Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

 Nature of Statutory Criteria/Case Summary:  An enrollee has requested Praluent for treatment of his medical condition.  Findings:  The physician reviewer found that the medical records document hyperlipidemia, and inability to tolerate statin therapy and no documented obstructive coronary disease, as a high calcium score does not equate to obstructive coronary disease.  In this circumstance, there is no documentation that the patient has heterozygous familial hypercholesterolemia.  Heterozygous familial hypercholesterolemia usually manifests by a combination of physical examination findings and LDL levels that are usually significantly higher than the patients current level.  In addition, there is no documented angina, no documented ischemia on stress testing, and no documented coronary stenosis on angiography.  Moreover, there are other non-statin medications that have been demonstrated to improve cardiovascular outcome that have not been documented to be prescribed.  Praluent is indicated for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL cholesterol.  This patient does not fit those criteria.  All told, the requested medication Praluent is not medically indicated for the treatment of this patient.  Final Result:  The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested urine estrogen metabolite testing for treatment of her medical condition. Findings:  The physician reviewer found that review of the submitted evidence indicates the patient is on hormone therapy and also has a number of medical problems that may put her at additional risk using hormone therapy, in particular compounded hormones. The patient requests urinary testing as a tool to make such use safer by testing her urinary hormone levels.. Despite claims to the contrary, evidence is inadequate to support increased efficacy or safety for individualized hormone therapy regimens based on salivary, serum, or urinary testing. Due to the pharmacokinetics of estrogen metabolism, urinary estrogen levels do not correlate with serum levels of the hormones being measured. Such measurements do not allow for a more safe use of these compounded products. Moreover, there is a lack of literature demonstrating the utility for urinary testing to guide the use of hormone therapy. Also, the American College of Obstetricians and Gynecologists (ACOG) specifically recommends against such testing. For the reasons provided, urine estrogen metabolite testing is not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in obstetrics and gynecology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested breast tomosynthesis for evaluation of her medical condition.   Findings:  Three physician reviewers found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  As noted by researchers, breast tomosynthesis has the potential to change conventional mammographic screening and diagnostic imaging with possible improvements in cancer detection, decreased callbacks, and fewer false positive biopsies.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Thus, breast tomosynthesis was likely to have been of greater benefit than other methods of evaluating this patient.   Final Result: Three reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications:   All three reviewers are board certified in diagnostic radiology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested a lumbar traction device for treatment of his medical condition. Findings:  Three physician reviewers found that there is insufficient high-quality data from peer-reviewed published studies to conclude that the mechanical lumbar traction is clinically effective in the management of chronic mechanical low back pain. Overall, the literature does not support the requested device in this clinical setting.  In sum, the requested device is not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy such as exercise and topical thermal modalities. Final Result: Three reviewers determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications:   All three reviewers are board certified in physical medicine and rehabilitation and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested epidermal growth factor receptor (EGFR) gene analysis and Foundation One testing for evaluation of his medical condition.  Findings:  Two physician reviewers found that the EGFR gene analysis and Foundation One testing were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Glioblastoma multiforme (GBM) is an incurable disease. The standard of care is resection of the GBM maximally followed by treatment with temozolomide. On temozolomide treatment concomitant with radiation therapy, a randomized clinical trial showed only 26.5% two-year survival compared to 10.4% in the cohort receiving radiation only. Most GBM tumors recur and then the treatment options are limited. Initially, this patient was tested for EGFR amplifications and mutations and phosphatase and tensin homolog (PTEN) loss. There is sufficient medical evidence to suggest that these two molecular markers are important predictors of response to EGFR inhibition. Subsequently, the patients tumor was submitted to Foundation One for molecular testing to identify mutations that allow enrollment in appropriate clinical trials. Recently, it has become important to identify mutations that may be amenable to targeted therapy. Researchers performed a study of 86 patients where the progression-free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. Given the above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Two reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications:   One reviewer is board certified in medical oncology and is actively practicing. Two reviewers are board certified in internal medicine with sub-specialty certification in medical oncology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested nighttime licensed vocational nurse (LVN) services for treatment of her medical condition. Findings:  The physician reviewer found ALS is a progressive neurodegenerative disorder that causes muscle weakness and disability, with a median survival of three to five years. Symptomatic management is the mainstay of treatment for ALS. Skilled nursing care, according to Medicare benefit policy manual, includes care for a G-tube and suctioning via a tracheostomy. In this case, the patient suffers from a neurodegenerative disorder and further decline in her function and medical condition is expected.  The patient has a tracheostomy and requires regular suctioning overnight to maintain a patent airway. Care for both a feeding tube and a tracheostomy can be taught to a layperson, however, it is medically necessary to provide the care of a skilled nurse while that layperson (caregiver) is sleeping.  Therefore, nighttime LVN services are medically necessary in this clinical setting. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: The reviewer is board certified in internal medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested implantation of an Inspire Upper Airway Stimulation Device for treatment of his medical condition.   Findings:  Two physician reviewers found that implantation of an Inspire Upper Airway Stimulation Device is not likely to be more effective for this patient than other available options. Although the device is U.S. Food and Drug Administration (FDA) approved for obstructive sleep apnea intolerant to CPAP, the amount of literature that supports its use is not substantial or convincing. Specifically, the studies have been small and not designed as a head to head comparison of more accepted therapies for OSA. The use of upper airway stimulation devices remains a new technology and will require ongoing review as new data emerges comparing the device to other more conventional forms of OSA therapy. For the reasons provided, the requested services are not likely to be more beneficial than standard medical therapy in this clinical setting. Final Result: Two reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: One reviewer is board certified in neurology with sub-specialty certification in sleep medicine and is actively practicing. Two reviewers are board certified in internal medicine with sub-specialty certification in pulmonary disease and is actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested magnetic resonance imaging (MRI) for the evaluation of his medical condition.  Findings:  The physician reviewer found that there is sufficient support for the requested services in this clinical setting.  There are several treatment options for prostate cancer.  These include active surveillance, radiotherapy, and surgery.  In addition to the risk of tumor recurrence, each of these treatment options carries significant risk of morbidity.  The risks of continuing urinary incontinence and erectile dysfunction are potential complications that are experienced by many patients.  It is not unreasonable to have as much information as possible to help guide a treatment choice, and avoid unnecessary surgery.  In this patients case, based on his Gleason score, active surveillance would likely be excluded as a possibility.  There are instances of both false positive and false negative findings with MRI.  The issue is further complicated by the large number of MRI options.  MRI can be performed simply for anatomic delineation.  However, it can also be performed with diffusion weighting, with dynamic contrast enhancement, with spectroscopy, and with multiparametric imaging.  There are several articles published which note the increased accuracy with multiparametric MRI.  All told, the requested MRI is medically indicated for the evaluation of this patient.  Final Result: The reviewer determined that the requested services are medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: The reviewer is board certified in diagnostic radiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested breast tomosynthesis for evaluation of her medical condition.  Findings:  Three physician reviewers found that tomosynthesis allows the provider to separate various layers of breast tissue to better detect abnormalities. This has been shown to be most useful in the evaluation of the dense breast tissue. The services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Three reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: All three reviewers are board certified in diagnostic radiology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested a Lemtrada infusion for treatment of her medical condition.  Findings:  The physician reviewer found that Lemtrada is U.S. Food and Drug Administration (FDA) approved for patients who have tried at least two previous therapies for treatment of MS which have failed. Based on the documentation submitted for review, it is not clear that the patient has failed treatment with Gilenya as she has not consistently been on the medication. Her last documented relapse which prompted the switch to Lemtrada, occurred soon after re-initiation of Gilenya. In this case, the patient has highly active disease and needs aggressive therapy. However, treatment with Gilenya has not been used consistently. Moreover, most providers reserve Lemtrada for the most refractory cases due to its significant serious side effects. Given the clinical documentation submitted for review, the medical necessity for Lemtrada infusion has not been established in this clinical setting. Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Harvoni for treatment of his hepatitis C virus.  Findings:  The physician reviewer found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) treatment guidelines, there are several treatment options with similar efficacy in general that are recommended for treatment-naive patients with HCV genotype 1a infection. The recommended regimens include: daily Harvoni for 12 weeks (Class I, Level A); and daily fixed-dose combination of Viekira Pak and weight-based ribavirin for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) (Class I, Level A). Viekira Pak and weight-based ribavirin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HCV genotype 1a infection in treatment-naive patients. The SAPPHIRE-I trial reported a high sustained virologic response (SVR) of 95.3% with 12 weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir and ribavirin (Feld, et al). In this case, the patient is requesting Harvoni out of concern for possible ribavirin side effects. However, no drug-to-drug interactions were identified in the patients medical records. In addition, the submitted records do not support hemolytic anemia, renal impairment, autoimmune hepatitis, or documented hemoglobinopathies to contraindicate either Viekira Pak or ribavirin. Moreover, Viekira Pak with ribavirin and Harvoni are both equally rated and recommended in this clinical setting by AASLD/IDSA guidelines. In sum, the medical necessity for Harvoni has not been established in this clinical setting. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and Daklinza for treatment of her hepatitis C.  Findings: The physician reviewer found that according to joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions.  In treatment-naive genotype 3 patients, therapy is recommended with Sovaldi and Daklinza for 12 weeks.  This patient is ineligible for alternative regimens requiring peginterferon due to a pre-existing condition.  For these reasons, Sovaldi and Daklinza are medically necessary for the treatment of this patients hepatitis C infection. Final Result: The reviewer determined that the requested medications are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary:   An enrollee has requested osteochondral allograft transplant for treatment of his medical condition.   Findings:  Three physician reviewers found that the submitted documentation does not demonstrate the superior benefits of the requested services.  Osteochondral allograft is not indicated as a salvage procedure for advanced osteoarthritis, such as in this case.  Osteochondral allograft transplantation has been demonstrated to be a safe and effective treatment of large osteochondral and chondral defects of the knee in appropriately selected patients.  Higher rates of successful allograft transplantation are observed in younger patients, unipolar lesions, normal or corrected malalignment, and defects that are treated within 12 months of symptom onset.  Patients with bipolar lesions, uncorrectable malalignment, advanced osteoarthritis and those over 40 tend to have less favorable outcomes.  In this case, there is no single osteochondral defect, but rather eburnation of the medial compartment is described by the radiologist with advanced osteoarthritis of the medial compartment and moderate changes in the patellofemoral joint.   The allograft will be bipolar and large in size.  A review of the literature indicates that such allografts usually fail.  In sum, the requested osteochondral allograft transplant is not likely to be more efficacious than standard treatments.   Final Result: Three reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications:  All three reviewers are board certified in orthopedic surgery and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.