HHS' inspector general's office issued 91 pages of draft guidance, available Tuesday in the online Federal Register, to supplement its 1998 voluntary compliance regulations for hospitals.
The supplementary guidance, in the works since June 2002, synthesizes previously issued guidance, advisory opinions and safe harbors.
"There's nothing groundbreaking, but it's an expansive compendium," said healthcare attorney Anne Haule of Ungaretti & Harris, Chicago.
Haule said the emphasis placed on record-keeping in hospital referrals to post-acute providers, such as home health agencies, is noteworthy. "Administrators are pretty sophisticated in understanding referral relationships with their doctors but may not be as aware of hospital outside referrals to contractors," she said.
Healthcare attorney Paul Danello of Ropes & Gray, Washington, said the guidance correlates physician self-referral laws and Medicare antikickback statutes, "raising the bar" for hospital-physician transactions. Danello said it's also significant that the inspector general's office will allow hospitals to subsidize physicians' medical malpractice premiums in some cases and appears to bless economic credentialing.
"Properly done, the inspector general said hospitals that refuse privileges to physicians with significant conflicts of interest would not appear to implicate the antikickback statute," Danello said. "We haven't heard that before."