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

Summary Reviewer 1

The patient is a 59-year-old female who has been diagnosed with a uterine leiomyosarcoma. She was initially diagnosed in August 2001, at hysterectomy, with the finding of a 1.5 cm leiomyosarcoma. After surgery, she received radiation therapy. She was then well until mid-2016 when a computed tomography scan revealed a pelvic mass, confirmed by positron emission tomography scan. Biopsy was positive for recurrent leiomyosarcoma. She underwent debulking surgery and was started on adriamycin with olaratumab. Her tissue was sent for FoundationOne assay. The patient has requested reimbursement for the FoundationOne test performed on 11/14/16. The Health Insurer has denied reimbursement on the basis that services at issue were investigational for the evaluation of this patients medical condition. There is a lack of support for the services at issue in this clinical setting.  FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability of the clinician, or yields a result that is reliably clinically beneficial. There are various non-randomized studies exploring the value of molecular profiling but these studies are not definitive or compelling as to the efficacy of the assay.  A randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets. Finding a mutation does not guarantee that a treatment directed at that mutation will produce a clinically meaningful response. All told, the FoundationOne test performed on 11/14/16 was not likely to have been more efficacious than other methods of evaluating this patients medical condition.   Therefore, for the reasons stated 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 2

The patient is a 57-year-old male with AL amyloidosis with cardiac involvement. Prior treatment has included Cytoxan, dexamethasone, Velcade, and Kyprolis. The provider has recommended treatment with daratumumab (Darzalex). The patient has requested authorization and coverage for Darzalex. The Health Insurer has denied this request indicating that the requested medication is considered investigational. As noted in the medical literature, Darzalex is an anti-CD38 monoclonal antibody used in multiple myeloma. Case reports and a retrospective study described the safety and efficacy of daratumumab in patients with relapsed or refractory AL amyloidosis (Sher, et al; Kaufman, et al). Toxicity was similar to that observed in patients with multiple myeloma. All told, the requested Darzalex is 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 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 50-year-old male enrollee has requested authorization and coverage for Repatha SureClick. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypercholesterolemia.  The physician reviewer found that Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved only for patients with heterozygous familial hypercholesterolemia or for patients with documented clinical atherosclerotic heart disease who require additional lowering of LDL cholesterol. This patient does not fit either of those criteria. The presence of coronary calcium does not equate to coronary obstruction, and there is no documented obstructive coronary stenosis or clinical cardiovascular disease, such as stroke, myocardial infarction, angina, ischemia on stress testing, or prior coronary revascularization. PCSK9 inhibitors have not been adequately studied in other patient populations, such as this patient with an elevated calcium score but no documented clinical cardiovascular disease. The current guidelines do not recommend the use of PCSK9 inhibitors in this primary prevention setting. Thus, Repatha SureClick is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer  
 
The patient is a 61-year-old female who presented to her provider on 8/18/22. The patient has 
requested  authorization  and  coverage  for  tonsillectomy  and  adenoidectomy    surgery  for 
removal of growth on tonsil. The physician reviewer found that submitted documentation does 
not support the medical necessity of the requested service. Patel and colleagues report that adult 
tonsillectomy may be indicated for infections, biopsies, tonsillar stones, and obstructive sleep 
apnea. Bowers and Schaitkin note that mucoceles may be managed with surgical excision, 
marsupialization,  laser  ablation,  cryotherapy,  intralesional  steroid  injection,  and  sclerosing 
agents. Given that current medical literature does not support tonsillectomy and adenoidectomy 
for  treatment  of  a  superficial  mucocele,  the  requested  service  is  not  medically  indicated. 
Therefore, tonsillectomy and adenoidectomy  surgery for removal of growth on tonsil is not 
medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 43-year-old male enrollee has requested authorization and coverage for the medication Ocrevus injection 300/10 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees remitting relapsing multiple sclerosis. The physician reviewer found that as per the medical literature and the submitted information by the patients provider, Ocrevus is a medication that has been shown as beneficial for treatment of relapsing remitting multiple sclerosis. However, the record shows that this patient only has a history of taking the medication Copaxone for disease modification since 1999. As such, there may be other multiple sclerosis medications that may be as clinically effective as Ocrevus. An alternate medication, fingolimod, has been shown as beneficial in treating relapsing remitting multiple sclerosis.  The documentation provided does not show that this patient has had an adequate trial and failure of fingolimod. While this patient has a history of hypertension, it is not a contraindication to the medication fingolimod.  Additionally, fingolimods prescribing parameters include close monitoring of medication administration, especially with the first dose, to mitigate any potential adverse effects.  Moreover, Ocrevus also has significant side effects including increased risk of certain types of cancer.  The provider states a concern that the patient is positive for the John Cunningham virus. However, there is also the possibility that this patient may develop progressive multifocal leukoencephalopathy or PML with Ocrevus, as it is an immunosuppressant.  In general, all multiple sclerosis disease modifying medications have clinical implications or side effect profiles. In this patients case, the documentation provided does not show an adequate trial or contraindication to the preferred medication fingolimod. Fingolimod could be a reasonable option with the appropriate clinical evaluation, management, and support for this patient.  In sum, the requested medication, Ocrevus injection 300/10 mL is not medically necessary for treatment of this patients medical condition. Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 68-year-old female enrollee has requested reimbursement and prospective authorization and coverage for epidural injections from 6/06/16 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 medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  The patient has extruded disc material as well as a disc protrusion.  These structural defects are not going to be altered by epidural steroids.  The patient has spinal stenosis, and the medical literature has shown that epidural steroid injections do not alter the course of the underlying pathology.  Radcliff and colleagues compared patients with lumbar spinal stenosis who received epidural steroid injections with patients who did not receive epidural injections during the first three months of the study.  The authors noted a worse outcome in the steroid treated group.  The current medical evidence does not support the services at issue in this clinical setting.  All told, epidural injections from 6/06/16 forward were not and are not medically indicated for the treatment of this patient.  Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

The parent of 10-year-old male enrollee has requested reimbursement for biofeedback treatment services provided from 3/05/18 through 5/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that attention deficit/hyperactivity disorder is thought to be the most common psychiatric disorder of school-age children. Although the cause is unknown, there are many theories under investigation involving brain anatomy and chemistry. Genetics and environmental factors may also play important roles. Neurofeedback has been extensively studied in the attention deficit/hyperactivity disorder population. Previous meta-analyses have contradicted the methods and results from those that came prior, making it difficult to come to a consensus regarding the efficacy of this treatment technique. Bussalb and colleagues concluded that neurofeedback is an effective treatment for attention deficit/hyperactivity disorder, with studies showing a statistically significant improvement on assessment. More intense treatment was found to increase clinical efficacy. Micoulaud-Franchi and colleagues noted improvement in the inattention dimension of attention deficit/hyperactivity disorder symptoms. Therefore, biofeedback treatment services provided from 3/05/18 through 5/14/18 was likely to have been superior over other available treatment options.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 25-year-old male enrollee has requested authorization and coverage for upper jaw surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee who has been diagnosed with obstructive sleep apnea syndrome. The physician reviewer found that there is sufficient support in the medical literature for the requested services in this clinical setting.  Studies have shown that the presence of abnormalities in the anterior maxilla results in a high nasal floor, which constricts the nasal passageways and causes increased nasal airway resistance. Surgical correction results in improved nasal breathing which is a result of a widened airway space brought about by maxillary arch expansion. This may be accomplished by a number of techniques which may include rapid palatal expansion, surgical assisted rapid palatal expansion, and segmental Le Fort I osteotomies. The submitted documentation notes an intolerance to CPAP and an RDI score of 23.8. Given this patients symptoms, surgical correction is indicated. In sum, the requested upper jaw surgery is medically necessary for the treatment of this patients medical condition.Therefore, for the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 27-year-old female enrollee has requested reimbursement for genetic testing including methylenetetrahydrofolate reductase (MTHFR) gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for bleeding disorder.  
 
 The physician reviewer found that there is support for a portion of the services at issue in this clinical setting. This patient has a family history of a prothrombin gene mutation. Most clinicians would recommend testing for all five major thrombophilias, which includes factor V Leiden mutation. It is not uncommon for patients to carry more than one mutation. Testing for factor V Leiden mutation is likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. Regarding MTHFR mutation, homozygosity for these genetic variants is a relatively common cause of mildly elevated plasma homocysteine levels in the general population, often occurring in association with serum folate levels in the low normal range. High quality epidemiologic studies have not found a significant increase in venous thromboembolism risks among individuals homozygous for MTHFR polymorphisms. As such, testing for MTHFR is unlikely to be more beneficial than any available standard of care. Therefore, a portion of the genetic testing provided on 7/1/17 was likely to be more effective than the standard therapy available. Specifically, common variants and factor V Leiden mutation are more likely to be effective than the available standard therapy.  Based upon the information set forth above, a portion of the services 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 partially overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/31/18. 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 this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. 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. In sum, DecisionDx-Melanoma testing performed on 10/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 59-year-old female enrollee has requested authorization and coverage for Alvesco 160 mcg inhaler, 1 puff twice per day for one year. 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 Alvesco (ciclesonide) has been approved by U.S. Food and Drug Administration for the treatment of persistent asthma. Ciclesonide is converted to an active metabolite desisobutyryl-ciclesonide in the lungs. The anti-inflammatory effect of desisobutyryl-ciclesonide is much higher than ciclesonide. Therefore, the local effect of the metabolite is higher, with lower systemic side effects. Ciclesonide has favorable pharmacokinetic and pharmacodynamic properties as inhaled corticosteroid, including low oral bioavailability, high plasma protein binding and rapid systemic clearance, high pulmonary deposition and distribution, and long pulmonary residence duration. These advantageous properties make ciclesonide an effective treatment option with low side effects.  The medical records indicate that this patient has tried another inhaled corticosteroid which was associated with increased symptoms of fatigue, and her symptoms were well maintained on ciclesonide. Therefore, it is medically appropriate to maintain the patient on the current ciclesonide to minimize side effects and improve asthma symptoms. Therefore, Alvesco 160 mcg inhaler, one puff twice per day for one year is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

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.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The parent of a 14-year-old female enrollee has requested reimbursement for genetic testing performed on 4/30/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that the current medical evidence does not support the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network states while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In addition, the use of DecisionDx-Melanoma testing has not been validated in children. Thus, genetic testing performed on 4/30/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that Osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. Bone mineral density (BMD) assessment, via dual-energy x-ray absorptiometry (DEXA) is the standard for evaluation and diagnosis of osteoporosis.  However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. The medical evidence suggests that biochemical markers may be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. The medical evidence supports the services at issue in this clinical setting. Therefore, collagen crosslinks testing performed on 11/18/17 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.