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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for treatment of her chronic hepatitis C virus genotype 1a.  Findings:  Three physician reviewers found that Harvoni was approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C genotype 1 infection in both treatment-naive and treatment-experienced patients. Per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) guidelines, all patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. FDA approved antiviral therapy regardless of fibrosis score. Therefore, based upon this approval supported by large clinical trials listed below, Harvoni should be approved in this patient as she already had fibrosis and Harvoni would help to prevent further progression of cirrhosis to decompensated state, and its potential complications. Thus, the requested Harvoni is supported as medically necessary for treatment of this patients hepatitis C virus. Credentials/Qualifications: The three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology 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: Overturned

The parent of a five-year-old male enrollee has requested speech therapy and occupational therapy for the treatment of the enrollees autistic disorder. Findings:  Three physician reviewers found that autism spectrum disorder is a medical condition of unknown origin. Myers and colleagues supported speech therapy for the treatment of autistic children. Occupational therapy is cited as being recommended but not proven due to methodological difficulties in proving its value. Schaaf and Miller indicate that occupational therapy utilizing sensory integration can be successful in improving function in autistic children. Most authorities recommend extensive occupational and speech therapy for autistic children. Two hours per week of speech therapy and two hours per week of occupational therapy are medically indicated and appropriate for treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

The enrollee is requesting authorization and coverage for the medication, bexarotene, 75mg, 8 capsules PO daily. The patient has multiple skin lesions of the scalp, torso, and arms. A scalp biopsy showed T-cell lymphoma. The plan is for treatment with bexarotene. Three specialists believe methotrexate use is not in the patients best interest, due to the side effects, black box warning, and potential for liver damage. Studies show bexarotene can also cause liver damage. Studies also show methotrexate, combined with other medications, works better than bexarotene. Literature shows standard treatments work well for treating this disease.Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician 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 similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Remicade for treatment of the enrollees ulcerative colitis. Findings:  The physician reviewer found that per the U.S. Food and Drug Administration prescribing information for Inflectra, it is biosimilar to Remicade. Specifically, there are no clinically meaningful differences between the biosimilar product and the reference product per the package insert.  Clinical studies have concluded that switching patients with inflammatory bowel disease from Remicade to Inflectra is not inferior to continued treatment with Remicade.  Additionally, two randomized, double-blinded trials (PLANETAS and PLANETRA) demonstrated no difference between Remicade and Inflectra in pharmacokinetic parameters, safety, and efficacy.  Data from extensions of these studies, and real world data in patients with inflammatory bowel disease, suggest that switching from Remicade to Inflectra is not associated with adverse outcomes.  For these reasons, Remicade is not medically necessary for the 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.  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: Upheld

A 63-year-old female enrollee has requested for Botox injections for treatment of her migraine headaches and cervicalgia.   Findings:  Two physician reviewers found that botox is not a first-line therapy for either migraine headaches or cervical neck pain. Although its use has resulted in benefit in refractory cases of headaches, there is insufficient evidence to support Botox over more thoroughly studied and proven first- and second-line headache prophylactic medications. In this patients particular clinical situation, there is no documentation submitted that this patient has failed more standard medications; nor was there any documentation submitted which specified contraindications for the use of these medications. Botox is only indicated for the treatment of migraines if there is documented evidence of failure or contraindication to standard preventive agents.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene testing (DecisionDx-Melanoma). Current medical literature does not support the use of DecisionDx-Melanoma testing for the staging or treatment of thin melanomas over standard treatment with a wide local excision. The National Comprehensive Cancer Network (NCCN) guidelines on the treatment for thin melanomas do not include the use of DecisionDx-Melanoma testing. The American Academy of Dermatology (AAD) also does not include the use of molecular genetic testing for the treatment of primary cutaneous melanoma. In this clinical setting, the use of DecisionDx-Melanoma testing would not have changed the management of this patient. Therefore, gene testing (DecisionDx-Melanoma) was not likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the gene testing (DecisionDx-Melanoma) at issue was not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the service at issue was not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in dermatology 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: Overturned

A 41-year-old female enrollee has requested a laparoscopic sleeve gastrectomy for treatment of her obesity.  Findings:  The physician reviewer found that this patient has a BMI of 35 with hypertension and history of a cerebral vascular accident (stroke) related to hypertension. As such, she meets National Institutes of Health Consensus Guidelines criteria for clinically severe obesity and is an appropriate candidate for bariatric surgery. Laparoscopic sleeve gastrectomy is a well-accepted weight loss procedure with proven results for patients with clinically severe obesity. Therefore, the proposed procedure is medically necessary for this patient. As with any weight loss procedure, the patient should undergo appropriate dietary and psychological evaluations prior to surgery.
Appeal type: Experimental/Investigational
Decision: Upheld

A 62-year-old female has requested coverage for past real-time heart monitoring (CPT code 93229) for evaluation of her paroxysmal symptomatic supraventricular tachycardia.  Findings:  Three physician reviewers found that the patient has a history of paroxysmal symptomatic supraventricular tachycardia.  She was evaluated using a real-time heart monitor (CPT code 93229).  There is a lack of documentation indicating that the patient underwent or was unable to undergo other types of monitoring, including continuous off-line 24-hour to 48-hour Holter monitoring or off-line patient-activated or auto-triggered event recording.  The Health Plan has denied reimbursement for real-time heart monitoring and reported that the services at issue were investigational for the evaluation of this patient.The services at issue were not likely to be more effective than other available methods of evaluation.  In this clinical setting, non-real-time (off-line) monitoring devices, such as 24-hour to 48-hour Holter monitoring or self-activated event monitoring, would have been appropriate.  In less common cases of infrequent asymptomatic dysrhythmias that require identification, non-real-time (off-line) monitoring devices with auto-triggering capability should be sufficient.  There is no documentation to indicate the patient is not able to effectively manage these standard monitoring devices and no indication that these have been previously obtained to evaluate the patients condition.  Current expert consensus guidelines endorsed by several national organizations consider Holter monitoring and patient-activated event recorders appropriate initial tests for evaluation of supraventricular dysrhythmias.  All told, real-time heart monitoring (CPT code 93229) was not likely to have been superior over other available tools for evaluating this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for DecisionDx-Melanoma test. The enrollee was diagnosed with malignant melanoma of the right mid upper back.  He was seen for evaluation of moles on his trunk that had been present for years.  He has a family history of melanoma. An irregular brown macule was noted on his right mid-upper back and a shave biopsy was done. Findings:  The physician reviewer found that the dermatopathology report showed malignant melanoma, superficial spreading type, arising in association with a nevus,without ulceration, peripheral margins involved. A complete excision of the lesion was performed. The pathology report showed dysplastic nevus with free margins.  The DecisionDx-Melanoma test result was Class 1 Sub-class: 1A, which is associated with a low risk of recurrence within five years. His physician indicates this information helps determine the most appropriate treatment plan for these enrollees. The results of the DecisionDx-Melanoma test revealed the enrollee has class 1A associated with the lowest risk of recurrence within five years, which suggests a very low risk of metastatic potential already ascertained on the original biopsy. There are no long-term follow up studies available regarding the effectiveness of the test. The testing would not be effective or useful in treatment planning. The initial evaluation for risk of metastasis in enrollees with cutaneous melanoma uses the staging criteria, which includes sentinel lymph node status. The stage at presentation of melanoma has a significant impact on the course of the disease, holds prognostic value and dictates the recommendation in treatment.  The sentinel lymph node status is a proven prognostic tool that identifies a subset of the enrollees with high-risk disease. Although there are recent studies that show statistical analysis related to enrollee outcomes, the OncotypeDx-Melanoma test has not been supported by current guidelines. The results of this testing has not yet been accurately correlated into treatment that will improve enrollee outcomes. In a enrollee with a low risk, there is no medical justification available in current medical literature for a genetic test that has only completed interim data analysis, and has not yet definitely been shown to improve enrollee health outcomes. DecisionDx-Melanoma test is not currently recommended by any standard treatment guidelines.Final Result: Three of the three reviewers determined that the requested service was not likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in dermatology 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

A 57-year-old male enrollee has requested a 21st Century Scientific Electric Leg Bag Emptier for treatment of his quadriplegia and neurogenic bladder.  Findings:  The physician reviewer found that patients with spinal cord injury (SCI) are at high risk of recurrent urinary tract infection (UTI). In addition, complications from UTIs pose significant health risks to this patient population. In the case under review, the patient has requested reimbursement for a medical device that will permit appropriate Foley catheter management when a caregiver is not available. He continues to work, which requires him to be able to manage the catheter without the assistance of a caregiver. Without the device, the patient is at increased risk of medical complications. As such, the device provides a clear health benefit to the patient and conversely, is not an item of convenience. Therefore, the 21st Century Electric Leg Bag Emptier was and is medically necessary for treatment of the patients neurogenic bladder and should be reimbursed appropriately
Appeal type: Medical Necessity
Decision: Upheld

A 64-year-old female enrollee requested authorization and coverage of physical therapy. The Health Plan denied the request indicating that the requested therapy is not medically necessary for treatment of the enrollees chronic neck and back problems.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the Health Plans denial on the basis that the requested therapy is not medically necessary.
Appeal type: Medical Necessity
Decision: Upheld

A 71-year-old male enrollee has requested for Provigil, 100 mg for treatment of his multiple myeloma.  Findings:  The physician reviewer found that Provigil is not the standard of care for treatment of sleep disorders in multiple myeloma. There are many different chemotherapeutic approaches to the treatment of myeloma, but Provigil is not recommended for the associated side effects. Finally, this patient has daytime fatigue and sleep problems, possibly related to medications, insomnia, and pruritus, and it is unclear from the records whether conventional alternatives have been tried. Thus, with a paucity of clinical data supporting the use of Provigil for fatigue and sleep disorders during treatment with chemotherapy, or its use in patients with multiple myeloma, the use of Provigil for management of this patients condition has not been demonstrated in the records provided for review.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Maxalt for treatment of her migraine headaches  The physician reviewer found that Maxalt (rizatriptan) is an effective medication in the triptan class to treat acute migraine. Rizatriptan is a small molecule and therefore there should not be any significant difference between generic and branded drugs. The patient indicates that the generic form does not work and she has increased headaches. However, this is not supported in the medical records submitted for review. According to the American Headache Society, any patient with four or more migraines a month should be considered for preventive therapy which may help reduce the number of headaches and often allows the headaches to be more amenable to acute therapy. In this case, it does not appear she is under the care of a neurologist or headache specialist. Given the lack of documentation demonstrating that the patient has failed generic rizatriptan, the brand name Maxalt 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 neurology with sub-specialty certification in headache 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic laboratory testing provided for evaluation of the enrollees cutaneous melanoma. Findings: The physician reviewer has found that the DecisionDx melanoma assay tests the tissue genetics of the melanoma to help stratify whether a thin melanoma is high risk for metastasis. The DecisionDx test has shown some impressive accuracy in thin melanomas like this patients tumor. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Further, DecisionDx testing is not supported for patients with intermediate thickness melanoma tumors. All told, the genetic laboratory testing provided was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: All three physician reviewers determined that the testing at issue was 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 dermatology 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: Overturned

A 24-year-old female enrollee has requested for Meridia 10 mg for treatment of her asthma and obesity.  Findings:  The physician reviewer found that Sibutramine (Meridia) has been approved by the FDA which states that, Meridia is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Meridia is recommended for obese patients with an initial body mass index  30 kg/m2, or  27 kg/m2 in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension). The American Association of Clinical Endocrinologists (AACE) indicates that, Pharmacotherapy, in conjunction with a basic weight management program, is suitable for patients with a BMI > 30 or for patients with a BMI of 27 to 29 and at least one major comorbidity. The Obesity Society considers pharmacotherapy only if a patient has not lost 1 pound per week after 6 months of combined lifestyle therapy.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 24-year-old female who experienced significant weight loss following gastric bypass surgery. The patient underwent evaluation by two plastic surgeons. The patients physician notes the patient is still morbidly obese. The patient has a skin rash in the suprapubic region, a large abdominal pannus and folds, large arm folds, and a typical bat wing type deformity. In addition, the patient reports experiencing rashes on her back, abdomen, arms, breasts, and thighs. The enrollee has requested authorization and coverage for a panniculectomy, brachioplasty, and lower body lift.The patient is requesting authorization for panniculectomy, brachioplasty and lower body lift. She has been examined by two plastic surgeons who noted the presence of a rash in the suprapubic area. However, both physicians indicated the patient was still morbidly obese and therefore, a panniculectomy was not medically indicated. Based upon the information provided, the patient is not an appropriate candidate for panniculectomy at this time. If the patient continues to lose weight her request for a panniculectomy should be reconsidered. Furthermore, brachioplasty and lower body lift are body-contouring procedures and are generally cosmetic in nature. There is no medical necessity for these procedures based upon the evidence provided. For these reasons, I have determined that the requested procedures are not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested sensory based occupational therapy for treatment of the enrollees medical condition.Findings: The medical evidence indicates that sensory based interventions can be very effective for children with autism spectrum disorder and behaviors including emotional regulation.  The study by Pfeiffer and colleagues included blinding comparison, and showed that sensory integration interventions helped with autistic tendencies and engagement in therapies.  The systematic review by Watling and Hauer found that sensory integration techniques can help with social interactions and mannerisms.  In this case, the enrollee had sensory based occupational therapy in the past and was making better progress.  All told, the requested sensory based occupational therapy is medically indicated for the 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 developmental-behavioral pediatrics, 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.