Good News, Bad News On Federal Legislation Affecting Clinical Labs


On Federal Legislation Affecting Clinical Labs

By Gail O. Guterl

When it comes to legislative issues, the clinical laboratory profession has reason to rejoice and also to be concerned, legislative observers caution.

Two bills–one in the House of Representatives, the other in the Senate–that would have weakened the effect of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) by waiving physician office laboratories (POLs) did not pass before Congress adjourned for the November elections.

The Archer bill (HR 1386), proposed by Rep. Bill Archer (R-TX), chairman of the powerful Ways and Means Committee, is essentially dead, said Dennis G. Weissman, editor of the G-2 Report. The bill would have exempted most POLs from compliance with CLIA ’88. Only POLs that perform Pap smear analysis would have been required to adhere to the CLIA regulations.

An identical bill in the Senate, SB 877, proposed by Sen. Kay Bailey Hutchison (R-TX), also died when Congress adjourned.

“What happens in the future depends on the makeup of Congress after the elections,” Weissman told
ADVANCE. “If the Republicans retain a majority they will probably resurrect the issue in the next Congress. However, Clinton would likely veto the bill because the administration is not in favor of exempting POLs.”

The exemption was supported by the influential American Medical Association and American Society of Internal Medicine and opposed by the Coalition to Preserve Safe Testing, a group of a dozen laboratory organizations that worked for more than a year to develop opposition to the bills. The coalition’s most active members are the American Association of Bioanalysts (AAB), International Society for Clinical Laboratory Technology (ISCLT), American Society for Microbiology (ASM), American Association for Clinical Chemistry (AACC), American Medical Technologists (AMT), Clinical Laboratory Management Association (CLMA), American Society for Clinical Laboratory Science (ASCLS) and American Society of Clinical Pathologists (ASCP).

Vince Stine, manager of government affairs for AACC, believes the Archer bill did not pass because of the “effective job the lab community did in getting the message out.

“Representatives of the coalition contacted members of Congress and made a concerted effort to present their opposition to this issue,” Stine said.

Judy Davis, chair, ASCLS government affairs committee, agreed.

“The lab organizations really pulled together on this,” she said. “The physicians’ groups have more staff to work on this, but we [the coalition] worked well together with great results.”

However, Davis pointed out, while the death of the bill is reason to rejoice, the loss of “two of the three most vocal champions in Congress for our side is a big concern.”

Davis was referring to the retirement from the Senate of William Cohen (R-ME) and Nancy Kassebaum (R-KS), chairman of the Senate Labor and Human Resources Committee. The third supporter, Sen. Barbara Mikulski (D-MD) will remain in Congress.

Add the loss of those advocates to expected Medicare cuts in 1998, and clinical laboratorians realize they can’t relax their vigilance or enjoy their success for long.

While Medicare fees for laboratory services will increase January 1997, the whole issue of Medicare reimbursement is up for debate once Congress reconvenes, Weissman said.

“The Medicare Trust runs out of money in 2001,” said Davis. “Congress will look at reducing the fee schedule and will look at competitive bidding and administration simplification by uniform direct billing.”

She believes Congress will scrutinize more issues that impact on managed care.

“You’ll see a lot more discussion of issues that affect managed care,” she said. “We’ve already seen a first-time direct assault on state insurance laws–laws that prohibit portability and consideration of pre-existing conditions when issuing insurance coverage. We also saw the 48-hour rule passed, for 1998, allowing new mothers and their babies a 48-hour minimal hospital stay. Other laws will require offering health benefits in an equal fashion.”

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