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McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

PilieroMazza PLLC

OCI Mitigation Plans: Proposed Rule Emphasizes Compliance and Increased Enforcement

PilieroMazza PLLC on

PilieroMazza recently published a client alert regarding a Proposed Rule on Organizational Conflicts of Interest (OCI). On January 15, 2025, DoD, GSA, and NASA (collectively, the Government) issued a Proposed Rule (Proposed...more

A&O Shearman

DoD Cybersecurity Maturity Model Certification requirements go into effect

A&O Shearman on

On December 16, 2024, the new Cybersecurity Maturity Model Certification (CMMC) 2.0 program from the U.S. Department of Defense (DoD) will go into effect. CMMC 2.0 aims to improve cybersecurity standards within the defense...more

McCarter & English, LLP

CMS Proposes Further Changes to Medicare Overpayment Rule

McCarter & English, LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule, 89 FR 61596, that revives portions of a 2022 proposal to amend the Medicare Overpayment Rule. The 2024 proposed rule comes after...more

BakerHostetler

(Cyber)Security Theater 101 - Georgia Tech, a Teachable Moment

BakerHostetler on

On August 22, 2024, the United States intervened in a whistleblower suit against the Georgia Institute of Technology, initially filed by current and former members of Georgia Tech’s cybersecurity team, alleging that Georgia...more

Fox Rothschild LLP

The Future of DOD Cybersecurity Is Here – The CMMC 2.0 Proposed Rule

Fox Rothschild LLP on

On August 15, 2024, the Department of Defense (DOD) announced the much-anticipated Proposed Rule that would amend the Defense Federal Acquisition Regulation Supplement (DFARS) to include Cybersecurity Maturity Model...more

Epstein Becker & Green

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

Epstein Becker & Green on

Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more

Skadden, Arps, Slate, Meagher & Flom LLP

How Defense Contractors Can Prepare Now for CMMC Implementation

The Department of Defense (DoD) is currently reviewing and adjudicating the public comments received in response to its proposed regulations implementing its Cybersecurity Maturity Model Certification 2.0 program (CMMC)....more

Proskauer - Health Care Law Brief

CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments

In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more

Goodwin

Paying for Buy-Side Investment Research: New Rules Ease the US-UK Divide

Goodwin on

In our previous alert, Paying for Buy-Side Investment Research: Will the FCA’s Third Way Ease the US-UK Divide?, we discussed the consultation issued by the Financial Conduct Authority (FCA) on proposed rules on payment...more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes to Amend Overpayment Rule-Questions Remain Regarding How the Rule Will be Implemented Should CMS Adopt the False...

On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning...more

Troutman Pepper Locke

New Staffing Mandates for Long-Term Care Facilities

Troutman Pepper Locke on

Last month, on April 22, the Centers for Medicare & Medicaid Services (CMS) issued its Minimum Staffing Standards for Long-Term Care Facilities final rule, which will apply to any long-term care (LTC) facilities that receive...more

Akin Gump Strauss Hauer & Feld LLP

FCA to Permit Research Bundling

The Financial Conduct Authority (FCA) is seeking views on proposed rules that would allow asset managers to opt for bundled payments for third-party investment research, reversing a significant aspect of the UK’s...more

Jones Day

The Department of Defense Proposes the Much-Anticipated CMMC 2.0

Jones Day on

On December 26, 2023, the Department of Defense ("DoD") published a proposed rule to implement the Cybersecurity Maturity Model Certification ("CMMC") 2.0, which will establish comprehensive cybersecurity requirements for...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

CMMC 2.0: Defense Contractors Get Ready

Goodwin on

The US Department of Defense (DoD) has issued a proposed rule to implement its long-awaited Cybersecurity Maturity Model Certification program (CMMC 2.0). This proposed rule — released on December 26, 2023, and published in...more

Pillsbury Winthrop Shaw Pittman LLP

Department of Defense Delivers Highly Anticipated CMMC Proposed Rule

The proposed rule requires contractors to make annual affirmations regarding their cybersecurity maturity, thus increasing their risk of False Claims Act Liability. The proposed rule allows for limited use of Plans of...more

Holland & Knight LLP

Department of Defense Releases Long-Awaited CMMC Proposed Rule

Holland & Knight LLP on

Two years after announcing the second iteration of the U.S. Department of Defense's (DoD) Cybersecurity Maturity Model Certification (CMMC) program, the DoD released its proposed rule that, if adopted, will implement the...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Akin Gump Strauss Hauer & Feld LLP

Government Contractors Beware: New Cybersecurity Rules and False Claims Act Enforcement Actions on the Rise

Two years after the Department of Justice (DOJ) established its Civil-Cyber Fraud Initiative, there has been a recent uptick in enforcement and regulatory activity related to cybersecurity. September opened with the unsealing...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Perkins Coie

Proposed FAR Rules Introduce New Compliance Obligations and False Claims Act Risks for Government Contractors

Perkins Coie on

The Federal Acquisition Regulatory (FAR) Council published two proposed rules on October 3, 2023, that would impose significant new cybersecurity obligations on government contractors, including requiring them to share...more

Morrison & Foerster LLP - Government...

The FAR Council’s Proposed Cybersecurity Overhaul: Lots Of Questions, But Only Some Answers

In what can best be described as a tsunami of cybersecurity regulation, the Federal Acquisition Regulation (FAR) Council—consisting of the Department of Defense (DoD), General Services Administration (GSA), and National...more

Sheppard Mullin Richter & Hampton LLP

Two New Cybersecurity Proposed Rules Mean Big Changes for Federal Contractors

On October 3, 2023, the FAR Council released two long-awaited proposed rules for federal contractor cybersecurity stemming from the Biden Administration’s Cybersecurity Executive Order from May 2021 (Executive Order 14028)....more

Venable LLP

OMB Pre-Releases Much-Anticipated Rewrite of the Uniform Guidance

Venable LLP on

On December 26, 2013, the Office of Management and Budget (OMB) issued the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (commonly referred to as the "Uniform Guidance"). The...more

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