News & Analysis as of

Healthcare Distributors

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Sheppard Mullin Richter & Hampton LLP

Texas Considers Comprehensive AI Bill

Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more

Arnall Golden Gregory LLP

OIG Approves Dental Supplies Distributor’s Plan to Expand Loyalty Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-10 (the “Opinion”) to a dental supplies distributor (the “Requestor”...more

Gardner Law

State Registration Enforcement

Gardner Law on

Are you licensed to sell in these states? Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more

Epstein Becker & Green

Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more

Sheppard Mullin Richter & Hampton LLP

MSPV 2.0 Is Dead – Long Live MSPV

It’s official: the Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program is no more. The VA has announced that it will not revive MSPV 2.0 following several unusually painful protests at...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Stinson LLP on

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Holland & Knight LLP

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Mintz - Health Care Viewpoints

Former ArthroCare CEO and CFO Charged with Securities Fraud, Wire Fraud

On July 16, 2013, the U.S. Department of Justice (DOJ) indicted Michael Baker and Michael Gluk, the former CEO and CFO, respectively, of ArthroCare Corp. – a Texas-based publicly traded surgical device company. Baker and...more

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