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

Nature of Statutory Criteria/Case Summary: The patient is diagnosed with multiple sclerosis (MS). The medical records indicate ongoing and worsening function of the left lower extremity despite treatment with Avonex, Tysabri, Aubagio, and high dose steroids. The patients gait showed an increase in the muscle spasms and spasticity in the left side. There is weakness in the lower extremity and he requires the use of a cane and/or walker for ambulation. On 10/9/18, the provider noted the Bioness GO FES is indicated to help prevent falls. Without the device, the enrollee is must stop every two to three steps. Findings:  Three physician reviewers found that according to the available evidence, the Bioness GO functional electrical stimulator (FES) is not superior to standard available treatment modalities in this clinical setting. Two large randomized trials have shown improved patient satisfaction with FES. However, the authors reported that no significant difference was observed between FES and a standard ankle foot orthosis (AFO). A small randomized trial examining neuromuscular stimulation for footdrop in patients with multiple sclerosis revealed in the area of walking speed failed to demonstrate a clinically significant benefit to the neuromuscular stimulation over an exercise class (Esnouf, et al). In addition, Prenton and colleagues performed a meta-analysis of five randomized controlled trials which included over 800 patients comparing AFO to FES. The researchers concluded that AFOs have equally positive combined-orthotic effects as FES on key walking measures for foot drop. Given these findings, the Bioness GO FES device is not likely to be more beneficial for the treatment of the patients condition than any available standard therapy.Final Result: The reviewers determined that the requested device 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: Physician reviewers 1, 2 and 3 are board certified in neurology 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for gene test. She found a palpable mass in her left breast.  A lesion and two other areas of microcalcifications were found on mammography. A biopsy showed ductal carcinoma in situ of the left breast. The enrollee has a family history of pancreatic cancer. Her OB/GYN and breast surgeon recommended genetic testing for BRCA genes and genetic counseling. The gene testing was performed. This was negative with no clinically significant mutation identified. The enrollee subsequently underwent a double mastectomy. Her post-surgical diagnosis was anatomic stage 2B, prognostic stage 1B breast cancer that is estrogen receptor and progesterone receptor positive, HER-2/neu negative, with left axilla sentinel node involvement. She was seen for genetic counseling. The enrollee meets guidelines for genetic testing. She is a young woman with infiltrating ductal cancer and node-positive disease.  The guidelines also indicate it is appropriate for this testing to be ordered by an OB/GYN, breast surgeon or genetic counselor. Complex or high-level genetic testing may be appropriate for certain patients due to family or personal history, or due to the presentation and the diagnostic results of the patient. Multigene assays are a way to personalize systemic adjuvant therapy choices as the available assays have strong prognostic capability. Identifying mutations in either the BRCA1 or BRCA2 genes in a woman with breast cancer can influence her immediate and long-term management decisions regarding systemic therapy and early investigation in the treatment trajectory can most influence cancer care. Final Result: Three of the three reviewers determined that the requested services are 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 general 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 one-year-old male enrollee has requested speech therapy services for treatment of the enrollees delays in receptive and expressive language development.  Findings:  The physician reviewer found that in this patients case, the requested speech therapy services are medically necessary for treatment of his receptive and expressive language delay. 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 noted 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 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 reported that children with difficulties that persist into primary school may have long-term problems concerning literacy, socialization, behavior, and school attainment.  These reviewers concluded there is a positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulties. This patient has severe receptive and expressive language delay, and this is negatively impacting his ability to communicate in an age-appropriate manner. Studies have shown that speech and language therapy can result in significant improvement in this clinical situation. All told, the requested speech therapy services are medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a five-year-old male has requested occupational therapy for treatment of his autism. Findings:  The physician reviewer found that Myers, et al. recommends this modality, although the authors also note there is limited literature concerning occupational therapy in the treatment of autism. However, subsequent to this report, Case-Smith and Arbesman compiled a meta-analysis of the literature, documenting the value of occupational therapy in the autistic childhood population. Pfeiffer and colleagues found that occupational therapy is an efficacious therapy for reducing many of the unwanted mannerisms associated with autism. May-Benson and Koomar performed a meta-analysis of 27 journal articles utilizing sensory integration occupational therapy techniques for autistic children and concluded that the therapy was effective. All told, there is ample literature support for the use of occupational therapy in the treatment of children with autism.
Appeal type: Medical Necessity
Decision: Upheld

A 38-year-old female enrollee requested authorization and coverage for DIEP flap breast reconstruction surgery. The health plan has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees breast cancer.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the health plans denial on the basis that the requested procedure is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for corneal collagen cross-linking. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral keratoconus. Findings:  Based on the patients vision loss and progression, the cross-linking procedure was the most appropriate and effective treatment available. The medical literature supports the use of cross-linking in patients who are diagnosed with keratoconus and progression.  There is a strong body of evidence that shows corneal collagen cross-linking is a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full thickness corneal transplant. Furthermore, corneal collagen cross-linking for corneal ectasias fulfills an unmet need. There is a lack of other treatment options available to slow or halt disease progression. As such, corneal collagen cross-linking procedure was likely to have been of greater benefit than the standard methods for the treatment of this patients medical condition. Final Result: Two of the three reviewers determined that services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications:  All three reviewers are board certified in ophthalmology 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 patient is a 52-year-old woman diagnosed with breast cancer. She has been found to have a 2.2cm moderately differentiated invasive cancer. Her cancer is estrogen receptor positive and node negative. In an effort to further define her risk of recurrence and her need for adjuvant chemotherapy, her tissue was submitted to Oncotype DX analysis. The results indicated a recurrence score of 24, placing her at intermediate risk for recurrence without chemotherapy. Accordingly, she elected to receive adjuvant chemotherapy. At issue is whether the Oncotype DX assay was medically necessary for evaluation of the patients condition.Oncotype DX assay is a 21-gene analysis of breast cancer cells, which produces a recurrence score that predicts quite accurately the risk of distant recurrence of the cancer by 10 years if the patient is treated with hormonal therapy as the sole systemic treatment. There is good literature support for its reliability. The assay has been shown to be valid only in node-negative, estrogen receptor positive tumors. The assay has become very important as it is particularly in this group of breast cancer patients that it is very difficult to make recommendations about adding adjuvant chemotherapy. Indeed, this assay has been rapidly adopted by many oncologists as part of their standard evaluation of such patients, and Medicare has approved it use.For the reasons set forth above, I have determined the diagnostic procedure at issue was medically necessary for evaluation of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

A 46-year-old female enrollee has requested Zomig for the treatment of her migraine headache. Findings:  The physician reviewer found that this patient has chronic migraine (e.g., greater than 15 migraine days/month). The use of 24 Zomig a month is not medically necessary and is likely to worsen her condition. A prescription of 15 Zomig 5 mg/month is medically indicated and reasonable based upon the information provided. Furthermore, there are a variety of medications, especially in combination that are potentially of benefit for a patient in this situation.
Appeal type: Experimental/Investigational
Decision: Overturned

A female enrollee requested breast tomosynthesis for medical evaluation of her medical condition.  Findings:  Two physician reviewers found that in recent years, there have been several studies that have supported the use of breast tomosynthesis as a more accurate study than routine screening mammography.  All told, breast tomosynthesis was likely to have been of greater benefit than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a fifteen year-old male with traumatic brain injury is requesting authorization and coverage of in-patient treatment.  Reviewers Findings:  The reviewing physician found that the requested services are not medically necessary for treatment of the patients medical condition.  The Health Plan denial was upheld.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the requested services are not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested a power wheelchair for treatment of his medical condition.   Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested power wheelchair. In this case, the patient is an independent ambulator. The records do not demonstrate that the patient would be bed or chair confined without a power mobility device.  There are no impairments that would preclude the patient from using a knee walker or propelling a manual wheelchair. The patient does not have neurological, musculoskeletal, cardiopulmonary or other organ system impairments that would preclude him from using an optimally configured manual wheelchair to accomplish his mobility-related activities of daily living. Any mild strength deficits can be addressed with exercise and strengthening. Moreover, physical activity is highly appropriate and recommended for persons with conditions such as diabetes, hypertension and for general musculoskeletal health (Hagen, et al). Moreover, manual wheelchair use has been shown to provide significant health benefits use over power wheelchair use for persons with mobility impairments (Keyser, et al; Hastings, et al). Therefore, based on the clinical documentation submitted, the power wheelchair is not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the requested equipment 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 physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for blood test (prothrombin G20210A (factor II)) for evaluation of the enrollees risk for thrombosis. Findings:  2/3 of the physician reviewers found that there is support in the medical literature for the blood test that was done in this patients case. The factor V mutation, also known as factor V Leiden, has the potential to induce hypercoagulopathy. A long airplane flight or automobile trip, as in this specific case, may trigger this condition. Importantly, the prothrombin G20210A mutation adds to this risk such that compound heterozygous patients can have up to 20-fold increased odds of developing DVT. The testing in this clinical setting would have directly altered treatment recommendations. In sum, the blood test (prothrombin G20210A (factor II)) was likely to have been more efficacious than any other methods of evaluating this patients medical condition. Final Result: 2/3 of 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 reviewer number one is board certified in internal medicine with sub-specialty certification in hematology 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.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in hematology 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.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in hematology 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

The parent of a 1-year, 11-month-old male enrollee has requested speech therapy for treatment of the enrollees speech delay. Findings:  The physician reviewer found that 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 and therefore is medically necessary for this patient.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for biofeedback therapy. The submitted documentation supports the medical necessity of the requested services. The records document fecal incontinence unresponsive to conservative therapy including medications and pelvic floor exercise. The American Society of Colon and Rectal Surgeons Clinical Practice Guideline for the Treatment of Fecal Incontinence states that biofeedback should be considered as an initial treatment for patients with incontinence and some preserved voluntary sphincter contraction. The American College of Gastroenterology guideline for the management of benign anorectal disorders states that pelvic floor rehabilitative techniques such as biofeedback are effective and superior to pelvic floor exercises alone in patients with fecal incontinence who do not respond to conservative measures. The medical literature supports the use of biofeedback as an effective therapy for fecal incontinence. Therefore, the requested biofeedback therapy is medically necessary 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 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 54-year-old male enrollee has requested emission tomography (PET) scan and associated laboratory testing performed for evaluation of his history of melanoma. Findings:  Two physician reviewers found that there is a lack of support for the services at issue in this clinical setting.  The documentation noted a history of melanoma, with no current signs or symptoms of metastatic disease.  Trotter and colleagues reported that in the absence of abnormal laboratory values, physical findings or clinical symptoms, routine PET scanning has an extremely low yield for detecting metastasis.  Buzaid and Gershenwald noted that imaging studies should be done if symptoms are present.  There is a lack of support for obtaining surveillance PET scans for the detection of asymptomatic occult tumor.  Therefore, the superior efficacy of the PET scan and associated laboratory testing has not been established.
Appeal type: Experimental/Investigational
Decision: Overturned

A female enrollee requested Afirma FNA Thyroid Analysis testing for medical evaluation of her thyroid nodule.  Findings:  Two physician reviewers found that in this case, the patient was facing total thyroidectomy if malignancy was present and only a subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis. The gene expression test done by Veracyte has demonstrated a very high negative predictive value for malignancy (Alexander, et al; Chudova, et al). The overall conclusions of the last two cited studies are that unnecessary thyroid surgeries may actually be prevented by implementation of the gene expression test. The studies are well conducted and their utility demonstrated in the medical literature. In this case, the Afirma test performed was clinically indicated and likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

A 61-year-old male enrollee has requested mental health inpatient care services for the treatment of his major depressive disorder with psychotic features. Findings:  The physician reviewer found that the patient was chronically depressed and anxious and was prescribed multiple medications. He presented with no clear safety risk or psychotic features as of the last authorized date of service. The patient could have safely been discharged. The records provided document that as of the first date in question the patient was less depressed, less anxious and had decreased somatic preoccupation.  His degree of depression did not warrant mental health inpatient care services on the dates in question. As such, these services were not medically indicated.