Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A 46-year-old female enrollee has requested reimbursement for the graft procedure, Graffix Core for treatment of the enrollees hallux limitus, right foot. Findings:  The physician reviewer found that It is well-established in the medical literature that the Grafix Core graft is effective for use in patients with non-healing diabetic foot ulcers. However, the medical literature does not support the use of the Grafix Core graft for application over denuded cartilage. Further studies must be performed to evaluate the efficacy of amniotic membrane and stem cell membranes over diseased cartilage. Based on the available documentation and current peer-reviewed medical literature, the application of the graft procedure, Grafix Core provided on 5/30/17 was not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.  Final Result: All three reviewers determined that the service at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Medical professional reviewer number one is board certified in podiatry 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.Medical professional reviewer number two is board certified in podiatry 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.Medical professional reviewer number three is board certified in podiatry 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:An enrollee has requested reimbursement and prospective authorization and coverage for electrical bone growth stimulator for treatment of the enrollee who had a right bunionectomy.  Findings:  The physician reviewers found that there is support in the medical literature for the efficacy of the services at issue in this clinical setting. This patient underwent a first metatarsal first cuneiform joint fusion/bunionectomy right foot. It was noted that patient continued to have pain and swelling to the surgical area. Subsequently, hardware was removed and the surgical site was found not to be fused. The literature advises that noninvasive electrical bone growth stimulators are considered effective for the treatment of nonunion or congenital pseudarthrosis of the appendicular skeleton. It is recommended that 45 days must have passed since the date of fracture and or surgical treatment. In this patients case, the fracture gap is less than 1 cm and serial radiographs or appropriate imaging studies confirm that no progressive signs of healing have occurred. In this case surgical intervention and visualization of the joint indicated that the first metatarsal first cuneiform joint had not fused in over seven months. Therefore, electrical bone growth stimulator was and is likely to be more beneficial for treatment of the patients medical condition than the available therapy options. Final Result: Two of three reviewers determined that the  services at issue were and are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers number one, two, and three are board certified in podiatry and 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization coverage for eyelid surgery (CPT 67908  repair blepharoplasty conjunctive-tarso-mullers muscle-levator resection (1 unit) and CPT 15823  blepharoplasty upper eyelid with excessive skin (1 unit)) for treatment of the enrollees bilateral dermatochalasis and myogenic ptosis. Findings:  The physician reviewer found that upper eyelid ptosis can lead to functional impairment requiring surgical repair. According to American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) there are three important elements that must be documented to meet the requirement for functional indication for repair: clinical notes documenting patient complaints of visual impairment secondary to abnormal eyelid or brow position resulting in limitation of daily activities such as reading, driving, and difficulty seeing objects approaching from the periphery, or redundant upper eyelid skin resulting in looking through the eyelashes or seeing the upper eyelid skin; clinical notes documenting a margin reflex distance (MRD) of 2 mm or less for blepharoptosis repair; and peripheral visual field testing performed with the eyelid and brow in the resting position that documents a baseline superior visual field of 30 degrees or less from fixation and improvement of at least 12 degrees over baseline with eyelid and brow elevation. Both manual, including Goldmann and tangent screen, and automated fields are acceptable. The measurement of a patients superior visual field is defined as the lowest point seen at the vertical meridian. In this case, the patient meets all three requirements including documentation supporting MRD less than 2 mm and superior visual field restriction to 20 degrees in right eye which improves to more than 30 degrees with taping; and restriction to 25 degrees in left eye which improves to 30 or more with taping.  A technical guide to reading the visual field is to look at the vertical bar where each tick mark is 10 degrees. The large black squares indicate where the patient could not see. In the untapped right eye, the lowest dark square is at 20 degrees and possibly even 15 degrees. In the left it is at 25 degrees. Therefore, the request for eyelid surgery (CPT 67908  repair blepharoplasty conjunctive-tarso-mullers muscle-levator resection (1 unit) and CPT 15823  blepharoplasty upper eyelid with excessive skin (1 unit)) has been established as medically necessary. Final Result: The reviewer determined that the requested surgery 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 ophthalmology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Spinraza. Findings: The physician reviewer found that Spinraza binds to intron splicing silencer-N1 (ISS-N1) a site present ten nucleotides down to the junction of exon 7 and intron 7, modulating the splicing of SMN2 pre-mRNA transcript to increase the inclusion of exon 7, thereby increasing the production of full length SMN2 protein. Major evidence of its efficacy came from a sham controlled phase 3 clinical study. Spinraza is also the first drug approved by the U.S. Food and Drug Administration (FDA) for treatment of SMA in children and adults. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition.Credentials/Qualifications: The reviewer is board certified in neurology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary:The parent of a transgender male enrollee has requested authorization and coverage for the medication testosterone cypionate for treatment of the enrollees gender dysphoria.Findings:  The physician reviewer found that the documentation submitted supports the medical necessity of the requested medication in this clinical setting. Hormonal treatment with gender affirming hormones is accepted as standard of care for both adolescents and adults diagnosed with gender incongruence. The records document that this patient has undergone a complete medical and psychological evaluation and continues to participate in therapy. He is a good candidate for medical management with hormones. The records indicate that he has the support of his parents and therapists. Similar to other adolescents with gender dysphoria, his medical history includes anxiety, depression and history of self harming behaviors. With treatment, his symptoms have improved. This patients positive emotional changes are well supported in the medical literature in that medical treatment improves the psychological well being in those adolescents who are diagnosed with gender dysphoria. Therefore, testosterone cypionate is medically necessary for the treatment of this patients gender dysphoria. Final Result: The 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: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology and metabolism and expertise in transgender medicine 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for Tysabri 300 mg every four weeks for treatment of the enrollees multiple sclerosis. Findings:  The physician reviewer found that Tysabri has the highest relapse reduction rates among all disease modifying therapies. Studies have compared efficacy and treatment persistence in treatment-naive patients with relapsing multiple sclerosis initiating natalizumab compared with interferon- (IFN-)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries (Spelman, et al). Studies provide Class IV evidence that first-line natalizumab for relapsing multiple sclerosis improves relapse and treatment persistence outcomes compared to first-line IFN-/GA. For these reasons, Tysabri 300 mg every four weeks has been established as medically necessary for treatment of the patients medical condition. Final Result: The 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: The reviewer is board certified in neurology 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: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A male enrollee has requested authorization and coverage for trigger point injections for treatment of the enrollees thoracic spondylosis.  Findings:  The physician reviewer found that the request for trigger point injections are not medically necessary for treatment of the patients medical condition. The documentation provided for review shows the patient is being treated for thoracic pain after a motorcycle accident in 2009. Trigger point injections are indicated when there is documentation of the presence of a twitch response as well as referred pain and after a failure of conservative treatments. In this case, the presence of a twitch response with referred pain pattern is not documented in the information provided for review. Additionally, the degree and duration of pain relief after the previous trigger point injection procedure is not documented. For these reasons, the requested services are not considered medically necessary for the treatment of the patients medical condition. Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation with sub-specialty certification in pain medicine 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Saxenda for treatment of the enrollees obesity, sleep apnea, hypertension, and gastroesophageal reflux disease (GERD). Findings:  The physician reviewer found that in 2012, the American Association of Clinical Endocrinologists (AACE) published its position statement designating obesity as a disease. As such, obesity is a disease that needs to be treated medically. There are several guidelines and algorithms designed to treat obesity. According to the AACE guidelines, pharmacotherapy should be offered to patients with obesity, when potential benefits outweigh the risks, for the chronic treatment of the disease. Colleagues noted that Saxenda 3 mg per day is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic bodyweight management in adults with an initial body mass index (BMI) of 30 kg/m2 (obese) or a BMI of 27 kg/m2 (overweight) and at least one bodyweight-related comorbidity [e.g. hypertension, dyslipidaemia, type 2 diabetes mellitus or obstructive sleep apnoea (OSA). Colleagues found that the addition of Saxenda on a low calorie diet led to an additional ~6% weight loss compared with those patients who continued the lifestyle intervention alone. As this patient is noted to be obese with a BMI of 34 kg/m2 with comorbidities including hypertension, GERD and sleep apnea, Saxenda is supported as medically necessary. Final Result: The 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: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested coverage for gene test (CPT 81545) Afirma performed for evaluation of the enrollees thyroid nodule. Findings:  Three physician reviewers found that the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The American Thyroid Associations guidelines indicate that for nodules with FLUS cytology, investigations such as repeat FNA or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. Informed patient preference and feasibility should be considered in clinical decision-making.  In this case, the patient has a thyroid nodule with worrisome features and the cytopathology consistent with FLUS. The result of the Afirma GEC from the same specimen was benign. This information was important to determine the decision whether to perform a thyroidectomy and may prevent the need for a repeat biopsy or diagnostic hemithyroidectomy. In addition, there is sufficient support in the peer reviewed literature demonstrating the benefits of genetic testing in thyroid nodules. Final Result: Three 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 endocrinology, diabetes and metabolism and are 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: male enrollee has requested authorization and coverage for nusinersen (Spinraza) for treatment of the enrollees spinal muscular atrophy (SMA) III. Findings:  The physician reviewer found that Spinraza is a modified antisense oligonucleotide (a synthetic genetic material) that binds to a specific sequence in the intron downstream of exon 7 of the SMN2 transcript. Spinraza causes the inclusion of exon 7 in the SMN2 transcript, leading to production of full length functional SMN protein. Spinraza can be appropriate for the treatment of spinal muscular atrophy in patients when there is confirmation of the diagnosis by either: SMA diagnostic test results confirming no copies of SMN1 or by molecular genetic testing of 5 q SMA for a homozygous gene deletion, homozygous conversion mutation, or compound heterozygote and when there is documentation of either genetic testing confirming no more than two copies of SMN2 or when there are SMA-associated symptoms before six months of age. In this case, the patient had significant symptoms beginning in adulthood with progressive symptoms beginning in his 40s. However, he has three copies of the SMN2 gene and is therefore not considered a candidate for treatment with Spinraza. Thus, the requested Spinraza is not supported as medically necessary for treatment of this patients spinal muscular atrophy. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in pulmonary disease 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the nerve testing (autonomic testing) performed for evaluation of the enrollees small fiber neuropathy symptoms. Findings:  The 3 physician reviewers found that in this case, the patient was under evaluation for multiple symptoms that suggested neuropathy. Small fiber neuropathy can be difficult to diagnose as clinical testing and EMG may be normal. Skin biopsy for small fibers may be helpful, but many patients have other associated symptoms that may indicate involvement of small autonomic fibers which may associated with acroparesthesias (tingling in the hands and feet), abnormal tearing, gastroparesis, constipation, orthostatic hypotension, loss of cardiac beat to best variability, and abnormal pupillary responses. This condition, especially when there is autonomic involvement may be associated with a paraneoplastic syndrome in which case an occult cancer may be found, or autoimmune disorders. Autonomic testing has been relatively mainstream for decades and is supported in the peer reviewed literature. Based on the clinical documentation submitted for review and the support in the peer-reviewed literature, the nerve testing (autonomic testing) performed was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.  Final Result: The 3 reviewers determined that the diagnostic procedure 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: Physician reviewer number one is board certified in neurology 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.Physician reviewer number two is board certified in neurology 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.Physician reviewer number three is board certified in neurology 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.