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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Botox injections for treatment of her medical condition. Findings: Two physician reviewers found that the use of Botox injections in clinical medicine has significantly improved management of many movement disorders, spasticity, and syndromes of autonomic over activity. In a pilot study from Australia of women with chronic pelvic pain and demonstrable spasm in the pelvic floor muscles, a reduction in pressure was found when botulinum toxin type A was injected, and a diminution of pain symptoms was noted. A follow up study of small patient numbers was performed to evaluate the treatments effect on pelvic floor pressure, pain response, and impact on quality of life. In this randomized controlled trial, 60 women with chronic pelvic pain and high-tone pelvic floor dysfunction were randomized to receive 80 units of Botox type A (BTA) injected into their pelvic floor muscles (n = 30) versus saline (n = 30) and followed for 26 weeks. The BTA group showed a significant decrease in both nonmenstrual pelvic pain and dyspareunia compared with baseline. In the placebo group, only dyspareunia was reduced. There was no difference when the pain scores of the two groups were compared. Resting vaginal pressures were significantly lower in the BTA group for up to 16 weeks after injection. Reported side effects included temporary urinary and anal incontinence. A significant placebo effect was noted. The primary and secondary outcomes were not well defined. There were significant intragroup differences in pain, but it can be concluded that there is no significant treatment effect when compared to placebo. Therefore, there is a lack of definitive evidence in the peer-reviewed literature that Botox injections are significantly effective for the patients medical condition. At this time, more trials are needed to confirm its effectiveness in the treatment of chronic pelvic pain. As such, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: Two reviewers determined that the requested services are 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: All three physician reviewers are board certified in obstetrics and gynecology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested ruxolitinib (Jakafi) for treatment of his myeloproliferative neoplasms (MPN). Findings: The physician reviewer found that myeloproliferative syndromes are clonal disorders that present as chronic myelogenous leukemia, chronic myelomonocytic leukemia, polycythemia vera, essential thrombocythemia, or primary myelofibrosis.  Chronic myelomonocytic leukemia (CML) is a disorder that has both myelodysplastic and myeloproliferative features.  CML is defined by the presence of the BCR-ABL rearrangement whereas CML has been associated with a different set of tyrosine kinase gene rearrangements such as PDGFRB and JAK2.  All of these disorders can present with leukocytosis, predominantly neutrophils. Recently, chronic neutrophilic leukemia was analyzed by next generation sequencing and gain of function mutations of CSF3R were identified in 59% of patients. This gene encodes the receptor for the GM-CSF growth factor, which utilizes JAK enzymes for signal transduction.  A patient with the T618I mutation had treatment response to ruxolitinib in a well-regarded study. In sum, the use of ruxolitinib is medically necessary for the treatment of the patients chronic neutrophilic leukemia.  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 medical oncology 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: An enrollee has requested Norco for treatment of her chronic knee pain and back pain. Findings:  The physician reviewer found that the requested Norco is not medically necessary in this clinical setting.  Current standard of care for chronic pain is treatment using a multi-disciplinary pain management practice to include physical therapy, massage therapy, cognitive behavioral therapy, and injections to help reduce pain. Studies show that patients who are diagnosed with non-malignant chronic pain often worsen or their pain recurs as a result of opioid rebound. Baron and colleagues reported that high dose opiates might contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold and potentially masking resolution of a pre-existing pain condition. In this retrospective study, the majority of patients undergoing detoxification of high dose opiates for chronic pain reported a significant decrease in pain at the end of the study, further supporting the theory of opioid-induced hyperalgesia. The medical literature supports treatment of non-malignant chronic pain by weaning patients off short-acting opiates and having them participate in adjunctive therapy including non-narcotic medications, physical therapy, massage therapy, or cognitive behavioral therapy. Ballantyne and colleagues reported that prolonged use of opiates might induce tolerance, abnormal pain sensitivity, and hormonal effects. The aim of current guidelines is to protect patients from the adverse effects of opioid therapy. For these reasons, the requested Norco is not medically necessary to treat the patients chronic pain. 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 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 Sovaldi and Daklinza for treatment of his hepatitis C virus.  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. In treatment-naive genotype 3 patients (regardless of interferon eligibility), therapy is recommended with Sovaldi and Daklinza for 12 weeks. This is based on the ALLY-3 study, which showed a cure rate of 97% (Nelson, et al; Hezode, et al). Delay in treatment may result in decreased survival (Jezequel, et al). For these reasons, the requested treatment with Sovaldi and Daklinza is supported as medically necessary for the treatment of this patients hepatitis C infection. Final Result: The reviewer determined that the requested medications 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 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for 12 weeks for treatment of her hepatitis C virus (HCV).  Findings:  The physician reviewer found that Harvoni is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor. These medications are Food and Drug Administration (FDA) approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. In addition, Harvoni carries the highest recommendation of the American Association for the Study of Liver Diseases and Infectious Diseases Society of America (Rating: Class I, Level A ) for treatment of HCV patients with this patients characteristics. Once-daily ledipasvir-sofosbuvir  (Harvoni) with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection. (Afdhal et al). In patients, similar to this patient, with viral loads less than 6 million IU/ml, ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis (Kowdley et al). Further, there was no additional benefit with extension of the duration of treatment (Kowdley et al). Therefore, although Harvoni is medically appropriate in this setting, the requested duration of 12 weeks is not medically necessary for treatment of the patients medical condition.  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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni for treatment of his hepatitis C virus.  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 or viral load. The guidelines recommend that treatment-naive genotype 1a 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 (Kowdley, et al; Afdhal, et al). AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For these reasons, the requested treatment with Harvoni is 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested inpatient psychiatric services for treatment of the enrollee's behavioral health condition. Findings:  The physician reviewer found that the patient was not actively suicidal and had no acute comorbid substance use or medical issues that were identified.  The patient was scheduled to see her psychiatrist and it is reasonable that she could have been maintained in the community until the psychiatric appointment.  The records do not demonstrate that the patient required hospitalization with 24-hour nursing or physician monitoring.  All told, inpatient psychiatric services were not medically necessary for the treatment of this patient.  Final Result: The reviewer determined that the services at issue were 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 psychiatry with sub-specialty certification in child and adolescent psychiatry 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 immune cell function assay testing for evaluation of his medical condition.  Findings:  Three physician reviewers found that the testing in dispute is a measure T-cell function and has been shown to have correlation with the degree of immunosuppression in a patient and associated rejection or infection.  It is used in conjunction with drug level monitoring to guide immunosuppressive therapy decisions.  There is sufficient support for the services at issue in this clinical setting.  Immune cell function assay testing has becoming a standard of patient monitoring and has been used as an adjunct to monitoring the overall immunosuppressive state of the transplant patient.  All told, immune cell function assay testing was likely to have been superior over 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:  One reviewer is board certified in surgery and is actively practicing.  Two reviewers are board certified in surgery with sub-specialty certification in surgical critical care 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested Zepatier and ribavirin for treatment of his hepatitis C virus.  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. Per guidelines, patients with HIV co-infection are high priority for treatment. The guidelines state that Testing for resistance-associated variants (RAVs) that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, and who have  reasons for urgent retreatment. The specific drugs used in the retreatment regimen should be tailored to the results of this testing. Based on HIV co-infection, urgent treatment is needed in this case. This patient has no NS5A RAVs. The guidelines further state that For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and [ribavirin] RBV for 24 weeks is recommended.  This is based on a 100% cure rate in RAV-free patients who have failed Harvoni. There is also robust data supporting Harvoni in patients who have failed peginterferon/ribavirin with telaprevir (LONESTAR) and Harvoni in HIV co-infection (ION-4 trial). In contrast, there is a lack of clinical data supporting use of Zepatier or Zepatier/ribavirin in patients who have failed Harvoni; furthermore, Zepatier is not recommended by AASLD/IDSA guidelines in patients free of NS5A RAVs.  For these reasons, treatment with Zepatier and ribavirin for 16 weeks is not supported by current medical guidelines and clinical evidence as medically necessary for the treatment of this patients hepatitis C infection.Final Result: The reviewer determined that the requested medications 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 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni and ribavirin for 24 weeks for treatment of his hepatitis C virus. 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 nonliver-related conditions. According to the guidelines, patients with cirrhosis are considered highest priority for treatment. In patients with decompensated cirrhosis and/or liver transplant candidacy or hepatocellular carcinoma, guidelines recommend treatment with Harvoni with ribavirin for 12 weeks. The Harvoni recommendation is based on the SOLAR-2 trial, which demonstrated efficacy in this population, and evidence for increased survival with treatment (Flamm, et al; Jezequel, et al).  According to the AASLD/IDSA guidelines, the significance of a positive HCV RNA test result at week 4 that remains positive but lower, at week 6 or week 8 is unknown; there is no recommendation to stop therapy or extend therapy based on the 4 week viral load at this time.  In summary, AASLD/IDSA guidelines support 12 weeks of Harvoni and ribavirin in this case, and because ribavirin was started late, four additional weeks of Harvoni and ribavirin would be appropriate. However, there is no support for the requested 12 additional weeks of Harvoni and ribavirin. For these reasons, the requested treatment with Harvoni to be used with ribavirin for another 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 treatment duration 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested a power wheelchair for treatment of her medical condition.  Findings:  The physician reviewer found that the records forwarded for review do not establish that the patients mobility-related activities of daily living needs could not be sufficiently resolved with an optimally fit manual wheelchair at this time.  The records do not establish that the patient would be bed or chair confined without a power mobility device.  Based on the available records, a power mobility device is not medically necessary for this patient given that her mobility deficits in the home can be addressed by other means (i.e., an optimally fit manual wheelchair), which would be more health beneficial than a power mobility device.  Ongoing exercise through ambulation (aided with an appropriate assistive device) would be expected to provide significant health benefits use over power wheelchair use.  Manual wheelchair use has been shown to provide significant health benefits use over power wheelchair use for persons with mobility impairments.  All told, the requested power wheelchair is not medically indicated for the treatment of this patient. Final Result: The reviewer determined that the requested equipment 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 physical medicine and rehabilitation 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: An enrollee has requested a 12 week prescription for Sovaldi and Daklinza for the treatment of his hepatitis C infection.   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. Patients with cirrhosis are high priority for therapy. Per the guidelines, cirrhotic treatment-naive genotype 2 patients should be treated with Sovaldi and ribavirin or Sovaldi and Daklinza for 16-24 weeks. These recommendations are based on multiple randomized clinical trials (Zeuzem, et al; Lawitz, et al; Sulkowski, et al). Thus, based on current guidelines, the patient requires at least 16 weeks of treatment with Sovaldi and Daklinza to treat his hepatitis C virus. Since the requested treatment duration of 12 weeks is inconsistent with current guidelines, the requested regimen is not medically necessary for treatment of the patients condition. Final Result: The reviewer determined that requested regimen of Sovaldi and Daklinza for 12 weeks 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 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.