July 2012 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles

Task Force Opposes PSA Screening at Any Age

Despite the controversy that erupted when its draft recommendations were released last year, the United States Preventive Services Task Force (USPSTF) did not change its grade “D” recommendation against prostate-specific antigen (PSA) screening for prostate cancer in its final recommendation statement issued in May. The recommendation does not cover the use of PSA for surveillance after diagnosis or treatment of prostate cancer.

In laying out the case for its recommendation, USPSTF noted that it considered five randomized, controlled trials of PSA screening, but that no study found a difference in overall or all-cause mortality. USPSTF also focused on harms of screening. According to the task force, one man in 1,000 avoids death from prostate cancer due to PSA screening. However, for every 1,000 men who are screened, 30–40 will develop erectile dysfunction or urinary incontinence due to treatment and two will experience a serious cardiovascular event. For every 3,000 screened, one will die due to complications from surgery.

Many groups of physicians came out against the USPSTF recommendation, contesting the task force’s interpretation of the clinical trails. They warned of a future of more men presenting with advanced disease who might have been treated earlier if screening had not been curtailed.

The most recent update on PSA testing from USPSTF came in 2008, when the task force found insufficient evidence to recommend screening for men younger than 75 years and recommended against screening older men.

More information is available from the USPSTF website.

Medical Device Tax Repeal Takes Step Foreword

The House voted in June in favor of repealing the $20 billion medical device excise tax included in the Affordable Care Act, slated to take effect January 1, 2013. The repeal effort, led by Erik Paulsen (R-Minn.), had some 200 co-sponsors from the Republican-controlled House. The 2.3% tax would apply to makers of in vitro diagnostics as well as other medical devices. The Advanced Medical Technology Association (AdvaMed) has estimated it could double the taxes on some companies, and cost up to 43,000 jobs.

While the House passed the bill, H.R. 436, the Protect Medical Innovation Act of 2011, Democrats said it will face an uphill battle in the Senate, where Democrats see the bill as a Republican effort to defund healthcare reform. In addition, the White House has promised to veto any efforts to repeal or defund elements of the Affordable Care Act.

The bill is available from the Library of Congress THOMAS website.

CDC Calls for All Baby Boomers to Get HCV Test

The Centers for Disease Control and Prevention (CDC) released draft recommendations proposing that all Americans born between 1945 and 1965—the Baby Boom generation—get a one-time test for the hepatitis C virus (HCV).

Baby Boomers account for more than 75% of adults infected with hepatitis C in the U.S., and are five times more likely to be infected than other adults, according to CDC. Yet most do not know that they have the virus because hepatitis C can damage the liver for many years without symptoms. More than 15,000 Americans—mostly in this age group—die each year from hepatitis C-related illness, such as cirrhosis and liver cancer, and deaths have been increasing steadily for over a decade. The draft recommendations will be finalized later this year.

CDC emphasized that new treatments are now available that can cure up to 75% of infections, and even more promising treatments are expected in the near future. Current CDC HCV guidelines call for testing individuals with a known risk for the disease. Studies have found that most persons do not perceive themselves to be at risk and are not screened.

More information is available from the CDC hepatitis website.

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