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

Diagnosis: Malocclusion, crossbite
Treatment: Braces/monthly visits
The insurer denied braces/monthly visits.
The health plan's determination is overturned. 

The patient in question is a female with a Class III malocclusion, moderate spacing of the upper and lower arches and anterior crossbite of teeth # (number) 8-9. She is treatment planned for Braces and Monthly Visits to correct her malocclusion. This is under review.

Braces and monthly visits are medically necessary. The patient has crowding with teeth #8-9 in crossbite. These teeth have a high risk for restorative problems in the future due to their traumatic occlusion with the mandibular teeth. She is already damaging her 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. Orthodontic treatment now will likely prevent the need for future expensive periodontal and restorative procedures. For these reasons, the requested orthodontic treatment is medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's disease
Treatment: lab work/blood tests
The insurer denied Measurement of Serum Antibodies to Vedolizumab.
The health plan's determination is upheld. 

The patient is a female under management for Crohn's Disease (CD). The patient has been on multiple treatments including Pentasa, 6-MP (Mercaptopurine), infliximab, adalimumab, ustekinumab and vedolizumab.  

The proposed Measurement of Serum Antibodies to Vedolizumab is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Vedolizumab is a drug with low immunogenicity and therefore measurement of serum antibodies to the drug is not necessary. This differs from anti- tumor necrosis factor (TNF) drugs such as infliximab where the development of antibodies is quite common. Secondly, there was a comprehensive recent meta-analysis that demonstrated that proactive testing of drug levels (again primarily done for anti-TNF medications) is not superior to standard of care. As stated in the review by Shmais and others, there is insufficient data to advocate for proactive or reactive testing of vedolizumab levels until more high quality, controlled data becomes available.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's disease
Treatment: lab work/blood tests
The insurer denied Measurement of Serum Antibodies to Vedolizumab.
The health plan's determination is upheld. 

The patient is a female with Crohn's disease, with prior failure of Pentasa and 6-mercaptopurine, infliximab, Humira, Entyvio, and Stelara, and a switch back to Entyvio. Testing showed Entyvio level of 51, as well as lack of anti-Entyvio antibodies.

Measurement of Serum Antibodies to Vedolizumab is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient was restarted on Entyvio after using it in the past, and had testing for anti-Entyvio antibody levels. According to the American Gastroenterological Association (AGA) Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease, "In adults with active inflammatory bowel disease treated with anti-tumor necrosis factor (TNF) agents, the AGA suggests reactive therapeutic drug monitoring to guide treatment changes", but the use of such testing is not recommended in patients treated with Entyvio. The testing can be useful in patients on anti-TNF medications when there is loss of response and uncontrolled disease.
In this case, active disease was not documented at the time of testing, and the patient was not on an anti-TNF medication. American College of Gastroenterology guidelines for the treatment of Crohn's disease also recommend testing for anti-drug antibodies only when there is documented uncontrolled disease. Additionally, "there is not much research yet involving the restarting of the newer therapies of vedolizumab (Entyvio)...ut these agents have fairly low immunogenic potential and restarting them does not appear to have a high risk of stimulating antidrug antibodies". Furthermore, the antibodies to Entyvio can be transient.
For these reasons, the requested testing is not likely to be more beneficial than any standard treatment in this case.
Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Crohn's disease
Treatment: lab work/blood tests
The insurer denied Measurement of Serum Antibodies to Vedolizumab.
The health plan's determination is upheld. 

This patient is a female with Crohn's disease who has previously tried and failed 6-MP (mercaptopurine), two anti-tumor necrosis factor (TNF) alpha agents (infliximab and adalimumab) and ustekinumab. She was started on Entyvio (vedolizumab) and had prior exposure to this medication. 

Measurement of Serum Antibodies to Vedolizumab is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
While therapeutic levels of infliximab and adalimumab are well established in the medical literature, there are less data on appropriate therapeutic levels of vedolizumab and ustekinumab since these medications have been available for only a few years as opposed to nearly two decades for the anti TNF agents. At this time, there are still no studies comparing either proactive or reactive TDM (therapeutic drug monitoring) with empiric vedolizumab optimization. Therefore, although there are emerging data that may show an association between drug concentrations and outcomes, they are not sufficient to guide specific induction and maintenance drug concentrations for vedolizumab and ustekinumab other than confirming that there is detectable drug.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: Intraosseous basivertebral nerve ablation

The insurer denied coverage for intraosseous basivertebral nerve ablation

The denial is upheld 

The patient has been diagnosed with degenerative disc disease with associated vertebrogenic low back pain with Modic end-plate changes at lumbar vertebrae (L) three through four [3-4] on magnetic resonance imaging (MRI). It is noted the patient has tried and failed conservative therapy, such as activity modification, medical branch blocks (MBB), medication management, (Medrol Dose Pak, meloxicam, Motrin, and Tylenol), and physical therapy (PT). The treating provider is requesting therapy with the Intracept procedure (Intraosseous basivertebral nerve ablation), which is under review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes. 

Medicare does not have an National coverage determinations (NCDs) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. Local Coverage Determinations (LCDs) do not exist at this time. 

Intraosseous basivertebral nerve ablation does not have final approval from the appropriate regulatory bodies for this diagnosis. 

U.S. Food and Drug Administration (FDA) gave 510(k) clearance for the INTRACEPT Intraosseous Nerve Ablation System. However, literature does not sufficient evidence to inform definitive conclusions about the clinical safety and efficacy of the Intracept procedure.     

Since this procedure does not have established clinical efficacy, the patient is not a good candidate for intraosseous basivertebral nerve ablation.  There are adverse risks, which are increased over standard treatment/services. 

There is a lack of long-term comparative data on the efficacy and safety of percutaneous vertebral and vertebral endplate procedures. As such, the adverse risks are increased of standard treatment options.     

In summary, the denial of intraosseous basivertebral nerve ablation and coverage for the requested service 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 substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: Intraosseous basivertebral nerve ablation

The insurer denied coverage for intraosseous basivertebral nerve ablation

The denial is upheld 

Reviewer #2:

This patient has a history of low back pain beginning 9 months ago. The patient has had multiple treatments including activity modification, medial branch block injections, medication management, and physical therapy. Medication trials have included: Medrol Dose Pak, Meloxicam, Motrin, and Tylenol. 
The patient had an magnetic resonance imaging (MRI) performed at Zwanger- Pesiri Radiology. The MRI demonstrated Modic type I changes at disc spaces L (lumbar) 3-L4.   The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L3 and L4.

Urits et al (6) also commented on the need for more research on this promising technique:  "reproducible large RCTs are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

Another recent review Schnapp et. al. 2022 "Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature" concluded after a review of 12 articles that study demographics need to be diversified, there is a lack of true control groups lacking due to crossover, very few high level long terms studies have been published, funding is mostly industry-led, and the studies are limited to a very specific chronic pain population.   Additionally, the Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG) do not recommend treatment with the Intracept procedure because further trials with longer-term outcomes and less risk of bias are required.

In summary, the denial of 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first two vertebral bodies, lumbar or sacral (Intracept), 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, each additional vertebral body, lumbar or sacral (list separately in addition to code for primary procedure (Intracept) and coverage for the requested service 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 substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Vaginitis.

Treatment: Laboratory testing.

The insurer denied coverage for: Laboratory testing.

The denial is: Upheld.

The patient presented with symptoms of urinary tract infection (UTI). The provider ordered the following test: SureSwab advanced Vaginitis Plus.

Diagnosis of vaginitis is based on clinical symptoms, potential of hydrogen (pH) of the vaginal fluid and microscopic examination of the discharge. Ideally, a diagnosis of bacterial vaginosis (BV) is made if 3 out of 4 of "Amsel's criteria" are met: A strong fishy odor on adding alkali to vaginal fluid (positive amine test) Clue cells (vaginal epithelial cells heavily coated with bacilli) on microscopy Thin, white, homogenous discharge Vaginal pH greater than 4.5. Microscopic examination may also reveal motile trichomonads or candida hyphae. The presence of Gardnerella vaginalis on culture cannot be used to diagnose BV, since it is present in approximately 50% (percent) of healthy women. Culture of trichomonas and candida may be helpful if clinical symptoms are suggestive, and microscopy is negative. Mixed infections are also common, with trichomonas, candida or both coexisting with BV. Deoxyribonucleic acid (DNA) probes have been developed to directly detect the presence of candida, trichomonas and Gardnerella. 

According to American College of Obstetrics and Gynecologists (ACOG), microscopy is the first line for diagnosing vulvovaginal candidiasis and trichomoniasis. The Centers for Disease Control (CDC) and Prevention also recommend the gram stain as the gold standard for diagnosis of vaginal infections and recommend use of Amsel's criteria if a gram stain is not available. The CDC states that the Deoxyribonucleic acid (DNA) probes "have acceptable performance characteristics" compared to the gram stain but make no recommendation for their use. There are no high-grade evidence-based peer reviewed studies published in the medical literature to support the efficacy of the technology which consists of: a. Meta-analyses of randomized trials; or b. Randomized controlled trials.

Based on all of the above, the testing done by Quest Diagnostic was not medically necessary. Adequate history, physical examination and office microscopy should rule out the presence of these infections.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for a vaginal panel from Quest Diagnostics is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Transaminitis; Gallstone disease
Treatment: Inpatient admission
The insurer denied: Inpatient admission
The denial is upheld.

The patient is an adult female admitted to the hospital with transaminitis and the presence of gallstone disease. The patient was in severe abdominal pain. The patient had elevated liver function tests.

The inpatient admission was not medically necessary.

The documentation indicates there is no evidence that inpatient stay is necessary. The patient had transaminitis with acute abdominal pain. Imaging showed only evidence of cholestasis. There were no other diagnoses that necessitated inpatient admission. The patient underwent uneventful laparoscopic cholecystectomy and was discharged. There is no documentation that supports inpatient level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mixed dentition
Treatment: Braces
The insurer denied: Braces
The denial is upheld.

The patient is an adolescent male with mixed dentition. He has a Class II skeletal and soft tissue profile, tapered arch forms, and moderate lower anterior crowding with the lower left lateral incisor crowded out. Upper right and left and lower left canines are rotated, overbite is approximately 20% (percent), overjet is approximately 4-5 millimeters (mm), and there is no presence of a cross bite. The request for braces was initially denied coverage by the health plan, because the patient did not have any automatic qualifiers for orthodontic treatment and did not meet handicapping labio-lingual deviation (HLD) Index criteria of scoring 26 or higher. The denial is being appealed.

The braces are not medically necessary.

While this patient has rotated teeth, constricted dental arches, and dental crowding, he does not qualify for comprehensive orthodontics for adolescent / transitional dentition. Review of the submitted documents show he does not qualify for any of the automatic qualifiers (i.e, cleft palate or cranio-facial anomaly, trauma, detailed documentation of a speech issue, a deep impinging overbite, anterior cross bite, overjet greater than 9mm, negative overjet (3.5mm or greater), or impacted incisors or canines that will not erupt into the arches without orthodontic or surgical intervention). Also, this reviewer calculated the handicapping labio-lingual deviation (HLD) Index score for this patient to be 10. This does not reach the level of handicapping malocclusion. Therefore, given the above, orthodontic treatment is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: ulcerative colitis
Treatment: Stelara
The insurer denied Stelara. 
The health plan's determination is overturned. 

This patient is a young female with a history of ulcerative colitis (UC). She tried and failed infliximab. Under review is the medical necessity of Stelara.

Stelara is medically necessary for this patient. Stelara is Food and Drug Administration (FDA) approved for the treatment of Crohn's disease and ulcerative colitis in adults. Despite the lack of FDA approval for pediatric patients, there are many peer reviewed publications supporting the efficacy and safety of Stelara in children with inflammatory bowel disease.
A report by Dayan JR et al, showed that ustekinumab (Stelara) is efficacious and safe in pediatric patients with inflammatory bowel disease.
According to Koudsi, Mounzer, et al: "In this retrospective, multicentral study, ustekinumab proved to be efficient in paediatric patients resistant to anti-TNF (tumor necrosis factor). The PCDAI (Pediatric Crohn Disease Activity Index) has been significantly improved in patients with severe disease, treated with Ustekinumab."
Finally, per Dhaliwal, Jasbir, et al: " Ustekinumab demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC".
Therefore, the off-label use of Stelara in refractory cases of pediatric ulcerative colitis is appropriate. This patient has already tried and failed the available alternatives. Therefore, Stelara is medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes Mellitus 
Treatment: Humalog Kwikpen (insulin lispro (human))
The insurer denied Humalog Kwikpen (insulin lispro (human)).
The determination is upheld.

This is a male patient diagnosed with type 2 diabetes mellitus (T2DM). This request is for Humalog. He is on a Medtronic 670 G. He is on U500 insulin via insulin pump. He is on Humalog; Humulin; Ozempic; Dexcom G6 and Omnipod 5. As documented, he tried and failed Novolog.
His hemoglobin A1C was 7.5 percent (%); 8 %; and 7.1 %.

The formulary alternative Fiasp will be as effective as the requested medication.
There are no studies demonstrating superiority of one rapid acting insulin analog over another [1-7]. There is no evidence of a contraindication or previous trial or adverse reaction to the formulary alternative Fiasp. The patient is reported to have tried and failed Novolog. The patient can try Fiasp.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia areata. 
Treatment: Xeljanz. 
The insurer denied Xeljanz. 
The determination is upheld. 

This is a female patient with alopecia areata (AA). Her occipital scalp and left temporal scalp are affected. She has failed intralesional Kenalog. The medication under review is Xeljanz. 

The requested health service/treatment of Xeljanz is not medically necessary for this patient. 
There are no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Xeljanz for this patient's condition as an accepted standard of practice in the United States prior to the conventional alternatives. There is no documentation the patient has exhausted all topical options, and that it would therefore be medically necessary to start systemic treatment with Xeljanz, which would carry a higher side effect profile. 
There is no documentation provided that the patient has tried and failed topical immunotherapy, such as Diphenylcyclopropenone (DPCP). Chiang et al writes their 2015 study findings: that for DPCP "treatment success, defined as 50% terminal hair regrowth, was reached in 71 percent (%) of alopecia totalis patients and in 56% of alopecia universalis patients" (1). Moreover, there is no documentation that the patient has tried and failed topical squaric acid. Topical squaric acid dibutylester is a sensitizing agent which is also used for the treatment of alopecia areata, and has been shown to be effective in several studies (2). Based on the documentation provided, the patient has not tried and failed all topical therapies available. These topical medications, which have been shown to be effective for the patient's condition, should be tried and failed prior to initiating Xeljanz. Therefore, Xeljanz is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dysphagia
Treatment: Inpatient Admission
The insurer denied coverage for: Inpatient Admission 
The denial is: Upheld

The patient presented with dysphagia. The patient was hemodynamically stable. The abdominal exam was benign. The patient underwent an upper gastrointestinal endoscopy. The endoscopy did not reveal any evidence of an esophageal obstruction or acute disease. The patient tolerated the procedure well and no complications were reported. 

Milliman Care Guideline (MCG) A-0203 lists clinical indications for upper gastrointestinal (GI) Endoscopy. Dysphagia is an indication for this procedure if there is a concern about an ingested foreign body. However, this procedure is listed as ambulatory care. 

This patient had dysphagia and required an urgent endoscopy to see if there was a foreign body that needed to be removed. There was no obstruction and no complications were reported. The MCG guidelines advise that this is an ambulatory procedure. The patient did not need an acute care inpatient hospitalization. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for full hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Low Back Pain

Treatment: Pain Injections (64483 x 1, 64484 x 1)

The insurer denied coverage for Pain Injections (64483 x 1, 64484 x 1)

The denial is overturned

This patient has chronic low back pain lumbar radiculopathy.  The patient has had Epidural steroids with excellent response.  The request is for an injection after 12 months from the first injection.

Manchikanti et al (1) state: "Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness."

Olivera et al (2) concluded:

"A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term."

Similarly, Official Disability Guidelines (ODG) guidelines (3) state:

"Criteria for use of Epidural Steroid Injections (ESIs): 

Note: The purpose of ESI is to reduce pain and inflammation, thereby facilitating progress in more active treatment programs during healing. There is no evidence that ESIs alone offer any meaningful long-term functional benefit. 

"(1) Injections should be administered using fluoroscopy (live X-ray) and injection of contrast for guidance. Ultrasound guidance is not recommended. 

(2) Initial injection: At the time of initial use of an ESI for an acute, new onset episode, a maximum of 1 to 2 injections should be administered. A repeat block is not recommended if there is inadequate response to the first block (with an initial adequate response defined as pain relief and improved function of at least 50%(percent) for a minimum of 2-3 weeks). Approval of a second block requires documentation of the response to the first block. There should be an interval of at least 2 weeks between injections. This recommendation only applies to the initial injection treatment."

The requested block is medically reasonable and necessary.

There is no clinical practice guideline that states that Epidural Steroids are contra-indicated after one year of therapy.

Based on the above, the insurer's denial must be reversed. 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 Pain Injections (64483 x 1, 64484 x 1) is substantiated.