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

A 48-year-old female enrollee has requested a fecal transplant for treatment of the enrollees history of C. difficile enteritis.  Findings:  Three physician reviewers found that fecal transplantation for refractory C. difficile-associated diarrhea has been reported in the medical literature. There have been controlled clinical trials involving small number of patients that seem to show effectiveness.  However, the submitted documentation does not demonstrate that the patients current symptoms are due to persistent or recurrent C. difficile toxin infection.  A colonoscopy performed on the said date was endoscopically normal, and colon mucosal biopsies were reportedly normal. No pseudomembranes were endoscopically detected which, if present, could have perhaps supported a diagnosis of C. difficile toxin-associated colitis/diarrhea. Even if C. difficile toxin was present in her stool and confirmed by stool analysis, there is no guarantee that the presence of C. difficile toxin would be the reason for her diarrhea. There are no current stool study results that demonstrate that the patients diarrhea, nausea, and vomiting are due to persistent C. difficile-associated diarrhea.  There is a potential detrimental effect of transplanting a pathogen into an immunocompromised patient.  Thus, the requested fecal transplant is not likely to be of greater benefit than other available treatment options.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a two-year-old male enrollee has requested  speech therapy for treatment of the enrollees developmental speech and language delay.  Findings:  The physician reviewer found that per Nelson and colleagues, speech and language development is considered by experts to be a useful indicator of a childs overall development and cognitive ability and is related to school success.  The authors noted that identification of children at risk for developmental delay or related problems may lead to intervention services and family assistance at a young age when chances for improvement are best.  Speech and language delay must be taken seriously in young children, because the long-term consequences may be substantial.  As noted by Law and colleagues, approximately 6% of children have speech and language difficulties.  The authors noted that children whose difficulties persist into primary school may have long-term problems concerning literacy, behavior, socialization, and school attainment.  These reviewers concluded that there is a positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulties.  McLaughlin noted that there are good data available to support the effectiveness of speech therapy for children with primary expressive language disorder.  This patient has expressive language delay that significantly impairs his ability to communicate effectively and function socially. Based on the medical literature, speech and language therapy is medically necessary and appropriate to address his speech and language challenges.  All told, the requested speech therapy is medically indicated in this patients case.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for DecisionDX-melanoma test for evaluation of his malignant melanoma. Findings:  The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the staging system as documented by Balch and colleagues. Mitotic index has also been thought to add a bit more to the prognostics. By these determinations, this patient has an excellent prognosis. DecisionDX is a study of 31 genes in the melanoma cells. It then classifies that melanoma as either high or low risk for recurrence. The National Comprehensive Cancer Network (NCCN) guidelines state there is interest in these newer genetic profiles. However, medical studies are not clear as to how DecisionDX data compares to the 10 year data of the Balch determinations and whether it is useful in clinical practice for patients with a good prognosis, as is true in this patients case. This patient will most likely not undergo sentinel node biopsy, in view of his excellent prognosis. While this test has some limited support for its use in identifying treatment options for those patients diagnosed with cutaneous melanoma, this assay has not been shown to be superior over other modes of therapy.  Final Result: The reviewers determined that the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Reviewers 1, 2, and 3 are board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewers 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: Upheld

A 56-year-old male enrollee has requested for bilateral canaloplasty procedures for treatment of his glaucoma.  Findings:  Three physician reviewers found that the current status of the scientific data, Cheng and colleagues concluded that, Viscocanalostomy and deep sclerectomy were less effective than trabeculectomy in the treatment of open-angle glaucoma. Thus, although some studies suggest that there were fewer documented complications with canaloplasty than trabeculectomy, Mosaed and colleagues concluded that, Trabeculectomy is still the most effective IOP-lowering procedure performed today despite the potential complications. Accordingly, the requested canaloplasty has not been established.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni for 12 weeks for treatment of his hepatitis C virus.  Findings:  The physian reviewer found that according to the most 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 non-liver-related conditions. Per guidelines, treatment-naive genotype 3 patients should be treated with one of three regimens: Sovaldi/Daklinza for 12 weeks, Sovaldi/ribavirin with peginterferon for 12 weeks, or Sovaldi/ribavirin for 24 weeks.  Harvoni is not U.S. Food and Drug Administration (FDA) approved for treatment of genotype 3 and is not recommended by the guidelines, which note that the ELECTRON-II trial showed 64% cure rate with the requested regimen of Harvoni for 12 weeks. The activity of ledipasvir (part of Harvoni) against genotype 3 hepatitis C has been shown to be weak.  Although treatment is indicated in this case, and AASLD guidelines cite data showing increased survival with earlier treatment, alternatives for safe and effective therapy are available and recommended by AASLD. For these reasons, the requested treatment with Harvoni for 12 weeks is not supported as medically necessary for the treatment of this patients hepatitis C infection. 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 gastroenterology 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for referral to a registered dietician. Findings:  The physician reviewer found that treatment of adult obesity includes education and training regarding a comprehensive lifestyle change with dietary therapy, exercise, behavior modification, and if needed, drug therapy. Identifying an individuals risk for adverse medical outcomes due to obesity is needed to determine the most effective or necessary approach. Individuals with a BMI of 30-34.9 kg/m2 are at moderate risk. These individuals should be offered or referred to intensive, multicomponent behavioral intervention programs that include information that will enable them to make dietary changes and increase physical activity. Medication management should also be considered. The initial step for management and education should reasonably come from a medical provider. The goal of dietary therapy is to reduce the total number of calories consumed. There is no one single diet that fits all individuals. In this case, the submitted documentation does not reflect that the patient has failed an attempt at weight loss with the medical weight management program that is available at the recommendation of her provider. Additionally, there is no indication that the patient has received education from her provider regarding dietary changes or that her medical provider is unable to provide education regarding dietary changes. Under these circumstances, the requested referral to a registered dietician is not medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested services are not medically necessary to treat the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal 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: Upheld

A 59-year-old female enrollee has requested authorization and coverage for Far Infrared Radiant Heat therapy (FIRHT for treatment of her skin condition.  Findings:  The physician reviewer found that although FIRHT units do not provide any significant tissue penetration, they may still provide clinical benefits (Crinnion). There are reports that therapeutic use of this FIRHT for a variety of cardiovascular problems, improvement in lung function, and pain relief. However, currently there are no data in the medical literature regarding the use of FIRHT for skin diseases. In general, treatment of dermatophyte infection involves primarily oral and/or topical formulations of azoles or allylamines, particularly itraconazole and terbinafine. Topical medications applied once or twice daily are the primary treatment indicated for tinea corporis/cruris, and tinea pedis/manuum. Use of oral anti-fungals may be practical where the tinea involvement is extensive or chronic, or where application of a topical is not feasible. Recently, topical amorolfine and ciclopirox formulations have been approved for use in milder onychomycosis cases and relapse of infection remains a problem. Appropriate follow-up and education of patients on proper foot hygiene are also important components in providing effective therapy (Gupta, et al). Antibiotics are used for systemic and topical skin diseases treatment, taking advantage of their antiseptic, bacteriostatic and also their anti-inflammatory and immunomodulating properties. In cases of localized external skin layer infections, a topical treatment is adequate. In cases of widespread and deeper infections a systemic treatment is needed. The latter dermatological diseases are mostly treated by beta-lactam antibiotics macrolides and tetracycline. In topical treatment, mostly erythromycin, Clindamycin, mupirocyne and fusidic acid are used. The most common bacterial skin diseases where topical treatment is sufficient are: impetigo contagiosa; folliculitis; and erythrasma. Systemic treatment is required in cases of severe staphylococcal and streptococcal infections, secondary bacterial infections, acne vulgaris, rosacea, and dermatosis with bacterial antigens pathogenesis influence (McDonald, et al.)Anti-fungal and anti-microbial drugs are usually an effective treatment for the type of skin disease diagnosed in this patient. Failure may have been caused by development of drug resistance by the microorganisms on the patients skin, which could be addressed by performing antibiotic sensitivity tests. However, there is currently no persuasive data showing how FIRHT could improve skin infections with associated dermatitis. Alternative approaches with unpredictable outcomes, like FIRHT, are not medically necessary because the appropriately used standard methods of diagnosis and treatment are sufficient to resolve this common medical problem.
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:  The physician reviewer 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 should be treated except those with limited life expectancy due to non-liver-related conditions.  This applies regardless of fibrosis stage or viral load.  Per the guidelines, patients with HIV are prioritized for treatment due to risk for complications.  The guidelines recommend the same hepatitis C treatment as patients without HIV, but drug-drug interactions should be taken into account.  Per the guidelines, treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks.  These guideline recommendations are based on multiple randomized clinical trials. For these reasons, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for the treatment of this patients hepatitis C infection. 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 gastroenterology 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

A 36-year-old male enrollee has requested for Kapidex 60mg for treatment of his gastroesophageal reflux disease. Findings:  The physician reviewer found that the patient has atypical reflux symptoms without heartburn.  Neither endoscopic reports nor pH studies of the esophagus have been provided.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for an Omnipod (wireless insulin pump) and related supplies. Researchers note that insulin pump use and continuous glucose monitoring are associated with improved glycemic control. While researchers report that improvement of glycemic control among the insulin pumps appears to be fairly consistent, medical literature note that Omnipod users perceived substantial quality of life benefits from the device. In this clinical setting, given that continuous glucose monitoring is associated with improved glycemic control and quality of life, the requested equipment and supplies are medically indicated. Therefore, an Omnipod (wireless insulin pump) and related supplies are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested equipment and supplies are 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for oral enteric-coated budesonide. Findings:  The physician reviewer found that the American Association for the Study of Liver Diseases (AASLD) included budesonide in recommendations for first-line treatment of autoimmune hepatitis. The guidelines cited a 90% first-pass hepatic metabolism of budesonide, resulting in a lower risk of systemic side effects. Zandieh and colleagues found that budesonide had successfully been used to treat patients with autoimmune hepatitis who were intolerant to prednisone and azathioprine. Gleeson noted that budesonide was recommended in non-cirrhotic patients who developed prednisolone-related side effects. In this case, the patient had type 1 diabetes and reported elevated blood sugar as a side effect of prednisone. She was documented as stable, using budesonide to treat her autoimmune hepatitis. Therefore, oral enteric-coated budesonide is medically necessary for the treatment of this patient.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 gastroenterology 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

The patient is a 67-year-old female with a non-healing ulcer of the left ankle. She has a possible history of scleroderma. The patient has requested coverage for Regranex for treatment of the ulcer. The Health Plan has denied the request on the basis that the requested medication is not medically necessary.The Health Plans denial should be upheld. The use of Regranex in non-diabetic ulcers has not been studied and is considered an off-label use. The treatment alternatives offered by the Health Plan such as Granulex and Santyl are medically reasonable and appropriate options for wound care. A trial of Granulex and Santyl is indicated before treatment with Regranex is pursued. Therefore, I have determined that the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

A 50-year-old female enrollee requested a wireless capsule endoscopy for medical evaluation of her gastroparesis, abdominal pain, nausea, and vomiting. Findings:  Two physician reviewers found that this patients symptoms are likely due to a functional disorder such as irritable bowel syndrome or perhaps secondary to adhesions in the pelvis. There is no evidence of occult or overt GI bleeding or a small bowel neoplasm by history or radiographs. In this clinical scenario, a wireless capsule endoscopy of the small bowel is not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

A 57-year-old female enrollee has requested an MRI of the left knee for evaluation of the enrollees left knee arthritis.  Findings:  The physician reviewer found that in a recent case presentation at the American Academy of Orthopaedic Surgeons Annual Meeting, Khanuja stated that more than half of patients who underwent MRI did not require this imaging modality for the diagnosis and treatment of their knee osteoarthritis. Although some providers sometimes utilize MRI either with or instead of weight bearing x-rays for diagnosis, weight bearing x-rays are sufficient to diagnose osteoarthritis of the knee. This patient received an x-ray and underwent examination by an orthopedist. The specialists assessment based on physical examination and interpretation of the x-ray was osteoarthritis  left knee greater than right knee. Based on the medical records provided, an MRI is not medically necessary for evaluation of the patients condition. Given the available peer reviewed medical literature and the medical records, the Health Plans denial is appropriate and should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for radiofrequency ablation (RFA) of right perforator vein adjacent to the right medial malleolus ulcer (CPT 36475-RT, including image guidance and monitoring). Traditional treatment options for recurrent venous ulceration have consisted of prolonged compression, wound debridement, and elevation. The current treatment guidelines from the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) recommend correction of reflux, especially when the source of reflux is in close proximity to the ulcer. Based on the SVS and AVF guidelines, this patient meets the requirements for the requested RFA treatment. The guidelines state that, In a patient with venous leg ulcer (C6) and incompetent superficial veins that have reflux to the ulcer bed in addition to pathologic perforating veinswe suggest ablation of both the incompetent superficial veins and perforator veins in addition to standard compressive therapy to aid in ulcer healing and to prevent recurrence (ODonnell, et al.). In this case, two incompetent perforator veins have been identified in close proximity to the ulcer. RFA of the incompetent perforator veins is likely to accelerate wound healing and may also lessen the likelihood of recurrence. All told, the requested RFA of right perforator vein adjacent to the right medial malleolus ulcer (CPT 36475-RT, including image guidance and monitoring) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested RFA of right perforator vein adjacent to the right medial malleolus ulcer (CPT 36475-RT, including image guidance and monitoring) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services 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 reviewer 1 is board certified in general surgery with subspecialty certification in vascular surgery and is actively practicing. Physician reviewer 2 is board certified in general surgery with subspecialty certification in vascular surgery and is actively practicing. Physician reviewer 3 is board certified in general surgery with subspecialty certification in vascular surgery 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.