Reprinted with Permission from the Birmingham Medical News
If you ask a healthcare provider to state the healthcare laws and regulations that give them a headache, you are likely to receive a range of responses. The compliance burden in healthcare does not originate from a single law or set of laws, but from diverse sources such as the Anti-Kickback Statute, MACRA, HIPAA (and the HITECH ACT), EMTALA, the Anti-Markup Rule, the Civil Monetary Penalties Law, and a number of other federal laws and regulations. Then, of course, there are the state laws, licensing requirements, coding and billing guidelines, and the rules of state boards. The list could go on, and branches out in various directions based on the type of provider involved. Many (and perhaps most) of these laws may be necessary evils: they do attempt to serve important functions in a complicated landscape. Yet the burden they impose is undeniable, and one of the most worrisome for many physicians and hospitals is the Physician Self-Referral Statute, more commonly known as the Stark Law (the “Stark Law”).
The Stark Law restricts physicians from making referrals for certain designated health services (“DHS”) to an entity with which he or she has a financial relationship, which includes ownership, investment, or compensation relationships, unless the physician qualifies for one or more exceptions. The DHS at issue cover a wide range of services, including, but not limited to, clinical laboratory services, therapy services, certain imaging services (such as MRIs, CAT scans, and ultrasound services), durable medical equipment and supplies, and outpatient prescription drugs. In addition to its severe penalties (e.g., liability for all of the payments received under the impermissible relationship; potential False Claims Act or Civil Monetary Penalties consequences; the possibility of exclusion from the Medicare program), what makes the Stark Law so threatening is that it is a strict liability statute. The government does not need to prove an element of intent to establish a Stark Law violation, and unlike the safe harbors of the Anti-Kickback Statute, the Stark Law exceptions must be completely satisfied: there is no mercy extended for practices only slightly outside of an applicable Stark Law exception.
Download the full article “The Stark Law: A Reminder and Request” written by Christopher Thompson.