Contents of this page:

Thompson to lead HHS – priorities outlined in speech

Federal Health Budget – ASM Staff Assists Coalition in Educating Budget Committee about Health Priorities

ASM Signs onto Coalition Letter –Bush Administration Urged to Support Funding for Public Health Threats and Emergencies Act

Antimicrobial Resistance – Action Plan Released by HHS

Stark II Rules on Physician Referrals – designated health services defined

CPT Codes -- HCFA Program Memorandum on Clinical Laboratory Fee Schedule includes Cross-Walking Decisions for 2001

CLIAC Meeting – summary of February 7-8 meeting, including FDA’s proposed guidance document for waived tests

Revision to Standards for Infectious Substances and Genetically Modified Microorganisms – Proposed Rule issued by Department of Transportation

"Tuberculosis in the Workplace" – IOM publishes report

For more information:

Federal Register
Government Printing Office
General Accounting Office
Occupational Safety and Health Administration
ASM's Tuberculosis Statement
Institute of Medicine

Suzy Leous, Office of Public Affairs

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ASM Clinical Microbiology Issues Update
February 2001

Thompson to lead HHS

Thompson's Speech

On January 24, the United States Senate unanimously confirmed President Bush’s nomination of Tommy G. Thompson as Secretary of the Department of Health and Human Services (HHS).

Secretary Thompson outlined his priority issue areas in a speech he delivered on February 2. Priorities include Medicare reform (prescription drug coverage), flexibility in federal programs such as Medicaid and the State Children’s Health Insurance Program (SCHIP) to help expand coverage for the uninsured, "Patient’s Bill of Rights" legislation, organ donation, food safety, and research.

While it is still unclear who will be nominated and appointed to direct the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), the Bush Administration has retained Jeffrey Koplan, MD, as director of the Centers for Disease Control and Prevention (CDC), John Eisenberg, MD, as Administrator of the Agency for Healthcare Research and Quality (AHRQ), and David Satcher, MD, as United States Surgeon General.

Federal Health Budget

ASM staff participated in meetings with Congressional Budget Committee staff regarding the importance of adequately funding programs in the Public Health Service Act. The Coalition for Health Funding, which includes ASM, organizes such visits each year, to inform the Budget Committee about the various health programs administered by agencies including the National Institutes of Health, the Centers for Disease Control and Prevention and the Food and Drug Administration. The Budget Committee develops the Budget Resolution which sets limits on funding by categories of spending, for example health, and is intended to guide congressional appropriators in their annual recommendation of funds for federal agencies. The Coalition urged the Budget Committee to set a figure high enough to adequately support Function 550 of the Budget Resolution, which includes Public Health Service programs. ASM also signed onto a letter drafted by the Coalition for Health Funding to Secretary Thompson, outlining examples of health challenges of the 21st Century and urging adequate funding for the agencies within HHS which are responsible for responding to such challenges.

The outline of the Administration’s FY 2002 Budget is expected to be released on February 28. A more detailed budget will be sent to Congress on April 3.

ASM Signs onto Coalition Letter

ASM joined several public health organizations in sending a letter to Ann Phelps, health care policy advisor for President Bush to urge full funding for the implementation of the Public Health Threats and Emergencies Act, the newly enacted law which focuses on antimicrobial resistance and bioterrorism. ASM provided scientific expertise on antimicrobial resistance and bioterrorism to Senator Bill Frist (R-TN) and Senator Edward Kennedy (D-MA), co-authors of the legislation, during the drafting of the legislation. The coalition letter states the importance of assuring that ongoing agency work in antimicrobial resistance and bioterrorism is not disrupted or subject to any budget cuts. The letter also stresses the need to devote adequate resources to achieve the objectives of the Act.

Antimicrobial Resistance Action Plan

Action Plan
ASM Comments on draft plan

The Department of Health and Human Services (D-HHS) released its final Action Plan to Combat Antimicrobial Resistance on January 18. The Action Plan, drafted and implemented by the Centers of Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), has four major components: surveillance, prevention and control, research, and product development. Within the four components are 84 action items, including 13 priority action steps considered essential to addressing antimicrobial resistance.

ASM provided several comments to the draft Action Plan in August of 2000, and several of the comments were included in the final version of the Plan. Furthermore, ASM’s Public and Scientific Affairs Board (PSAB) met with officials from CDC, FDA, and NIH on February 16 to discuss the plan. PSAB is also organizing a session on the Action Plan the General Meeting in Orlando, on May 21 at 2:30pm.

Stark II Rules on Physician Referrals

The Health Care Financing Administration (HCFA) issued Phase I of its rulemaking on the "Physicians’ Referral to Health Care Entities With Which They Have Financial Relationships," and was published in the January 4 Federal Register. Otherwise known as "Stark II," the 1993 law introduced by Representative Pete Stark (D-CA), expanded the original Stark law (enacted in 1989) to include more "designated health services" and Medicaid healthcare services. The original law was created to prohibit a physician from referring a patient to a health care provider/entity for designated health services, including clinical laboratory services, if the physician or the physician’s immediate family member has a financial relationship with the service provider. The January 4 rule helps interpret the law by providing more specifics on "designated health services," clarifies exceptions to the rule, and also provides guidance on structuring financial arrangements.

For Medicare clinical laboratory services, the January 4 rule clarifies the 1993 Stark law to includes the designated health services specifically defined by the 80000 series of the Current Procedural Terminology (CPT) codes (2000 edition), with the exception of the following blood component collection services:

86890 Autologuous blood process
86891 Autologuous blood, op salvage
86915 Bone marrow/stem cell prep
86927 Plasma, fresh frozen
86930 Frozen blood prep
86931 Frozen blood thaw
86932 Frozen blood freeze/thaw
86945 Blood product/irradiation
86950 Leukacyte transfusion
86965 Pooling blood platelets
86985 Split blood or products

For all other clinical laboratory services, the rule uses the following HCPCS level 2 codes:

G0001 Drawing blood for specimen
G0026 Fecal leukocyte examination
G0027 Semen analysis
G0103 Psa, total screening
G0107 CA screen; fecal blood test
G0123 Screen cerv/vag thin layer
G0124 Screen c/v thin layer by MD
G0141 Scr c/v cyto, autosys and md
G0143-G0145 Scr c/v cyto, thinlayer, rescr
G0147 Scr c/v cyto, automated sys
G0148 Scr c/v cyto, autosys, rescr
P2028 Cephalin floculation test
P2029 Congo red blood test
P2031 Hair analysis
P2033 Blood thymol turbidity
P2038 Blood mucoprotein

The proposed rules will to go into effect on January 2, 2002, with the exception of home health referral provisions, which will go into effect April 6, 2001. The April 6 effective date is consistent with the Assistant to the President’s memorandum of January 20, 2001, which imposed a 60-day delay in effective dates necessary to give Department

officials the opportunity for further review and consideration of new regulations. Comments on the rule will be accepted by HCFA until April 4, 2001.

CPT Codes – HCFA Program Memorandum on Clinical Laboratory Fee Schedule includes Cross-Walking Decisions for 2001

Program Memorandum

On November 29, the Health Care Financing Administration (HCFA) issued a Program Memorandum regarding implementation of the 2001 Clinical Laboratory Fee Schedule and mapping for the 2001 Current Procedural Terminology Codes (CPT) codes for Clinical Laboratory tests. The transmittal includes a number of reimbursement decisions affecting clinical microbiology. First, a number of charges for new codes have been established at a fraction of the rates of codes to which they are "cross-walked," under the Reasonable Charge Payment Methodology. Second, the reimbursement for the multianalyte test kit for Candida, Gardnerella, and Trichomonas is linked now to a single code instead of the previous three codes. Finally, payment for HIV resistance testing was determined by adding reimbursement attached to the previous composite codes. A copy of the Program Memorandum can be found on HCFA’s web site.

As mentioned in the last issue of the Clinical Microbiology Issues Update, ASM’s Professional Affairs Committee members Vickie Baselski, Alice Weissfeld and Lynne Garcia are in the process of preparing an analysis of the CPT 2001 codes to assist ASM members with understanding the changes. Furthermore, ASM plans to meet with HCFA to discuss reimbursement issues such as the cross-walking decisions referenced in the HCFA November 29 Program Memorandum.

CLIAC Meeting Summary

CLIAC Meeting Minutes
List of Waived Tests (CDC)
List of Waived Tests (FDA)
CLIA Waiver Criteria  (.pdf version)
ASM Waived Test Testimony

On February 7-8, ASM members Joe Campos, Dave Sewell, and Alice Weissfeld attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta, GA. The meeting focused primarily on three issues: the shortage of laboratory personnel, the criteria for waiver of laboratory tests, and genetic testing.

Workforce Issues: A report was presented on the meeting hosted by the Coordinating Council for Clinical Laboratory Workforce (CCCLW – formerly the ASCLS Summit on the Shortage of Clinical Laboratory Personnel). The representatives from eighteen professional groups who attended the CCCLW meeting agreed that the shortage of laboratory personnel is worsening. The CCCLW proposed a strategic plan for the collection of data documenting the problem, marketing the profession, recruitment, and financing education. The participating organizations agreed to assume lead roles for the development of components of the strategic plan. CLIAC agreed that the workforce shortage is an important national problem that can affect the quality of laboratory testing and accreditation agencies (e.g. JCAHO) need to be informed of the problem.

Waived Tests: CLIAC discussed at length the criteria for waived tests and the impact of waived tests on patient care. The discussion highlighted the complexity of the problem as seen by the various regulatory agencies, the manufacturers, and the end users. The number and scope of waived products is increasing and will lead to an increase in the number of laboratories that only perform waived tests. For example, Quidel Corporation’s Quick Vue influenza test and ZymeTx Inc.’s ZstatFlu influenza test have been waived and we have been told that FDA is evaluating many more infectious disease diagnostics.

Data was presented from a quality assessment survey of laboratories performing waived testing in Washington, Arkansas, and New York. Generally, laboratories performing only waived tests had CLIA deficiencies in the areas of quality control and following the manufacturer’s instructions. Fewer deficiencies were observed in locations affiliated with accredited laboratories.

HCFA reported that approximately 75% of 170,000 CLIA laboratories have only a certificate of waiver or PPMP certificate and therefore are not regulated. Generally these laboratories perform less than 10,000 tests per year. Because an earlier study of waived laboratories in Ohio and Colorado indicated that 50% of these laboratories had CLIA deficiencies, the study was expanded to include eight additional states. The preliminary results of this survey indicate a similar percentage of laboratories with CLIA deficiencies. HCFA will present a final report of this study at the CLIAC meeting in May.

The FDA presented its draft guidance document for CLIA waiver criteria as an alternative to the criteria included in the 1995 Proposed Rule (60FR 47534) published in the Federal Register on September 13, 1995. This draft guidance document is seen as an interim review process until a final regulation is accepted and the public will have 90 days to submit comments to the FDA, once the document is officially published in the Federal Register. The draft guidance lists the following criteria that a test must meet to be waived: 1) the test must be simple, 2) the test has insignificant risk of erroneous error, 3) the test is accurate, and 4) labeling (package insert) is consistent with proposed waiver criteria. The test should contain a failure alert mechanism to prevent erroneous results. The FDA interprets "accurate" to mean test performance (i.e. the test performs the same in the hands of untrained users as it does in the hands of laboratory professionals) and not analytical accuracy. CLIAC members suggested that the term "comparability" be used in place of "accurate." Prior to the release of the draft guidance document, FDA conducted a public workshop where ASM provided testimony on this important issue. ASM is also planning to submit comments on the draft document and welcomes input into this process. Please forward any comments you may have to

Genetic Testing: CLIAC became involved in providing advice on the regulation of genetic testing in 1998. On May 4, 2000 a Notice of Intent (NOI) was published, advising the public that the Department of Health and Human Services will be preparing a Notice of Proposed Rulemaking to revise the CLIA regulations applicable to human genetic testing. A CLIAC workgroup evaluated the NOI comments and presented their recommendations to the full CLIAC. A report was also presented on the meeting of the Secretary’s Advisory Committee on Genetic Testing (SACGT). Although there are areas of overlap between CLIAC and SACGT, CLIAC’s expertise is in laboratory testing while SACGT is in the medical/social areas of genetic testing. Both groups will provide advice to CDC and HHS on crafting the appropriate CLIA requirements for genetic testing.

Polio Eradication: CLIAC endorsed the eradication of polio worldwide. CDC is preparing to survey laboratories in January 2002 to request their assistance in destroying all materials that may contain poliovirus or request listing on a national inventory maintained by CDC. This issue was discussed with the ASM’s Public and Scientific Affairs Board on February 16.

CDC Proposed Quality Institute: CDC proposed that a Quality Institute be formed to discuss the impact of new technology on test quality and outcome. The format would emphasize problem solving and would involve representatives from all areas of healthcare.

Quality Control Update: In 1996, ASM recommended the revision of the frequency of Quality Control specified in CLIA 88. CDC and HCFA agreed with ASM’s recommendations and it is expected that the CLIA regulations will be revised sometime in 2003.

Revision to Standards for Infectious Substances and Genetically Modified Microorganisms issued by Department of Transportation

ASM Comments on Proposed Rulemaking
Copy of Standards

On January 22, the Department of Transportation (DOT) issued a proposed rule, Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Microorganisms. In 1998, ASM responded to the DOT’s Advanced Notice of Proposed Rulemaking on this topic and made recommendations in nine subject areas of the proposed rule, including the World Health Organization (WHO) risk group designations for classifying infectious agents; specific language used for labeling diagnostic specimens; packaging and labeling requirements for other biological products; labeling requirements for genetically modified organisms; placarding of vehicles carrying biological materials; standards for transport of medical waste materials; handling and labeling of waste stocks and microbial cultures; segregation of infectious materials from foodstuffs; and, definitions for genetically modified organisms.

ASM is in the process of preparing comments on the January 22 Proposed Rule and encourages you to respond as well. A copy of the rule, including details on where to send comments, can be found on ASM’s web site. Final public comments are due to the Department of Transportation by April 3, 2001. Please send copies of your comments to

"Tuberculosis in the Workplace"

IOM Report
ASM Written and Oral Comments on Tuberculosis in the Workplace

The Institute of Medicine (IOM) recently released a new study, "Tuberculosis in the Workplace," which reports that tuberculosis continues to remain a threat to some health care, correctional facility, and other workers in the United States. The IOM recommends that such facilities remain aware of efforts to protect workers from the risk of exposure, and concludes that regulations set by the Occupational Safety and Health Administration (OSHA) on preventing occupational tuberculosis, could have a positive effect on reducing the risk. The IOM further recommends that the OSHA regulations could be effective in the workplace provided that three basic conditions are met: 1)consistency with tuberculosis control measures that appear to be effective, 2) an increase or sustaining of the level of compliance with those measures, and 3) flexibility for organizations to adapt tuberculosis control measures appropriate to the level of risk facing workers.

On August 7, 2000, ASM member Mary Gilchrist, testified before IOM’s Committee on Occupational Exposure to Tuberculosis. ASM’s testimony focused on the scope of the 1997 OSHA-proposed rule, which creates confusion and constraints on laboratories because it references an outdated edition of the Centers for Disease Control and Prevention (CDC)/National Institutes of Health (NIH) Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines. ASM also expressed concern that the 1997 OSHA-proposed rule did not apply to all employees of the laboratory. ASM recommended that the laboratory community be called upon to develop new rules which can improve worker safety. While the specifics of ASM’s testimony were not included in the Report, some of ASM’s general themes were included, such as the confusion between the CDC guidelines and the OSHA proposed rule, as well as the need for flexibility in the rule, to protect those workers most at risk. Both the written and oral statements can be found on ASM’s Public Affairs web site.

The IOM Report was requested by Congress in 1999. Congress was interested in finding out if health care workers were at a greater risk of infection, disease and mortality from tuberculosis, and if the 1997 OSHA-proposed rule was sufficient in helping to minimize or eliminate this risk.