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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the digital breast tomosynthesis for evaluation of the enrollees breast cancer examination. Findings:  Three physician reviewers found that Tomosynthesis is approved for clinical use by the U.S. Food and Drug Administration (FDA) and by the Centers for Medicare and Medicaid Services (CMS) for reimbursement. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography the American College of Radiology (ACR) urged the technique be removed from the investigational category due to the advantage it brings radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass and architectural distortion resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional (2D) imaging alone. In this case, post lumpectomy architectural distortion would be expected and the addition of tomosynthesis provides added confidence in separating post-operative distortion from recurrent cancer. Thus, the addition of tomosynthesis was likely of greater value to the patient than had her exam been done with 2D imaging alone. Accordingly, the digital breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The 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. 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: Overturned

A 59-year-old male enrollee has requested for Avastin for treatment of his breast cancer. Findings:  Two physician reviewers found that the use of bevacizumab in combination with paclitaxel has been shown to improve progression-free survival in a randomized phase III cooperative group study of the Eastern Cooperative Oncology Group. Both paclitaxel and docetaxel are taxanes and have known efficacy in breast cancer treatment.
Appeal type: Medical Necessity
Decision: Overturned

A 68-year-old male enrollee has requested Zometa for treatment of his multiple myeloma with spinal metastasis. Findings:  The physician reviewer found that biphosphonates are a class of drugs that appear to decrease bone resorption in situations such as osteoporosis as well as in metastatic cancer to bone. They have become standard therapy in many types of cancer including myeloma. In such situations, they decrease the rate of skeletal complications such as fractures or the need for radiation therapy. The issue in this case is the choice of biphosphonate: Zometa or pamidronate IV. Pamidronate is the older of the two drugs. It requires at least two hours of infusion time monthly. Zometa is given over 15 minutes monthly. Rosen reported on a randomized study of Zometa versus pamidronate involving 1648 patients with myeloma or breast cancer. Though in many endpoints there was equality between the two drugs, those who received Zometa had a significantly lower incidence for the need for radiation therapy as compared to patients receiving pamidronate. Thus, this study does provide some justification for the use of Zometa over pamidronate. Furthermore, myeloma patients on Velcade often have to visit their oncologists office more than once per week. The additional burden of a two-hour (or more) monthly infusion of pamidronate can be quite burdensome in this setting. Zometa has become the standard in most oncology practices. Its use in this particular case is medically reasonable and necessary and should be authorized.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Mavyret 40-100 mg, three tablets daily for eight weeks. The submitted documentation supports the medical necessity of the requested medication regimen. 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 should be treated, except those with limited life expectancy due to nonliver-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 Mavyret for eight weeks. These recommendations are based on multiple randomized clinical trials showing high cure rates, and the medication is U.S. Food and Drug Administration approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage.  Guidelines cite data showing reduced survival with delayed treatment. For these reasons, Mavyret 40-100 mg, three tablets daily for eight weeks is medically necessary for this patient.Final Result: The reviewer determined that the requested medication regimen 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 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested digital breast tomosynthesis for evaluation of the enrollees 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.  In this patients case, her breasts have been described as heterogeneously dense.  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, especially considering the area of right-sided asymmetry.  Thus, digital breast tomosynthesis was likely to have been more efficacious than other treatment alternatives.Final Result: Three reviewers determined that the service 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 physician reviewers are board certified in diagnostic radiology 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: Overturned

 The patients parent has requested authorization and coverage for tacrolimus 0.1% ointment. Atopic dermatitis is a chronic, highly pruritic inflammatory disorder of the skin. The disease may be associated with complications that include secondary infections. Frequent disruption of sleep is common, and emotional stress associated with the illness can have a significant impact on quality of life for patients and families. The physician reviewer found that  the treatment of patients with atopic dermatitis. In addition, the U.S. Food and Drug Administration (FDA) issued a recommendation for its topical use in patients two years of age and older that have moderate-to-severe atopic dermatitis and that have not responded to other treatments. This patient has moderate-to-severe atopic dermatitis that did not respond to a long-term topical corticosteroids therapy. Moreover, topical tacrolimus is an FDA approved second-line treatment for pediatric patients with atopic dermatitis two years of age and older. The patients condition has failed treatment with steroidal cream and emollients but improved on tacrolimus. Given this support, the requested tacrolimus 0.1% ointment is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for spinal surgery. This patient experienced short-term relief from right-sided back and leg pain with prior surgery. The operative notes reported that a disc herniation was not found, nor was disc material removed, although there was evidence of local narrowing. Thus, the patient does not have recurrent herniated nucleus pulposus. Since the patient underwent a surgery, he has received eight physical therapy sessions, but there is no indication whether the patient participated in a home exercise program. There is no documentation of failure of at least 12 weeks of conservative management. In addition, the records do not report that he received epidural steroid injections or other injections. He has no documented symptoms or signs nor findings of a lumbar radiculopathy. He has no symptoms of neurogenic claudication. He has no evidence of instability. There is no documentation of nerve root compression. There is no correlation of his imaging with his clinical condition. There is no evidence of spondylolisthesis nor stenosis. For these reasons, the patient fails to fulfill the current criteria for lumbar fusion. Accordingly, the requested spine surgeryand two day stay is not medically necessary for treatment of this 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 neurological 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

The patient is a 53-year-old woman who has bilateral breast implants. A mammogram was performed in September 2002, which showed bilateral implants. There were also benign appearing calcifications in the left breast. The patient wishes to obtain a breast ultrasound instead of a mammogram. The Health Plan has denied the patients request indicating that a breast ultrasound is not medically indicated.It is true that there is a small risk of rupturing the implants with mammography, especially with older implants. However, ultrasound of the breast has never been considered a primary screening method. Ultrasound has been used in addition to mammography to evaluate a specific finding or to further evaluate breasts with dense tissue. Currently, breast ultrasound as a screening exam is under evaluation. Ultrasound cannot evaluate microcalcifications, which may be an indication of malignancy. Current scientific literature indicates that if screening sonography is to be used, it should be considered a supplement to screening mammography; a woman should not forgo mammography. Ultrasound is not a substitute for mammography and therefore, is not medically necessary at this time. Ultrasound may be indicated in the future, depending on the physical exam and mammogram findings. Based upon the information set forth above, I have determined that the requested ultrasound is not medically necessary for evaluation of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

A 57-year-old male enrollee requested authorization and coverage of an injection of Supartz. The Health Plan denied the request indicating that the requested injection is not medically necessary for the treatment of the enrollees right knee pain.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the Health Plans denial on the basis that the requested injection is not medically necessary at this time.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage/reimbursement for (1) Evenity injections (210 mg), and (2) Evenity injections (210 mg) administered every four weeks. The U.S. Food and Drug Administration (FDA) approves the use of Evenity (generic name romosozumab), for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or in patients who have failed or are intolerant to other available osteoporosis therapy. Studies in current medical literature on the use of romozosumab for the treatment of osteoporosis primarily concentrate on postmenopausal women with severe osteoporosis, with T-scores greater than -3.5 or with fragility fractures. Given that romosozumab is not considered initial therapy for most patients with osteoporosis, and as the records do not demonstrate a history of fracture, the services at issue were not and are not medically necessary. Therefore, (1) Evenity injections (210 mg), and (2) Evenity injections (210 mg) administered every four weeks were not and are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the medication at issue was not and 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 rheumatology 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 Harvoni 90-400 mg for 12 weeks for treatment of his hepatitis C virus. Findings:  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 should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Additionally, the guidelines report that patients with certain extrahepatic manifestations of hepatitis C, such as cryoglobulinemia, should be prioritized for treatment.  Per the guidelines, treatment naive, genotype 1 patients should be treated with Harvoni. The guidelines recommend that non-cirrhotic treatment, naive, genotype 1 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 approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. Final Result: The reviewer determined that the requested medication regimen 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 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested three-dimensional breast tomosynthesis for evaluation of her medical condition. Findings: Three physician reviewers found that there is sufficient support for the services at issue in this clinical setting.  The benefits are related to the tomographic qualities of the technique and relate to the ability of radiologists to separate dense underlying glandular tissue from underlying architectural distortion.  The addition of breast tomosynthesis to screening mammography has become popular among radiologists due to an associated decrease in callbacks and increase in detection of small cancers.  Thus, the addition of tomosynthesis to the two-dimensional mammographic images was likely to have been more beneficial to the patient than two-dimensional mammography alone.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 physician reviewers are board certified in diagnostic radiology 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: Overturned

Nature of Statutory Criteria/Case Summary: The enrollee has requested reimbursement for bilateral mastectomy for treatment of the enrollees gender dysphoria and were not reconstructive in nature. Findings:  The physician reviewer found that There is support in the medical literature for the services at issue in this clinical setting. This patient has documented gender dysphoria and is in the transition to becoming a male. The patients age should not be a sole determinant of medical necessity. The records note evidence of abnormal breasts for a male despite the use of hormonal therapy and would have not have likely resolved with continued therapy. An examination in February 2017 noted evidence of breasts that were consistent with the female gender. Since this patients condition would not have resolved even with hormone therapy, surgical intervention to treat this patients dysphoria was clinically appropriate. Therefore, the bilateral mastectomy performed on was medically necessary for treatment of this patients gender dysphoria. With regard to whether the services at issue were considered reconstructive in nature, the submitted documentation revealed that the patients breast development constituted an abnormal structure of a male body. The patients breast development should be more consistent with an adult male body. Reconstructive surgery is performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. In this patients case, the abnormal breasts was a developmental abnormality for a male. This surgery is generally performed to improve function, but may also be performed to approximate an appearance more closely resembling a male chest, to the best extent possible. In this patients case, he had evidence of an abnormal chest for a male. The patients breasts should be more consistent with a male chest. As such, the surgery offered a more than minimal improvement in the appearance of this patients chest. All told, the bilateral mastectomy performed was reconstructive in nature. Final Result: The reviewer determined that the services at issue were medically necessary for treatment of the patients medical condition and were reconstructive in nature. 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: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Synvisc-One injections in both knees. Per the medical literature, although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patient has a history of bilateral osteoarthritis and several years of documented benefit from prior Synvisc-One injections. The patient has tried and failed other conservative treatments, with the alternative being a total knee arthroplasty. Given the patients limited options and based on the current medical literature, the requested services are medically indicated. Therefore, Synvisc-One injections in both knees are medically necessary for the treatment of this patient.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 orthopedic 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.