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Health and Human Services Inspector General Janet Rehnquist laid out her blueprint for the Office of Inspector General’s (OIG) anti-fraud initiatives last week. The result was a mixed bag for compliance officers.
On the one hand, Rehnquist promised expanded use of administrative remedies and systematic scrutiny of quality of care. But she also announced a streamlined civil settlement recovery process that may offer some relief as well as specific steps to improve the use of corporate integrity agreements (CIAs) and make them more cost-effective.
"I think you will see many positive changes," Rehnquist told attendees at a health care fraud conference in Washington, DC, cosponsored by the Philadelphia-based Health Care Compliance Association and the Washington, DC-based American Health Lawyers Association. She added that she has her own ideas about health care fraud enforcement, which primarily stem from her experience as an Assistant U.S. Attorney.
Rehnquist says her first objective is to streamline the civil recoveries process by improving communications and coordination among federal agencies as well as state and local law enforcement officials. She also plans to more effectively employ the civil monetary penalties (CMP) law and exclusion authorities to root out fraudulent providers.
Examples of this new, more proactive approach include the OIG’s imposition of CMPs for physicians participating in kickback schemes and the recent exclusion of a nursing home provider for failing to adequately care for its elderly residents.
According to the IG, the latter exclusion illustrates that while financial schemes threaten the financial integrity of health care systems, abuse and mistreatment of seniors is just as egregious. To improve enforcement of quality
of care, Rehnquist has instructed the OIG to scrutinize "patterns" of care in order to uncover systemic problems, especially in nursing facilities.
"I don’t want to just cherry-pick at the symptoms," she asserts. "We need a holistic approach to determine patterns and systemic failures and address those failures with administrative authorities."
Rehnquist added that she plans to strengthen the OIG’s partnership with state Medicaid Fraud Control Units and work with other federal agencies, law enforcement, and providers to develop an integrated response to quality-of-care issues.
Rehnquist also indicated that she recognizes the evolution of the government’s compliance efforts, especially as those efforts relate to CIAs. The vast majority of providers "get it right" despite complex regulations, because they have good internal controls, she maintains. But while she plans to emphasize voluntary disclosure, she was equally emphatic that CIAs sometimes are required.
Rehnquist says the OIG plans to streamline the civil settlement process by dividing False Claims Act (FCA) civil cases into three broad categories. The OIG has determined that some FCA cases can be settled without a CIA; while in other cases, the resolution of the OIG’s exclusion authorities can wait until after the settlement of the FCA case.
There is, however, a third group of cases where insufficient internal controls require that
a CIA is imposed as "an integral part" of FCA settlements. Rehnquist says the OIG is developing criteria to be used to make those determinations.
In addition, Rehnquist announced that CIAs will be modified to reduce the financial impact of CIAs. Already, the OIG has amended compliance provisions contained in certain settlement agreements.
Now the OIG plans to change several of the independent review organization requirements in order to reduce costs and redesign the sample methodology to improve its effectiveness and reduce cost.
Specifically, Rehnquist says CIAs will require the use of a full statistically valid sample only in instances where the initial probe sample shows an unacceptable error rate. "If the error rate is within an acceptable mean, there will be no need for a full, statistically valid sample," she explains.
The OIG also will look for ways to increase reliance on providers’ internal controls. Once finalized, these modifications will be incorporated into future CIAs and, where appropriate, will be made available to providers already operating under CIAs, she adds.
In addition to drafting compliance guidance for drug manufacturers, the OIG now is updating the existing guidance to make sure it reflects current regulations and payment systems, Rehnquist says.