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Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

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On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Knobbe Martens

Renewed Efforts in Congress for Pharmaceutical Patent Reform

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With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more

Woodruff Sawyer

Reminder: RxDC Reporting Due June 1st

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With the 2024 reference year RxDC reporting deadline approaching in June, plan sponsors should re-familiarize themselves with the reporting requirements. The 2024 reference year RxDC Reporting Instructions have been released,...more

Maynard Nexsen

2025 Alabama Legislative Update: Regular Session - Week One

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Senator Gudger Officially Elected Senate Pro Tempore This week, Garlan Gudger was sworn in as the new President Pro Tempore of the Alabama State Senate. Pro Tempore Gudger, a Republican from Cullman, was elected unanimously...more

Alston & Bird

Health Care Week in Review: Senate Finance Committee Advances HHS Secretary Nominee RFK, Jr. to the Full Senate; President Trump...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott+

McDermott+ Check-Up: February 7, 2025

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Key Nominations Move Forward. The Senate Finance Committee advanced Robert F. Kennedy (RFK) Jr.’s nomination to lead the US Department of Health & Human Services (HHS) in a 14 – 13 vote along party lines. The nomination now...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

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On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Quarles & Brady LLP

HIPAA Reproductive Health Care Privacy - New Administration Evaluating Its Position

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As the Trump administration stakes dramatically new positions on matters across the federal government, we are waiting to learn its view on the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule,...more

Morgan Lewis - ML Benefits

Medicare Part D Creditable Coverage Online Disclosure Due March 1

Each year, employers that provide prescription drug coverage to Medicare-eligible individuals through a group health plan must complete a two-step process regarding the prescription drug coverage they offer to active...more

Robins Kaplan LLP

ANDA Approvals - Winter 2024

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Latham & Watkins LLP

Overview of Trump’s Executive Order on Pediatric Gender Dysphoria Matters

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Navigating the Trump administration executive order impacting pediatric gender dysphoria evidence, coverage, disclosures, regulation, legislation, and enforcement as well as grants to certain medical institutions, including...more

Foley & Lardner LLP

Physician Practice Private Equity Transactions – A Refresher

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All indications appear to point toward a robust market for health care mergers and acquisitions (M&A) in the coming year. Inflation — finally — appears to be easing. With that, we may continue to see interest rate cuts from...more

King & Spalding

White House Rescinds Memorandum Freezing Federal Spending

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Two days after the White House Office of Management and Budget (OMB) issued a memorandum freezing all federal grants until at least February 10, 2025, the OMB issued a memorandum reversing the spending freeze....more

Foley & Lardner LLP

The Colorado AI Act: Implications for Health Care Providers

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Artificial intelligence (AI) is increasingly being integrated into health care operations, from administrative functions such as scheduling and billing to clinical decision-making, including diagnosis and treatment...more

ArentFox Schiff

Proposed Changes to the HIPAA Security Rule: What Regulated Entities Need to Know

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In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 13 - February 2025

Generally, the last day of a legislative week can end around noon. Not so for lawmakers today!  It turned into a hectic day with lawmakers pushing forward the people’s business so that they could return home for a long...more

Akerman LLP - Health Law Rx

Blizzard of Executive Orders Signals Trump Administration’s Healthcare Priorities

As harsh winter weather swept the nation’s capital, President Donald Trump commenced his second term by signing a blizzard of Executive Orders (EOs) that span many hot-button issues. Several of the EOs signal President...more

Bradley Arant Boult Cummings LLP

HHS’s Proposed Security Rule Updates Will Substantially Increase the Controls Needed to Comply with the Technical Safeguard...

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are tackling the proposed updates...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

Goodwin

EU Biosimilar Regulatory and Launch Updates

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CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more

Arnall Golden Gregory LLP

Industry Group Challenges Mental Health Parity Act Final Rules

On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed a lawsuit against the U.S. Department of Health and Human Services and other federal agencies, seeking to invalidate the final rules under the Mental Health...more

Parker Poe Adams & Bernstein LLP

Third Circuit Upholds Verdict Against Home Health Agency Based on Employee Travel Time During Working Day

For most non-exempt employees, the Fair Labor Standards Act considers time spent traveling during the working day to be compensable working time. Last week, the Third Circuit Court of Appeals applied this principle to travel...more

Knobbe Martens

Heading Towards an Optimistic Initial Public Offerings (IPOs) Resurgence in 2025?

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On January 16th, 2025, GT Medical Technologies, announced that it has raised $37 million in Series D financing round. The financing round was led by Evidity Health Capital and joined by Accelmed Partners. Current investors...more

Goodwin

BioNTech Acquires Biotheus To Boost Oncology Strategy

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On February 3, 2025, BioNTech SE (“BioNTech”) confirmed the completion of its acquisition of biotechnology company Biotheus for an upfront payment of $800 million and up to $150 million in potential milestone payments. ...more

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