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

A 55-year-old female enrollee has requested for the use of AlloDerm in breast reconstruction surgery post-mastectomy for treatment of her post-mastectomy condition.   Findings:  Three physician reviewers found that prosthetic breast reconstruction with implant or expander is a current standard in immediate breast reconstruction post-mastectomy. A key issue with this surgical technique is attaining adequate pectoralis major muscle coverage of the implant/expander such that the prosthesis is held in place within the mastectomy pocket. Muscle loss during mastectomy and the poor quality of the remaining muscle could preclude extending the muscle over the prosthesis and securing it at the lower breast pole. Current options to supplement the muscle deficiency include the transfer of autologous tissue from the latissimus dorsi, the elevation of the external oblique muscle together with its rectus abdominus fascia for implant coverage, or the elevation of the serratus anterior muscle for lateral implant coverage. All of these options introduce further morbidity and, in the case of the latissimus tissue, has the added disadvantage of donor site complications.  The strength and flexibility of AlloDerm, as well as its ability to resist infection and rejection and to rapidly regenerate into viable tissue without scarring and fibrosis, makes it an ideal tissue substitute to supplement the muscle deficit at the lower breast pole. As a tissue replacement at the lower breast pole, AlloDerm helps to define the shape and contour of the reconstructed breast and better defines the inframammary pole.   A study by Spear of 100 patients undergoing implant expander coverage with AlloDerm has shown no incidence of hematoma, seroma, infection, or implant exposure as well as a decreased incidence of capsular contracture.  At least eight other studies show that AlloDerm can prevent rippling, symmastia, implant malposition, and bottoming-out, all common problems with expander based breast reconstruction.  AlloDerm is incorporated into the surrounding tissue and late re-operative biopsies show that over time AlloDerm takes on the histologic characteristics of fascia.  Based on the medical literature, the use of AlloDerm for breast reconstruction is appropriate and represents appropriate care.
Appeal type: Medical Necessity
Decision: Upheld

A 55-year-old female enrollee has requested for a powered wheelchair or scooter for treatment of her chronic obstructive pulmonary disease (COPD).  Findings:  The physician reviewer found that the Centers for Medicare and Medicaid Services (CMS) criteria states that power wheelchairs are not medically necessary if the primary purpose of use is to assist patients with community mobility. In addition, the criteria stipulate that the primary intended use for power wheelchair should be to assist patients complete mobility related activities of daily living (MRADLs) within the home. There is no documentation of difficulties with MRADLs within the home, the requested power scooter or wheelchair is not medically necessary for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for cyst removal and bone graft. The Health Plan has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition and are not reconstructive in nature.  Findings: The documentation provided does not support the medical necessity of the requested services at this time. The patient has a lesion within his anterior maxilla, which is in need of treatment. However, the records do not indicate that a current biopsy of the lesion has been performed. In this clinical setting, standard of care dictates that an incisional biopsy should be performed prior to the surgery as this will guide final and definitive therapy.  The records indicate that the differential for this lesion is broad and a final definitive surgical plan for resection and reconstruction is ideally made after a biopsy and a histopathology confirming the nature of the lesion. Should the biopsy indicate that the lesion is an odontogenic keratocyst, options for treatment can include resection and reconstruction versus marsupialization which would be less invasive for this patient. Given that the nature of the patients lesion is unknown, the cyst removal and bone graft have not been established as medically necessary until a definitive diagnosis can be provided. With regards to the whether the requested services are reconstructive in nature, the submitted records do not support whether or not the patients lesion constitutes an abnormal structure of the body at this time.  A recent biopsy has not been performed or provided and as noted above, a definitive diagnosis would need to be indicated prior to the requested surgery. For these reasons, the submitted documentation does not support that the requested cyst removal and bone graft are reconstructive in nature.Final Result: The reviewer determined that requested services are not medically necessary and are not reconstructive in nature for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in oral and maxillofacial 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 Gardasil human papillomavirus (HPV) three-dose schedule vaccine. Findings: The patient presents with a history of abnormal pap smear and she is at continued risk of cervical cancer. The Gardasil HPV vaccine series is U.S. Food and Drug Administration (FDA) approved for patients ages 9 through 45 years of age for prevention of cervical cancer caused by multiple HPV types. Per a study, vaccination against HPV is recommended to prevent new HPV infections and HPV-associated diseases, including some cancers. This patient may not have been exposed to all the different HPV types thus far, therefore vaccination is still considered protective. Given this support, the requested Gardasil HPV three-dose schedule vaccine 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. 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: Upheld

A 58-year-old female enrollee has requested alcohol sclerosing injections for treatment of her plantar fasciitis. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services.  The current medical evidence does not support alcohol sclerosing injections in this patients case.  The submitted records document plantar fasciitis, and the patient has a history of heel pain.  There is a lack of support in the medical literature for the use of alcohol sclerosing injections for the treatment of plantar fasciitis.  Cortisone injections are standard of care for the treatment of this patients condition.  All told, the requested alcohol sclerosing injections are 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 reimbursement for DecisionDX-Melanoma multivariate gene expression assay for evaluation of his cutaneous melanoma. Findings:  Three physician reviewers found that The staging and prognosis of cutaneous malignant melanoma is classically determined by the system spelled out by Balch. There may be some further value in adding the mitotic rate to this system.  According to the Balch staging, this melanoma would be classified as a T3a stage IIA. There is no information in the records submitted as to whether he had sentinel node done. DecisionDX is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or class 2 (with a distant metastasis free five year survival of about 90% versus. 65-80%. Gerami and colleagues reported on 217 cases, with good correlation between DecisionDX data and prognosis in patients undergoing sentinel node biopsy. However, it is unclear how the five year DecisionDX data compares to the ten year Balch data and whether it can be used to make clinical recommendations. Researchers reported on 156 cases but there was not sufficient follow-up to determine the actual value of the test. The National Comprehensive Cancer Network guidelines state that there is interest in these types of assays, but they can only be used in the context of a clinical trial.  At present, the available studies do not show that there is expected clinical benefits from using DecisionDX assay. Final Result: The 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: Reviewers 1, 2, and 3 are board certified in internal medicine with sub-specialty certification in medical oncology and is 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 a 24-week treatment duration with Harvoni for treatment of the enrollees hepatitis C virus (HCV).  Findings:  The physician reviewer found that Harvoni for 24 weeks is not medically necessary for treatment of the patients medical condition. The American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommends several options with similar efficacy for patients such as in this case with compensated cirrhosis and HCV genotype 4 infection in whom prior treatment has failed. Per AASLD/IDSA guidelines the options include daily fixed-dose combination of (Harvoni) ledipasvir/sofosbuvir for 12 weeks, daily fixed-dose combination of paritaprevir/ritonavir/ombitasvir and weight-based ribavirin for 12 weeks, daily sofosbuvir for 12 weeks and daily weight-based ribavirin plus weekly peginterferon for 12 weeks and daily sofosbuvir and weight-based ribavirin for 24 weeks. With specific reference to the Harvoni regimen proposed In the SYNERGY trial, 20 patients with HCV genotype 4 infection were treated with ledipasvir/sofosbuvir for 12 weeks. Of these patients, 40% were treatment experienced and 40% had advanced fibrosis. Preliminary data demonstrate efficacy, with 95% achieving [sustained virologic response at 12 weeks] SVR12 based on an intention-to-treat analysis. As such, AASLD/IDSA guidelines support a 12-week Harvoni course in this clinical setting. All told, the requested medication duration is not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the requested medication duration 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 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 66-year-old male enrollee requested a 12-week course of Olysio 150 mg in combination with Sovaldi 400 mg for medical treatment of the enrollees hepatitis C genotype 1a.  Findings:  Three physician reviewers found that applying the guidelines from the American Association for the Study of Liver Diseases (AALSD), the use of the requested combination of medications is not likely to provide this patient with an improved health outcome beyond that expected with standard therapies. Further, the combination of Sovaldi and Olysio has not been shown in large, prospective, randomized, controlled clinical trials to be superior to standard alternatives in the treatment of hepatitis C. All told, the requested medications are not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

A forty-seven year-old male with arthritis in the right hip is requesting authorization of a metal on metal hip replacement with computer navigational assistance.  Reviewers Findings:The three reviewing physicians found that the patient can be appropriately treated without the use of computer navigational assistance.  The three physicians concluded that the Health Plan denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for the medication oxcarbazepine.Findings: Three out of three physician reviewers found that the requested medication oxcarbazepine is not likely to be more beneficial than any other available standard treatments for the patients medical condition.According to the International Society for Bipolar Disorders Task Force report on pediatric bipolar disorder, the anticonvulsants divalproex sodium and carbamazepine have not fared well head-to-head with second-generation antipsychotics (SGAs). The Task Force report noted that in two meta-analyses, treatment effect was less robust with anticonvulsants than with SGAs. The report stated that a randomized controlled trial (RCT) of divalproex extended release was negative, as was a large RCT of oxcarbazepine, and a topiramate RCT in youth was interrupted prior to its completion due to negative results in adult studies. According to a 2011 Cochrane Database of Systematic Reviews, there are insufficient trials of adequate methodological quality on oxcarbazepine in the acute treatment of bipolar disorder to inform us on its efficacy and acceptability. The Cochrane authors stated that, From the few studies included in this review, oxcarbazepine did not differ in efficacy compared to placebo in children and adolescents. It did not differ from other active agents in adults. It may have a poorer tolerability profile compared to placebo. The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults states that the use of oxcarbazepine in treating bipolar disorder is a fourth line treatment, after the second generation antispychotics, lithium, and electroconvulsive therapy. Therefore, the current evidence does not support the use of oxcarbazepine in treating pediatric bipolar disorder. Furthermore, there is no evidence that oxcarbazepine is superior to treatments that include second generation antipsychotics and lithium. Thus, the requested medication oxcarbazepine is not likely to be more beneficial than any other available standard treatments for the patients medical condition.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial than any other available standard treatments for the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in psychiatry, with subspecialty certification in child and adolescent psychiatry, and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and are 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 authorization and coverage for Intracept procedure at L3-S1. This patient presents with chronic midline low back pain and bilateral sciatica. Recent imaging revealed multilevel disc desiccation and disc height loss as well as Modic endplate changes. Treatment over the last six months has included Norco, non-steroidal anti-inflammatory drugs (NSAIDS), physical therapy, and epidural steroid injections without adequate symptomatic relief. The provider has recommended the Intracept procedure at L3-S1. A review of the peer-reviewed medical literature suggests that the Intracept procedure has been demonstrated to be safe and effective for the treatment of patients with vertebrogenic pain who have failed conservative treatment modalities. De Vivo and colleagues reported successful treatment at three- and 12-month follow-up. The authors noted that clinical success was achieved in 54 of 56 patients for pain and disability. Similar results were reported by Khalil and colleagues, who concluded that, minimally invasive radiofrequency ablation of the basivertebral nerve led to significant improvement of pain and function at three-months in patients with chronic vertebrogenic related low back pain. Given this support, the requested Intracept procedure at L3-S1 is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the requested Intracept procedure at L3-S1 is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in orthopedic surgery 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 patient has requested reimbursement for bilateral knee Orthovisc injections. The Health Plan denied the request and reported the services at issue were not medically necessary for the treatment of this patient. At issue in this case is whether bilateral knee Orthovisc injections were medically necessary for the treatment of the patients medical condition. Review of the current medical literature pertaining to viscosupplementation reveals mixed results.  Although viscosupplementation may relieve knee pain in some patients with osteoarthritis, it is unknown which patients will benefit. Viscosupplementation can only be recommended in patients with a history of lasting benefit from prior injections and in carefully selected cases where the options are limited. A clinical trial by Campos and colleagues found that viscosupplementation increased functional scores in patients with severe osteoarthritis of the knee, especially within three months of injection. In this case, the patient has a history of lasting benefit from prior viscosupplementation injections. The patients options are limited, with the alternative being total knee arthroplasties. The medical evidence supports the services at issue in this clinical setting. Therefore, bilateral knee Orthovisc injections were medically necessary for the treatment of this patient. Final Result: The reviewer determined that the services at issue were 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.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nurtec ODT (rimegepant). This patient presents with a history of migraines. Treatment has included nortriptyline. The patients provider has recommended treatment with Nurtec ODT. Migraine is a common neurological disorder with several treatment options. Nurtec ODT is from the CGRP family of medications. Its efficacy in management of migraine has been shown in several studies. As a result of the available evidence, the U.S. Food and Drug Administration (FDA) approved Nurtec ODT for migraine management. In the medical literature, Croop and colleagues noted that, In the acute treatment of migraine, a single 75 mg dose of rimegepant in an orally disintegrating tablet formulation was more effective than placebo. Given this support, the requested Nurtec ODT (rimegepant) 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. Credentials/Qualifications: The reviewer is board certified in neurology with subspecialty certification in vascular 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.