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FDA Announces Proposed Rule Regarding Laboratory Developed Tests

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Considerations for Addressing DOJ’s Corporate Compliance Guidance on Mobile Devices and Messaging Platforms

In light of the DOJ’s most recent guidance on the use of personal devices and third-party messaging applications by corporate personnel, this White Paper addresses issues and challenges that companies are facing in this area...more

Medical Payment Products and Health Care Pricing Practices Draw CFPB Attention

The Consumer Financial Protection Bureau (“CFPB”), Department of Health and Human Services (“HHS”), and United States Treasury have issued an interagency Request for Information (“RFI”) focused on the offering and provision...more

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more

HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more

The U.S. Supreme Court Affirms the Government's Authority to Dismiss FCA Qui Tam Cases After Declining to Intervene

The False Claims Act's ("FCA") use of qui tam relators (private individuals bringing suit on behalf of the government) has long raised both procedural and substantive challenges....more

The U.S. Supreme Court Clarifies the Scienter Standard for False Claims Act Cases

The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more

Sixth Circuit Denies Rehearing in Important Anti-Kickback Statute Case

The decision should prove helpful for those in the health care and life sciences industries whose daily operations require compliance with the federal Anti-Kickback Statute ("AKS")....more

Sixth Circuit Narrows Scope of Anti-Kickback Statute

In Short - The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...more

DOJ Updates Corporate Compliance Program Guidance and Announces New Policy Initiatives and Enforcement Resources

In Short - The Situation: As a follow-up to the deputy attorney general's September 2022 memorandum, the U.S. Department of Justice ("DOJ" or "Department") announced in March 2023 significant updates to its corporate...more

DOJ Announces New Voluntary Self-Disclosure Policy for All U.S. Attorneys' Offices

On February 22, 2023, the U.S. Department of Justice ("DOJ" or "Department") announced the Voluntary Self-Disclosure Policy ("VSD Policy" or "Policy"), detailing the circumstances under which a company can receive credit for...more

2022 False Claims Act Statistics Reveal More New Cases and More Settlements (But Lower Total Recoveries)

In Short: - The Situation: The United States Department of Justice ("DOJ") recently issued statistics and a related press release regarding its fiscal year ("FY") 2022 enforcement activity under the False Claims Act...more

Senate Judiciary Committee Revisits Drug Pricing Reform Bills

The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more

Vital Signs Digital Health Law Update | Winter 2023

Note From the Editors - We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers take an in-depth look at...more

U.S. National Institute of Standards and Technology Releases AI Risk Management Framework

The National Institute of Standards and Technology ("NIST") has released its AI Risk Management Framework ("AI RMF") as a resource to reportedly assist individuals, organizations, and society identify risks associated with...more

DOJ Criminal Division Announces Revisions to its Corporate Enforcement Policy

In Short - The Situation: On January 17, 2023, the U.S. Department of Justice ("DOJ" or "Department") announced significant revisions to the Criminal Division's Corporate Enforcement Policy....more

U.S. Supreme Court to Determine Scienter Standard for False Claims Act Cases

In a momentous event for False Claims Act cases throughout the country, the Supreme Court has granted certiorari to decide the applicable scienter standard....more

Supreme Court Increasingly Wading Into False Claims Act's Morass

In Short - The Situation: The federal False Claims Act ("FCA") allows the United States to dismiss the action if the qui tam relator "has been notified by the Government of the filing of the motion and the court has...more

Global Spotlight on Labor Trafficking in Health Care and Corporate Supply Chains

Courts and legislatures both in the United States and abroad continue to prioritize the eradication of labor trafficking in corporate supply chains, including those in the health care industry. For example, in the United...more

White House Announces Artificial Intelligence Bill of Rights

The Artificial Intelligence Bill of Rights sets forth voluntary guidelines that companies utilizing or developing technology with artificial intelligence can follow to protect users....more

California Attorney General Initiates Novel Investigation Into Potential Health Care Algorithm Bias

On August 31, 2022, the California Attorney General delivered letters to 30 hospitals and health systems across California requesting information regarding commercial decision-making technology tools and their potential...more

Eighth Circuit Requires But-For Causation for False Claims Act Suits Alleging Kickbacks

In Short - The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...more

HHS-OIG Approves Provision of Zero-Interest Financing to Medical Device Customers

The Situation: The practice of manufacturers making available to customers favorable and even zero-interest financing for significant purchases of medical devices is understood to be common and often expected by customers...more

DOJ Announces Second-Largest Annual Total Recoveries in False Claims Act History

DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. - The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more

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