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 Harvoni for eight weeks for treatment of the enrollees chronic hepatitis C virus 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. 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. Non-cirrhotic patients with viral load of less than 6,000,000 IU/mL, such as this patient, can be treated for eight weeks. These guideline recommendations are based on multiple randomized clinical trials. The AASLD and IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, the requested treatment with Harvoni for eight weeks is supported as medically necessary for the treatment of this patients hepatitis C infection.  Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 43-year-old female enrollee requested laparoscopic radiofrequency ablation of fibroids (Acessa System of Radiofrequency Ablation for medical treatment of the enrollees uterine fibroids.  Findings:  The physician reviewer found that Radiofrequency ablation is a new alternative, with initial small studies indicating that it may be a reasonable surgical approach for well-selected patients with fibroids.  However, the preferred approach for laparoscopic therapies for fibroids remains laparoscopic myomectomy rather than radiofrequency ablation.  Additionally, appropriate candidates for radiofrequency ablation include women with fewer than four leiomyomas.  This patient was noted to have at least four fibroids and thus is not a suitable candidate for radiofrequency ablation.  In this patients case, there are a number of available standard treatments that have not been tried which are likely to provide relief of her symptoms.  All told, laparoscopic radiofrequency ablation of fibroids (Acessa System of Radiofrequency Ablation) is not medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a two-year-old female enrollee has requested  for speech therapy for treatment of the enrollees significantly delayed expressive language skills as well as speech production.  Findings:  The physician reviewer found that as noted by Nelson and colleagues, speech and language development is considered by experts to be a useful indicator of a childs overall development and cognitive ability and is related to school success.  The authors reported that identification of children at risk for developmental delay or related problems may lead to intervention services and family assistance at a young age when chances for improvement are best.  Speech and language delay must be taken very seriously in young children, because the long-term consequences may be substantial.  According to Law and colleagues, approximately 6% of children have speech and language difficulties.  The authors noted that children whose difficulties persist into primary school may have long-term problems concerning literacy, socialization, behavior, and school attainment.  These reviewers concluded that there is a positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulties.  McLaughlin noted that there are good data available to support the effectiveness of speech-language therapy, particularly for children with primary expressive language disorder.
Appeal type: Medical Necessity
Decision: Overturned

A 38-year-old female enrollee requested authorization and coverage of the medication Celebrex. The Health Plan denied the request indicating that the requested medication is not medically necessary for treatment of the enrollees back pain.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer overturned the Health Plans denial on the basis that the requested medication is medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

A 65-year-old male enrollee has requested epidural steroid injections and epidural lysis of adhesions for the treatment of his lumbar radiculopathy. Findings:  Two physician reviewers found that the information available for review indicates the patient had persistent symptoms with a poor response to conservative treatment. Epidural steroid injections are indicated for radicular pain, especially if medications and other modalities are ineffective. Although epidural lysis of adhesions is not considered a first-line therapy for this type of back symptoms, it was a reasonable therapeutic approach in this instance given the current medical literature and the refractory nature of the patients pain.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Otezla. Findings: Systemic non-biologic treatment of psoriasis is indicated when topical treatments do not achieve sufficient control of disease and is especially important for patients with involvement of the scalp or other difficult to treat areas. The U.S. Food and Drug Administration (FDA) has approved several non-biologic systemic options for psoriasis including methotrexate, cyclosporine, acitretin, cyclosporine, and apremilast. However, there are severe potential side effects with these medications and immunosuppressive agents have been associated with increased risk of infection. In addition, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) guidelines report stronger evidence supporting treatment with Otezla as compared to acitretin. In this case, the records document that the patient has failed topical therapies for treatment of her diagnosis of psoriasis vulgaris including triamcinolone and excimer laser. The records demonstrate that treatment with a systemic non-biologic agent is appropriate for management of this patients condition. Given these findings, the requested Otezla are medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in dermatology 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 laparoscopic sleeve gastrectomy. In this case, the patient has a diagnosis of morbid obesity despite multiple dietary efforts. The documentation reflects that a thorough multidisciplinary evaluation including psychological, dietary and medical workups have cleared her for weight loss surgery. Given that this patient meets current medical guidelines for bariatric surgery, the requested service is medically indicated. Therefore, laparoscopic sleeve gastrectomy is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service 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 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 48-year-old female has requested an MRI for an evaluation of her hypersomnolence. Findings:  The physician reviewer found that the patient has reported symptoms of excessive daytime sleepiness. Obstructive sleep apnea has been diagnosed, as well as depression. The causes of daytime fatigue are diverse, including disturbed nighttime sleep from any cause, as well as depression and many other medical conditions. The medical literature does not support the notion that brain MRI is sensitive or useful in the diagnosis of daytime fatigue, in the absence of focal neurological signs or symptoms or signs or symptoms of central apnea on pneumocardiogram. Such signs and symptoms are not present in this case. Thus, there is no clinical indication for the proposed MRI.
Appeal type: Urgent Care
Decision: Overturned

A 56-year-old female has requested approval for past treatment of varicose veins provided on three dates at issue on an emergent basis.   Findings:  The physician reviewer found that this patient had a long-standing history of venous insufficiency, although she had not followed through on definitive treatment. She reports that she was traveling throughout Europe and South America during the dates at issue and felt that her legs acutely worsened. She became concerned and sought treatment. Her physician in Ecuador recommended and performed bilateral greater and lessor saphenous vein ablations as well as phlebectomies. The patient states that she is now cured and she is seeking approval for these procedures on the basis that she required immediate medical attention. Her particular concern was the risk of deep vein thrombosis (DVT) with travel.At issue in this case is whether a prudent layperson in the patients circumstances would have sought immediate medical attention on the dates at issue.  California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part.A prudent layperson would reasonably seek immediate medical attention if concerned about the possibility of DVT as the cause of worsening symptoms. However, once a DVT was ruled out by an ultrasound, a prudent layperson would not believe that multiple bilateral lower extremity procedures were required on an immediate basis to treat her long-standing chronic venous insufficiency. It would have been reasonable for the patient to use compression and even maybe lovenox for her long flight, but as far as the need for immediate surgical intervention before undertaking long air travel, there is no imminent need for treatment. In fact, evidenced-based recommendations in this setting are as follows: Individual risk factors for air travel-related VTE include age over 40 years, gender (female), women who use oral contraceptives, varicose veins in lower limbs, obesity and genetic thrombophilia. Prevention measures include environmental protection such as keeping the pressure inside the airplane cabinet in hypobaric condition, avoiding dehydration and prolonged sitting. For individuals at increased risk, venous blood stasis can be reduced by wearing elastic stockings and prophylactic use of low-molecular-weight heparin. Further, the fact that the services were rendered over the course of several weeks does not support the contention that the patient reasonably believed the services were required on an immediate basis. Therefore, although the ultrasound of the lower extremities met prudent layperson criteria for emergency care, the rest of the services the patient received on the dates at issue did not meet prudent layperson criteria for emergency care.
Appeal type: Experimental/Investigational
Decision: Upheld

A 45-year-old female enrollee has requested radiofrequency neurolysis of the sacral facet joints (S1, S2, S3) for treatment of her lumbar facet syndrome and lumbar degenerative disease.  Findings:  Two physician reviewers found that to perform radiofrequency neurolysis the diagnosis must be established based on physical signs and diagnostic blocks (concordant response to diagnostic blocks), specifically for sacroiliac joint pain. In this case, the patient underwent two intraarticular injections into the facet joints as well as sacroiliac joints bilaterally under anesthesia. The relief was assessed post operatively within one hour. Consequently, it is not known if the relief was concordant with the second block providing longer relief than the first one. Additionally, because the facet joint injections, sacroiliac joint injections, and transforaminal epidural injections were all performed in one setting, it is not possible to determine if the patient meets diagnostic indications for radiofrequency neurolysis. Moreover, the patients attempts at conservative management have not described. In light of the above, there is insufficient evidence demonstrating that radiofrequency neurolysis is likely to be more beneficial for this patient than any available standard therapeutic interventions.
Appeal type: Medical Necessity
Decision: Upheld

A 38-year-old female enrollee requested Synvisc injections to the right knee for medical treatment of her knee pain.  Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services in this patients case.  The medical records document mechanical malalignment of the patella, and chondromalacic changes were noted at the lateral facet of the patella.  The requested Synvisc injections are not likely to be beneficial in the setting of mechanical issues of alignment and tracking.  The current medical evidence does not support the requested service in this clinical setting.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: an enrollee has requested authorization and coverage for intravenous (IV) Stelara. Findings:  The physician reviewer found that Stelara is the biologic therapy most recently approved by the U.S. Food and Drug Administration (FDA) for treatment of Crohns disease. Two randomized, placebo controlled trials formed the basis for the FDA approval. However, there has not yet been a head-to-head trial of Stelara compared to Humira. There is also evidence demonstrating improved health outcomes with use of Humira in long-term studies, which are not available for Stelara. This patients treatment for Crohns disease has included use of steroids and Lialda. The records do not document either a lack of response or unacceptable side effects from steroids. The patient also has not been treated with anti-TNF agents such as Humira. Currently, there is a paucity of data supporting the clinical utility of Stelara for treatment of Crohns disease when first-line treatments have not been exhausted. Further, although the patient expressed concern regarding hepatosplenic T-cell lymphoma (HSTCL), there has only been one case reported in a patient who used Humira without concomitant immunosuppression. All told, the requested IV Stelara is not medically necessary for treatment of this 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 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

Xyosted (testosterone enanthate) is an FDA-approved medication for treatment of male hypogonadism. A clinical trial was done to evaluate the efficacy and safety of a subcutaneous testosterone enanthate auto-injector administered weekly to men with hypogonadism. The conclusion of the trial noted the dose adjusted subcutaneous testosterone enanthate auto-injector demonstrated a steady serum total testosterone pharmacokinetic profile with small peak and trough fluctuations. The clinical trial  found that the device was safe, well tolerated and virtually painless, indicating that subcutaneous testosterone enanthate auto-injection offers a testosterone delivery system that is a convenient weekly option to treat testosterone deficiency. Another clinical trial was done of patients with symptomatic testosterone deficiency and concluded that the subcutaneous testosterone enanthate auto-injector has a favorable safety profile and is well-tolerated, with a stable pharmacokinetic profile. Studies have also shown that it is less painful than intramuscular injection. Xyosted is therefore a good option for men who are unable to continue intramuscular injection therapy. In this case, the patient has symptomatic hypogonadism that responded to testosterone replacement therapy with intramuscular injection of testosterone cypionate. The patient is unable to tolerate this treatment, however, due to pain at the injection site.The patient also has concerns about topical therapy with the risk of exposure to his family. The patient was placed on Xyosted subcutaneous injections, and he tolerated subcutaneous injection well and noted improvement in his symptoms and testosterone levels. Under these circumstances, the requested medication Xyosted is medically necessary to treat the patients medical condition. Final Result: The reviewer determined that the requested medication is medically necessary to treat the patient's medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in urology 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 reimbursement for DecisionDX-Melanoma Class I investigational for the evaluation of the enrollees malignant melanoma. Findings:  Three physician reviewers found that the patient was diagnosed with a cutaneous melanoma in the skin located in his epigastric region. At that time he was found to have an invasive melanoma, non-ulcerating, Clark Level II, Breslow thickness 0.35, and no mitoses were seen. The provider recommended tissue sampling in an effort to determine the patients prognosis. The patients tissue was sent for DecisionDX- Melanoma Class I assay and testing. The patient requested reimbursement for the testing. The Health Plan has denied reimbursement because the Health Plan deems the services at issue as experimental/investigational for the evaluation of this patient. This denial is the subject of this appeal and determination. The prognosis of cutaneous melanoma has classically been determined by the staging system as documented by the researchers. The mitotic index has also been viewed to add a bit more to the prognostics. DecisionDX-Melanoma is a study of 31 genes in the melanoma cells. It then classifies that melanoma as either high or low risk for recurrence. The National Comprehensive Cancer Network (NCCN) guidelines state that there is interest in these newer genetic profiles, but only in the context of a clinical trial. Currently, medical studies are not clear as to how DecisionDX data compares to the 10 year data of the Balch determinations and whether it is useful in clinical practice for patients with a good prognosis, as is true in this patients case. This assay, was used in an effort to determine this patients prognosis. While this test has some limited support for its use in identifying treatment options for those patients diagnosed with cutaneous melanoma, this assay has not been shown to be superior over other modes of therapy. As such, DecisionDX-Melanoma Class I assay was not likely to be more effective than available standard therapy for the evaluation of this patient. Final Result: The reviewers have 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: All three physician reviewers are board certified in internal medicine with sub-specialty certification in medical oncology and are 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: Upheld

This patient is a 49-year-old woman with chronic pain due to degenerative disc disease. She is requesting ongoing and chronic nerve block and epidural injection therapy for her pain management. The Health Plan has determined the requested services are not medically necessary for treatment of the patients medical condition.The utilization of chronic and ongoing nerve blocks and epidural injections in the management of chronic discogenic pain is not medically appropriate or indicated. Such therapy is utilized primarily in radiculopathy syndromes and on occasion for acute exacerbations of pain, but not on a chronic basis. Physical therapy/rehabilitation and strengthening exercises are the standard of care long-term management tool for chronic discogenic pain that is not amenable to surgery. Nerve blocks and epidurals are utilized only on occasion for acute exacerbations. Therefore, I have determined the requested services are not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.