Health Care Reform and the Clinical Laboratory

Vincent Stine

Vincent Stine, PhD

December 2009



On November 7, the House of Representatives narrowly passed the Affordable Healthcare for America Act on a partisan vote of 220-215. The $1.1 trillion comprehensive health measure will extend health coverage to an uninsured 36 million persons by a combination of federal subsidies and an expansion of existing government health programs.

Among the key provisions for clinical laboratories are a number of positives: foremost, an expansion in the number of insured is likely to produce an increase in overall testing volume. The bill’s focus on preventive care may result in more cholesterol and diabetes testing. The House measure also promotes the use of comparative effectiveness research to assist healthcare professionals evaluate which tests or test methods are most appropriate for specific health conditions and subpopulations.

On the payment side, the House plan cuts provider payments by over $300 billion, including reimbursement for clinical laboratories, as a means of financing reform. Starting in 2010, the laboratory consumer price index (CPI) update will be reduced annually by a ‘productivity’ adjustment, which typically ranges from 1.1 to 1.6 percent. This would be a permanent reduction in the CPI update -- approximately $5 billion over five years.

Medical device manufacturers are also subject to provider cuts. Under the House bill, medical devices will be assessed a 2.5 percent surtax at the point of sale. This translates into a $20 billion tax on medical devices over the next ten years. Of concern to manufacturers, too, is a provision creating a National Registry for class III and class II medical devices.

Now that the House has completed its work, the Senate plans to take up the issue. They are expected to debate and amend this legislation through the month of December. If Senate Democrats are able to reach agreement and garner enough votes to ensure passage, then the House and Senate will appoint a conference committee to meet in January to work out a compromise bill.


Vince Stine, PhD, is the Director of Government Affairs for AACC, where he is responsible for legislative and regulatory affairs for the Association. He is the staff liaison to the Government Relations, Evidence-Based Medicine and Pediatric Reference Range Committees.

Dr. Stine is also an Adjunct Professor of Political Science at The George Washington University, where he teaches American Political Parties and Religion and Politics. Prior to joining AACC in 1990, Dr. Stine worked four years on Capitol Hill as a Legislative Assistant to former Maryland Representative Roy Dyson.

Dr. Stine has a Master’s Degree in Public Administration from George Mason University and a Doctorate in Public Policy from the University of Maryland, Baltimore County.

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