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

Summary Reviewer 


A 61-year-old female enrollee has requested authorization and coverage for Forteo pen injector 20 mcg per dose  600 mcg/2.4 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis. The physician reviewer found that Osteoporosis is an increasingly widespread condition, affecting more than one half of patients ages 50 and older. Of these, approximately 80% are women. Fractures are the most dangerous aspect of osteoporosis (Old and Calvert). Until recently, pharmacological options for the treatment of osteoporosis have been limited to antiresorptive agents, including the oral bisphosphonates. Newer treatment agents have become available over the past few years, including Forteo, which was initially approved for treatment of osteoporosis in 2002. Forteo is a recombinant form of the biologically active component of parathyroid hormone which has been shown to increase bone mass and prevent fractures in osteoporotic bone (Drake, et al). Recent data has demonstrated that Forteo may aid in the healing of fractures and non-unions in osteoporotic patients (Babu, et al). Forteo is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Since this patient has sustained repeated fractures while on bisphosphonate therapy, the requested Forteo pen injector 20 mcg per dose  600 mcg/2.4 mL is medically necessary for treatment of her osteoporosis. 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 1 
 
A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on 
6/05/20. 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 according to National Comprehensive Cancer Network (NCCN) guidelines, assessment 
of peripheral blood involvement optimally by flow cytometry is important for staging and is also 
useful to differentiate cutaneous T-cell lymphoma with peripheral blood involvement from other 
forms of leukemic T-cell lymphomas. Flow cytometry allows for the assessment of a population 
of  expanded  CD4+  cells  with  abnormal  immunophenotype.  Since  this  is  a  rare  disease, 
investigation into the tissue and blood needs to be performed to be able to direct optimal 
treatment. If there is clonality in the peripheral smear, then the treatment will be directed 
systemically, not just to the skin. There is no other test that will be more beneficial at the current 
time to help stage the systemic component of mycosis fungoides. Therefore, laboratory testing 
performed on 6/05/20 was likely to have been more beneficial than any available standard 
therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.  The physician reviewer found that current quality evidence shows that the use of the myoelectric elbow-wrist-hand orthosis increases gross manual dexterity, increases the quality of task performance and enables subjects to grasp objects like a cup significantly faster. Myoelectric elbow-wrist-hand orthosis facilitates clinically meaningful increases in functional task performance. Moderately impaired stroke survivors exhibit severely diminished ability to incorporate their affected upper extremities into daily activities and subsequently have limited treatment options. This limitation often necessitates prescription of compensatory strategies and/or assistive devices to facilitate  independence, with limited involvement from the paretic upper extremity, making many activities extremely difficult. In contrast, current evidence supports that paretic arm disability may be significantly reduced while wearing a myoelectric elbow-wrist-hand orthosis, allowing for immediate use of the paretic arm and hand with little device training. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand and finger is likely to be more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. The physician reviewer found that Adenocarcinoma of the lung should be tested for certain molecular abnormalities, including ALK, EGFR and ROS-1. Each of these has a therapeutic implication. In this case, EGFR and ALK testing were done on the initial tissue biopsy, so it is not necessary to check these on Guardant360 assay. The other use of Guardant360 assay is to look for a target at which therapy can be directed. Thus far, such use has not been shown to be clinically beneficial for the vast majority of patients. A randomized study by Le Tourneau and colleagues failed to demonstrate that choosing therapy based on molecular profiling was superior to choosing therapy based on conventional judgment. Therefore, Guardant360 testing 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: Upheld

Summary Reviewer 1

A 34-year-old female enrollee has requested reimbursement for homocysteine testing performed on 6/10/20 and 9/23/20.  The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. At issue is whether the services at issue were likely to have been more beneficial for evaluation of the enrollees condition than any available standard therapy. The physician reviewer found that Hyperhomocysteinemia has been associated with vascular disease, venous thromboembolism, obstetric complications, osteoporosis, dementia and cognitive impairment in Parkinsons disease. Homocysteine levels are generally measured if an individual is suspected of having homocystinuria. Lowering homocysteine levels has not been shown to prevent cardiovascular events, prevent dementia or decrease thrombotic events. Some individuals with Hashimotos thyroid disease have an undiagnosed mutation in the MTHFR gene, causing high homocysteine levels. However, routine testing of homocysteine levels is not recommended, as treatment of this disorder has not shown to decrease the incidence of thrombosis or cardiovascular events. In this case, the patient has a history of Hashimotos thyroid disease. In October 2019, she had comprehensive testing showing normal B12, folate and homocysteine levels. There is a lack of support for repeat homocysteine testing in this setting. Therefore, homocysteine testing performed on 6/10/20 and 9/23/20 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 53-year-old female enrollee has requested authorization and coverage for Nerlynx 40 mg. The Health 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 Neratinib (Nerlynx) is U.S. Food and Drug Administration (FDA) approved for extended adjuvant treatment (as a single agent) of early-stage HER2 positive breast cancer (following adjuvant trastuzumab-based therapy). Neratinib has demonstrated improvements in recurrence rates when used in the adjuvant setting following treatment with single-agent trastuzumab, particularly in patients with HER2 positive tumors that are larger and estrogen receptor positive. There is a lack of data on the safety or efficacy of neratinib in patients whose adjuvant therapy included pertuzumab (Perjeta). The use of neratinib following adjuvant trastuzumab is usually limited to higher-risk (by stage), HER2 positive breast cancers. There is a lack of data for the benefit of neratinib in women who have received pertuzumab or T-DM1 as part of their neoadjuvant treatments. Use of neratinib in this setting is not supported by the National Comprehensive Cancer Network and is not considered a standard of care. This patient received pertuzumab in both the neoadjuvant and adjuvant setting. Therefore, Nerlynx 40 mg is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation 
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is 
investigational for the treatment of the enrollees locally advanced esophagus cancer. The physician 
reviewer found that PBT is likely to be more beneficial for treatment of the patients condition than any 
available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
The patient is a 45-year-old male who presented with a seizure in 2022.  The patient has 
requested authorization and coverage for proton beam therapy. The physician reviewer found 
that guidelines do not endorse the routine use of proton therapy in the treatment of brain 
tumors. In this case, the patients brain tumor invades into the brain stem and hippocampus. 
Proton therapy is absent of the low dose bath associated with conventional treatment using 
photon techniques and is able to limit the integral radiation dose compared to treatment with 
photons. The comparative planning submitted shows a significant reduction in the dose the brain 
stem and hippocampus using proton therapy. Treatment with protons would be expected to be 
associated with less neurocognitive toxicities compared to standard treatment with photons. 
Therefore, the requested proton beam therapy is medically necessary for the treatment of this 
patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that high-intensity focused ultrasound therapy for prostate cancer is a relatively new procedure. The U.S. Food and Drug Administration (FDA) has approved this procedure to be safe for the treatment of prostate ablation. However, there is no specific indication for the treatment of prostate cancer. The safety and efficacy of this treatment is currently being evaluated. The medical evidence has not demonstrated that this form of treatment is superior to conventional treatment options. Thus, high-intensity focused ultrasound performed on 8/14/17 was not likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were 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 3

A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). 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 the records document lumbar spinal stenosis with moderate to severe leg, buttock, groin, and back pain, sensory and motor dysfunction, and evidence of neurogenic claudication. She has tried and failed over six months of conservative treatment. The provider has advised a minimally invasive surgery consisting of insertion of a Superion interspinous process stabilization spacer, which is a less invasive indirect decompression procedure for patients who fail conservative treatment before undergoing a laminectomy and fusion. The patient is an appropriate candidate for this minimally invasive surgery. There are several treatment options for patients with lumbar spinal stenosis. These include the traditional invasive lumbar decompression and fusion and continued conservative care. When conservative care is not effective, the interspinous spacer decompression using the Superion device offers a minimally invasive procedure with documented good results for patients who fail conservative treatment. The Superion interspinous lumbar decompression is a minimally invasive, low-risk procedure for the treatment of lumbar spinal stenosis, which is safe and effective by maintaining sagittal alignment of the vertebrae at that level. This limits the possibility of device dislodgment or migration, and preserves the mobility and structural integrity of the spine. Thus, the requested CPT codes 22869 and 22870 (insertion of stabilization device without decompression) are likely to be more beneficial for treatment of the patients medical condition than any standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The patient is a 57-year-old male with a history of recurrent palpitations over  approximately an eight year period. The episodes are infrequent but typically are relieved with a Valsalva maneuver. He has had approximately four or five episodes over the  previous year when he was seen in April 2017. Per the medical record provided, the patient had ambulatory electrocardiogram (ECG) monitoring, which was unsuccessful in diagnosing the clinical arrhythmia. An echocardiogram performed on 4/14/17 demonstrated normal left ventricular function, no gross valvular abnormalities and mild mitral regurgitation by Doppler. On 9/20/17, a comprehensive electrophysiological study was performed, which demonstrated a dual abnormal atrioventricular (AV) node physiology, induction of non-sustained AV node reentrant tachycardia, inducible non-sustained atrial tachycardia and no inducible ventricular tachyarrhythmias.  However, the patients clinical arrhythmia could not be induced. An implantable loop monitor was inserted following the electrophysiology study. The patient has requested reimbursement for implantable event recorder inserted on 9/20/17. The Health Insurer has denied this request for reimbursement. Per the Health Insurer, the procedure at issue was investigational for treating this patients medical condition. In the study by Giada and colleagues, patients with symptoms of palpitations and without severe structural heart disease, a diagnosis of the clinical arrhythmia was significantly more likely with the use of an implantable loop monitor than with a conventional strategy. The patient has had recurrent significant palpitations suggestive of a supraventricular tachycardia with associated lightheadedness over several years. Conventional ambulatory monitoring did not yield a diagnosis. The treatment strategy in this case involved identifying the specific arrhythmia followed by treatment with radiofrequency ablation. In this patients case, the use of an implantable loop monitor allowed the best opportunity for a definitive diagnosis. As such, the implantable event recorder inserted on 9/20/17 was likely to have been more effective than the conventional diagnostic strategy for the evaluation of this patients medical condition. 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: Upheld

Summary Reviewer 3


A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.   The physician reviewer found that in the documentation available for review, there is a lack of radiographic evidence of facet arthropathy at the L5-S1 location. In addition, it is unclear why the procedure was performed with steroids. The current peer-reviewed medical literature requires medial branch blocks to be performed using either solely lidocaine or bupivacaine and require a pain diary for the day to verify when the local anesthetic wore off for medial branch blocks (Manchikanti, et al). Further, these injections are not to be performed when patients have significant radicular pain. Finally, there is a lack of documentation of a home exercise program, physical therapy or other conservative, non-invasive and non-pharmacological, treatment options. Thus, the in-office surgical injections provided on 8/4/15 were 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 services at issue were 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 


A 62-year-old male enrollee has requested has requested authorization and coverage for Sovaldi. 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 that according to the 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. Re-treatment is supported by the presence of diabetes mellitus, which is associated with rapid progression of fibrosis per the guidelines. In patients who have failed an NS5A inhibitor such as Harvoni, testing for NS3 and NS5A resistance-associated variants is recommended. In patients with both NS3 and NS5A resistance-associated variants, retreatment is recommended with Sovaldi, Zepatier, and ribavirin for 12 weeks, based on a 100% cure rate in the C-SWIFT study using this regimen (Lawitz, et al). The guidelines cite data showing decreased survival with delay in therapy (Jezequel, et al). For these reasons, the requested treatment with Sovaldi, to be used with Zepatier and ribavirin for 12 weeks is medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medication 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 15-year-old male who has been diagnosed with growth hormone deficiency. 
The patients parent has requested authorization and coverage for Norditropin Flexpro 15 
mg/1.5 ml pen injector. The physician reviewer found that Somatotropin therapy, such as 
Norditropin Flexpro 15 mg/1.5 ml pen injector, is medically necessary for the treatment of 
growth hormone deficiency in children. On 5/26/21, this patient met the auxologic criterion for 
growth hormone deficiency of one-year height velocity Z-score below -2 for chronological age. 
On 7/07/21, he met the diagnostic criteria for growth hormone deficiency by failing two 
standard growth hormone provocative tests with L-arginine and clonidine. Standard of care for 
evaluation of pediatric short stature includes direct measurements of parental heights. 
Nevertheless, his predicted adult height by the Bayley-Pinneau method based on the height 
observed on 5/26/21 was significantly lower than (more than one standard deviation below) 
the mid-parental target height. Therefore, Norditropin Flexpro 15 mg/1.5 ml pen injector is 
medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing performed on 12/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.