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

Summary Reviewer 3


A 61-year-old female enrollee has requested coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees left hip and buttock pain. The physician reviewer found that Polly and colleagues performed a randomized controlled trial of minimally invasive sacroiliac joint fusion using triangular titanium implants was compared to nonsurgical treatment at 12 months. A total of 148 patients with sacroiliac joint dysfunction were randomly assigned to minimally invasive sacroiliac joint fusion with triangular titanium implants or nonsurgical treatment. The study showed that minimally invasive sacroiliac joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction caused by degenerative sacroiliitis or sacroiliac joint disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. In addition, Whang and colleagues compared sacroiliac joint fusion using triangular titanium implants to nonsurgical management.  The conclusions were that at six-month follow-up the minimally invasive sacroiliac joint fusion using triangular titanium implants was more effective than nonsurgical management in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions. In this case, physical examination and multiple diagnostic sacroiliac injections have identified the pain generator. Therefore, evidence of neural compression on the imaging studies is not relevant. Based upon a review of the recent literature, the requested minimally invasive sacroiliac joint fusion has been established as 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 requested services are 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: Upheld

Summary Reviewer 1
A 47-year-old male enrollee has requested reimbursement for automated evacuation of meibomian glands performed on 2/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees meibomian gland dysfunction. The physician reviewer found that the automated evacuation of meibomian glands performed on 2/2/15 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. This procedure utilizes a device that heats the palpebral surface of upper and lower eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid for 12?minutes, thereby expressing the meibomian glands during heating (Friedland, et al). The study results by Finis and colleagues showed that a single thermodynamic treatment is effective in the treatment of meibomian gland dysfunction and that the effects last for at least six months. Although automated evacuation of meibomian glands have promise, there is a lack of evidence in the medical literature supporting that the services at issue were more effective than standard therapy such as hot compresses and lid hygiene. 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: Medical Necessity
Decision: 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 44-year-old male with a history of morbid obesity and hypercholesterolemia. The patient has requested authorization and coverage for Saxenda. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that according to the U.S. Food and Drug Administration (FDA), Saxenda is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia).  The initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention: a combination of diet, exercise, and behavioral modification. All patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss.  When a patient with a body mass index greater than 30 kg/m2 or a BMI of 27 through 29.9 kg/m2 with comorbidities, such as hypertension or diabetes mellitus, has failed to achieve weight loss goals through diet and exercise alone, pharmacologic therapy is suggested. In this case, limited documentation was provided despite requests. The submitted records do not document that the patient has failed treatment with counseling, calorie restriction and increased physical activity to achieve weight loss goals. Therefore, Saxenda is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 43-year-old female enrollee has requested reimbursement for services (HCPCS codes L0637, L0456 and L3030) provided on 3/2/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees back pain. The physician reviewer found that this patient received a lumbar brace on 3/02/18, foot orthotics on 3/13/18, and thoracic brace on 3/20/18. In this case, the progress notes on 3/02/18 indicated that the patient already achieved 20 to 25% improvement in her low back pain. She was given a back brace without explanation of medical necessity. On 3/20/18, the patient reported a 50 to 55% improvement in her mid-back pain, and the records do not demonstrate the need for a thoracic supporting brace. Back support has not been found to reduce lower back pain or help prevent lower back pain in this setting. The treatment note dated 3/13/18 indicated that the patients back and hip condition had improved approximately 40 to 45%, and the patient received a pair of foot orthotics. There is no documentation of foot symptoms or gait dysfunction warranting foot orthotics. Therefore, HCPCS codes L0637, L0456 and L3030 provided on 3/02/18, 3/13/18 and 3/20/18 were not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 56-year-old male enrollee has requested reimbursement for des-gamma-carboxy prothrombin (DCP) testing performed on the enrollee on 5/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that non-alcoholic steatohepatitis (NASH) can progress to hepatocellular carcinoma (HCC) (Yasui, et al). Yasui and colleagues performed a study to examine the clinical and pathological course of how NASH progresses to HCC. The authors found that NASH progressed to HCC after a median follow-up period of 3.8 years (range: 0.5-11.6 years). All patients had been identified as having HCC during screening, which included 12 patients assessed by ultrasound, four patients assessed with computerized tomography, two patients that underwent serum des-?-carboxy prothrombin testing and one patient that underwent serum a-fetoprotein testing. In addition, the meta-analysis by Bertino and colleagues resulted in the following conclusion A search of the literature was made using cancer literature and the PubMed database for the following keywords: markers and HCC, a-fetoprotein (AFP) and HCC, Des-?-carboxy prothrombin (DCP) and HCC, squamous cell carcinoma antigen-immunoglobulin M complexes (SCCA-IgM Cs). Despite the large number of studies devoted to the immunohistochemistry of HCC, at the present time, the absolute positive and negative markers for HCC are still lacking, and even those characterized by very high sensitivity and specificity do not have a universal diagnostic usefulness. In conclusion none of the three biomarkers (AFP, DCP, SCCA-IgM Cs) is optimal. Currently the recommended screening strategy for patients with cirrhosis includes the determination of serum AFP levels and an abdominal ultrasound every six months to detect HCC at an earlier stage. Given the above, the DCP testing performed on 5/29/15 has not 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 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: Overturned

Summary  
 
The patient is a 48-year-old female with a history of episodic migraine headaches with associated 
nausea, severe weakness, and ataxia. The provider has recommended continued treatment with 
Qulipta. The Health Insurer has denied the requested treatment as not medically necessary for the 
treatment  of  the  patients  medical  condition.  This  denial  is  the  subject  of  this  appeal  and 
determination. The physician reviewer found that Qulipta is in class of drugs called gepants, 
developed for the preventive treatment of episodic migraines in adult patients. Gepants play a 
crucial role in migraine pathophysiology and  are now established for preventive and acute 
treatments (Edvinsson, et al.). Gepants demonstrated efficacy and tolerability in the preventive 
treatment of migraines and are effective at reducing monthly migraine days (Ailani, et al.). 
According to the American Headache Society (AHS) consensus statement, patients with migraines 
should be considered for preventive treatment when attacks significantly interfere with patients 
daily routines despite acute treatment, attacks are frequent, and there is failure or overuse of acute 
treatments. The AHS further states that gepants should be personalized according to the needs of 
individual patients. In this case, the patient has a history of episodic migraines and has tried and 
failed multiple acute treatments, which fulfills the AHS criteria for preventative treatment. The 
AHS recommends that treatment plans involving the preventive use of gepants be personalized 
according to the needs of individual patients. For these reasons, the requested Qulipta 60 mg tablet 
is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.   The physician reviewer found that lumbar medial branch blocks are not investigational and are standard of care for lumbar facet mediated pain. Lumbar facet blocks are indicated for DDD and facet mediated pain in the axial lumbar spine. There are a multitude of studies indicating reduced pain, improved function and better quality of life following these injections. All told, the in-office surgical injections performed on 8/4/15 were likely to have provided this patient with an improved health outcome as compared to standard available therapies. 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: Upheld

Summary Reviewer 

The parent of a 15-year-old male enrollee has requested reimbursement for residential substance use disorders treatment provided from 8/21/18 through 9/03/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining the necessary level of care for children. In terms of risk of harm, the records support a score of 1. The medical records indicate that the patient was not actively or passively suicidal. There were no reports of self-harm, and his risk of suicide was continuously rated as none. With regards to functional status, the records support a score of 2. The patient had some issues with level of function due to mental illness and relational issues, but overall showed appropriate daily functioning while in treatment. In terms of comorbidity, the records support a score of 1. The patient does not have a history of past medical issues. His last substance use was several months prior to the disputed timeframe. With regards to level of stress of the recovery environment, the records support a score of 2. The patient was noted to have a safe and sober living situation. In terms of level of support of the recovery environment, the records support a score of 2. The patients family was involved in treatment. With regards to resiliency and treatment history, the records support a score of 3. It appears that the patient had good response to the five months in the residential treatment center as evidenced by stable mood, cooperation in therapy, sobriety and insight into his need for treatment. In terms of acceptance and engagement of the patient, the records support a score of 2. The patient actively participated in therapy, and he was cooperative with consistent engagement. With regards to acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with staff. Thus, the patient has a composite score of 15. This score correlates with outpatient services. Therefore, residential substance use disorders treatment provided from 8/21/18 through 9/03/18 was not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 34-year-old female enrollee has requested authorization and coverage for Sovaldi and RibaPak. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found that according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) all patients with chronic HCV regardless of fibrosis, should be treated except those with limited life expectancy due to non-liver-related conditions. Per the AASLD/IDSA guidelines, non-cirrhotic genotype 2b patients should be treated with Sovaldi and ribavirin for 12 weeks. This is based on multiple randomized controlled trials and Sovaldi is U.S. Food and Drug Administration (FDA) approved for patients with chronic hepatitis C genotype 2 regardless of fibrosis stage (Zeuzem, et al; Lawitz, et al; Jacobson, et al). AASLD guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, the requested treatment with Sovaldi and RibaPak is supported as medically necessary for the treatment of this patients hepatitis C infection. For the reasons provided, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3   
A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene test 
(CPT 81529) performed on 5/27/21. The Health Insurer has denied this request and reported that 
the services at issue were investigational for the evaluation of the enrollees medical condition. 
The physician reviewer found that in this case, a pathology report dated 4/30/21 reported stage 
IA cutaneous melanoma arising in a junctional dysplastic nevus. GEP testing is an evolving 
modality and may assist in differentiating precancerous from malignant lesions. While some 
studies show its efficacy in risk stratification in melanoma, it is unclear if GEP performs better 
than standard methods such as histopathologic risk factors and SLNB. In this clinical setting, the 
NCCN  guidelines  for  cutaneous  melanoma  recommend  only  wide  excision  and  do  not 
recommend GEP. Therefore, the DecisionDx-Melanoma gene test (CPT 81529) performed on 
5/27/21 was not likely to have been more beneficial for evaluation of the patients condition than 
any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2 
 
The parent of a seven-year-old female enrollee has requested authorization and coverage for 
Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested 
medication is investigational for the treatment of the enrollees alopecia. The physician reviewer 
found that there is a large body of growing evidence that JAK inhibitors, including tofacitinib, are 
efficacious and safe for the treatment of alopecia areata. The FDA recently approved the use of 
Olumiant, a JAK inhibitor, for the treatment of alopecia areata. Given this FDA approval, the use 
of JAK inhibitors for the treatment of alopecia areata is considered standard therapy. Current 
medical literature supports the improvement of alopecia treated with tofacitinib. Ibrahim and 
colleagues report that oral tofacitinib is a successful treatment for alopecia areata. Liu and 
colleagues conclude that tofacitinib should be considered for the treatment of severe alopecia 
areata, alopecia totalis, and alopecia universalis. In this case, the patient has extensive alopecia 
areata. Given that this patient has tried and failed multiple therapies including topical steroids, 
minoxidil, and topical tofacitinib, and systemic prednisone, and has responded well to tofacitinib, 
it is likely that Xeljanz will be more beneficial than any other standard treatment. Therefore, 
Xeljanz 5 mg tablet is likely to be more beneficial for treatment of the patients condition than 
any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 69-year-old female who presented with an abnormal mammogram. This revealed a mass on the right side measuring 0.7 cm. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services in this clinical setting. Current guidelines do endorse the use of intraoperative radiation therapy in the treatment of breast cancer. This patient would fall into the suitable group for the use of intraoperative radiation in patients with invasive ductal cancer. Phase 3 studies have shown equivalent outcomes in patients who undergo standard radiation therapy and intraoperative radiation therapy. The main benefit with intraoperative radiation therapy is that it can be done in a shorter course of time, and the patient does not require extra trips to a radiation oncology facility. Furthermore, treatment with intraoperative breast radiation treats only part of the breast, which may be associated with improved cosmesis. Therefore, intraoperative radiation therapy is medically necessary for the treatment of this patient.