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FEPA: the New Tool in the DOJ’s Fight Against Corruption

Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA).  The Act, which has been referred to as  “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a … Continue Reading

The End of “Chevron” or Its Rebirth?

Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US … Continue Reading

Webinar:  The New Foreign Extortion Prevention Act – What It Means for US Companies

On Tuesday January 30, we hope you will join a seasoned team of former Department of Justice (DOJ) prosecutors for what will certainly be a robust a discussion on “the most consequential anti-foreign-bribery law passed in almost 50 years”: the Foreign Extortion Prevention Act (FEPA). Passed as part of the National Defense Authorization Act (NDAA), … Continue Reading

US Antitrust Agencies Release 2023 Merger Guidelines

On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the … Continue Reading

Federal Courts Continue to Grapple with Causation in Anti-Kickback-Based False Claims Act Cases

Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations.  Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United … Continue Reading

Considering DPF Certification? It May be Worth Considering APEC Certifications, Too

It has become commonplace to talk about compliance becoming more and more of a challenge amidst the increasing complexities and fragmentation of regulations worldwide. Data protection compliance is no exception. As new requirements continue to mushroom across the globe with escalating frequency and accompanied by heightened repercussions for any failure to meet expected standards, global … Continue Reading

Join us on September 28 for a Webinar on Washington’s My Health My Data Act and other Consumer Health Data Regulation

With its private right of action and expansive scope – extending far beyond Washington state’s borders and applying to a wide swath of health- and non-health-oriented companies alike – Washington’s My Health My Data Act is poised to be more ground-shifting than any other consumer privacy law that came before it. Join Kyle Fath, Bola … Continue Reading

Supreme Court Clarifies Knowledge Requirement for False Claims Act Liability

In April, we previewed two significant False Claims Act (FCA) cases before the U.S. Supreme Court, United States ex. rel. Schutte v. SuperValu, Inc., No. 21-1326 (“SuperValu”), and United States ex. Rel. Proctor v. Safeway, Inc., No. 22-111 (“Safeway”).  The FCA provides that “any person who knowingly presents, or causes to be presented, a false or fraudulent claim” to the United … Continue Reading

Healthcare Companies and Companies Doing Business with the US Government – Supreme Court Appears Likely to Clarify False Claims Act (FCA) Knowledge Requirements

The Supreme Court recently heard oral argument in the appeal of two False Claims Act (FCA) cases from the Seventh Circuit that called into question the level of intent, or scienter, required to establish corporate liability under the FCA for “knowingly” overbilling the government for goods or services.  The Court’s eventual decision may have widespread … Continue Reading

Sixth Circuit Limits Anti-Kickback Claims Brought Under False Claims Act

Recently, the Sixth Circuit issued an important decision limiting the scope of claims alleging violations of the Anti-Kickback Statute that are brought under the False Claims Act. In Shannon Martin, M.D., et al. v. Hathaway, et al., No. 22-1463 (March 28, 2023), the court clarified the meaning of remuneration under the Anti-Kickback Statute. Squire Patton … Continue Reading

Bankruptcy Court Doors Swing Open For Cannabis Companies, But Just Slightly

Are bankruptcy doors now opening for cannabis companies?  A recent decision from a California bankruptcy court indicates perhaps so, at least for cannabis companies that are no longer operating. Squire Patton Boggs partner Mark Salzburg discusses this case and its implications on our Restructuring GlobalView blog, available at this link.… Continue Reading

Revamping of Cosmetics Regulation and Safety

President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes … Continue Reading

California’s Senate Bill 1019 Seeks to Expand Access to Mental Health Benefits for Medicaid Enrollees

In an effort to expand access to mental health services, on September 30, 2022, California’s Governor approved Senate Bill 1019, which modifies the California Welfare & Institutions Code as it relates to Medi-Cal managed care plans (“MMCP”). No later than January 1, 2025, MMCPs must develop and implement an annual outreach and education plan for … Continue Reading

Healthcare Non-Competes in 2022: Status Following Recent Developments

For healthcare entities that use non-compete agreements, the landscape has changed as much recently as it has at any point in recent memory.  Several developments at the federal level have created a potential pitfall that did not materially exist until recently, i.e., a non-compete agreement violating antitrust law.  Further, several recent state laws have heightened … Continue Reading

Healthcare Research: A Transatlantic and Trans-European Dialogue Seminar

On November 23rd, a Squire Patton Boggs partner will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues.  Topics to be explored include: What are the challenges that companies need to face in order to promote research with health data? What should evolve in the legal framework … Continue Reading

COVID-19 Vaccine Mandate Fundamentals for Healthcare Employers

Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status.  Fortunately, they now have much more certainty, which allows for more specific and detailed planning to address the myriad vaccination-related requirements that … Continue Reading

OSHA and CMS to Require Employers to Mandate Vaccines or Weekly Negative Tests

The Occupational Safety and Health Administration, as well as the Centers for Medicare & Medicaid Services, are preparing to issue new requirements that will have a major impact on healthcare employers, as well as other employers across the U.S.  On Thursday, the executive branch announced its plans to have OSHA require employers to ensure that … Continue Reading

Will Patents Become More Political? The PTO Begins to Implement Arthrex

In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). … Continue Reading

Healthcare Employers Take Note: OSHA Issues New Temporary Standard

Since the outbreak of COVID-19, the Occupational Safety and Health Administration had limited itself to issuing general guidance concerning COVID-19, as opposed to specific rules or standards. On Thursday, however, OSHA announced that it will issue its first standard specific to COVID-19 for healthcare workers. Although the standard is temporary, it creates significant obligations for … Continue Reading

Webinar: Got Data?: How the Health Data Rules are Changing

On June 1, an SPB Partner and other industry experts will co-present on the ABA Webinar: Got Data?: How the Health Data Rules are Changing. The program, organized by the American Bar Association (ABA) will address recent and upcoming developments impacting health data including, CMS and ONC final rules on information blocking and interoperability, HIPPA and guidance … Continue Reading

Federal Appellate Court Tosses Out HIPAA Penalty for Healthcare Data Breaches, Criticizes OCR

In a dramatic rebuttal of how the Department of Health and Human Services Office of Civil Rights’ (“OCR”) has historically enforced HIPAA with potential far-ranging consequences, the Fifth Circuit Court of Appeals recently handed down a landmark decision criticizing and restricting how OCR interprets HIPAA and OCR’s penalty authority.  OCR brought an enforcement action against … Continue Reading

AHLA Podcast: Labor and Employment Issues with COVID-19 Vaccine Distribution

Squire Patton Boggs Of Counsel Will Kishman recently participated with Kristin McGurn, Seyfarth Shaw LLP, in an American Health Law Association’s (AHLA) Speaking of Health Law podcast, “Labor and Employment Issues with COVID-19 Vaccine Distribution.”  It has been published on the AHLA’s Speaking of Health Law channel, and is available to the public.  You may … Continue Reading

HHS pirouettes back to original position that Provider Relief Fund payments may be used to replace gross revenue, not just profits, lost due to the coronavirus

On October 22, the Department of Health and Human Services (HHS) updated its guidance on how hospitals and other providers should report their use of the nearly $135 billion in Provider Relief Fund payments that have been distributed.  The Provider Relief Fund, initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is … Continue Reading

CMS Adds 11 New Approved Telehealth Services During the COVID-19 Pandemic and Updates Guidance to States on Medicaid Telehealth Expansion

On October 14, the Centers for Medicare and Medicaid Services (CMS) announced that it has expanded its list of telehealth services approved for Medicare beneficiaries during the COVID-19 Public Health Emergency (PHE).  The eleven telehealth services CMS just added are for cardiac and pulmonary rehabilitation.  CMS approved them using an expedited process it unveiled in … Continue Reading
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