The federal government has revised its model compliance program for clinical laboratories by omitting instructions on how to bill for certain blood tests that were the subject of a wide-ranging investigation.
HHS' inspector general's office said it eliminated those instructions from its laboratory compliance guidelines because HCFA no longer reimburses laboratories for a battery of tests that many once ran routinely.
Since 1996 federal investigators have been looking into whether hospital laboratories have been billing Medicare for certain tests individually when they should have been submitting a single bill, a practice called "unbundling." That practice can increase the total compensation a laboratory receives.
Citing flawed data, the U.S. Justice Department recently scaled back its investigation of laboratory unbundling (July 13, p. 6).
The new laboratory compliance guidelines, published last week in the Federal Register, revise a model compliance program first published in March 1997. The guidelines aim to help laboratories develop safeguards to prevent Medicare fraud and abuse.
One attorney who reviewed the revised guidelines last week said they are an improvement over the original set because the compliance instructions are more detailed.
"It says, `Here are the issues we think your compliance plan, at a minimum, should address,"' said Donna Thiel, an attorney with Gardner, Carton & Douglas in Washington.
The new guidelines clarify several fraud-and-abuse-related matters. For instance, they say laboratories should not give physicians a price below market value for private-sector tests to induce Medicare business.
Federal prosecutors may judge such pricing schemes to be kickbacks, which violate Medicare law.