Evolving payment models along with increasing amounts of publicly available data could present new compliance challenges for healthcare governing boards, according to new guidelines released by the federal government and industry groups Monday.
“New forms of reimbursement (e.g., value-based purchasing, bundling of services for a single payment, and global payments for maintaining and improving the health of individual patients and even entire populations) lead to new incentives and compliance risks,” according to the guidelines for healthcare boards on compliance oversight, created through a first-of-its-kind partnership between HHS' Office of Inspector General, the American Health Lawyers Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association.
Sandy Teplitzky, a principal at Ober Kaler who helped create the guidelines on behalf of the American Health Lawyers Association, said the groups behind the document felt it important to come together now to assist boards. He said it's been years since similar guidance was issued, and much has changed in healthcare in a short period of time.
Compliance might seem relatively straightforward to the employed leaders of healthcare organizations, but it seems less concrete for board members, many of whom are volunteers with varying levels of healthcare experience, he said.
“The concept is to provide some guidance and practical tips to try to avoid problems as opposed to coming in later and saying, 'We gotcha,'” Teplitzky said. “One of the goals of this document is to provide the boards with … the questions they should be asking.”
The guide notes that new payment models have spurred consolidation among healthcare providers and more employment and contractual relationships, such as those between hospitals and doctors. Boards, as a result, should be asking their organizations how they review those relationships for compliance with the Stark law's restrictions on self-referral and the anti-kickback statute.
That particular guideline isn't driven by cases the OIG has seen but is something that boards should be aware of generally “because the world is changing,” said Greg Demske, chief counsel to the inspector general.
The guide also warns that “emerging trends in the healthcare industry to increase transparency can present healthcare organizations with opportunities and risk.” The guide cites as examples CMS' Quality Compare Measures, CMS physician payment data and data on payments from pharmaceutical and device manufacturers to physicians now available through the Sunshine Rule.
In light of this data, boards might want to compare their own data against those of peers and incorporate national benchmarks when assessing risk and compliance, the guide suggests. It also warns boards of organizations that employ physicians to be aware of relationships between physicians and other healthcare entities and whether those relationships could affect clinical and research decisionmaking.
“Because so much more information is becoming public, Boards may be asked significant compliance-oriented questions by various stakeholders, including patients, employees, government officials, donors, the media, and whistleblowers,” according to the guide.
The guidelines touched upon a number of other matters, including the 60-day repayment provision of the Affordable Care Act. The rule requires that providers report and refund any overpayments to Medicare or Medicaid within 60 days of identifying overpayments. The guide suggests that a board would benefit from asking management about efforts to develop policies for identifying and returning overpayments, though the regulations to do so aren't yet final.
Roy Snell, CEO of the Health Care Compliance Association, said it's significant that the guidelines specifically emphasize the importance for boards of keeping compliance officers independent.
The guidelines state, “OIG believes an organization's Compliance Officer should neither be counsel for the provider, nor be subordinate in function or position to counsel or the legal department, in any manner.”
Most healthcare organizations already have independent compliance officers, but there can be pressures to limit that independence, Snell said.
“We need the constant reminder that by definition a compliance officer isn't a compliance officer unless they're independent,” Snell said. “We need to have it independent so leadership can get advice that comes from an unbiased perspective.”
Snell said this is the first time such a recommendation has been stated so clearly, and it's likely to reach beyond healthcare into other industries thinking about their own compliance issues.