Healthcare providers practice in one of the most highly-regulated industries in the country and are under intense scrutiny by the government and private insurance companies. You can be subject to civil and criminal investigations including those conducted by the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services Office of Inspector General (HHS-OIG), Department of Justice (DOJ), Office of Civil Rights (OCR), Federal Bureau of Investigation (FBI), and Drug Enforcement Administration (DEA) as well as state and local agencies. I can assist and defend you in these investigations.
When considering federal investigations, two important aspects are the Anti-Kickback Statute and the Stark Law.
In 2017, spending on healthcare consumed 28% of the federal budget, a larger share than national defense and second only to social security/unemployment. Healthcare’s share of the budget will grow as the federal government continues to extend its tentacles into this aspect of the economy. And as it does so, the government will likely continue trying to control escalating costs using any tool at its disposal. One tool it is using with more frequency and aggression is the Anti-Kickback Statute (AKS).
The AKS makes it a crime to knowingly and willfully solicit or receive remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by a federal healthcare program. The penalties for violating the statute are steep. Each violation is punishable by up to a $25,000 fine, 5 years in prison, or both.
The language of the AKS is shockingly broad and ambiguous, and its penalties severe including criminal charges, hefty fines, and possible imprisonment. It criminalizes actions which would be perfectly legal in other industries.
Recognizing that AKS criminalizes a broad swath of conduct and is difficult to interpret, Congress authorized the Department of Health and Human Services to create “safe harbors.” These safe harbors provide ways you can structure your transaction to avoid AKS liability. Many of the safe harbor structures would technically violate the AKS—but for the regulation’s explicit promise that the “practices shall not treated as a criminal offense.” Each safe harbor has stringent requirements which must be met to qualify for protection.
I can help evaluate your transactions and circumstances to determine your risk under the AKS and whether a safe harbor may apply. I can also assist in structuring your practices so that they fall within a safe harbor.
If the federal government has already initiated an investigation, served you with a subpoena, or executed a search warrant, I can help you evaluate your rights and options.
The Stark Law prohibits physicians from referring Medicare or Medicaid patients for designated health services to entities in which the physician (or an immediate family member) has an ownership interest. It also prohibits the entity from submitting a bill for services arising from a prohibited referral.
Unlike the Anti-Kickback Statute, Stark imposes only civil penalties. Nonetheless, violating Stark can subject you to severe monetary fines of up to $15,000 per violation and up to $100,000 for a Stark circumvention scheme. The government can also exclude you from participating in Medicare and Medicaid.
Stark is a strict liability law, which means a violation of its provisions—even if unintended—will subject you to liability.
There are numerous statutory and regulatory exceptions to Stark. Many of these exceptions are complex and they must be followed precisely to ensure no Stark liability. If structured properly, an exception may be available for the following compensation arrangements and services.
Given the risks you face, it is important to structure your transaction to ensure you have complied with all facets of any exception. I can help you evaluate your situation to avoid Stark liability. If you are already the subject of a government investigation, I can advocate for you.