Healthcare Compliance Terms: There’s a Stark Difference

It’s not “Somebody Else’s” Problem

If you’re a busy clinician or healthcare administrator, you likely feel overwhelmed just trying to provide care to your patients and operate your program. Self-education on compliance and regulatory issues can often get put off or relegated to the ‘someday’ task list.

Unfortunately, the news is filled with stories about healthcare professionals who didn’t weave compliance education into their daily practice. State and Federal prosecutors, as well as the HHS Office of the Inspector General are looking closely for signs of waste, fraud, and abuse within the Medicare program, and it can be easy to run afoul of these regulators when referring patients to healthcare partners for care.

Anti-Kickback Statute versus Stark Law: Start here

If you are someone who routinely makes referrals for common patient needs such as rehabilitation, lab services, home health, or hospice care, a good compliance base can start with knowing the difference between two of the main rules the government uses to enforce good practice.

• The physician self-referral law or Stark Law prevents certain financial arrangements with physicians unless the arrangements meet specific requirements. In essence, this means that a physician can’t make referrals to an entity that they have a financial relationship with unless they meet certain exceptions. For example, a hospitalist referring patients to a specific home health organization in which they are a co-owner.
• The Anti-Kickback Statute (AKS) prohibits the actions of offering, paying, soliciting, or receiving remuneration in exchange for referrals of patients or other healthcare business paid by the federal government. Examples of kickbacks might be gift cards, trips, or expensive meals given to any referral source in direct and express exchange for a referral.
  • It’s critical to note that AKS applies to non-physicians or clinicians such as Nursing Home Administrators, billers/coders, or even community members such as pastors or social service professionals. If you refer a patient for service and receive compensation for that referral, the Anti-Kickback statute will apply.

Where do they apply?

Stark law applies only to physician arrangements and the referral of specific designated health services (DHS):

• Clinical laboratory services
• Physical therapy services
• Occupational therapy services
• Outpatient speech-language pathology services
• Radiology and certain other imaging services
• Radiation therapy services and supplies
• Durable medical equipment and supplies
• Parenteral and enteral nutrients, equipment, and supplies
• Prosthetics, orthotics, and prosthetic devices and supplies
• Home health services
• Outpatient prescription drugs
• Inpatient and outpatient hospital services

The Anti-Kickback Statute AKS applies to all individuals or entities who make or receive referrals of patients whose care is paid by the federal government (Medicare, Medicaid, Tricare) or of other business paid by the federal government.

There are exceptions or “Safe Harbors” to these laws.

Regulators and policymakers understand that ensuring proper and individualized patient care is filled with complex systems to navigate, and ensuring appropriate efficiency isn’t always straightforward. To accommodate these nuances, there are some exceptions to Stark law and the Anti-Kickback statute:

• Stark exceptions:
  • The Stark law has a “de minimis” exception, which means that certain items below a dollar-threshold are excluded and not considered a violation. There is a de minimis exception to Stark for non-monetary (or monetary-equivalent) items or services, up to $429 in 2021, provided that the items or services:
    • Do not take into account the value or volume of referrals or other business generated,
    • The compensation has not been solicited by the physician or his/her practice group,
    • The compensation does not violate the anti-kickback statute.
  • There are a variety of exceptions for financial arrangements with physicians, such as a bona fide employment exception, a space or office rental exception, and a personal services exception.
  • It’s also important to note that intent does not matter with Stark law- even if you violated it by accident or without intent, it is still a violation. Therefore, it is critical that every arrangement meet every element of the applicable exception.
• Anti-Kickback Statue Exceptions:
  • With AKS, the intent does matter: you have to have the intent to offer, pay, solicit or receive renumeration in exchange for referrals.
  • There is no de minimis exception to the AKS – any compensation whether monetary, monetary equivalent (like a $5 gift card), item, or service regardless of value that is offered, requested, given, or received in exchange for referrals can be a violation.
  • ‘Intent’ is important in the AKS because a referral source may, for instance, be taken out for a meal over an educational session on a certain clinical procedure, and as long as there was no expectation of a direct referral, it may not violate the AKS.

As a general rule, you should begin thinking about fitting all arrangements with referral sources into one of the safe harbors to maximize your compliance.

Bottom line: Evaluate your current practices through the lens of both Stark and Anti-Kickback

If you routinely make referrals of patients or business that is ultimately funded by government programs like Medicare or Medicaid, both Stark Law and the Anti-Kickback statute most likely apply to you. You should evaluate your compensation relationships with both in mind as you work to build a compliant practice.

• Of these, compliance with the Stark law may be easiest to ascertain if there is no physician or designated health service involved.
• It’s important to note that even if the Stark exceptions/safe harbors are met, you should also analyze through the lens of the Anti-Kickback Statute.

Finally, there are some new exceptions to Stark and Anti-Kickback safe harbors that were released in 2021 to accommodate some value-based programs such as Direct Contracting Entities and Accountable Care Organizations, among others.

Nobody wants to run afoul of state or federal regulators when it comes to their professional practice. Building a culture of ongoing compliance starts with understanding these terms and how they might apply to you and the critical work you do in healthcare every day.

Understanding patient eligibility when referring to hospice is a core component of a compliant practice. Click here to view a series of short videos on hospice eligibility by disease