American Association for Clinical Chemistry
Better health through laboratory medicine
Government Affairs and the Lab

Government Affairs and the Lab
Annual Healthcare Forum Delivers for Labs Under Pressure

By Bill Malone

Laboratorians have become accustomed to feeling like the ‘little guy’ in national political debates such as healthcare reform. However, even when healthcare has not been the top priority of the White House, laboratory professionals cannot become passive or drop their guard when it comes to government affairs. Lab managers in particular know that if they’re not up-to-date with what Congress and regulators are doing, their institutions and their careers are on the line. For many, staying on top of government affairs is the main reason for getting involved in professional associations like AACC and ASCLS.

For more than a decade, the AACC/ASCLS Healthcare Forum at AACC’s Annual Meeting has provided a window into the efforts of lab advocates who work closely with Congress and regulators. The forum is both an annual wrap-up of government activities that affect labs, as well as an opportunity for attendees to ask tough questions and hear from government officials, lobbyists, and consultants who craft policy. The 2010 Healthcare Forum takes place today from 2:30 p.m.–5 p.m. in room 204AB of the Anaheim Convention Center.

The often standing-room only crowd at the forum demonstrates just how critical legislative and regulatory issues are for laboratorians, said Elissa Passiment, CLS, executive vice president of ASCLS, and a frequent speaker at the forum. “Laboratory managers really feel the pressure from regulators, and they believe that if they don’t know what’s coming down the road, they simply cannot plan properly to keep their operations running,” she said. “They’re worried that they’re going to be caught off guard and possibly risk their jobs because they weren’t knowledgeable enough about an issue.”

A Decade of Tracking Government Affairs

For more than 10 years, the Healthcare Forum at AACC’s Annual Meeting has kept laboratorians abreast of the latest legislative and regulatory developments that affect labs. Organized by Vince Stine, PhD, director of government affairs at AACC, in cooperation with ASCLS, the forum has tackled many of the same topics over the years. Here’s a look back at what’s been discussed.

2000

  • Reimbursement—IOM Report on Clinical Lab Payments (pre-study)
  • New CLIA quality control standards
  • Medicare coverage process

2001

  • Reimbursement—IOM Report on Clinical Lab Payments (post-study)
  • New CLIA waiver criteria
  • Medical privacy standards

2002

  • Trends in Medicare reimbursement
  • Changes in CLIA
  • Negotiated rulemaking

2003

  • Direct-access testing
  • Current issues in Medicare reimbursement
  • Patient safety

2004

  • Managing the staffing shortage
  • Medicare reform
  • CLIA update
  • FDA and clinical cooperation for TDM and pharmacogenomics

2005

  • New FDA CLIA waiver criteria
  • The reimbursement landscape
  • Status of clinical laboratory workforce

2006

  • Medical errors
  • Health IT
  • Medicare modernization
  • Coping with the staffing shortage

2007

  • FDA oversight of laboratory-developed tests
  • Changes on the horizon for CLIA
  • Competitive bidding

2008

  • Comparative effectiveness research
  • Alternate quality control methods
  • Competitive bidding
  • NIH National Children’s Study

2009

  • FDA post-market surveillance
  • Genetic testing oversight
  • Healthcare reform

Didn’t We Solve That Problem?

What keeps laboratorians awake at night? Looking back over the 12 years that the Healthcare Forum has been offered at AACC’s annual meeting, just about every topic that worries labs has been on the agenda, from competitive bidding to the lab fee schedule to compliance with the Clinical Laboratory Improvement Amendments (CLIA, See Box below). In fact, several of the same topics keep coming back—and not just because laboratorians are so eager to revisit them. Congress and regulators have a tendency to resurrect headaches for labs just when lab advocates think a problem has been solved, explained Passiment.

“I have been very active in government affairs since the mid-1980s, and the topics we were talking about then are the same topics that we are dealing with today,” she said. “We are constantly being challenged with either the next generation of regulators or legislators who find these issues anew and then we’re back to the same conversations, whether it’s competitive bidding or a lab copay, these issues keep resurfacing, decade after decade.”

Coping with this cycle of educating successive generations of legislators and regulators is what keeps AACC and ASCLS hard at work year after year, Passiment explained. For example, lab advocates successfully defeated efforts to establish competitive bidding in the 1980s, only to find Congress retrying the idea in the last 5 years. “This is why we keep talking with Congress year after year about these issues,” Passiment said. “I wish we could put some of these bad ideas to rest for good, but so far we haven’t found a way to do that.”

This Year’s Agenda

Genetic testing and electronic health records (EHRs) are featured in the program this year, as well as a presentation from FDA about the agency’s view on CLIA test categorization—a contentious topic among laboratorians, many of whom worry that manufacturers are pushing too hard to get more tests waived and not subject to CLIA oversight. With a waiver, the assumption is that a test is so simple and accurate that the likelihood of erroneous results is negligible, or poses no reasonable risk of harm to the patient if the test is performed incorrectly. However, many lab observers want FDA to be more conservative and make sure tests submitted for a waiver are really as error-free as the manufacturers suggest, explained Don Lavanty, Esq., of the law firm J.T. Rutherford and Associates in Arlington, Va.

Healthcare Forum 2010

Wednesday, July 28, 2:30 p.m.–5 p.m.
Room 204 AB Anaheim Convention Center

Moderator
Don Lavanty, JD, J.T. Rutherford and Associates, Arlington, Va.

The FDA and the CLIA Test Categorization Process
Carol Benson, MA, FDA, Silver Spring, Md.

CLIAC’s Efforts to Improve the Quality of Genetic Testing
Elissa Passiment, EdM, CLS (NCA), ASCLS, Bethesda, Md.

Evidence-Based Laboratory Practice:
Promoting the Quality and Utility of Genetic Tests

Ira Lubin, PhD, FACMG, CDC, Atlanta, Ga.

The Geisinger Approach to Integration EMRs
Within its Laboratory Systems
Jay Jones, PhD, DABCC, FACB, Geisinger Health System, Danville, Pa.

“The CLIA-waived category is a big issue right now,” said Lavanty, who also is legislative counsel for ASCLS. “People are worried that some waived tests really shouldn’t be waived, and that a whole lot more goes into these tests than just pushing a button and out comes the result.” Manufacturers have pushed tests toward the waived category so that more labs in more places can use their tests. Physicians’ offices or other settings that only use waived tests don’t have to keep up on CLIA regulations and enjoy reduced overhead expenses, Lavanty explained. “Another concern that people have now is that some of these waived tests are really quite comprehensive and could be misread or misapplied, leading to bad outcomes for patients and drawing increased scrutiny for all labs from regulators and Congress,” he said.

As a member of the Clinical Laboratory Improvement Advisory Committee (CLIAC), Passiment will offer this year’s attendees a true insider perspective on how CLIA officials are approaching genetic testing, and CLIAC’s efforts to develop best practices for labs in this area. Chartered in 1992, CLIAC provides scientific and technical advice and guidance to the Secretary for Health and Human Services on how clinical labs are regulated, the impact on medical and laboratory practice of proposed revisions to standards, as well as modification of standards to accommodate advances in technology.

“There has been controversy within CLIAC about genetic testing, and whether or not it needs its own set of regulations within the structure of CLIA, similar to the way cytology has really been focused on more specifically than any of the other disciplines within CLIA,” explained Passiment. “The Centers for Medicare and Medicaid Services has made it clear that they don’t believe that genetic testing requires this, while there are other stakeholders who disagree.” This topic has been an ongoing discussion, not only at the CLIAC meetings, but also at the meetings of the Secretary’s Advisory Committee on Genetics, Health, and Society, Passiment explained. To this end, CLIAC convened two workgroups to formulate and publish guidelines for laboratories performing genetic testing that will help them practice good laboratory practices. At this year’s Healthcare Forum, Passiment will discuss the contents of those guidelines, one of which is already published, and another which is pending. These guidelines are being published through CDC’s Morbidity and Mortality Weekly Report.

Stay Tuned

After taking in all the forum has to offer this year, laboratorians will want to keep up with the government affairs programs at AACC and ASCLS, especially as the details of healthcare reform legislation get hashed out, emphasized Lavanty.

Congress will need to make several updates as it fine tunes the implementation of the law, and during this process Lavanty believes there is still room to negotiate some of the cuts to labs to make them easier to swallow. “We’re asking that the Secretary of Health and Human Services be given the authority to do some sort of negotiated rulemaking on the impact of the cuts, how they could be redirected, and perhaps cutting waived tests more than non-waived tests since they don’t have any overhead,” Lavanty said. “We believe there is an opportunity to make some changes, and we’ve received some pretty good response on the Hill, that we will take the cuts, but we’d like to see the cuts applied in a more efficient manner.”

Healthcare reform has been a landmark issue on which AACC, ASCLS, and other organizations advocating for labs have worked together. It’s this same spirit of cooperation that makes the Healthcare Forum so successful, said Passiment. “The important thing that I think is wonderful about the healthcare forum is that it brings the members of both societies together. We meet in the same venue, and we have these two huge programs, but we still often don’t spend enough time together, and this forum is a testament to the membership of both groups that they really support this with their attendance.”