Persius/imr-appeals huggingface dataset:
Summary Reviewer 1


A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).   The physician reviewer found according to peer-reviewed published literature, there is only one lower esophageal sphincter (LES) augmentation device designed for the treatment of GERD at this time.  The LINX device has been approved for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. Two post-approval studies are designed to evaluate the long-term effectiveness of the device and incidence of adverse events; however, comparative studies with other anti-reflux surgeries are still needed. While there is some medical literature in support of the use of the LINX device for patients with GERD, appropriate patient selection is crucial before anti-reflux procedures. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. In this patients case, the records reflect that he has undergone much of this pre-operative assessment and that he has GERD based on pH recording. However, neither his radiographic studies in 2011 nor 2015 evidenced gastroesophageal reflux. As such, he cannot be considered medically refractory given the intermittency of documented reflux. Also, implantation of LINX in this clinical setting must be approached with caution given the patients charted complaint of dysphagia.  As such, the LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is 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.
Summary Reviewer 

A 30-year-old male enrollee has requested reimbursement for substance use residential treatment provided from 7/04/18 through 7/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. The patients abuse of alcohol was impairing his daily routine and contributing to significant impairment across multiple domains of functionality. As such, specialty care was indicated. However, the patient completed an uncomplicated detoxification.  He was maintaining sobriety and was motivated for recovery. His girlfriend was supportive. He had safe housing. Despite his comorbid obsessive-compulsive disorder, the patient did not have a psychiatric condition or medical illness that required placement at the residential level of care. Further, the patient had no history of chemical dependency treatment, such as sponsored community programming, outpatient counseling, anti-craving medication, intensive outpatient services, partial hospitalization or placement in a sober living environment.  This is significant in this case for two reasons. First, modern psychiatric practice favors treatment in the community, as outcome measures and therapeutic gains are optimized in this environment. Second, there was no evidence to suggest that similarly comprehensive, evidence-based services provided a less restrictive treatment setting for this stable, motivated and otherwise healthy patient would have been insufficient or inadequate at the time. With that said, discharge on a federal holiday would have incurred a needless gap in treatment and thus would have been inappropriate. The extra day also afforded opportunity to address his severe craving, as it appears that acamprosate was added the following day. On 7/05/18, the patients craving was mild. There was no mention of medication intolerability or non-adherence. His appearance was appropriate, and he had no impairment in memory, concentration or thought processing. In sum, the patient had improved with the treatment intervention. He was autonomous and was maintaining motivation for sobriety. Further, he had not failed a less restrictive treatment course during the episode of illness. As such, the substance abuse residential treatment services at issue were no longer medically necessary as of 7/05/18. Thus, substance use residential treatment provided on 7/04/18 was medically necessary, but not thereafter. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
Summary Reviewer 

A 41-year-old male enrollee has requested authorization and coverage for rituximab injections 100 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pretibial myxedema. The physician reviewer found that the use of rituximab for ocular related findings associated with Graves disease is supported by peer-reviewed medical literature. However, there is a paucity of large, controlled studies demonstrating the safety and efficacy of rituximab for treatment of pretibial myxedema (Heyes, et al; Ferreira-Hermosillo, et al). As this patient does not have any documented ocular related findings associated with Graves disease, the requested rituximab injections 100 mg are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Summary  
The patient is a 53-year-old female with a history of primary melanoma of the cervix with an 
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider 
reported that the patient was diagnosed in April 2022. The records noted that the patient had 
undergone initial treatment with four cycles of ipilimumab with nivolumab. The Health Insurer 
has denied the requested medication as not medically necessary. This denial is the subject of this 
appeal and determination. The physician reviewer found that the records document that this patient 
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B 
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa. Per 
the  National  Comprehensive  Cancer  Network  (NCCN)  guidelines  for  melanoma,  mucosal 
melanoma should be treated as diseases distinct from cutaneous melanoma, with care tailored to 
the individual patient. The U.S. Food and Drug Administration (FDA) has approved Tukysa for 
the treatment of patients with HER2 positive breast cancer or HER2 positive colon cancer, to be 
taken in combination with other agents. However, there is a lack of FDA approved indication or 
support for use of Tukysa for use as monotherapy in the treatment of this patients cancer. Strickler 
and colleagues reported that studies are ongoing to evaluate the efficacy of Tukysa as monotherapy 
and to validate the reported findings from their trial. Overall, there is a lack of data to suggest that 
Tukysa as single agent therapy is safe and effective in this patients clinical setting. All told, the 
requested Tukysa (tucatinib) 150 mg #120/30 days is not medically necessary for treatment of this 
patient.
Summary Reviewer 1

The patient is a 46-year-old female with severe cervical spondylosis with progressive involvement of C5-6 and C6-7 levels and associated radiculopathy. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational. Cervical disc arthroplasty has been approved by the US Food and Drug Administration (FDA) and has been demonstrated preserve some motion and provide decreased incidence of adjacent level disease when compared with anterior cervical discectomy and fusion. The need for revision surgery is also less than anterior cervical discectomy and fusion (Gao, et al; Wu, et al; Radcliff, et al). For these reasons, the cervical artificial discectomy performed on 4/13/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the surgery at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Summary Reviewer 

The patient is a 49-year-old male with a history of chronic low back pain. On 7/30/20, the records noted that the patient has a displaced lumbar disc and left lumbar radiculitis. The physician reviewer found that the 2019 American Society of Interventional Pain Physicians (ASIPP) guidelines for use of sedation during routine pain management injections states, aGiven that patients undergoing pain procedures typically are anxious and in pain, mild to moderate sedation is acceptable for many patients.a The guidelines further state, aDeeper sedation should only be undertaken in the presence of anesthesia providers and for patients who have high anxiety, complex pharmacotherapy, or a low pain threshold when undergoing more painful interventional pain procedures. In special cases, the risk of patient movement during a procedure resulting in potential inadvertent injury may justify a deeper anesthetic state.a
The American Society of Anesthesiologists also published a statement regarding the use of sedation for pain management injections and concluded, aSignificant anxiety may be an indication for moderate (conscious) sedation or anesthesia services. In addition, procedures that require the patient to remain motionless for a prolonged period of time and/or remain in a painful position may require sedation or anesthesia services.a
In this case, the patient has a confirmed diagnosis of generalized anxiety disorder for which he is receiving medical treatment. The provider notes stated that the patient would undergo a lumbar epidural steroid injection but would require sedation because of a fear of needles. There is documentation from 2/16/18 showing that the patient suffered a severe case of vasovagal response during a lumbar medial branch block that was completed under local anesthetic only. He has a confirmed diagnosis of anxiety and known needle phobia which would make it difficult for him to undergo the epidural injection while remaining motionless. He also has a history of vasovagal response to previous injections done under local anesthetic only. Based on the medical records for review and current national guidelines, the request for monitored anesthesia care for the lumbar epidural steroid injection was medically indicated. Therefore, anesthesia for diagnostic or therapeutic nerve blocks and injections provided on 7/30/20 was medically necessary for the treatment of this patient.
Summary Reviewer 2

A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that Alopecia areata is autoimmune in nature and brings psychological manifestations as well as physical. The use of Xeljanz has shown some promise, with better results than any other available standard treatment, other than maybe long-term oral steroids, which are limited by their side effects. In this clinical setting, Xeljanz is likely to offer this patient the safest option to treat her ongoing disease. In sum, Xeljanz 5 mg are likely to be of greater benefit than other treatment modalities. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Summary Reviewer 2

A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that interspinous spacers were developed to avoid the risks of a traditional laminectomy via a less invasive technique that is reversible. The device is placed percutaneously in the interspinous space with minimal disruption of the spinal anatomy. The goal is to limit extension of the spine, minimizing the effects of spinal degeneration and enlarging the spinal canal and neural foramina area. This patient is being treated for lumbar spinal stenosis with neurogenic claudication. While there are many interspinous devices on the market, none have high quality research to demonstrate superiority over the current standard of care, simple decompression. The use of an interspinous spacer for spinal stenosis as a minimally invasive, stand-alone procedure has shown high failure and complication rates.  Until data exists that demonstrate noninferiority of these devices to the current gold standard treatment, simple decompression, the use of the requested device as a standalone procedure should be considered investigational for the treatment of the patients condition. In sum, the requested surgical insertion of an interspinous process spacer is not likely to be more beneficial than other available standard therapy.
Summary Reviewer 3

A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient had a long history of neurogenic claudication. He has failed conservative treatment for over six months, including nonsteroidal anti-inflammatory drugs, opioids, physical therapy, epidural steroid injections, and bracing. His provider has recommended minimally invasive interspinous process spacer using the Superion device. Nunley and colleagues presented a four-year follow-up of 89 patients who underwent the procedure for spinal stenosis. At four years after the procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success in terms of back and leg pain. The minimally invasive implantation procedure of the Superion device provided relief of symptoms of intermittent neurogenic claudication in these patients with moderate lumbar spinal stenosis. The second article referenced is a five-year follow-up and indicated that 75 percent of these patients continued to do well and did not require any other treatment such as an open decompression/fusion procedure. Thus, the requested surgical insertion of an interspinous process spacer is likely to be more beneficial than other available standard therapy.
Summary Reviewer  
 
The patient is an 80-year-old male with a history of psoriatic arthritis and osteoarthritis of both 
knees with associated chronic bilateral knee pain. The patient has requested reimbursement for 
hyaluronan injections (Synvisc-One) performed on 9/09/21. The physician reviewer found that 
an exhaustive review of the current medical literature pertaining to viscosupplementation 
reveals mixed results. Evidence from eight systematic reviews and six randomized controlled 
trials indicates that although viscosupplementation may relieve knee pain in some individuals 
with osteoarthritis, it is not known as to which individuals will benefit. Different studies have 
tried mixing hyaluronic acid with corticosteroids, platelet-rich plasma, and other agents to make 
it more effective. Guidelines from organizations such as the American Academy of Orthopedic 
Surgeons  indicate  that  the  evidence  is  not  conclusive.  In  light  of  the  foregoing, 
viscosupplementation can only be recommended in individuals with a history of lasting benefit 
from prior injections and in carefully selected cases where everything else has been tried and the 
options are limited. In this case, the medical records dated 9/09/21 state that the patient had 
received Synvisc-One injections into both knees in the past with good results. Therefore, he 
presented with recurrent bilateral knee pain for additional injections. There is sufficient support 
for the services at issue in this clinical setting. Therefore, hyaluronan injections (Synvisc-One) 
performed on 9/09/21 were medically necessary for the treatment of this patient.
Summary Reviewer 3

A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Sheu and colleagues in Current Opinion in Gastroenterology, concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. Another best evidence review concluded that long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration approval (Bauer, et al). One peer reviewed journal published a letter stating that there are 11 reports of endoscopically confirmed LINX erosion through the esophagus in the publicly-accessible U.S. Food and Drug Administration (FDA) Adverse Events database (Bielefeldt, et al). Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al in Surgical Endoscopy). The currently available peer reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial than standard treatment, surgical fundoplication. The American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). All told, the requested endoscopic anti-reflux procedure (LINX) is not likely to be more beneficial than the standard methods of treating this patients medical condition. Therefore, for the reasons stated above, the requested procedure is 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.
Summary Reviewer 1


A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed medical literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 7/29/16 was not 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 service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Summary Reviewer

The patient is a 15-year-old male with a history of short stature. Per the submitted documentation, he underwent growth hormone stimulation testing in 2010, which showed that he was sufficient in growth hormone production. In March 2016, the predicted adult height was calculated to be 62.5 with the chronological age of 12 years and bone age of 12 years 6 months. The mid-parental height is 68.5. The records noted pretreatment growth velocity of 4.8 cm per year, which was low.  He was started on growth hormone therapy on 5/11/16 due to growth failure or low growth velocity and poor height prediction. The patients parent has requested coverage for Nutropin AQ. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation supports the medical necessity of the requested medication. The U.S. Food and Drug Administration has approved the use of growth hormone therapy for idiopathic short stature or non-growth hormone-deficient short stature defined as height standard deviation less than or equal to -2.25 or less than or equal to 1.2nd percentile for age and gender. This patient had improvement in growth velocity to 7.6 cm per year. This patient meets the criteria for idiopathic short stature. He was prescribed growth hormone therapy and has shown good response to growth hormone treatment with adequate monitoring and minimal side effects. The medical evidence supports the requested medication in this clinical setting. Thus, Nutropin AQ is medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Summary Reviewer 

A 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Optune therapy (E0766) from 6/19/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees glioblastoma multiforme. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. Optune (Novo-TTF) is a novel portable medical device which is worn on the scalp and generates low-intensity alternating electric fields. This was initially approved for use in the treatment of glioblastoma in 2011. Stupp and colleagues demonstrated that Optune is less toxic than Temodar, with the same overall survival statistics. The advantage of the combination of Optune with Temodar was reaffirmed in the review by Taphoorn and colleagues. All told, Optune therapy (E0766) from 6/19/18 forward was and is medically necessary for the treatment of this patient. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.