A review of the records reveals the member to be an adult male with a birth date of 03/28/1966. The member has a diagnosis of non-small cell lung cancer (NSCLC). The member’s treating provider, Brion Lock, MD a VeriStrat® testing for the member, which was performed on 02/11/2016. The carrier has denied coverage of VeriStrat® testing that was performed on 02/11/2016 as experimental and/or investigational and not medically necessary. There is a letter from the carrier to Biodesix, Inc. dated 06/30/2016 which states in part: “Claim number 201603086651381 (Biodesix, Inc.) was denied as services that are experimental/investigational are not a covered benefit. Total billed charges of $3,480.00 may be billed to Mr. Charles Henderson at the non-network …show more content…
The VeriStrat® testing performed on 02/11/2016 was not medically necessary for the treatment of this member’s condition. The expected benefit of the recommended or requested health care service or treatment is not more likely to be beneficial to the claimant than any available standard health care service or treatment. The adverse risks of the recommended or requested health care service or treatment are substantially increased over those of available standard health care services or treatments. The previous denial should be upheld. Findings: This member is a 50-year-old male with Stage IV tonsil cancer diagnosed in April 2014 with metastases found in his lung and bone. VeriStrat® is a blood-based predictive and prognostic proteomic test for patients with advanced non-small cell lung cancer who test negative for EGFR mutations (EGFR wild-type) or for those whose EGFR mutation status is unknown. VeriStrat® was presented in April 2012, at the 3rd European Lung Cancer Conference in Geneva, Switzerland. The VeriStrat® test was validated through a retrospective analysis, which was performed on serum samples from advanced non-squamous non-small cell lung cancer (NSCLC) patients treated with the combination therapy of Avastin and plus erlotinib. The VeriStrat® test was able to identify …show more content…
Results showed that VeriStrat® testing was able to identify a group of patients who have worse progression free survival (PFS) when treated with Femara alone, independent of Her2 status. VeriStrat® testing may be useful for clinical decision-making, about treatment with erlotinib and erlotinib combinations. Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology group. Per the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of non-small cell lung cancer, this testing (VeriStrat proteomic testing) is medically appropriate for patients with a performance status of 0 to 2 who had progression with initial chemotherapy treatment and may be candidates for treatment with erlotinib. This member had metastatic tonsil cancer and not lung cancer. This was confirmed on the latest biopsy in 2016. Thus, the use of the testing for purposes of clinical-decision making for this member who has a diagnosis of metastatic tonsil cancer would be considered experimental and/or investigational and not medically
Heather is a 48 year old patient who was referred to my group by her oncologist in bowling green. She had chronic _______and now has a 4.0cm lesion with __________but no lymph node involvement, luckily. Aside from being a heavy tobacco smoker and of heavy weight, she is otherwise healthy. Patient will have surgical resection this week.
John Doe is a 57-year-old male who was diagnosed with Esophageal Cancer in January of 2017. He attended the St. Bernards Cancer Center located in Jonesboro, AR for consultation and treatments. His initial consultation was February 9, 2017 with one of the oncologists. At the first appointment, John met with the registrar personnel to complete all required paperwork, met with a nurse, nurse practitioner, cancer navigator, and oncologist. After his initial visit, the treatment plan was completed by staff members and he would begin treatments in the following weeks. John received both radiation and chemotherapy to treat his diagnosis. He began radiation and chemotherapy treatments on February 27, 2017 and finished on April 6, 2017. His radiation treatment was scheduled daily and his chemotherapy treatments were scheduled twice weekly for six weeks. He has a two-week follow-up appointment scheduled for April 21, 2017. At this follow-up visit, John will meet with a nurse, cancer navigator, and oncologist. This visit is solely
CALGB40603 (NCT00861705) is a randomized phase II trial with a 2 × 2 factorial design that explored the addition of carboplatin ± bevacizumab to neoadjuvant weekly paclitaxel followed by dose-dense AC in 443 patients with stage II/III TNBC (Sikov, et al. 2014) The pCR rate improved from 41% to 54% with the addition of carboplatin; bevacizumab had no added benefit. It is important to note that neither of these studies was powered to detect disease-free or overall survival (OS) benefit.( Ingrid et al.,2014)
The SEER is a population-based cancer database by National Cancer Institute. The SEER 13 represents approximately 14% of the population of the United States and includes 13 cancer registries - San Francisco-Oakland, Connecticut, Detroit, Hawaii, Iowa, New Mexico, Seattle (Puget Sound region), Utah, Atlanta, San Jose-Monterey, Los Angles, Alaska Natives, and rural Georgia. High quality data are collected from hospitals and cancer treatment centers. The database includes primary tumor site, staging, patient demographics, treatment modality and survival statistics (10). We selected adult patients (≥ 18 years) diagnosed with first primary HCC between January 1992 and December 2011. We excluded cases diagnosed at autopsy and those lost to
The expected benefit of the recommended or requested health care service or treatment is not more likely to be beneficial to the claimant than any available standard health care service or treatment.
James is a 74-year-old male who is diagnosed with Waldenstrom macroglobulinemia (C88.0), along with bipolar disorder and anxiety. James is status post splenectomy, roughly about 10.5 years, along with taking Ibrance, but still experienced aggressive disease progression. His most recent PET/CT scan concluded diffuse new hypermetabolic metastases involving the left palatine tonsil, lingual tonsils, multiple cervical, mediastinal, axillary, retroperitoneal, intrapelvic and left inguinal lymph nodes, with a new 8.4 cm metastasis located medial to the left kidney, resulting in moderated left hydro nephrosis, and a new right perirectal metastasis. James is also experiencing weight loss, fatigue, loss of appetite, depression, abdominal pain, constipation
This invaluable data can then be compared to patients with similar molecule profiles, often time revealing more opportunities for treatment and care by enabling doctors to peak into the potential future of the patients cancer.
Quality Assessment of Diagnostic Accuracy Studies (QUADAS) is a tool to assess the quality of diagnostic accuracy studies included in systematic reviews [16]. Included studies are further evaluated with QUADAS criteria. To perform accuracy analyses, we take fully into account the following items: patients enrollment criteria clearly described; patients receive the same reference standard regardless of the index test result; the positive index test results interpreted by cytopathological analyses, histopathological method, surgery and/or other reference standards; patients with suspected lung cancer were enrolled in consecutive method or not-defined; blinded judgment of needle aspiration biopsy results; reporting of uninterpretable/ indeterminate/
Pathway has designed an additional test to detect the efficacy of a specific treatment in a person already diagnosed with cancer, and if developments are followed closely, we may see great improvements in the prevention, detection and treatment of this threatening
Staging of non-small cell lung cancer is described with the TNM system. T stands for tumor, it’s size and how far it has spread, N stands for the lymph nodes, and M stands for metastasis, spread to other organs. All of these are combined and a stage is assigned to each group.
The microscopic anatomy of human neoplasms is a source of valuable biomarkers, which can be classified as diagnostic, prognostic, and/or predictive. Prognostic histologic biomarkers are those that are informative about a patient’s future outcome (e.g. overall survival). A number of these prognostic biomarkers, such as tumor grade in breast cancers, are used in routine diagnostic practice. Other biomarkers, such as tumor infiltrating lymphocytes in non-small cell lung carcinomas, are in the process of being validated. Yet others await discovery.
The expected benefit of the requested health care service is not proven to be more likely than not to be beneficial to the claimant than any available standard health care service (eg standard mammography and breast ultrasound).
Lung cancer is a malignant transformation and growth of the cells of the lung and the airway tissues. It is usually divided into two main types: Small Cell Lung Cancer (SCLC, 15%) and Non-Small Cell Lung Cancer (NSCLC, 85%) with the latter further subdivided into several subtypes such as Squamous, Large Cell, and Adenocarcinoma among other rare subtypes. Each subtype has its own unique growth and spread pattern with some being more aggressive than others. Lung cancer is staged according to the American Joint Committee by the TNM system, where T stands for the size, N for nodal involvement and M for the presence of distant metastases. The knowledge of the lung cancer main types, subtypes and stage, and the presence of specific molecular and genetic signatures, help the clinician determine the treatment approaches be it surgical, radiation, chemotherapy and the combination of, in addition to the appropriate type of chemotherapy.
First, identifying patients that are at increased risk for recurrence after curative resection and therefore clinical management of these patients would include more aggressive strategies, including adjuvant treatment. Such markers are considered prognostic, able to distinguish clinical outcomes regardless of therapy selection (21), and most well-known examples of such markers (or signatures) are Oncotype DX ® or MammaPrint ® utilized in breast cancer. Secondly, once adjuvant therapy is determined to be necessary for a patient, biomarkers that guide selection of specific therapies, or predictive biomarkers, are also of high interest for early stages of lung cancer. Predictive biomarkers guide patient selection for specific treatment options and have demonstrated their utility in enriching patients that are likely to derive substantial clinical benefit verses those that may not (21). In lung cancer, many prognostic and predictive markers and signatures have been assessed, however, to date, only predictive markers (e.g. EGFR, ALK) have been clinically validated and incorporated into practice guidelines for advanced stages (5). Selected biomarkers utilized in clinical practice, have been studied or are under active investigation for early stages of lung cancer are summarized in Table
PI3K pathway of CRC is characterized by genetic alterations commonly the loss of expression of PTEN pro¬tein and mutations in PIK3CA. These molecular events may coexist with BRAF and KRAS mutations making it more difficult to predict their clinical value. However, PTEN loss corresponds to advanced tumors and has been associated with worse survival in CRC. EGFR activates the PI3K pathway and alterations in the PI3K pathway logically might influence the response to anti- EGFR treatment. (Chanjuan & Kay.2012)