Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for gene panel testing. The enrollee is a pregnant female who underwent gene panel testing for autosomal recessive and X-linked genetic conditions.  The treating obstetrician indicated the test results would play a critical role in the enrollees decision to elect or decline an invasive diagnostic procedure, which presents a small risk of miscarriage, but would allow for prompt referral to appropriate specialists.  Findings: The physician reviewer found that  the enrollee was found to be a carrier for Usher syndrome, type IIA. Genetic counseling was provided, which included an explanation of the risks of having an affected child.  The father of the baby was then tested for Usher syndrome with negative results. The medical literature indicates clinical experience and information regarding the utility of expanded carrier panels is limited and currently under investigation An extensive joint statement in the medical literature specifies information related to criteria for conditions to be included on expanded carrier panels, recommendations related to interpretation of molecular findings, as well as needs for further data collection and research. They indicate the proper selection of appropriate disease-causing targets for general population-based carrier screening should be developed using clear criteria, rather that simply including as many disorders as possible. There is ongoing research regarding the role of expanded carrier panels and the impact on reproductive outcomes is expected to be available in the future when the panels are more focused and standardized. The conditions tested are intended to be significant, meaning that they cause a problem for a child.  Currently, however, expanded carrier screening is testing for a large number of conditions that do not meet these criteria. This enrollee has no personal or family history suggestive of an increased risk of a significant genetic disorder that would meet criteria for testing.  Expanded carrier panels are not currently the standard of care. Final Result: Three of the three reviewers determined that the requested services are not likely to be more beneficial than any other available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in Obstetrics and Gynecology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for fentanyl (Actiq) 600 mcg LPOP, quantity 90; fentanyl (Actiq) 400 mcg LPOP, quantity 90; fentanyl (Actiq) 400 mcg LPOP, quantity 60; fentanyl (Actiq) 200 mcg LPOP, quantity 60; and fentanyl (Actiq) 200 mcg LPOP, quantity 30. The Centers for Disease Control and Prevention (CDC) guidelines on opioid prescribing suggest comprehensive steps at all stages of opioid initiation, monitoring, continuation, and discontinuation. The CDC guidelines note clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patientBefore starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. The guidelines also note clinicians should evaluate benefits and harms of continued therapy with patients every three months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.This review focuses on a period of tapering treatment of opioid, rather than opioid maintenance. During the timeframe under review, opioid weaning took place for this patient who had been on long-acting morphine with fentanyl breakthrough for several years. Therefore, a weaning process off fentanyl would typically involve a slower course. The only alternative would have been for the patient to have undergone a detoxification process. Based on the records, a reduction of this high of dosage of Actiq on an outpatient basis as performed in this case was medically appropriate. Therefore, fentanyl (Actiq) 600 mcg LPOP, quantity 90; fentanyl (Actiq) 400 mcg LPOP, quantity 90; fentanyl (Actiq) 400 mcg LPOP, quantity 60; fentanyl (Actiq) 200 mcg LPOP, quantity 60; and fentanyl (Actiq) 200 mcg LPOP, quantity 30 were medically necessary for the treatment of this patient.Final Result: The reviewer determined that the medication at issue was 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 anesthesiology with sub-specialty certification in pain 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 Decision of Health Plan

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement of Decision Dx-Melanoma Gene Assay for a diagnosis of malignant melanoma. He saw a surgical oncologist for a lesion on his right leg that performed a biopsy of the skin of the right medial leg. Findings:The pathology report showed it was positive for malignant melanoma. DecisionDx testing was ordered and the report showed Class 1, Sub-class: 1A, which is associated with a low risk of recurrence within five years.  According to the medical literature, the DecisionDx-Melanoma test is a 31-gene panel assay used to determine the risk of recurrence and metastases of the melanoma. However, there is no definitive data regarding its use for risk classification in cutaneous melanoma and the test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy either as standard of care or in clinical trials. Gene subsets differ from study to study and prospective clinical trials testing the utility of these techniques have yet to be reported.  The test does not provide any additional benefit or information compared to the standard of care procedures. The literature indicates definitive assessment of the sensitivity and specificity of this test should be conducted in patients who are representative of the general primary melanoma patient population.  Guidance on interpretation of the results is of critical importance.Final Result: Three of the three reviewers determined that the requested service is not likely to be more beneficial than any available standard testing for treatment of the enrollees medical condition. Credentials/Qualifications: One reviewer is board certified in hematology and medical oncology; the second reviewer is board certified in surgical oncology; the third reviewer is board certified in 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 Decision of Health Plan

Nature of Statutory Criteria/ Case Summary: The enrollee requested the medication, OxyContin. She has a history of lumbar spondylolisthesis that causes back and radiating leg pain rated as ten out of ten. Findings:  The physician reviewer found that Her pain worsens with prolonged bending, standing, walking, coughing, and sneezing. She has taken narcotics and muscle relaxers, had physical therapy, chiropractic care, a spinal cord stimulator implantation, and steroids (both oral and epidural injections) for chronic pain. Spinal fusion surgery at the levels of L4-L5 and L5-S1 was performed.  Post-operatively, a patient controlled anesthesia (PCA) pump with Dilaudid for pain management and physical therapy were provided. The enrollee had excessive pain and could only stand at the side of the bed for physical therapy, so she remained on the PCA pump.  The next day her PCA pump was discontinued and she was given OxyContin twice per day with Percocet and Dilaudid injections, but still complained of pain, so Dilaudid every six hours was started.  The orthopedist indicated better pain control was needed and OxyContin every eight hours was added to the enrollees pain management regimen. The pain was much more tolerable and she was discharged with a prescription for ten days of OxyContin.   Her surgeon indicates the surgery was extensive and she needed a much more potent medication post-operatively, which was OxyContin. Review of the medical literature indicates postoperative opioid requirements will typically be greater and may be more difficult to control in patients with chronic pain. Assessment of the patients pain includes the nature and intensity of the pain, past and current treatments for the pain, any underlying or co-occurring disorders and conditions, and the effect of the pain on the patients physical and psychological functioning. The medical record indicates this enrollee does not simply have acute post-operative pain but has had chronic pain for years. Prior to surgery, she was chronically on narcotics, including Norco six/day and Butrans, an extended release medication.  Thus, it was appropriate to increase the strength of the opiates for worsening baseline chronic pain due to surgery. Final Result: The reviewer determined that the requested medication was medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified 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 similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/ Case Summary:  The enrollee requested coverage for the injection, onabotulinumtoxina, two units. Findings:  The physician reviewer found that the enrollee has a medical history of eustachian tube dysfunction, Ehlers-Danlos syndrome, and hypothyroidism. She is also diagnosed with fibromyalgia and temporomandibular joint (TMJ) pain. She currently uses a mouth guard, splint therapy, massage therapy, physical therapy, trigger point injections, acupuncture and cupping to address her TMJ pain. She was seen by an ear, nose and throat (ENT) specialist and saw an oral and maxillofacial surgeon, who recommended onabotulinumtoxina injections, two units, to treat her jaw pain. Most peer-reviewed literature in regard to the use of onabotulinumtoxina injections for TMJ consists of case reports and anecdotal reports on efficacy. There are no randomized controlled studies that report any benefit or any greater benefit than conventional treatments for managing TMJ or myofascial pain. A search of the results for controlled trials comparing botulinum toxin therapy (BTX) (onabotulinumtoxina) versus any alternative intervention or placebo concluded no consensus could be reached on the therapeutic benefit of botulinum toxin therapy on temporomandibular disorders. In light of this, it is not supported that onabotulinumtoxina would be efficacious in managing the enrollees TMJ pain. Final Result: Three of the three reviewers determined the requested treatment is not likely to be more beneficial than any other available standard treatments for the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in oral and maxillofacial 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for home infusions of Gammagard (human intravenous immune globulin) 40 grams every two (2) weeks. According to the practice parameters from the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology, this patients presentation is consistent with a primary antibody deficiency. The patient has evidence of hypogammaglobulinemia as well as recurrent sinusitis and pneumonia. The patients baseline total IgM and IgG are low and laboratory studies revealed low titers to polysaccharides. She has had other conditions which have required treatment that is known to deplete B-cells. In addition, the records document a failed response to a pneumonia vaccine. Given this patients hypogammaglobulinemia, low IgM, low B-cell numbers, and poor polysaccharide response, the patient meets the criteria for common variable immune deficiency (CVID). The medical literature supports a role for IVIG in this clinical setting. This patient continues to have infections despite monthly IVIG infusions at home. The guidelines support an increase in the IVIG interval to every two weeks to determine if there is a reduction in the frequency of infections. As noted by the provider, infusions at home will also help prevent the risk of the patient developing recurring infections involving the lung, which improved with IVIG at home. Therefore, the home infusions of Gammagard (human intravenous immune globulin) 40 grams every two (2) weeks are medically necessary for treatment of this patients CVID. 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 subspecialty certifications in allergy and immunology and rheumatology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for custom foot orthotic inserts. The current medical evidence supports the requested equipment in this clinical setting. Researchers concluded that the use of custom-made foot orthoses improved the level of forefoot pain in rheumatoid arthritis, hallux valgus and secondary metatarsalgia. This patient presents with severe foot pain and functional mobility limitations. Clinical examination findings and radiographic evidence are consistent with a pes planus deformity and hallux valgus. He has failed to improve with activity modification. The literature supports the use of custom orthotics in this clinical setting. Therefore, custom foot orthotic inserts are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested equipment 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 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A parent of an enrollee has requested authorization and coverage for private duty nursing services, including 40 hours per week of services with a licensed vocational nurse, 16 hours per week of services with a registered nurse, and one to two visits per certification period of registered nurse supervisory services.Dravet syndrome is a severe encephalopathy characterized by prolonged febrile and afebrile seizures starting some time in or after the first year of life. Prior to onset of seizures, infants are developmentally appropriate. The seizures frequently become treatment-resistant, and patients over time develop cognitive, motor, and behavioral delays. Most cases are caused by a mutation in the sodium channel gene SCN1A, although other genes have also been implicated in cases with similar presentations. Patients may manifest multiple types of seizures, including myoclonic seizures, absence seizures, and complex partial seizures. One of the key features of Dravet syndrome is fever sensitivity. Some patients may have seizures triggered by a hot bath, hot weather, or exercise. Photosensitivity may also occur. Treatment includes anticonvulsant medications and seizure prevention, when possible. Infection prevention and treatment of fevers is important, and prevention of overheating from weather and activity is also necessary. This patient has a number of skilled nursing needs. He is at risk for seizure activity, aspiration, hypoxia, skin breakdown, neurostorming with severe spasticity causing pain, and abdominal pain with vomiting from feeding intolerance. This patient requires constant monitoring and frequent interventions around-the-clock. The requested private duty nursing hours with registered nurse supervision are medically necessary and appropriate. Therefore, private duty nursing services, including 40 hours per week of services with a licensed vocational nurse, 16 hours per week of services with a registered nurse, and one to two visits per certification period of registered nurse supervisory services are 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 pediatrics with sub-specialty certification in pediatric 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: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for continued mental health inpatient level of care services and electroconvulsive therapy (ECT).Findings: Per the Centers for Disease Control and Prevention (CDC), this patient has multiple risk factors concerning for suicide including a family history of suicide and previous suicide attempts. In addition, he has a history of depression and substance abuse and he has endorsed feelings of hopelessness and isolation. The records indicate that ECT has improved the patients mood but that he remains at significant risk. The American Psychiatric Association (APA) guideline states that, measures such as hospitalization should be considered for patients who pose a serious threat of harm to themselves or others. Further, the APA noted that, ECT is recommended as a treatment of choice for patients with severe major depressive disorder that is not responsive to psychotherapeutic and/or pharmacological interventions, particularly in those who have significant functional impairment or have not responded to numerous medication trials. This patients illness is severe and he has failed multiple medication trials. As per Fink and colleagues, the rapid relief of severe depression, mania, and psychosis by ECT is accompanied by the rapid reduction in suicide drive. Given this patients ongoing suicide risk, he still meets criteria for inpatient hospitalization and treatment with ECT. Therefore, continued mental health inpatient level of care services and ECT provided was and is medically necessary for treatment of this patient. Final Result: The reviewer determined that the services at issue were and 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 psychiatry 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for whole exome sequence analysis testing.Findings:  Three physician reviewers found that the medical evidence supports the requested services in this case. This patients diagnosis has not been established, and he has multiple complex findings. Whole exome sequencing can be used to identify the underlying molecular basis of a genetic disorder in an affected individual. Whole exome sequencing may identify disease-associated genetic variants across a diverse spectrum of human diseases, which directly affects treatment. In sum, whole exome sequence analysis genetic testing is likely to be superior over other methods of evaluating this patient. Final Result: The reviewers determined that the requested services are 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 and 2 are board certified in clinical genetics and genomics and are actively practicing. Physician reviewer 3 is board certified in clinical biochemical genetics 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.