Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticariaThe physician reviewer found that there is a lack of support in the medical literature for LHR test in a clinical setting for the evaluation of chronic idiopathic urticarial (CIU).  There is some utility of the LHR test as a research tool. Current evidence does not support routine clinical use of autologous serum skin testing or for LHR/basophil histamine responsiveness for the diagnosis of CIU. Chronic urticaria index is a test which consists of basophil (leukocyte) histamine release assay. If the test is positive (index greater than 10), the patient may have chronic autoimmune urticaria.  The test is nonspecific.  It measures only histamine release from the patients cells and compares it to a normal control. It does not measure antibodies or autoantibodies.  Patients with a chronic form of urticaria with a positive functional anti-FceR test result likely have an autoimmune basis for their disease. A positive result does not indicate which autoantibody is present. This LHR test is usually combined with thyroid function, antithyroid microsomal titers, and peroxidase antibody titers.  The result is reported as an index value. The reference range for a healthy non-CU population is less than 10. Values greater than or equal to 10 indicate that donor basophils were stimulated by patient serum to release histamine. The larger the value, the more histamine released. The CU index test (basophil histamine release test, AKA, Leukocyte histamine release test) has not been approved or cleared by the U.S. Food and Drug Administration. Although commercial assays are now available, the utility of testing for basophil histamine release and autoantibodies to the high-affinity IgE receptor or autoantibodies to IgE have not been established. Whether detection of basophil histamine release or autoantibodies identifies a clinically unique population or will lead to a change in management is also currently unclear. The American Academy of Allergy and Immunology guidelines for this test indicate it is primarily used in a research setting. All told, (CPT code 86343) leukocyte histamine release test (LHR) that was rendered on 10/20/15 was not likely to be more effective than the available standard methods of evaluating this patient. Therefore, for the reasons stated above, the services at issue were 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: Insurer Denial Upheld

Summary Reviewer 


A 60-year-old female enrollee has requested reimbursement for OxyContin provided from 7/23/15 through 9/22/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees medical condition.   The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the medication at issue in this patients case.  The current medical evidence does not support the use of OxyContin in this clinical setting.  The records do not show that non-opioid treatment options have been exhausted.  The records have not documented behavior therapy for pain, despite research to support its use.  Therefore, OxyContin provided from 7/23/15 through 9/22/15 was not medically indicated for the treatment of this patient.  Therefore, the medication at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 63-year-old male enrollee has requested authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has been diagnosed with acute obstructive sleep apnea. The physician reviewer found that the patient is a 63-year-old male diagnosed with obstructive sleep apnea (OSA).  He was diagnosed by a polysomnography in 2013 which indicated an apnea-hypopnea index (AHI) score of 56.5 consistent with severe OSA. The record documents failure of an extended trial of continuous positive airway pressure (CPAP) therapy.  The patient underwent septoplasty and inferior turbinate reduction on 7/1/15.   A subsequent sleep induced endoscopy indicated a palatal collapse. An uvulopalatopharyngoplasty was performed on 8/5/15.  Another polysomnography was performed on 11/24/15 which showed an AHI score of 34.5.  A follow up discussion with a provider noted options of upper airway stimulation as well as maxillo-mandibular osteotomy. The patient requests authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer denied this request indicating that the requested services are investigational for treatment of this patients medical condition. The current medical literature has not shown the superior efficacy of the requested services in this clinical setting. There is a lack of independent data regarding the effectiveness of this technique when compared to available standard therapies. At this time, further outcomes data, including those regarding long term effects, are needed before it is possible to support that implantation of cranial nerve stimulator is likely to be more effective than the available standard options. While there are some studies that show the benefits of this procedure, these outcomes are documented for selected patients. These are patients who have failed CPAP therapy, who show absence of concentric airway collapse on sleep endoscopy and who are not obese.  This patient has not had a trial of CPAP therapy after having undergone nasal and palatal surgery. The documentation provided does not show that he has absence of concentric airway collapse. Lastly, he is obese based on the body mass index criteria.  Therefore, in this patients case, the implantation of a cranial nerve stimulator is not likely to be more effective than the standard options available for the treatment of this patients medical condition. 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: Insurer Denial Upheld

Summary Reviewer 3

A 63-year-old male enrollee has requested authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has been diagnosed with acute obstructive sleep apnea. The physician reviewer found that the patient is a 63-year-old male who has a history of obstructive sleep apnea (OSA) and poor sleep. He is status post palate surgery and septoplasty. He underwent sleep endoscopy which revealed antero-posterior collapse at the velum and base of tongue. His Epworth sleepiness scale was reported at 4/24. He had a body mass index (BMI) of 34.6 when he underwent a polysomnography in 2013. That study also revealed an apnea-hypopnea index (AHI) score of 56.5. On 11/24/15, another sleep study was performed. The patients AHI score was document at 34.5. He failed continuous positive airway pressure (CPAP) therapy and was treated with bilevel therapy. The treating provider discussed implantation with cranial nerve stimulator as an option for treatment. The patient requests authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer denied this request as investigational for treatment of this patients medical condition. OSA is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity with long-term adherence rates approaching 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. The STAR trial demonstrated that cranial nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA (Woodson, et al). However, these studies were performed in a subset of patients with OSA. Patients with concentric airway collapse, BMI greater than 32 and AHI less than 20 or greater than 50 were excluded. In this patients case, his BMI was 34.6 and his recent AHI was 34.5. All told, in this patients case, the current medical evidence does not support the superiority of implantation of cranial nerve stimulator over the available standard 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: Insurer Denial Overturned

Summary Reviewer 1

The patient is a 64-year-old male with a diagnosis of hypogonadism. His symptoms include decreased energy and libido, mood swings, sleepiness and changes in fat/muscles. His pre-treatment testosterone level was 208 in 2011. The patient has been treated with testosterone injections and Testopel. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The use of Testopel is appropriate only for patients with an appropriate diagnosis of hypogonadism based on criteria recommended by national and international guidelines. Guidelines require measurement of two morning testosterone levels along with follicle-stimulating hormone/luteinizing hormone (FSH/LH) levels prior to initiation of therapy to identify the presence of and type of hypogonadism. In this case, the documentation submitted for review does not support that this was performed. In addition, patients who are on testosterone replacement should be monitored with laboratory work-up that includes testosterone, hematocrit, prostate-specific antigen (PSA), and lipid profile initially at frequent intervals and annually thereafter. Based on the clinical documentation submitted for review, the Testopel implants provided on 1/21/16 and 5/26/16 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Based upon the information set forth above, the services at issue were 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: Insurer Denial Overturned

Summary Reviewer 2

The patient is a 64-year-old male with hypogonadism manifested with low libido and low energy levels. His total testosterone was 208 in 2011. He was treated with Testopel pellets on 1/21/16 and 5/26/16. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The Testopel implants provided on 1/21/16 and 5/26/16 were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Testopel is an alternative approved method of treating hypogonadism in an older male. It offers the advantages of maintaining a steady level of testosterone over many months. In addition, it eliminates the need for repeat daily or weekly or monthly dosing and is not dependent upon varying factor as to absorption like with testosterone gels and creams. Based on the clinical documentation submitted for review, the services at issue were likely to be more beneficial for treatment 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 treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

The patient is a 64-year-old male with a diagnosis of hypogonadism since 2011. In a letter dated 1/21/16, the provider notes the patients symptoms include decreased libido, decreased energy, mood swings, fat accumulation, sleepiness, and reduced muscle mass. The patient has been treated with Testopel since August 2015. On 3/16/16, his testosterone level was 187. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The Testopel implants provided on 1/21/16 and 5/26/16 were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Testosterone replacement therapy (TRT) is recommended for older men with either low serum testosterone or low testosterone plus accompanying symptoms of hypogonadism. Serum testosterone levels of less than 300 is considered to be low, and testosterone levels of less than 250 is considered to be frank hypogonadism. Most experts support TRT for older men with frank hypogonadism and symptoms. TRT produces a number of established benefits in hypogonadal men, including increased muscle mass and strength, decreased fat mass, increased bone mineral density, and improved sexual function. In this case, the services at issue were likely to be more beneficial for treatment 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 treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 61-year-old female enrollee has requested authorization and coverage for Hizentra. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees nonfamilial hypogammaglobulinemia. The physician reviewer found that although the records indicate that the patient presents with recurrent infections, there is a lack of supporting documentation, such as chest x-rays, computed tomography of the sinuses or antibiotic logs, to confirm recurrent infections. In addition, the record does not demonstrate that the patient has been vaccinated with pneumococcal vaccines with pre and post vaccinations titer, which is evidence of persistent hypogammaglobulinemia. There is also no documentation that the patient has trialed prophylactic antibiotics or other therapies such as aggressive allergic rhinitis treatment, vaccination with conjugate pneumococcal vaccine or a trial of prophylactic antibiotics. The diagnosis of common variable immune deficiency (CVID) requires significantly reduced total serum concentrations of immunoglobulin, low immunoglobulin A (IgA) and/or immunoglobulin M (IgM), poor or absent response to immunization and exclusion of other immunodeficiency states or causes. In this case, the patient is reported to have low total IgG, but none of the other criteria of CVID (Chapel et al; Chapel and Cunningham-Rundles). Other causes of hypogammaglobulinemia have not been evaluated to include gastrointestinal or urinary loss of protein. Furthermore, the treatment of hypogammaglobulinemia with replacement immunoglobulin remains controversial. Most experts recommend treatment which includes immunization with conjugated pneumococcal vaccine (Prevnar 7 or 13), aggressive treatment of other conditions predisposing to recurrent sinopulmonary infections, increased vigilance and appropriate antibiotic therapy for infections, prophylactic antibiotics and intravenous immunoglobulin/subcutaneous immunoglobulin (IVIG/SCIG). In this case, the patients immune system has not been fully evaluated, there has not been aggressive treatment of her possible comorbid conditions. The documentation does not support that IVIG is safe and effective in this clinical setting. In sum, the documentation submitted for review fails to demonstrate a primary immunodeficiency related to antibody deficiency. Although there is evidence of hypogammaglobulinemia, the records lack a full evaluation of the patients immune system. As such, the request for Hizentra is not medically necessary for treatment of the patients medical condition. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Khalil and colleagues performed a randomized controlled trial to compare the effectiveness of intraosseous radiofrequency ablation of the basivertebral nerve to standard care for the treatment of chronic low back pain. The authors noted maintenance of clinical improvement at two years following radiofrequency ablation of the basivertebral nerve. This trial included 140 patients with chronic low back pain that had been present for at least six months, with Modic Type 1 or 2 vertebral endplate changes. The patients were divided into two groups; half received the Intracept and the other half received standard care. The results showed clear superiority of radiofrequency ablation of the basivertebral nerves compared to standard care. In this case, the patient has chronic low back pain with Modic Type 1 vertebral endplate changes at L4-5 and L5-S1. The provider has tried other options, with documented failure. The requested Intracept procedure is known to have a high rate of success. Therefore, the requested Intracept procedure is likely to be more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Khalil and colleagues performed a prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. The authors concluded that minimally invasive radiofrequency ablation of the basivertebral nerve led to significant improvement of pain and function at three months in patients with chronic vertebrogenic related low back pain. Fischgrund and colleagues concluded that patients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited sustained clinical benefits in the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) pain scores, and maintained high responder rates at two years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain. She has failed to respond to nonsurgical management. Therefore, the requested Intracept procedure is likely to be more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a sparse amount of published clinical data to support the use of this treatment modality.  An industry sponsored trial by Becker and colleagues involved 17 patients who were treated for refractory chronic low back pain. The authors concluded, aAblation of the basivertebral nerve for the treatment of chronic lumbar back pain significantly improves patientsa self-reported outcome early in the follow-up period; the improvement persisted throughout the one-year study period.a Fischgrund and colleagues performed a multicenter randomized control trial involving 225 patients with refractory low back pain. The authors noted, aPatients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited significantly greater improvement in Oswestry Disability Index (ODI) at three months and a higher responder rate than sham treated controls.a While there is a small amount of supporting data which suggests some short-term patient reported outcomes with the Intracept procedure, some of this data is industry sponsored. The single randomized controlled trial demonstrates some potential short-term benefit, but is lacking long-term efficacy and safety data. Clinical conclusions on this procedureas safety and efficacy require longer-term safety and efficacy data prior to accepting it as standard of care. Thus, the requested Intracept procedure is not likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 57-year-old female enrollee has requested authorization and coverage for endovenous ablation therapy of incompetent vein. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees chronic venous insufficiency. The physician reviewer found that the documentation does not support the medical necessity of the requested endovenous ablation therapy of incompetent veins for treatment of this patients varicosities. The most recent evaluation documents that the patient is doing well and is without complaints or concerns and is using compression stockings as prescribed. Therefore, there is no indication for additional treatments. Accordingly, the requested endovenous ablation therapy of incompetent vein is not supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.