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

Summary Reviewer 1

A 27-year-old male enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and associated inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. American College of Gastroenterology guidelines for the management of reflux disease state that more evidence is needed before LINX can be recommended. Skubleny and colleagues concluded, aLong-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation.a Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention. Sheu and Rattner concluded, aThe long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined.a The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment. LINX has significant potential adverse effects and can be associated with poor outcomes. Therefore, LINX Reflux Management System (code 43284) and associated inpatient bed day is not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

The parent of a 12-year-old female enrollee has requested authorization and coverage for surgery (ApiFix procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that the ApiFix procedure is a less invasive procedure compared to the standard rodding and fusion of idiopathic adolescent scoliosis. The procedure consists of pedicle screw based instrumentation inserted around the apex of the main scoliotic curve. There is a ratchet mechanism that elongates the device with postoperative exercises, resulting in a gradual curve correction. There is no need for a fusion. In the reference by Floman and colleagues, three adolescent females aged 13-16 years with curves between 43-53 and Risser sign of 1-4 underwent surgery with ApiFix. Two pedicle screws were inserted around the curve apex and the ratchet device was attached to the screws. No fusion was performed. Two weeks after surgery, the patients were instructed to perform exercises to correct the curve. Curves were reduced and maintained between 22- 33. Patients were pain-free and were able to perform their spinal exercises. Postoperatively, the expected gradual elongation of the device was observed. No curve progression was seen. The curves corrected with exercise and growth modulation. No complications were observed. There is sufficient support for the requested services in this setting. Therefore, the requested surgery (ApiFix procedure) is likely to be more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 53-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided from 8/27/14 through 10/15/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found review of the submitted documentation and relevant literature demonstrates the medical necessity for the services at issue. Based on the documentation provided for review, the patient is a 53-year-old male with a newly recognized cardiomyopathy in the setting of rapid atrial fibrillation and syncope on 8/19/14. The cause of the syncope is not certain and may have been due to a sustained ventricular dysrhythmia in this setting. Therefore, protection against the possibility of recurrent syncope from ventricular tachycardia by placement of a defibrillator is indicated and considered standard accepted practice in the medical community (Russo, et al). Defibrillator placement was also recommended by the provider treating the patient at the time. However, defibrillator placement needed to be delayed both to see if the patients cardiomyopathy was reversible after cardioversion out of atrial flutter and because his INR was too high. During this period of delay it was reasonable and appropriate, to prescribe an external wearable defibrillator to help protect against recurrent syncope. A prophylactic wearable external defibrillator is indicated since accepted criteria for an implantable defibrillator were met (unexplained syncope in setting of severe cardiomyopathy) and placement of an implantable defibrillator needed to be significantly delayed. Therefore, the wearable cardioverter defibrillator provided from 8/27/14 through 10/15/14 was medically necessary for the treatment of the patients medical condition. For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 49-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of atrial septal defect. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found that based on the records provided, the patient is a 49-year-old male with a history of a cryptogenic renal infarction in 2015, migraine headaches and a patent foramen ovale.  Although there is an association with patent foramen ovale and both cryptogenic strokes and migraines, it is not clear that this patient's renal infarction was due to paradoxical embolization (no deep vein thrombosis identified) and current literature does not consistently demonstrate improved outcomes with patent foramen ovale closure compared to medical therapy.  A randomized prospective trial by Furlan and colleagues did not demonstrate relative benefit of patent foramen ovale closure compared to standard medical therapy. Therefore, at this time the use of percutaneous closure devices for treatment of a patent foramen ovale in the setting of a documented transient ischemic attack or cryptogenic stroke has not been established, except in specific circumstances where alternative therapies, such as when aspirin or warfarin are not tolerated, alternative therapies are contraindicated, alternative therapies have failed, or in a clinical trial. Given the medical literature cited above and the documentation submitted for review, the requested services are not likely to be more beneficial than any standard treatments for this patient medical condition. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 42-year-old female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this patients case.  In this clinical setting, measuring infliximab drug levels and antibodies to infliximab was appropriate. Although the reaction the patient had appeared to have been relatively mild, there is concern that with future infusions the severity of the reactions may escalate.  The testing performed was indicated in order to accurately measure antibody levels.  Thus, Anser IFX Assay testing was likely to have been more effective than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 61-year-old female enrollee has requested reimbursement for the monitored anesthesia care (MAC) services provide on 12/15/14 during a colonoscopy. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees colorectal screening.  The physician reviewer found that MAC is often utilized when it is important to have a dedicated anesthesiologist or anesthesia provider present during a particular diagnostic or therapeutic procedure. There are several indications for MAC including the patients clinical condition, comorbidities, past medical history, and the potential need to convert to a general anesthetic. MAC also includes the administration of other medications and agents necessary for patient safety and to support vital physiologic functioning. More than conscious sedation, MAC is characterized and defined by the anesthesiologists assessment and management of a patients actual or anticipated physiologic derangements or medical problems that may occur during a procedure. In this patients case, there was no documentation of a particular medical issue or comorbid disease process that would have required MAC services instead of conscious sedation. Typically it is appropriate to perform a screening colonoscopy with conscious sedation. During conscious sedation, a physician supervises or personally administers sedatives and/or analgesic medications during a diagnostic or therapeutic procedure. In this case, conscious sedation would have been appropriate. Thus, the MAC services provided on 12/15/14 were not medically necessary for evaluation of this patients medical condition. Given these above discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
 
The patient is a 44-year-old female who has been diagnosed with severe Raynauds with 
ulceration. The patient has requested authorization and coverage for Botox injectable 100 unit 
every 90 days for a year. The physician reviewer found that treatment of severe and refractory 
Raynauds disease must be individualized based on clinical findings, presentation, and other 
studies. As the presentation of the patient is advanced and rare, the literature has mainly case 
reports and small studies supporting the use of Botox for severe and ulcerating Raynauds 
disease, although more recently there have been larger clinical trials. Due to the patients low-
normal blood pressure, additional blood pressure agents (such as different calcium channel 
blockers) are contraindicated because of hypotensive risk. This patient has documented findings 
consistent with severe Raynauds disease, including digital ulceration of hands and toes. Recent 
literature supports the use of Botox for Raynauds syndrome for systemic sclerosis. In addition, a 
randomized controlled trial by Motegi and colleagues supported the efficacy of Botox for 
treatment of Raynauds disease and decrease in ulcerations. Given the refractory nature of the 
patients disease, the presence of ulcerations, which suggests potential loss of function if the 
disease continues, and support for use of Botox from clinical trials, there is sufficient support for 
Botox in this clinical setting. Therefore, Botox injectable 100 unit every 90 days for a year is 
medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 40-year-old female enrollee has requested authorization and coverage for posterior lumbar interbody fusion (PLIF) spinal surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. The physician reviewer found that evidence-based medical guidelines and peer-reviewed literature support lumbar fusion in the setting of disc pathology and degenerative disease when associated with evidence of spinal instability or surgically-induced temporary intraoperative instability, chronic pain, and failure of conservative treatment.  This patient reported a marked increase in her chronic low back pain and disability following a traumatic event in February 2016.  She has reported persistent and worsening low back pain with increasing levels of disability interfering with activities of daily living and work ability. Clinical findings are consistent with MRI and CT imaging evidence of nerve root compromise at the L4-5 and L5-S1 levels with bilateral pars defects at L5 and 4 mm lytic spondylolisthesis of L5 on S1. There was borderline instability documented at the L2-3 and L3-4 levels. Discogram confirmed concordant pain at the L4-5 level, with no concordant findings at L3-4. Detailed evidence of a recent, reasonable and/or comprehensive nonoperative treatment protocol trial and failure has been submitted. The treating provider has planned complete facetectomies and foraminotomies to achieve adequate nerve root decompression which would result in temporary intraoperative instability in the pre-existent setting of spondylolisthesis and pars defects, and necessitate fusion. Therefore, the requested PLIF spinal surgery is medically indicated for the treatment of this patient.  Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer

A 27-year-old female enrollee has requested authorization and coverage for Humatrope. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has been assessed with adult growth hormone deficiency.  A review of the record indicates that the enrollee has been diagnosed with adult growth hormone deficiency. The enrollee reported that she has been taking the growth hormone since the end of 2010. In a letter dated 9/6/17, the provider reported that the enrollee had a pre-treatment of insulin like growth factor-1 (IGF-1) of 184 ng/mL with a mean of 237 and a range of 87-368. The provider reported that the enrollee started her growth hormone stimulation to assess for growth hormone deficiency and peaked at 5.5 ng/mL. The record indicates that the enrollee had been diagnosed with Cushings syndrome in 2009. The enrollee has requested authorization and coverage for Humatrope.  The Health Insurer indicates that the requested medication is not medically necessary. Per the Health Insurer, the enrollee did not meet the Health Plans clinical criteria for the requested medication. Therefore, the Health Insurer denied coverage for the requested medication.  At issue is whether the requested medication is medically necessary for treatment of this enrollees medical condition.I have determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 38-year-old male enrollee has requested authorization and coverage for chemotherapy administration into the peritoneal cavity via indwelling port or catheter (hyperthermic intraperitoneal chemotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested services in this clinical setting.  The use of heated intraperitoneal chemotherapy for colon cancer with peritoneal carcinomatosis is not considered to be standard of care.  The current medical literature does not support the requested services in this patients case.  The National Comprehensive Cancer Network guidelines do not support hyperthermic intraperitoneal chemotherapy in this patients case.  Therefore, the requested hyperthermic intraperitoneal chemotherapy is not likely to be of greater benefit than other treatment modalities.  Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 12-year-old female who was seen by a pediatric endocrinologist on 12/14/20. Her height was 146.0 cm, which is below the 35th percentile or -0.41 standard deviations below the norm for age and gender. The patientas parent has requested authorization and coverage for Norditropin FlexPro 30 mg/3 mL. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. The records support poor growth, short stature relative to the mid-parental height and growth hormone deficiency. The records document deceleration from the 75th to the 50th percentile in height between 4 and 6 years of age, after which her height had gone down to the 50th percentile and stayed at the 50th until she was seen by the endocrinologist. On the day of visit, the patientas height was 146 cm (34th percentile). The mid-parental target height is 171.45 cm. Her predicted adult height is 62.75a, which is -2 standard deviations below the genetic mean height. She has failed an initial clonidine stimulation test as well as a second stimulation test. Brain MRI noted asmall appearing concave pituitary gland measuring up to 3.7 mm in maximal height.a Small pituitary gland can be seen in growth hormone deficiency and panhypopituitarism. Growth hormone therapy is medically indicates in this setting. Growth hormone deficiency was the first indication for recombinant human growth hormone approved by the U.S. Food and Drug Administration (FDA). In this case, the records document growth hormone deficiency upon performing the stimulation test. Therefore, Norditropin FlexPro 30 mg/3 mL is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 59-year-old male enrollee has requested authorization and coverage of Harvoni for 12 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found 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. The guidelines do not recommend deferring treatment in patients with illicit alcohol or drug use, and in fact prioritize patients who use intravenous drugs due to benefits in disease transmission reduction.  The patient should be considered treatment-naive because he failed interferon rather than PEG-interferon.  The guidelines recommend that non-cirrhotic treatment-naive patients, or those who failed PEG-interferon/ribavirin, should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For the reasons stated above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 46-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier testing performed on 9/6/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). The Afirma Gene Expression Classifier utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA 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 (Duick, et al). For these reasons, the Afirma Gene Expression Classifier testing performed on 9/6/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 49-year-old female enrollee has requested reimbursement for the arthrodesis, interbody fusion, discectomy, decompression and related services provided on 9/6/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees left arm pain and neck pain with cervical kyphotic deformity and grade 1 spondylolisthesis at C4-5.  The physician reviewer found that the available medical records document the presence of degenerative spondylolisthesis and associated radiculopathy and myelopathy. Thus, anterior cervical discectomy and fusion was medically necessary in the presence of extensive degenerative disc disease with degenerative spondylolisthesis and clinical evidence of radiculopathy and myelopathy. However, the currently available evidence is insufficient to support the use of mesenchymal stem cells in this procedure (Khashan, et al; McAnany, et al). Given these findings, the surgery including the C4-5 anterior cervical discectomy and fusion using interbody PEEK cage and allograft, C5-6 anterior cervical discectomy and fusion using interbody PEEK cage and allograft, and C6-7 anterior cervical discectomy and fusion using interbody PEEK cage and allograft, bilateral foraminotomies at C4-5, C5-6, and C6-7, and placement of anterior cervical plate at C4-7 using NuVasive system, fluoroscopic guidance, and reduction of kyphotic deformity was appropriate, reasonable, and medically necessary, and the stem cell portion of the procedure of 9/6/16 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.