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
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
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
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 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
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
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
The Department of Justice (“DOJ”) recently announced its largest ever health care fraud and opioid enforcement action. In a coordinated effort, DOJ charged 345 defendants with more than $6 billion in fraud losses for submitting false and fraudulent claims to federal health care programs and private insurers. The nationwide enforcement operation has been in motion since April … Continue Reading
On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her … Continue Reading
Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially … Continue Reading
Most readers are likely familiar with the landmark decision issued by the U.S. Supreme Court last week, in which the Court held that Title VII prohibits discrimination on the basis of sexual orientation and transgender status. (Read more about this decision here.) That decision not only provided important clarification to the scope of protections for … Continue Reading
Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing. Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors. They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading
New guidance provided by the U.S. Department of Health and Human Services (HHS) on June 13 delays the quarterly reporting requirement for Provider Relief Fund recipients. The initial report no longer is due in early July.… Continue Reading
Capital One has been ordered to disclose its cybersecurity report about a data breach. We provide tips on how to keep such reports under protection of the attorney client privilege in our post here at the Consumer Privacy World blog by Colin Jennings, Ericka Johnson, and Dylan Yépez. … Continue Reading
The CARES Act requires Medicare providers to attest to multiple certifications. Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.… Continue Reading
