Sixth Circuit Defines False Claims Standards

The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for “remuneration.”  In a recent decision by the Sixth Court of Appeals, the Court found that a hospital’s decision not to hire an …

Anti-Kickback Statute and Stark Law Recent Updates

Those serving in the health care industry are all too familiar with the Anti-Kickback Statute and the Stark Law – physician self-referral and fraud and abuse laws that prohibit financial payments or incentives for referring patients, specifically a Medicare or Medicaid patient. In December 2020, The Officer of Inspector General (OIG) Final Rule and the …

The Regulatory Sprint to Value-Based Care

On December 2, 2020, the CMS and the OIG published the rules modifying the safe harbors under the Anti-Kickback Statute[1] and exceptions under the Stark Law[2]. This article presents an overview of the value-based rules, which became effective on January 19, 2021. CMS and OIG coordinated many aspects of the value-based rules, and this section …

New Safe Harbors for Telehealth

New and modified safe harbors to the Stark Law and Anti-Kickback statue allow healthcare providers and entities more flexibility to create and expand telehealth platforms in compliant fashion. On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) finalized the rules modifying the safe harbors …

The OIG’s FAQs Related to COVID-19

The  Office of the Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) has developed a process for interested parties to obtain regulatory compliance guidance from the OIG prior to pursuing  arrangements related to COVID-19. The OIG has dubbed this process FAQs–Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease …

Compliance Outside of Health Care

Many providers are familiar with compliance in a health care context. They know to make agreements compliant with the Stark Law and the Anti-Kickback Statute, for instance. But the keys to a good compliance system (policies and procedures, designation of a compliance officer/committee, training and education, communication, ethics and culture, top-down compliance, enforcement, auditing and …

Kicking Off 2020 with Anti-Kickback Statute and Stark Law Reforms: What You Need to Know

You’ve probably heard that every provider’s favorite laws, the Anti-Kickback Statute and its related, strict liability counterpart, the Stark Law (formally known as the Physician Self-Referral Law), are getting a makeover from the Department of Health and Human Services (HHS). Here’s what you need to know. Quick Legal Refresher: (A) What is the Anti-Kickback Statute? …

HHS’s Proposed Modification to the Personal Services Safe Harbor Under the Anti-Kickback Statute

On October 9, 2019, the U.S. Department of Health and Human Services (“HHS”) released newly proposed modifications to the safe harbor provisions for the Federal Anti-Kickback Statute. Among other proposals, HHS is proposing three substantive changes to the personal services safe harbor. Section 1128B(b) of the Social Security Act (commonly referred to as the “Anti-Kickback …