Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2


A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. 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 the patient with ovarian cancer received chemotherapy but debulking surgery revealed residual tumor. This suggests marked chemotherapy resistance. Her providers submitted her tumor specimen for mutational analyses to identify other therapies.  Von Hoff and colleagues performed a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors.  In sum, the gene testing performed on 11/01/15 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: Insurer Denial Upheld

Summary Reviewer 3


A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. 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 the current medical evidence has not demonstrated the superior efficacy of the services at issue in this clinical setting.  There is a lack of data supporting an enhanced survival benefit for the use of molecular profiling in the front-line setting for treatment, as few actionable mutations are identified and primary treatment strategies are relatively standard.  The role in recurrent/refractory disease is developing and identification of specific targets for either clinical trial selection or selection of chemotherapy agents may be helpful, although this has yet to be proven.  Thus, gene testing performed on 11/01/15 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 62-year-old female enrollee has requested authorization and coverage for Lucentis (ranibizumab intravitreal solution pref syr 0.5 mg/0.05 ml). 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 the submitted documentation supports the medical necessity of the requested medication. Gerding and colleagues reviewed outcomes studies on the use of ranibizumab and recommended early treatment of macular edema associated with retinal vein occlusion. Other studies have demonstrated that this medication is safe and effective for decreasing macular edema and improving visual acuity compared to the previous standard of care treatment, focal laser treatment. Intravitreal anti-VEGF drugs, such as ranibizumab, are the standard of care treatment for this patients disease. Based on the medical records, the patient has macular edema secondary to central retinal vein occlusion. As the patient has central retinal vein occlusion with macular edema, ranibizumab is an appropriate, clinically effective treatment and is medically necessary. Therefore, Lucentis (ranibizumab intravitreal solution prefilled syringe 0.5 mg/0.05 ml) is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

The patient is a 61-year-old female with a left-sided thyroid nodule. Cytology from a fine needle aspiration biopsy was indeterminate. A specimen was subsequently sent for Afirma gene classifier analysis. The patient has requested reimbursement for the gene test provided on 12/21/16. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of this patient. While a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign. Afirma gene classifier analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on fine needle aspiration biopsy, thereby avoiding unnecessary surgeries. Because it is sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. Therefore, the gene test provided on 12/21/16 was likely to have been superior over 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: Insurer Denial Overturned

Summary Reviewer 2

The patient is a 61-year-old female with a history of sarcoma. Per the records, positron emission tomography (PET) scan showed a thyroid nodule. A biopsy was consistent with atypia of undetermined significance. Therefore, the specimen was sent for genetic testing. The patient has requested reimbursement for the gene test provided on 12/21/16. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of this patient. There is sufficient support for the services at issue in this clinical setting. In this patients case, pathology was consistent with atypia of undetermined significance. The submission to genetic studies was appropriately done in this case, because it was important for medical decision making. The results of this testing were important to determine whether to perform thyroidectomy or not, and the extent of surgery. With a benign result, surgery may be avoided. The test is in vitro, which confers no physical risk to the patient. The sample is obtained at the same time of the fine needle aspiration biopsy, and no additional procedure is needed. In sum, gene test provided on 12/21/16 was likely to have been of greater benefit than other available modalities for 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: Insurer Denial Overturned

Summary Reviewer 3

The patient is a 61-year-old female with a history of a thyroid nodule. Fine needle aspiration was indeterminate. The provider recommended Afirma testing. The patient has requested reimbursement for the gene test provided on 12/21/16. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of this patient. The medical evidence supports the services at issue in this patients case. Genetic testing is generally considered standard protocol on all fine needle aspirations done on thyroid nodules. The medical literature indicates that this test can be utilized to avoid unnecessary surgeries. Thus, gene test provided on 12/21/16 was likely to be 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The parent of a 17-year-old male enrollee has requested reimbursement for mental health residential treatment provided from 6/10/16 through 9/16/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. In cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining necessary level of care for children. With regards to risk of harm, the records support a score of 4. The records documented suicidal gestures/attempts and injury to others. The documentation noted a history of marked impulsivity and poor judgment. In terms of level of support of the recovery environment, the records support a score of 2. The patient had a supportive environment. With regards to functional status, the records support a score of 3. The patient had issues in school, and his learning was adversely impacted by attention deficit/hyperactivity disorder. In terms of resiliency and treatment history, the records support a score of 5. The patients response to prior treatment had been minimal. With regards to comorbidity, the records support a score of 1. The patient had no comorbidity. In terms of acceptance and engagement of the child, the records support a score of 3. The patient had a history of rejecting clinical providers. With regards to level of stress of the recovery environment, the records support a score of 3. The patients family had limited ability to respond to the patients development. In terms of acceptance and engagement, the records support a score of 2. The patients parents had a history of developing therapeutic relationships with care providers. Thus, the patient has a composite score of 23. Based on this score, residential treatment level of care was medically necessary. Thus, mental health residential treatment provided from 6/10/16 through 9/16/16 was medically necessary for the treatment of this patient. Therefore, 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: Insurer Denial Overturned

Summary Reviewer 


A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b.  The physician reviewer found that according to the most recent 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, regardless of fibrosis, should be treated except those with life expectancy less than 12 months due to non-liver-related comorbid conditions. Patients who have failed treatment with peginterferon and ribavirin are recommended to be re-treated with daily Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). This patient should not be considered a failure of Sovaldi/ribavirin as he did not complete that therapy. Further, resistance to the medication due to prior use is not a concern. In the COSMOS trial, sofosbuvir resistance was not observed (Lawitz, et al). Based on published evidence of safety and efficacy in the published literature, and clinical guidelines, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for treatment of this patients hepatitis C virus infection. 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: Insurer Denial Upheld

Summary Reviewer 1

A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. 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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There is currently insufficient high quality clinical outcomes reported in the peer-reviewed medical literature to allow one to make definitive conclusions regarding the relative safety and efficacy of proton radiation for rectal cancer, as compared to standard of care photon-based radiotherapy. This patient could have been treated safely and effectively with photon-based radiotherapy. Therefore, proton beam therapy provided from 5/20/19 through 7/12/19 was not likely to have been more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. 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 compared to standard radiotherapy with photon-based intensity modulated radiation therapy, the benefit of proton therapy is that with its Bragg Peak, radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. Comparing dosimetric parameters, proton therapy will always appear superior to photon-based intensity modulated radiation therapy. However, this dosimetric benefit does not always translate into an actual clinical benefit to the patient. While there are several dosimetric studies evaluating proton therapy for rectal cancer, there is a lack of studies evaluating clinical benefit. In this case, the treating provider submitted a comparison dose-volume histogram of intensity modulated proton therapy versus photon therapy. However, the photon therapy was a three-dimensional conformal plan and not an intensity modulated radiation therapy plan. Thus, a true comparison of the benefit of protons versus photons cannot be made. In sum, proton beam therapy provided from 5/20/19 through 7/12/19 was not likely to have been more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. 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 standard treatment for rectal cancer is with photon techniques. Currently, there is a lack of clinical data in the medical literature to suggest that treatment with protons offers a clinical benefit compared to conventional radiation therapy techniques for tumors of the rectum.  Consensus group guidelines do not support the use of proton therapy in this setting. Also, there is a lack of phase 3 studies that demonstrate proton therapy is associated with less side effects compared to standard therapy with photons in patient with pelvic malignancies. The dose comparison was reviewed as well and showed no clinically significant benefit with the use of protons over standard techniques, as all standard dose metrics are being met with the standard plan. Thus, proton beam therapy provided from 5/20/19 through 7/12/19 was not likely to have been more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. 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 inoperable advanced pancreatic cancer is an incurable disease, but chemotherapy can prolong survival. In all cases, the genetic mutations that are present with pancreatic cancer can provide prognostic significance and can help direct therapy. Mutational analysis is also part of the algorithms that are included within the National Comprehensive Cancer Network guidelines. According to the National Comprehensive Cancer Network guidelines, aGermline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes. Genetic counseling is recommended for patients who test positive for a pathogenic mutation or for patients with a positive family history of cancer, especially pancreatic cancer, regardless of mutation status.a  The guidelines also state, aTumor/somatic gene profiling is recommended for patients with locally advanced/metastatic disease who are candidates for anticancer therapy to identify uncommon mutations...Testing on tumor tissue was preferred; however, cell-free DNA testing can be considered if tumor tissue testing is not feasible.a In this case, the records noted that tissue-based testing was not feasible. There is sufficient support for the services at issue in this clinical setting. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. 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 pancreatic cancer has notably been a difficult cancer to treat. With the emergence of new agents to treat pancreatic cancer, particularly biologics, clinical trial strategies incorporating principles of molecular biology and new imaging methods as well as results from preclinical studies are important. Per the National Comprehensive Cancer Network guidelines, tumor/somatic gene profiling is recommended for patients with locally advanced/metastatic disease who are candidates for anti-cancer therapy to identify uncommon mutations. Molecular profiling or next-generation sequencing can help identify available therapies and identify clinical trials. It can also evaluate for microsatellite instability, mismatch repair and tumor mutational burden status to determine eligibility for immunotherapy. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. 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 Guardant assay is a multigene assay that looks at cell-free DNA in the blood, presumably shed by cancer cells. In certain situations, where tissue biopsy is not feasible or safe, it can be used instead of a tissue biopsy assay. The hope with this and other similar assays is that they will identify a molecular target at which a therapeutic drug can be aimed to produce a clinically beneficial outcome. Thus far, however, the assay has not been shown to yield reliable and clinically useful results. A randomized study by Le Tourneau and colleagues did not demonstrate advantage to treating based on such an assay versus conventional judgment. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer


The patient is a 63-year-old male who presents with recurrent sinusitis with symptoms of rhinorrhea, nasal congestion, nasal discharge and facial pain. The patients prior medical history is also significant for moderate persistent asthma, allergic rhinitis, gastroesophageal reflux disease (GERD), hypertension, and deviated septum/polyps. The patient also with reported history of asthma with complaints of cough and wheezing. The patients has been treated with ProAir HFA, Flonase, fluoxetine, intranasal saline, and Losartan. The patient has requested authorization and coverage for Dulera 100 mcg/5 mcg inhaler. The Health Insurer has denied this request indicating that the requested medication is not medically necessary. There was no documentation provided in terms of spirometry, bronchodilator response or bronchoprovocation testing that this patient has a confirmed diagnosis of asthma. In addition, no records were provided on the patients current symptoms or longevity of disease. Furthermore, there is no documentation that the patient has failed treatment with other inhaled corticosteroid/long-acting B2-agonist (ICS/LABA) medications such as Advair, Breo, Symbicort, or generic fluticasone/salmeterol, which are on the Health Insurers formulary. Given these findings, the requested Dulera 100 mcg/5 mcg inhaler is not supported as medically necessary for treatment of this patients medical condition.  Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 46-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. 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 the patient has obstructive sleep apnea. The drug induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse at the velum and tongue base/epiglottis. The patient has not been able to tolerate the APAP device. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. At this point, the patient is a candidate for the Inspire device, given the intolerance to APAP, anterior posterior collapse, no central apnea, and body mass index (BMI) and apnea-hypopnea index (AHI) within FDA criteria. There is sufficient support for the requested services in this clinical setting. Therefore, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is likely to be more beneficial than other available standard therapy.