American Association for Clinical Chemistry
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April 2009 Clinical Laboratory News: Regulatory Profiles

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April 2009: Volume 35, Number 4

Budget Bills Boosts Healthcare Spending

Beyond the money in the stimulus package set aside for healthcare initiatives, such as $19 billion for healthcare IT (HIT) and $1.1 billion for comparative effectiveness research, the federal government’s budget for the rest of this year also increases funding for agencies focused on healthcare.

NIH funding goes up 3.2%, CDC is up 3.8%, and FDA will get a 21% boost. In addition, AHRQ receives $50 million specifically for comparative effectiveness research, adding up to a $20 million increase over its 2008 budget. Other efforts include an additional $125 million for community health centers; $75 million for states to expand health insurance; $22 million to combat hospital infections; and an additional $27 million to support small, rural hospitals. Signed by President Obama in March, the Omnibus Appropriations Act of 2009 finishes Congress’s work on this year’s budget that had stalled due to conflicts with the Bush administration. A compromise continuing resolution had been in place that funded the federal government at 2008 levels. A summary of key provisions is on the House Appropriations Committee website.

Looking ahead to next year, Obama’s budget plan ramps up healthcare spending even further, although fewer details are available. The president’s budget features a $634 billion reserve fund for expanding health insurance, and also focuses on funding HIT and comparative effectiveness spending. Other highlights include a doubling of the funding of cancer research at NIH and more money for HIV/AIDS prevention and treatment. More information is available from the White House website.

IOM Report Says HIPAA Privacy Rule Inadequate

An Institute of Medicine (IOM) report on the Health Insurance Portability and Accountability Act (HIPPA) finds that the rule does not adequately protect the privacy of personal health information and hinders research. According to the committee that wrote the report, “Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research,” Congress should take a new approach to protecting personal health information in research that is separate from HIPAA.

The HIPPA privacy rule is difficult to reconcile with other federal regulations that govern research, according to the report. In addition, organizations that collect and use health data vary widely in their interpretation of the rule. Finally, the rule does not apply uniformly to all health-related research.

To deal with these problems, the report recommends that HHS and other federal agencies develop a new approach that includes ethical oversight of research when using personal information without consent is necessary. One idea is to use local ethical review boards that assess projects on a case-by-case basis. Similarly, the report suggests that some institutions could be certified to carry out this kind of research after showing that they have policies in place to ensure privacy and security. The report is available from the IOM website.

SACGHS Releases Report on Gene Patents

The HHS Secretary’s Advisory Committee on Genetics Health and Society (SACGHS) released its preliminary report on the effects of gene patents and licenses on patient and clinical access to genetic tests. Overall, the report found no broad or consistent evidence that patents have a positive or negative effect on patient access to genetic testing.

The report found that while in some cases patents helped motivate companies or researchers to develop genetic tests, it was not a “uniformly necessary incentive,” except in the case of tests for rare alleles, where patents were often important in stimulating commercial interest. Similarly, though the report cautions that patents have the potential to inflate prices and utilization of genetic tests, other factors keep this potential inflation under control. Finally, the report found clear evidence that when a patented test is licensed to many providers, efforts at innovation proceeded; however, for the sole provider business model, the report notes many allegations that innovation was held back. The report is available on the SACGHS website.