Society News
ASCP Hosts Conference to Examine the Future Role of the Specialty
Last month, ASCP convened a panel of leaders in health care both from within the field as well as those external to the profession 1) to evaluate the current role of laboratory medicine and pathology in the practice of medicine and 2) to provide recommendations for transforming laboratory services to remain relevant and effective in the rapidly evolving health care system.
Pathology’s Future: A View from Leaders in Health Care, supported with a grant from the Abbott Fund, brought together a distinguished cadre of individuals with expertise in the various facets of health care delivery. The charge of this panel was to:
- Evaluate the current role of pathology and laboratory medicine within
the practice of medicine and identify innovative services or practices that
will serve to better complement patient care and improve patient outcomes
- Recommend practical steps for laboratories to implement these
transformative services
- Determine an effective means for laboratories to measure improved patient outcomes as a direct result of enhanced laboratory services.
In addition to pathologists, the panel included clinicians, researchers, government officials, hospital administrators, IT specialists, experts in quality and public health. Among the participants were Robert H. Brook, MD, ScD, Vice President of the RAND Corporation and Director of RAND Health; Ronald A. Paulus, MD, MBA, Executive Vice President, Geisinger Health System; and Julie L. Gerberding, MD, MPH, former Director of the Centers for Disease Control and Prevention, to name a few. ASCP’s Past President, Lee H. Hilborne, MD, FASCP, MPH, DLM(ASCP)CM, and Vice President, John E. Tomaszewski, MD, FASCP, also participated in the discussions.
Panelists discussed the role of pathologists and laboratory professionals in a number of areas: development and impact of new technologies, increased involvement in patient care delivery and guideline development, personalized medicine, employing laboratory data to prevent overutilization, and global efforts to ensure international standards and quality. The discussions initiated at the conference mark the beginning of what will be continued dialogue on how pathology and laboratory medicine must evolve to meet the needs of tomorrow’s patients. Look for follow-up from these discussions in upcoming editions of
ePolicy.
Congress
Senate, House Health Care Reform Plans Advance
ASCP Active in Deliberations with Senate
Legislative proposals to reform the U.S. health care system continue to advance in the Senate and House of Representatives.
Senate Bill
The Senate Finance Committee recently began work to develop legislation on health reform. An initial legislative draft developed by Committee chairman Max Baucus called for a $750 million tax, or about 2-3 percent, on clinical laboratory testing revenues. ASCP, the American Clinical Laboratory Association and the College of American Pathologists joined together to raise concern about the proposal. Instead of a permanent tax on laboratory testing, the Finance Committee replaced the tax with a temporary 1.75 percent reduction of the clinical laboratory fee schedule. The fee schedule reduction would last from 2011 to 2015. The tax would have applied to all clinical laboratory revenues, including anatomic pathology services.
Another proposal under consideration by the Finance Committee that could affect clinical laboratories is a proposed productivity adjustment. The proposal would require that as annual updates to the various Medicare fee schedules are calculated, the federal government would reduce the annual update by an amount equal to the estimated annual increase in productivity. For example, if productivity were estimated to be 1.4 percent for the year, that amount would be deducted from any increase in the fee schedule. With regard to the clinical laboratory fee schedule, however, the Senate proposal has clarified that the productivity adjustment cannot cause the annual update to become negative.
Two other provisions currently a part of the Chairman’s Mark, a legislative blueprint for consideration by the Committee, are an extension of existing provisions allowing for Technical Component billing by independent laboratories performing services for Medicare inpatients and “reasonable reimbursement” for laboratory services provided at small rural hospitals.
House Bill
In the House of Representatives, the Energy and Commerce Committee recently considered a number of amendments to a bill, HR 3200, it approved in July. These amendments will be included with previous versions of HR 3200 amended by the three House Committees working on health legislation: the Committees on Education and Labor, Ways and Means, and Energy and Commerce. The House measure contains a productivity adjustment provision on clinical laboratories that is similar to the proposal under consideration in the Senate Finance Committee.
The House bill also extended provisions allowing for TC billing by independent labs performing services for Medicare inpatients and “reasonable reimbursement” for laboratory services provided at small rural hospitals. House leadership plans to craft a single bill for consideration of the full House of Representatives later this fall.
SGR Formula
Both the Senate and House plans address the sustainable growth rate (SGR) formula used to calculate the annual update on physician fee schedule, though the two chambers of Congress address this issue in different ways. The Senate bill would reverse the projected cuts in the physician fee schedule caused by the sustainable growth rate, but would not provide a permanent fix to the SGR. In contrast, the House blueprint for reform reverses the projected cuts but also repeals the SGR.
Federal
ASCP Comments on Draft Technology Assessment on LDTs
The Agency for Healthcare Research and Quality (AHRQ) released a draft technology assessment in July on the current status of laboratory-developed molecular tests (LDMTs) at the request of the Coverage and Analysis Group at the Centers for Medicare & Medicaid Services (CMS). The report,
Quality, Regulation and Clinical Utility of Laboratory-Developed Tests, summarizes the available scientific evidence on the quality of laboratory-developed molecular tests, which are currently not regulated by the U.S. Food and Drug Administration (FDA). The objectives of the assessment, which was prepared by the ECRI Institute Evidence-Based Practice Center, were to summarize 1) the types of LDMTs currently available for conditions relevant to the Medicare patients over 65 years of age; 2) the methodologies developed to assess analytical and clinical performance of molecular tests; 3) the current role of Federal agencies in regulating LDMTs; and 4) the quality standards that have been developed to date by regulatory bodies, the industry, and the medical community.
In response to AHRQ’s call for public comment on the draft, ASCP submitted a letter last month noting the failure of the assessment report to include reference to CLIA’s role in ensuring clinical validity, addressed in the June 2009 Morbidity and Mortality Weekly Report (MMWR). In this report, CLIA charges laboratory directors and technical supervisors with the responsibility for ensuring that test methods are both appropriate for the intended clinical application and provide quality results. With regard to clinical utility, ASCP cautions that it remains a subjective standard dependent on how clinicians utilize assay results in managing patient treatment, and not on an objective quality inherent in the test method. ASCP has been concerned that requiring proof of clinical utility as a pre-requisite for marketing of these assays might impede or even prevent patient access to them. The nature of these molecular assays allows for nimble clinical intervention utilizing the latest published research, and ASCP remains concerned that a lengthy approval process that requires evidence of clinical utility might ultimately hinder the development of these assays.
ASCP Informs Laboratory Training Programs Regarding DOL Grants
ASCP has been working with the laboratory professional training community about the availability of health care sector stimulus grants through the Department of Labor (DOL). A number of clinical laboratory training programs have been in touch with ASCP over the past several months to indicate their desire to submit grants through the DOL. The deadline to submit a grant is October 5, 2009. To view a copy of our alert, which provides a direct link to the DOL grants, please
click here.
Waived Testing Discussed by CLIAC
In early September, the Clinical Laboratory Improvement Advisory Committee (CLIAC) met to discuss issues pertaining to laboratory testing quality and oversight. The Committee discussed three issues: assessing the performance and impact of waived testing, assuring laboratory testing quality during public health emergencies, and the current state of HIV testing.
With regard to the issue of quality at waived testing facilities, one presenter for the Centers for Medicare and Medicaid Services noted that CMS continues to find problems at waived testing sites. The presenter noted that a 1999 survey of laboratories in Colorado and Ohio found that 50 percent of waived and provider-performed microscopy (PPMP) laboratories suffered from quality problems. In 2001, a CMS study found that of 436 waived and PPMP labs examined, 32 percent had quality problems. CMS is now reporting new data indicating that in almost 900 waived labs surveyed by CMS, 24 percent were not performing quality control as required by the manufacturer, 21 percent were staffed by personnel that had not been trained or evaluated, and 13 percent did not have the manufacturer’s instructions on proper test device use.
During discussion of the issue, CMS asked CLIAC for guidance on a proposed study to assess waived labs and the quality of their work. CMS indicated that it is contemplating whether the amount of federal oversight currently provided waived labs is sufficient or whether additional measures, such as imposing personnel, proficiency testing, or regular survey requirements, are necessary to help provide quality testing by these facilities.
CLIAC heard several presentations on test quality pertaining to the spring 2009 outbreak of Swine-origin influenza A. Presentations were provided on the Food and Drug Administration’s role in assuring test quality during public health emergencies as well as the experiences of one public health laboratory dealing with significant increases in Swine flu-related testing demand.
On the topic of HIV testing, CLIAC heard and discussed several presentations that concerned evolving diagnostic technologies, including an overview of a recent CDC study on alternative algorithms for HIV diagnosis. On this latter topic, a publication from the Association of Public Health Laboratories,
HIV Testing Algorithms: A Status Report, was presented.
CMS Initial Determinations on Pricing New Laboratory Tests Follow ASCP Recommendations
CMS recently unveiled its initial determinations for pricing a series of new laboratory tests for which it is creating new CPT codes. For the most part, the list of new codes follows ASCP’s recommendations. To see ASCP’s recommendations and CMS initial determinations,
click here.
Reports
IOM Releases Report on Improving Healthcare Quality through Standardized Data Collection
In September 2009, as a response to the request of the Agency for Healthcare Research and Quality (AHRQ), the Institute of Medicine (IOM) released a report on standardization pertaining to data collection in order to improve healthcare quality. In an effort to decrease disparities in access to and improve quality of healthcare, the Subcommittee on Standard Collection of Race/Ethnicity Data for Healthcare Quality formed by the IOM recommends a more standardized approach when collecting data on race, ethnicity and language categories. At present, many groups in the population are overlooked when devising interventions due to the generalization of these variables. In order to achieve a more “widespread collection and utilization” of data, the subcommittee suggests the inclusion of granular ethnicity information as an addition to the existing Office of Management and Budget (OMB) race and Hispanic categories. They also recommend gathering data on a patient’s self assessment of hisorher English language proficiency and preferred spoken language when communicating with a healthcare provider to determine gaps in communication. By adhering to these recommendations, the probability of recognizing an individual’s race, ethnicity and language would increase, leading to a better understanding of the overall population’s healthcare needs.
To promote consistency and ensure effective outcomes from this proposal, they implore the Department of Health and Human Services (HHS) to provide a “nationally standardized list for granular ethnicity categories and spoken and written languages.” HHS, along with the Office of the National Coordinator for Health Information Technology (ONC), are also asked to include as part of their requirements “variables of race, Hispanic ethnicity, granular ethnicity, and language need” when funding healthcare programs and setting electronic health record standards. Data collected utilizing this approach is believed to have the potential to decrease disparity and elevate the quality of health care at both the national and local levels. Hospitals, health plans, physician practices, healthcare researchers, and local, state and federal agencies are called upon to implement this recommendation so that proper interventions and policies may be formed.
To access full report, see link
http://www.iom.edu/CMS/3809/61110/72796.aspx.