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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Harvoni for 12 weeks for treatment of the enrollees chronic hepatitis C virus (HCV) genotype 1a. Findings:  The physician 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. The guidelines recommend that all patients should be treated, regardless of fibrosis stage or substance use. The guidelines recommend that non-cirrhotic treatment naive genotype 1 patients should be treated with Harvoni for 12 weeks. These 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 hepatitis C genotype 1 regardless of fibrosis stage. In addition, the use of Zepatier is not appropriate for this patient due to concurrent use of atorvastatin. The AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret 100-40 mg tablets for eight weeks. Findings:  The physician 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. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic, treatment-naive, genotype 1a patients should be treated with Mavyret for eight weeks. These 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 hepatitis C, genotype 1 regardless of fibrosis stage. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, Mavyret 100-40 mg tablets for eight weeks is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication regimen 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: Overturned

The parent of a two-year-old female enrollee has requested speech therapy for treatment of the enrollees speech delay.  Findings:  The physician reviewer found that with regard to diagnosis, language disorders are identified when a patient has difficulty with expressive language, receptive language, or pragmatic language. Speech disorders are identified when a patients voice, fluency, or articulation call attention to the speaker because his or her speech is sufficiently different from the norm. Speech and language development should be consistent with a patients overall development and can be tracked using typical milestone markers. As speech therapy is recommended for young patients with speech delay, the primary goal of treatment is to give the patient a reliable way to exchange ideas and information in her daily social and educational environment. Treatment is tailored to the specific communication needs of each patient, which vary with disorder type and severity, age, and the etiology of the condition. Speech therapy is the standard of care for patients with speech delay and therefore is medically necessary for this patient.
Appeal type: Medical Necessity
Decision: Upheld

A 58-year-old male enrollee has requested CyberKnife radiosurgery for treatment of prostate cancer.  Findings:  Two physician reviewers found that numerous treatment alternatives exist for early prostate cancer. Unlike CyberKnife, the more standard treatment options have a defined course and a predictable outcome in this setting. CyberKnife has not typically been used for prostate cancer. This technology has most commonly been applied to craniospinal tumors because of the bony landmarks necessary for the machine to work properly. There has not been sufficient study of CyberKnife in the treatment of prostate cancer.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for treatment of her hepatitis C virus (HCV). Findings:  The physician reviewer found that according to the most recent medical guidelines, 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 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 hepatitis C genotype 1 regardless of fibrosis stage. The medical guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested three-dimensional breast tomosynthesis for evaluation of her medical condition. Findings: Three physician reviewers found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Therefore, three-dimensional breast tomosynthesis was likely to have been more efficacious than other methods of evaluating this patient. Final Result: Three reviewers determined 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: 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 Epclusa for 12 weeks. Findings:  The physician reviewer found that 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. Patients with cirrhosis are high priority for treatment. This patient failed an eight week course of Viekira Pak, but that is not a recommended treatment course for genotype 6 hepatitis C. As a complete course of treatment has never been used, the patient should be considered treatment-naive. Per the guidelines, Epclusa is recommended as first-line for treatment-naive genotype 6 patients, based on the ASTRAL-1 trial clinical trial showing a 100% cure rate. For these reasons, the request for Epclusa 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: Overturned

Nature of Statutory Criteria/Case Summary: An  enrollee has requested authorization and coverage for Harvoni 90-400 mg for eight weeks. Findings:  The physician reviewer found that According to the 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. This applies regardless of fibrosis stage, and advanced fibrosis is not required for treatment. Per guidelines, treatment-naive genotype 1 patients should be treated with Harvoni. Patients with viral load of less than 6,000,000 IU/mL can be treated for eight weeks. These guideline recommendations are based on multiple randomized clinical trials . AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni for eight weeks is medically necessary for treatment of the patients hepatitis C infection. Final Result: The 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: Physician reviewer number one 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: Overturned

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni for eight weeks for treatment of her hepatitis C virus.  Findings:  Two physician reviewers found that according to the recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy (less than 12 months) due to non-liver-related conditions. In treatment-naive genotype 1 patients, therapy is recommended with Harvoni as a Class I, Level A recommendation. 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 hepatitis C genotype 1 regardless of fibrosis stage. Additionally, treatment of patients before they progress to cirrhosis is advantageous. A prospective study of 820 F0-F1 patients reported 93% 15-year survival in treated F0-F1 patients versus 88% in untreated patients. Based on evidence of safety and efficacy in the published literature, and clinical guidelines, Harvoni is medically necessary for eight weeks in this case.  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.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a three-year-old male enrollee has requested  applied behavioral analysis (ABA) therapy for treatment of the enrollees autism.  Findings:  The physician reviewer found that applied behavioral analysis (ABA) has been shown to be effective in treating behaviors associated with autism spectrum disorder (ASD). All told, treatments based on operant principles of learning are more effective for reducing maladaptive behaviors than alternative treatments. An article from Dawson and colleagues discusses a 5-year randomized and controlled study on 48 children with autism. The authors found significant improvements in IQ and adaptive behaviors using an Early Start Denver Model interaction based on developmental and ABA principles and with at least 25 hours of intervention services weekly. Similarly, Warren and colleagues reviewed 34 studies on early intervention in autism. The authors concluded that studies of Lovaas-based approaches, early intensive behavioral intervention variants, and the Early Start Denver Model resulted in some improvement in cognitive performance, language skills, and adaptive behavior skills.  Treatment intensity may play an important role and ABA therapy must be implemented at a sufficient intensity in order to provide optimal outcomes (Kelley, et al. and Granpeesheh, et al.). Although the most significant gains are made after one year of ABA therapy when compared to controls, further gains have been noted in subsequent years of therapy (Sallows, et al.). The requested duration of therapy for this three-year-old patient with autism is medically reasonable and appropriate. Given the patients documented deficits, it is medically necessary that he receive six months of ABA therapy beginning on the date requested.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Supartz hyaluronan injections. Hyaluronic acid injections for osteoarthritic knee pain is an established part of osteoarthritic knee pain treatment algorithms and generally considered a second-line treatment after independent exercise, weight loss and medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen. Multiple studies have documented efficacy, although the magnitude of benefit varies between studies and individual patients. With long-term and widespread use, the injections have been confirmed to be safe with no severe or systemic side effects. The requested hyaluronic acid injection is a standard treatment option which is likely to be beneficial for this patients painful knee osteoarthrosis. Thus, the requested Supartz hyaluronan injections are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.One reviewer found that the requested Supartz hyaluronan injections are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: Two of the 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:  One reviewer is board certified in orthopedic surgery and is actively practicing. One reviewer is board certified in orthopedic surgery and is actively practicing.  One reviewer is board certified in orthopedic surgery and is 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay for evaluation of the enrollees prostate cancer. Findings:  The physician reviewers found that once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and prostate-specific antigen level.  This helps guide the most appropriate therapy for patients taking into account their age and comorbidities.  Many patients will not require therapy and may be followed closely instead.  Oncotype DX is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS).  The testing performed was indicated in this clinical setting.  The medical evidence supports the Oncotype DX test to better stratify such patients with localized disease.  In sum, Oncotype DX Prostate Cancer Assay testing was likely to have been of greater benefit than other methods of evaluating this patient.  Final Result: Two of three reviewers determined 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: Physician reviewers number one, two, and three are board certified in internal medicine with sub-specialty certification in medical oncology 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

The parent of a four-year-old male  has requested applied behavioral analysis (ABA) therapy for treatment of his autism.  Findings:  The physician reviewer found that applied behavioral analysis (ABA) is a behavioral approach with a longstanding history of application with children on the autistic spectrum. ABA programming utilizes scientifically validated methods that are incorporated into a comprehensive individualized plan for patients with autism (Foxx). In a study comparing children who received intensive behavioral treatment to those who received a more eclectic treatment modality, the behavioral treatment group exhibited larger increases in IQ and adaptive functioning, as well as less aberrant behaviors and social problems, than did the other group (Eikeseth, et al.). Howard and colleagues reported similar results. Behavioral approaches are considered to be first line treatment for autistic spectrum disorders, along with speech and language therapy and many consider the advances made in the treatment of children with autism spectrum disorders to be attributable to applied behavior analysis therapy (Matson, et al.). All told, ABA therapy has been practiced and studied for decades, and studies show positive results from consistent implementation of this method. ABA therapy is a standard modality for the treatment of children with autism spectrum disorder.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for treatment of his hepatitis C virus (HCV).  Findings:  The physician 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. This applies regardless of fibrosis stage or viral load. Specifically, the guidelines state that quantitative HCV RNA testing is recommended prior to the initiation of antiviral therapy to document the baseline level of viremia, but do not require repeated testing of viral load prior to initiating therapy.  Per guidelines, non-cirrhotic genotype 1 patients who have failed peg-interferon and ribavirin 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 hepatitis C genotype 1 regardless of fibrosis stage. AASLD guidelines cite data showing decreased survival with delayed treatment. For these reasons, the requested treatment with Harvoni 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.