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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for surgery to revise a deformed, contracted scar, mid abdomen, 15 cm vertical by 20 cm horizontal subcutaneous symmetrically distributed fibrous tissue. Findings:  The physician reviewer found that the surgery to revise a deformed, contracted scar, mid abdomen, 15 cm vertical by 20 cm horizontal subcutaneous symmetrically distributed fibrous tissue is medically necessary for treatment of the patients medical condition. The patient underwent a ventral hernia repair and panniculectomy that was complicated by loss of the umbilicus and significant wound healing issues. Although the patient has healed her wounds, her clinical documentation and review of the photographs note that she has a severely abnormal contour of the lower abdomen with loss of the umbilicus. This is not a normal appearance for the abdomen following her medically necessary procedures. The patient has an additional functional deficit associated with painful scarring. Based on these facts, the planned revision is consistent with reconstructive surgery and not cosmetic surgery one study analyzed a series of massive panniculectomies greater than 10 pounds following massive weight loss and to investigate the outcomes achieved. The authors noted Complications included wounds requiring debridement, dressings, vacuum-assisted closure therapy and/or delayed primary closure (20 percent), and seroma requiring drain replacement or dressings (28 percent). In this case, the patient required prolonged healing following umbilical loss and large wounds. The current appearance of the patients abdomen is severely abnormal and she has evidence of painful scarring.  The planned procedure for revision is consistent with reconstructive surgery that is medically necessary. The planned revision is a treatment of a significant complication following her previous surgery. Although the patient has evidence of a functional deficit with painful scarring, the major aspect of this determination is based on the severely abnormal contour of the abdomen.  Final Result: The reviewer determined that the requested surgery is medically necessary and reconstructive in nature for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The physician reviewer is board certified in plastic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A female enrollee requested authorization and coverage of extracorporeal shock wave therapy (orthotripsy) for treatment of bone spurs on heels.  The health plan denied the enrollees request indicating that the requested treatment is not medically necessary.One podiatry reviewer performed a medical necessity Independent Medical Review.  The podiatry reviewer upheld the health plans denial on the basis that, because the records do not demonstrate that the patient has undergone all conservative treatments, the requested therapy is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

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 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, 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 (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 the 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

A 62-year-old female enrollee has requested a reduction mammoplasty for the treatment of her bilateral gigantomastia. Findings:  The physician reviewer found that the concept supported in the medical literature is that patients who present with the typical symptoms of macromastia and who have a confirmatory exam benefit greatly from breast reduction surgery. As noted by Kerrigan, weight loss and conservative therapy do not improve symptoms of macromastia. This patients symptoms were unlikely to improve unless she had a breast reduction.  The peer-reviewed literature strongly supports the concept that this patients breast reduction was medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

A 47-year-old female enrollee requested authorization and coverage for a split queen size adjustable bed for the treatment of Multiple Sclerosis. The Health Plan denied the enrollees request indicating that the requested treatment is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the requested equipment is not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a 35-month-old male enrollee has requested  for speech therapy for treatment of the enrollees expressive language impairment. Findings:  The physician reviewer found that speech therapy is indicated with any delay greater than 25% (Law, et al.). Improvements have been noted following speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulty (Law, et al.). Treatment for language disorders is predicated primarily on the childs language profile and level of communication skills (Feldman and Messick). Children who participate in speech-language treatment show better improvement than those children who receive no treatment (Feldman and Messick). Gallagher, et al. evaluated speech and language interventions for preschool children with specific language impairment and found statistically greater improvement with intensive direct speech therapy delivered by speech and language therapists over an eight-month period when compared to no intervention or nursery-based intervention.Therefore, the requested therapy is medically appropriate and necessary for this patient.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of her 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 non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per the guidelines, treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. This guideline recommendation is 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. 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: Medical Necessity
Decision: Overturned

A 28-year-old male enrollee has requested acute inpatient hospitalization for the treatment of his bipolar affective disorder and mental and behavioral disorder due to alcohol use. Findings:  The physician reviewer found that the submitted clinical evidence demonstrates that the patient continued to require an acute inpatient level of care during the period at issue. The patients providers described the patient as a potentially vulnerable patient whose clinical course was complicated by his comorbid bipolar illness. The patient seemed motivated for treatment. A significant new stressor during the dates of services at issue was his relatives diagnosis of recurrent breast cancer. Such a stressor further supports the medical necessity of continued acute inpatient hospitalization, especially considering the patients history of recidivism, serious comorbid condition and lack of psychosocial support. Additionally, he was just beginning to stabilize on his medications. Thus, acute inpatient hospitalization provided during the period at issue was medically indicated for this patient.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Viekira Pak for treatment of her 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), the recommended regimen for treatment-naive patients with HCV genotype 1a infection include daily fixed-dose combination of paritaprevir/ritonavir/ombitasvir plus twice-daily dosed dasabuvir and weight-based ribavirin for 12 weeks as a Class I, Level A rating.  Paritaprevir/ritonavir/ombitasvir plus dasabuvir and weight-based ribavirin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HCV genotype 1a infection in treatment-naive patients based on registration trials. Based on the support provided, the request for Viekira Pak is medically necessary for treatment of the patients HCV, genotype 1a.  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 Afirma Gene Expression Classifier (GEC) for evaluation of her thyroid nodule. Findings:  Three physician reviewers found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign. The Afirma thyroid FNA analysis utilizes a GEC in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. The 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: Reviewer 1, 2, and 3 are board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)) performed on 7/13/17, and the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)). The National Comprehensive Cancer Network (NCCN) guidelines strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care in this clinical setting. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. For these reasons, the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)), and the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)) was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.One reviewer found that the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)), and the Guardant360 genetic testing (except the approved BRAF (CPT 81210) and EGFR (CPT 81235)) was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Two of the 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:  One reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. One Reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing.  One Reviewer is board certified in internal medicine with sub-specialty certification in medical oncology 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: Medical Necessity
Decision: Upheld

The spouse of an 85-year-old male has requested continuous cardiac monitoring on a telemetry unit in an acute care setting for treatment of his diagnosed acute respiratory failure and anoxic brain damage. Findings:  The physician reviewer found that this patient suffered an out-of-hospital cardiac arrest and was treated with amiodarone medication among other measures.  There were no dysrhythmias while he was monitored on continuous telemetry for several weeks during hospitalization, and the patient was deemed to not be an eligible candidate for an implantable defibrillator given his ongoing anoxic brain damage and poor prognosis.  This recommendation is consistent with current guidelines.  In this circumstance of no dysrhythmias for several weeks after initiation of amiodarone therapy and no plans for implantation of a cardioverter defibrillator due to anoxic brain injury and poor prognosis, continued use of cardiac telemetry is not medically necessary and is not considered standard accepted practice in the medical community.   Current practice guidelines recommend continuation of cardiac telemetry while being evaluated for the cause of the event and while corrective/preventive treatment is being instituted.  In this patients case, corrective/preventive treatment consists of amiodarone and no additional anti-arrhythmic therapy or device placement.  Therefore, since appropriate treatment has been instituted and extended monitoring on treatment has not revealed dysrhythmias, continuous cardiac monitoring on a telemetry unit in an acute care setting is not medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Insulin Potentiated Targeted Chemotherapy involving Gemzar and Cytoxan. Findings:  The physician reviewer found that Insulin potentiated targeted chemotherapy with Gemzar and Cytoxan is not a standard chemotherapy regimen. Insulin potentiated targeted chemotherapy with Gemzar and Cytoxan is not FDA approved, nor is it supported by major drug compendia or the medical literature. This approach is not mentioned in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for breast cancer. Studies are largely in vitro and not in vivo and published in open access journals. Accordingly, the requested Insulin Potentiated Targeted Chemotherapy involving Gemzar and Cytoxan is not medically necessary for the patients medical condition.Final Result: The reviewer determined that the requested services are not medically necessary for the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine, with subspecialty certification 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

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for Nutropin AQ NuSpin.Findings: The U.S. Food and Drug Administration (FDA) has approved somatotropin to treat idiopathic short stature (ISS), defined as standing height below -2.25 SDs without identifiable cause. Standard of pediatric endocrine care for suspected growth disorders includes documentation of testicular volumes to monitor pubertal timing and tempo, and brain magnetic resonance imaging (MRI) with and without contrast to exclude intracranial masses. In this case, this patient displays normal growth velocity, current height above -2.25 SDs, and predicted adult height within 2 SDs of mid-parental target height. Their growth pattern and bone ages have been consistent with mild constitutional delay of growth and development as well as the familial growth pattern. Therefore, Nutropin AQ NuSpin is not medically necessary for the 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 pediatrics with sub-specialty certification in pediatric endocrinology 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: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested clomiphene citrate for treatment of his hypogonadism.  Three physician reviewers found that clomiphene citrate as evidenced by case reports will increase testosterone and has been shown to have equal short-term efficacy to topical androgen therapy. Clomiphene citrate is almost exclusively recommended for infertility and considered off-label for young men with decreased testosterone and there is little long-term evidence for its effectiveness. As such, there is a lack of evidence that clomiphene citrate would have greater efficacy in this patients case than topical testosterone replacement. For the reasons provided, the requested medication is not likely to be more effective than other modalities.  Final Result: Three reviewers determined that the requested medication is 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 reviewers are board certified in urology 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Singulair 10 mg tablets, instead of its generic equivalent. Findings:  The physician reviewer found that Singulair and generic montelukast were approved by the U.S. Food and Drug Administration (FDA) in 2012. To obtain FDA approval, a generic manufacturer has to make a product with the same manufacturing, packaging, and quality standards as the name-brand product. The study by Zaid and colleagues confirms the interchangeability and comparative effectiveness of generic and brand montelukast. In that study, the two preparations of generic and brand montelukast were found to have the same bioequivalence with comparable safety and efficacy profile in healthy volunteers. Hence, substitution of one for the other is the standard of care. In addition, there is a lack of evidence provided demonstrating that generic montelukast is ineffective for this patient. All told, the request for Singulair 10 mg tablets, instead of its generic equivalent 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: Physician reviewer number is board certified in internal medicine with sub-specialty certification in pulmonary disease and critical care 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.