Federal

ASCP Thanks Members for Participating in “Stop Pod Labs Now”;
3,000 letters sent to CMS, Congress

The Centers for Medicare and Medicaid Services (CMS) is considering comments on its 2008 physician fee schedule proposed rule as well as comments the agency received from ASCP and a large number of our members. As part of our continuing work to address potentially abusive billing practices, ASCP’s Stop Pod Labs Now campaign generated close to 3,000 letters to CMS and Congress.

The proposed rule attempts to prevent clinicians from marking up the cost of laboratory tests by imposing an anti-markup provision on both the technical and professional component of a bill. The only allowed exception to the anti-markup provision would be if the performing supplier of the services is a full-time employee of the billing group or entity.

In related news, CMS recently released the Phase III Stark final rule (PDF). The Stark III rule is intended to clarify the Agency’s interpretation of the Stark Law, in particular prohibited self referrals, and respond to certain comments about the Phase II rule. In comparison with the changes being proposed under the 2008 physician fee schedule, the Stark III rule has little direct effect on pathology and laboratory medicine.

Two items of interest include “walk-in” patients and contractual arrangements between independent contractor physicians and the practice(s) for which they provide services. With regard to walk-ins, CMS declined to include “walk-in” patients in the consultation provisions, meaning that patient services provided after an initial visit may qualify as a prohibited self-referral. The Stark III rule also requires independent contractor physicians to have a direct contractual relationship with the billing practice. This will affect the way practices that rely on management or staffing companies provide services.

Congress

Momentum to Repeal CMS Competitive Bid Demo Builds
Legislation Introduced in Senate; ASCP Issues Action Alert to Members

In late September, Senators Ken Salazar (D-CO) and Pat Roberts (R-KS) introduced S. 2099, "the Preserving Access to Laboratory Services Acts of 2007" a bill to repeal the Centers for Medicare & Medicaid Services (CMS) proposed competitive bidding project for laboratory services. In the House of Representatives, the Chairwoman of the House Committee on Small Business Nydia Velázquez (D-NY) has introduced H.R. 3453, the “Community Clinical Laboratory Fairness Act of 2007.” In September, Velázquez invited ASCP Vice President for Public Policy Jeff Jacobs to participate in a Committee roundtable about health care issues and their effects on small businesses. The Chairwoman has been very vocal on the need to repeal the competitive bidding demonstration project. She has joined the laboratory community in expressing concern about the potential negative effect of the demonstration project on both Medicare beneficiaries as well as small laboratories.

CMS was mandated under the Medicare Modernization Act (MMA) of 2003 to conduct a demonstration project on the competitive acquisition of laboratory services under Medicare Part B clinical laboratory fee schedule. As we have reported in the past, the proposal has been poorly received from the onset. The community remains concerned that such a model would take a huge toll on small business operations and vulnerable populations including nursing home residents and home-bound patients. Moreover, ASCP is concerned that competitive bidding has the potential to reduce this integral component of health care delivery to a commodity, limit the number of labs available to serve patients, and compromise quality.Similar to ASCP's comments last year, the Society once again called on CMS to clarify that the Medicare reassignment of benefits rules pertaining to contractual arrangements are subject to program integrity safeguards relating to the right of payment for diagnostic tests.

ASCP supports both the Senate and House versions of the repeal legislation and recently issued an Action Alert calling on all members of the laboratory team to support repeal of the ill-conceived CMS demonstration project.

States

CA Legislature Passes Direct Billing Law
Society Urges Governor’s Signature

The California Legislature voted last month to expand its direct billing law to include anatomic pathology services. S.B. 661 passed the State Senate unanimously and the State House by a 68-2 vote. The legislation would prohibit clinicians from billing patients and third party payers for anatomic pathology services not performed directly or supervised by a clinician.

Currently, clinicians in the state are prohibited from billing patients or third-party payers for cytological services relating to the examination of gynecological slides. In addition, current law prohibits markups on all other clinical laboratory services.

ASCP applauds the California Legislature for recognizing the need to protect its citizenry from abusive billing practices. The potential for profit by marking up test charges can distort medical decision-making, causing over-utilization and increasing costs. It can also adversely affect patient care. The Society has written to Gov. Arnold Schwarzenegger urging him to sign this important legislation into law: “The need to preserve the standard of pathology and laboratory medicine and how it is practiced is paramount. Direct billing assures that patient care and quality come first in the laboratory and that practices such as mark-ups, over-utilization, and inflated health care costs are not obstacles in providing quality care.”

The California Society of Pathologists worked for over two years to help secure passage of this legislation.

ASCP Continues to Urge Changes to NY Licensure Law

ASCP recently wrote to NY State Sen. William T. Stachowski (D-Buffalo), supporting legislation he introduced to address some of the problems with the New York Clinical Laboratory Technology Practice Act (CLTPA). The bill introduced by Senator Stachowski, S. 6103, would establish a licensure category for histotechnologists and histotechnicians.

Due to technical flaws with the legislation that established licensure for New York laboratory personnel, the State Department of Education, which oversees the licensure of laboratory personnel, has maintained that they lack the authority to create separate licensure categories for categorical technologists and technicians, such as histotechnologists and histotechnicians.

Since the enactment of the CLTPA, the Department has been trying to license histotechnologists and histotechnicians (and other categorical technologists) as generalist “clinical laboratory technologists.” But now that the “grandparenting” provisions—temporary provisions enabling licensure (permanent) under more lenient conditions—have expired, licensure of laboratory personnel has become more complicated.

In writing Senator Stachowski, ASCP supported the Senator’s initiative, arguing that the current licensure law needs substantial revision. While establishing licensure categories for histotechnologists and histotechnicians is necessary, it does not resolve all of the problems that must be addressed. Consequently, ASCP urged that the legislation be modified to establish licensure categories for all categorical laboratory personnel, such as pathologists’ assistants, microbiologists, blood bankers, etc. ASCP also urged that the legislation be modified to require the Department to recognize accredited clinical programs. Additionally, ASCP advocated that the bill should require the Department to accept work experience as a means to satisfy the state’s clinical training requirement for generalist medical technologists and most categorical technologists.

ASCP Aids in the Nomination of Pathologist to MA CKD Task Force

ASCP worked in conjunction with the Massachusetts Society of Pathologists to identify a clinical pathologist for nomination to the Massachusetts Chronic Kidney Disease (CKD) Task Force. The Task Force is comprised of stakeholders gathered together to build consensus and to advance the CKD public health agenda. An additional aim is to push back legislation to mandate estimated glomerular filtration rate (eGFR) reporting, created in some states. The eGFR is a measurement of kidney function that has been touted among proponents to be the most accurate assessment of kidney function.

The state Massachusetts Department of Health will be leading the effort. Gary Horowitz, MD, FASCP has been nominated to serve on the Task Force. Horowitz is the Director of Clinical Chemistry at Beth Israel Deaconess Medical Center in Boston and Associate Professor of Pathology, Harvard Medical School. Dr. Horowitz strongly recommends reporting of eGFR but opposes a mandatory reporting requirement. ASCP initially received the request to help identify a clinical pathologist from the National Kidney Foundation (NKF).

Meeting Highlights

Genetic Testing Summit Held in DC

ASCP participated in a two-day conference on genetic testing last month in Washington, DC. Organized by the Genetic Alliance, Eyes on the Prize: Truth Telling about Genetic Testing, brought together a variety of stakeholders to examine issues in genetic testing and discuss ways to advance the field that assure quality without stifling innovation. Representatives from various government agencies, professional societies, hospital and independent laboratories, and academia were on hand to provide updates on the latest developments in genomics research, test development and commercialization, and the impact of genetic testing on the practice of medicine. Key topics that continue to be a source of debate within the community included quality assurance in genetic testing, in particular, the establishment of clinical and analytical validity, as well as federal oversight of these tests.

ASCP President John S.J. Brooks, MD, FASCP, recently submitted a comment letter to the Food and Drug Administration (FDA) outlining ASCP’s concerns regarding the regulation of genetic tests. Brooks’ letter was in response to the revised FDA draft guidance released in July on the agency’s intent to regulate in vitro diagnostic multivariate index assays (IVDMIAs), which includes many genetic tests. ASCP ePolicy will continue to monitor and report any developments in policy and or legislation on the proposed regulation of genetic tests.