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Washington's forecast for 2005.

As the 109th Congress undertakes a slew of legislative challenges, major issues will affect laboratory professionals. MLO invited experts from four respected organizations to share their thoughts on the coming year's legislative tussles.

Katharine I. Ayres, MT(ASCP) CT, Director

Legislative and Regulatory Affairs

Clinical Laboratory Management Association (CLMA)

On Medicare reform: Amid ongoing deficit spending, Congress will continue to look for savings. Cutting new prescription drug benefits may be too politically sensitive, so additional cuts to the Medicare program could target clinical laboratories and hospitals.

On competitive bidding: Lab groups are embroiled in the competitive-bidding demo project mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). As the demo project progresses, CLMA and other lab associations will continue to ensure its fair conduct.

On lab accreditation: Lab deficiencies in Maryland prompted congressional hearings in 2004. The resulting Clinical Laboratory Compliance Act of 2004 (HR 5311) proposes eliminating announced lab inspections. The Medicare Hospital Accreditation Act of 2004 (HR 4877, S 2698) was introduced to strengthen CMS oversight of the JCAHO accreditation program. Lab performance and CLIA effectiveness could fall under further congressional scrutiny.

Rocky Lamplugh, MT, Judiciary Councillor

American Medical Technologists (AMT)

On competitive bidding: The competitive-bidding demo is most significant due to the potential impact from the results of this three-year project. Although quality should be comparable among labs due to CLIA regs, no single bid winner can accommodate every Medicare patient in every setting in a large geographical area. Other issues are site selection, bid pricing, participation, and claims processing.

On medical-error reduction: Lab errors constitute only a portion of the 98,000 American deaths from medical errors reported in AARP's November Bulletin, but such reports dictate that immediate corrective measures be implemented; some labs have implemented Six Sigma performance standards. Pre-analytical (specimen collection and handling) and post-analytical (result reporting and delivery) are main problem areas. Labs should interface their LISs with the EMR systems in their respective service regions.

On Medicare reform: Medicare reform will target all healthcare costs as legislators seek budget relief. The co-pay-ment issue may resurface in spite of the 2004 deal reached to drop co-payment legislation in exchange for a five-year CPI freeze on lab reimbursement. A phlebotomy fee increase will be pursued.

On HHS' Office of the Inspector General: The 2005 OIG plan includes continuous monitoring of Medicare claims for fraud, abuse, or aberrant medical-necessity orders; OIG will continue to enforce compliance with CLIA, Stark II regs, and the Exclusionary Excessive Charge Rule, as well as monitor other lab/provider relationships.

Scott Becker, Executive Director

Association of Public Health Laboratories (APHL)

On emergency preparedness funding: Appropriations for federal FY 2005 concluded prior to December, and the proposal to reduce funding for state/local emergency preparedness grants by $105 million was rejected. Funding at less than 2004's level of $871 million--which includes a significant share for public health labs--would have resulted in decreased preparedness, reduced responsiveness, and weakened citizen protection. Full use of personnel, equipment, and material purchased with these funds allows public health labs to respond to emerging infectious diseases and was crucial to enabling state labs to test for SARS. Comparable benefits occur with monkeypox, West Nile virus, and a host of other infectious diseases. Funding for state/local emergency preparedness grants will be reduced by almost $30 million for the Cities Readiness Initiative and by the 0.8% across-the-board reduction included in the omnibus bill. Likely re-allocation of these funds for new initiatives will further erode their intended use.

On the personnel shortage: The lab community continues to bear the burden of the health workforce shortage; APHL again collaborates to improve this circumstance.

Vince Stine, Director of Government Affairs

American Association for Clinical Chemistry (AACC)

On Medicare reform: In 2004, the all-time high budget deficit exceeded $400 billion. Significant cuts can be expected, therefore, in Medicare and Medicaid; lab co-payments and cuts in the lab fee schedule are likely to be proposed.

On lab accreditation: New CLIA legislation by Rep. Elijah Cummings (D-MD) includes whistle-blower protections and requires unannounced (in lieu of announced) lab inspections. GAO's study on the role of private accrediting organizations and forthcoming Maryland legislation could serve as catalysts for getting this issue on the broader congressional agenda.

On competitive bidding: Labs should monitor the ongoing competitive-bidding demo project currently under design by Research Triangle Institute. CMS must submit an interim report to Congress by Dec. 31, 2005. Early this year, the FDA plans to issue a new guidance on CLIA waivers that could significantly increase the types and number of tests in the least-regulated category.

By Amy Chambers, Associate Editor

As has been the history of MLO's "Washington Report," this space will be devoted in 2005 to keeping readers abreast of ongoing issues and new legislation affecting the clinical laboratory and its professional managers and technicians. If there is a particular legislative question or a legislative topic of special interest to your organization, please e-mail: washingtonreport@mlo-online.com.
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Author:Chambers, Amy
Publication:Medical Laboratory Observer
Geographic Code:1USA
Date:Jan 1, 2005
Words:830
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