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Dentons

Ep. 45 – Update Your Return of Overpayments Policy to Align With CMS Changes to the 60-day Rule

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Providers are required by federal law to return Medicare and Medicaid overpayments within 60 days of identifying the overpayment or they can be liable under the False Claims Act. Since 2016, providers have relied on Centers...more

Littler

OSHA Withdraws Proposed Rules Involving COVID-19 and Infectious Diseases

Littler on

Last week, OSHA published a notice in the Federal Register that it was withdrawing its proposed rule, Occupational Exposure to COVID-19 in Healthcare Settings, effective immediately. OSHA explained it was withdrawing the...more

Epstein Becker & Green

At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration...

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Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers....more

Mintz

Health Law Diagnosed – The 2024 Election and Health Care Policy

Mintz on

In the latest episode of Health Law Diagnosed, host Bridgette Keller dives into potential health care policy changes on the horizon following the November 2024 election. She is joined by Alex Hecht, ML Strategies Executive...more

Akin Gump Strauss Hauer & Feld LLP

Delivering Emergency Price Relief for American Families and Defeating the Cost-of-Living Crisis

The Order requires all executive departments and agencies to deliver emergency price relief, consistent with applicable law, to the American people and increase the prosperity of the American worker. This will include actions...more

Ballard Spahr LLP

Key Takeaways From the 2025 J.P. Morgan Health Care Conference

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Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more

Akin Gump Strauss Hauer & Feld LLP

Withdrawing the United States from the World Health Organization

This Order directs the United States to withdraw from the World Health Organization (WHO). Additionally, the EO revokes (1) the Presidential Letter to the Secretary-General of the United Nations signed on January 20, 2021,...more

McDermott+

Healthcare Preview for the Week of: January 21, 2025

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First Official Week of Trump 2.0 - President Trump officially began his second term yesterday. He briefly discussed healthcare in his first inaugural speech, committing to tackle chronic disease and keep children safe,...more

Benesch

Dialysis & Nephrology Digest - January 2025

Benesch on

Happy New Year and welcome to our 2024 Trade Secret and Restrictive Covenant Year in Review. 2024 was less stressful and dramatic than most people feared at the start of the year, but there still were some significant rulings...more

Foley Hoag LLP - Cannabis and the Law

Kentucky Cannabis Marketplace Begins to Bloom

Medical cannabis in the Commonwealth of Kentucky is now legal as of January 1, 2025, with increasing opportunities for businesses and patients alike. Investors and market participants should be aware that, although cross...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

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Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Venable LLP

Red Dye No. 3 Ban at FDA and What's Next

Venable LLP on

On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

Goodwin

How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

Goodwin on

Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

McCarter & English, LLP

Season of Enforcement: OCR Announces Its Sixth Enforcement Action of 2025

With 2025 barely three weeks old, the US Department of Health and Human Services Office for Civil Rights (OCR) has already announced six enforcement actions for the new year. Particularly significant is the advancement of...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Ropes & Gray LLP

False Claims Act Insights: Key Takeaways from DOJ’s Fiscal Year 2024 Cases & Recoveries

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The U.S. Department of Justice (DOJ) announced last Wednesday that settlements and judgments under the False Claims Act (FCA) exceeded $2.9 billion in fiscal year 2024—up approximately 5% from last year. DOJ’s announcement...more

Morrison & Foerster LLP

DOJ Announces $2.92 Billion in False Claims Act Recoveries in Fiscal Year 2024

The Department of Justice published its False Claims Act (FCA) statistics for Fiscal Year 2024 this month, revealing a nearly 40% increase in whistleblower filings, increased recoveries year over year, and a near record...more

Dinsmore & Shohl LLP

DEA Expands Telemedicine Flexibilities Through Three New Rules

Dinsmore & Shohl LLP on

The landscape of telemedicine in the United States is undergoing a profound transformation. On January 16, 2025, the Drug Enforcement Administration (DEA) unveiled a series of regulatory changes designed to expand and...more

Groom Law Group, Chartered

This Week From the Hill (January 19 – 25, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Hogan Lovells

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

Hogan Lovells on

On January 14, 2025, the U.S. Food and Drug Administration (FDA) issued its proposed rule on front-of-package nutrition labeling (FOPNL). With certain exemptions, the proposed rule would require food products to display an...more

Hogan Lovells

FDA unveils long-awaited guidance on AI use to support drug and biologic development

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The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

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