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* ePolicy News - April 1, 2008
ePolicy Special Report:
Judge Grants Temporary Injunction in Pathology Anti-Markup Lawsuit
After CMS Refuses to Grant an Unconditional Thirty Day Extension
A Federal judge has issued a temporary injunction in a lawsuit brought against the U.S. Department of Health and Human Services for its efforts to prohibit clinicians from marking up the professional or technical component of anatomic pathology services they order but do not perform.
The injunction prevents the Centers for Medicare and Medicaid Services (CMS) from implementing its anti-markup (anti-pod lab) rule until a trial or further order from the court. ASCP President Lee H. Hilborne, MD, MPH, FASCP, DLM(ASCP)CM noted that “while ASCP is disappointed that the judge granted a preliminary injunction in the case, we are hopeful that the lawsuit will ultimately be decided in CMS’s favor. At this point, the judge’s decision to grant the injunction appears to be based, not on the merits of the rule that is being challenged, but rather over a disagreement with CMS over the nature of an additional 30-day delay in the implementation of the anti-markup rule that was requested by the judge.”
The rule was a top advocacy priority of ASCP and resulted from thousands of emails written by ASCP members as part of ASCP’s Stop Pod Labs Now campaign. The rule, once implemented, will prohibit clinicians from marking up the professional or technical component of anatomic pathology services they order but do not perform. President Hilborne praised the CMS rule, calling it “critical to assuring that patients have fair access to pathology services that are provided in a manner consistent with ethical practices.”
On March 28, a hearing was held on the lawsuit by Judge Rosemarie Collyer to consider two motions: one requesting a temporary injunction barring CMS from implementing its anti-markup rule and the other from CMS requesting dismissal of the lawsuit. The judge indicated she was not yet ready to rule on the merits of the two motions, so she gave CMS until Monday, March 31 to agree to an additional thirty day extension on its implementation of the anti-markup rule. CMS, however, did not exactly provide Judge Collyer what she wanted. CMS granted the extension, but reserved the right to recoup the costs of any pathology services that violated the anti-markup rule billed during extension, if CMS wins the lawsuit. This was different than the previous extension that expired on March 31 under which no recoupment was allowed.
In response, Judge Collyer issued a preliminary injunction to preserve the status quo. The judge’s order effectively continues the extension that previously was in effect and prevents CMS from recouping the costs of any anatomic pathology services billed in violation of the anti-markup rule until there is a trial or further order from the court.
The lawsuit, Atlantic Urological Associates, P.A. et al v. Leavitt, lists the following as plaintiffs in the case: Atlantic Urological Associates, P.A.; Sam Michaels, M.D.; Rebecca Page; Urology Care, Inc.; Urology Center of Alabama, P.C.; and Uropath, LLC.
The anti-markup provision bars physician practices or suppliers from marking up the cost of the technical or professional components of a Medicare reimbursed anatomic pathology service if it is purchased from an outside supplier or performed at a site other than the “same building” of the billing practice or supplier. The new rules are 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, as part of its Stop Pod Labs Now campaign and other members of the pathology and laboratory community (See November 2007 ASCP E-Policy News for more information).
When CMS published its final physician fee schedule for 2008, it had planned to apply the anti-markup restriction to all diagnostic services. It subsequently postponed implementation of the rule to diagnostic services other than anatomic pathology (See Feb. 2008 ASCP E-Policy News for more information and see second story).
According to the Federal Government’s motion to dismiss the lawsuit, CMS’s rationale for promulgating its anti-markup rule was a concern that allowing physician groups to “realize excessive profit when billing Medicare for services…may lead to patient and program abuse in the form of overutilization of services and may result in higher costs to the Medicare program.”
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.”
Congress
ASCP Announces Support for Cytology Proficiency Testing Legislation, Expresses Concern Regarding CMS Process to Revise Regulation
The ASCP Board of Directors is pleased to see recent changes to the Cytology Proficiency Testing (PT) Legislation, addressing the principles ASCP articulated regarding Cytology PT and incorporating specific ASCP recommendations to assure the public that the pathology community was concerned about health and safety of patients served by our laboratories. As a result, on April 1, 2008 the ASCP Board of Directors (BOD) announced support for H.R. 1237, the Cytology Proficiency Improvement Act of 2007.
In a positive development, the latest version of H.R. 1237 now captures the language found in S. 2510. S. 2510 underscores ASCP’s desired provisions including empowerment of the laboratory director in the PT process; the original House bill did not incorporate this key aspect into cytology PT. “ASCP is delighted to support the revised House legislation to modernize cytology PT and we are very pleased that the College of American Pathologists chose to modify the original legislation to include ASCP recommended provisions to empower the laboratory director,” stated ASCP President Lee H. Hilborne, MD, MPH, FASCP, FCAP, DLM(ASCP)CM. ASCP’s July 2007 document "Framework for a Revised Cytology PT Regulation (PDF)" outlines in detail this position. The newest legislation would replace the current PT program that focuses solely on an individual testing program with that of an annual CME requirement under the oversight of the laboratory director.
The ASCP is extremely disappointed that the regulatory process, under the domain of the Centers for Medicare and Medicaid Services (CMS), has been unable to revise the current PT regulations in response to the evidence presented by the scientific community through the CLIAC and other venues. These regulations were first expected at the end of 2006, then by December 2007, and now we are not sure of the next anticipated release. “What is most unfortunate is that the entire cytology/pathology community has been seeking an updated cytology PT regulation for the past three years—and in reality, for more than a decade,” stated Hilborne. Despite CMS’s lack of movement regarding modifying the regulations, the ASCP still intends to comment on the draft regulations whenever they are released. When the draft regulations are released by CMS, the ASCP recommends that the pathology community work collaboratively and present a unified response.
House Again Passes the Genetic Information Nondiscrimination Act
Last month, the U.S. House of Representatives again passed the Genetic Information Nondiscrimination Act of 2007 (GINA), a landmark bill designed to protect Americans from genetic discrimination by employers and insurance companies. GINA prohibits health insurers and group health plans from charging higher premiums or denying coverage based on an individual’s genetic predisposition to a disease. The bill also makes it unlawful for employers to use genetic information when making decisions regarding hiring, firing, job placement or promotion decisions.
Sponsors of GINA hope the bill will allay public apprehension about participating in genetic studies. The bill had previously passed the house on April 25, 2007 with overwhelming support. Representatives passed GINA by a margin of 264-148 this time as part of the Paul Wellstone Mental Health and Addiction Equity Act of 2007 (H.R. 1424), introduced by Representative Patrick Kennedy (D-RI). This bill would require health insurance companies to offer benefits for mental health and substance-related disorders under group health plans. Representative Louise Slaughter (D-NY) attached GINA to the Kennedy bill, she explained, “because most mental health diseases are genetically linked; GINA is a natural addition.”
Companion legislation has been introduced in the Senate (S. 358) to prevent genetic discrimination and is currently in committee. It is unclear which bill the Senate will ultimately approve, but President Bush has indicated that he is ready to sign the bill once it is approved by Congress.
Laboratory Professionals Collectively Harness Political Clout
Seek Change from Capitol Hill Lawmakers
Members from the American Society for Clinical Laboratory Science (ASCLS), the American Society for Clinical Pathology (ASCP) and the Clinical Laboratory Management Association (CLMA) joined forces March 17-18 for their Annual Legislative Symposium and Hill Day. The three laboratory organizations bring in members from across the country to speak in a collective voice to legislators on Capitol Hill. Some 130 laboratory professionals took the issues of competitive bidding, the laboratory personnel workforce shortage and modernization of the clinical laboratory fee schedule to their respective Senators and Representative. The two-day legislative symposium kicked off with an explanation of the legislative and regulatory issues central to the laboratory profession as well as provided a “how to lobby” overview, with tips on meeting with Members of Congress, the organizational structure of Congress, and effective articulation of one’s message. The legislative symposium is designed to give laboratory professionals knowledge of the political process and to engage them in the process so that they can make a difference in the practice of their profession and ultimately in the care of their patients.
Society News
Hilborne Appointed to AMA Physician Consortium for Performance Improvement
ASCP President Lee H. Hilborne, MD, MPH, FASCP, FCAP, DLM(ASCP)CM has agreed to represent ASCP on the American Medical Association’s Physician Consortium for Performance Improvement. The consortium is composed of over 100 national medical specialty and state medical societies; the Council of Medical Specialty Societies; American Board of Medical Specialties and its member-boards; experts in methodology and data collection; the Agency for Healthcare Research and Quality; and Centers for Medicare & Medicaid Services.
Consortium activities are carried out through cross-specialty work groups established to develop performance measures for physicians from evidence-based clinical guidelines for select clinical conditions. Dr. Hilborne looks forward to working with the College of American Pathologists and the entire field of medicine on this important project.
ASCP Hosts CCCLW Meeting in Chicago
The ASCP hosted the first quarter meeting of the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) last month in Chicago. The CCCLW is a coalition of non-profit laboratory professional organizations, federal entities, and companies that have joined forces to address the shortage of clinical laboratory personnel and other issues in the profession.
CCCLW held a strategic planning session in January in which member organizations identified four strategic directions and formed workgroups to develop and implement initiatives in each area. ASCP will work with other member organizations on business initiatives to address the workforce shortage, activities aimed at improving the profile of the profession, and strategies to enhance recruitment. The 2007 ASCP Wage and Vacancy Survey, to be released in the coming months, will offer valuable data as the coalition moves forward with its activities.
The next CCCLW meeting is scheduled for June 9th. If you would like additional information on this group, contact Andrea Bennett at andrea.bennett@ascp.org.
resources: related to this section
documents
July 30, 2008
ePolicy Special Report:
Senate Approves ASCP-Supported Medicare Bill; ASCP Members Urged to Contact White House
July 1, 2008
ePolicy Special Report:
House Approves ASCP-Supported Medicare Bill
June 1, 2008
ePolicy Special Report:
Judge Dismisses Anti-Markup Lawsuit
May 1, 2008
March 4, 2008
August 30, 2007
September 12, 2007
September 30, 2007
November 2, 2007
December 2, 2007
January 1, 2008
January 21, 2008
February 4, 2008
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