Federal
ASCP, Lab Community Respond to Assault on CMS Anti-Pod Lab Rule
The American Society of Clinical Pathology and members of the clinical laboratory community have banded together in support of key provisions of the Centers for Medicare and Medicaid Services’ recent final physician fee schedule rule for 2008. CMS’s new rule bars the markup of diagnostic tests, such as pathology services, by clinician group practices. The final rule, however, is under continued assault from several physician groups opposed to the reassignment and self referral changes. Some of these groups are now urging CMS to scrap the rule due to issues related to regulatory procedure.
The new rules are, in large part, the result of the work done by ASCP and its membership, thousands of whom wrote federal legislators and regulators urging that CMS block the mark-up of pathology services. The rules are intended, in part, to block so-called pod labs by prohibiting clinician group practices from marking up the cost of laboratory services. The arrangements engaged in by these entities and clinicians, according to the U.S. Department of Health and Human Services Office of Inspector General, “can distort medical decision-making, cause overutilization, increase costs and result in unfair competition” as well as “adversely affect the quality of patient care.”
ASCP and the laboratory coalition have been in regular communication with CMS to provide political support for the agency’s new rule. ASCP has urged the agency to move forward with implementation of the new rules regarding reassignments and self referral. ASCP has opposed calls for CMS to delay implementation of the rule.
CMS has indicated that it plans to release a clarification on the rule, possibly before January 1, 2008, as there are several technical questions pertaining to compliance with the rule. However, it is not anticipated that the upcoming clarification will provide group practices a loophole to the new rules.
FDA Organizes Roundtable on Troponin Testing
In December 2007, at the request of the U.S. Food and Drug Administration (FDA), representatives from the clinical laboratory community convened to provide the agency with input regarding the cardiac biomarker, troponin. The roundtable was prompted by FDA concern that new guidelines developed by the National Academy of Clinical Biochemistry (NACB) recommend a standard of care not attainable by troponin assays currently on the market. NACB guidelines recommend clinical intervention when the troponin I value is greater than the 99th percentile of the normal population. The FDA has not approved any assays based on the clinical performance of such low concentrations of troponin I and is concerned that the potential for false negatives exists.
The roundtable participants discussed ways to address inconsistencies in troponin assays while still meeting the needs of clinicians who now rely heavily on troponin to determine risk stratification of patients with acute coronary syndrome and the diagnosis of myocardial infarction. One possible approach included the establishment of new labeling for “high sensitivity” cardiac troponin assays, similar to the labeling of high sensitivity C-reactive protein assays. The criteria for high sensitivity troponin assays would be based on NACB and other clinical guidelines for high quality tests, and provide laboratorians and clinicians with more accurate information regarding the capabilities of these assays. New labeling would also serve as a market incentive to manufacturers for developing better quality troponin assays.
Roundtable participants recommended the development of a white paper to address the need for high sensitivity troponin assays, establish criteria for designating assays as high sensitivity, as well as a strategy for harmonization of troponin results. ASCP will continue to monitor this issue and report new developments in future editions of ePolicy.
ASCP Responds to SACGHS Draft Report on Oversight of Genetic Testing
In November, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) released a draft report entitled U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services (HHS). The report is an extensive review of the status of genetic testing regulation and how genetic information is currently applied in patient care and management. Included are discussions on analytical validity, clinical validity, and clinical utility of genetic tests, possible gaps in testing oversight that may compromise patient safety, evidence development for oversight of genetic and genomic tests, and new approaches to demonstrate the clinical validity and utility of genetic testing in clinical practice.
In the report, SACGHS urges the HHS Secretary to take steps to enhance interagency coordination so that agencies with regulatory roles, such as the Centers for Medicare & Medicaid Services and the Food and Drug Administration, are working synergistically with one another and with the various knowledge generation agencies including the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the National Institutes of Health. The laboratory community, including ASCP, has repeatedly expressed concern that a lengthy approval process for genetic assays may stifle innovation, increase healthcare costs, and limit patient access to beneficial diagnostic tools. At the center of this debate is the definition used to classify a particular assay as a genetic test. Many in the laboratory community feel that the broad definition used in the SACGHS report as well as in previously released FDA draft guidance publications could potentially include many established non-genetic tests that to date have posed no public health concern.
ASCP President, Lee H. Hilborne, MD, outlined these concerns in a letter to the SACGHS submitted on behalf of the American Society for Clinical Pathology. ASCP will continue to monitor the regulation of genetic testing and will report any new developments in ePolicy.
Congress
Medicare Bill Disappoints; Congress Provides Temporary Fix to 10 Percent PFS Cut
With the House of Representatives approving a Medicare bill on a vote of 411-3, legislation providing a temporary override of a projected cut in physician reimbursement rates will soon be sent to President Bush for his approval. The legislative package would provide temporary relief from the projected 10.1 percent cut in the physician fee schedule (PFS) but it would not repeal the competitive bidding project CMS is about to impose on clinical laboratories in the San Diego area.
The projected 10.1 percent cut comes as a result of the flawed sustainable growth rate formula CMS uses to determine its annual update of the PFS. The projected cut would be replaced with a 0.5 percent increase through June 30, 2008. By not providing the funds to override the projected PFS cut for all of 2008, Congress has created uncertainty on physician reimbursement rates after June 30, 2008.
Additionally, the bill would extend the technical component pathology billing exception. By extending this provision, independent clinical laboratories may, in certain situations, bill Medicare directly for the technical component of inpatient and outpatient surgical pathology services.
The bill also provides a 1.5 percent bonus for the Medicare physician quality reporting initiative (PQRI) through December 31, 2008. The PQRI, however, is unlikely to provide significant additional reimbursement to pathologists or clinical laboratories. There are only two performance measures that have been developed so far for pathology and clinical laboratories.
Particularly disappointing to the laboratory community is that Congress did not include legislative provisions to repeal the clinical laboratory competitive bidding demonstration project. During prior discussions with congressional leaders, it appeared that provisions to repeal the demonstration project would be included. Unfortunately, by the time Congress finalized its Medicare bill these provisions were dropped.
This setback, however, will not deter ASCP from pressing Congress to repeal the competitive bidding program (see accompanying article below).
Going Once, Going Twice...
CMS’ Competitive Bidding Demo to Continue
The Centers for Medicare & Medicaid Services (CMS) proposed competitive bidding demonstration project for laboratory services is moving forward despite efforts by the American Society for Clinical Pathology and the Clinical Laboratory Coalition, of which ASCP is a member. The laboratory community had been hopeful that Congressional pressure on CMS would facilitate the repeal of the demonstration project.
Although legislation in the House of Representatives, H.R. 3453, the “Community Clinical Laboratory Fairness Act of 2007”, and in the Senate, S. 2099, “the Preserving Access to Laboratory Services Acts of 2007” had gained momentum, neither bill had gathered enough support to move forward as stand alone legislation. To expedite repeal, ASCP and the laboratory community had been negotiating with key Senate and House leaders to include repeal language in the final Medicare package. Unfortunately these efforts were unsuccessful as the principal negotiators scaled back the final package without the repeal provisions. This leaves CMS free to continue the competitive bidding project as planned.
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.
Society Issues
Laboratory Community Connects
Combined Hill Day Underscores Power of Political Process
With the impending Presidential election taking center stage, Americans have become keenly aware the power they possess in the ballot booth. However, the message that they too can make a difference in public policy may not be as clear. Laboratory professionals, however, are preparing to exercise that power as the American Society for Clinical Laboratory Science, the American Society for Clinical Pathology and the Clinical Laboratory Management Association join forces for a combined Capitol Hill Day. The two-day legislative symposium, slated for March 17-18, 2008, is designed to take the issues laboratory practitioners face daily to federal lawmakers. Members of each organization will visit their respective House members as well as Senators to discuss issues such as repeal of Competitive Bidding, the laboratory personnel shortage and the need to modernize the fee schedule.
Prior to taking their message to Capitol Hill, participants will receive training on the “how-to’s” of lobbying, including information on the organizational structure of Congressional offices, the roles and responsibilities of Congressional staff, and committees and their areas of jurisdiction.
The registration fee for the symposium is $195.00 if postmarked by February 20 and $250.00 after that date. ASCP encourages your participation; the Legislative Symposium is an annual event aimed at those in the laboratory profession gaining first-hand knowledge of the political system in action as well as a clear understanding that one can make a difference.
If interested in participating in the Legislative Symposium, contact Shaun Hill at (202) 347-4450, ext. 27 or by email.