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

Summary Reviewer 2

A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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 there is sufficient support for the services at issue in this clinical setting. Bone turnover marker assays measure collagen breakdown products released from osteoclasts and osteoblasts during the process of bone resorption and formation. Bone turnover markers are useful for monitoring osteoporosis treatment. This patient was on bisphosphonate therapy for six years and is currently on a drug holiday. Her provider is monitoring her bone turnover markers so that she can decide the timing of restarting antiresorptive therapy, if needed in the future. The services at issue were medically appropriate in this clinical setting. In sum, collagen crosslink testing provided on 4/17/19 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 57-year-old male enrollee has requested authorization and coverage for Praluent. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees coronary artery disease status post drug eluting stent (DES) placement. The physician reviewer found that the documentation provided for review establishes that this patient has severe multi-vessel coronary artery disease. He is currently being treated with ezetimibe, but his LDL cholesterol is still not at goal. His most recent LDL cholesterol was 91, which is over the target range of less than 70. He was intolerant of both simvastatin and pravastatin due to muscle pain and fatigue. Thus, he meets all of the criteria for treatment with Praluent. The use of Praluent in this instance is clinically indicated and is supported by published guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) (Grundy, et al; Rosenson, et al). Given this support, the requested Praluent is medically necessary for treatment of this patients severe, multi-vessel coronary artery disease. Based on the foregoing discussion, 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 3

A 62-year-old female enrollee has requested authorization and coverage for Xeljanz.A review of the record indicates that the enrollee has been diagnosed with alopecia areata. In an
undated letter, the provider reported that the enrollee has tried squaric acid, Rogaine, and
intralesional Kenalog injections.The Health Insurer indicates that the requested medication is investigational for the evaluation of
the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the
requested medication. The physician reviewer found that the medical evidence supports the requested medication in this clinical setting. The records dated
10/30/20 documented 100% surface area of affected scalp. Her prior treatment included squaric
acid, Rogaine, and intralesional Kenalog injections. Per the records, this patient has failed typical
first-line and second-line therapies. Based on the medical literature, a JAK inhibitor would be the
next ideal choice for therapy. Therefore, Xeljanz is likely to be more beneficial than other available
standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that current medical evidence has not established the superior efficacy of the requested medication in this patientas case. Ringold and colleagues noted, aIn patients with juvenile idiopathic arthritis (JIA) and polyarthritis and moderate or high disease activity receiving a first tumor necrosis factor inhibitor (TNFi) (with or without disease-modifying antirheumatic drug (DMARD)), switching to a non-TNFi biologic (tocilizumab or abatacept) is conditionally recommended over switching to a second TNFi.a The authors also noted, aA second TNFi may be appropriate for patients who had a good initial response to their first TNFi (i.e., secondary failure), particularly failure due to the presence of suspected or measured antidrug antibodies to the first TNFi.a Furthermore, the authors also noted, aIn patients with JIA and polyarthritis and moderate or high disease activity despite a second biologic, using a TNFi, abatacept, or tocilizumab (depending upon prior biologics received) is conditionally recommended over rituximab. In this case, the medical record does not indicate that the patient utilized non-TNFi biologics, such as tocilizumab and abatacept, or a second TNFi after failing Humira therapy. All such options would be in keeping with the 2019 guideline. These options are recommended prior to rituximab therapy. Data on the use of rituximab in JIA is very limited. In addition, the patientas provider planned to combine Humira with rituximab as indicated in the 5/19/20 office visit note. Data supporting the efficacy and safety of such combination therapy for JIA appears scarce and is not supported by the medical literature. Rituximab prescribing information states there is limited data available on the safety of the use of rituximab with other biologic agents or DMARDs other than methotrexate. Therefore, Rituxan is not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia.  The physician reviewer found that the decompression procedure (neurolysis) performed on 10/5/15 was likely to be more beneficial for treatment of the patients occipital neuralgia than any available standard therapy. There is some medical literature supporting the use of neurolysis for the treatment of occipital neuralgia. Although there is a lack of data demonstrating superior results with the neurolysis, several studies have shown good results for treatment of the occipital neuralgia. In this case, the patient presented with intractable occipital neuralgia and treatment with neurolysis 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 procedure 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 68-year-old male requested authorization and coverage for UroLift procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees benign prostatic hyperplasia (BPH).The physician reviewer found that UroLift has been approved by the U.S. Food and Drug Administration and is considered a treatment option by the American Urologic Association Residency Education program on BPH management. This treatment option is most beneficial in men who wish to avoid retrograde ejaculation, increased risk of bleeding and retention, which are normally found in prostatic vaporization, or transurethral electro-resection of the prostate (TURP). A recent publication has reported the five year follow up of a pivotal trial of UroLift with equal efficacy and lower complications compared to historical TURP analogous data. Accordingly, UroLift is likely to be more efficacious than other alternatives for treatment of this patients symptoms. 
Therefore, for the reasons stated above, the requested procedure 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.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 34-year-old male enrollee has requested reimbursement for the chiropractic services provided from 5/17/14 through 7/5/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck pain, upper back pain and shoulder pain.   The physician reviewer found the records demonstrate that this patient had significant improvement in neck disability index and functional upper extremity index with chiropractic treatment provided from 5/17/14 through 7/5/14. The patient was returned to functional status after this course of chiropractic care. According to current medical research, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner. With the objective improvement, the chiropractic treatment sessions provided on 5/17/14, 5/19/14, 7/2/14, and 7/5/14 were appropriate and provided substantial improvement in this patients functional status. Thus, the chiropractic services provided from 5/17/14 through 7/5/14 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were 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 parent of a 10-year-old female enrollee has requested authorization and coverage for Nutropin growth hormone (GH) therapy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature and ulcerative colitis.   The physician reviewer found that the records provided for review demonstrate that this patient has extreme short stature with an adult height prediction that is less than 59 inches, which is short enough to meet U.S. Food and Drug Administration (FDA) criteria for a trial of GH therapy for idiopathic short stature. Although some of the patients growth failure may be attributed to underlying ulcerative colitis, poor nutritional intake, and poor weight gain, her ulcerative colitis is currently inactive, she is not receiving steroid medications that can impair growth, and her weight for her height is appropriate. Her normal ESR, iron studies, and complete blood count are evidence that her underlying ulcerative colitis is under control, yet she continues to have a poor growth velocity and has a very short adult height prediction. According to Pediatric Endocrinology Society guidelines, a trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests but who meet most of the following criteria: (1) height more than 2.25 SDs below the mean for age or more than two SDs below the mid-parental height percentile; (2) growth velocity less than 25th percentile for bone age; (3) bone age more than two SDs below the mean for age; (4) low serum IGF-1 and/or IGFBP-3; and/or (5) other clinical features suggestive of GH deficiency. This patient meets most of these criteria. Thus, GH therapy is indicated to improve her height potential. Accordingly, the requested Nutropin GH therapy is supported as medically necessary for treatment of this patients short stature. Based on these findings, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2 
The parent of a one-year-old female enrollee has requested authorization and coverage for a whole 
genome test. The Health Insurer has denied this request and reported that the requested service is 
investigational for the enrollees of the enrollees ataxia. The Health Insurer indicated that the 
requested  service  is  investigational  for  the  evaluation  of  the  enrollees  medical  condition. 
Therefore, the Health Insurer has denied coverage for the requested service. At issue is whether a 
whole genome test is likely to be more beneficial for evaluation of the enrollee's condition than 
any available standard therapy. The physician reviewer found that while whole genome sequencing 
may be effective at finding a diagnosis in complex patients in whom other genetic tests are 
negative, there are alternative, simpler tests addressing ataxia telangiectasia. In this clinical setting, 
ATM gene testing would have a 90% yield. In this case, the requested service is too big of a test 
and does not justify the risk of unknown variants. The records did not note the rationale behind the 
urgency of the requested rapid whole genome sequencing test and how this may affect the patients 
management. Therefore, a whole genome test is not likely to be more beneficial for evaluation of 
the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

The parent of an eight-year-old male enrollee has requested authorization and coverage for Exondys 51. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees Duchenne muscular dystrophy. The physician reviewer found that there is sufficient support for the requested medication in this patients case. All other treatments for DMD are palliative, whereas Exondys 51 is disease-modifying. The patient has been on Exondys 51 on a clinical trial since 2015. His DMD disease trajectory is very different from that of his affected peers, who by the patients age, typically need to use a stroller for community excursions, developing muscle cramps and fatigue with exercise. In September 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval for eteplirsen (Exondys 51), a drug that acts to promote dystrophin production by restoring the translational reading frame of DMD through specific skipping of exon 51 in defective gene variants. Eteplirsen is applicable for approximately 14% of patients with DMD mutations. Most treatments currently available for DMD are palliative, aimed at prolonging the ability to walk, improving breathing and cardiac function. Treatment with corticosteroids has been found to be the most effective option for patients, resulting in improved muscle strength, prolongation of the ability to walk, and better pulmonary function. However, corticosteroids only delay disease progression, and treatment is associated with significant side effects, including weight gain, osteoporosis and cataracts. In this patients case, the requested medication is likely to be superior over other treatment options. In sum, Exondys 51 is likely to be more efficacious 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


The parent of a 14-year-old male enrollee has requested authorization and coverage for the ReWalk Exoskeletal Device durable medical equipment (DME). The Health Insurer has denied this request indicating that the requested equipment is investigational for treatment of the enrollees T8 incomplete spinal cord injury due to spinal tumor.  The physician reviewer found the ReWalk exoskeleton relies on arm strength to maintain balance and posture with bilateral Canadian crutches. This patients level of cord dysfunction at T8 is significantly below the intervention of his arms and his skills as a pianist would imply significant arm dexterity. Both his rehabilitation provider and his physical therapist state that he has mastered the system and can ambulate when fitted with the exoskeleton. In the medical literature, Goemaere and colleagues noted concern that non-standing paraplegics will lose bone density. Kunkel and colleagues reported improved bone density with standing and as well as reduction in contractures. Jain and colleagues found that there is a significant impact with standing in the emotional well-being of a paraplegic. Further, White and Hayes found success with use of the ReWalk system in their studies. Moreover, the U.S. Food and Drug Administration (FDA) approved the ReWalk system as a medical device in 2014 for use in this clinical setting. Given this support, the requested ReWalk Exoskeletal Device DME is likely to provide this patient with an improved health outcome beyond that anticipated with standard available alternatives. Based upon the information set forth above, the requested equipment 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from 
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service 
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis. The 
physician  reviewer  found  that  in  this  case,  the  patient  meets  criteria  for  hereditary 
hemochromatosis. Kowdley and colleagues report that phlebotomy remains the mainstay of 
therapy  for  hereditary  hemochromatosis.  The  American  College  of  Gastroenterology  
recommends that phlebotomy be used as the first-line treatment in patients diagnosed with 
hereditary hemochromatosis, as determined by C282Y homozygosity or C282Y/H63D compound 
heterozygosity. The guidelines further recommend against chelation as the first-line therapy for 
hereditary hemochromatosis, given the effectiveness of phlebotomy, the associated side effects 
of chelation including hepatic and renal toxicity, and the relatively small sample size of clinical 
trials supporting chelation. However, the guidelines note that iron chelation may be used in the 
treatment of hereditary hemochromatosis for the patient who is intolerant or refractory to 
phlebotomy or when phlebotomy has the potential for harm, such as in patients with severe 
anemia or congestive heart failure. Phlebotomy in fit patients with biochemical or clinical 
evidence of iron overload is proven to improve overall survival and reduce end organ damage, 
such  as  by  cirrhosis  or  heart  failure,  due  to  iron  overload.  In  the  maintenance  of 
hemochromatosis, phlebotomy is also recommended as needed to keep serum ferritin below 50-
100  ug/L.  Intolerance  of  phlebotomy,  such  as  congestive  heart  failure  with  unstable 
hemodynamics, may be an indication for alternative therapies such as erythocytapheresis or iron 
chelation therapy. There are three chelating agents currently approved by the U.S. Food and Drug 
Administration (FDA) for the treatment of secondary iron overload, but none that are approved 
for primary iron overload and hereditary hemochromatosis. Deferoxamine has been approved 
for the treatment of secondary iron overload in thalassemia, with adverse effects including 
retinopathy and auditory toxicity. Deferiprone is an oral chelator which is approved for the 
treatment  in  transfusion-dependent  patients  with  thalassemia  when  chelation  with 
deferoxamine  is  inadequate,  with  significant  side  effects  including  neutropenia  and 
agranulocytosis. Deferasirox, the most recently approved oral chelator, has side effects including 
gastrointestinal upset, rash, aminotransferase elevation, and renal toxicity, which can occur in 
more than 10% of  all patients.  In this clinical setting, phlebotomy is considered standard 
treatment and is likely to be superior to other treatments such as erythocytapheresis or iron 
chelation therapy. Therefore, therapeutic phlebotomy from 1/6/21 through 1/26/21 was likely 
to have been more beneficial for treatment of the enrollee's condition than any available 
standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 39-year-old male enrollee has requested reimbursement for the sleep study performed on 3/30/17. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees obstructive sleep apnea (OSA). The physician reviewer found based on the medical literature and the presented clinical records submitted for review, the sleep study performed on 3/30/17 was not medically necessary for evaluation of the patients medical condition. In this case, the patient has no documentation demonstrating lung disease, heart disease or neuromuscular disease. There is no documentation of dementia or impairment. In sum, there is a lack of objective documentation provided for review that supports the medical necessity of a facility based sleep study. The sleep study could have been performed in a home setting. For the reasons provided, the sleep study performed on 3/30/17 was not medically necessary for evaluation of the patients medical condition. Therefore, the service at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.   The physician reviewer found the RT300 FES cycle was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The RT300 cycle has not been demonstrated to prevent secondary long-term cardiovascular dysfunction or promote cardiac conditioning. In addition, the RT300 has not been proven to result in changes in muscle strength and volume that lead to clinically significant functional improvement in long-term patient outcomes. The RT300 FES cycle is not reasonably expected to reduce the long-term deficits secondary to this patients injury and assist the patient to maintain and achieve functional capacity in performing daily activities. Baldi and colleagues suggested that neuromuscular electrical stimulation may increase muscle mass in some spinal cord injury patients with disuse atrophy, however, the literature does not demonstrate that this leads to improved health outcomes such as reduced fracture risk from increased bone density. All told, the peer-reviewed medical literature does not support the RT300 FES cycle provided on 2/10/16 as likely to be more beneficial for treatment of this patients medical condition than standard available treatment options. Based upon the information set forth above, the equipment at issue was 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.