BALTIMORE — There are 10 things physicians can do—or avoid doing—to help protect themselves from federal prosecution for fraud, D. McCarty Thornton said at a forum sponsored by the American Health Lawyers Association.
Mr. Thornton, formerly chief counsel at the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services and now an attorney in private practice, offered his “Top 10” in reverse order:
10Personal favors to referral sources are over. That message was reinforced by both the TAP pharmaceutical lawsuit and OIG's recent guidance to pharmaceutical firms regarding proper marketing techniques, he said. “This means no NFL tickets, no fancy dinners, nothing for spouses, no free computers, and don't put strings on any kind of 'educational grant.'
9Don't be the low-hanging fruit … The number of federal agents investigating fraud is declining, so each agent has stacks of potential cases to choose from. “You don't want to stick out” by being an outlier on claims or engaging in other questionable behavior, he noted.
8… But also be wary of being in the crowd. Don't go along with any questionable behavior simply because large groups of people are doing it. “Common sense is a lot of it,” Mr. Thornton said.
7If you are mulling over a business deal, consider whether it will pose a problem under the anti-kickback statute. “The further the deal is away from clinical decision making, the more leeway you have under the kickback statute, because the number-one purpose of the statute is to prevent the corruption of medical decision making,” he said. “If the deal concerns office software for billing or practice management, it doesn't really affect where or how clinical decisions are made, and you have a lot more leeway under the kickback statute.”
6Get as close to a safe harbor or advisory opinion as possible. “Document the business reasons why you can't fully comply with the safe harbor,” he said. “And you adopt the principles in the relevant OIG guidance to the extent you can. There is more written guidance from the anti-kickback statute—by far—than on any other criminal statute in the U.S. Code … the OIG has spoken on a lot of the issues involved.”
5Consider fair market value of the “safe unharbor.” Using fair market value in all transactions “provides excellent overall protection” from fraud allegations. Fair market value should be used for necessary, justifiable services, and it should be determined “by an independent, reliable source using recognized methodology,” he said.
Mr. Thornton noted that fair market value “never will be a safe harbor, because the government doesn't want to get into a 'Battle of the Experts' about your valuation experts [versus] their valuation experts, but it still is the basic talisman for safety under the anti-kickback statute.”
4Don't muddy your own shoes. “No fooling around with documents or withholding information,” Mr. Thornton admonished. “And don't ask for the 'odds' on getting caught” with a particular scheme.
3Check compliance on an ongoing basis. “Make sure deals are properly implemented” and that everyone involved is fulfilling their responsibilities, Mr. Thornton said.
2Document, document, document. “Document that the deal is for legitimate business purposes, that it's at fair market value, what services are provided, and how much time is spent providing them,” he said.
1Greed is good—not. “The number-one red flag to investigators is a return on investment or compensation that seems excessive,” he said.
Mr. Thornton had some advice for hospital compliance officers, warning them about the use of 'economic credentialing.' “Requiring a minimum level of practice to ensure proficiency is fine, but asking the doctor to refer 50% of his patients is going too far,” he said.
He also warned physicians to be careful about what they accept from pharmaceutical companies. Despite recent guidelines on the subject, “some doctors are still being led astray by being paid hundreds of dollars for filling out a simple form,” he said.
“We still have serious issues out there, and doctors need counseling and education,” he added.