Federal

San Diego Labs Sue to Stop Competitive Bidding Project

Aid from Congress Urgently Needed
San Diego laboratories have filed a lawsuit to stop the federal government from requiring labs to competitively bid for reimbursement on more than 300 tests. The suit calls for a public notice and an opportunity to comment on the demonstration project. Opponents of the Centers for Medicare & Medicaid Services’ (CMS) competitive bidding demonstration project for laboratory services performed under Medicare Part B support the lawsuit. It was filed in the U.S. District Court of Southern California.

ASCP and others in the laboratory community contend that the demonstration project is flawed in its approach and would adversely impact clinical laboratories and patients. The Society continues to pursue legislative intervention by urging Congressional representatives and Senators to support H.R. 3453, the “Community Clinical Laboratory Fairness Act of 2007,” and S. 2099, the “Preserving Access to Laboratory Services Act of 2007.” Both bills seek to repeal the competitive bidding demonstration project. You, too, can urge your local Congressional delegation to support these bills by visiting ASCP’s eAdvocacy Center.

For labs in the San Diego area, the need to address these concerns immediately is paramount. Bids are due by February 15, with winners being announced in April and initial reimbursements slated to be made in July. The plaintiffs in the lawsuit, Sharp HealthCare, Scripps Health and the Internist Laboratory of Oceanside, hope that a federal judge will halt the demo before the February 15 bidding deadline, on the grounds that the laboratories will either be forced to shut down or to close their laboratory outreach services if they are not among the winning bidders.

Background
In 2003 Congress directed CMS to conduct a demonstration project on the competitive acquisition of laboratory services reimbursable under the Medicare Part B clinical laboratory fee schedule. This Congressional mandate came as a result of Section 302(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The purpose of the demonstration is to determine whether competitive bidding can be used to provide quality Part B clinical laboratory services at a price below current Medicare reimbursement rates.

The premise of the three-year project is to lower Medicare costs by requiring labs to follow a competitive bidding process for specific tests that physicians typically order. The project may appear to affect only those in the demonstration site areas. ASCP, however, is concerned that the data gleaned from the project could be applied nationally. This could force smaller laboratories to close, denying patients access to laboratory services and ultimately jeopardizing the quality of laboratory services to patients.

ASCP’s Washington staff with continue the progress being made in both San Diego and on Capitol Hill and will keep readers apprised of the latest developments related to halting CMS’ competitive bidding demo.

ASCP Succeeds in Stopping Pod Labs

ASCP has succeeded in its efforts to shut down pod labs. After extensive lobbying by the Society, the Centers for Medicare and Medicaid Services (CMS) implemented the anti-markup provisions it proposed as part of its 2008 physician fee services, at least for pathology services.

Initially, CMS planned to apply the anti-markup provisions to all physician services. Days before the rule was to go into effect, CMS responded to pressure from opponents of the anti-markup rule who urged the agency to delay implementation. ASCP had waged an 11th hour campaign to shield anatomic pathology services from the delay. In the end, the Agency delayed until January 1, 2009, application of the new anti-markup rules to services other than anatomic pathology services.

The development is a big victory for ASCP and its members, who sent thousands of letters to CMS and Congress as part of ASCP’s Stop Pod Labs Now campaign. The rule bars physician practices or suppliers from marking up the cost of the technical or professional components of a Medicare-reimbursed diagnostic test if the service is purchased from an outside supplier or performed at a site other than the “same building” of the billing practice or supplier.

The new rules seek to prevent clinicians from using the centralized building criterion of the Stark law’s in-office ancillary exception to markup the cost of anatomic pathology services. The mark ups of anatomic pathology and other services were causing a host of problems, such as overutilization of diagnostic services, increased costs, and declining revenue for clinical laboratories and pathologists.

Society Issues

ASCP and Laboratory Community Prioritize Solutions to Workforce Shortage

ASCP participated in a strategic planning session of the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) in January. The CCCLW is a coalition of laboratory associations and industry partners working to improve responses to the shortage of clinical laboratory personnel.

As part of the strategic planning session, the group reviewed several tasks necessary to address the shortage of qualified laboratory professionals, such as ASCP’s data collection, marketing, recruitment, and educational financing. Addressing the laboratory professional workforce shortage is a high priority for ASCP. The Society is pleased that so many organizations are willing to work together to find solutions to the problem.

Laboratory Community Joins Forces to Deliver United Legislative Message to Lawmakers

Laboratory professionals are joining forces to take a message of solidarity to Capitol Hill. The American Society for Clinical Laboratory Science, the American Society for Clinical Pathology, and CLMA will join forces for their annual Capitol Hill Day/legislative symposium on March 17-18, 2008. The event informs federal lawmakers about the daily issues facing laboratory practitioners. Members of each organization will visit their respective House Representatives and Senators to discuss issues such as Medicare Reimbursement, Competitive Bidding, Personnel Shortages, and Funding for Title VII and Title VIII. Participants also will receive training in lobbying and will learn about the organizational structure of Congressional offices, the roles and responsibilities of Congressional staff, and committees and their areas of jurisdiction.

Registration fee for the symposium is $195 if postmarked by February 20, or $250 thereafter. ASCP encourages your participation. The purpose of the Legislative Symposium is to provide laboratory professionals first-hand knowledge about the political system in action and the understanding that one person can make a difference.