Federal

ASCP Secures Anti-Pod Lab, Anti-Markup Reforms in CMS Final Rule

ASCP has succeeded in securing regulatory provisions in the 2008 Medicare Physician Fee Schedule (PFS) final rule to block clinicians from marking up the costs of diagnostic services, such as pathology and laboratory services. On November 1st, the Centers for Medicare and Medicaid Services (CMS) released its final physician fee schedule, which included a number of regulatory provisions supported by ASCP to prevent “pod labs” and clinicians from engaging in abusive billing practices.

The anti-pod lab provisions of the rule are a victory for ASCP and its members, thousands of whom took part in ASCP advocacy campaigns designed to persuade CMS to promulgate regulations reforming the physician self-referral and reassignment provisions to prevent abusive billing arrangements. Unfortunately, the PFS also contains a 10.1 percent negative update for physician reimbursement, caused by the flawed sustainable growth rate formula. Congress is expected to take action to reverse this cut in physician reimbursement rates in an omnibus Medicare legislative package by the end of the year.

CMS’s 2008 PFS final rule would impose anti-markup provisions on the technical and professional components of purchased tests and tests furnished under a reassignment arrangement. In the proposed rule, CMS had initially stated that the only exception to the anti-markup provision would be when the performing supplier of the test is a full-time employee of the billing entity. Because of the physician in-office ancillary exception to the self referral rules, this would have covered full-time employees at a “centralized building,” such as a pod lab. For a description of a pod lab, click here to see the second article in ASCP’s July ePolicy entitled “CMS Defines Pod Lab Arrangements.”

However, when CMS released its final regulation it indicated it was changing the full-time employee exception to cover testing performed by full- and part-time employees and independent contractors. Importantly, CMS also changed its rules to require that the test must be performed in the “office of the billing physician or supplier.” CMS clarified that the “`office of the billing physician or other supplier’ is space in which the physician organization provides substantially the full range of patient care services that the physician organization provides generally.” This change means that tests performed in a “centralized building” would be subject to the anti-markup provisions. Thus, the final rule would prevent clinicians from utilizing pod labs to markup the cost of pathology and laboratory services reimbursed by Medicare.

Because the rule still allows clinicians to use contractual arrangements to markup diagnostic services provided in their offices, the CMS reforms aren’t as strong as ASCP would prefer. Yet because such services would have to be performed in the physician’s office, ASCP is hopeful that the new rule will provide a meaningful deterrent from much of the abuse that has occurred over the last few years.

Santa Ana Winds Stall Initial Phase of Competitive Bidding Demo

Advocacy Efforts Continue to Advance, Repeal Still Priority No. 1

The Centers for Medicare & Medicaid Services (CMS) was slated to host its first “Bidder’s Conference” on October 31 in San Diego, CA, the announced initial site of the agency’s proposed Competitive Bidding Demonstration Project for laboratory services. However, the extensive fires in the state coupled with the severe Santa Ana Winds have put the agency’s plans on hold.

Advocates seeking repeal, however, have not halted their push. In fact, the week CMS announced the first site of the proposed demo, ASCP members sent over 1,100 letters to their respective Senators and Representatives urging support of repeal legislation. ASCP, along with the entire laboratory community, has long maintained opposition to such a project and continues to work to garner support for H.R. 3453, the “Community Clinical Laboratory Fairness Act of 2007,” and S. 2099, the “Preserving Access to Laboratory Services Acts of 2007.” The bills, introduced by Representative Nydia Velázquez (D–NY) and Senators Ken Salazar (D–CO) and Pat Roberts (R–KS), respectively, seek to repeal the competitive bidding demonstration project for laboratory services under Medicare proposed by CMS. The message is being heard; members on both sides of the aisle have signed on as co–sponsors of both the House and Senate bills.

The concern surrounding the demonstration project is multi–faceted. Although the demo may appear to affect only those in the demonstration site areas, the data gleaned from this demonstration project could be applied nationally, forcing smaller laboratories to close, denying patients accessible laboratory services, and ultimately jeopardizing the quality of laboratory services to patients. Moreover, CMS has not demonstrated an ability to maintain public health and patient safety standards if it were to implement this project. Patient safety and care should serve as the basis for all decision making in the health care arena, particularly when the perceived cost savings is minuscule. ASCP’s concerns over the proposed demonstration project are detailed in the Society’s Competitive Bidding Fact Sheet (PDF).

CMS was mandated 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.

However, ASCP believes that implementation of this demonstration project would adversely impact clinical laboratories and patients. Therefore, ASCP continues to is urge its entire membership as well as our colleagues in pathology and laboratory medicine to use the ASCP eAdvocacy Center to take a stand and repeal the demonstration project. To help ASCP’s efforts to repeal competitive bidding, please use the eAdvocacy center to write your legislators.

Congress

Society Supports Increased Funding for Title VII, Medical Research

Needed Revenue Lies in Labor HHS Appropriations Legislation

The American Society for Clinical Pathology (ASCP) continues to support increased funding for Title VII (allied health professions programs) and Medical Research as it relates to the administration of laboratory medicine. Such funding is appropriated through Congressional action. Appropriations legislation recently passed the House of Representatives (H.R. 3043). Similar legislation was passed in the Senate (S. 1710) but amendments are still being debated. ASCP supports additional resources being allocated to the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality (AHRQ). These are some of the agencies under the Department of Health and Human Resources that are responsible for the protection and maintenance of public health.

Coding

ASCP to Brief AHA on Need for Coding Changes

In response to a petition from ASCP to change its coding guidelines, the American Hospital Association (AHA) will soon consider ASCP’s request to change its guidelines regarding the use of physician reports for hospital discharges. AHA policies do not allow hospital coders to extract information directly from the pathologist’s report when coding hospital discharges. ASCP’s proposal would allow coders to glean information directly from the pathologist’s report.

AHA’s current policies require coders to obtain a clarifying note from the patient’s physician or use less specific information from the physician reports and notes. ASCP’s proposal would provide the greatest degree of specificity, which facilitates proper medical coding. ASCP President Lee Hilborne, MD, MPH, FASCP, DLM(ASCP), plans to speak before the Coding Clinic for ICD-9-CM, which will be hosted by the CMS in mid–November.

Society Issues

ASCP Addresses the Laboratory Workforce Shortage

Recruitment and retention of well–trained medical laboratory professionals is becoming increasingly more difficult for laboratories across the country. The U.S. Bureau of Labor Statistics (BLS) projects that by 2014, an additional 81,000 technologists and technicians will be needed to replace retirees and 68,000 to fill new positions. As the baby boomer generation enters retirement, laboratories will suffer the loss of skilled labor while experiencing a demand for services by the large population of aging boomers.

There are many dimensions to the shortage issue. Challenges to recruitment and retention of laboratory professionals include low salary compared with other health professions, lack of visibility of the profession, limited advancement opportunities, and closure of training programs. Maintaining adequate staffing levels is critical to providing quality healthcare. ASCP recognizes the shortage of laboratory personnel to be a high priority issue for the membership and is involved in several initiatives to better understand the contributing factors and how best to address them.

The 2007 ASCP Wage and Vacancy Survey will be distributed this month to laboratories across the country. This survey, done biennially, provides a thorough benchmarking of key employment statistics in America’s clinical laboratories and is one of the most important services the ASCP can do for its membership and the profession. The survey traditionally has monitored trends by geographic regions, type of laboratory, and job category. This year’s survey will be tracking additional vacancy, education and certification trends in specific areas within clinical laboratories. Data gleaned from the ASCP Wage and Vacancy Survey aids the entire industry by providing a forum for discussion and strategic planning.

ASCP is also involved in workforce shortage initiatives on a more local level. Later this month ASCP will be co–sponsoring a forum with the Connecticut Society of Pathologists to examine their state’s laboratory personnel shortage. This summit will bring together a wide variety of stakeholders, including pathologists, educators, laboratory managers and practitioners, hospital administrators, representatives from the clinical diagnostic industry, and state legislators to engage in dialogue that will lead to real–time solutions to this impending crisis.

ASCP recognizes that the laboratory workforce shortage is a complex problem; the Society’s initiatives alone can in no way solve this nationwide dilemma. It is, however, an opportunity to dialogue, strategize and hopefully pull resources so that collectively the laboratory community might more effectively tackle this threat to the field.

Laboratory Community Connects on Common Advocacy Agenda

Combined Legislative Day to Underscore Need for Lawmakers to Act

The American Society for Clinical Laboratory Science, the American Society for Clinical Pathology and CLMA will 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 Medicare Reimbursement, Competitive Bidding, Personnel Shortages and Funding for Title VII and Title VIII.

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.

Future of Pathology Practice Addressed at Fellow Council Forum in New Orleans

ASCP Fellow Council Chair Janice Jesse, MD, FASCP introduced the Fellow "town hall" session on Oct. 19, at this year’s ASCP Annual Meeting by asking the audience to participate in a discussion about the future of laboratory medicine. The interactive session highlighted many of the hottest issues facing the field of pathology. Audience members and the panel touched on a variety of topics that fell into three categories—optimizing patient care, the role of government regulation, and the challenges of managing a pathology practice in the 21st Century.

ASCP President Lee Hilborne, MD, MPH, FASCP, DLM(ASCP), spoke about the future of pathology and challenged the audience to be vocal about their changing profession. The panel’s discussion with the audience included topics such as the future and current impact of telepathology services through outsourcing and insourcing, contractual joint ventures, adoption of a health information technology system that incorporates laboratory medicine and the changing role of Medicare on issues from pay for performance to reimbursement, etc.