U.S. Congress considers CLIA referral legislation

Nov. 18, 2012

The House of Representatives recently passed a significant piece of legislation for clinical medical laboratories, the Taking Essential Steps for Testing Act. (H.R.6118). This bill gives the Centers for Medicare and Medicaid Services (CMS) greater flexibility in determining the appropriate sanctions for a clinical laboratory that sends a proficiency testing (PT) specimen to an outside laboratory for analysis. Currently, laboratories are barred from sending a PT sample to another laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88).

The penalties for noncompliance with the PT provision can be quite severe. A clinical laboratory that violates this requirement loses its CLIA certificate for two years. In addition, CMS bars the owner and laboratory director of the facility from owning or directing a clinical laboratory for two years. The concern among lawmakers and the clinical laboratory community is that facilities that mistakenly send out PT samples receive the same onerous penalties as those that seek to “game” the system.

According to Rep. Michael Grimm (R-NY), the author of the House measure, H.R.6118 is needed to help the “growing number of hospitals and independent labs which have accidentally referred PT samples to other labs.” Without congressional intervention, he asserts, many quality laboratories could go out of business or be forced to contract with an outside laboratory, which could cost them millions of dollars. H.R.6118 allows CMS to employ lesser sanctions if it determines that such sanctions are warranted.

One example of the difficulties associated with the current approach involves the Ohio State University Wexner Medical Center (OSUWMC) clinical laboratory. This facility self-reported to its accrediting body, the College of American Pathologists (CAP), and the Ohio Department of Health, the state agency responsible for enforcing CLIA’88, that it had mistakenly sent six PT samples to outside laboratories since 2009. CMS notified OSUWMC earlier this summer that its CLIA license and its ability to bill Medicare would be revoked effective August 10, 2012. The Ohio laboratory has appealed this decision.

The OSUWMC is getting strong bipartisan support from its Congressional delegation, which recently sent a letter to Department of Health and Human Services Secretary Kathleen Sebelius expressing their concerns about the CMS decision. The federal lawmakers argued that revoking the OSUWMC’s CLIA license “is an extreme interpretation of the applicable statutory provision—it is a punishment that exceeds the nature of the offense.” The lawmakers also pointed out the potential impact of closing the medical center’s laboratory:

“97 percent of all inpatient encounters and 24 percent of all outpatient encounters at OSUWMC involve the ordering of laboratory services. The Laboratory—which is the central laboratory among a larger network of laboratories—is an essential part of OSUWMC’s patient care delivery system. It supports a comprehensive cancer center, transplant center, emergency departments, operating rooms, and intensive care units….A revocation of the Center’s CLIA certification, followed by a full shutdown of the Laboratory and its affiliated network of laboratories, would be devastating to the care of patients.

If enacted, H.R.6118 would give CMS the discretionary authority to deal with the OSUWMC situation without having to immediately revoke the laboratory license. Instead of pursuing a one-size-fits-all approach, the federal agency would have the option of applying a number of intermediate sanctions either separately or in combination, such as imposing a directed plan of action, state onsite monitoring, or a civil money penalty, and/or requiring personnel retraining. CMS would retain the power to apply more severe penalties if necessary.

H.R.6118 has strong backing from the laboratory community. AACC, CAP, The American Clinical Laboratory Association (ACLA), and American Medical Technologists (AMT) have all endorsed the measure. AACC argued that “CMS must have flexibility to impose lesser sanctions when a laboratory refers the sample by mistake.” Similarly, ACLA asserted the legislation is necessary to prevent “the wasteful time and expense that occurs when a laboratory’s CLIA certificate is revoked under these circumstances.”

Now that the House has passed H.R.6118, the bill moves to the Senate, where Senators Amy Klobuchar (D-MN) and Jeanne Shaheen (D-NH) have introduced a similar measure (S.3391). The Senators are hoping to move the bill through the Upper Chamber quickly and get a final bill to President Obama by November. S.3391 cleared its first hurdle on September 19 when it passed the Senate Health, Education, Labor and Pensions Committee.

If the Senate fails to take up this issue, there is a possibility that CMS may address the issue on its own. The Clinical Laboratory Improvement Advisory Committee (CLIAC), an advisory panel to the agency, has recommended that CMS change the PT standards to distinguish between acceptable and unacceptable PT referral. 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” without fear of being penalized. CMS has not stated if, and when, such a change would take place.

To get a copy of H.R.6118, visit the Library of Congress website THOMAS at http://thomas.loc.gov/home/thomas.php. To view a listing of groups supporting the measure, visit the Energy and Commerce website at http://energycommerce.house.gov/letter/letters-support-hr-6118-taking-essential-steps-testing-act.

Vincent Stine, PhD, is Director of Government Affairs for the American Association for Clinical Chemistry (AACC), responsible for legislative and regulatory affairs for the Association. He is the staff liaison to the Government Relations, Evidence-Based Laboratory Medicine, and Pediatric Reference Range Committees. Dr. Stine is also an Adjunct Professor of Political Science at George Washington University.