American Association for Clinical Chemistry
Better health through laboratory medicine
December 2008 Clinical Laboratory News: Regulatory Profiles

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December 2008: Volume 34, Number 12

  NHGRI Supports Study of DTC Genetic Testing

The Genetics and Public Policy Center at Johns Hopkins University received a 2-year, $589,318 grant to study the field of direct-to-consumer (DTC) genetic testing. The study will look at how companies offer tests and test interpretation to consumers while bypassing the traditional healthcare model. The study will also investigate who orders the tests, how they use the information, and how the ordering and testing processes are regulated. Genetic tests for more than 1,300 diseases or conditions are now available, with the number climbing rapidly. Theoretically, almost any genetic test could be offered directly to consumers, and more than 30 companies have tests on the market, explained the study’s principal investigator, Gail Javitt, JD, MPH, who is also the center’s law and policy director. She also noted that while a lot of anxiety exists about DTC genetic testing, there’s a paucity of information about the industry or consumers who purchase the tests. More information about the study is available on the center’s website.

AdvaMed, AHA, AHIMA Support Move to ICD-10

Urging the Department of Health and Human Services (HHS) not to delay the switch to the new ICD-10 coding system, AdvaMed, AHA, and AHIMA voiced their support of ICD-10 in a letter to Congress (CLN November, 2008). The three associations argue that Congress’s goals of improving quality, reducing medical errors and infections, and modernizing health IT won’t move forward without the switch. “The time for moving forward is long overdue,” the letter reads. “The ICD-9 code set was never designed to provide the increased level of detail required to support emerging needs such as biosurveillance, quality reporting, and development for pay-for-performance programs. The National Committee on Vital and Health Statistics concluded in 2003 that we were ready to transition to ICD-10. Now is the time to act on that recommendation.” The letter also argues that vendors will continue buying and building products for the old ICD-9 system until the switch takes place, and that those systems will be expensive to retrofit in the future. The letter is available online.


Audit Finds Slack Enforcement of HIPPA Security Rule

A recent audit by the HHS Office of Inspector General found that CMS had done too little to make sure that healthcare providers and insurers followed the HIPPA security rule, a law that requires all electronically transmitted health information be kept confidential and protected from unauthorized use. CMS did not have effective mechanisms to make sure that healthcare entities were complying with HIPPA or that electronic information was being protected, although CMS did have a good process for receiving and processing complaints, according to the report. In response, CMS has moved ahead with a plan to conduct compliance reviews of covered entities. The report is available on the HHS Office of Inspector General’s website.

Presidential Advisory Council Urges Support of Personalized Medicine

The President's Council of Advisors on Science and Technology (PCAST) issued a report outlining priority areas and policy recommendations for personalized medicine, including a call for a greater role for the federal government to provide funding, coordinate research, and eliminate regulatory hurdles. Applauded by the Personalized Medicine Coalition (PMC), of which AACC is a member, the PCAST report lays out a blueprint for pushing more widespread adoption of personalized medicine by healthcare providers. The report also recommends that government work with industry to facilitate research by putting together a collection of high-quality biological specimens accompanied by comprehensive disease annotations. The report’s authors also note reimbursement problems with genomics-based molecular diagnostics. Currently reimbursed at the same rate as other laboratory tests, these molecular tests should be reimbursed based on their value in patient care, the report concluded. The report is available on the PCAST website.