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

Nature of Statutory Criteria/Case Summary: An enrollee has requested an Afirma gene test for evaluation of her medical condition. Two physician reviewers found that thyroid nodules are commonly managed by diagnostic fine needle aspiration to evaluate the cytopathology. In this case the finding by this standard technique was atypia of undetermined significance (Baloch, et al). This diagnostic category creates a dilemma with regards to recommended surgery. In this case, the patient was facing total thyroidectomy if malignancy was present, but only subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted for gene expression analysis. The Afirma gene test has demonstrated a very high negative predictive value for malignancy (Alexander, et al; Chudova, et al). The overall conclusions of the last two cited studies are that unnecessary thyroid surgeries may actually be prevented by implementation of the gene expression test. The studies are well conducted and the utility of the Afirma gene test has been demonstrated in the medical literature. As such, the he Afirma Gene Expression Classifier test was likely to be more beneficial for evaluation and treatment of the patients medical condition than any available standard therapy.   Final Result: Two reviewers determined that the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications:   All three reviewers are board certified in internal medicine with sub-specialty certification in medical oncology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a two-year-old male has requested speech therapy services for treatment of his autism. Findings:  The physician reviewer found that there is a robust body of medical literature supporting speech therapy for autistic children. Myers, et al. stated that people with autism spectrum disorders (ASDs) have deficits in social communication, and treatment by a speech-language pathologist usually is appropriate.  Most children with ASDs can develop useful speech, and chronologic age, lack of typical prerequisite skills, failure to benefit from previous language intervention, and lack of discrepancy between language and IQ scores should not exclude a child from receiving speech-language services. Turner, et al. performed a controlled study comparing autistic children, who did and did not receive speech therapy and concluded that those patients who did receive therapy had far greater communication skills than those who did not receive speech therapy. The report of the Speech and Language Association states that all autistic children can benefit from speech therapy.  This report emphasizes that age, either early or late in life, is not a barrier to speech therapy. All told, it is medically necessary that this patient receive individual speech therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

A 55-year-old female enrollee has requested the Oncotype DX tumor assay for evaluation of her breast cancer.  Findings:  Three reviewers found that Oncotype DX is a clinically validated assay of the breast tumors expression of 21 genes. This tumor assay quantifies the likelihood of distant recurrence in a select group of women. The assay was validated by the NSABP in a large independent multi-center clinical trial that also demonstrated the recurrence score was predictive of relapse free survival. Its accuracy exceeded standard measures such as patient age, tumor size, and grade. In this particular patients case, chemotherapy would likely have been recommended given the size of her tumor. However, the results of her assay supported treatment with hormonal therapy alone allowing her to forgo chemotherapy. This assay was critical in navigating the patients plan of care.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing. Findings:  Three physician reviewers found that pharmacogenomics is the use of genetic polymorphisms to guide medication treatment decisions. A review of the literature shows there have been few rigorously conducted randomized clinical trials to assess the effectiveness of using pharmacogenomics for the treatment of major depressive disorder. A recent meta-analysis by Rosenblat and colleagues included four randomized controlled trials and two open-label cohort studies. The authors noted that there was overall an improved outcome (improved rates of response and remission) for the group that used pharmacogenomics to help guide treatment.  However, in all of the randomized controlled trials, the treating provider was not blinded. Additionally, the studies had other methodological flaws, and some were under-powered to show an effect. At the present time, there is insufficient evidence to support improved patient outcomes when pharmacogenomic data are used to guide medication selection for the treatment of major depressive disorder. Therefore, the superior effectiveness of genetic testing not been established. Final Result: The reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1 is board certified in clinical genetics and genomics and is actively practicing. Physician reviewers 2 is board certified in clinical biochemical genetics and is actively practicing. Physician reviewers 3 is board certified in clinical cytogenetics and genomics and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 42-year-old female enrollee has requested authorization and coverage for a PET/CT scan for evaluation of her breast cancer. Findings:  The physician reviewer found that PET/CT scans are mainly utilized in the evaluation of patients with stage III or IV breast cancer and for the evaluation of response to treatment in patients with known metastatic breast cancer. The National Comprehensive Cancer Network guidelines do not advocate for the use of PET/CT scans in patients with stage I or stage II breast cancer.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for 12 weeks for treatment of his hepatitis C.  Findings:  Three physician reviewers found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy less than 12 months due to non-liver-related comorbid conditions.  Patients with cirrhosis are considered highest priority for therapy.  Harvoni for 12 weeks is recommended for cirrhotic, treatment-naive patients with hepatitis C, genotype 1 infection.  Based on the medical literature and clinical guidelines, Harvoni for 12 weeks is medically indicated for the treatment of this patient.  Final Result: Three reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.   Credentials/Qualifications: All three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 55-year-old female enrollee has requested Botox injections for the treatment of her migraine headaches. Findings:  Three physician reviewers found that although Botox is certainly not a first-line therapy for headache, there is adequate literature demonstrating its use for refractory headache disorders.  This is a case of a patient who has failed numerous first-line therapies for headache, including both prophylactic and abortive therapy.  In addition, her history is significant for a marked previous response to Botox therapy.  This previously documented response to Botox in the context of the refractory nature of her headaches makes the use of Botox medically necessary and appropriate in this case.
Appeal type: Medical Necessity
Decision: Upheld

A 73-year-old male enrollee has requested for proton beam radiotherapy for treatment of his prostate cancer. Findings:  The physician reviewer found that there is a lack of evidence in the literature demonstrating that the outcome after proton therapy, either with respect to PSA control, tumor control, or toxicity, is better than intensity modulated radiation therapy.  Of note, the bulk of data for proton therapy with prostate cancer is from patients with low-intermediate risk prostate cancer.  A recent review article by Mendenhall and colleagues addresses treatment of these high-risk patients, but makes no mention of the use of proton therapy.  All told, the requested proton beam radiotherapy is not medically indicated for the treatment of this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

A 59-year-old female enrollee has requested for sclerotherapy for treatment of her varicose veins.  Findings:  Three physician reviewers found that the literature does not favor sclerotherapy over standard of care treatments for refluxing veins. Corabian and Harstall reviewed the available literature and commented that in the short-term follow up, sclerotherapy shows promise, but the authors favored surgery over sclerotherapy after a two- to three-year follow up period. This patients records do not demonstrate that the sclerotherapy sessions were intended to treat lifestyle limiting symptoms, nor is there documentation of a concerted effort to try conservative treatment prior to treatment with sclerotherapy
Appeal type: Experimental/Investigational
Decision: Overturned

A 48-year-old female enrollee has requested a laparoscopic sleeve gastrectomy for treatment of her obesity. Findings:  Two physician reviewers found that laparoscopic sleeve gastrectomy has now been performed worldwide several thousand times with excellent results. Recently published eight-year follow-up studies show weight loss to be maintained with results as good as or even better than Roux-en-Y gastric bypass. Uglioni, et al. showed that after five years, there was a 39% failure rate after laparoscopic gastric band. Another factor to consider is that the patient will require the use of anti-inflammatory medication for her joint pain which could be problematic with a Roux-en-Y gastric bypass operation because of potential peptic ulcer formation. Furthermore, Roux-en-Y gastric bypass has greater potential for serious metabolic problems than laparoscopic sleeve gastrectomy and is more difficult to convert if the procedure fails. All told, laparoscopic sleeve gastrectomy is the most appropriate weight loss procedure in this particular setting.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:   An enrollee has requested breast tomosynthesis for evaluation of her medical condition.  Two physician reviewers found that in this patients case, the services at issue were likely to have been superior over other available modalities.  The current medical evidence supports breast tomosynthesis in this clinical setting.  The addition of breast tomosynthesis to digital mammography has been associated with an increase in detection of small cancers.  Thus, the technique has proven to be of greater value when added to screening digital mammographic views than screening mammography alone.  All told, breast tomosynthesis was likely to have been of greater benefit than other methods of evaluating this patient.  Final Result:  Two reviewers determined that that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: All three reviewers are board certified in diagnostic radiology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a 22-month-old male enrollee has requested speech therapy for treatment of the enrollees speech delay. Findings:  The physician reviewer found that the patient is at the 7th percentile which is approximately 1.5 standard deviations below the mean. In general, there is insufficient evidence or established criteria which would classify this level of disability as a disorder for which speech therapy is medically necessary. In sum, there is insufficient evidence in the accepted guidelines to establish that speech therapy services are the standard of care in this clinical setting. Therefore, based on the medical literature cited above and the documentation submitted for review, the requested services are not medically necessary for treatment of the patients medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested  a positron emission tomography (PET) scan for evaluation of her medical condition. Findings: Three physician reviewers found that the current medical evidence supports the requested services in this clinical setting.  It is important to have a sense of the activity of the disease before initiating relatively invasive and potentially harmful immunosuppressive or biological drugs.  Conventional laboratory indicators are non-specific and are often misleading.  Currently, PET scanning is the optimal modality in assessing activity.  Other modalities such as angiography, magnetic resonance imaging (MRI), and ultrasound are more geared to display anatomy.  In sum, the requested PET scan is likely to be more efficacious than other methods of evaluating this patient.Final Result: Three reviewers determined that the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: All three physician reviewers are board certified in diagnostic radiology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Monovisc injection in both knees.An exhaustive review of the current medical literature pertaining to viscosupplementation reveals mixed results. Evidence from eight systematic reviews and six randomized controlled trials indicates that although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. Viscosupplementation stimulates the production of endogenous hyaluronic acid and slows the degradation of articular cartilage in the knees. Different studies have tried mixing hyaluronic acid with corticosteroids, platelet rich plasma, and other agents to make it more effective. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patient has had good response to viscosupplementation in the past. Furthermore, the patients options are limited as the patient is not a candidate for total knee arthroplasties due to the mild degree of osteoarthritis. Therefore, Monovisc injection in both knees is medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the requested service is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Synvisc injections. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis treatment algorithm recommends intra-articular hyaluronic acid for management of knee osteoarthritis as second-line treatment in patients who remain symptomatic despite use of non-steroidal anti-inflammatory drugs. This recommendation is based upon accumulating evidence that intraarticular hyaluronic acid provides a significant benefit in knee osteoarthritis. There is good evidence that intraarticular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intraarticular corticosteroids. Evidence from real-life studies of repeat courses of intraarticular hyaluronic acid demonstrates an improvement in pain or function lasting up to 40 months (12 months after the last injection cycle), a reduction in use of concomitant analgesia by up to 50%, and suggests that there may be a delay in the need for total knee replacement of around 2 years. The clinical benefit of intraarticular hyaluronic acid on knee osteoarthritis may be twofold: (i) mechanical viscosupplementation of the joint (allowing lubrication and shock absorption) and (ii) the re-establishment of joint homeostasis through induction of endogenous hyaluronic acid production, which continues long after the exogenous injection has left the joint. A systematic review of overlapping meta-analyses comparing viscosupplementation with other nonoperative treatment modalities for knee osteoarthritis. Their analysis shows that the current highest level of evidence suggests that intraarticular hyaluronic acid is a viable option for knee osteoarthritis. Its use results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. Here, this patient with knee osteoarthritis has previously tried viscosupplemntation (i.e., Synvisc injections) with good results. She has tried and failed other conservative treatments. Current medical evidence supports the use of viscosupplementation for patients with this condition. As such, Synvisc injections of the left knee are medically necessary for this patient.Final Result: The reviewer determined that the requested service is medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for treatment of her hepatitis C virus.  Two physician reviewers found that according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) guidelines, 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. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. Thus, the recommendation is not deny patients treatment if the patient has early stage disease, but to provide treatment to avoid complications from advanced disease, including liver failure and extrahepatic complications. In addition, AASLD/IDSA guidelines recommend Harvoni for patients with hepatitis C genotype 1a.  As such, the patients request for Harvoni is medically necessary.  Final Result:   Two reviewers determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: One reviewer is board certified in gastroenterology and is actively practicing. Two reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.