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


Regulatory Profiles

CLIAC Releases Long-awaited Report on Proficiency Testing

The proficiency testing (PT) program could be made more effective and less burdensome for labs if improvements were made to how new PT analytes are added and how PT challenges are graded, according to recommendations from the Clinical Laboratory Improvement Advisory Committee (CLIAC), a federal advisory panel that reports to the Secretary of the Department of Health and Human Services (HHS) about lab issues. CLIAC also suggested that the Centers for Medicare and Medicaid Services (CMS) clarify rules about PT referral, in which a lab may send a PT specimen to a reference lab as part of standard procedures.

CLIAC’s recommendations, published online in December, propose developing a defined list of analytes for which PT is required. The list should be separate from, but linked to regulations, allowing the list to be more easily updated. CLIAC also recommended a 2-year phase-in period for implementing required PT after adding analytes to the list. Factors to be considered for adding required PT analytes to CLIA regulations should include: whether PT exists and material is available, the volume of testing for an analyte, clinical relevance, and the cost of adding an analyte.

The committee also recommended that designations for PT samples being ungradable should be clarified to distinguish between situations when there are too few participants to grade and when there are a sufficient number of participants, but consensus is not reached.

On the subject of PT referral, CLIAC recommended that CMS distinguish acceptable PT referral from unacceptable PT referral in regulations, allowing CMS more flexibility in imposing sanctions on laboratories. Designation of acceptable PT referral would allow laboratories to treat PT exactly as patient samples and perform reflex or referral testing when it is included in their standard procedure for patients. Laboratories should provide documentation to the referral laboratory on the nature of the referral, and referral laboratories should not be penalized.

CLIAC’s recommendations will be forwarded to the HHS secretary for further review and consideration, but it’s uncertain if and when proposed changes to CMS regulations would be published. The minutes of the committee’s recent meeting are available online.

NY Prohibits Labs From Helping Docs Buy EHRs

In a potential setback to labs that have pursued business from physician offices by helping to pay for new health information technology infrastructure, the New York State Department of Health has notified labs that they may not provide electronic health record systems (EHRs) to physicians under state rules. Federal laws allow a lab to pay for up to 85% of EHR cost, and the federal anti-kickback rules contain exceptions for such arrangements when certain requirements are met. However, the exceptions cannot preempt relevant state laws.

The state’s letter notes that healthcare providers may ask laboratories to donate or contribute to the cost of the interface to client EHRs, regional health information organizations (RHIOs), or other health information exchange entities as the deadline looms for bonus payments to physicians who implement such systems. The letter emphasizes that “it will be critical for laboratories to employ adequate information technology staff to update laboratory information systems and interface client EHRs, RHIOs, or other qualified entity with the laboratory’s LIS.”

However, the letter goes on to remark that the state has identified some “abusive business practices” in which labs are offering providers new EHRs and other software as an incentive for the provider to refer patient specimens for testing. “This arrangement may influence the provider’s choice of laboratory, rather than his or her relying on quality, timely access to results or the specific needs of patients. As such, these arrangements have the potential to adversely impact competition, reduce quality of services, and risk potential overutilization of health care services, resulting in unnecessary increased overall healthcare costs,” the letter asserts. 

CMS Launches Innovation Center

The Centers for Medicare and Medicaid Services (CMS) recently launched its new Center for Medicare and Medicaid Innovation that will examine reforming current payment systems. The program emerged as a provision of the 2010 healthcare reform law and plans to examine new care and payment models, focusing on more coordinated care and bundled payment.

The center aims to consult stakeholders across the healthcare sector to establish an “open innovation community” that serves as an information clearinghouse of best practices and helps providers rapidly implement new care models piloted under the healthcare reform law. For example, eight states will participate in the Multi-Payer Advanced Primary Care Practice Demonstration project for patient-centered medical homes, a program intended to encourage integrated care that focuses on primary care physicians. The Federally Qualified Health Center Advanced Primary Care Practice Demonstration will test the effectiveness of providers working in teams to treat low-income patients at community health centers.

More about the Innovation Center is available from its new website.

Patient-Centered Outcomes Research Institute Starts Work

The Patient-Centered Outcomes Research Institute (PCORI), created under the healthcare reform law, held an inaugural public meeting on November 23, 2010, to explain its structure and begin work on outlining its mission. Starting in 2012, the panel will receive $150 million annually, to fund and supervise comparative effectiveness research (CER) and disseminate findings. PCORI is charged with partnering with the private sector to accelerate research.

The new panel has significant barriers to succeeding in its mission. Many existing agencies, such as the Agency for Healthcare Research and Quality, the National Institutes of Health, and the Food and Drug Administration, already fund CER projects. During the meeting, the PCORI Board debated who the primary constituency of the new institute should be, with some arguing that the main target of the studies should be physicians and others seeing patients as the main focus. PCORI will also face a potentially hostile Congress as it looks to expand its reach. During the debate over the healthcare reform legislation, Obama administration officials suggested that CER would save money by helping providers focus on the most successful treatments, but detractors, including Representative John Boehner (R-Ohio), who is expected to become House speaker, criticized the research and likened CER to rationed care.

More information is available from the Government Accountability Office website.

Grants Announced for State Health Data Exchange Pilots

The Office of the National Coordinator for Health IT announced the availability of grants for 10 states, a total of about $16 million, to promote breakthroughs in health information exchanges that will include lab data. Called the Health Information Exchange Challenge Program, the initiative will fund new pilot programs and boost what funding states already have received to establish the data exchanges. Awards will range from $1 million to $2 million for each state.

The awards are intended to help develop technology and approaches that will be developed in pilot sites and then shared, reused, and leveraged by other states and communities to increase nationwide interoperability. The five themes of the grants include: achieving health goals through health information exchange; improving long-term and post-acute care transitions; giving patients access to their own health information; developing tools and approaches to search for and share granular patient data (such as specific lab results for a given time period); and fostering strategies for population-level analysis.

More information about the grants is available online.