Persius/imr-appeals huggingface dataset:
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2
A 19-year-old female enrollee has requested reimbursement for electromyography (EMG) and electroencephalogram (EEG) monitoring during spine surgery performed on 12/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that comprehensive or multimodal intraoperative neurophysiological monitoring (IONM) is essential in patients undergoing major spinal correction surgery. IONM is considered a standard of care modality that is used to improve safety of surgical deformity correction. EMG provides immediate actionable information in evaluating whether pedicle screw breaches the cortex and impinges on the spinal canal and/or nerve root and also evaluates excessive mechanical spinal distraction. Nerve conduction velocity (NCV) is important in monitoring intraoperative injurious positional pressures, particularly in this case involving a long procedure while in a prone position. Intraoperative EEG changes can occur. These EEG changes can potentially detect what may become an ischemic focal decrease in cerebral blood flow resulting from hypotension in the setting of a stenotic cerebral artery, further establishing EEG modalityas critical importance in IONM. Significant alterations in cerebrospinal fluid pressures, which can occur during major corrective spinal surgery, may also be reflected in EEG waveform. Multimodal IONM also represents the standard of care for these difficult and risky spinal procedures. Therefore, EMG and EEG monitoring during spine surgery performed on 12/05/19 was likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that idiopathic sudden sensorineural hearing loss is hearing loss of at least 30?dB in at least three contiguous frequencies within at least 72 hours. There are many different theories to explain it, and many different modalities are used for its management, such as systemic steroids, intratympanic steroid injection, hyperbaric oxygen therapy, antiviral drugs, and vasodilators or vasoactive substances. Autoimmune inner ear disease assumes that there is an autoimmune component of the etiology of the hearing loss. Derebery and colleagues evaluated the safety and efficacy of intratympanically injected golimumab as a steroid-sparing agent for patients with steroid-dependent autoimmune inner ear disease. The results demonstrated that this treatment stabilized hearing in 3 of 7 per-protocol subjects with autoimmune inner ear disease and allowed a complete tapering off of prednisone in those seven subjects. The authors noted that studies with larger samples sizes are warranted. Haynes and colleagues reported difficulty in proving efficacy of a single modality is present in all studies on sudden sensorineural hearing loss secondary to multiple treatment protocols, variable rates of recovery, and a high rate of spontaneous recovery. At this time, the current peer-reviewed scientific medical literature is insufficient to establish the clinical utility, safety and efficacy of this treatment in this clinical setting. Thus, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was not and is not likely to be of greater benefit than other available treatment modalities. Based upon the information set forth above, the medication at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found calprotectin is a small calcium-binding protein and is a member of the S100 family of zinc-binding proteins found primarily in neutrophils. Any disturbance to the mucosal architecture due to the inflammatory process, results in leakage of neutrophils, and hence, calprotectin, into the lumen and its subsequent excretion in feces. Studies have demonstrated that of patients with Crohns in remission, only a small percentage had a significant within-individual variability for calprotectin concentrations over three samples suggesting that measurements are reliable (Walsham and Sherwood; Schoepfer, et al; Sipponen, et al). Given this support, the fecal calprotectin testing performed on 11/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 34-year-old female enrollee has requested reimbursement for genetic testing for birth defects performed on 3/28/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the American College of Obstetrics and Gynecology (ACOG) addressed the issue of the use of cell free DNA testing stating given the performance of conventional screening methods, the limitations of cell free DNA screening performance, and the limited data on cost effectiveness in the low risk obstetrical population, conventional screening methods remain the most appropriate choice for first-line screening for most women in the general obstetric population. Given the lack of support by national guidelines, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapies.Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer. The physician reviewer found that the use of proton beam therapy is an accepted radiation technology that has proven efficacy and tolerability. Certain conditions, such as base of skull chordomas and chondrosarcomas and pediatric central nervous system malignancies, are probably best treated with proton therapy, due to the sharp dose fall off, allowing high dose delivery to the tumor, while relatively sparing the neighboring normal tissue. Data on proton beam therapy for oropharyngeal cancers are scant. Likewise, scant data compare outcomes with proton beam therapy versus intensity modulated radiation therapy. While preliminary dosimetric data suggests that proton beam therapy may be better at sparing pharyngeal constrictor muscles, spinal cord, parotid glands, larynx, and brainstem, whether dose reduction to any of these structures (beyond what intensity modulated radiation therapy can achieve) results in any benefit in clinical outcome is unknown. For most head and neck cancers, intensity modulated radiation therapy should also be able to readily spare the salivary glands, pharyngeal constrictors, spinal cord, brainstem, mandible and other normal tissues. In this patients case, there is a lack of documentation that intensity modulated radiation therapy would result in an unacceptable plan. The case records do not adequately demonstrate the need for proton therapy using dosimetric evidence. A plan comparison was provided, but it is not evident that the proton beam radiation plan results in clinically meaningful reduction in any normal tissue. All told, the requested proton beam therapy is not likely to be superior over other available treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 46-year-old male enrollee has requested reimbursement for the gastrointestinal (GI) effects comprehensive profile stool testing performed on 1/10/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.  The physician reviewer found that stool pathogen panels use of polymerase chain reaction (PCR) are not incorporated into standard medical practice. The American Academy of Family Practice guidelines for evaluation of chronic diarrhea, including investigation of suspected inflammatory bowel disease, also do not recommend stool PCR testing panels for multiple pathogens (Juckett and Trivedi). In addition, the use of calprotectin to diagnose change in bowel habits has not been recommended. Per the American College of Physicians (ACP) a specialist might measure fecal calprotectin, but only in conjunction with detailed history-taking, clinical examination, and serum inflammatory markers or other blood tests, to determine the need for endoscopic evaluation (Forbes, et al). The ACP also stated that fecal calprotectin is elevated in several other gastrointestinal diseases, including viral, bacterial, and protozoal causes of infective diarrhea (Forbes, et al). The impact of this testing on management and its appropriateness in guiding therapy decisions in patients with unexplained diarrhea has not been demonstrated. The findings can be redundant with standard methods of diagnosis, such as colonoscopy or sigmoidoscopy, or other serum markers of inflammation. Furthermore, clinical studies do not support a standardized action, such as empiric use of antibiotics or empiric therapy for inflammatory bowel disease, for a positive result. Clinical guidelines and medical literature do not definitively support the use of the testing at issue. Therefore, the GI effects comprehensive profile stool testing performed on 1/10/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 46-year-old male enrollee has requested authorization and coverage for Vemlidy 25 mg daily. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B. In comparison with tenofovir disoproxil fumarate (Viread), which the patient is taking, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with lower incidence of side effects, such as osteopenia and renal disease. As hepatitis B is chronic in this case, with the possibility of increased disease activity when treatment is discontinued, the request for 12 months of treatment is appropriate. Therefore, Vemlidy 25 mg daily is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 43-year-old enrollee has requested reimbursement and prospective authorization and coverage for tobramycin/betamethasone/itraconazole compound from 7/25/16 and 8/3/16 and forward. The Health Insurer has denied this request indicating that the compounded medications were and are considered investigational for treatment of the enrollees chronic sinusitis. The physician reviewer found that there is some support for the efficacy of the compounded medications in this clinic setting. Chronic rhinosinusitis (CRS) is a highly prevalent disease in the adult and pediatric population. Although oral medications are effective in controlling some symptoms, they are associated with side effects and long-term use is not ideal. Thus, topical therapies have emerged as an alternative delivery method for localized, high-concentration medication with less side effects. Topical saline and intranasal steroids appear to consistently demonstrate therapeutic benefits, as evidenced by significant clinically relevant improvements and lack of serious side-effects. Nasal sprays and nasal irrigation are common delivery options for topical steroids. Physiologic saline irrigation is beneficial in the treatment of symptoms of CRS. In this case, low-level evidence supports the effectiveness of topical antibiotics in the treatment of CRS. Therefore, it is reasonable to continue additional therapy with nasal irrigations in this patient, who is status post sinus surgery and has been treated with multiple rounds of antibiotics. As such, tobramycin/betamethasone/itraconazole compound administered on 7/25/16 and 8/3/16 forward was and is likely to be more effective than the available standard options for treatment of this patients medical condition. Therefore, for the reasons stated above, the compounded medications were and are likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 44-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan of parathyroid gland provided on 7/19/16. The Health Plan has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees hyperparathyroidism. The physician reviewer found the traditional approach to parathyroid surgery consists of bilateral neck exploration with the goal of identifying and visually inspecting all four parathyroid glands. However, in the past few decades imaging studies have made it possible to localize parathyroid adenomas preoperatively (Mohebati and Shaha). More recently, the fusion of SPECT with x-ray based CT has proved to be more accurate and sensitive for localization of adenomas and may also help provide additional anatomic information to the surgeon pre-operatively (Liddy, et al). Therefore, the SPECT scan of parathyroid gland provided on 7/19/16 has been established as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 48-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 1/09/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma.The physician reviewer found that this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Although this patient had high risk results, it is unclear how treatment and surveillance recommendations would be altered. Thus, DecisionDx-Melanoma testing provided on 1/09/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 34-year-old male has requested authorization and coverage for multileaf collimator device. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this patients case.  CPT code 77338 should only be billed once per IMRT plan, not once per beam nor once per delivery. As such, there should only be a single billing of CPT code 77338 for each time CPT code 77301 (for IMRT planning) is billed.  Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The parent of a four-year-old male enrollee has requested authorization and coverage for Botox 100 units. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the use of Botox injection in treating refractory chronic constipation has been well-studied and supported by sufficient peer-reviewed literature. Keshtgar and colleagues performed a randomized clinical trial and noted that botulinum toxin is equally effective and less invasive than myectomy of the internal anal sphincter for chronic idiopathic constipation and fecal incontinence in children. 
Per Halleran and colleagues, Botox injection into the anal sphincters is an accepted practice in children with severe functional constipation. Studies have indicated that Botox is effective for children with chronic constipation and that injection may be considered in patients with intractable constipation unresponsive to medication, regardless of anal sphincter dynamics. The request for Botox injection in this case is consistent with the generally accepted practices. Therefore, J0585 - Botox 100 units are likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 61-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, Harvoni is first-line therapy for treatment-naive genotype 1 patients. Non-cirrhotic patients with a viral load below six million IU/mL can be treated with Harvoni for eight weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, Harvoni should be approved as medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 32-year-old female enrollee has requested reimbursement for the Prometheus Anser ADA testing performed on 4/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that monitoring patients on Humira with measurement of Humira levels and antibodies to Humira continues to be an area of intense investigation. Some data suggests that Humira levels correlate inversely with disease activity. However, there is a lack of controlled data which have identified the optimal drug level. Given the paucity of peer-reviewed medical literature supporting the clinical utility of the Anser ADA test in this circumstance, the Prometheus Anser ADA testing performed on 4/10/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.  The physician reviewer found that there is sufficient support in the peer-reviewed literature for the services at issue in this clinical setting. According to the study by Ciatto and colleagues, the addition of breast tomosynthesis reduces false positives and increases cancer detection when compared to two-dimensional mammography alone. Moreover, Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (Skaane, et al). Given the support above, the breast tomosynthesis performed on 10/21/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.