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In a rapidly evolving health care landscape, almost all health care organizations reported an increased need for regulatory compliance in recent years.¹ To navigate these turbulent waters, a powerful alliance between health care compliance and leadership is not just a choice — it's a necessity.

In modern health care systems, the need to emphasize patient safety, ethical practices and regulatory compliance has never been greater. To navigate the complex landscape of health care regulations and to ensure high-quality care, health care organizations must foster a strong partnership between their compliance teams and other leadership.

Based on my 17 years of experience working in the Integrity and Compliance department at Trinity Health, I offer my insight on the importance of this alliance and how it can effectively promote both regulatory compliance and strong operational performance within a health care system.

PARTNERSHIP IN ACTION
To demonstrate the importance of a partnership between compliance and leadership, I point to a recent whistleblower case in which Trinity Health resolved a Department of Justice (DOJ) investigation last year into the medical necessity of certain surgery procedures. The initial inquiry was three years ago, and we heard nothing for most of this period. Then, suddenly, the DOJ scheduled a meeting with our facility leadership to discuss their results. The DOJ shared that their experts had determined an 85% error rate for the charts they reviewed, and they presented Trinity Health with a settlement demand of nearly $10 million.

Trinity Health disagreed with the DOJ expert's findings. The Integrity and Compliance team partnered with legal, clinical, information technology, finance and revenue departments to conduct further internal review. Through this collaboration, Integrity and Compliance demonstrated that all charts reviewed by the DOJ met necessary medical criteria and that the surgeries had prior payer approval and were correctly billed. We determined that we owed nothing and were paid correctly. We reported our results to the DOJ and a few months later, the whistleblower opted out of the claim. The judge closed the case, and even though the DOJ's experts had originally noted an 85% error rate, they also walked away from the case.

This result would not have been possible without the collaboration of all the departments working together with Integrity and Compliance. The bottom line was that instead of owing $10 million, our system paid back nothing. This investigation demonstrates the value of an effective Integrity and Compliance program and the value collaboration with leaders of different departments can bring.

PROMOTING A CULTURE OF INTEGRITY
At Trinity Health, we thoughtfully named our work the Integrity and Compliance program, as the realm of ethics and responsible conduct, compliance and integrity are often discussed interchangeably. However, it is important to note that each word has a significant difference in meaning.

Compliance focuses on meeting regulatory requirements and refers to adhering to external laws and regulations and following internal policies. Complying with laws and regulations is the very minimum expected at Trinity Health. One of our core values is integrity: "We are faithful to who we say we are." For us, compliance simply means, "Let's go out and not break the law today," or asking ourselves, "Can I do this?" Integrity means, "Let's do the right thing today," and forces us to ask ourselves, "Should I do this?" This should be an important distinction in health care today. Health care is arguably one of the most regulated industries, and the fact is that most of our compliance challenges are in gray areas with room for different interpretations.

A good example is in the early 2000s, when a health care services company unrelated to our system was in the news and paid the DOJ more than $900 million to resolve false claim allegations.² More than $788 million of the $900 million was to resolve claims arising from the company's receipt of excessive "outlier" payments (payments intended for limited situations involving extraordinarily costly episodes of care). These claims resulted from the hospitals' alleged substantial inflating of their charges for higher-priced services and supplies in excess of any cost increases associated with patient care and billing.

The same consultants who assisted the other organization approached Trinity Health to promote a service that could improve revenues by increasing outlier charges to the Medicare program. The consultants said that "everyone was doing this" and tried to convince Trinity representatives that they should not miss out on this additional revenue. The potential revenue increase was significant, and the question of "Can I do this?" came up. But, with Trinity Health's emphasis on integrity, the real question became, "Should I do this?" At the end of the day, the system's C-suite executives decided this was something they should not do — it didn't feel right. They took a step back, considered how this practice could be viewed by the public, media and regulators five years from now, and asked themselves, "Should we do this?"

The key is to promote a culture of integrity. The partnership between compliance and leadership encourages a culture of integrity and ethical behavior. This takes time and will not occur overnight. It takes trust. What is the first thing someone thinks of when they get a call from integrity and compliance? It's that they are in trouble, like the police or the IRS showing up at their door. Changing this perception is important so that relationships can become more collaborative.

BUILDING TRUST, ESTABLISHING RELATIONSHIPS
Trinity Health's Integrity and Compliance program addresses each element of an effective corporate compliance program (see graphic for further details).

The program has four primary goals:

1. Promote ethical behavior and conduct standards by all who work in Trinity Health, including colleagues, volunteers, medical staff and suppliers.
2. Foster an organizational culture that promotes compliance with laws, regulations and professional standards.
3. Educate and train all Trinity Health employees concerning the system's commitment to act with integrity and honesty, and follow all laws and regulations that apply to Trinity Health's operations.
4. Establish systems to monitor Trinity Health's operations continuously, and identify and correct any violations or deficiencies in a timely and appropriate manner.

To meet these goals and establish collaborative relationships, it's important to be invited to certain meetings to listen and provide guidance. The goal is to provide value and support business strategies where possible so that departments automatically invite Integrity and Compliance colleagues to the table in the future. There are many departments in a health system corporate office: clinical, finance, legal, payor strategies, revenue and supply chain, to name a few.

More than 15 years ago at Trinity Health, the Integrity and Compliance program staff developed an approach to work with revenue leaders on various projects. However, colleagues were not always invited to all meetings. Examples of this included when new service lines were established, billing changes were made for certain services or a consultant was brought in for a review. Over time, trust was built and senior leaders saw that Integrity and Compliance colleagues could provide valuable insight to help the decision-making process, providing proactive guidance to align with regulatory requirements. The results of this relationship created a standing meeting with revenue and the Integrity and Compliance team, where today a broad range of issues are discussed. By integrating compliance considerations into strategic planning, leaders can make informed decisions that prioritize both business objectives and regulatory compliance.

Building trust and showing how the Integrity and Compliance program adds value helps form a more solid alliance with leaders. For example, we have always worked closely with Colleague and Labor Relations staff. As a branch of our human resources department, they investigate human resources issues that come to us via our Compliance hotline. They know that we defer to their expertise and vice versa. The director of the Colleague and Labor Relations team admired our complaints processes and database so much that they asked us to help build a similar module for them. Now, our systems are maintained by the same staff, and, with our complex and evolving organizational structure, our hierarchies are managed together at a single point so reports can be aggregated, trends can be observed, etc. This valuable new organizational process resulted from the trust and collaboration established between both departments.

A LEGACY OF INTEGRITY
The evidence of our Integrity and Compliance program's strong relationships with leadership is clear as we protect Trinity Health's legacy and integrity:

• We have had no Corporate Integrity Agreements (a document that outlines the obligations to which a health care entity agreed as part of a civil settlement) or mandated compliance requirements in Trinity Health's 23-year history.
• With our integrity focus, we have kept our reputation clean and stayed out of media headlines for corporate ethical lapses.
• Our ministries recognize that we provide value-added, cost-effective integrity/compliance services, as illustrated by our program results and stellar internal services surveys.
• Our Board of Directors expresses gratitude for our support in fulfilling their governance oversight responsibilities.

A strong partnership between health care compliance officers and leadership is essential in ensuring regulatory compliance and effective leadership within the health care sector. By prioritizing patient safety, promoting ethical conduct, mitigating legal risks, fostering strong leadership values and achieving operational excellence, health care organizations can build a foundation of trust and deliver high-quality care to their patients. Collaboration between compliance and leadership enables health care organizations to navigate the complex regulatory landscape successfully while ensuring compassionate and ethical health care services.

ANDREI M. COSTANTINO is vice president of Integrity & Compliance at Trinity Health. He has more than 30 years of executive experience specializing in multiple areas, including regulatory compliance issues, Medicare and Medicaid fraud defense work, compliance risk assessments, and compliance/reimbursement education and training.

NOTES

1. "Regulatory Overload: Assessing the Regulatory Burden on Health Systems, Hospitals and Post-acute Care Providers" American Hospital Association, October 2017, https://www.aha.org/sites/default/files/regulatory-overload-report.pdf.
2. "Tenet Healthcare Corporation to Pay U.S. More than $900 Million to Resolve False Claims Act Allegations," Department of Justice, June 29, 2006, https://www.justice.gov/archive/opa/pr/2006/June/06_civ_406.html.