HHS Inspector General warns that CMP authorities will be expanded
Days after the Health and Human Services’ (HHS) Office of Inspector General (OIG) released a draft guidance for the pharmaceutical industry, drug makers fell under heavy scrutiny in the OIG's Work Plan for 2003. "Pharmaceutical companies have been on the radar screen for a couple years, and that is going to continue," says Gary Eiland, a partner with Vinson and Elkins in Houston. "But not to the exclusion of the more traditional areas dealing with hospitals and providers."
According to Eiland, many issues in the Work Plan fall in the latter category, such as diagnostic-related groups (DRG) window issues and hospital transfer issues, as well as patients discharged from the acute care setting and readmitted to a post-acute care setting. "One of the items even suggests that they were looking to see whether the three-day DRG window should be expanded to a 14-day window," he says. "That would be significant."
The OIG says this review will focus on DRGs that contribute to the highest percent of Medicare payments outside the DRG window. "From the standpoint of an investigation, that is a logical way to focus," says Eiland. "But at some point in time, I think you have to decide what falls in the DRG and what does not."
In the area of Medicaid, the OIG also plans to look at the three-day stay requirement, Eiland notes. Some state Medicaid programs have a similar DRG window. Basically, the OIG wants to see if some of the same problems exist for Medicaid payment in those states that the OIG previously uncovered regarding Medicare, according to Eiland.
He says the OIG appears to be adapting many of the items it previously examined under Medicare, such as graduate medical education, the DRG window, patient transfers, and credit balances. "Basically, it is some of the old issues applied to a new setting," he says.
Gabe Imperato, a partner with Broad and Cassel in Ft. Lauderdale, says the Work Plan shows that the OIG is becoming more sophisticated in its focus. Specifically, he points to the OIG's scrutiny of physician ownership of ambulatory surgical centers, the cost of surgeries, and medical necessity of inpatient psychiatric stays. Diagnostic testing in emergency rooms also is somewhat new, he adds.
Health care attorney Howard Young of Arent Fox in Washington, DC, says the Work Plan also includes an increased focus on quality-of-care and quality oversight reviews, as well as hospital privileging issues.
"Focusing on quality oversight issues is not new," Young observes. He points out that the government clearly has been focusing on quality of care issues related to nursing homes and continues to do so. "On the hospital side, it is somewhat new," he cautions.
The former OIG attorney notes that, with respect to enforcement, there has not yet been any successful effort using the False Claims Act on quality-of-care issues related to hospitals. He says the new Work Plan may help get "creative juices flowing" in that regard. Whether there is any merit to that approach is another matter, he adds.
Imperato says it will be important to watch how much enforcement takes place through the civil monetary penalty (CMP) laws and exclusion statutes. HHS Inspector General Janet Rehnquist reiterated her intent to expand the use of those authorities earlier this month.
Young notes that for more than a year, the OIG has publicly touted that approach. He says some CMP authorities related to kickbacks have been on the books since the Balanced Budget Act of 1997 that have not been used very much. "Clearly, the [OIG] Office of Counsel is gearing up to use that authority with more regularity," he warns, "and success breeds success."
According to Young, that CMP basically amounts to an intermediate sanction. "It is short of a criminal prosecution," he explains. "But it is not a free pass, either." He also notes that the OIG has increased staff in the Office of Counsel to pursue those cases.
To the extent that health care fraud enforcement continues to be a priority, Imperato predicts the OIG will spearhead that initiative more than it has in the past, simply because there are more competing priorities for the Department of Justice.
According to Young, False Claims Act cases that are not pursued by the Department of Justice, and possibly fraud cases involving individuals pursuant to settlements with an institution, also may be a focus of OIG attention.
Imperato says that, while he has seen some increased activity over the past year in connection with physician kickback cases, the jury still is out on how broadly the OIG will use its CMP authority. "I am waiting to see a little more pervasive impact than I have seen so far," he says. "Maybe it is on the horizon."