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

Summary Reviewer 

A 38-year-old female enrollee has requested authorization and coverage for Tymlos. The Heath Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that pregnancy affects bone turnover and mass significantly, but pregnancy-associated osteoporosis is a rare and heterogeneous condition. In a premenopausal woman with osteoporosis, bone mass may be improved by sufficient intake of calcium and vitamin D in addition to increased physical activity. In patients who require pharmacological treatment, teriparatide is the best treatment. The half-life of teriparatide is an hour, which is much shorter than that of bisphosphonates, making it safe for fertile women. Teriparatide can be a therapeutic option for the treatment of pregnancy-associated osteoporosis. There are pharmacological therapy modalities that can be used in pregnancy and lactation induced osteoporosis. Bisphosphonates are effective, but there are some concerns that they accumulate in bone and may expose fetus in subsequent pregnancies. Tymlos is a human parathyroid hormone related peptide analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Tymlos is not indicated for use in females of reproductive potential. There is a lack of human data regarding Tymlos use in pregnant women to inform drug associated risks. There is a paucity of data on the use of Tymlos in premenopausal women or pregnancy induced osteoporosis. There are articles and case studies reporting successful use of teriparatide in cases of premenopausal pregnancy induced osteoporosis in women who wish to consider additional pregnancies, like in this case. The records do not indicate why the decision was made to change from teriparatide to Tymlos. Therefore, Tymlos (abaloparatide) is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 28-year-old female enrollee has requested reimbursement for computer-aided detection performed on 4/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has BRCA2 gene mutation. The physician reviewer found that there is sufficient support for the services at issue in this patients case. In young females, breast tissue is almost always mammographically dense, which limits the utility of mammography. MRI is the procedure of choice for annual screening in these patients due to the high sensitivity of the test for breast cancer. Mammography also is of use beginning at age 30, and annual examination with both modalities is recommended at that age. Per the medical evidence, computer-aided detection performed on 4/20/18 was likely to have been of greater benefit 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: Experimental
Decision: Upheld

Summary Reviewer 1

A 52-year-old male enrollee has requested authorization and coverage for CPT 43284 (magnetic sphincter augmentation). 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 magnetic sphincter augmentation (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 also 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 aseverea 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 There are 29 reports of LINX erosion through the esophagus in the publicly-accessible FDA Adverse Events database, among other adverse events. 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, CPT 43284 (magnetic sphincter augmentation) is not likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 46-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Januvia. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees diabetes.  The physician reviewer found that Diabetes is a progressive disease, which typically manifests with increasing loss of glycemic control over time in spite of lifestyle and pharmacologic intervention. Although type 2 diabetes is initially due to insulin resistance, studies have shown that patients with this disease also may have a decline in pancreatic beta cell function, which begins as early as 12 years before diagnosis and continues throughout the disease process (Fonseca). New diabetic medications have been developed which are being used earlier in the course of treatment of diabetes. Among these is the DPP4 inhibitors (DPP4i), such as Januvia, which are a class of newly developed antidiabetic drugs which help lower blood glucose levels and may help preserve pancreatic beta cell function (Godinho, et al). In addition, the 2015 comprehensive management algorithm published by the American Association of Clinical Endocrinologists (AACE) recommends that this medication may be used as either monotherapy or in combination therapy for treatment of diabetes (Garber, et al). While this patient responded well to combination therapy of Januvia and metformin, his glycemic control worsened after switching to another medical regimen. Improper management of diabetes could increase a patients risk of developing complications from diabetes and possibly lead to a more rapid progression of diabetes. Consistent with these findings, treatment with Januvia was and is medically necessary for treatment of this patients diabetes. Based on the foregoing discussion, the medication at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 96-year-old male with a history of ongoing eczema.  The patient has requested authorization and coverage for Dupixent 300 mg. The Health Insurer has denied this request and reported 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 physician reviewer found that Dupixent is used for chronic eczema that is moderate to severe. This patient has moderate-to-severe disease that is interfering with his daily activities, like sleep. He has tried many traditional treatments without success. Dupilumab (Dupixent) is safe, effective, and U.S. Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe atopic eczema. It would be medically reasonable and necessary for this patient to use Dupixent to treat his refractory moderate-to-severe eczema. There are multiple trials showing its efficacy and safety. Therefore, Dupixent 300 mg is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer  
 
The patient is a 56-year-old female who presented in 2012 with breast 
cancer. The patient has requested authorization and coverage for 
stereotactic body radiation therapy. The physician reviewer found the 
submitted documentation fails to demonstrate the medical necessity of the 
requested services. The use of stereotactic body radiotherapy in 
metastatic breast cancer is not standard of care. Stereotactic body 
radiotherapy allows for the use of a high dose of radiation to a small 
volume and is generally utilized in the curative setting. This patient 
requires palliative radiotherapy, and the standard technique is typically 
with 3D conformal radiotherapy. There is a lack of meaningful clinical 
data to support the routine use of stereotactic body radiotherapy in 
patients with widespread metastases. Furthermore, there is a lack of 
published randomized trials that support the use of stereotactic body 
radiotherapy over standard treatment. The current National Comprehensive 
Cancer Network guidelines also do not support the routine use of 
stereotactic body radiotherapy in treatment of breast cancer. In this 
case, the provider noted the plan to use stereotactic body radiotherapy 
to target a single lung metastasis that is not responding to systemic 
therapy. In this setting, there is no proven benefit of stereotactic body 
radiation therapy to the one progressive lesion. Therefore, the requested 
stereotactic body radiation therapy is not medically necessary for the 
treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a nine-year-old male. The patients parent has requested reimbursement for speech therapy provided from 1/12/19 through 10/19/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.   The physician reviewer found that the patient has autism spectrum disorder and attention deficit/hyperactivity disorder, predominantly inattentive subtype. He has significant impairment in the appropriate social use of pragmatic language, which is causing difficulty with social interaction with his peers and adults. His language difficulties are also adversely affecting his school performance. The patient will be at significant risk of anxiety and depression as a result of his language impairment. Maiano and colleagues estimated that 44% of children with autism are bullied at school. This is frequently due to their difficulty interacting appropriately with others. Helland and Helland recommended that the substantial influence of pragmatic language abilities on social function and in resolving interpersonal conflicts with peers needs to be considered in children with autism, and that further development of therapy plans and interventions targeting pragmatics is strongly needed. There is sufficient support for the services at issue in this clinical setting. Therefore, speech therapy provided from 1/12/19 through 10/19/19 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 34-year-old male has requested reimbursement for polymerase chain reaction (PCR) testing performed on 8/03/17. 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 that the patient did not have clinical evidence of infectious mononucleosis. The evaluation on 8/03/17 suggests a viral pharyngitis. He had already been given an extended spectrum penicillin antibiotic. The rash was not suggestive of mononucleosis. This disease may cause a macular rash, but it does not produce a pustular eruption.  Importantly, the patient did not have a lymphocytosis. Additionally, PCR testing on blood is not a test used to make a diagnosis of monoucleosis.  The tests sole use is in highly immunocompromised individuals who may have a viremic illness. Thus, PCR testing performed on 8/03/17 was not likely to have been more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 63-year-old female enrollee has requested reimbursement for the Prolia injection performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Denosumab (Prolia) is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone (McClung, et al). Prolia is U.S. Food and Drug Administration (FDA) approved for the treatment of postmenopausal osteoporosis in women at a high or increased risk of fracture who have failed or are intolerant to other available osteoporosis therapy. Fractures are the most dangerous aspect of osteoporosis, which can lead to acute and chronic pain (Old and Calvert). In this case, the patient failed bisphosphonate therapy (Actonel). As such, the Prolia injection provided on 11/21/14 was likely to be a more beneficial treatment than standard medical therapy in this clinical setting. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment 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 


The parent of a 17-year-old female enrollee has requested authorization and coverage for external ambulatory insulin delivery system (Omnipod). The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that transition to the Omnipod pump is medically necessary for this patient. This patient has had malfunctioning of her Medtronic pump and adverse reactions to the site insertions while engaged in competitive swimming. She is able to successfully employ insulin pump therapy to control her diabetes and has had excellent adherence to diabetes management tasks, but she requires a different type of pump due to her active lifestyle. Treatment with the Omnipod insulin management system has been found to be associated with clinically meaningful and statistically significant improvement in glycemic control, reduction in daily insulin requirement and reduction in the frequency and severity of hypoglycemic episodes analogous to the Medtronic pump. The medical evidence supports the requested device in this patients case. All told, the requested external ambulatory insulin delivery system (Omnipod) is medically necessary for the treatment of this patient. Therefore, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on 
11/29/19. The Health Insurer has denied this request and reported that the services at issue were 
investigational for the evaluation of the enrollees medical condition. The physician reviewer 
found that molecular testing has become a vital part of testing in non-small cell lung cancer and 
can help direct treatment decisions. The most extensive data on molecular testing is on tissue 
samples from either a primary lung tumor or metastatic tumor. Both National Comprehensive 
Cancer Network and American Society of Clinical Oncology guidelines do not recommend the 
regular use of cell-free DNA tests, such as Guardant 360, in lieu of a tissue diagnosis. False 
negative rates can be significant, and there is a lack of published guidelines on the standards for 
analytical performance. In the setting where insufficient tissue can be obtained, circulating tumor 
DNA testing can be considered. However, in this case, tissue was obtained and molecular testing 
was able to be performed.  Therefore, laboratory testing performed on 11/29/19 was not likely 
to have been more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen. The physician reviewer found that Benralizumab (Fasenra) is a cytotoxic monoclonal antibody directed against IL-5 receptor alpha that is approved by the U.S. Food and Drug Administration (FDA) as add-on therapy in patients with severe asthma and an eosinophilic phenotype. The submitted documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy. There is sufficient support for the requested medication in this clinical setting. Therefore, the requested Fasenra Pen is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 64-year-old male enrollee has requested reimbursement for electrical stimulation device used for cancer treatment on 1/24/19, 2/24/19 and 3/24/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in 2011, the U.S. Food and Drug Administration (FDA) approved a portable medical device that generates low-intensity alternating electric fields, also known as Optune, for the treatment of recurrent glioblastoma. Approval was based on results of a clinical trial that randomized 237 patients to tumor treating fields (TTF) or chemotherapy. Similar survival was observed in the two arms, and TTF therapy was associated with lower toxicity and improved quality of life. Consensus-based guidelines published by the National Comprehensive Cancer Network (NCCN) include alternating electric field therapy as a treatment option for patients with recurrent glioblastoma as adjuvant therapy in combination with temozolomide. Therefore, electrical stimulation device used for cancer treatment provided on 1/24/19, 2/24/19 and 3/24/19 was medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary  
The  patient  is  a  50-year-old  female  who  presented  to  her  provider  on  11/1/22  with  an 
exacerbation of chronic pain in the left shoulder. The patient has requested authorization and 
coverage for prescription tramadol HCL tablet 50 mg. The physician reviewer found that at issue 
is whether prescription tramadol HCL tablet 50 mg is medically necessary for the treatment of 
this patient. The submitted documentation supports the medical necessity of a portion of the 
requested medication. In this case, the patient has chronic pain in her shoulder due to a rotator 
cuff tear. Her previous medications include the antidepressant trazadone and buspirone for the 
treatment  of  anxiety  disorder.  She  has  also  been  on  long-term  treatment  with  high-dose 
ibuprofen, which may be associated with significant gastrointestinal complications including 
ulcers and bleeding. The Centers for Disease Control and Prevention (CDC) guideline on chronic 
pain includes the recommendation to limit opioids for acute pain in most cases to three to seven 
days based on evidence showing an association between use of opioids for acute pain and long-
term use. In this case, given that the patient has tried nonsteroidal anti-inflammatory drugs 
(NSAIDs), antidepressants, anticonvulsants, and acetaminophen, a prescription for seven days of 
tramadol  HCL  tablet  50  mg,  dosed  every  six  hours,  is  medically  indicated.  Therefore,  a 
prescription for seven days of tramadol HCL tablet 50 mg, 30 pills, is medically necessary for the 
treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

The patient is a 46-year-old female with a history of left abdominal pain and left hip pain. The patient reported that she has experienced pain on the left side since the spring of 2016. She has been seen by urologist and gynecologist. Physical therapies were prescribed. An orthopedic provider recommended fluoroscopically guided injection into hip joint. The patient reported that her pain was relieved. On 12/22/16 magnetic resonance imaging (MRI) was performed. MRI of the hip noted complex tear anterior left acetabular labrum, full thickness of labral base. The tear was best seen in sagittal fat saturated proton density left hip sequence.  On 1/31/17, an operative note indicated that preoperative and postoperative diagnosis was left hip pain, labral tear and impingement. Postoperative diagnosis noted degenerative labral tearing left hip pincer type impingement. Procedure left hip arthroscopic pincer lesion resection and labral debridement were performed. The following were indications for surgery: pain relief response on injection and MRI showing complex labral tear with possible cam type impingement. The summary of intraoperative findings: mild degenerative joint disease left hip, small area of fissuring and cartilage softening, extensive degenerative labral tearing, pincer lesion between 11 and 12 oclock with no obvious CAM lesion. The patient has requested reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for treatment of this patients medical condition. There is sufficient support for the efficacy of the services at issue in this clinical setting. Femoroacetabular impingement syndrome and its treatment is now well established and the technical requirements are well within the experience of an orthopedic surgeon skilled in arthroscopic techniques. The study published by Ganz and colleagues includes two year follow-up with improved ranges of motion and reduction in pain. This procedure involved dislocation of the hip and because of that there is added potential for morbidity. An extra-articular approach using an arthroscopic technique is reasonable and has been technically well developed. In a study by Espinosa and colleagues, extra-articular surgery with labral refixation was followed in a two year follow-up period with 48% good results, 20% moderate results and 4% poor results. The studies cited are level III and level IV studies. As such, the hip surgery performed on 1/31/17 was likely to have been more effective for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.