Articles on Compliance Strategies

Featured HBD Story October 4, 2007

HHS's OIG Steps Up Enforcement of Quality of Care, Shares Quality-Related Fraud-Fighting Tools With States

Reprinted from REPORT ON MEDICARE COMPLIANCE, the nation's leading source of news and strategic information on false claims, overpayments, compliance programs, billing errors and other Medicare compliance issues.

The HHS Office of Inspector General (OIG) is going full speed ahead with its enforcement efforts in the quality arena, according to Lewis Morris, chief counsel to Inspector General (IG) Daniel Levinson. The IG has made it clear that perpetrators of harm to Medicare and Medicaid beneficiaries are at the top of OIG's list right now, Morris said.

"We have been tasked with coming up with a robust multi-agency quality-of-care-initiative," Morris said Sept. 24 in Baltimore at the Fraud and Compliance Forum, sponsored by the American Health Lawyers Assn. (AHLA) and Health Care Compliance Assn. Fifteen training conferences are under way involving OIG, U.S. attorneys' offices and state attorneys general/Medicaid fraud control units.

"We are doing training programs across the country," Morris said. OIG will share its quality-related fraud-fighting tools with the states and, in turn, learn about theirs, he said. "That collaboration has already manifested itself in cases against substandard care by nursing homes."

Information leading to cases against providers with quality problems is coming from new sources. Not only are there whistle-blowers spurred by the federal False Claims Act, but now, in many states, whistle-blowers are coming forward under state false claims laws enacted and/or strengthened because of an incentive from the federal Deficit Reduction Act (DRA), Morris said.

Also, the DRA requires entities doing at least $5 million a year in business with Medicaid to train employees on the False Claims Act and whistle-blower provisions. That means nurses and other clinicians "who stood by silently when patients were abused now have a very strong financial incentive to come forward" and report the abuse to the government, he said.

OIG and CMS also are turning more to the mining of quality and reimbursement data to uncover potential patient abuse and "never events." Never events are serious errors that should never occur and are expensive to treat. Examples include surgery on the wrong body parts, major medication errors and mismatched blood transfusions.

Some whistle-blowers are now using these same data-mining strategies, which should motivate organizations to ensure their patient-safety monitoring and oversight systems are effective.

The government uses a variety of theories to make these cases. There are criminal statutes, such as criminally negligent homicide, which can be used to punish facilities when patients die because of terrible care (e.g., nursing-home residents are allowed to freeze to death). But more often, Morris said, the government will pursue quality-of-care cases using the False Claims Act. The premise is that the provider failed to provide care but billed for it anyway, he said. Morris emphasized that rather than enforcers focusing on isolated instances, they should instead concentrate on systemic failures — "those who provide substandard care over a [sustained] time period" and cases where care was of such poor quality that it might as well not have been provided.

From another angle, there is medically unnecessary care. "Excessive care can be worse than no care at all," he said.

Providers might be surprised at the trouble they can get into with OIG for failure to meet professionally recognized standards of care. In a twist, OIG can use its permissive exclusion authority to kick a provider out of Medicare and Medicaid for professional misconduct involving any patient, regardless of whether that patient is insured by Medicare, Morris said.

OIG also is relying more on corporate integrity agreements (CIAs) — compliance measures mandated in many fraud settlements — to monitor quality of care as well as fiscal integrity. OIG recently issued a final draft of a resource guide developed with AHLA to help board members oversee quality of care in their organizations.

"We are beginning to look to boards to ensure fiscal integrity and CIA oversight," said Morris.

Board Oversight Heightens

As the new OIG/AHLA resource guide explains, board members have a duty of care to their organizations, Washington, D.C., attorney Doug Hastings said at the conference session. That means acting in good faith, as a prudent person reasonably would act in the best interest of the organization. Boards must do their homework on quality of care, but ultimately rely on organization managers to get the job done without second-guessing it.

Also, there's the reasonable inquiry standard. "The mere passive receipt of information is no longer good enough," said Hastings, who is with the law firm Epstein, Becker & Green. There's a balancing act, he said. The board shouldn't second guess, "but it must do appropriate due diligence." The challenge here, said Hastings, is "how do you calibrate a reasonable level of due diligence?"

A number of recent initiatives that link efficiency and quality can help boards pinpoint the level of due diligence they need to exercise, Hastings said. These include CMS value-based health care initiatives and Institute of Medicine pay-for-performance recommendations. Details are in the OIG/AHLA resource guide.

"With the emerging quality issues, there is lots of activity around monitoring and reporting" health outcomes, he said. Board members should be "reflecting on processes and oversight in your organization — whether they are appropriate and whether reporting mechanisms are in place," Hastings maintained. There are compliance implications and a direct reimbursement impact through CMS's Hospital Compare program, which reduces DRG payments for hospitals that fail to report on the clinical steps taken in response to the presentation of certain symptoms.

"We are at a unique time. There is an opportunity for leadership from the board" and for positive change, Hastings said. Boards should "try to get their arms around what quality improvement means," but it will cost money and require organizations to accept transparency.

The bottom line is, quality needs the same attention from the board as the attention given to financial affairs, he said. And the board must stop thinking of quality and cost efficiency as contradictory. They are "complemen-tary.elements of an effective health care system," Hastings said.

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