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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Verzenio 150 mg tablets, twice a day. The U.S. Food and Drug Administration (FDA) has not approved Verzenio for the adjuvant treatment of patients with breast cancer after neoadjuvant chemotherapy. There is a lack of support for treatment with Verzenio in the major drug compendia and the medical literature. Findings reported by Johnston and colleagues suggest that Verzenio may have a role in the treatment of patients with hormone receptor (HR) positive, HER2 negative breast cancer, following treatment with radiation, neoadjuvant chemotherapy, and/or adjuvant chemotherapy. However, the findings in the monarchE study are preliminary and additional data are needed to determine whether Verzenio is safe and effective for use in this patients clinical setting (Johnston, et al.). Additional data are needed to understand the long-term impact from the adjuvant use of CDK4/6 inhibitors in this setting. Although the monarchE study assessed early recurrence, this may have a different biology from last recurrences. Moreover, the findings of the PALLAS trial note that two year of adjuvant treatment with a CDK4/6 inhibitor and endocrine therapy did not improve invasive disease-free survival compared with adjuvant chemotherapy alone. The authors concluded that, this regimen cannot be recommended in the adjuvant setting. Given these findings, the requested Verzenio 150 mg tablets, twice a day are not medically necessary for 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 subspecialty certifications in medical oncology and hematology 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

A 42-year-old female enrollee has requested a duodenal switch procedure for treatment of her morbid obesity. Findings:  The physician reviewer found that in this case is whether the duodenal switch procedure is medically necessary for this patient as opposed to the alternatives mentioned above. Duodenal switch has added risk over the three alternatives. Despite this increased risk, duodenal switch has been proven to be a superior procedure in the treatment of super morbidly obese patients with BMIs of 50 or above. However, this patient does not fall within this category. Additionally, due to this patient's family history of gastric cancer,the patient's possibility of developing dumping syndrome and since the patient is on anti-inflammatory medication, the RNYGBP and Lap-Band procedures are not appropriate.The other alternative mentioned is gastric sleeve (lateral sleeve gastrectomy). The lateral sleeve gastrectomy procedure eliminates the possibility of pouch dilatation or fistula formation and is a safer option for patients on anti-inflammatory therapy. Additionally, there are fewer incidences of morbidities with lateral sleeve gastrectomy than with duodenal switch. The evidence-based literature demonstrates there are no reported metabolic side effects or dumping with lateral sleeve gastrectomy since the pylorus is preserved.  The submitted evidence does not demonstrate that this particular patient requires a duodenal switch procedure. The Health Plan's alternative of lateral sleeve gastrectomy is a medically appropriate option in this case.
Appeal type: Medical Necessity
Decision: Upheld

A 35-year-old male has requested Cialis 20mg (six tablets per month) for treatment of his erectile dysfunction.  Findings:  The physician reviewer found that PDE5 inhibitors block the degradation of cyclic guanosine monophosphate (cGMG) by the enzyme phosphodiesterase type 5.  The process of sexual stimulation involves the release of nitric oxide in the vasculature of the corpus cavernosum of the penis. Nitric oxide results in increase of cGMP and leads to the relaxation of smooth muscle in the blood vessels supplying the corpora cavernosa. The result is increased blood flow leading to erection.  In sum, the PDE5 drugs improve erection by improving blood flow to the penis.  As part of his workup and evaluation, the patient had a penile ultrasound test which showed normal blood flow to the penis and normal response to injection.  This would indicate no impairment of blood flow to the penis, either at rest or with stimulation. Therefore, the requested medication is not medically indicated, as testing has demonstrated normal blood flow.  All told, the requested Cialis 20mg (six tablets per month) is not medically indicated for the treatment of this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested breast tomosynthesis for evaluation of her medical condition.  Findings:  Three physician reviewers found that the current peer-reviewed medical literature supports the use of tomosynthesis in the routine screening population. The addition of digital breast tomosynthesis reduces false positives and increases cancer detection when compared to two dimensional full field digital mammography alone. The data suggests the additional of digital breast tomosynthesis reduces recall rates, allows for separation of structures to differentiate architectural distortion from masses and overlapping fibroglandular tissue, and has increased cancer detection. Thus, in this clinical setting, the use of the digital breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.  Final Result: Three reviewers determined that the diagnostic procedure at issue was 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

A 46-year-old female enrollee has requested  a panniculectomy for treatment of her excess skin. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services.  The patients photographs do not show any abnormal body structure.  The reviewed records document the existence of maceration and rash from skin irritation/infection.  However, this apparently resolved with treatment, as none was described at the subsequent examination.  Additionally, no maceration or rash is visible in the photographs.  Therefore, the patients condition does not constitute an abnormal structure of the body and the requested services are not reconstructive in nature.  In sum, the requested panniculectomy is not medically indicated for the treatment of this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested AmniSure testing for evaluation of her medical condition. Findings:  Three physician reviewers found that the diagnosis of ruptured membranes can generally be made on the basis of clinical examination and nitrazine and fern testing.  There have been false positive results from AmniSure.  In this patients case, the records do not document that there was clinical confusion as to the presence or absence of ruptured membranes by physical examination, nitrazine testing, or ferning.   It does not appear that these standard evaluations were performed.  The routine use of AmniSure to diagnose ruptured membranes is not recommended.  Thus, AmniSure testing was not likely to have been more efficacious than other methods of evaluating this patient. Final Result: Three reviewers determined that the services at issue were not likely to be more beneficial for evaluation 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 obstetrics and gynecology 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested suction lipectomy for treatment of the enrollees medical condition.  Findings: The physician reviewer found that in this patients case, there is well-documented evidence of lipedema of the lower extremities.  This has affected her function with chronic pain and difficulty with ambulation.  Conservative management has included attempted weight loss, exercise, compression stockings, physical therapy, manual self-compression and lymphatic drainage without resolution.  Photographs provided show a significant condition of the lower extremities with sparing of the feet consistent with her diagnosis of lipedema.  Liposuction is a well-known therapy for lipodystrophy and has been shown to provide possible functional improvement in lipedema.  The current medical evidence supports the requested services in this clinical setting.  This patients lipedema is significantly affecting her function, and she has failed treatment with reasonable conservative measures.  Therefore, the requested suction lipectomy is medically necessary for the treatment of this patient. Additionally, the requested services are also reconstructive in nature.  This patients condition constitutes an abnormal structure of the body.  She has abnormal enlargement of the extremities that are out of proportion to uninvolved structures.  This is a developmental abnormality, as this appears to have begun after puberty.  The planned surgery will be performed to improve function.  Additionally, the requested suction lipectomy is likely to provide more than a minimal improvement in the appearance of the lower extremities.  In sum, the requested suction lipectomy is reconstructive in nature and is medically indicated for the treatment of this patient.Final Result: The reviewer determined that the requested services are reconstructive in nature and 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 plastic surgery 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

A 49-year-old male enrollee has requested liposuction and/or excision of lipoma and excessive tissue of the upper back, posterior neck, back and head for treatment of his lipodystrophy. Findings:  The physician reviewer found that liposuction can be necessary to treat focal lipodystrophy of the neck as a result of taking medically necessary medications to treat a disease. However, as is prudent prior to undertaking any surgical procedure, all reasonable non-operative measures to alleviate symptoms or to improve conditions should be exhausted prior to the procedure. In this patients case, there is no documentation as to any non-surgical measures having been tried and failed (e.g., medications for pain or physical therapy to improve his neck function). Davison and colleagues enumerate some non-operative measures that are appropriate for patients with lipodystrophy. In this case, detailed documentation regarding the characteristics of the lipoma/excess tissue has not been provided and there is no evidence of attempts with non-surgical measures for symptom relief. As such, the medical necessity of the requested service has not been established.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee requested magnetic resonance imaging (MRI) of the neck spine and back spine without dye for medical evaluation of his chronic back pain.  Findings:  The physician reviewer found that the clinical documentation submitted for review does not demonstrate that the patient has an abnormal neurologic exam or unequal reflexes on exam. In addition, there is no documentation of a course of physical therapy in the medical records provided. Based on the medical literature and clinical documentation provided, the request for MRI of the neck spine and back spine without dye is not medically necessary for evaluation of the patients medical condition.Final Result: The reviewer determined that the requested services are not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in diagnostic radiology with sub-specialty certification in interventional 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for biopsy of a right ovarian cyst and a hysterosalpingogram. The submitted documentation supports the medical necessity of a portion of the requested services. Ovarian cysts noted on ultrasound are typically followed with repeat scanning in six to eight weeks to monitor for resolution. In this case, the patient underwent a pelvic ultrasound that showed a small ovarian cyst that is consistent with a hemorrhagic cyst. There are no unique clinical circumstances noted in the submitted records that would support ovarian cyst biopsy, as this is not consistent with evidence-based standard of care. Therefore, the requested biopsy of the right ovarian cyst is not medically necessary to treat the patients medical condition.There is sufficient support for the requested hysterosalpingogram. A hysterosalpingogram is a standard diagnostic test for the work-up of infertility.  The diagnoses listed in the clinical documentation for this patient include infertility as an active problem. Therefore, a hysterosalpingogram is medically indicated to assess this diagnosis. Thus, the requested hysterosalpingogram is medically necessary for the evaluation of this patient. Final Result: The reviewer determined that a portion of the requested services is medically necessary to treat the patients medical condition. Therefore, the Health Plans denial should be partially overturned.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: Medical Necessity
Decision: Overturned

A 20-year-old male enrollee has requested inpatient treatment stay for treatment of his behavioral health problems. Findings:  The physician reviewer found that during the dates of service at issue, this patient was beginning to recompensate following necessary acute seclusion/restraint and anti-agitation medications. He remained labile, agitated and demonstrated little, if any, insight into his psychiatric concerns. His level of agitation, combined with the prior safety concerns posed at home, made it medically necessary for the patient to remain at an inpatient hospitalization level of care through the second day of treatment. Such intensity of service was required for his safety, monitoring and psychotropic therapy. However, from the third day of treatment through discharge, the patient was able to demonstrate reasonable control and improved insight which allowed him to participate in recommended therapies. This included acknowledgement of admitting the role of substance abuse as part of his mental health concerns. Thus, based on the patients medical condition from the third day of treatment onward, he could have been safely and appropriately treated at a lower level of care such as an intensive outpatient program level of care.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested  loperamide for treatment of her medical condition. Findings: The physician reviewer found that loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies. However,  U.S. Food and Drug Administration (FDA) guidance suggests dosing for these indications is appropriate at considerably lower milligrams than this patient routinely consumes. Toxicity is case-reported to include dependency, respiratory depression, catatonia, and the drug has the potential for euphoric effects that in some cases have required administration of naloxone or referral for drug rehabilitation.  In this case, the patients daily loperamide requirements are outside of the norm, and the requested doses are not standard of care. Moreover, it is unclear from the provided records that the patient has exhausted all conventional medications in treatment of the underlying cause of her diarrhea for which ostensibly loperamide has been required. Given the above, the support for the requested medication is not medically necessary for treatment of this patients medical condition.  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: Medical Necessity
Decision: Overturned

A 49-year-old female enrollee has requested for a cardiac stress test for evaluation of her risk for congestive heart failure.  Findings:  The physician reviewer found that the American Heart Associations (AHA) published guidelines for cardiovascular disease prevention in women would most likely recommend cardiac stress testing for further evaluation of the patient in this case. The medical literature shows that there is a higher incidence of atypical symptoms in women who present with coronary disease and this patient presents with atypical chest pain in addition to a positive family history of premature coronary artery disease. Thus, a non-invasive diagnostic procedure, such as the cardiac stress test, is medically indicated for further risk stratification in this patient. It should be noted that echocardiography alone will not identify occult coronary disease unless the patient has in fact had a prior infarction.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  The parent of an enrollee has requested Nucala (mepolizumab) for treatment of the enrollees medical condition.  Findings:  The physician reviewer found that the patients allergist, has drawn a comparison between eosinophilic gastritis and Eosinophilic Esophagitis (EoE), speculating that the long-term complications of eosinophilic gastritis may include the type of fibrosis that can be seen in the esophagus of patients with EoE. In EoE, this fibrosis can lead to esophageal narrowing and structuring, with swallowing dysfunction.  However, there is not a clear association between eosinophilic gastritis and mechanical gastric dysfunction. Considering the published literature, mepolizumab is not medically indicated in the clinical setting of eosinophilic gastritis. There is a lack of evidence in the peer-reviewed literature supporting Nucala (mepolizumab) would be helpful 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 pediatric 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: Overturned

Nature of Statutory Criteria/Case Summary: The representative of an enrollee has requested reimbursement for Guardant360 genetic testing. Per the National Comprehensive Cancer Network (NCCN) guidelines, EGFR, ROS1, ALK, and BRAF testing was appropriate in this clinical setting. Per the NCCN guidelines, it has not been determined if molecular markers are useful in treatment determination and prognosis other than tests referenced above. The Guardant360 testing offers a comprehensive panel of molecular genetic markers on an individuals tumor to identify markers than can help guide therapy decision making. As Guardant360 provides genetic testing to guide therapy, and this is the subject of an ongoing phase II trial, there is a lack of data to support its routine use in the evaluation and treatment of patients with adenocarcinoma. Thus, the EGFR, ROS1, ALK, and BRAF portions of the testing were likely to be more beneficial for evaluation of the patients medical condition than any available therapy, while the remainder of the genetic testing was not likely to be more beneficial for evaluation of the patients medical condition than any available therapy.One reviewer found that the genetic testing was not likely to be more beneficial for evaluation of the patients medical condition than any available therapy.Final Result: Two of the three reviewers determined that a portion of 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 partially overturned.Credentials/Qualifications:  One reviewer is board certified in internal medicine and medical oncology and is actively practicing. One Reviewer is board certified in internal medicine, oncology, and hospice and palliative medicine and is actively practicing.  One Reviewer is board certified in internal medicine, hematology, and oncology 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.