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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for bioidentical hormone pellet therapy. Findings:  The physician reviewer found that there is a lack of evidence in current medical literature on the efficacy, safety, or adverse effects of bioidentical hormone pellet therapy, which are custom-compounded, multihormone regimens with dose adjustments based upon serial hormone monitoring. Pinkerton and Constantine note that more research on the efficacy, safety, and consistency of compounded hormone therapy that is not approved by the U.S. Food and Drug Administration (FDA) for treatment of menopausal symptoms is needed. The Endocrine Society reports that there is no rationale for routine prescribing of unregulated, untested, and potentially harmful custom-compounded bioidentical hormone therapies. In this case, the requested medication is not likely to be more beneficial than traditional hormone replacement therapy or conservative measures. Therefore, bioidentical hormone pellet therapy is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested (bioidentical hormone pellet therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested medication 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: Physician reviewers 1, 2, and 3 are board certified in obstetrics and gynecology 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 patient has requested authorization and coverage for selective internal radiotherapy (SIRT) using Yttrium-90 radioembolization therapy. Patients with breast cancer with liver metastases are candidates for treatment with radioembolization, which has been shown to improve patient health outcomes. The current peer-reviewed literature suggests that radioembolization may be associated with a greater response than chemotherapy in this clinical setting. Further, guidelines endorse the use of radioembolization therapy for treatment of this patients breast cancer with liver metastases . The medical records indicate this patient does not have any documented contraindication to the requested treatment. All told, SIRT using Yttrium-90 radioembolization spheres is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy is considered likely to be more beneficial than any available standard therapy.Final Result: Two of the three reviewers determined that the requested services are 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:  One reviewer is board certified in radiation oncology and is actively practicing. One Reviewer is board certified in radiation oncology and is actively practicing.  One Reviewer is board certified in radiation oncology 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: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Brand name Topamax. A retrospective study by Lang and colleagues observed that in previously seizure-free patients, switching the manufacturer of antiepileptic drug (AED) therapy was associated with a higher risk for seizure recurrence. The authors concluded that it is prudent to avoid switching the manufacturer of anticonvulsants in seizure-free patients. In a review of the evidence for and against switching AED therapy, Studies noted that, Patients with highly labile seizure control or optimal seizure control (i.e. seizure-free or their seizure frequency has been markedly reduced) should not be switched to generics and should be maintained on their usual brand version for their AED therapy. In this case, the patients seizures were controlled on brand name Topamax. The provider reported that the patient experienced an increase in the frequency of auras and side effects on the generic formulation of Topamax. Based on the current medical literature, it is advised that patients should not be switched to the generic formulation when a patients seizures have been controlled on a brand name medication. For these reasons, the requested brand name Topamax is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested brand name 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 neurology 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 right knee hyaluronan or derivative (Hyalgan, Supartz or Visco-3) for intra-articular injections. Evidence from systematic reviews and randomized controlled trials indicate that although viscosupplementation may relieve knee pain in some patients with osteoarthritis, data has not established which patients will benefit. Guidelines from the American Academy of Orthopedic Surgeons (AAOS) indicate that the data on safety and efficacy of viscosupplementation remain inconclusive. As such, the AAOS does not currently recommend viscosupplementation as routine treatment for osteoarthritis of the knees. Viscosupplementation is reserved for patients with a history of lasting benefit from prior injections and in cases where the remaining options are limited. In this case, the patients records include documentation of excellent lasting relief from prior viscosupplementation. Furthermore, cortisone injections and other conservative measures have not been effective. Given these findings, the requested right knee hyaluronan or derivative (Hyalgan, Supartz or Visco-3) for intra-articular injections weekly for three doses are medically necessary for 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 orthopedic 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50-100 mg one tablet daily for 16 weeks. 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 recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naive genotype 1a patients should be treated with regimens including Zepatier with ribavirin for 16 weeks when nonstructural protein NS5A resistance is present. When NS5A resistance is present, Zepatier and ribavirin for 16 weeks is recommended by the guidelines, based on a 100% cure rate in the C-EDGE TE trial.  In this patients case, the specific M28 mutation found is known to result in lower efficacy of Zepatier. Therefore, 16 weeks of Zepatier with ribavirin would be indicated. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment . For these reasons, Zepatier 50-100 mg one tablet daily for 16 weeks is medically necessary for the treatment of this patients hepatitis C infection.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The parents of a 26-year-old male enrollee have requested inpatient rehabilitation therapy (including physical therapy, occupational therapy and speech therapy) for the treatment of the enrollees traumatic brain injury. Findings:  The physician reviewer found that the patient currently is not cognitively appropriate for an admission to the Sharp Rehabilitation Facility. The patient is not responsive to pain, is unable to track objects and inconsistently responds to commands. The patient and his family should be given optimal training for home care. The patient should be given reconsideration for admission to the Sharp Rehab Facility if he shows sufficient cognitive improvement.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma Gene Expression Classifier testing for evaluation of the enrollees thyroid nodule. Findings:  Three physician reviewers found that while a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate.  Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign.  The Afirma Gene Expression Classifier test utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on fine needle aspiration biopsy, thereby decreasing the need for unnecessary surgeries.  Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. Final Result: Three 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: All three physician reviewers are board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism 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 16-year-old female enrollee has requested for residential treatment for treatment of the enrollees behavioral health issues.  Findings:  The physician reviewer found that applying the American Psychiatric Association (APA) treatment guidelines for residential treatment the patient meets the criteria for residential level of care during the period under review as she was unsafe to adequately care for her self within the community. Moreover, the patient reportedly experienced a disturbance in mood resulting in behavior that could not be safely managed in a less restrictive setting. Given the patients imminent risk of deterioration in functioning due to the presence of severe multiple and complex psychosocial stressors, treatment in a supervised 24-hour controlled setting was clinically indicated.
Appeal type: Medical Necessity
Decision: Upheld

A 38-year-old female enrollee requested authorization and coverage of a total vaginal hysterectomy. The Health Plan has denied the request indicating that the requested procedure is not medically necessary for treatment of the enrollees pelvic pain.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

An enrollee has requested authorization and coverage for hypoglossal nerve stimulation device. There is evidence to establish that implantation of a hypoglossal nerve stimulation device results in improved health outcomes for patients with OSA. Currently, patients with a positive OSA diagnosis, CPAP failure or intolerance, a BMI less than 32 kg/m2, and favorable palatal collapse are considered for hypoglossal nerve stimulation. Medical literature shows that patients achieve a benefit from the implantation and electrical stimulation of the hypoglossal nerve for treatment of OSA. This patient meets the clinical criteria for surgical management of his OSA symptoms with the requested procedure. He has undergone a drug induced sleep evaluation documenting the location of obstruction with anteroposterior collapse at the tongue base. The patient has narrowing of the hypopharyngeal and anteroposterior palatal airway on sleep endoscopy. Given these findings, the requested hypoglossal nerve stimulation device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested hypoglossal nerve stimulation device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are 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: Physician reviewers 1 and 2 are board certified in otolaryngology and are actively practicing. Physician reviewer 3 is board certified in internal medicine and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for continued group speech therapy for treatment of the enrollees autism spectrum disorder. Findings:  The physician reviewer found that review of the submitted documentation demonstrates the medical necessity of continued group speech therapy. Based on the documentation submitted for review, the patient has difficulties with social skills in the home and school setting. The testing performed did not evaluate his skills in a social setting. In this clinical setting, group speech therapy is medically necessary to address his pragmatic speech problems that stem from the patients autism. All told, continued group speech therapy has been established as medically necessary for treatment of the patients medical condition. 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 physician reviewer is board certified in pediatrics with sub-specialty certification in developmental and 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.
Appeal type: Experimental/Investigational
Decision: Upheld

A 41-year-old female enrollee requested the LINX procedure for medical treatment of her gastroesophageal reflux disease.  Findings:  Three physician reviewers found that in this patients case, the requested services are not likely to be of greater benefit than other treatment options.  The LINX procedure may be beneficial for select patients with gastroesophageal reflux disease symptoms despite maximal medical therapy.  However, there is a lack of support for the requested services in this clinical setting.  Per the submitted documentation, this patients gastroesophageal reflux disease symptoms do not correlate with her reflux episodes.  Therefore, her symptoms may be more functional in nature, and the LINX procedure is not likely to be beneficial.  All told, the superior efficacy of the requested LINX procedure has not been established.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a 16-year-old female has requested coverage for labiaplasty for treatment of her stated condition of hypertrophied labia.  Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested procedure.  It appears as if the patient has slight prominence of her labia minora or labia majora tissues, depending on which note is reviewed.  Photographs were not submitted for review. Upon presenting for a second opinion, the provider noted that this appeared to be a normal anatomical variant. Lloyd and colleagues described a study where measurements were taken from a number of females.   A wide range of normal anatomy was noted.  The authors noted that although previous work has defined the labia minora as hypertrophic and thus deserving of corrective surgery if the maximum distance from the base to edge was greater than 4 cm, they found that labia minora dimensions displayed much greater variation.  In this patients case, the provider submitted a note with measurements.  However, the note does not clarify whether the provider is describing the labia majora or labia minora, and interpretation of labial anatomy requires information regarding relative size.  There is inconsistency in the records as to which labial structures are allegedly hypertrophied.  The provider has reported that the patient has been struggling physically and emotionally for two years with issues related to her hypertrophied labia.  However, the prior medical records do not support this.  In this patients case, the requested procedure is not medically necessary.  Additionally, the alleged hypertrophied labia do not constitute an abnormal structure of the body.  The dimensions noted do not rise to the level that the literature suggests is the threshold at which labial reduction surgery may be contemplated.   All told, the requested labiaplasty is not reconstructive in nature and is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 47-year-old female with a multiple year history of progressive fatigue, weakness, and malaise. In addition, the patient has a prior history of hot thyroid nodule treated with radioiodine ablation with resultant hypothyroidism. She is currently over medicated with thyroid hormone replacement as evidenced by suppressed thyroid stimulating hormone. She has had multiple tests performed without definitive diagnosis. She has had less than adequate growth hormone stimulation testing but with resultant normal values that have been interpreted by her physicians as inadequate. The patients provider has recommended a six to twelve month trial of growth hormone, which the Health Plan has denied.The Health Plans denial should be upheld. The growth hormone stimulation test used is inaccurate. Thus, it appears there has been much misinterpretation of the hormone data. The thyroid test results indicate over-medication not pituitary hypofunction. Low estradiol and testosterone are expected in a post-menopausal woman (as indicated by her markedly elevated follicle-stimulating hormone (FSH) results). The high FSH level indicates normal pituitary gonadotropin function for a post-menopausal woman. Her bone density is average for her age though it is concerning that she lost spine and hip density from one measurement to the next. This may be due to her early (but not premature) menopause. It is not noted when she started and for how long she took Fosamax and its timing related to the bone mineral densities. Furthermore, the multiple random cortisol and ACTH tests are meaningless due to the moment-by-moment variations of these hormones. No measure of 24-hour urine free cortisol, the gold standard, is noted.Based upon the information set forth above, I have determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

A 35-year-old female enrollee has requested coverage for rituximab for treatment of her neuromyelitis optica.  Findings:  Two physician reviewers found that she has relapsing-remitting multiple sclerosis and neuromyelitis optica.  As a result of her disease, the patient has experienced weakness, and she has had multiple severe relapses requiring ventilator support.  The patient has failed therapy with Avonex and Tysabri.  Her provider has recommended rituximab. There is adequate support in the medical literature for the use of rituximab for the treatment of neuromyelitis optica.  In this patients case, she has documented neuromyelitis optica and multiple sclerosis.  In this clinical situation, the requested therapy is likely to be of greater benefit than other available treatment alternatives. Undertreated or untreated multiple sclerosis and neuromyelitis optica could lead to severe disability.  The current medical evidence supports the use of rituximab in this patients case.