A new anti-kickback law applied to all payers may inadvertently jeopardize the way labs compensate sales personnel, even as increased en- forcement under false claims and Stark mandates have combined to raise a tangled web of compli- ance issues for clinical and AP labs.
In enacting the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), Congress has unwittingly approved an unprecedented expansion of federal anti-kickback liability to private-pay referrals. Intended to address the Nation’s opioid crisis, EKRA enables the government to monitor provider arrangements intended to generate business for any laboratory service, not only those related to individuals in treatment for substance abuse disorders, paid by a federal healthcare program or commercial health insurer.
Meantime, labs and AP groups continue to run afoul of existing fraud and abuse prohibitions which, taken together with modifications to the physician self-referral rule plus the prospect of future changes to the Stark law, create a climate where heightened compliance vigilance is a necessity.
S. Craig Holden
Shareholder, Baker Donelson
Chief Compliance & Ethics Officer, Inform Diagnostics
Jane Pine Wood
Chief Legal Counsel, BioReference Laboratories
President, Dennis Weissman Associates, LLC