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People who have spent years in compliance know relevant regulatory guidance inside and out. But workforce — or stakeholder — turnover may mean it’s time to check in on some updates, as well as refresh knowledge about the four big compliance laws.

Find out more from CJ Wolf, MD, MEd, CPC, COC, CHC, CHPC, CHRC, CIA, who gave the presentation “Understanding the New OIG Compliance Program” at AAPC’s HEALTHCON Regional 2024.

Understand These 4 Major Compliance Laws

Make sure you’re familiar with the Office of Inspector General (OIG) General Compliance Program Guide (GCPG), Wolf said, because it offers comprehensive coverage of relevant federal law, compliance programs, resources, and other information necessary for the healthcare industry.

Don’t miss: The OIG has changed the way it shares updated guidance and policies: The changes are now posted directly to their website instead of published in the Federal Register.

Here are the four major compliance laws everyone in healthcare should be familiar with:

1. Anti-Kickback Statute: The OIG says that violating this statute can “induce medically unnecessary testing and inappropriately steer medical tests to providers who may not return timely or quality results.” Although a lot of the enforcement actions to date have targeted the folks giving the kickbacks, it’s important to remember that the statute addresses anyone giving, receiving, or asking for kickbacks. It’s an intent-based law — an enforcement action must prove intent, Wolf said.
   The statute is designed to underscore the significance of letting medical decisions based on medical reasons rather than financial influences, he said. And remember, the financial influence doesn’t need to be as explicit as an envelope full of cash. It could be offering marketing help by paying for radio ads or a lease on rental space that’s below market value, Wolf explained.
   “I’ve noticed over the last few years that physicians that are getting kickbacks are starting to be enforced against, as well,” Wolf said.
2. Stark Law: The intention of Stark Law, which is also known as physician self-referral, is similar to the Anti-Kickback Statute. Stark Law aims to provide guiderails to make sure medical decision making is based on what’s best for the patient and isn’t compromised by improper financial influence.
   Unlike the Anti-Kickback Statute, Stark Law is based on strict liability — you either follow the rules, or you don’t, Wolf said, and the requirements can sometimes be burdensome.
   Wolf provided an example of trying to incentivize specialist clinicians like neurosurgeons to come to a region and provide services, but being in violation of Stark Law for paying them above fair market value.
3. False Claims Act(FCA): The FCA originated during the Civil War when the Union armies were being cheated by suppliers; for example, paying for 20 healthy horses but actually getting 10 healthy and 10 sick, Wolf explained. Since then, the FCA has evolved to encompass not just horses or healthcare, but any false claim against the government.
   More enforcement actions are leveled against the healthcare industry than other industry due to sheer volume, Wolf explained, because every medical claim submitted for payment to Medicare, Medicaid, or Tricare is a claim to the government. FCA, as it’s currently written, has provision protecting whistleblowers and even offering them a percentage of any money recovered — a tool the federal government can and does wield successfully.
   An example of a violation of FCA might be upcoding, like reporting evaluation and management (E/M) codes that don’t support the level of service actually provided.
4. Civil Monetary Penalties Law (CMPL): Civil monetary penalties can be leveled against individuals or entities if they violate certain laws, including drug price reporting; false and fraudulent claims; grains, contracts, and other agreements; kickbacks; misuse of words and emblems belonging to the U.S. Department of Health and Human Services (HHS) or the Emergency Medical Treatment and Labor Act (EMTALA); physician self-referral; and the possession, use, or transfer of select agents and toxins; according to the OIG. CMPs can also include affirmative exclusions, where an individual or entity is prohibited from participating in any federal healthcare program for a specified period of time. Exclusion penalties can go beyond clinical workers — anyone, or any entity, that is involved in services reimbursed by the federal government can face this penalty, Wolf explained.

Top tip: Exclusion screenings should be conducted on people, as well as business associates, Wolf recommended — because an organization working with an excluded person or entity will have to repay all the funds received, plus possible extra penalties.

Peek Into New Influences on Healthcare

People who have been working in healthcare for years are familiar with the rules and regulations like the aforementioned laws that, in many ways, define the industry. But as the healthcare sector keeps growing in economic importance, people who know a lot more about making money than compliance or patient care are looking for opportunities.

The OIG is already talking about an increasing number of new entrants to the healthcare sector, like established and startup tech companies and new investors, as well as entities that provide services that have not traditionally been part of healthcare, like social services, food delivery, and care coordination services. These newcomers are garnering attention from the OIG because they’re bringing business norms from other industries.

“Business practices that are common in other sectors create compliance, risk in healthcare, including potential criminal, civil, and administrative liability,” Wolf said. He said the OIG was especially interested in private equity, because some private equity firms seem to be putting money into healthcare mostly for a return on investment.

While healthcare businesses need to be financially sound, the U.S. Department of Justice (DOJ) already has several cases involving private equity firms’ decisions after investing in the healthcare industry.

One such case involved a hospital and its private equity investors drumming up outlier payments by boosting their cost-to-charge ratios. Wolf mentioned this case to illustrate that the DOJ procured settlements from the hospital ($18 million) and the investors themselves ($12 million) because it could prove that the private equity investors were influencing the hospital’s decisions and actions.

Keep these compliance laws and the OIG’s priorities in mind as your practice looks to 2025 and another year staying compliant — and in business.

Rachel Dorrell, MA, MS, CPC-A, CPPM, Development Editor, AAPC