July 2009 Clinical Laboratory News: Regulatory Profiles

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July 2009: Volume 35, Number 7

Senate Committee Outlines Healthcare Reform Plans

A broad blueprint for healthcare reform legislation was recently released by the powerful Senate Health, Education, Labor, and Pensions (HELP) Committee, chaired by Senator Edward Kennedy (D-Mass.). Along with a separate draft measure still being worked out by the Senate Finance Committee, the HELP committee’s policy briefing paper will ultimately form the foundation of the Senate’s healthcare reform bill. The plan covers several areas that could impact labs, including offering access to healthcare to more people through greater insurance coverage, as well as emphasis on preventive and wellness care that is based in part on testing.

The HELP plan would not create a single-payer system, but almost all Americans would be required to obtain health insurance. To this end, the plan includes sliding-scale premium assistance for low-income families to purchase private insurance, as well as a publicly-sponsored and guaranteed plan. To help consumers find appropriate private or public insurance, the plan also would set up a health benefits exchange that will allow easier comparisons of insurance options as well as the ability to select and purchase coverage online through a new national website.

The plan also seeks to improve the overall quality and efficiency of healthcare, with a focus on prevention and wellness that includes promoting evidence-based medicine and giving providers incentives to screen for diabetes, cancer, as well as depression, tobacco cessation, and nutritional counseling. The congressional panel advocates education of healthcare providers through a new federal Patient Safety and Clinical Delivery Institute that would disseminate best practices information.

The HELP committee’s policy paper, “A New Vision for American Health Care: Strengthening What Works and Fixing What Doesn’t,” is available online from the committee’s website.

Study Shows Potential Comparative Effectiveness Savings

If implemented correctly, comparative effectiveness (CE) has the potential to improve care and reduce healthcare costs for Americans, according to a new study from Deloitte Healthcare Solutions. The study aimed to find ways that the U.S. can learn from other countries’ methods of incorporating comparative effectiveness research. In a profile of national CE programs in the U.K., Australia, Canada, and Germany, the study looked at screening for colon cancer, use of statins for high cholesterol, and surgical treatment for benign prostatic hyperplasia. “The results of our study demonstrate that, while the lessons from the other countries’ approaches to comparative effectiveness are instructive, a cut-and-paste approach will not work in the United States,” said Paul H. Keckley, PhD, executive director of the Deloitte Center for Health Solutions. “Comparative effectiveness can be seen as an engine for renewed innovation in the design and delivery of evidence-based care. Healthcare IT, such as electronic health records, may also play a critical supporting role in its evolution.”

The full report from Deloitte Center for Health Solutions is available online.

Plans for Future of Genomics Research Made Public

A new report from the National Human Genome Research Institute (NHGRI) outlines a big picture assessment of the state of genome sequencing in the U.S. and puts forward ideas of how the institute expects to make greater progress in this area. Developed by NHGRI and a group of outside experts at a March workshop, the report notes that “computational biology methods, resources, and infrastructure have not kept pace with the increased rate of sequence output by the entire community, and the need to integrate sequence data with other biological and biomedical information is growing. Infrastructure, tools and expertise for computational biology will be needed by the entire scientific community as biology becomes more data-driven. NHGRI will need to play a role in filling this need, along with other funding agencies.”

The report points out that while NHGRI will continue to have a central role in genomics research, the institute will need to organize researchers from around the country to face the challenges in the next chapter of DNA sequencing. These new challenges include greater demands on informatics infrastructure to analyze very large data sets; difficulty in finding enough samples that have proper consent; and new, smaller research groups using new technology to create information that is much more dispersed. To deal with these problems, the report suggests the agency continue its large-scale sequencing projects, but also work strategically with other research groups by, among other things, creating sample repositories, promoting large-scale sequencing using next-generation technologies for cancer that involve sequencing the full genomes of all tumors paired with constitutional DNA, and better integrating the work of smaller projects.

The full report is available on the NHGRI website.

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