American Association for Clinical Chemistry
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April 2012 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles

HHS Sees Progress on EHR Incentive Program

The Department of Health and Human Services (HHS) announced that the number of hospitals using health information technology (IT) has more than doubled in the last 2 years, with nearly 2,000 hospitals and more than 41,000 doctors receiving $3.1 billion in incentive payments for ensuring meaningful use of health IT under the Affordable Care Act’s electronic health record (EHR) incentive provision.

The survey conducted by the American Hospital Association and reported by the HHS Office of the National Coordinator for Health IT found that the percentage of U.S. hospitals that had adopted EHRs jumped from 16% to 35% between 2009 and 2011. As many as 85% of hospitals now report that by 2015 they intend to take advantage of the incentive payments made available through the Medicare and Medicaid EHR Incentive Programs. But adoption of EHRs in physician offices remains much lower, less than 10%. EHR incentive payments for physicians can be as high as $44,000 under the Medicare EHR Incentive Program and $63,750 under the Medicaid EHR Incentive Program.

In a related announcement, HHS also released a proposed rule outlining the second phase of the EHR incentive payments. Phase two includes a list of additional clinical quality measures that may be implemented in 2014. Among other requirements, hospitals will need to add computerized physician order entry (CPOE) for lab orders and make EHR records available to patients online.

More information about the announcements are available from the department website.

NIH Launches Genetic Test Registry

The National Institutes of Health (NIH) has launched its long-awaited genetic test registry, a website intended to help consumers and healthcare provides navigate a rapidly changing landscape of genetic tests. The free resource, called the Genetic Testing Registry (GTR), was developed by the National Center for Biotechnology Information (NCBI), part of NIH’s National Library of Medicine.

Many called for such a registry in light of Food and Drug Administration (FDA) concerns about direct-to-consumer (DTC) genetic tests. FDA stepped up oversight of DTCs in 2010 and 2011, sending warning letters to many of the leading DTC firms.

According to NIH, the GTR will be updated frequently, using data voluntarily submitted by genetic test providers. Information will include the purpose of the test and its limitations; the name and location of the test provider; whether it is a clinical or research test; what methods are used; and what is measured. It will not, however, contain confidential information about people who have had genetic tests, or individual test results.

NIH will require submitters to agree to a code of conduct that stipulates that the information they provide is accurate and updated on an annual basis. If submitters do not adhere to this code, NIH can take action, including requiring submitters to correct any inaccuracies or to remove such information from GTR.

The GTR is available online.

Congress Cuts Lab Reimbursement to Pay Docs

In an eleventh hour deal, Congress extended the payroll-tax cut and unemployment benefits, and avoided drastic cuts to the Medicare physician payment rate—at great cost to labs. Beginning next year, a 2% cut to the Clinical Laboratory Fee Schedule will pay for approximately 15% of the $18 million Middle Class Tax Relief and Job Creation Act of 2012. The cut will drain some $2.7 billion from labs over 10 years. In a letter to congressional leaders, American Clinical Laboratory Association President Alan Mertz noted that with labs only representing 1.6% of Medicare spending, they will absorb “a significantly disproportionate share of the offsets” for the bill.

Mertz urged Congress to reconsider the fee schedule cuts considering the fact that labs face reductions from other legislation as well, including the Affordable Care Act and expected cuts from the Budget Control Act of 2011 that allowed an increase in the nation’s debt ceiling.

The bill, H.R. 3630, is available from the Library of Congress’s THOMAS website.