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
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
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more
On July 11, 2023, OIG posted Advisory Opinion 23-04 regarding the use of an online healthcare directory for Federal healthcare program beneficiaries to find and book appointments with medical providers. Requestor sought OIG’s...more
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”). Prior...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
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...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
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
Report on Medicare Compliance 30, no. 4 (February 1, 2021) - Saint Peter’s University Hospital and New Brunswick Cardiac Cath Lab LLC in New Jersey have agreed to pay $3.04 million to settle a civil monetary penalty case...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
As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...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
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
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
HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations - On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...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