Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.” This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
Physician consolidation continued on a robust pace this past year, despite, or maybe because of, the Pandemic. Physician-owned orthopedic practices appear to be no exception to this trend. Interestingly, orthopedic...more
For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more
The Department of Health and Human Services (“HHS”), in collaboration with the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”), has issued two final rules clarifying certain...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
On November 20, 2020, over one year after releasing proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law), the Department of Health and Human Services’ Office of the Inspector...more
As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more
The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare &...more
Two new healthcare fraud and abuse final rules, effective Jan. 19, 2021, may increase flexibility for private equity firms exploring opportunities in the healthcare space as well as private equity-backed healthcare platforms...more
In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect. These changes, which are part of the...more
On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final...more
The U.S. Department of Health and Human Services (“HHS”) recently issued two corresponding final rules amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”),...more
HHS Announces Formation of FCA Working Group - On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more
OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly. Introduction - On November 20,...more
On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion...more
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more
With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more