September 2009 Clinical Laboratory News: Regulatory Profiles

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September 2009: Volume 35, Number 9

ASCP Board of Registry and NCA Unite

The American Society for Clinical Pathology Board of Registry (BOR) and the National Credentialing Agency (NCA) have officially formed a single certification agency for lab professionals with the new name, the ASCP Board of Certification (BOC). A more unified lab profession will have greater credibility to advocate for the profession and make it easier for employers to understand an applicant’s credentials and set standards for entry level competency, said BOR Chair Kathleen Becan-McBride. The BOC will take effect on October 23, 2009, at which time the NCA will be dissolved as a corporation.

The BOC board will be composed of five ASCP Fellows (pathologists), five ASCP lab professionals, four ASCLS representatives, two from the Association of Genetic Technologists, and nine others from other organizations and the public. All BOC certifications will have the ASCP suffix attached, and current and active certifications will be transferred to the ASCP BOC, with no examination required for the transfer. The medical technologist (MT) and clinical laboratory scientist (CLS) designations will be called medical laboratory scientists (MLS), with the designation MLS(ASCP). More information on the transition is available online.

Congress Reacts to Worries on Use of Comparative Effectiveness Research

Two bills, one in the House of Representatives (H.R.2824) and one in the Senate (S.1259), aim to keep CMS from using comparative effectiveness research to make coverage decisions. With much of the healthcare reform debate focused on reducing costs, public worry emerged that comparative effectiveness could be used to deny coverage of expensive drugs or procedures. The controversy came about as a result of the bill intended to stimulate the economy—the American Recovery and Reinvestment Act (ARRA)—that set aside $1.1 billion for comparative effectiveness research. Although ARRA already specified that this research could not be used for coverage decisions, the ensuing public interest and anxiety did not go unnoticed by Congress. Both bills make the ban on using the research for making coverage decisions more explicit, and make it clear that comparative effectiveness should only be used to help doctors and patients make their own treatment decisions. With Congress still working on the details of healthcare reform, these bills are regarded as essentially placeholders for amendments to forthcoming reform legislation. To review the bills, go online.

Fee Schedule Update Looks Bleak: -1.9%

Labs should expect a 1.9% reduction from the 2010 update for the Medicare Laboratory Fee Schedule based on the latest Consumer Price Index (CPI) data, a measure of inflation CMS uses in its annual review of the payment scheme. The latest data show a 1.4% drop in prices across the economy. Another factor in the lab fee reduction is a 0.5% cut enacted by Congress last year, a compromise born out of negotiations to repeal the laboratory competitive bidding program. More information about the fee schedule is available from the CMS website.

Reimbursement Fix Suggested by OIG

The HHS watchdog group, the Office of the Inspector General (OIG), recommends that CMS correct inconsistencies in the lab fee schedule, possibly by setting a national base rate for each lab test. In a report, “Variation in the Clinical Laboratory Fee Schedule,” OIG found that carrier rates for nearly all lab tests varied, but 83% of rates were at the national limit amount (NLA), a ceiling Congress put on lab reimbursement in 1985 that won’t let any one lab test be reimbursed for more than 74% of the median of all regional carrier rates.

The report also found that for 97% of the lab tests OIG reviewed, at least one carrier paid a different amount from the NLA. Eighty-three percent of all carrier rates were at the NLA and 89% of total lab claims were paid at the NLA. The report notes that when the first rates were put together in 1985, the carriers used data that may not have accurately coincided with a test’s cost. “Since then, methods used to update carrier rates have incrementally added to the variation in carrier rates,” the OIG noted.

According to the report, Medicare payments in 2007 would have been about $100 million less if all tests had been paid at the NLA. If CMS wants to act on the report to reform lab test reimbursement and make it more uniform, it will have to ask Congress for legislation supporting a change, a move on which CMS “does not concur at this time,” according to a CMS response included in the report. The full report is available from the OIG website.

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