The records have been reviewed. The member is an adult female with a birth date of 05/12/1964. She has a diagnosis of early stage colon carcinoma. Her treating provider, Stephen Grabelsky, MD recommended the Oncotype DX Colon Cancer Assay.
The carrier has denied coverage of Oncotype DX Colon Cancer Assay as experimental and/or investigational and not medically necessary. There is a letter from the carrier to Genomic Health Inc., dated 06/28/2016 which states:
“When claim number 201512106349125 (Genomic Health Inc.) was initially processed, it was denied as services that are experimental/investigational are not a covered benefit. The Oncotype DX colon cancer assay procedure is a genetic test. Ms. Gelch 's policy specifically excludes coverage for genetic testing. There is no benefit available for genetic testing services under Ms. Gelch 's policy.”
There is a letter from Patrick Jensen at Genomic Health, Inc., dated 08/05/2016, that states:
“Ms. Gelch had the Oncotype DX Colon Cancer Assay performed to assist in determining an appropriate, individualized, post-surgical treatment decision, as recommended and ordered by her physician, Dr. Stephen Grabelsky. HUMANA ONE POS has denied this Oncotype DX claim based on a presumption this test was experimental/investigative.”
Final External Review Decision:
Although the carrier’s decision to deny coverage for the Oncotype DX as experimental and/or investigational was not appropriate, the testing that was performed on
The study had a higher possibility of a residual confounding bias because the measure of association between the use of previous colonoscopy results was bound to be mixed up other factors under investigation that could not give an opportunity for getting the most accurate results. In this study, the conclusions indicated that risk reduction of colorectal cancer was observed for both the right-sided and left-sided colon cancer.
When people have a genetic test done, whether it is presymptomatic, prenatal, newborn, or carrier testing, professionals have the ability to access them. This becomes a main concern of those who get genetic tests done because they have the capability of being dropped by their employer or insurance The companies cannot discard a person because of their genetic predispositions, but they can find loopholes to get rid of them legally. Direct-to-Consumer tests, however, cannot be accessed by employers or insurance companies without consent. “Thanks to the Genetic Information Nondiscrimination Act (GINA) signed into law in 2008, consumers need not worry about the impacts on their health insurance policy and employee status as a result of pursuing DTC genetic testing” (Su 1). This way, a person can understand their genetic predisposition without the fear of being dropped by an insurance or an employer.“The initial criticism of DTC genetic testing highlighted harms from both advertising of tests and access to tests in the absence of a health care provider intermediary” (Javitt and Hudson 2), but Direct-to-consumer tests remove the fear of outside companies finding out about their susceptibilities to genetic diseases. Many people believe Direct-to-consumer tests can be inaccurate, but with the extensive knowledge of DNA, and what is not discovered, there will be mistakes whether it is done by a medical professional or not.
The carrier has denied coverage of Olipaub (Lynparza) as experimental and/or investigational and not medically necessary. There is a letter from the carrier to the member dated 04/12/2016, which states in part:
In the summer of 2009, the Food and Drug Administration and the 23andMe organization started negotiations on regulating the company’s delivery of genetic health probability data. A couple of years after, the FDA all of a sudden alerted the organization to quit offering its Personal Genome Service. The FDA felt the test was considered a “medical device”. This classification would require the organization to gain FDA approval. The letter served as a notice to the organization since they were no more speaking with the office.
One of the many goals developed by the United States Government in its Healthy People 2020 campaign was to “reduce the number of new cancer cases, as well as the illness, disability, and death caused by cancer” (Healthy People 2020, 2016). This goal is further broken down by cancer types. The goals for colorectal cancer (CRC) is to reduce the 2007 baseline mortality rate of 17.1 deaths per 100,000 to 14.5 deaths per 100,000 and to increase the proportion of adults to receive colorectal cancer screening (CRCS) based on the most recent guidelines by the year 2020. The American Cancer Society (ACS,
After the completion of the Human Genome project, breakthroughs in associating gene variations to drug response or risk of certain medical conditions provided an avenue for genetic technology. The numerous applications that genetic information could play in a someone’s healthcare also provided an environment where consumers could be perceptive to the idea of obtaining their genetic information. Though advancements were made in genetic information and technology, the average consumer could not afford the testing provided by the traditional testing as part of a healthcare system. So a clear advantage of DTC genetic testing is the reduced cost associated with these companies. Some other advantages in allowing consumers to access their genetic information include consumer empowerment, and making informed decisions about healthcare. Studies have shown that consumers feel more empowered to make informed choices about their health when their genetic risks are known.3 But the limitations still exist with consumer accessing their genetic information, especially when the test reveals negative
Thus, if patients fill out the pre-Likert questionnaire for patient preference on a particular procedure, then a specific screening will be performed. The two screening tests that will be administered are 1) Traditional Optical Colonoscopy: an invasive screening procedure that examines the entire colon for signs of polyps and medical conditions such as adenomas, colorectal neoplasia etc. (de Wijkerslooth et al., 2010). 2) CT Colonography: a non-invasive screening procedure that examines the entire colon for signs of polyps and medical conditions such as adenomas, colorectal neoplasia etc. (de Wijkerslooth et al., 2010). There are some additional differences between these two. Sedation and biopsies can only be performed via the colonoscopy, and lesions located in other parts of the abdomen and pelvis can be found with CTC. Participants in the study will be further randomly selected and randomly assigned to four treatment groups which will be explained later in the
Genetics, a study of individual genes and their outcome, has advanced tremendously in the last 20 years. Understanding an individual’s genetic composition and environmental risk factors are critical to predicting disease before the onset of symptoms. By positively identifying the cancer markers with genetic screening, the natural progression of disease can either be slowed or stopped. Through the United States Services Preventative Task Force (USPSTF) recommendations, the Affordable Health Care Act (ACA), objective is to provide genetic screening tests for populations defined at risk. In 2013, the ACA guidelines have clarified their guidelines from 2005 in order to reduce confusion of coverage with insurance companies and redefine
The increased understanding of genetics, largely the result of the completion of the Human Genome Project, has helped change the face of modern medicine. Genetic testing of an individual can not only help identify current diseases and disorders, but also help suggest treatment modalities and identify potential future illnesses. For example, patients with a family history of breast cancer can be tested for the breast-cancer gene, and, if positive, decide whether to pursue preventative therapies, such as pre-cancerous mastectomies. However, it is critical for healthcare workers to understand all of the ramifications of genetic testing so that they can answer patient questions about those tests. For example, if a genetic test can identify a disorder, but there is no preventative care or treatment for that disorder, will that knowledge help or harm the individual?
The National Academy of Science defines genetic screening as the systematic search of a population for persons with latent, early, or asymptomatic disease. The term genetic testing is often used interchangeably, but differs in that it only targets those individuals believed to be at high risk for an inherited condition. Genetic screening has a much broader target population. As genetic screening becomes easier, faster, and less expensive, there is a growing debate about who should be tested, what those results should be used for, and who should have access to those results. Before addressing these questions it is necessary to understand the basic processes involved in genetic screening.
The index colonoscopy and biopsies are accurate in distinguishing CD from UC in 89% of cases.15 However, this differentiation is challenging at times. Features that raise suspicion of CD include the following:
Since they held the patent on the gene, they could just sit on it and do nothing...” (Apecs.) This can significantly hinder human advancement and potential patient care. If a gene sequence is not used to its fullest potential to be studied and researched, then any possible medical uses will not be discovered until the expiration of the patent. The genetic company Myriad was under fire when one of their cancer screening tests came back as a false negative, other genetic companies asked permission to look further into it, hoping to improve the test, but since myriad had sole rights to the gene , they declined permission for further speculation from other companies
Preliminary data from the Royal Marsden Hospital have shown that, in patients with poor-risk rectal cancer,
Chronic diseases are becoming increasingly prevalent in the United States and around the world. Although preventable, chronic diseases can last anywhere from 3 months to a life time. Cancer is a chronic disease that is termed epidemic because the number of cases has increased highly over the years. Colorectal cancer, also known as colon cancer is one of the many cancers and it accounts for over 9% of all cancer incidents. According to the Center for Disease Control (CDC), colorectal cancer is the second leading cause of cancer deaths in the U.S. (Center for Disease Control, 2016). This paper will discuss colorectal cancer and its symptoms and causes. It will also touch upon the morbidity and mortality rate, treatment, prevention strategies and future improvements for the treatment and prevention of this chronic disease.
Primary care providers (PCP) can play a key role in educating and encouraging high risk individuals and in a patients understanding of risk perceptions and acceptance of genetic risk associated to LS cancers, as PCP support is influential in an individual’s ability to adjust to carrier status and acceptance of surveillance regimens (Marquez et al., 2013; Marzuillo et al., 2013). PCP’s knowledge of LS screening of patients with cancers in a health care delivery organizations can be instrumental in assessing of LS, implementation, and knowledge of collaborating with a genetic team in a patients care, ensuring test completion and follow up to abnormal screening, which can result in successful implementation of routine screening and assist patients in adhering to a colonoscopic surveillance program (de jong et al., 2005; Marzuillo et al., 2013). The incidence of cancer in young onset has raised steadily for the last three decades, due to different types of cancer, more specifically, undetected genetic cancers seen in LS (Rosato et al., 2013; NIH, 2016).