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McDermott Will & Emery

Are We There Yet? DoD Issues Final Rule Establishing CMMC Program

McDermott Will & Emery on

The US Department of Defense (DoD) published a final rule codifying the Cybersecurity Maturity Model Certification (CMMC) Program. The final CMMC rule will apply to all DoD contractors and subcontractors that will process,...more

Maynard Nexsen

SBA Proposes Rule That Will Change M&A Landscape for Small Business, Recertifications to Impact Award Eligibility

Maynard Nexsen on

The Small Business Administration ("SBA") recently issued a proposed rule that changes the effect of a concern's size recertification following mergers and acquisitions ("M&A") activity. Notably, the proposed rule is...more

Schwabe, Williamson & Wyatt PC

SBA’s Proposed Rule: Affiliation and Negative Control

Comments are due by October 7, 2024. On Friday, August 23, the Small Business Administration issued a proposed rule that would significantly change the SBA’s HUBZone small business contracting program and other small...more

Bass, Berry & Sims PLC

HHS Proposed Rule Seeks to Align Health IT Procurement Standards to Leverage Interoperable Data

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On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements....more

Schwabe, Williamson & Wyatt PC

SBA’s Proposed Rule: Impact on HUBZone and 8(a) Programs

On Friday, August 23, the Small Business Administration issued a proposed rule that would make significant changes to the SBA’s HUBZone small business contracting program, as well as modifications to other small business...more

Holland & Hart LLP

the buzz: Cannabis News & Policy Update - July 2024

Holland & Hart LLP on

Welcome to the buzz, our monthly cannabis news and policy update. Your at-a-glance source for regulatory developments, agency announcements, and trends impacting the cannabis industry. - This month's highlights include: ...more

DarrowEverett LLP

Summarizing Proposed Changes to Florida Rules of Civil Procedure

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The Florida Supreme Court has taken steps to improve the efficiency and effectiveness of civil litigation, and it has issued two separate per curiam opinions introducing proposed substantial amendments to the Florida Rules of...more

Stinson LLP

FinCEN Proposes Expanding AML Rules to Investment Advisers

Stinson LLP on

On February 13, 2024, the Financial Crimes Enforcement Network (FinCEN) of the U.S. Department of Treasury (Treasury) issued a "Notice of proposed rulemaking" (proposed rule) that would require Securities Exchange Commission...more

Schwabe, Williamson & Wyatt PC

New FAR Cybersecurity Requirements for Federal Contractors

This is an advisory update of key responsibilities for contractors under a proposed new Federal Acquisition Regulation (FAR) rule that standardizes cybersecurity requirements for a Federal Information System (FIS). The...more

Davis Wright Tremaine LLP

Banking and Consumer Regulatory Digest - November 2023

The following newsletter provides a roundup summarizing enforcement actions, guidance, rulemakings, and other public statements taken by a federal and/or state financial services regulatory agency, specifically focusing on:...more

Bass, Berry & Sims PLC

FDA Takes Definitive Step Toward the Regulation of LDTs

Bass, Berry & Sims PLC on

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Goodwin

OCC Proposes Rules for CRA Benchmarks and Fair Access

Goodwin on

In the News. The Office of the Comptroller of the Currency (OCC) issued a long-awaited rule seeking comment on its proposed approach to determine the Community Reinvestment Act (CRA) evaluation measure benchmarks, retail...more

Ballard Spahr LLP

CFPB issues proposed rule to require debt collectors to make disclosures for time-barred debts

Ballard Spahr LLP on

The CFPB has issued a proposal that would require debt collectors to make specified disclosures when collecting time-barred debts (Disclosure Proposal).  The Disclosure Proposal supplements the Bureau’s proposed debt...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment Management Update - January 2020

In this issue, we summarize regulatory, litigation and industry developments from October 2019 to early January 2020 impacting the investment management sector, including SEC action on use of derivatives by registered...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

Seyfarth Shaw LLP on

In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Faegre Drinker Biddle & Reath LLP

SEC Proposes Wide-Ranging Changes to Investment Adviser Marketing Rules

On November 4, 2019, the Securities and Exchange Commission (SEC) released a proposed rule amendment (the Marketing Amendment) that would substantially modify SEC Rules 206(4)-1 (the Advertising Rule) and 206(4)-3 (the...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Robinson+Cole Health Law Diagnosis

CMS Proposes Rule Clarifying Physician Self-Referral Law Rules for Group Practice Profit Sharing

On October 9, 2019 the Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published a proposed rule making changes to the Physician Self-Referral Law, also called the Stark Law (PSR...more

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

Womble Bond Dickinson on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more

McDermott Will & Emery

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

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The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

Bricker Graydon LLP

CMS proposes changes to SNF/NF compliance program requirements

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On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule, entitled “Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Efficiency, and Transparency,” that, if...more

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