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CMS rollbacks and EKRA: A word of caution for diagnostic labs

The United States Centers for Medicare and Medicaid Services (CMS) has rolled back some regulatory provisions in response to the current coronavirus pandemic. Officials reason that these rollbacks will help to better ensure patients can get the testing, diagnosis and treatment needed during these uncertain times.

Which regulations did the agency roll back?

The agency has made a number of changes, including:

  • Referrals. CMS has relaxed some of the Stark Law and Anti-Kickback Statute (AKS) requirements that result in criminal charges for certain financial relationships between medical professionals. The CMS hopes the change will allow physicians and medical practitioners to better work together to meet patient's needs during these uncertain times.
  • Eased lab test ordering requirements. CMS has also made it easier for diagnostic labs to move forward with testing and receive reimbursement. The agency accomplished this goal by removing a requirement that the patient first receive an order by a treating physician before the lab was eligible for coverage for the test.

It is important to note that these changes do not mean the government has completely eased back. Prosecution for alleged regulation violations continues.

What does this mean for EKRA and diagnostic labs?

Officials continue to investigate labs for alleged violations of the Eliminating Kickbacks in Recovery Act (EKRA). Federal, private and commercial labs can face prosecution if accused of failing to follow these regulations. Although it is important to move forward with COVID-19 and related testing, labs must do so wisely. A misstep in marketing or payments to employees could result in allegations of an EKRA violation. The government will move forward if they believe a lab is involved in fraudulent billing practices.

Allegations of an EKRA violation are serious. Each individual conviction can result in up to 10 years imprisonment and fines of $200,000. As such, it is wise for those who face allegations of violating EKRA to seek legal counsel experienced in this niche area of health care law.

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