Despite the progress that has been made over the years, it is evident that the United States is still struggling to combat the opioid epidemic. In 2018, an estimated 10.3 million individuals misused opioids, and 2 million had an opioid use disorder.1

During his previous campaign, President Donald J. Trump pledged that his goal was to “cut nationwide opioid prescriptions by one-third,” and recent data suggest that the total number of opioids prescribed per month in the United States decreased by 34% between January 2017 and February 2019.2

Since his inauguration in January 2017, many attempts have been made to develop legislation to tackle the opioid epidemic. One major piece of legislation that Trump signed is the Substance Use- Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act.3 This act aimed to expand access to recovery and treatment services by minimizing access to opioids.

A subdivision of the SUPPORT Act, found in section 8122, is the Eliminating Kickbacks in Recovery Act (EKRA), which became effective on October 24, 2018, when the SUPPORT Act was signed into law.4 EKRA was developed as an attempt to eliminate “patient brokering,” the process by which individuals refer patients with substance use disorder to clinical treatment facilities, laboratories, and recovery homes in exchange for kickbacks.5 Those in violation of EKRA are subject to fines of up to $200,000 and imprisonment for up to 10 years, respectively, per occurrence.6 The primary motivation behind this piece of legislation was to protect an already potentially vulnerable population from unscrupulous treatment providers for substance use disorder.

EKRA is intended to complement existing federal fraud and abuse laws designed to regulate the use of referrals in the health care field, including the federal Anti-Kickback Statute (AKS). Although EKRA mirrors the language of the existing AKS, it has several notable differences. First and perhaps most significantly, the act applies to all payers, including commercial insurance plans and self-paying customers, making it more expansive than AKS, which applies only to federal health care programs.6 This expansion was based on the realization that the services of many addiction treatment programs are often funded by private insurance or self-pay methods.

Additionally, EKRA differs from the statute in the language pertaining to employment compensation. Although AKS’ safe harbors allow for payments to an employee as long as there is an established bona fide employment relationship, EKRA’s exception states that payments may not differ based on the amount billed to the health care benefit program, or number of individuals referred, or procedures performed.6

Finally, the difference between EKRA and AKS that has raised the most concern among health care providers is the inclusion of “laboratories” under the applicable subject entities. EKRA states that it applies to all improper referrals to clinical treatment facilities, laboratories, or recovery homes, regardless of whether the referred service relates to treatment for substance use disorder, and it describes laboratories as any amendments-certified clinical laboratory for patient improvement.6 Even though this law was developed specifically in response to the opioid crisis, its broad language expands the legislation to include laboratories that perform testing unrelated to substance use.

Because of the broad language used in EKRA, governmental regulators are expected to give more clarification and detail in the near future regarding the interpretation and intent of the law.7 This new piece of legislation has caused those involved in several outpatient specialty areas outside the substance use disorder treatment field to reconsider the arrangements they have with employees and other health care providers. Improper business arrangements, including kickbacks, can take place in multiple ways. Moving forward, it is crucial that all health care providers exercise great caution when entering into business relationships to ensure compliance with EKRA.
 
Julia G. Keogh, PharmD, is a pharmacy intern at Rite Aid in Lexington, Kentucky.

Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.



REFERENCES
  1. Key substance use and mental health indicators in the United States: results from the 2018 National Survey on Drug Use and Health. Substance Abuse and Mental Health Services Administration. August 2019. Accessed July 20, 2020. www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf
  2. HHS fact sheet: combating the opioid crisis. US Department of Health & Human Services. April 24, 2019. Accessed July 20, 2020. hhs.gov/about/news/2019/04/24/hhs-fact-sheet-combating-the-opioid-crisis.html
  3. Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub L No. 115-271. Accessed July 20, 2020. https://www.congress.gov/bill/115th-congress/house-bill/6
  4. Eliminating Kickbacks in Recovery Act of 2018, 8 USC §8122 (2018). Accessed July 20, 2020. https://www.congress.gov/bill/115th-congress/house-bill/6
  5. Benkoff RN, Wachler DT. EKRA: enactment and implications of the SUPPORT Act’s new all-payor federal antikickback law. American Bar Association. March 1, 2019. Accessed July 20, 2020. https://www.americanbar.org/groups/health_law/publications/aba_health_esource/2018-2019/march/ekra/
  6. Morgan LB, Smith A. The Eliminating Kickbacks in Recovery Act of 2018 (EKRA): a new federal kickback law applicable to all payors. Dorsey Health Law blog. August 22, 2019. Accessed July 20, 2020. https://dorseyhealthlaw.com/the-eliminating-kickbacks-in-recovery-act-of-2018-ekra-a-new-federal-kickback-law-applicable-to-all-payors/
  7. Levin DI. Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) and marketing arrangements. HealthCare Appraisers. August 9, 2019. Accessed July 20, 2020.
  8. healthcareappraisers.com/eliminating-kickbacks-in-recovery-act-of-2018-ekra-and-marketing-arrangements/