Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
The FTC’s Rule Banning Non-Compete Agreements | What You Need to Know
An In-Depth Analysis of the CFPB’s Proposed Overdraft Rule - The Consumer Finance Podcast
The FTC Takes Initiative to Stop Junk Fees
Understanding the CFPB's Proposed Digital Payments Larger Participants Rule and Its Implications for Digital Assets — The Consumer Finance Podcast
Instant Decline, Instant Relief? Unpacking the CFPB's Proposed Rule on NSF Fees — Payments Pros: The Payments Law Podcast
Redefining Banking: A Conversation on the CFPB's Proposed 1033 Rule — Payments Pros: The Payments Law Podcast
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
The FTC Announces Three Important Developments
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule – Crossover Episode With Regulatory Oversight Podcast – The Consumer Finance Podcast
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule — Regulatory Oversight Podcast
The Future of Digital Consumer Payment Applications: CFPB's Proposed Larger Participant Rule – The Consumer Finance Podcast and Payments Pros Podcast
Alternatives to Noncompetes: Intellectual Property Alternatives to Noncompetes
Employment Law Now VII-135-Summer 2023 Wrap-Up Part 1 (NEW DOL OVERTIME RULE)
Podcast - Insights on the FTC's Approach to Digital Health Companies
Podcast - SEC's Oversight on Cybersecurity Requirements
The FTC's Proposed Rule to Fight Impersonation Scams
CFPB's Larger Participant Rule for Consumer Payments - The Consumer Finance Podcast
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
This Week in Washington: CBO releases analysis of health insurance rates; Senate Finance Committee Chairman releases draft legislation concerning labor and delivery unit closures; House Oversight and Accountability Committee...more
This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for...more
This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy...more
On April 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule and press release revising the regulations governing the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program,...more
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more
This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual...more
This Week in Washington: Congress passes continuing resolution; CMS releases final rule concerning prior authorization....more
This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes...more
This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs...more
On May 26, 2023, CMS published a proposed rule that would implement new policies under the Medicaid Drug Rebate Program (MDRP) to: (1) address situations in which drug manufacturers incorrectly report or misclassify their...more
Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more
Lots of Healthcare Activity in Congress - Activity in Congress focusing on healthcare issues has increased over the last few weeks and is not slowing down anytime soon. This week, the Senate Health, Education, Labor, and...more
Congress - The House and Senate are in recess for Memorial Day. House - Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation...more
This Week in Washington: President Biden Reiterates Healthcare Priorities and Announces Initiatives in his State of the Union Address...more
This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more
This week in Washington: Discussions on infrastructure and prescription drug changes continue. ...more
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
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
On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers to pharmacy...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more