one of the formulary medications, which are equal in terms of efficacy and safety to the non-formulary drug.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Deviated Nasal Septum and Nasal Valve Collapse
Treatment: Repair of Nasal Vestibular Stenosis 
The insurer denied the repair of nasal vestibular stenosis.
The health plan's determination is overturned.
The patient is a female who underwent a septoplasty, turbinectomy and repair of nasal valve/vestibular stenosis using spreader autologous harvested septal cartilage grafts. She had symptoms consistent with nasal congestion/obstruction. The nasal endoscopy/clinical examinations were consistent with nasal valve stenosis, deviated septum and turbinate hypertrophy. She underwent maximal medical therapy, including intranasal corticosteroids without improvement in symptoms. The patient underwent septoplasty, turbinectomy and repair of nasal valve/vestibular stenosis.

The patient has completed maximal medical therapy for nasal congestion/obstruction, including using intranasal corticosteroids, nasal strips, and a thorough clinical examination and in-office nasal endoscopy. Given that the patient had numerous anatomic causes for persistent nasal congestion/obstruction, including nasal valve stenosis, the proposed health service/treatment repair is likely to be more beneficial than standard medical care. Given the presence of nasal vestibular stenosis, standard septoplasty and turbinectomy would likely be insufficient for adequate control of symptoms. The patient does meet appropriate criteria, both by clinical standard and by the health plan's written criteria.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Deviated Nasal Septum and Nasal Valve Collapse
Treatment: Repair of Nasal Vestibular Stenosis 
The insurer denied the repair of nasal vestibular stenosis.
The health plan's determination is overturned.
The patient is a female with a history of a deviated nasal septum and nasal valve collapse. The surgeon was requesting a repair of her vestibular stenosis based on the patient's examination. The procedure was denied because it was "not demonstrated through prevailing peer-reviewed medical literature to be safe and effective for treating or diagnosing the condition."
The surgery was performed in which the nasal septum was repaired along with correction of the internal nasal valve. The pre-operative treatment included Flonase to help with the nasal congestion. In addition, the examination before the surgery did show collapse of the internal nasal valve.

The patient had evidence of nasal valve collapse on examination and failed conservative therapy. Based on the clinical history and examination, the procedure was indicated. This is more likely to be beneficial. There was no evidence that this was cosmetic or should be considered experimental.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Deviated Nasal Septum and Nasal Valve Collapse
Treatment: Repair of Nasal Vestibular Stenosis 
The insurer denied the repair of nasal vestibular stenosis.
The health plan's determination is overturned.
The patient is a female with nasal obstruction. Medical management included nasal steroids. The examination revealed a deviated septum, turbinate hypertrophy and nasal valve collapse. The patient underwent a closed septorhinoplasty. A nasal valve was repaired with spreader grafts.

The repair of the patient's nasal valve collapse with spreader grafts is considered the standard of care treatment for a person with nasal valve collapse refractory to medical management. There are no medical alternatives to this procedure. There are no surgical alternatives to this procedure that have been shown to improve outcomes in the long term. This is not a cosmetic procedure. This is not an experimental or investigational procedure.
The cause of nasal obstruction can often be attributed to pathologic conditions of the nasal valve.[4] The key physical examination finding in nasal valve compromise is inspiratory collapse of the nasal sidewall. Functional rhinoplasty encompasses the surgical techniques used to address obstruction occurring in this area. These techniques aim to increase the size of the nasal valve opening and/or strengthen the lateral nasal wall and nasal ala, preventing dynamic collapse. A narrow internal valve can only be corrected by cartilage internal middle vault grafts (i.e., spreader grafts).[5]
Septorhinoplasty is a well-accepted procedure by otolaryngologists to improve functional nasal breathing complaints in patients who have failed medical management.[9] It is not considered an investigative procedure. The procedure in this patient was not cosmetic.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypogonadism. 
Treatment: Chorionic Gonadotropin 10000 units intramuscular (IM) solution reconstituted. 

The insurer denied coverage for Chorionic Gonadotropin 10000 units intramuscular (IM) solution reconstituted. 

The denial is overturned. 

 This case involves a young adult under review for coverage of Chorionic Gonadotropin. The laboratory report revealed a low testosterone level of 51. Testing seven weeks later showed a low level of 208. Lab results also showed high Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels. A clinical note reported the patient had a diagnosis of hypogonadism and Klinefelter syndrome. Current medications included Chorionic Gonadotropin as well as anastrozole. The determination letter reported the requested medication was denied due to a lack of documentation of failure of preferred formulary alternatives to include testosterone cypionate and testosterone enanthate. The letter reported the patient was on Clomid, but testosterone levels were not improving. It was noted that the formulary medication would not be fit for the patient due to a disruption of sperm production. The patient was recommended for Human Chorionic Gonadotropin to help improve testosterone levels. 

Chorionic Gonadotropin 10000 units intramuscular (IM) solution reconstituted is considered medically necessary for this patient. In this case, the patient has evidence of low testosterone levels. Given his current age and fertility issues, the formulary alternatives of testosterone cypionate and testosterone enanthate are contraindicated. The use of Human Chorionic Gonadotropin would be supported and medically necessary. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Chorionic Gonadotropin 10000 units intramuscular (IM) solution reconstituted is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shoulder, Hip, Back and Knee pain
Treatment: Physical Therapy Services
The insurer denied the request for physical therapy services.
The health plan's determination is upheld.

The patient is a female with shoulder, back, hip, and knee pain. The patient was previously treated with physical therapy. 
Within a reasonable degree of medical certainty, the health plan, in its determination of medical necessity, acted reasonably, with sound medical judgment and in the best interest of the patient.

Within a reasonable degree of medical certainty, the requested health service/treatment of physical therapy services is not medically necessary for this patient. The patient has shoulder, back, hip, and knee pain. The patient was previously treated with physical therapy. The physical therapy (PT) notes indicate that she was treated with therapeutic activities to improve flexibility, strength, balance, and coordination. In an undated document, she had bilateral shoulder pain, right knee pain, back pain, and left hip pain. Her pain level was 2 to 8 out of 10. Her range of motion (not stated if active or passive) was: right shoulder 121 flexion, 76 abduction, 40 extension, 54 external rotation and 90 internal rotation, the left shoulder was 140 flexion, 105 abduction, 50 extension, 68 external rotation and 90 internal rotation. For her right hip the range of motion was 116 flexion, 35 abduction, 12 extension, 30 external rotation and 31 internal rotation, the left hip was 120 flexion, 42 abduction, 12 extension, 28 external rotation and 31 internal rotation, the right knee was 135 for flexion, and the left knee was 136 for flexion. Her strength was 3 plus (+) out of 5 to 4 minus (-) out of 5.

The patient's left hip was in persistent spasms. The right shoulder and knees were improving and she had no worsening of symptoms.
The PT note stated that she had hip and knee "reduction in pain." Then there is a PT note that stated that she had some increased right hip pain. The left hip was sore. 

The Official Disability Guidelines recommends 10 visits over 8 weeks for shoulder pain, 10 visits over 8 weeks for back pain, 9 visits over 8 weeks for hip pain 12 visits over 8 weeks for knee pain. These treatments could be provided at the same time and therefore, the Official Disability Guidelines would recommend 12 physical therapy visits over 8 weeks for this patient. 
It is indicated that her therapy would have already reached the 8 week point and therefore, the Official Disability Guidelines would not recommend continuing physical therapy for the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shoulder, Hip, Back and Knee pain
Treatment: Physical Therapy Services
The insurer denied the request for physical therapy services.
The health plan's determination is upheld.

The patient is a female with shoulder, back, hip, and knee pain. The patient was previously treated with physical therapy. Within a reasonable degree of medical certainty, the health plan, in its determination of medical necessity, acted reasonably, with sound medical judgment and in the best interest of the patient.

Within a reasonable degree of medical certainty, the requested health service/treatment of physical therapy services is not medically necessary for this patient. The patient has shoulder, back, hip, and knee pain. The patient was previously treated with physical therapy from "at least 12/6/21. The physical therapy (PT) notes indicate that she was treated with therapeutic activities to improve flexibility, strength, balance, and coordination. In an undated document, she had bilateral shoulder pain, right knee pain, back pain, and left hip pain. Her pain level was 2 to 8 out of 10. Her range of motion (not stated if active or passive) was: right shoulder 121 flexion, 76 abduction, 40 extension, 54 external rotation and 90 internal rotation, the left shoulder was 140 flexion, 105 abduction, 50 extension, 68 external rotation and 90 internal rotation. For her right hip the range of motion was 116 flexion, 35 abduction, 12 extension, 30 external rotation and 31 internal rotation, the left hip was 120 flexion, 42 abduction, 12 extension, 28 external rotation and 31 internal rotation, the right knee was 135 for flexion, and the left knee was 136 for flexion. Her strength was 3 plus (+) out of 5 to 4 minus (-) out of 5.

The patient's left hip was in persistent spasms. The right shoulder and knees were improving and she had no worsening of symptoms.
The PT note stated that she had hip and knee "reduction in pain." Then there is a PT note that stated that she had some increased right hip pain. The left hip was sore. 

The Official Disability Guidelines recommends 10 visits over 8 weeks for shoulder pain, 10 visits over 8 weeks for back pain, 9 visits over 8 weeks for hip pain 12 visits over 8 weeks for knee pain. These treatments could be provided at the same time and therefore, the Official Disability Guidelines would recommend 12 physical therapy visits over 8 weeks for this patient. It is indicated that her therapy would have already reached the 8 week point and therefore, the Official Disability Guidelines would not recommend continuing physical therapy for the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cerebrovascular accident
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission.
The denial is overturned.

This case involves an adult patient. The emergency department note reported the patient had a chief complaint of sudden onset of right-sided headache radiating down the arm with numbness and tingling for 30 minutes. Past medical history was significant for anxiety, asthma, diabetes, heart disease, hypercholesteremia, and hypertension. Physical examination noted right upper and lower extremity drift with sensory deficits as well as partial right facial droop. Tissue plasminogen activator (tPA) was administered. The National Institutes of Health Stroke Scale (NIHSS) score was 7. A Computed Tomography (CT) scan was completed. The patient was admitted for acute cerebrovascular accident. 

Milliman Care Guidelines (MCG) recommends admission for a NIHSS score greater than 2 as well as significant weakness. In this case, the patient had a NIHSS score of 7 and required tPA. There was weakness and facial droop on examination. Inpatient admission was supported. Treatment could not have been rendered at a lower level of care. As such, the hospital admission was considered medically necessary for this patient.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. 

The medical necessity for the inpatient hospital admission is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizure.
Treatment: Inpatient Hospital Stay.
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

This is a female patient who was admitted to the hospital after a seizure. The patient has a diagnosis of epilepsy and had a seizure. She hit her neck during the seizure. The patient was admitted to the hospital and underwent a computed tomography (CT) scan of the head and magnetic resonance imaging (MRI) of the brain. These studies were unremarkable. The patient also underwent an electroencephalogram (EEG) which was consistent with primary generalized epilepsy. During the hospital admission, the patient had no further seizures. The patient was discharged from the hospital on levetiracetam 1500 milligrams (mg) twice daily. The patient was also continued on lamotrigine 25 milligrams (mg) daily. Outpatient follow up with her neurologist was recommended. At issue is the medical necessity of an inpatient stay.

The requested inpatient stay was not medically necessary.
The patient presented to the hospital after a seizure. Following the seizure, the patient had no further seizures in the emergency room or during the inpatient stay. The patient did not have any new neurologic deficits, such as significant or disabling weakness. The patient did not have any findings on magnetic resonance imaging (MRI) of the brain, such as a stroke, mass, or bleeding. The patient was previously diagnosed with epilepsy and underwent an electroencephalogram (EEG) that again confirmed a diagnosis of primary generalized epilepsy. During the hospital stay, the patient's dose of levetiracetam was increased to 1500 mg twice daily. The patient was continued on lamotrigine 25 mg daily. During the hospital stay, the patient did not have any significant laboratory or vital sign abnormalities. The patient did not require any rehabilitation services on discharge. The care could have been provided at a lower level.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Urge Incontinence and Retention.
Treatment: Urinary device/treatment (InterStim).
The insurer denied: Urinary device/treatment (InterStim).
The denial is: Overturned.

The patient is a female with urge incontinence and retention for at least 1 year duration who has treatment with a stage I Interstim implant. She has tried two beta-3 agonists and 4 anticholinergic medications without sufficient benefit. She has tried dietary modification with a reduction of caffeine and sugary drinks. The incontinence is having a severe impact on her quality of life according to the attending physician (AP) letter of appeal. Botox is contraindicated due to her recurrent urinary tract infections (UTIs) and retention per the AP letter of appeal. The subject under review is the medical necessity for the InterStim treatment.

The requested treatment with urinary device (InterStim) is medically necessary for this patient.
She has failed multiple first and second line therapies for urge incontinence.
Per the American Urological Association (AUA) Guidelines, she is an appropriate candidate--
"Guideline Statement 20: Clinicians may offer sacral neuromodulation (SNS) as third-line treatment in a carefully selected patient population characterized by severe refractory overactive bladder (OAB) symptoms or patients who are not candidates for second-line therapy and are willing to undergo a surgical procedure."
She also meets the Food and Drug Administration (FDA) Indication: "Sacral Neuromodulation delivered by the InterStim system for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments."