Singapore has open-sourced the world’s first AI governance testing framework and toolkit, called “AI Verify”. As a single integrated software toolkit operating within a user’s enterprise environment, AI Verify allows users to conduct technical tests on their AI models, and record process checks for reporting to any shareholders or regulatory bodies. Additional toolkits can be … Continue Reading
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
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
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
In a blow to the Biden Administration’s goal to heighten enforcement of labor-related competitor agreements, a Maine jury on Wednesday acquitted four home-health operators who were accused of conspiring to fix the wages of home-health workers in the Spring of 2020. The U.S. Department of Justice (“DOJ”) had alleged that the operators violated Section 1 … Continue Reading
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
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
In a recent decision, the United States Court of Appeals for the Ninth Circuit affirmed dismissal of a medical provider’s complaint against a Medicare Advantage Organization (“MAO”) because the provider failed to exhaust all administrative remedies under the Medicare Act. Glob. Rescue Jets, LLC v. Kaiser Found. Health Plan, Inc., 30 F.4th 905 (9th Cir. … Continue Reading
Months following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the reproductive health climate remains clouded with terms lawyers—not to mention patients—never like to hear: “wait and see,” “to be decided,” “gray area,” “it depends.” Perhaps nowhere is the information gap of more crucial import than at the moment a patient walks through … Continue Reading
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
You’ve just been informed that an employee who apparently contracted COVID-19 from an exposure in your workplace brought the virus home, and now their spouse, who is in a high-risk category, has contracted the virus and is in the hospital. Do you as the employer face potential liability for the spouse’s illness? More than two … Continue Reading
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
The Biden Administration’s Interim Final Rule implementing provisions of the No Surprises Act suffered its first major legal setback yesterday. Judge Kernodle of the Eastern District of Texas issued a decision vacating portions of the Rule relating to the independent dispute resolution (“IDR”) process that the Act creates. As we’ve previously reported, the No Surprises … Continue Reading
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
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
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
In March 2020, the State Medical Board of Ohio issued guidance temporarily relaxing Ohio’s telemedicine rules for physicians, permitting physicians to use telemedicine in place of in-person visits in many circumstances for the duration of Ohio’s COVID-19 state of emergency declaration. With Governor DeWine’s termination of the state of emergency in June of 2021, the … Continue Reading
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
For a third time, the Supreme Court has declined to strike down the Affordable Care Act (the “ACA”), this time in a 7-2 ruling in the case of California v. Texas. The Court held that Texas and the 17 other challenging states (the “Plaintiffs”) did not have standing to challenge the ACA, avoiding the need … Continue Reading
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
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
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
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
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
