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

Summary Reviewer 3

A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network guidelines. Thus, DecisionDx-Melanoma testing performed on 12/11/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 46-year-old male enrollee has requested authorization and coverage for Acthar Gel. The Health 
Insurer has denied this request indicating that the requested medication is investigational for the 
treatment of the enrollees sarcoidosis. The physician reviewer found that while the U.S. Food 
and Drug Administration (FDA) approves the use of Acthar Gel for the treatment of sarcoidosis, 
the  European  Respiratory  Society  (ERS)  clinical  practice  guidelines  note  that  the  initial 
pharmacological treatment for symptomatic pulmonary sarcoid with concern for adverse clinical 
outcomes  is  a  corticosteroid,  such  as  prednisone.  In  patients  unable  to  tolerate  steroids, 
experiencing  disease  relapse  with  steroid  taper,  or  with  disease  that  has  not  been  fully 
controlled, methotrexate may be utilized as a second-line treatment agent. Other second-line 
agents  following  the  use  of  methotrexate  include  azathioprine,  mycophenolate  mofetil, 
hydroxychloroquine, or leflunomide, if needed. Third-line agents include biologic drugs such as 
infliximab or adalimumab. The use of Acthar Gel may be considered after the trial and failure of 
these second and third-line treatment options. In this case, the records note that the patient has 
tried methotrexate and azathioprine. However, the records do not document that the patient 
has tried and failed treatment with second-line and third-line agents such as mycophenolate 
mofetil, leflunomide, infliximab or adalimumab as is typically expected prior to the use of Acthar 
gel. In this clinical setting, the requested medication is not likely to be more beneficial for the 
treatment of sarcoid than second-line and third-line agents therapies including mycophenolate 
mofetil, leflunomide, infliximab or adalimumab as recommended by clinical practice guidelines. 
Therefore, Acthar Gel is not likely to be more beneficial for treatment of the patients condition 
than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 43-year-old female enrollee has requested authorization and 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 low back pain. The physician reviewer found that this patient meets the criteria for a minimally invasive SI fusion. In the peer-reviewed medical literature, Polly and colleagues reported on a randomized controlled trial of 148 patients treated with minimally invasive SI joint fusion using triangular titanium implants or nonsurgical treatment with follow-up at one year. The authors concluded that this level one study showed that minimally invasive SI 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 SI joint disruptions. In another recent study, Whang and colleagues found that six month follow-up from this level one study showed that minimally invasive SI 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 SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions. Based upon a review of the recent literature, the requested minimally invasive form of SI joint fusion is 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 21-year-old female enrollee has requested reimbursement for the Game Ready system provided on 9/10/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is support in the medical literature for the services at issue in this clinical setting. The study by Martimbianco and colleagues investigated the use of cryotherapy after arthroscopic knee surgery, finding that cold compression results in reduced pain 48 hours after surgery. In addition, Block states that cryotherapy and static compression is commonly used for acute injuries as this intervention is thought to be most effective if applied almost immediately after injury or at the conclusion of an operative procedure. Thus, there is benefit noted in the immediate post-operative period. As such, the services at issue provided after knee surgery 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: Upheld

Summary Reviewer 3 
A 57-year-old female insured has requested reimbursement for a blood test performed on 
3/7/23. The Health Insurer has denied this request indicating that the service at issue was 
considered investigational for the evaluation of the insureds rheumatoid arthritis. The physician 
reviewer found that the American College of Rheumatology (ACR) does not recommend the use 
of Vectra DA testing for the diagnosis of rheumatoid arthritis or to measure disease activity, as 
there is a lack of definitive evidence finding a beneficial effect on health outcomes (England, et  al.). Johnson and colleagues report that Vectra DA testing demonstrates weak correlations with 
established scoring options including the SDAI and CDAI. According to the authors, further 
assessment of the performance characteristics of Vectra DA testing is warranted. All told, the 
blood test performed on 3/7/23 was not likely to have been more beneficial for the evaluation 
of the patients condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 54-year-old male enrollee has requested authorization and coverage for Androgel. 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 low testosterone can lead to such complications as reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue. For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL.  The general target level for testosterone ranges from 350 to 750 ng/dL, which is roughly the range for healthy, androgen-sufficient adult men. Testosterone levels should be monitored three to six months after initiation of treatment in order to assure that the patients testosterone level is optimal, and the dose of testosterone replacement therapy should be adjusted accordingly. The medical evidence supports the requested medication in this clinical setting. Therefore, AndroGel is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 55-year-old female enrollee has requested reimbursement for gene test (molecular profiling) performed on 2/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of lung cancer. The physician reviewer found the medical literature supports that adenocarcinoma of the lung should be tested for specific molecular abnormalities such as EGFR mutation. These have clear therapeutic implications (Temel, et al).  In this patients case, Tarceva was used because of her initial EGFR L858R mutation. Patients with that mutation, who are then treated with Tarceva, upon progression, can be found to have a further EGFR mutation (T790M). This appears to be true in about 50% of such patients, and it too has therapeutic significance.  One can test for such mutations either through tissue biopsy or in this case, through Guardant blood DNA assay. If a tissue biopsy is deemed inadvisable by the clinician, then the Guardant assay is considered reasonably accurate and easier on the patient. In this patients case, however, there were two tissue biopsies performed at about the same time as the Guardant assay. One of these biopsies showed no EGFR mutations; one showed the L858R mutation, but neither showed the T790M mutation. Thus, in this clinical setting there is no likely benefit to the additional Guardant assay. As such, the gene test (molecular profiling) performed on 2/18/16 was not likely to have been of greater benefit than the available standard methods of evaluating this patients medical condition. Based upon the information set forth above, the services at issue were not likely to have been 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 1

A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. The physician reviewer found that the prostatic UroLift system is a novel, minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way so it does not block the urethra. Recent clinical trials including prospective sham controlled randomized studies have shown that the UroLift is safe and effective in relieving lower urinary tract symptoms due to BPH without significantly compromising sexual function. Compared with standard available alteratives, UroLift is minimally invasive procedure without a requirement of general anesthesia and with a potentially shorter operative time, which may provide cost benefits. A recent prospective, randomized, multinational study compared the outcome of UroLift to transurethral resection of the prostate and concluded that participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. Thus, the UroLift procedure performed on 4/3/17 was 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 service at issue was 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: Overturned

Summary Reviewer 3

The parent of a nine-year-old transgender male enrollee has requested authorization and coverage for Supprelin LA KIT 50 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees gender dysphoria. The physician reviewer found that based on current medical literature, it does not appear that prepubertal suppressive therapy in a pediatric patient with gender dysphoria is beneficial. Gonadotropin-releasing hormone (GnRH) agonists have been used off label for pubertal suppression in gender dysphoric children including two that are approved for the treatment of precocious puberty: leuprolide by intramuscular injection and histrelin (Supprelin LA), a subcutaneous implant with yearly dosing. However, no available medication has current U.S Food and Drug Administration approval for suppressing physiologic hormonal development in pediatric patients with gender dysphoria. The American College of Pediatricians recommend against prepubertal suppressive therapy in gender dysphoric patients. Through suppression of the hypothalamic pituitary axis, these agents prevent development of secondary sex characteristics, but also inhibit bone growth and interfere with estrogen or testosterone dependent brain maturation and inhibit fertility. In addition, suppressive therapy with histrelin may lead to irreversible changes resulting in transgender hormone therapy and/or surgery in pediatric patients who would have been expected to resolve the gender dysphoria with normal growth and development without suppressive therapy. In sum, Supprelin LA kit 50 mg is not likely to be more beneficial for the treatment of the patients gender dysphoria than any other standard therapy. 
Based upon the information set forth above, the requested medication 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: Upheld

Summary Reviewer 3


A 58-year-old female enrollee has requested reimbursement for autonomic nerve testing performed on 9/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting.  Autonomic testing is reserved for clinical presentations where autonomic abnormalities are part of the presenting symptoms, which are absent in this patients case.  Sudomotor testing is indicated for possible diabetic neuropathy and is not currently an accepted standard of care in the evaluation of limb pain.  Thus, the superior efficacy of autonomic nerve testing performed on 9/03/15 has not been established.  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: Experimental
Decision: Upheld

Summary Reviewer 2


A 59-year-old female enrollee has requested reimbursement for a cooling or combined cooling/heating device. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the device at issue in this clinical setting.  Evidence-based medical guidelines and peer-reviewed literature indicate there is a lack of large volume long-term studies evidencing significant overall outcome differences with regards to continuous flow cryotherapy versus standard cold packs, in surgeries of this type. Additionally, the use of the combined cold/deep vein thrombosis prophylaxis unit is not supported for this patient.  There are limited deep vein thrombosis risk factors identified for this patient. There is no documentation that anticoagulation therapy would be contraindicated.  Therefore, the device at issue was not likely to have been more beneficial for the treatment of the patients medical condition than standard cold packs.  Based upon the information set forth above, the device at issue was 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 2

A 59-year-old female enrollee has requested reimbursement for the computed tomography (CT) scan performed on 11/17/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for evaluation of the enrollees risk of coronary artery disease. The physician reviewer found that although there is some research showing an association of coronary artery calcium with risk of heart disease, the American College of Cardiology (ACC) has not endorsed this as a Class I recommendation for screening for heart disease. The ACC guidelines emphasize standard risk assessment formulations such as the Framingham score and the fasting lipid panel. According to the American Heart Association recommendations for screening in women The role that novel [cardiovascular disease] CVD risk biomarkers (e.g., [high-sensitivity C-reactive protein] hsCRP or advanced lipid testing) and imaging technologies (e.g., coronary calcium scoring assessment) should play in risk assessment and in delineation of appropriate preventive interventions is not yet well defined. For these reasons, the CT scan performed on 11/17/16 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 diagnostic procedure 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 2
A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. The physician reviewer found that the DecisionDX-melanoma gene expression profile test  has been developed in patients with stage I and II cutaneous melanoma. However, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. In addition, this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials according to published data available. Per the National Comprehensive Cancer Network (NCCN) guidelines, the gene expression profile test is still not recommended for routine (baseline) genetic testing of primary cutaneous melanomas. Accordingly, the gene test performed on 8/12/16 was not likely to have been of greater benefit than available standard therapy for the evaluation of this patient.Therefore, for the reasons stated above, the services at issue were not likely to have been 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 2 
 
A 47-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 8/26/21. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous 
melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for 
those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be 
amenable to excision, but this suggests a high risk for the development of metastatic disease in 
the future. Such patients may be observed or treated with interferon-alpha. The data on 
DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node 
biopsy. There has also been some lack of consistency between various genes being used as 
biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the 
treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma  testing performed on 8/26/21 was not likely to have been more beneficial than any available 
standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 37-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that overall, there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than standard surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Further, the American College of Gastroenterology (ACG) guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX procedure is not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure 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.