Organizations often struggle to navigate the fine line between research activities and quality improvement activities. This can be complicated by a lack of coordination between the quality improvement and research departments in both large and small organizations. In this article, we will explore the differences between these two disciplines and how to appropriately determine if an activity is quality improvement or research.

In November 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the General Compliance Program Guidance (GCPG). The GCPG is described as a “reference guide for the health care compliance community and other health care stakeholders.”^[1] OIG specifically states the Guidance is not meant to “constitute a model compliance program” or be “one-size-fits-all,” but rather it is intended to set forth voluntary guidelines and compliance tips for all individuals and entities that play a role in the healthcare industry.^[2]

The U.S. Department of Health and Human Services Office of Inspector General’s (OIG) recently updated General Compliance Program Guidance (GCPG) reinforces healthcare boards prior direction that was published regarding governing bodies’ compliance oversight role.^[1]

We often learn the most important lessons from negative experiences. I once heard a compliance leader state just how hard it was to find talented team members in the geographic area where their healthcare system was located. On its face, this was not a controversial statement since compliance, as a profession, faces the same challenge as other fields during a time of shifting labor and demographic conditions—hiring and retaining good staff.

The main problem with that statement was that the leader voiced it in front of four team members, all of whom immediately looked down toward the ground. By easy association with the leader’s statement, the team must not be talented.

That very comment—and the leadership belief and established culture leading to it—set the tone for failure.

A good place to determine an organization’s billing and coding compliance risks is by looking at Recovery Audit Contractor (RAC) requests and results. It is important for compliance officers to be on a revenue integrity committee that monitors them. Many of these potential billing errors are identified through outside data analysis.

As most of you know, the Centers for Medicare & Medicaid Services (CMS) has retained contractors called RACs to reopen and revise initial determinations or redeterminations of claims within four years from the date of the initial determination or redetermination upon established good cause.

Split (or shared) visits—the current term used by the Center for Medicare & Medicaid Services (CMS)—allow non-physician practitioners (NPPs) and physicians who work for the same employer/entity to share patient visits on the same day by billing the combined work under the physician’s National Provider Identifier (NPI) and receive 100% of the Medicare Physician Fee Schedule (MPFS), or the NPP’s NPI for reimbursement of 85% of the MPFS.

A compliance program’s success is seen in its ability to engage each person in the organization—not only senior leaders and managers but all frontline staff—in their individual compliance responsibilities. Compliance is everyone’s job. But how can the compliance program reach every individual in a meaningful way? Staff need more than the knowledge that a compliance program, a code of conduct, and policies exist; they need a personal understanding of how to do one’s job compliantly and a commitment to doing the right thing and speaking up if there is suspected noncompliance. Frontline staff engagement is an organization’s first line of defense against fraud, waste, and abuse. We must instill in all staff that they are critical to our organization’s success, not just in patient care, quality, and safety, but in our organization’s compliance.

DT: I know we have been in the compliance field and part of HCCA for many years, and you are now retiring. What are some of your memories from when HCCA first started?

SD: I remember the excitement of working to build a new profession. As government regulations and guidance began to become bigger and broader, that group of the first compliance officers came together to start to decide what we wanted our profession to look like. We recognized that we had a wonderful chance to define what worked and then share it with others. We were excited as more and more people joined HCCA. I’m proud of how my career has mirrored the growth and complexity of the healthcare compliance profession.

If you have not seen the U.S. Department of Justice’s news release on the H. Lee Moffitt Cancer Center & Research Institute Hospital, in the past few months I urge you to read it and absorb what it means for your billing compliance in research. Moffit agreed to a $19.5 million dollar resolution of liability related to a self-disclosure of improper billing for clinical trial costs in January of this year. Voluntarily disclosing and fully cooperating with the government’s investigation resulted in a settlement both to Medicare and the state’s Medicaid plan.^[1]

I was cleaning out my research collection a couple months ago. One that caught my eye was an article about telehealth. This article was published in 2018, and the author’s perspective made me laugh. In the piece, the author discussed telehealth and how they did not believe it would ever catch on. They reasoned that it was not real healthcare, insurance would never pay for it, and patients would not want to talk to their providers over the phone because they wanted to see them face to face. Oh, how times have changed!