Federal

Court Contends Temporary Restraining Order Unnecessary

CMS’ Competitive Bidding Demo Continues, For Now

A federal court last month denied a request by three San Diego laboratories to issue a temporary restraining order aimed at blocking the Centers for Medicare & Medicaid Services (CMS) proposed competitive bidding demonstration project for laboratory services. The lawsuit filed January 29 against the Department of Health and Human Services maintained that the competitive bidding process being imposed on Medicare beneficiaries in the San Diego area failed to protect small business and threatened harm to both the laboratory industry and the patients it served.

The government however argued that such a challenge was unwarranted at this juncture; it was just a demonstration project and since no winners or losers had been decided upon, no harm had come to anyone. Moreover, the government further argued that the court was unable to review the merits of the case based on jurisdictional and other technical legal impediments unique to the Medicare program. The court did grant the plaintiffs an opportunity to respond to the jurisdictional and technical issues raised.

In the meantime, CMS is moving forward. Laboratories were to submit bids by February 15 for 303 laboratory tests in order to remain eligible for Medicare reimbursement. The plaintiffs in the lawsuit will seek to have the court issue a preliminary injunction prior to April 11, 2008, when CMS is slated to announce the winning bidders.

The American Society for Clinical Pathology and the Clinical Laboratory Coalition, of which ASCP is a member, has fought hard against the competitive bidding demonstration project. While the demo may appear to affect only those in the demonstration site areas, the data gleaned from this demonstration project could be applied nationally, forcing smaller laboratories to close, denying patients accessible laboratory services, and ultimately jeopardizing the quality of laboratory services to patients. CMS has not demonstrated an ability to maintain public health and patient safety standards if it were to implement this project.

The laboratory community had been hopeful that Congressional pressure on CMS would facilitate the repeal of the demonstration project. Neither H.R. 3453, the “Community Clinical Laboratory Fairness Act of 2007”, nor S. 2099, “the Preserving Access to Laboratory Services Acts of 2007” gained enough momentum to halt the demonstration project before it had a chance to move forward. Proponents of repeal remain optimistic that there is still of chance to thwart these efforts through Congressional action.

CMS was directed by Congress in 2003 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. ASCP believes that implementation of this demonstration project would adversely impact clinical laboratories and patients.

ASCP and the Coalition will continue to pursue strategies to halt or delay this flawed demonstration project. Any further developments will be reported in upcoming issues of ePolicy.

CLIAC Marks CLIA’s 20th Anniversary, ASCP Addresses Workforce Shortages

On February 20-21, the Clinical Laboratory Improvement Advisory Committee (CLIAC) met in Atlanta to discuss a number of issues affecting the laboratory industry. The meeting marked the 20th anniversary of the Clinical Laboratory Improvement Amendments (CLIA). As part of this event, CLIAC examined the needs for quality then versus today. The panel also heard presentations and discussed the impact that standards and accreditation have had on laboratory quality.

CLIAC examined the issue of laboratory workforce shortages. This discussion began with a presentation on the Coordinating Council on the Clinical Laboratory Workforce, of which ASCP is a member. In addition, ASCP addressed the panel on workforce issues, echoing concern about personnel shortages, including recent problems affecting cytotechnologist educational programs, and the need for a coordinated effort to address this issue. ASCP alerted the panel to a recent Senate hearing on the Title VII allied health educational programs, which can provide funding for programs that train laboratory personnel, and called for a collective effort to increase federal funding for these programs. In addition, CLIAC also discussed several presentations on the impact of implementing quality management systems on laboratory operations and biosafety.

Congress

Senate HELP Committee Focuses on Healthcare Workforce Shortage

The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing on Tuesday, February 12th to discuss the current healthcare workforce shortage. Representatives from a number of professional medical organizations provided testimony at the session, entitled “Addressing Healthcare Workforce Issues for the Future”. The hearing primarily centered on reauthorization of Title VII of the Public Health Service Act, which funds educational programs for physicians, nurses and the allied health professions while promoting diversity in the health professions.

In the past two years, funding to some of the Title VII programs, including the Allied Health Program which funded training programs for laboratory professionals, has been drastically cut. This decrease in funding unfortunately comes at a time when many allied health fields, including the field of clinical laboratory science, are experiencing a severe workforce shortage. In fact, while the Department of Labor projects that approximately 15,000 medical laboratory professionals will be needed each year through 2014, fewer than 5,000 individuals are graduating each year from accredited training programs.

On behalf of ASCP, Society President Lee H. Hilborne, MD, MPH, DLM(ASCP)CM, FASCP, submitted a statement (PDF) to the HELP Committee urging the Congress to restore funding for the Title VII Allied Health Programs to their FY 2005 levels of $300 million. He also urged Congress to consider the establishment of an independent title (outside VII) under the Public Health Services Act dedicated to the clinical laboratory. In addition, Hilborne asked Senators to cosponsor the Allied Health Reinvestment Act (sponsored By Senator Cantwell), S. 605. The Allied Health Reinvestment Act (AHRA) provides incentives for individuals to pursue allied health careers. The legislation does this via programs to support students interested in allied health careers and the academic institutions that train them. The legislation also assists with faculty development and provides for public service announcements to increase interest in allied health careers.

ASCP will continue to monitor Congressional activities regarding healthcare workforce issues in future issues of ePolicy.