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

Summary Reviewer 2


A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst. The physician reviewer found this patient had a cystic ovarian mass that was managed expectantly. A ROMA test was done to further support this treatment plan. No surgery was planned at the time the test was performed. As noted by Ueland and Li, the ROMA test was approved by the U.S. Food and Drug Administration (FDA) in 2011 to further assess the likelihood of malignancy in women who are planning to have surgery for an adnexal mass. There is a very specific indication for the ROMA test. This indication did not exist in this case. Therefore, the ROMA test performed on 6/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy, which was expectant management. 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 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 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 11/21/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


The parent of a seven-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the submitted documentation fails to establish the medical necessity of the requested medication. According to the documentation submitted for review, the patients height is not more than 2 SDS below the mean for age and gender, and his adult predicted height, based on the bone age and height assessment in March 2015, is approximately 66.5 inches, appropriate for his genetic potential. His growth factors are normal, he does not have any known morphological abnormalities of his pituitary gland, and there is no documentation of abnormal growth velocity for age. The delayed bone age is most consistent with a diagnosis of constitutional delay rather than GH deficiency. The patient underwent provocative testing with serial GH levels assayed for a period of three hours after the baseline measurement, but it is not clear from the results provided that two separate provocative tests were performed, with serial measurements of GH levels for 2-3 hours after each test independently. Although the U.S. Food and Drug Administration (FDA) has approved GH therapy for children with intrauterine growth retardation/small for gestational age with failure to catch-up in height, this patients height is not below the 3rd percentile on the growth curve, and thus he would not meet criteria for failure to catch- up in height. In addition, his adult height prediction is not short enough to qualify for GH on the basis of the FDA-approved idiopathic short stature indication. For the reasons provided, 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: Overturned

Summary Reviewer 


A 54-year-old male enrollee has requested authorization and coverage for Sovaldi and Olysio. 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 recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to nonliver-related conditions. Per the guidelines, patients with cirrhosis are high priority for treatment. After failure of NS5A inhibitors such as Harvoni, AASLD/IDSA guidelines state that patients who are high priority for treatment (such as this patient) should undergo testing for resistance-associated variants and retreatment when possible. When resistance to NS5A inhibitors is present and NS3 resistance is absent, as in this case, the recommended therapy is Sovaldi and Olysio with ribavirin for 24 weeks based on the resistance testing profile (Lawitz, et al; Buti, et al).  For these reasons, the requested treatment with Sovaldi and Olysio  is supported as medically necessary for the treatment of this patients hepatitis C infection. Therefore, based on the reasons stated above, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 46-year-old male enrollee has requested reimbursement for collagen crosslinking of the cornea including removal of the corneal epithelial performed on 10/18/16 and 11/1/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral corneal ectasia. The physician reviewer found that there is sufficient support for the superior efficacy of the services at issue in this patients case. Collagen crosslinking procedure has been well studied as a treatment option for corneal ectasia and to stabilize vision loss. Based on the patients vision loss and progression, crosslinking was the most appropriate and effective treatment available.  The services at issue are not considered experimental. Instead, crosslinking is validated by the medical literature findings. There is a large body of evidence demonstrating that this treatment is safe and effective for post refractive ectasia. This includes recent prospective placebo controlled trials with a large number of patients that demonstrate the effectiveness of stabilizing corneal ectasia and potentially delaying or preventing the need for full thickness corneal transplant.  Furthermore, corneal collagen crosslinking for corneal ectasias fulfills an unmet need. There is very few treatment options available to slow or halt disease progression. As such, treatment for this patients condition with collagen crosslinking of the cornea including removal of the corneal epithelial performed on 10/18/16 and 11/1/16 was likely to have been more effective than any other available option for this patient. 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: Overturned

Summary Reviewer 


A 60-year-old male enrollee has requested reimbursement for Xiaflex injections performed from 6/24/15 through 8/21/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation establishes the medical necessity of the services at issue. Xiaflex has been shown to have modest efficacy in clinical trials and is U.S. Food and Drug Administration (FDA) approved for patients with Peyronies disease with at least 30 degrees of curvature and a palpable plaque. Xiaflex is the only FDA approved drug for Peyronies disease and this patient is an appropriate candidate for Xiaflex. Therefore, the Xiaflex injections performed from 6/24/15 through 8/21/15 were medically necessary for treatment of the patients Peyronies disease. For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The parent of a 16-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intensive outpatient program services provided from 6/16/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that The American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) may assist in determining necessary level of care for children. With regards to risk of harm, the records support a score of 1 due to the patients lack of suicidal ideation or behaviors. In terms of functional status, the records support a score of 3. The patient has had deterioration in level of functioning in relationships with peers, adults and family. With regards to comorbidity, the records support a score of 2. The patient was noted to have substance use and several psychiatric issues. In terms of level of stress of the recovery environment, the records support a score of 3. The patient has severe problematic issues with family relationships. In terms of level of support of the recovery environment, the records support a score of 2. The patients family actively participates in treatment. With regards to resiliency and treatment history, the records support a score of 3 due to recent minimal progress in intensive outpatient program treatment. In terms of acceptance and engagement of the patient, the records support a score of 3. The patient participates somewhat in therapy, but appears non-committal. With regards to acceptance and engagement of the parents, the records support a score of 2. The parents work actively and constructively with clinicians. Thus, the patient has a composite score of 19.  This score correlates with intensive outpatient program services. Thus, intensive outpatient program services provided from 6/16/18 forward was and is medically necessary for the treatment of this patient. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 43-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 7/16/19. 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 the use of next generation sequencing (NGS) or molecular profiling is recommended by the National Comprehensive Cancer Network (NCCN) guidelines for patients with endometrial cancer as well as ovarian cancer. Molecular analysis can help classify difficult cases and provide future therapeutic targets. Individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. The NCCN guidelines recommend tumor molecular testing prior to initiation of therapy for recurrent or persistent ovarian cancer, if not previously done. Testing should include at least BRCA1/2, homologous recombination pathway genes, and microsatellite instability or DNA mismatch repair. This patient has two synchronous cancers, and the use of next generation sequencing may help solidify a treatment plan for this patient. Therefore, FoundationOne CDx testing performed on 7/16/19 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 57-year-old female enrollee has requested reimbursement for the gene test performed on 8/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the services at issue were not likely to be more effective than other methods of evaluating this patient. The clinical utility of the gene expression assay for cutaneous melanoma has yet to be determined. Moreover, the National Comprehensive Cancer Network (NCCN) Guidelines have not recommended this test outside of a clinical study (trial). In this patients case, the gene test performed on 8/12/15 was not likely to be superior to available standard therapy for the evaluation of this patients malignant melanoma. 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 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. 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 this patient had an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. In addition, the GEP on this patient was sent two years after diagnosis, making the information even less informative. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and 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. In sum, DecisionDx-Melanoma test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones. The physician reviewer found that there is some evidence in the medical literature to support the efficacy of the services at issue in this clinical setting.  Von Hoff and colleagues conducted a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progressive free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. Recent data on breast cancer also supports the use of FoundationOne testing. In this patients case, the results from FoundationOne profiling offers a rational selection of the next regimen.  In sum, gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) performed on 4/6/16 was likely to have been more efficacious than other methods of evaluating this patient. Therefore, for the reasons stated above, the services at issue were likely to have been 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: Overturned

Summary Reviewer 3


A 43-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/11/15.  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 the breast tomosynthesis performed on 7/11/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. Patients who have dense breasts benefit most from breast tomosynthesis which has the ability to separate out the overlapping structures with the possibility of demonstrating an otherwise occult tumor. In this case, the patient has heterogeneously dense breasts. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  All told, the services at issue were 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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 47-year-old male enrollee has requested authorization and coverage for endovenous vein ablation (CPT code 36478). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees varicose veins. The physician reviewer found that current Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines note the following recommendation, We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A) We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C(2); GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration =500 ms, vein diameter =3.5 mm) located underneath healed or active ulcers (CEAP class C(5)-C(6); GRADE 2B). This patient was diagnosed with CEAP class 2, with no deep vein thrombosis, and no palpable pulses. In sum, endovenous laser vein ablation (CPT code 36478) is not likely to be more beneficial than the other treatment options available for the treatment of this patient.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

A 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has severe and refractory disease that severely impacts his quality of life. He has tried many treatments. He is currently on a treatment regimen that is beneficial. The practice of prescribing patients with psoriasis two medications is commonly done and often yields better outcome than monotherapy. Both treatments have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis. According to the most recent guidelines published by the American Academy of Dermatology, there is no contraindication to using two FDA approved psoriasis medications together. A randomized controlled trial with the two agents is impractical. There is sufficient support for the requested medication in this clinical setting. Thus, Tremfya is likely to be more effective than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 42-year-old male enrollee has requested authorization and coverage for lumbar total disc arthroplasty (artificial disc). 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 the current medical evidence does not support the requested services in this clinical setting.  The long-term safety and efficacy of total disc arthroplasty has not been established.  There is the possibility of long-term complications of implantation of metal and metal methyl methacrylate devices in the spine.  Additionally, the studies to date do not adequately delineate the problem of component wear.  Van Den Eerenbeemt and colleagues noted that high-quality randomized controlled trials with relevant control groups and long-term follow-up are needed to evaluate the safety and efficacy of total disc replacement.  In sum, the requested lumbar total disc arthroplasty (artificial disc) is not likely to be superior over other available options.  Accordingly, 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: Medical Necessity
Decision: Upheld

Summary  
The patient is a 64-year-old female with a history of uterine serous carcinoma. The records reflect 
that the patient experienced abnormal vaginal bleeding in April 2022. The patient underwent a 
total  laparoscopic  hysterectomy,  bilateral  salpingo-oophorectomy,  bilateral  pelvic  sentinel 
lymphadenectomy, bilateral common iliac and para-aortic lymph node sampling and cystoscopy. 
The Health Insurer has denied the inpatient services from 8/11/22 through 8/12/22 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 this patient underwent a minimally 
invasive surgical procedure for the treatment of  uterine cancer.  According to  the medical 
documentation, the surgical procedure was uncomplicated and performed without difficulty. There 
is an abundance of evidence in the medical literature that supports the feasibility and safety of 
same-day discharge in patients receiving minimally invasive hysterectomy for both benign and 
cancer  diagnoses.  Therefore,  the  inpatient  services  from  8/11/22  through  8/12/22  were  not 
medically necessary for the treatment of this patient.