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

Summary Reviewer 


A 55-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) recommendations for treating hepatitis C, Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Denying treatment for patients with early stage hepatitis C is not supported by the peer-reviewed literature. Thus, the recommendation is not deny patients treatment if they have early stage disease, but to provide treatment to avoid complications from advanced disease, including liver failure and extrahepatic complications. In addition, the AASLD/IDSA guidelines state that high priority for treatment owing to high risk for complications include patients with fibrosis (Metavir F2). This patient has a Metavir score of F2. Furthermore, AASLD/IDSA guidelines recommend Viekira Pak, a daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks for patients with hepatitis C genotype 1 in whom prior treatment with peg-interferon and ribavirin has failed. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found medical studies have shown that the addition of three dimensional (3D) digital breast tomosynthesis (DBT) reduces false positives and increases cancer detection when compared to two dimensional full field digital mammography (FFDM, 2D) alone. Recall rates are reduced by 15-17%: 3D allows for separation of structures to differentiate architectural distortion from masses and overlapping fibroglandular tissue (asymmetries). Studies have also shown that there has been an increase in cancer detection by 33-53%: cancer detection increased from 6 cancers/1000 women screened with 2D to 8 cancers/1000 women screened with 3D. Three dimensional DBT allows better characterization of possible masses, spiculation, and architectural distortion.  In sum, there is sufficient evidence supporting the use of tomosynthesis for routine breast cancer screening. Thus, the breast tomosynthesis performed on 11/25/15 was likely to be more beneficial for this patient than any available standard modalities. 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 1

A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with progressively worsening neck pain that radiates into the right shoulder with right upper extremity pain and numbness. Her pain affects activities of daily living. Clinical examination findings have documented motor loss and apparent reflex changes generally consistent with imaging evidence of C4-5 and C5-6 disc pathology. She is status post prior anterior cervical discectomy and fusion at the C6-7 level. Detailed evidence of a recent, reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Under consideration is a request for total disc replacement at the C4-5 and C5-6 levels adjacent to the C6-7 fusion. Although there is literature support for two-level cervical artificial disc replacement, this surgical request for a two-level artificial disc replacement adjacent to a prior cervical fusion would constitute a hybrid construct for which there is a lack of large volume, long-term peer-reviewed outcome studies. The peer-reviewed literature by Rajakumar and colleagues submitted by the provider in support of this hybrid surgery request also concludes that more data from larger numbers of patients with long-term follow-up is required to confirm the safety and efficacy of this type of hybrid construct. Therefore, the requested total disc replacement is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


The parent of a 13-year-old male enrollee has requested authorization and coverage for growth hormone therapy (Humatrope).  The Health Plan has denied this request indicating that the requested therapy is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested therapy.  This patient has been treated with growth hormone therapy, and has apparently had a very good response in terms of increased height velocity.  Based on the medical records, this patients height velocity is consistent with simple constitutional delay.  As to the diagnosis of idiopathic short stature, he does not have absolute height standard deviation score more than 2.25 standard deviations below normal for age.  In terms of mid-parental height, the records indicate that he was 1.96 standard deviations below mid-parental height.  This patients bone age is not delayed.  Importantly, constitutional delay need not be treated with growth hormone supplementation.  There is a lack of support for the requested therapy in this clinical setting.  All told, the requested growth hormone therapy (Humatrope) is not medically indicated in this clinical setting.  Therefore, the requested therapy 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 65-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a. The physician reviewer found according to 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 life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, treatment naive genotype 1 patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic genotype 1 hepatitis C regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). For these reasons, the requested treatment with Harvoni is supported as medically necessary for the treatment of this patients hepatitis C infection. In conclusion, the requested medication is 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 physician reviewer found to the documentation submitted for review, the patient has evidence of a functional impairment related to her abnormal upper eyelid positions, related to significant eyelid ptosis. This is supported by physical examination, review of the photographs and functional improvement following her surgery. According to Zoumalan and Roostaeian Excess upper lid skin is the most common complaint a patient will describe with regard to the aging upper eyelid. Loss of elasticity results in increased skin folding over the lid crease. This is seen clinically as lash hooding where the skin overhangs and conceals the lid crease and, in severe cases, can even obstruct the visual field. Excess eyelid skin can obstruct the visual field and thus considered a functional problem. In this case, the patient presented with functional impairment related to her vision secondary to eyelid malposition in the form of ptosis. Her surgical procedure was consistent with correction and postoperatively she was noted to have improved vision. Therefore, the blepharoplasty performed on 6/3/16 was consistent with a medically necessary procedure.  Therefore, the procedure at issue was 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 patient is a 51-year-old female with a history of osteoporosis. The patient has requested 
authorization and coverage for Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL. 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 the 
submitted  documentation  supports  the  medical  necessity  of  a  portion  of  the  requested 
medication. Khosla and Hofbauer explain, Osteoporosis is an enormous and growing public 
health problem. Once considered an inevitable consequence of ageing, it is now eminently 
preventable and treatable.  Cremers and colleagues report that bisphosphonates have been the 
standard therapy for osteoporosis. Regarding recent progresses in the treatment of osteoporosis, 
Li and colleagues note that in patients with high or very high risk for fracture, sequential or 
combined therapies may be considered with the initial drugs being anabolic agents such as 
teriparatide and romosozumab. The U.S. Food and Drug Administration (FDA) approves the use 
of Evenity (generic name romosozumab) for the treatment of osteoporosis. Evenity is a strong 
anabolic medication, in contrast to the bisphosphonates, which have anti-resorptive effects. In a 
study of postmenopausal women with osteoporosis who were at high risk for fracture, Saag and 
colleagues report that treatment with Evenity for 12 months followed by alendronate resulted in 
a significantly lower risk of fracture than alendronate alone. McClung notes that  beginning 
treatment with an anabolic agent, such as Evenity, in patients at very high or imminent risk of 
fracture an effective and appropriate treatment plan. Therefore, Evenity (romosozumab-aqqg) 
injection 105 mg/1.17 mL for 12 months is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that there is current evidence-based medical guideline and literature support for the treatment of significantly symptomatic osteoarthritis of the knee when specific criteria have been met, including failed conservative treatment (including intraarticular steroids), osteoarthritis that was not advanced, and age under 50 years. Repeat platelet-rich plasma injections are only supported once a year if previous injection provided significant relief for over six months. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of platelet-rich plasma in the treatment of sacroiliac joint pain and wrist/hand disorders. In this case, there is no documentation as to the severity of the reported osteoarthritis of the patients right knee, details of prior conservative treatment failure, and rationale for exception to recommended age limits. There is no compelling rationale presented to support the necessity of platelet-rich plasma injections for the sacroiliac joint or bilateral hands/thumbs in the absence of evidence-based medical literature support. Therefore, platelet-rich plasma injections provided from 7/14/17 forward were not and are not likely to be of greater benefit than other available treatment options. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 45-year-old male enrollee has requested authorization and coverage for radiofrequency ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that Intra-articular steroid injection is a traditional approach to treating sacroiliac joint pain. For long-term pain relief, however, lesioning the sacral lateral branches may be a better approach. In a randomized, prospective study by Dutta and colleagues comparing the efficacy of intra-articular depo-methylprednisolone injection to that of pulsed radiofrequency ablation for sacroiliac joint pain, the radiofrequency ablation group demonstrated superior pain relief over the steroid injection group at 3-month and 6-month post-procedures. In addition, a recently completed multidisciplinary, multi-society effort to develop appropriate use criteria for sacroiliac interventions concluded that lateral branch radiofrequency neurotomy/radiofrequency ablation is an appropriate treatment for appropriately selected patients. There is sufficient support for the requested services in this clinical setting. Therefore, the requested radiofrequency ablation is likely to be more beneficial for treatment of the patient than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 40-year-old female with a myriad of medical comorbidities, including Ehlers-Danlos connective tissue disease. She was evaluated as a second opinion on 3/26/21 due to concern regarding a suspected tethered cord. The physician reviewer found that the entity of occult tethered cord syndrome is controversial in the neurosurgery field. The patientas surgeon admits as much in his documentation. A number of publications are available in this area. The provideras review provides a thorough assessment of this knowledge in the field. In the provideras review, the only randomized controlled study was conducted as a pilot by Steinbok and colleagues in 2016. These investigators compared surgical (filum sectioning) and medical management of patients with urologic symptoms refractory to conservative treatments. All had normal conus positions and abnormal urodynamics. Only 21 patients could be accrued after eight years of trying. No significant differences were found between the groups. Overall, the data are challenging to interpret on the basis of the retrospective nature of the reports, the variability of the studies, the very small sample sizes, and the fact that the only prospective randomized study yielded a negative result regarding surgery. Most of the studies involved children, and this patient is an adult. A reasonable number of the patients in the noted studies one could argue had findings that made their cases not aocculta. This patient has a reported normal neurological examination by both neurology and her neurological surgeon. MRI scan of the lumbar spine is normal. The urodynamic report has no interpretation, and there is no clear assessment by a urological specialist. There is no independent neurology assessment that indicates tethered cord as a consideration. The data in support of surgical intervention in the form of filum sectioning is weak at best, and the diagnosis of occult tethered cord syndrome remains controversial. There is a lack of support for the requested services in this clinical setting. Therefore, lumbar spine surgery and other related services (codes 63200, 13160 and 69990) and the associated inpatient bed day are not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer. The physician reviewer found that this patient had biopsy proven DCIS with extensive microcalcifications indicated on MRI. OncotypeDX was used to determine the risk of invasion in order to determine surgical decision making regarding lumpectomy versus mastectomy. However, OncotypeDX DCIS was developed to determine the need for radiation post-lumpectomy and not for surgical decision making. In addition, data regarding utility are still preliminary. This patient had extensive calcifications and the standard of care would be to biopsy the calcifications to determine the extent of the disease and to determine whether or not to proceed with mastectomy versus breast conserving therapy. As such, this test was not used in the correct context and was not likely to be more beneficial than the standard of care of using clinical factors to choose the extent of therapy. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Avastin injections from 2/27/14 forward.  The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found the current medical evidence does not support the services at issue in this clinical setting.  The use of Avastin has been well studied as an adjunct to chemotherapy in pancreatic cancer.  Kindler and colleagues reported a study of 602 patients with pancreatic cancer treated with either Gemzar or Gemzar with Avastin.  The authors noted that the addition of Avastin did not improve survival in advanced pancreatic cancer patients.  Van Cutsem and colleagues reported on 607 patients randomized to chemotherapy with or without Avastin.  The authors reported that there was no significant difference in overall survival with the use of the Avastin.  All told, Avastin injections from 2/27/14 forward were not and are not medically indicated for the treatment of this patient.  Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that the lab performing the sperm banking states testing for HTLV-I and HTLV-II are needed to meet requirements set forth by the U.S. Food and Drug Administration (FDA). Further, the FDA has issued guidelines for testing all donated blood for HTLV-I and HTLV-II. The FDA requirements indicate that HTLV testing is not investigational in this clinical setting. Moreover, sperm banking is considered standard of care for young men requiring chemotherapy. Accordingly, the HTLV testing performed on 4/25/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC)) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx melanoma assay, the tumor was classified as Class 2 with molecular signature associated with a high risk of near term (within five years) metastatic disease. Identification of the increased risk of recurrence of melanoma in this patient helped establishing an appropriate follow-up plan. Thus, the DecisionDx melanoma gene expression assay provided on 7/29/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.