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
As the lead agency for the Committee on Foreign Investment in the United States (CFIUS or the Committee), the U.S. Department of the Treasury released new proposed rules on April 11, 2024 intended to enhance the enforcement...more
On April 11, 2024, the Treasury Department announced a prepublication copy of a proposed rule amending the regulations of the Committee on Foreign Investment in the United States ("CFIUS") (the "Proposed Rule")....more
On April 15, 2024, the secretary of the Department of the Treasury, as chair of the Committee on Foreign Investment in the United States (CFIUS or Committee), published a notice of proposed rulemaking (Proposed Rule) to...more
On 15 April 2024, the Treasury Department’s Office of Investment Security published a Proposed Rule to revise the regulations governing the Committee on Foreign Investment in the United States (CFIUS or the Committee). The...more
On April 11, 2024, the U.S. Department of the Treasury issued a Notice of Proposed Rulemaking (NPRM) proposing a new rule updating the mitigation and enforcement provisions of the regulations administered by the Committee on...more
The U.S. Department of Treasury (“Treasury”), which is Chair of the Committee on Foreign Investment in the United States (“CFIUS” or the “Committee”), released a Notice of Proposed Rulemaking on April 11, 2024 (“NPRM”) meant...more
The Federal Acquisition Regulation (FAR) Council has proposed two new cybersecurity rules that would impose significant obligations and risks for federal government contractors. The proposed rules impose substantial cyber...more
On September 1, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency...more
On September 1, 2023, CMS issued the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule (the Proposed Rule), which imposes nurse staffing...more
The following is an edited version of a conversation between Goodwin partners Jonathan Hecht and Isaac Vinyarsh. Before joining Goodwin, Jonathan spent more than a decade in the SEC’s Division of Enforcement, including...more
The House and Senate are in recess and will return next week to resume healthcare activity. The Senate Health, Education, Labor and Pensions (HELP) Committee is seeking feedback on a staff-level bipartisan discussion draft to...more
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
On April 14, 2023, the National Highway Traffic Safety Administration (NHTSA) took a major step in formalizing its Whistleblower Program by issuing a notice of proposed rulemaking (NPRM) to formally promulgate regulations...more
On April 4, 2023, CMS issued proposed rules for Fiscal Year (FY) 2024 to update Medicare payment policies for skilled nursing facilities (SNFs) and inpatient psychiatric facilities (IPFs). CMS notes these rules are intended...more
The United States, the European Union, and Germany have recently adopted or proposed new rules requiring enhanced due diligence in supply chains, targeting human rights and environmental issues. This alert examines key...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
The U.S. Department of State (State Department) and U.S. Department of Commerce (Commerce Department), have recently previewed, proposed or finalized changes to relevant trade controls. These new regulatory updates include...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
In This Issue. The Financial Crimes Enforcement Network (FinCEN) issued a proposed rule about the establishment of a limited-duration pilot program for sharing suspicious activity reports (SARs); FinCEN published the final...more
On July 19, 2021, CMS published a proposed rule to update the payment policies, payment rates and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more
The Centers for Medicare and Medicaid Services (CMS) has proposed increasing the penalty for violations of the hospital price transparency rule in the proposed outpatient pay rule announced on July 19, 2021. Hospitals...more
On July 19, 2021 the Centers for Medicare and Medicaid Services (CMS), as part of proposed rule covering a variety of subjects, including Medicare Hospital Outpatient and Ambulatory Surgery Center PPS modifications, issued a...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
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