March 2010 Clinical Laboratory News: Regulatory Profiles

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March 2010: Volume 36, Number 3

Gene Patent Case Underway

The first hearings in federal court have begun in a case that has broad implications for biotechnology and personalized medicine. In May of last year, The College of American Pathologists and the Association for Molecular Pathology, among others, joined in an American Civil Liberties Union (ACLU) lawsuit challenging the patents controlled by Myriad Genetics for breast cancer risk testing. Should ACLU win the case, many other patent claims would be called into question, upending strategies for companies that hold patents on genes, including those used in pharmacogenomics and other diagnostics areas.

On February 2, ACLU lawyers argued before a U.S. District Court judge in New York that medical research was being held back by the BRCA1 and BRCA2 patents and that these genes are “an ancient secret of nature,” while attorneys representing Myriad Genetics and the University of Utah Research Foundation, which is also named in the lawsuit, countered that a ruling making these patents invalid would “wreck the foundation of the entire biotechnology industry,” according to the Associated Press. It could be months before the judge issues a ruling on whether the case can move forward.

Meanwhile, biotech and in vitro diagnostics companies are speaking out. The Biotechnology Industry Association (BIO), along with biotech and in vitro diagnostics companies, recently sent a letter to Secretary of Health and Human Services Kathleen Sebelius on the issue. The letter comes as a retort to recommendations laid out in the October 2009 meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS). At this meeting, SACGHS recommended that Sebelius work to create an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, or selling a test developed under the patent for patient care purposes, as well as an exemption from patent infringement liability for those who use patent-protected genes in the pursuit of research.

In the letter, BIO warns that weakening or eliminating the current patent system for genes will threaten the “innovation collaboration” in the U.S. and “undermine the foundations of American life science innovation,” as well as lead to a loss of jobs and a competitive disadvantage to other countries.

The SACGHS report is available online. The BIO letter is available on the BIO website.

Hospital Infection Control Inconsistent

Research by Consumer Reports using recently-released public data found that central line infection rates vary widely among states, cities, and even within healthcare systems. Consumer Reports also published a list praising 105 hospitals whose most recent public reports counted zero infections. Central-line infections account for approximately 15% of all hospital-acquired infections and approximately 30% of all 99,000 annual hospital-acquired infection-related deaths, according to the report.

For its analysis, Consumer Reports analyzed data from intensive care units at 926 hospitals in 43 states, using information from public state reports and from the Leapfrog Group, a nonprofit that collects voluntary hospital quality information. The investigation found “enormous variations…even within the same healthcare systems,” citing as an example Kaiser Permanente hospitals in the Los Angeles area. Kaiser’s Harbor City Medical Center reported no infections in the 1,769 days its ICU patients were on central lines in 2008, but Woodland Hills Medical Center reported 13 infections in 1,937 central-line days in its medical-surgical ICU, more than four times the nationwide average.

The full report, as well as the list of hospitals with no infections, is available from the Consumer Reports website.

NH Bill Would Expand Patient Rights to Medical Record

Lawmakers in New Hampshire are considering a bill that would go beyond the federal Health Insurance Portability and Accountability Act (HIPPA) privacy rules to ensure that patient medical records aren’t shared without permission. Under the proposed bill (HB 1649), patients could request an audit of all healthcare providers who accessed their records during the previous 3 years. The legislation would also require an organization to obtain patients’ consent before disseminating electronic health record data.

New Hampshire is unique in being the only state that, under law, considers patients to be the owners of their medical records, and has a history of strict privacy requirements. The enactment of HIPPA in 2003 actually widened what providers could do with patient records compared to existing state law, according to Laconia Citizen. HB 1649 aims to restore those additional protections.

The bill is available on the state legislature’s website.

President’s Budget Aims to Cut Waste in Medicare

Although President Obama’s 2011 budget continues to expand on the administration’s priorities in healthcare—such as healthcare information technology, comparative effectiveness research, and an additional $1 billion for National Institutes of Health research—the budget proposal also reaffirms focus on trimming waste in Medicare, closely following the predictions of observers in the clinical lab field that the Center for Medicare and Medicaid Services (CMS) will push increasing scrutiny over claims from laboratories and other providers (See CLN, January 2010 p.1).

To combat healthcare fraud and waste, Obama’s budget requests an increase of $250 million over the FY 2010 enacted level for this purpose at the Department of Health and Human Services. The administration’s estimates indicate that these investments would generate $9.9 billion in savings from “increased recoveries and prevention efforts.” In addition, the budget proposes legislative and administrative changes that could save $14.7 billion in Medicare and Medicaid over 10 years.

At CMS, $110 million in additional funds will go toward a new, comprehensive Health Care Data Improvement Initiative to transform CMS’s data environment from one focused primarily on claims processing to one also focused on data analysis and information sharing. According to the administration, these changes are vital to modernizing the Medicare and Medicaid programs by making CMS a leader in value based purchasing, improving systems security, and increasing analytic capabilities and data sharing with key stakeholders.

A fact sheet covering healthcare-related elements of the President’s 2011 budget is available from the White House website.

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