Information Trading How Information Influences the Health Policy Process (1997) / Chapter Skim
Currently Skimming:
6 Gene Mapping and Genetic Testing, Promises, and Problems: A Case Study on an Emerging Technology
6 Gene Mapping and Genetic Testing, Promises, and Problems: A Case Study on an Emerging Technology
Pages 99-119
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 99... ...
Congress: health insurance discrimination based on genetic information. There is a sense of urgency on Capitol Hill to craft policy that will protect U.S.
|
From page 100... ...
Who has the right to access it? At the same time, the Kassebaum-Kennecly bill, which aclclressecl the portability of insurance coverage and exclusion from coverage on the basis of preexisting conditions, focused attention on the reality of insurance discrimination.
|
From page 101... ...
Uncler the guise of education, these information brokers try to influence policy. The Deb ate of genetic information anc3 insurance discrimination has attracted "educators" from the insurance industry, the genetic research community, the biotechnology industry, anc3 consumer groups.
|
From page 102... ...
MCOs as a form of community-ratec3 health insurance will have to actress genetic discrimination at two levels: entry into the plan and members' access to diagnostic and therapeutic options. Some detractors are concerned that MCOs will use genetic information to discriminate, alleging that MCOs aIreacly use marketing and enrollment practices designed to "cherry-pick" or preferentially select only low-risk health clients.
|
From page 103... ...
A 1993 study clone by the Office of Technology Assessment (OTA) reported that 75 percent of chief executive officers in the insurance industry felt that they should have the autonomy anc3 authority to determine how to use genetic information (Office of Technology Assessment, U.S.
|
From page 104... ...
Imagine the impact if people obtain health insurance only after they have received a genetic diagnosis that portends a significant anc3 expensive disease. If the genetic information is confidential or cannot be considered a preexisting conclition, the insurance inclustry' s ability to accurately assess risk is clestroyoc3 anc3 it will either lose money or have to charge everyone higher premiums.
|
From page 105... ...
, the American Society for Human Genetics, the American College of Medical Genetics, and others (College of American Pathologists, 1996; Greely, 1995; Orkin and Motulsky, 19954. Commercial enterprises that are involved not only in research but also in the development of commercial products are categorized as the biotechnology industry.
|
From page 106... ...
The research community is also cognizant that the information being unraveled introduces new social, ethical, anc3 legal responsibilities and challenges (Orkin and MotuIsky, 19954. In response to these concerns, HOP created the Ethical, Legal and Social Implications Program (ELSI)
|
From page 107... ...
Health insurers shouIc3 consider a moratorium on the use of genetic tests in underwriting anc3 insurers shouIc3 undertake vigorous eclucation efforts. This 1993 task force report was largely ignorecl.
|
From page 108... ...
Part of that caution is to limit genetic testing to experimental status until more is unclerstooc3 about the specificity anc3 sensitivity of specific tests as well as knowing what to c30 with the information. Both the Institute of Meclicine and ELS} support the
|
From page 109... ...
Any suggestion from HGP that genetic testing is experimental until benefits and risks have been well iclentifiec3 and assessed threatens the biotechnology inclustry's ability to commercialize genetic tests (Benowitz, 19964. The biotechnology industry is unclerstanclably troublecl by HOP's monolithic stanc3 on how the "research community" feels.
|
From page 110... ...
Market forces shouIc3 be adequate to protect the quality of the available tests; federal regulation is not needled. Many have bet their financial futures on the belief that genetic research will increase the clemancis for genetic tests, the need for accurate tests, and the desire for genetically manipulated approaches to treatment.
|
From page 111... ...
Because federal regulation of these tests is a concern, the industry has been trying to demonstrate the inability of FDA to effectively approve genetic tests in a timely manner. In abolition, the biotechnology industry focuses on the right of American citizens to get genetic testing if they so desire because requiring regulation and clinical testing is allowing the federal government to be too paternalistic.
|
From page 112... ...
Even if it is positive, it means that the woman has an 85 percent chance of developing breast cancer in her lifetime. Is there any way to prevent it?
|
From page 113... ...
This unfortunately followed an already long history of racial discrimination. Although many advocacy groups for minorities plead for anticliscrimination in insurance coverage, their concerns go far beyond health insurance.
|
From page 114... ...
The number of briefings anc3 hearings on HOP, genetic information, anc3 potential discrimination attest to their commitment. Four bills in the Senate cluring the 104th Congress specifically aciciressec3 genetic information anc3 discriminations S.1416, The Genetic Privacy anc3 Noncliscrimination Act of 1995; S.1600, The Genetic Fairness Act of 1996; S.1694, The Genetic Information Noncliscrimination in Health Insurance Act of 1996; anc3 S
|
From page 115... ...
Genetic testing is aIreacly expanding beyond research settings in the absence of protective legislation. As genetic information continues to explode there will be numerous attempts to prohibit discrimination.
|
From page 116... ...
Often they must be repeated or valiclatecl by other tests. Results from genetic tests must be put into the context of a family pecligree; this requires a person trained in clinical genetics.
|
From page 117... ...
For example, rather than providing a solution for the use of all genetic information, perhaps a carve-out solution for the use of breast cancer-relatec3 genetic information would be an answer. After all, the availability of the test for the BRCAl mutation makes this a timely issue, the breast cancer coalition is very strong, anc3 the women's vote is important for reelection.
|
From page 118... ...
1996. Response to Federal Drug Administration's March 14, 1996 Federal Register proposal to regulate analyte reagents as Class I medical devices exempt from the premarket notification (510k)
|
From page 119... ...
1992. Genetic Tests and Health Insurance.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.