We Assist Clinical Diagnostic And Reference Labs
As anyone in the health care industry knows, the regulatory landscape is highly complex. Not only that, in recent years, government agencies have been vigorously investigating New York and New Jersey diagnostic and reference labs and lab owners for fraud, abuse and other violations such as waiving co-payments and patient deductibles and alleged sham leases with physicians.
These audits by the FBI, the Office of Inspector General (OIG) for the Department of Health and Human Services and insurance companies, such as Cigna and Horizon, have resulted in many physicians and lab owners being indicted on federal charges.
At Rivas Goldstein, LLP, we routinely represent independent clinical laboratory and physician-owned laboratory (POL) clients who are under investigation for matters such as routine waiver of co-payments and deductibles, billing and coding issues, self-referral and anti-kickback rule violations, and fee-splitting.
Is Your Lab Unintentionally Violating The Anti-Kickback Statute?
In 2015, the OIG issued an advisory opinion stating that exclusive arrangements between a laboratory and physician practices may be in violation of the Anti-Kickback Statute. The decision was unfavorable to labs and added complexity to the regulations that labs must adhere to.
The federal Anti-Kickback Statute is a federal regulation that prohibits the exchange, or offer of exchange, of any type of gift or payment in order to induce referrals for federal health care program business.
In the 2015 OIG advisory opinion, a lab proposed to do all lab services for certain physician practices, waiving out-of-network fees for patients whose insurance would send them elsewhere. The OIG responded by saying that the benefits doctors enjoy by working with one lab could potentially be considered kickbacks.
Ultimately, the decision shows that kickbacks include a broader category than what one may typically consider as “gifts or payments.” Legal advice is essential for clinical diagnostic and reference lab owners who want to ensure compliance with the Anti-Kickback Statute or the Eliminating Kickbacks in Recovery Act (EKRA).
We Represent Clinical Diagnostic And Reference Labs Of All Sizes
Whether your laboratory is well-established, new to the industry or offers a unique, specialty service, our health care lawyers can help you achieve the best outcome possible.
- We will proactively advise you to make sure that your business is compliant with federal regulations.
- We will represent you and your business after being audited by the FBI, State Medicaid Fraud Units, Zone Program Integrity Contractors and Commercial Carriers.
- We will help you achieve compliance so that you can move on in a positive direction and leave your problems in the past.