March 2012 Clinical Laboratory News: Regulatory Profiles

Industry Profiles

HHS Posts Central Line Infection Data to Hospital Compare Website

Hospital-acquired infections may be getting even more attention thanks to a successful effort to get rates of hospitals’ central line infections posted online. After a lobbying campaign by the Consumers Union, the Department of Health and Human Services is disclosing for the first time data on how hospitals across the country compare when it comes to central line-associated bloodstream infections (CLABSI) in intensive care units. CLABSI information for each hospital is posted on the federal government’s Hospital Compare website and will be updated quarterly. The website will also provide information for other hospital-acquired infections in the future.

Consumers Union, the nonprofit advocacy arm of Consumer Reports, has pushed since 2004 for more public information about hospital-acquired infections. The CLABSI infection information disclosed on Hospital Compare is based on only 3 months of data (January–March 2011) and shows how each hospital stacks up against the national benchmark for such infections.

Hospitals have also started reporting surgical site infection rates. That information will be posted on Hospital Compare every quarter beginning in 2013, starting with abdominal hysterectomy and colon surgeries.

These new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) pay-for-reporting program and include infections occurring in all patients, not just those covered by Medicare. Hospitals that participate earn higher Medicare payments.

More information is available online.

IRS Moves Forward with Tax on Tests and Other Devices

Increasing anxiety among companies that market in vitro diagnostics and other devices, the Internal Revenue Service (IRS) released proposed regulations that would implement a $20 billion medical device excise tax included in the Affordable Care Act, slated to take effect January 1, 2013.

The Advanced Medical Technology Association (AdvaMed) once again called on Congress to repeal the tax, citing a study that found up to 43,000 jobs would be at risk. According to AdvaMed President and CEO Stephen J. Ubl, device companies already report that they are laying off workers and reducing research and development in anticipation of the tax taking effect next year. U.S.-based device companies already face tough competition from outside the country due to higher U.S. corporate taxes, he added.

However, AdvaMed remains optimistic about getting the tax repealed. An effort in the House of Representatives to repeal the tax, spearheaded by Erik Paulsen (R-Minn.), now has more than 200 co-sponsors, enough to pass the bill in the House. So far, the repeat effort has no champion in the Senate.

More information is available from the AdvaMed website.

Moody’s Blames Healthcare Reform For Negative 2012 Outlook

Due to pressure to cut costs amid declining revenue, and challenges resulting from the uncertainty and transition of the Affordable Care Act, the outlook for the U.S. not-for-profit healthcare sector remains negative for 2012, according to a new Moody’s Investors Service report. The bond credit rating firm has reported a negative outlook for this sector since 2008, and said it will likely remain negative for several years.

Moody’s is projecting modest growth in hospital revenue over the next 18 months, but noted national economic weakness, regulatory challenges, and a weaker payer mix as negatives weighing on the sector.

“Ongoing uncertainty about changing regulatory requirements, healthcare reform, and severe federal budgetary stress is putting pressure on hospital management teams as they prepare for the coming era of lower reimbursements and different payment schemes under new business models,” said Moody’s vice president and senior analyst Brad Spielman, author of the report. “The pressure is being applied by all sources of hospital revenue, including Medicare, Medicaid, and commercial payers.”

The report does note some positive factors, including low interest rates, slow growth in expenses, and more state-administered provider fee programs that grant relief from lower Medicaid reimbursement.

The report, “U.S. Not-For-Profit Healthcare Outlook Remains Negative for 2012,” is available online.

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