Federal
ASCP Urges CMS to Fix Severe Flaws with Anti-Markup Rule
In a recent letter to the Centers for Medicare & Medicaid Services (CMS), ASCP urged the agency to fix several significant flaws with its recently revised anti-markup provisions. These provisions, modified by the 2009 Physician Fee Schedule final rule, were intended to further restrain physicians from engaging in self-referral of their diagnostic testing services by broadening the application of the anti-markup rules. The agency expanded its anti-markup rules to deal with all diagnostic services (previously the rule applied only to anatomic pathology services).
ASCP observed that the rule was poorly crafted, and that it appears to reenable specialty physicians to mark up the anatomic pathology services they order. One of the problems with the rule traces back to its supervision requirement. As CMS Clinical Laboratory Improvement Amendments (CLIA) officials and several prominent attorneys specializing in health care law have noted, neither Medicare nor CLIA specifies who must supervise the technical component (TC) of a pathology service. Consequently, it appears that supervision does not need to be provided by a pathologist. Any physician in a group practice would appear to be able to supervise the TC of an anatomic pathology service for the purposes of avoiding the anti-markup rule.
Additionally, ASCP raised concern with CMS about its removing references to the purchased test rules from the anti-markup rules. The result is that specialty physicians appear to be able to purchase anatomic pathology services then mark up the costs of these services when billing Medicare.
Both flaws appear to be an inadvertent oversights, as the rule claims to address CMS’ concerns about physician self referral. It was concern about the markup of pathology services, brought to light by ASCP’s advocacy efforts, that prompted CMS to create the anti-markup rules.
ASCP urged that these problems be addressed before the new rule goes into effect on January 1, 2009. In addition, ASCP signed onto a coalition letter with the American Clinical Laboratory Association and the College of American Pathologists (CAP) to urge CMS to address these problems before the rule goes into effect on January 1, 2009.
CMS Responds to ASCP PT Referral Concerns
Recently, CMS responded to ASCP’s August 28 letter raising concerns about the agency’s recent determinations of intentional proficiency testing (PT) referral. ASCP questioned whether some of CMS’ recent determinations of intentional PT referral were inadvertent or accidental in nature. Under the CLIA intentional PT referral requires the revocation of the laboratory’s CLIA certificate and bars the laboratory owner and laboratory director from owning or supervising a laboratory for two years.
In its letter to ASCP, CMS indicated that it recently began an education effort to increase awareness of the CLIA requirements. In support of this effort, CMS recently sent a letter to all non-waived laboratory directors titled “Proficiency Testing Referral – Risk of Severe Sanctions.” CMS has also contacted PT programs, requesting that they clearly indicate in their materials and report forms how PT tests are to be handled.
In addition, CMS indicated that it is “reviewing every case where improper PT referral is alleged to determine whether facts support a determination that the PT referral was inadvertent or accidental, thus lessening the potential impact to affected laboratories and assuring consistent outcomes.” Moreover, CMS indicated that it is considering refinements to its definition of intentional PT referral, which may lessen the impact of sanctions on those laboratories whose actions do not warrant the severe sanctions associated with intentional PT referral.
Congress
WILL WORKFORCE SHORTAGE STRIKE A CORD?
ASCP, Other Health Groups Hope Past Support Carries Over
ASCP and a host of other medical organizations that are part of the Health Professions and Nursing Education Coalition (HPNEC) have written President-Elect Obama to thank him for previous support of funding for Title VII and Title VIII programs and to urge full funding for the health professions and training programs be a part of a comprehensive strategy to improve the nation’s health care in his administration. ASCP believes that Title VII funding is an avenue to address the laboratory workforce shortage. Evidence continues to mount regarding the severity of the problem; the Clinical Laboratory Curriculum at the University of South Alabama is but the latest casualty. See related story
The programs run by the Health Resources and Services Administration (HRSA) are designed to train providers to meet the needs of special and underserved populations, as well as increase minority representation in the health care workforce. Title VII in particular has struggled to carry out its objectives due in large part to funding lost by a drastic 51.5 percent ($155 million) cut in fiscal year 2006.
The Society along with the other members of HPNEC maintain that the widespread provider shortages across all health disciplines must be addressed in order to bolster the health care workforce, particularly as the nation considers health care reform. The President-Elect’s “Plan for a Healthy America” highlights expanding funding for health care workforce training, which is clearly aligned with the objectives of Title VII. ASCP will report in future issues of e-Policy progress being made in funding health training programs as well as efforts to alleviate the laboratory workforce shortage.
State News
ASCP Welcomes Shift in CAP State Lab Professional Licensure Position
ASCP recently received a communication from the College of American Pathologists (CAP) indicating a change in CAP’s position on the state licensure of laboratory personnel. CAP’s new stance outlines criteria that if incorporated into future state licensure bills would result in CAP rescinding its opposition to licensure. CAP’s criteria include a number of detailed bullet points on issues such as scope of practice, the creation of limited specialty licenses, and minimum education requirements for each category.
The shift in position was announced in a letter to ASCP President Barbara J. McKenna MD, FASCP, from CAP President Jared N. Schwartz, MD, PhD, FCAP. Dr. McKenna welcomed the news and responded to Dr. Schwartz in a letter, “Going forward, we look forward to working with you in developing and maintaining high standards for laboratory professionals who are working to ensure patient safety and public health.”
ASCP has supported state licensure initiatives since 2005 to ensure that laboratory professionals possess appropriate academic and clinical training, pass competency-based examinations conducted by an approved national certifying organization, and participate in continuing education programs.
ASCP Board of Certification certification is the only certification that has approval in all 13 states that require licensure for laboratory personnel, including most recently New York and California. ASCP continues to work with states considering licensure requirements to develop appropriate laws that best serve patients and the public.
“Patients will benefit if the laboratory community is unified in states where licensure laws are pending. We welcome this announcement from CAP,” said Dr. McKenna.
Click here for ASCP’s complete Policy Statement on State Licensure of Laboratory Personnel.