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Public Affairs Report
ASM Attends State Department Biotech Working Group Meeting
On 25 October David Pramer, chair of the Public and Scientific Affairs Board Committee on Biotechnology and Industry, attended the third meeting of the State Department's International Economic Policy Working Group on Biotechnology, of which ASM is a member. The Working Group discussed the concept of "regulatory precaution" as it relates to biotechnology and food engineering, including a review of the European Union's precautionary principle. The National Academy of Sciences is considering a study of this issue, which could have a potential impact on research programs. The concept of regulatory precaution is used in risk analysis where scientific evidence is insufficient and negative effects on health are difficult to evaluate. The Working Group also discussed implementation of the Biosafety Protocol, which has been signed by over 70 countries and is expected to come into effect within the next two years. The Working Group is expected to continue to discuss biotechnology issues of importance to the new administration.
Congress Adjourns before Completing Funding Bills, Fails To Pass Medicare Relief Bill
On 3 November, Congress adjourned without approving the final FY 2001 Labor, Health and Human Services and Education (Labor/HHS/ED) spending bill, which contains funding for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). In addition, the so-called Medicare "Give Backs" bill, which proposed to restore approximately $30 billion in cuts resulting from the Balanced Budget Act of 1997, has also not yet been approved and cleared for the President's signature. A Continuing Resolution (CR) was passed by Congress to keep the government funded at its current level, until 5 December, when Congress is expected to return to Washington to finalize any outstanding pieces of legislation.
Negotiations between the administration and House and Senate appropriators were near completion, when leadership of the House and Senate halted the process due to opposition to legislative language regarding a Department of Labor standard on ergonomics. Before negotiations broke down, the FY 2001 spending bill included a 15% increase for the NIH and the CDC. ASM wrote to members of the House and Senate leadership and key members of the appropriations committees urging completion of work on the Labor/HHS/Ed appropriations bill and adoption of the pre-election agreed upon increases for NIH and CDC.
Lab Institute 2000
ASM staff, Suzanne Leous attended Lab Institute 2000, a national annual meeting sponsored by Washington G-2 Reports and the Johns Hopkins Department of Pathology, on 26-27 October. The meeting focused on legislative and regulatory issues affecting the delivery of diagnostic testing and related health care services including updates from various Federal agencies.
Of most interest to the group was the update on the Medicare "Give Backs" legislation (see related story) as well as the report from the Health Care Financing Administration (HCFA). HCFA reported that it is developing responses to the comments received on the proposed Medicare laboratory rule (which was published in March 2000), and it is unlikely that any rule will be implemented before 2002. HCFA also reported that it will extend the current Clinical Laboratory Improvement Amendments of 1988 (CLIA) phase-in requirements for moderate and high complexity quality control, and will also extend the phase in for board certification of laboratory directors holding doctoral degrees, to 31 December 2002. In addition, HCFA informed the group that it will expand its pilot study of CLIA-waived and provider-performed microscopy (PPM) laboratories to eight additional states. HCFA's initial study of Ohio and Colorado laboratories discovered that manufacturer's instructions for certain test procedures were not being followed, and, a number of laboratories in those states were also found to be performing tests outside the scope of their certification. Approximately 500 additional laboratories will be included in the expanded study. If problems are cited, HCFA will provide educational assistance to ensure that laboratories function accordingly.
CPT Coding Update
The 2001 edition of CPT, published by the American Medical Association, includes several changes for microbiology, including 32 new codes, 16 deleted codes, and 41 code descriptor modifications, which are scheduled to take effect 1 January 2001. The Public and Scientific Affairs Board's Professional Affairs Committee will provide a more detailed analysis of the new codes to assist in understanding the changes and will soon be posted on the ASM Public Affairs website.Copies of CPT 2001 can be ordered from the American Medical Association , or CPT On-Line Products .
ASM Represented at National Laboratory Training Network Meeting
On 23 October ASM member, Gerri Hall represented ASM at the National Laboratory Training Network (NLTN) Stakeholders Strategic Planning meeting in Atlanta, Ga. The purpose of the meeting was to solicit information and input from various scientific societies and organizations interested in the NLTN's future. ASM provided perspective on the state of laboratory science in the clinical setting, the impact of technological advances on the clinical setting, changes in laboratory personnel, and changes in educational methodologies which might impact the future of continuing education programs for laboratorians. The meeting was hosted by the Association of Public Health Laboratories and the Centers for Disease Control and Prevention.
Public Health Improvements Act Passes Congress
President Clinton signed H.R. 2498, the Public Health Improvements Act, into law on 13 November, after it was approved by the House and Senate on 26 October. ASM participated in the drafting of this legislation which will authorize key programs to improve public health infrastructure and the response to antimicrobial resistance and bioterrorism. Prior to the bill's passage, ASM testified on key issues and worked closely with the sponsors of the bill, Senator Frist (R-Tenn.) and Senator Kennedy (D-Mass.), participated in Capitol Hill visits to educate Hill staff of the legislation, and sent letters of support to Congress. ASM will work closely with the Centers for Disease Control and Prevention and other agencies involved in the implementation of this new law. Updates will be provided to ASM members at the Public and Scientific Affairs Board meeting in February as well as at the ASM General Meeting in May.
ASM Comments on APHIS's Proposed Rule on Pain and Distress in Research Animals
Animal Welfare; Definitions for and Reporting of Pain and Distress
On 3 November, ASM submitted comments on the proposed rule to clarify the definitions of pain and distress of animals used in research, testing, and teaching, under the direction of the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. ASM responded by recognizing the need to balance the necessity to conduct humane research and the moral need for proper animal care and the obligation to avoid or minimize pain and distress. ASM further stated that standardizing the definition would lead to additional ambiguity for researchers and other constituencies and would not, in fact, enhance the research communities' ability to recognize, or minimize animal pain and distress. APHIS published the proposed changes to the Animal Welfare Act in the Federal Register on 10 July. A copy of ASM's comments and the proposed rule can be accessed on the ASM website.
Education Board's Role at 2000 SACNAS Conference
ASM President Martha Howe and three individuals who have received ASM fellowships presented a scientific session "The Cutting Edge of Microbiology Education and Research" at the 2000 National Conference sponsored by the Society for the Advancement of Chicanos and Native Americans in Science (SACNAS) on Friday, 14 October in Atlanta, Ga. In addition to Howe, Rosa del Torres (R. D. Watkins Fellow, 1991-92), Timothy Gondre-Lewis (R. D. Watkins Fellow, 1996-97), and Asia Fuisa (ASM Minority Undergraduate Research Fellowship, 1997) described their research projects and career interests during the same session. ASM sponsored one workshop on inquiry-based learning for kindergarten through high school teachers. Two members of the ASM Committee on Precollege Education, Steve Wagner from Stephen Austin State University and Robin Patterson from Butler Community College, and a fifth-grade teacher, Lynn Wager from Texas, presented the teacher workshop.
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