By Heather Stith

Clinical laboratory employees could now face potential legal consequences of $200,000 fines or 10-year prison terms as a result of vague language in the SUPPORT (Substance Use disorder Prevention that Promotes Opioid Recovery and Treatment) for Patients and Communities Act that became law on October 24, 2018.

What The Law Means

This act consolidated several opioid-related bills. Section 8122 of the act, otherwise known as the Eliminating Kickbacks in Recovery Act (EKRA) of 2018, makes it a federal crime to receive or offer payment in exchange for referring patients to a recovery home, clinical treatment facility, or laboratory.

EKRA was conceived to combat patient brokers, third parties who are paid to bring in patients to addiction treatment facilities, by closing a gap in existing healthcare kickback law. The federal Anti-Kickback Statute, which has been around since the 1970s, only applies to services covered by federal health programs such as Medicare and Medicaid and has spelled out several exceptions or “safe harbors” for standard healthcare practices. The newer EKRA applies more broadly to services provided by any “healthcare benefit program” to include private payers that are common in addiction treatment, yet EKRA is vague about what circumstances would constitute a safe harbor.

The healthcare legal community and advocacy organizations such as the American Clinical Laboratory Association have raised the alarm about how the EKRA provision in the SUPPORT for Patients and Communities Act might affect existing financial arrangements for all laboratories, not just those that provide toxicology services, such as:

  • Donations of lab services to federally qualified health centers
  • Group purchasing organization administrative fees for lab marketing
  • Commission payments to lab salespeople
  • Salaries of lab phlebotomists who work in physicians’ offices with high order volumes
  • Free specimen collection supplies provided to physicians

How to Remain Compliant

These legal complexities highlight the increasingly fine line laboratories have to walk between compliance and competitiveness. hc1 Opioid Advisor™ is a way for laboratories to provide added value to their prescriber clients without running afoul of law enforcement. The proprietary consistency analysis, overdose risk scoring, and PDMP access deliver valuable information to prescribers that can help them provide the best possible care for patients while complying with state regulations. And improved patient care is a goal that laboratories, prescribers, payers, and the government can all agree on.
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