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

Physician 1: The patient is a 46-year-old male with degenerative disc disease. He has had a positive discogram at L4-5 and L5-S1. His provider believes the L5-S1 disc is responsible for the patients pain and is recommending artificial disc replacement with the Charite disc. The Health Plan considers this procedure experimental. The Health Plan is correct that the proposed procedure is considered experimental. There is no evidence to support disc replacement surgery for this patient. The proposed procedure is still under investigation and is not considered standard of care. The long-term success rate and safety profile remain unknown. Because there is no evidence supporting the long-term safety and efficacy of the proposed procedure, I have determined the requested procedure 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. Physician 2: The patient is a 46-year-old male with degenerative disc disease. He is seeking authorization for artificial disc replacement utilizing the Charite disc. The Health Plan has denied this request because it considers artificial disc replacement experimental.The current clinical evidence regarding the Charite III disc has allowed for Food and Drug Administration (FDA) approval that it is not inferior compared to fusion. Similarly, current studies appear to indicate it is not worse than fusion. Additional claims of efficacy are based upon a small number of short-term, non-randomized studies. A 300-patient FDA regulated investigational device exemption trial with long-term follow-up is underway. Without the results of this trial the Charite III disc replacement remains experimental. Furthermore, it is not established as superior to fusion. Therefore, I have determined the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 3: The patient is a 46-year-old male with degenerative disc disease with involvement at L4-5 and L5-S1. The patient has undergone IDET and obtained no relief. He is requesting authorization for artificial disc replacement at L5-S1. The Health Plan has denied authorization for the requested procedure. The proposed procedure is experimental without established long-term efficacy. The best published results reveal outcomes equivalent to fusion. However, the majority of studies show a failure rate of 35%. Furthermore, the long-term safety profile is unknown. In addition, there are other treatments available. For these reasons I have determined the requested procedure 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.
Appeal type: Medical Necessity
Decision: Overturned

A male enrollee requested Harvoni 90/400 mg for 12 weeks for medical treatment of his hepatitis C virus.  Findings:  Two physician reviewers found that according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for testing, managing, and treating hepatitis C, patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. Food and Drug Administration approved antiviral therapy regardless of fibrosis score. Therefore, this patient should be approved for Harvoni for 12 weeks in attempt to eradicate HCV infection and prevent further progression of fibrosis in the future and potential complications of advanced liver disease such as liver failure and hepatocellular carcinoma, and extrahepatic complications of HCV such as renal disease, diabetes, vasculitis and lymphoma. For the reasons provided, the request for Harvoni 90/400 mg for 12 weeks is medically necessary for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 23-year-old male enrollee has requested for out-of-network inpatient chemical dependency program treatment for treatment of his opioid drug addiction.   Findings:  The physician reviewer found that there is no convincing evidence here to mandate a medical necessary inpatient program, particularly out-of-network. There is no evidence of sufficient medical or acute psychiatric risk factors to require inpatient care.
Appeal type: Medical Necessity
Decision: Upheld

A 25-year-old male enrollee has requested chemical dependency residential treatment center (RTC) services for his polysubstance abuse.  Findings:  The physician reviewer found that according to the American Society of Addiction Medicine (ASAM) guidelines, this patient does not meet the criteria for substance abuse residential treatment level of care services. The patient is not currently demonstrating suicidal ideation, he does not have biomedical complications, and he is willing to accept treatment. There is no indication in the records provided for review that he requires the intensity of medical treatment and supervision provided at the RTC level of care. For these reasons, the requested services are not medically necessary for treatment of this patients medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene testing (fetal DNA testing for aneuploidy and sex determination) performed for evaluation of her pregnancy. Findings:  The physician reviewers found that the submitted documentation supports a portion of the services at issue.  Chromosomal abnormalities (aneuploidies) occur at an increased rate in women over 35 years of age, but can and do occur in younger women.  Various tests are available, but NIPT testing is now becoming routine even for women under age 35.  In this case, fetal DNA testing for aneuploidy and sex determination was performed. Per the medical evidence, the detection rates are lower and false-positive and failure rates are higher for sex chromosome abnormalities than for the autosomal aneuploidies. In this patients case, fetal DNA testing for aneuploidy was likely to have been more efficacious than other methods of evaluation. However, the superior efficacy of fetal DNA testing for sex determination has not been established. Final Result: The reviewers determined that a portion of the services 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 partially overturned. Credentials/Qualifications: Reviewers 1, 2, and 3 are board certified in obstetrics and gynecology 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: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested residential treatment for the enrollees behavioral health condition. Findings: The physician reviewer found that in this clinical setting, the services at issue were not medically necessary for the treatment of this patient. The patient was admitted with a Clinical Institute Withdrawal Assessment (CIWA) of 19. His vital signs were normal. The records also reflect that the patients maintenance dose of Ativan was within the range of what is used clinically for some anxiety disorders.  On admission, he was not suicidal or homicidal. He was medically stable.  Despite his self-ratings of 10/10 for most of his symptomatic features, it should be noted that the complications of his treatment were iatrogenic in nature. The patient was placed on a complicated medication regimen relative to a benzodiazepine withdrawal.  This same process could have been conducted on a daily outpatient basis with a compliant patient who was well informed, such as this patient. The records do not indicate that this patient received treatment at a lower level of care. There was no clinical evidence to indicate that this patient had biomedical complications, insight or learning deficits, or an unstable recovery environment that required 24 hour nursing or medical supervision.  Moreover, his course of treatment was not complicated by overwhelming or untreated psychiatric conditions. As such, he did not require 24 hour nursing and medical supervision at residential level of care. Therefore, the residential treatment center services were not medically necessary for treatment of this patient.Final Result: The reviewer determined that the services at issue were 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 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

A 59-year-old female has requested a sinus endoscopy with balloon dilatation for treatment of her chronic sinusitis.  Findings:  Two physician reviewers found that the patient has chronic maxillary and frontal pain. She has been treated with nasal steroids and antibiotics. In the peer-reviewed medical literature, Levine and Rabago concluded that although randomized controlled trials comparing balloon sinuplasty with conventional functional endoscopic sinus surgery have not been conducted, existing prospective and retrospective assessments suggest that balloon sinuplasty is a viable option for sinus intervention, either alone or in combination with conventional surgical treatment. While no randomized clinical trials comparing balloon sinuplasty to functional endoscopic sinus surgery have been performed, the procedure is considered equivalent by many experts in the treatment of patients with mild disease of the frontal and maxillary sinuses (Stewart and Vaughan). For these reasons, balloon sinuplasty should be approved in this patient as she has failed standard medical therapy and she has mild disease for which the requested procedure is likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested coverage for the medication Relizorb cartridges (immobilized lipase). The enrollee has cystic fibrosis and pancreatic insufficiency. He underwent a bilateral lung transplant with two episodes of transplant rejection in June 2017 and March 2019. His physician prescribed the medication Relizorb cartridges (immobilized lipase). The physician reports this medication will ensure proper nutrient intake and digestion of fats, and maintain adequate energy and protein stores. The physician reports this is necessary for his immune responses and to improve graft survival rate. This particular patient would benefit from the use of Relizorb during her nighttime tube feeds. The use of Relizorb is approved by the Food and Drug Administration (FDA) in children and is supported by studies to be safe and effective thereby elevating the use of this device to standard of care. Therefore, the medication Relizorb cartridges (immobilized lipase) is medically necessary to treat the patients medical condition. Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition.Credentials/Qualifications: The physician reviewer is board certified in pediatric 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 similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the spinal muscular atrophy (SMA) carrier testing. Findings:  Three physician reviewers found that recently, genetic carrier screening before and/or during pregnancy for certain genetic disorders has become an integral part of patient care. According to the American College of Obstetricians and Gynecologists (ACOG), screening for spinal muscular atrophy should be provided to all women who are considering pregnancy or are currently pregnant. The ACOG noted that spinal muscular atrophy in an autosomal recessive disease characterized by degeneration of spinal cord motor neurons that leads to atrophy of skeletal muscle and overall weakness. Due to the severity and relatively high carrier frequency, carrier screening for spinal muscular atrophy in the general prenatal population is warranted. On the basis of the current ACOG recommendations, the spinal muscular atrophy (SMA) carrier testing was likely to be more beneficial for evaluation of the patients condition than any available standard therapy.Findings:  Three physician reviewers found the spinal muscular atrophy (SMA) carrier testing was likely to be more beneficial for evaluation of the patients condition than any available standard therapy.Final Result: The reviewers determined that the spinal muscular atrophy (SMA) carrier testing was likely to be more beneficial for evaluation of the patients condition than any available standard therapy.Credentials/Qualifications: Physician reviewers 1 and 2 are board certified in obstetrics and gynecology and are actively practicing. Physician reviewer 3 is board certified in obstetrics and gynecology with subspecialty certification in maternal and fetal 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

A 21-year-old male enrollee has requested Subutex, 8 mg (30 tablets per month) for treatment of his opioid dependence in remission.  Findings:  The physician reviewer found that a review of the literature shows that buprenorphine-naloxone (Suboxone) and buprenorphine (Subutex) are effective in the treatment of patients with opioid substance addictions. Based on the available literature, it appears that buprenorphine, buprenorphine-naloxone, and methadone are similarly efficacious for the treatment of opioid-dependent patients (Boothby and Doerin). Similarly, Ling and colleagues found that, Strong evidence of buprenorphines therapeutic efficacy was demonstrated in clinical trials involving several thousand opioid-dependent participants, and in 2002, the Food and Drug Administration approved buprenorphine for the treatment of opioid dependence. Thus, there exists support for the efficacy of Subutex in the treatment of patients with opioid dependence. With regard to this patient, he presents with a history of opioid dependence secondary to pain related to bilateral knee problems. The patients initial evaluation states that, At this point, patient feels that his opioid abuse is in remission and the Suboxone is working well. Overall, it appears that the patient benefitted from the use of Subutex and the medication enabled the patient to be treated on an outpatient basis. Thus, despite the denial by the Health Plan the two prescriptions of Subutex should be reimbursed as they have been proven medically necessary for management of this patients medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for DecisionDx-UM genetic testing. There is solid scientific evidence in current medical literature that genetic testing of uveal melanoma tumor can stratify the tumors into high-risk and low-risk for systemic metastasis. Researchers found that gene expression profiling provides a highly accurate and biologically informative gold standard for molecular prognostication. The authors further note that molecular prognostic testing and enrollment of high-risk patients into clinical trials of targeted molecular therapy are rapidly becoming the standard of care in the management of uveal melanoma. It is clear that the service at issue is part of standard management in this clinical setting, and most of the leading centers and ophthalmologists caring for patients with uveal melanoma routinely use and offer this test to their patients. The results from such testing determine how closely to monitor and screen these patients for metastasis, and there is no doubt that having this risk information allows for a reduction in the frequency of screening for those in the low-risk category. The results of such testing provide critical prognostic information that would not be available otherwise, and while the results may not alter the course of the disease in cases where there is no adjuvant therapy currently available, such therapies may be available in the future. In the case of uveal melanoma, there may be limited chances to obtain this genetic information from the tumor, generally at the beginning of therapy, or much later if there is metastasis. When the patient undergoes radiation plaque therapy, the primary tumor will no longer be available to biopsy for this information. Therefore, DecisionDx-UM genetic testing was likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.Final Result: The reviewers determined that the service at issue were likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in ophthalmology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 69-year-old male enrollee has requested a crown (full cast, high noble metal, tooth number 2) for treatment of his dental condition. Findings:  The physician reviewer found that the submitted documentation supports the dental necessity of the services at issue.  Teeth with fractures often cause pain when forces are placed upon them.  The relief of pain provided by a provisional restoration indicates that a crown will be successful in alleviating these symptoms.  This patients symptoms resolved following placement of a provisional crown.  Given the documented clinical history, the crown (full cast, high noble metal, tooth number 2) was dentally necessary for the treatment of this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

A 50-year-old female enrollee requested Prolia (denosumab) injections for medical treatment of her osteoporosis.  Findings:  Two physician reviewers found that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the patient has severe osteoporosis at a young age. She tried bisphosphonates, which is the first line therapy for osteoporosis, and was intolerant. According to Rosen, Prolia may be used for treatment of patients with severe osteoporosis and a history of fracture. This patient has a history of fractures and is intolerant to bisphosphonates. Therefore, Prolia is likely to be a more beneficial for treatment of the patients osteoporosis than standard medical therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

A 76-year-old male enrollee has requested X-Stop surgery for treatment of his spinal stenosis.  Findings:  Three physician reviewers found that the X-Stop procedure has been granted marketing approval by the FDA; however, the FDA has required a post marketing approval study for seven years to determine its long-term safety and effectiveness. This study is currently underway and has not been reported or concluded, with a closing date of 11/21/12. The study reported by Kondrashov, et al. reported on only a small number of patients, over a short period of time, and therefore the results of this study cannot be generalized to a large population. There is insufficient evidence of any long-term benefits with the use of X-Stop (Chou and colleagues). Additionally, other studies demonstrated concern regarding the safety of this product, noting a high complication and failure rate. Thus, based on the literature published to date, there is a lack of high-quality data from large, randomized, well-controlled studies supporting the use of X-Stop in this clinical setting.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for Remicade infusions at a hospital-based outpatient infusion facility with ultrasound-guided placement of intravenous (IV) lines every four weeks. Reliable IV access is required for administration of Remicade. This patient has responded well to Remicade and he has been in clinical remission. However, the patients providers have had difficulty in obtaining IV access on multiple occasions. Gupta and colleagues reported that over 40% of patients receiving Remicade require hospital-based infusions. In patients with challenging IV access, the success of IV placement can be improved or enhanced with the use of ultrasound guidance. This patient is in remission on his current dosing regimen of Remicade. Thus, he should continue with this regimen. However, given his documented poor IV access, it is appropriate for him to receive Remicade at a hospital-based infusion center with specialists trained with ultrasound assistance for IV placement. Given these findings, the requested Remicade infusions at a hospital-based outpatient infusion facility with ultrasound-guided placement of IV lines every four weeks is medically necessary for 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 subspecialty certification in pediatric 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: Overturned

The parent of a six-year-old female has requested speech therapy for treatment of her autism. Findings:  The physician reviewer found that upon review of the patients evaluation and progress notes, the requested speech therapy is medically necessary for treatment of this patients autism spectrum disorder (ASD) and severe expressive and receptive language delays with socialization deficits. In the medical literature, the authors agree that language deficits are one of the core aspects of ASD, for which speech therapy provides professional help and guidance on communication development (Volmar and Weisner). The authors noted that language skills make a significant difference in the ability of children to control their environment. Given the support provided in the scientific data, ongoing speech therapy is a medically necessary component of the treatment plan for this patient with ASD and should be approved.