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

A 59-year-old male enrollee has requested authorization and coverage for an endoscopic maze procedure for treatment of the enrollees uncontrolled atrial fibrillation.  Findings:  Three physician reviewers found that the patient has an approximate 5 year history of diagnosed atrial fibrillation. The patient has a history of multiple cardioversions, multiple ablations, and medical management of his uncontrolled paroxysmal atrial fibrillation. The patient reports he is currently symptomatic. The patients provider has recommended the patient undergo an endoscopic maze procedure for treatment of his atrial fibrillation. The Health Plan has denied authorization for the proposed procedure, citing a lack of peer-reviewed data supporting its efficacy.  Review of the submitted documentation demonstrates that the patient is an appropriate candidate for a maze procedure, as the patient has uncontrolled atrial fibrillation that has been refractory to several other procedures. Based upon the available scientific data there is sufficient evidence to support the likelihood that the maze procedure will eradicate this patients atrial fibrillation. The maze procedure is  a well-accepted surgical option and there are CPT codes and DRG codes for this procedure. An endoscopic approach versus an open surgical procedure is a medically reasonable and appropriate option for this patient.  Although controlled, prospective, randomized trials for this therapy are lacking, recent studies demonstrate that this patient may very well benefit from this procedure. Given that the patients atrial fibrillation has failed to respond to several other treatment attempts, the requested procedure is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a 14-year-old female has requested coverage for speech therapy for treatment of her tongue thrust.  Findings:  The physician reviewer found that the current medical literature supports the requested speech therapy in this patients case.  According to the dental/orthodontic literature, tongue thrust often develops in the presence of anterior open bite in order to achieve anterior valve function.  Tongue thrust is thought to be associated with the resting posture of the tongue.   In this patients case, closure of the anterior open bite with orthodontic treatment did not resolve the tongue thrust, nor did her articulation disorder improve. In this clinical scenario, it is likely that the patients speech abnormalities are caused by an articulation disorder in conjunction with an anatomic abnormality. A comprehensive speech and language therapy assessment with subsequent treatment is medically necessary to address her speech difficulties.  All told, the requested speech therapy is medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

A twenty-seven year-old female with a history of excessive daytime somnolence and chronic fatigue is requesting for reimbursement and prospective authorization for Xyrem.  Reviewers Findings:The reviewing physician found that the patient has been evaluated and does have alpha-wave intrusions during stage III and IV sleep, and Xyrem is known to reduce alpha-wave intrusions and to improve stage III and IV sleep.  The physician concluded that the Health Plan denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Findings:  The physician reviewer found that The patient has requested authorization and coverage for positron emission tomography/computed tomography (PET/CT) scan. The records provided for review document that this patient has a history of bilateral breast cancer status post bilateral mastectomy. The patients provider has recommended evaluation with PET/CT for staging purposes. However, there is a lack of support for PET/CT for assessment of this patient based on the available documentation. The National Comprehensive Cancer Network (NCCN) guidelines do not recommend PET/CT scan as an initial staging diagnostic tool for the evaluation of patients with non-metastatic breast cancer work-up. The NCCN states that, Routine systemic staging is not indicated for non-metastatic (M0) cancer in the absence of signs or symptoms. The NCCN supports use of PET/CT with diagnostic CT when standard staging studies are equivocal or suspicious, or to identify unsuspected regional nodal disease and/or distant metastases when used in addition to standard staging studies. Although this patient has an unexpected cancer on the left breast with microinvasion of the lymph node, the provider did not recommend a standard initial staging tool such as a staging CT scan chest, abdomen, and pelvis with contrast to evaluate for any equivocal or suspicious findings. The patients records do not establish a current indication for evaluation with PET/CT. All told, the requested PET/CT scan is not medically necessary for this patient. Final Result: The reviewer determined that the requested services are not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa 400/100 mg for 12 weeks for treatment of the enrollees 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, regardless of fibrosis stage. Per the guidelines, Epclusa for 12 weeks is recommended as a first line regimen for non-cirrhotic treatment naive genotype 3 patients. This is based on the ASTRAL-3 trial for Epclusa, which showed a high cure rate. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. 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: Upheld

A 47-year-old male enrollee has requested dermabrasion to remove milia for the treatment of his milia. Findings:  The physician reviewer found that this patient is requesting coverage for dermabrasion treatment of the milia on his nose. Milia are considered to be inclusion cysts in the upper layers of the skin. While this structure is abnormal, its presence is not due to congenital defects, developmental abnormalities, trauma, infection, tumors, or disease. Nor is the procedure being requested to improve function or create a normal appearance as this is a minor skin condition that does not significantly impact function or appearance. Given that the condition does not significantly affect appearance, it is unlikely that more than minimal improvement in the appearance of the patient would result. Furthermore, the use of dermabrasion for the treatment of milia is not indicated under general concepts of medical necessity. As documented in the medical literature (George and colleagues and Berk and Bayliss) dermabrasion is a procedure used to treat a minor skin condition that does not affect functioning or severely impact ones life. All told, the proposed procedure is not indicated from a medical standpoint.
Appeal type: Experimental/Investigational
Decision: Overturned

A 61-year-old female enrollee has requested a Walk Aid (functional electrical stimulation unit) for medical treatment of her multiple sclerosis. Findings:  Two physician reviewers found that the requested Walk Aid is likely to be more effective for this patient than other available treatment options. According to the documentation submitted for review, this patient has gait impairment due to MS with residual spasticity and foot drop. The patients foot drop continues to impair gait, despite use of an AFO. The medical literature on the use of FES has shown potential benefits in speed of walking, oxygen uptake, and physiological cost in patients with spasticity from chronic central nervous system (CNS) lesions, as occur in MS, stroke, traumatic brain injury, or spinal injury. Moreover, a trial of the Walk Aid FES by the patient demonstrated benefit beyond that with an AFO. Therefore, based on the records provided for review it has been demonstrated that similar results could not have been achieved with a standard AFO. As such, the requested device is likely to be more beneficial than other treatment alternatives in this patients case.
Appeal type: Medical Necessity
Decision: Overturned

A 51-year-old female enrollee has requested a panniculectomy, abdominoplasty and circumferential body lift for treatment of redundant skin condition.  Findings:  The physician reviewer found that a panniculectomy will most likely eliminate the infections that the patient has suffered from. Because the infections are recurrent despite adequate hygiene and topical antifungal medications, the proposed panniculectomy would be considered medically necessary according to the ASPS Position Paper.
Appeal type: Experimental/Investigational
Decision: Upheld

A 45-year-old female enrollee has requested for intensity modulated radiation therapy for treatment of her breast cancer.  Findings:  Three physician reviewers found that standard breast conservation and post-operative radiation is the standard of care and has proven efficacy. The use of IMRT for breast conservation therapy is appropriately considered when standard tangent therapy results in an unacceptable amount of lung or heart being in the treatment field or in patients with very large pendulous breasts with significant skin folds. In these situations, IMRT has been shown to reduce the volume of lung and heart exposure and reduce skin reactions. Thus, when there is a need to give Adriamycin-based chemotherapy and to treat the axilla, supraclavicle, and/or internal mammary lymph nodes, limiting the radiation dose to the heart and lungs is crucial to reduce the potential for pneumonitis and long-term cardiac toxicity. Based on the records provided for review, this patient is not likely to require systemic chemotherapy and there is no need to treat the axilla, supraclavicle, or internal mammary lymph nodes with radiation. As such, IMRT is not likely to be more efficacious for this patient than standard radiation therapies.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for advanced lipoprotein testing for evaluation of the enrollees hypertension. Findings:  The physician reviewers found that primary prevention guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk. Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Randomized trials testing treatment with therapy available to reduce homocysteine levels have not shown significant outcomes benefits. Likewise, even though results of some of these specialized tests may be abnormal and considered independent risk markers for coronary disease, there are a lack of controlled trials that demonstrate outcome benefits by basing treatment on routinely obtained abnormal results. Final Result: All three reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers number one, two, and three are board certified in internal medicine with sub-specialty certification in cardiovascular disease 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: Upheld

A 23-year-old male enrollee has requested for the medication Namenda for treatment of his obsessive-compulsive disorder. Findings:  Two physician reviewers found that the drug is still being studied and multiple issues have not yet been determined. For instance, the clinical efficacy of this medication for OCD has not been established. There is inadequate data from which to conclude the drug is efficacious for the treatment of this condition. Another issue is that the patient is on multiple medications (including Remicade) for his medical conditions with a potential for drug-to-drug interactions.The use of Namenda for the treatment of OCD is not supported by the literature at this time. Additional data including the published results of the above-mentioned study are necessary prior to approving this medication for conditions other than dementia.
Appeal type: Medical Necessity
Decision: Upheld

A 56-year-old male enrollee has requested a continuous passive motion device and synthetic pad for treatment of his right knee status post total knee replacement surgery.  Findings:  The physician reviewer found that there have been several studies of CPM devices after total knee arthroplasty. A review of peer-reviewed Level 1 and Level 2 studies in the current medical literature does not support the use of a CPM device in the home following this procedure. Chen and colleagues studied 51 patients who were assigned randomly to physical therapy or physical therapy plus CPM. The study revealed that there was no difference between the two groups. The authors concluded that the use of CPM offered no added benefits. Subsequent studies have not demonstrated a significant increase in range of motion in the long-term from the use of a CPM machine following total knee replacement surgery.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni for treatment of his hepatitis C virus.  Findings:  The physician reviewer found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) treatment guidelines, there are several treatment options with similar efficacy in general that are recommended for treatment-naive patients with HCV genotype 1a infection. The recommended regimens include: daily Harvoni for 12 weeks (Class I, Level A); and daily fixed-dose combination of Viekira Pak and weight-based ribavirin for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) (Class I, Level A). Viekira Pak and weight-based ribavirin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HCV genotype 1a infection in treatment-naive patients. The SAPPHIRE-I trial reported a high sustained virologic response (SVR) of 95.3% with 12 weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir and ribavirin (Feld, et al). In this case, the patient is requesting Harvoni out of concern for possible ribavirin side effects. However, no drug-to-drug interactions were identified in the patients medical records. In addition, the submitted records do not support hemolytic anemia, renal impairment, autoimmune hepatitis, or documented hemoglobinopathies to contraindicate either Viekira Pak or ribavirin. Moreover, Viekira Pak with ribavirin and Harvoni are both equally rated and recommended in this clinical setting by AASLD/IDSA guidelines. In sum, the medical necessity for Harvoni has not been established in this clinical setting. 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested requested authorization and coverage for Epclusa for 12 weeks for treatment of the enrollee's 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. This applies regardless of fibrosis stage, and advanced fibrosis is not required for treatment. Per the guidelines, Epclusa is recommended as first-line therapy for treatment naive genotype 2 patients, based on clinical trials including ASTRAL-1 and ASTRAL-2, which showed a 99% cure rate and superiority to Sovaldi with ribavirin. Delay in treatment may result in decreased survival. For these reasons, Epclusa for 12 weeks 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: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for transcranial magnetic stimulation for 36 sessions.  Findings:  The physician reviewer found that The records document that this patient has a history of treatment resistant bipolar II disorder, anxiety, and depression. The provider reports that the patients symptoms have not adequately responded to treatment with medications from various classes of antidepressants and psychotherapy. The patients provider has recommended treatment with TMS. In 2020, the U.S. Food and Drug Administration (FDA) approved breakthrough device designation to TMS for the treatment of patients with bipolar depression. Multiple studies have demonstrated that repetitive TMS is an effective and safe intervention for patients with bipolar depression. McGirr and colleagues indicated that although bipolar disorder is characterized by episodes of mania/hypomania, depressive episodes present the greatest challenge for patients with the condition. The authors noted that neuromodulatory approaches such as repetitive TMS have been demonstrated to be efficacious in randomized doubleblind shamcontrolled trials for the treatment of patients with major depressive disorder. The authors concluded that more patients with bipolar depression treated with active repetitive TMS achieved clinical response as compared to patients who received placebo treatment. In addition, the requested TMS services for this patient are in accordance with the generally accepted standards of mental health and substance use disorder care, clinically appropriate in terms of type, frequency, extent, site, and duration, and not primarily for the convenience of the patient or provider. Based on this patients records and the current peer-reviewed medical literature, the requested TMS services for 36 sessions  are medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested services 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 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Forteo 20 mcg for treatment of the enrollees osteoporosis.Findings:  The physician reviewer found that antiosteoporosis agents consists of mainly of two types, antiresorptive agents and anabolic agents. Antiresorptive agents include bisphosphonates and denosumab, which the Health Plan indicates should be used prior to considering Forteo. According to Xue and colleagues treating patients with bisphosphonates during bone healing is controversial because osteoclasts are important for remodeling callus into cortical bone. Moreover, the available data suggests that bisphosphonates do not cause a clinically detectable delay to indirect bone healing regardless of the timing of bisphosphonate delivery in relation to the fracture.In this case, the patient had a recent fragility fracture that appears to not be healing properly, and a very low bone density in the spine. The patients degree of osteoporosis in the spine with a T-score -3.9 is concerning. This degree of osteoporosis at age 51 places the patient at great risk for compression fractures and their associated morbidity. If left untreated, the patients condition will likely worsen. In this clinical setting, the sequence of therapy is important. Based on the medical literature, the patients level of osteoporosis must be treated with Forteo first. It has been shown from early studies that the effect of Forteo is superior in increasing bone mass due to its anabolic effect of bone formation, and decreases spinal fractures by 65% versus a 50% decrease risk of fracture with bisphosphonates. Forteo therapy must be followed by an antiresorptive agent. Studies have shown that bisphosphonates given prior to Forteo, will decrease the efficacy of Forteo. There are also reports in the medical literature that Forteo showed to have positive effect on fracture healing, which is an issue in this case.  Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.