American Association for Clinical Chemistry
Better health through laboratory medicine
June 2011 Clinical Laboratory News: Regulatory Profiles

HHS Launches Value-Based Purchasing Program

The Department of Health and Human Services (HHS) announced a new initiative that will reward hospitals for the quality of care they provide to Medicare patients. The goal of the initiative, which is part of the Affordable Care Act, is to reduce costs. Under the new hospital value-based purchasing program, more than 3,500 hospitals across the country will be paid for inpatient acute care services based on quality of care, not just the quantity of the services they provide. 

In fiscal year 2013, an estimated $850 million will be allocated to hospitals based on their overall performance on a set of quality measures that have been shown to improve clinical processes of care and patient satisfaction.  This funding will be taken from what Medicare otherwise would have spent on patient care, and the size of the fund will gradually increase over time, resulting in a shift from payments based on volume to payments based on performance. Some of the quality performance measurements include: ensuring that patients with suspected heart attack receive care within 90 minutes; providing care to surgery patients within a 24-hour window to prevent blood clots; communicating discharge instructions to heart failure patients; and ensuring that hospital facilities are clean and well maintained. The measures to determine quality in the program will focus on how closely hospitals follow best clinical practices and how well hospitals enhance patients’ experiences of care.

The better a hospital does on its quality measures, the greater the reward it will receive from Medicare. CMS said it plans to add additional measures that focus on improved patient outcomes and prevention of hospital-acquired conditions. Measures that have reached very high compliance scores likely would be replaced, continuing to raise the quality bar.

More information about the value-based purchasing program is available online.

CMS Seeks Input on New Lab Codes

The Centers for Medicare and Medicaid Services (CMS) will hold a public meeting in Baltimore, Md. on July 18 to receive comments and recommendations on new Clinical Procedural Terminology (CPT) codes for lab tests. The meeting provides a forum for interested parties to make presentations and submit written comments on proposed payment for the new codes that will be included in Medicare’s clinical laboratory fee schedule for 2012. Written comments can continue to be submitted to the agency until September 23.

More information about the clinical laboratory fee schedule is available online.

Veterans Affairs Opens Genetic Database to Researchers

The Department of Veterans Affairs (VA) announced plans for a massive genetic database of veterans for gene-association studies and other research efforts. The Million Veteran Program (MVP) consolidates genetic, military exposure, health, and lifestyle information together in one single database. Authorized VA researchers, other federal health agencies, and academic institutions within the U.S. will be able conduct health and wellness studies to determine which genetic variations are associated with particular health issues. The program aims to advance disease screening, diagnosis, and prognosis and point the way toward more effective, personalized therapies by identifying gene-health connections. Launched in January at a single VA medical center, MVP is expanding to achieve the goal of national participation by veterans receiving VA care over the next 5 to 7 years.

To protect veterans’ confidentiality, blood samples and health information collected for the program will be stored in a secure manner and labeled with a special barcode system instead of personal information. The researchers who are approved to access samples and data will not receive the name, address, social security number, or date of birth of participating veterans. To ensure security, researchers will be able to access data through the VA GenISIS computing environment but will not be able to transfer data to their own information systems.

More information about the project is available online.

NIH Launches Provider Web Resource on Complementary and Alternative Medicine

A new online resource designed to give healthcare providers easy access to evidence-based information on complementary and alternative medicine (CAM) was unveiled by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH).

The portal on the NCCAM website at is aimed at all healthcare providers, and includes information on the safety and efficacy of a range of common health practices that lie outside of mainstream medicine—natural products such as dietary supplements, herbs, and probiotics.

This resource was developed based on a series of NCCAM-sponsored focus groups in which healthcare providers identified the need for an evidence-based, one-stop place to help answer questions on CAM. The website provides evidenced-based information on CAM, including systematic reviews and links to relevant clinical practice guidelines.

According to NCCAM, Americans annually spend nearly $34 billion out-of-pocket on CAM products and practices. Surveys show that nearly 40% of American adults and 12% of American children use some form of CAM.

The resources are available online.