Authored by Attorneys of Chaires, Brooderson & Guerrero, P.L.
According to the United States Department of Health and Human Services, our Nation is in the midst of an unprecedented opioid epidemic with an estimated over 130 deaths from opioid-related drug overdoses on a daily basis. In 2018 in Florida, opioid-related treatment costs exceeded $1 billion dollars and Florida hospitals treated approximately 18,000 opioid overdoses. Given the significant impact of the opioid crisis, federal and state governments alike are clamoring to implement laws to protect citizens. In October 2018, President Trump signed the SUPPORT Act, or the Substances Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. On its face, this very important and necessary legislation seeks to improve access for the prevention and treatment of substance abuse disorders. But there is much more to it than that.
Incorporated into the SUPPORT Act is legislation which seeks to prevent the abuse of increased treatment access. In a nutshell, providers should take note of the Eliminating Kickbacks in Recovery Act or "EKRA." Codified at 18 U.S.C. § 220 and similar to Florida patient brokering and anti-kickback laws, EKRA exists to prevent unlawful referrals to clinical treatment facilities, labs and recovery homes. EKRA penalties pertain to any individual who, with respect to services covered by a by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully:
(1) solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or
(2) pays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind-
(A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or
(B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory.
Penalties are heavy, as those found to be in violation of EKRA may be fined up to $200,000 and/or imprisoned for up to ten (10) years - per violation!
While the anti-kickback statute forbids payment or remuneration to induce or reward referrals of federal health insurance programs, EKRA goes beyond that. EKRA prohibits such for any health insurance business to labs, recovery homes, and clinical treatment facilities. Yes, ANY- to include, public, private, governmental and commercial health insurance programs. Even if the conduct is permissible under the anti-kickback statute, penalties can be imposed. Frighteningly, stricter requirements are also placed on arrangements with marketers than that which currently exists in the Federal anti-kickback status and in certain circumstances, penalties can be applied even if a party complies with a safe harbor to the anti-kickback statute.
EKRA is a new law, and as yet, lacks complete clarity. Providers, labs, facilities and recovery homes are encouraged to review EKRA to ensure compliance. While there are several exemptions that protect specifics arrangements, care needs to be taken to ensure complete compliance, particularly as such applies to services affecting interstate or foreign commerce. Some exceptions will not apply until 2023 and at least one exception is not even known at this time.
Chaires, Brooderson & Guerrero, P.L. assists our clients to navigate through state and federal government investigations; including the Florida Boards of Medicine, Dentistry, Pharmacy, Nursing, the U.S. Department of Justice, the Office of Inspector General (OIG), the Office of Civil Rights for HIPAA compliance and more. If the government is on the other side, we are on your side. For decades, each of our team members have dedicated their legal practices to the advocacy and education of health care professionals and health care entities. We advise on many of the aspects of health law including, Stark, Anti-Kickback statute, the Florida Patient Self-Referral Act and more. We additionally cater to medical business legal services such as Contracts, Ambulatory Surgery Center ("ASC") transactions, Business Relationships as well as many other types of health care business transactions. Each of our team members have been awarded the highest AV® rating by our legal peers through Martindale-Hubbell. As with any overview, the foregoing information has been provided to generally inform you and in no way serves as legal advice. For more information regarding health care law, regulatory law and administrative law, please visit www.chlawyers.com or contact our firm at (407) 834-2777. Chaires, Brooderson & Guerrero. Your advocate. Your shield.