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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Afirma Gene Expression Classifier (GEC) testing. The Bethesda System recommends a diagnostic hemithyroidectomy for this type of nodule. The recent American Thyroid Association guidelines state that for nodules with atypical of undetermined significance cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat fine needle aspiration (FNA) or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. If the genetic test is suspicious, the risk of malignancy increases to 40% and the risk of malignancy decreases to less than 6% with benign findings. In this case, the result of the Afirma GEC was suspicious for malignancy. This increases the patients risk of malignancy to 40%. This information was important to determine the decision whether to perform thyroidectomy. For these reasons, the Afirma GEC testing was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.One reviewer found that the Afirma GEC testing 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 endocrinology, diabetes and metabolism and is actively practicing. One Reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing.  One Reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for acetaminophen with codeine (Tylenol with codeine) liquid. The U.S. Food and Drug Administration (FDA) has issued its strongest warning against the use of codeine medications for use in children under 12 years of age. Specifically, the FDA states that codeine carries serious risks, including slowed or difficult breathingwhich appear to be a greater risk in children younger than 12 years. In this case, the patient is currently seven-years-old and has been diagnosed with a hyperextension injury to his right knee. The imaging of the joint did not reveal a fracture or dislocation. The provider recommended conservative management with ice, compression with ACE bandage, and elevation of the leg for knee pain. The patient was prescribed ibuprofen and Tylenol for pain control. The providers dated 4/29/19 state the patient has not exhausted the recommended therapeutic regimen of ice, compression, elevation, and ibuprofen and Tylenol. All told, the requested acetaminophen with codeine (Tylenol with codeine) liquid is not medically necessary for the treatment of knee pain.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in anesthesiology with subspecialty certification in pain management 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 42-year-old female enrollee has requested an MRI scan of the cervical spine for an evaluation of her headaches and neck pain. Findings:  The physician reviewer found that the MRI was not medically necessary to treat the patients medical condition. There are no physical examination findings of a cervical spine condition and no documentation of conservative measures for the cervical spine in the form of physical therapy, anti-inflammatory medications, pain medications, or a home exercise program. There is also no documentation of epidural steroid injections.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Kyprolis, 70 mg per square meter (m2), to be administered on days 1, 8 and 15, and the cycle repeated every four weeks.The medical literature does not support that the requested medication is medically necessary. Carfilzomib (Kyprolis) can be used as an appropriate standard of care for relapsed refractory multiple myeloma at a number of doses and in combination with a number of regimens. Dosing of carfilzomib at 70 mg per meter squared weekly, for three weeks out of every four, has been demonstrated to be efficacious in combination with dexamethasone and this combination and dose is considered acceptable as a standard of care. However, the proposed regimen of carfilzomib at 70 mg meter squared in combination with cyclophosphamide (brand name Cytoxan) and dexamethasone is currently under investigation. This regimen has been studied in a phase 1/2 study and demonstrated promising activity and safety. The regimen combination of carfilzomib, dexamethasone and Cytoxan has not yet been approved as a standard of care combination regimen for the treatment of relapsed refractory multiple myeloma. Use of this regimen would be considered investigational and therefore not medically necessary according to current standards of care for the treatment of relapsed refractory multiple myeloma. Accordingly, the requested dosage of 70 mg per square meter (m2) of Kyprolis, to be administered on Days 1, 8, and 15, and the cycle repeated every four weeks, is not medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine, with 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

A 61-year-old male enrollee requested authorization and coverage of an electric wheelchair for the treatment of Amyotrophic Lateral Sclerosis.  The health plan denied the enrollees request indicating that an electric wheelchair 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.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a 17-year-old male enrollee has requested for inpatient mental health services for treatment of the enrollees autism, anxiety disorder and obsessive compulsive disorder. Findings:  The physician reviewer found that the patient demonstrated severe symptoms throughout his inpatient stay. The patient required a comprehensive multidisciplinary treatment plan applied by specialized staff under 24-hour supervision to achieve the general goal of symptom decompression with a seamless transition to the outpatient setting. The inpatient mental health services provided were consistent with good medical practice in the United States.
Appeal type: Experimental/Investigational
Decision: Upheld

The enrollees parent requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) gene mutation testing. The enrollee underwent methylenetetrahydrofolate reductase gene mutation testing. Her father had genetic testing, which was positive for the mutation in the methylenetetrahydrofolate reductase gene. The enrollees father reports the gene mutation test informs the enrollee of the need to avoid folic acid, which is commonly found in many processed foods and vitamin supplements. He concludes that carriers of this gene mutation have a 30% higher probability of certain cancers and must be screened appropriately based on this additional risk. Literature shows there is no indication for MTHFR mutation testing in routine clinical practice in any enrollee group. A professional society advises MTHFR genetic testing should not be ordered as part of the clinical evaluation for risk of blood clots or recurrent pregnancy loss. The presence of MTHFR mutations does not require any special treatment, such as supplementation with folic acid, vitamin B6, or vitamin B12, and no additional concerns arise because of it. This enrollee is not known to have any medical problems. Researchers report that no certain link to medical problems, such as recurrent pregnancy loss, thrombophilia, hypertension, stroke, or the risk for birth defects in offspring has been connected to MTHFR mutations.Final Result: Three of the three reviewers determined that the requested services are 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 clinical cytogenetics 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Helicobacter pylori (H. pylori) serological antibody test (CPT 86677). Findings:  The physician reviewer found that the  American College of Gastroenterology (ACG) guidelines for dyspepsia support the use of H. pylori testing for evaluation of specific symptoms, as in this patients case. Current medical literature supports the use of H. pylori testing to rule out this infection as a cause for pain in well-selected patients. In this patient with dyspepsia and no documented prior treatment for H. pylori infection, the H. pylori immunoglobulin G (IgG) antibody would be expected to be elevated in the presence of ongoing infection. Use of the H. pylori serological antibody test can help avoid more extensive testing and facilitate treatment. In patients on proton pump inhibitors, the accuracy of alternatives such as breath testing or stool testing for H. pylori may be decreased. Furthermore, this provider noted that the patient is from Peru, which has an estimated 80% prevalence of H. pylori. For these reasons, the H. pylori serological antibody test (CPT 86677) was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the H. pylori serological antibody test (CPT 86677) was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in internal medicine with subspecialty 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: Upheld

A 58-year-old female enrollee has requested the compound medication triiodothyronine (T-3) for the treatment of her thyroid condition. Findings:  The physician reviewer found that patients with thyroid disease, or more specifically hypothyroidism, are usually treated with levothyroxine (T4). Various brands of this medication are available.  In some cases, physicians feel that triiodothyronine (T3) is useful along with levothyroxine, although this practice is somewhat controversial. In this case, however, the patients thyroid tests were normal so there is no evidence that thyroid hormone (T3 or T4) is clinically indicated for this patient.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a three-year-old male enrollee has requested speech therapy for treatment of the enrollees autistic disorder.  Findings:  The physician reviewer found that language deficits are one of the core aspects of autism, and speech therapy provides professional help and guidance on communication development for individuals with autism (Rogers). Stone et al. evaluated 34 children with autism at 2 years of age and re-evaluated them 2 years later to examine factors related to the development of spoken language. The only significant predictors were motor imitation and number of hours of speech and language therapy. The individuals with significant speech and language intervention improved in their language development. Goldstein also reviewed communication intervention for autism. This was done in peer-review research articles published over the past 20 years. The evidence supported the claim that effective interventions exist to teach communication skills to children with autism.  Language skills make a significant difference in the ability of children to control their environment and have been found to be an adaptive alternative to highly disrupted behaviors as noted in this patient. Ongoing speech therapy is a medically necessary component of the treatment plan. Speech therapy is medically necessary for this patient with Autism Spectrum Disorder and severe expressive and receptive language delays with socialization deficits. The patient should receive 2 hours of speech therapy/week of an intensive and direct language program.
Appeal type: Experimental/Investigational
Decision: Upheld

A 22-year-old female enrollee has requested cognitive rehabilitation treatment for her anxiety.  Findings:  The physician reviewer found that the patient has achieved subjective and objective benefits from cognitive rehabilitation treatment. In addition, there is evidence in the peer-reviewed medical literature demonstrating that this type of treatment helps patients to improve. Price and colleagues concluded that cognitive behavioral therapy is effective in reducing the symptoms of fatigue at post-treatment compared with usual care, and may be more effective in reducing fatigue symptoms compared with other psychological therapies. However, there is a lack of data supporting cognitive rehabilitation treatment for patients with CFS or Lyme disease. Therefore, the cognitive rehabilitation treatment at issue was not and is not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested a bone growth stimulator for treatment of his medical condition.  Three physician reviewers found that there is a lack of peer-reviewed literature evidencing long-term safety and efficacy of the device at issue in this clinical setting.  Randomized controlled studies on a larger scale are needed to validate the current evidence and generate more specific clinical guidelines.  There is a need for large and definitive trials that use patient-important outcomes.  Most literature supports rest as the most important treatment in the acute phase of a tibial stress fracture.  Patients may require relative rest and cessation of sport for prolonged periods of time, depending on the severity of their symptoms.  Cryotherapy is also commonly used in the acute period.  All told, the superior efficacy of the device at issue has not been established. Final Result: Three reviewers determined that the device at issue was not and 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 orthopedic surgery 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

The parent of a two-year-old male enrollee has requested coverage for individual speech therapy twice per week for 30 minute sessions for treatment of his severe language impairment.  Findings:  The physician reviewer found that in child development, delay in acquisition of speech is an important predictor for later problems. Research over the past 50 years has yielded several promising approaches and many specific intervention techniques designed to enhance the communication and language development of young children with intellectual and developmental delays and disabilities. In the clinical literature, Gallagher and Chiat found that, Studies of children with language impairment have reported emotional and behavioral problems in 50-75% of that population. In addition, various authors describe children with delayed speech development as being at high risk for other cognitive, social-emotional, and school-related problems. As such, language development is one of the most significant processes of early childhood development.  With regard to diagnosis, language disorders are identified when a patient has difficulty with expressive language, receptive language, or pragmatic language. Speech disorders are identified when a patients voice, fluency, or articulation call attention to the speaker because his or her speech is sufficiently different from the norm. Speech and language development should be consistent with a patients overall development and can be tracked using typical milestone markers. As speech therapy is recommended for young patients with speech delay, the primary goal of treatment is to give the patient a reliable way to exchange ideas and information in his or her daily social and educational environment. Treatment is tailored to the specific communication needs of each patient, which vary with disorder type and severity, age, and the etiology of the condition. Speech therapy is the standard of care for patients with speech delay. Therefore, the requested therapy is medically necessary for treatment of this patients speech delays at the frequency of twice per week for 30 minute sessions.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Advair Diskus aerosol powder 500-50 MCG/dose, 2 puffs a day. The U.S. Food and Drug Administration (FDA) approves the use of Adair Diskus for the management of chronic obstructive pulmonary disease (COPD). In this case, the patient has a diagnosis of COPD and tried and failed multiple alternative therapies. He has demonstrated a positive clinical response to Advair Diskus. Given current medical literature and in this clinical setting, the requested medication is medically indicated. Therefore, Advair Diskus aerosol powder 500-50 MCG/dose, 2 puffs a day is medically necessary for the 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 internal medicine with sub-specialty certifications 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.
Appeal type: Experimental/Investigational
Decision: Overturned

An enrollee has requested reimbursement for the three-dimensional (3D) digital breast tomosynthesis performed.  Findings:  The physician reviewer found that this technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the 3D digital breast tomosynthesis that was performed was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: The reviewers determined that the diagnostic procedure 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: the physician reviewers are board certified in diagnostic radiology 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

A 52-year-old female enrollee has requested Synvisc injections for treatment of her knee pain. Findings:  The physician reviewer found that the submitted records fail to demonstrate the medical necessity of the requested Synvisc injections.  The medical records document early degenerative osteoarthritis and a past history of multiple injections of hyaluronan.   The current medical evidence does not support Synvisc injections in this clinical setting.  There is a risk of aseptic inflammatory reaction due to an allergic response.  The risk for this reaction increases with repeated injections and may also be increased by reason of an already present autoimmune disorder.  In this patients case, she has systemic lupus erythematosus.  Additionally, there is a risk of iatrogenic infection.  Rutjes and colleagues conducted a systematic review and meta-analysis assessing the risks and benefits of viscosupplementation for adults with symptomatic knee osteoarthritis.  The authors concluded that viscosupplementation is associated with a clinically irrelevant benefit and an increased risk for serious adverse events.  All told, the requested Synvisc injections are not medically indicated for the treatment of this patient.