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

A 57-year-old male has requested  stereotactic body radiation therapy (SBRT) for treatment of his prostate cancer.  Findings:  Three physician reviewers found that the patient presented to his provider with an elevated prostate specific antigen (PSA) of 7.4. The patient was found to have Gleason score 3+3 adenocarcinoma stage T1c prostate cancer without evidence of perineural invasion. Currently, large scale and long-term clinical trials comparing SBRT with or without CyberKnife to standard treatments are not available. The National Comprehensive Cancer Network (NCCN) guidelines state that further studies are needed prior to recommending SBRT as standard therapy for patients with localized prostate cancer. Further, there are no clinical studies demonstrating superior efficacy or safety over the current standard treatments for prostate cancer. Given the lack of reliable scientific data showing improved health outcomes with SBRT over standard alternatives, including surveillance, the requested therapy is not likely to be more beneficial for treatment of this patients prostate cancer than any available modality.
Appeal type: Medical Necessity
Decision: Upheld

A 47-year-old female enrollee has requested lap-band surgery (laparoscopic banding) for treatment of her obesity.   Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity for the requested procedure. Bariatric surgery is indicated for patients with a BMI of 40 or above, or a BMI of at least 35 with severe co-morbid conditions. This is part of standard guidelines such as the National Institutes of Health (NIH) consensus guidelines for bariatric surgery. The patient has a BMI above the guidelines and the submitted medical records do not document the presence of serious co-morbid conditions such as diabetes, hypertension, coronary artery disease or sleep apnea. Moreover, there is a lack of documentation showing failed weight loss efforts. Thus the request for lap-band (laparoscopic banding) surgery is not clinically indicated at this time. All told, the medical necessity of the requested procedure has not been established.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for a chest computed tomography (CT) scan. Findings: The natural progression of ground-glass nodules is highly variable, ranging from self-resolving inflammatory processes to pre-malignant lesions resulting in adenocarcinoma. While there are no clear guidelines on how to best monitor existing pulmonary nodules, providers generally perform risk-stratification on patients with existing subsolid pulmonary nodules to help in guiding a CT surveillance program. In this case, the patient is a former smoker who presents with multiple, persistent ground-glass pulmonary nodules. The provider recommends low-dose chest CT for ongoing surveillance at the five-year interval. Given this patients risk factors, including significant smoking history, interval stability and persistence of the nodules, the ground-glass appearance of the nodules, and upper lobe location of two of the nodules in question, the requested service is medically indicated. Therefore, a chest CT scan is medically necessary for the evaluation of this patient.Final Result: The reviewer determined that the requested service is 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 internal medicine with sub-specialty certifications in pulmonary disease and  critical care 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: Medical Necessity
Decision: Upheld

The parent of a 17-year-old female has requested coverage for past psychiatric acute inpatient services for treatment of her behavioral health issues.  Findings:  The physician reviewer found that based on review of the available records, including the admission to a post-treatment facility, continued stay criteria for inpatient level of services were no longer met as of the date at issue. The treatment record and providers summary indicate that this patient was very compliant with treatment and participated well in groups. She had some clandestine behaviors of scraping herself with an eraser three times, which did not put her at any risk of harm. She also reported purging when staff was not watching her. The patients weight, body mass index (BMI), and vital signs remain within normal range.  These behaviors are typical of those routinely evaluated and treated at a lower level of care, and do not require the 24-hour level of care typically provided in the acute hospital setting.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for a regimen of Entyvio infusions 300 mg every four weeks. Entyvio is supported as primary therapy for patients with moderate-to-severe ulcerative colitis per the American College of Gastroenterology (ACG) guidelines. Dose intensification of Entyvio with infusions more frequently than every eight weeks has been studied in high-quality clinical trials. Randomized placebo-controlled trials support the safety and efficacy of more frequent dosing of Entyvio in patients who failed to achieve remission by week six to every four weeks instead of every eight weeks. Additionally, guidelines for the treatment of ulcerative colitis recommend dosage increase in the setting of uncontrolled disease, when the drug level is low and anti-drug antibodies are absent, as is present in this patients clinical setting. Without an increase in Entyvio dosing, this patient is at risk for complications of ulcerative colitis. In this clinical setting, the requested dose escalation of Entyvio to 300 mg every four weeks is supported by current medical literature (Park and Jeen). Therefore, the requested regimen of Entyvio infusions 300 mg every four weeks is medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested medication dosage is 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 subspecialty 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

A 52-year-old male enrollee has requested Tri-Luma cream for the treatment of his melasma. Findings:  The physician reviewer found that this patients symptoms constitute an abnormal condition of the body that is caused by disease. Melasma is an acquired disease that results in hyperpigmentation of the skin. It primarily occurs on the face although it can occur on other skin exposed to the sun. Men comprise only 10% of patients with this disorder and generally it affects dark skinned patients more often than those with light skin. There is a genetic component to the development of melasma and the condition is often a therapeutically challenging disease. Additionally, the requested medication is being used to create a normal appearance to the extent possible as pigmentary abnormalities, whether increased pigmentation as seen in melasma or loss of pigmentation as seen in vitiligo, are most debilitating in dark skinned races. As noted by Taylor and colleagues, pigmentary disorders pose significant negative impact on a persons health-related quality of life creating a need for effective treatments of pigmentary disorders based on their prevalence and effect on quality of life. The requested medication would be used to fade hyperpigmentation to produce as normal an appearance as possible in this patient. The requested medication will offer this patient more than minimal improvement in his appearance. As indicated by Grimes in his 1995 article, the bleaching agent Hydroquinone remains the most effective topically applied bleaching agent approved by the Food and Drug Administration for the treatment of melasma. This conclusion is reiterated by Grimes in his 2009 article in which he states that Hydroquinone remains the gold standard of topical agents for melasma.
Appeal type: Experimental/Investigational
Decision: Overturned

A 63-year-old female enrollee has requested a full body positron emission tomography (PET) scan for evaluation of her history of stage IV squamous cell carcinoma.  Findings:  Three physician reviewers found that PET/CT scanning is recognized by the Centers for Medicare and Medicaid Service (CMS) in the staging and follow-up treatment of head and neck cancer. The peer-reviewed medical literature demonstrates that PET/CT scan has been proven to detect head and neck tumor recurrence when it may be undetectable by other clinical methods. Additionally, fluorodeoxyglucose (FDG) permits highly accurate detection of head and neck cancer recurrence in the post-therapy period (Lowe, et al.). The early detection of head and neck cancer can improve survival rates. In this case, the patients provider states that the patient has no evidence of disease (NED) at this time, however, she continues to have pain in her neck on the right side. The provider indicates that this is likely fibrosis status post surgery and radiotherapy, however, the patients pain has not responded to physical therapy exercises. Therefore, this patient is not asymptomatic and given the sensitivity of PET/CT scans in detecting recurrence of head and neck cancer, it is reasonable for this patient to undergo another PET/CT diagnostic exam to rule out the recurrence of tumors.
Appeal type: Experimental/Investigational
Decision: Upheld

A 62-year-old male enrollee has requested daily interferon injections for the treatment of his mesothelioma. Findings:  Three physician reviewers found that the role of interferon in mesothelioma has not been demonstrated either in the resected adjuvant therapy or in metastatic/unresectable disease. It is not FDA approved, compendium listed or recommended by any expert consensus panel for this indication. The meeting abstract submitted with this appeal is a report of retrospectively treated patients who underwent resection followed by interferon therapy at the treating providers facility. While this unpublished report does demonstrate longer survival, interferon therapy still needs to be researched in a controlled, prospective study with larger numbers of patients and long-term follow-up data reported. Therefore, the therapy remains of unproven efficacy and superiority in this setting.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested proton beam radiation therapy for treatment of the enrollees prostate cancer.  Findings: Three reviewers found that based upon a review of the medical literature, proton beam radiation therapy is equivalent, but not more beneficial than standard available therapy, photon-based intensity-modulated radiation therapy (IMRT). The theoretical advantage of proton therapy is that it has a Bragg peak, resulting in decreased dose before and after the peak. This translates into a decrease in exposure of normal tissue in the low- to intermediate-dose range, but not in the high-dose range. Dosimetric studies have shown a benefit in bladder and rectal exposure with this regard, but so far, this does not appear to translate into actual decreased clinical side effect (Trofimov, et al; Sheets, et al). In addition, cancer control rates are also reportedly similar between photons and protons (Coen, et al). Accordingly, proton beam radiation therapy has not been established as likely to be more beneficial for treatment of the patients prostate cancer than any available standard therapy.Final Result: All 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 physician reviewers are board certified in radiation oncology and are actively practicing. The 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni 90-400 mg for treatment of the enrollees hepatitis C. Findings: The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication.  According to the most recent 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 limited life expectancy due to non-liver-related conditions.  The guidelines recommend that all patients should be treated, regardless of fibrosis stage.  The guidelines recommend that non-cirrhotic, treatment-naive, genotype 1b patients should be treated with Harvoni for 12 weeks.  These 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.  Zepatier for 12 weeks is also a recommended regimen, and the guidelines recommend either as acceptable therapy.  Thus, the Health Plans alternative Zepatier is medically appropriate for the treatment of this patient.  Therefore, the medical necessity of Harvoni 90-400 mg has not been established.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 physician 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

A 46-year-old female enrollee has requested a biologic ankle replacement for the treatment of her left ankle pain. Findings:  Three physician reviewers found that the efficacy of biologic ankle replacement remains unproven at this time. There are no prospective randomized studies to warrant its use other than for investigational purposes. Ankle replacement is performed very sporadically and is prone to high failure rate. This procedure, biologic replacement, has no significant published results to support its use at this time. As such, the requested procedure is not expected to be more beneficial than any other standard treatment in this setting.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested inpatient hospital services for treatment of the enrollee, who was injured in a motor vehicle accident. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue.  The patient was admitted after a motor vehicle accident with multiple injuries, including a T5 vertebral burst fracture.  Subsequently, the patient was able to ambulate with a front-wheeled walker.  He was not requiring any parental medications, his pain was controlled, and he was not having any problems with voiding or eating.  The documentation does not support that the patient required the inpatient level of care at issue; he could have been treated at a lower level of care.  All told, inpatient hospital services at issue were not medically indicated for the treatment of this patient. Final Result: The reviewer determined that the services at issue were 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 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Proton Beam Radiation Therapy (PBRT) services. Findings:  Three physician reviewers found that the current medical evidence has not established that treatment with PBRT offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Researchers evaluated the comparative effectiveness of intensity modulated radiation therapy (IMRT), proton therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. There were no other significant differences regarding toxicities between IMRT and proton therapy. A position statement released by The American Society of Radiation Oncology (ASTRO) in 2013 stated, At the present time, ASTRO believes the comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed, and thus the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. The National Comprehensive Cancer Network guidelines (v1.2018) endorse the position statement by ASTRO and state that no clear benefit of proton therapy has been demonstrated over standard treatment with photons and IMRT technique. Therefore, the services in issue were not likely to have been more beneficial than any available standard treatment for the patients medical condition.Final Result: The reviewers determined that the services in issue were 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: Physician reviewers 1, 2 and 3 are board certified in radiation oncology and are actively practicing. The 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the wireless capsule endoscopy (SmartPill Monitoring System) CPT code 91112 for evaluation of the enrollees gastroparesis. Findings:  The physician reviewer found that The SmartPill wireless capsule endoscopy is U.S. Food and Drug Administration (FDA) approved for evaluation of gastric emptying in gastroparesis, colonic transit in constipation and evaluation of generalized dysmotility. The device is recognized for assessment of gut dysmotilities by both the American Neurogastroenterology and Motility Society as well as by the American Gastroenterology Association. However, wireless capsule endoscopy has not been widely accepted as standard of care in clinical practice outside of tertiary care specialty centers and has not been demonstrated to be superior to gastric motility or colon transit testing. In this patients case, the available records do not support that she underwent a conventional gastric emptying scan prior to consideration of SmartPill deployment. Thus, the requested wireless capsule endoscopy (SmartPill Monitoring System) CPT code 91112 is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: Two of three reviewers determined that the requested diagnostic procedure is not likely to be more beneficial for evaluation of the enrollees medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one 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.Physician reviewer number two 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.Physician reviewer number three 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: Upheld

Nature of Statutory Criteria/Case Summary: A 29-year-old female requested reimbursement for air and associated ground ambulance transportation. Findings:  The physician reviewer found that The enrollee has f a history of anorexia nervosa for the past 10 years; brought to the emergency room with altered mental status; lethargic; bradycardic; hypotensive and hypothermic and was admitted to the intensive care unit. She was air transported in transfer to a facility where she had previously been treated for noted medical state at the time requiring continuous medical management.The patient had stabilized somewhat at the point of transfer and although important that she gets to an eating disorder facility. Air Ambulance transport is generally used for transport to the nearest facility or sometimes to get one to a particularly hyper-specialized medical facility that is more distant but only when in a medically unstable state. The patient could have either waited to be further stabilized to the point of not needing continuous medical care or if so ill as to needing medical transport, a nearer facility could have conceivably been located. Transport services were not in accordance with generally accepted standards of medical practice appropriate for the patient's illness and were therefore not medically necessary.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 psychiatry 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.