For several years now, the United States Department of Justice (“DOJ”) has indicated an increased desire to exercise its dismissal authority over qui tam actions, even over the objections of relators who initially brought the claims.  However, the slight uptick in such dismissals was seemingly stunted while United States ex rel. Polansky v. Exec. Health Res., Inc., 599 U.S. 419 (2023) (which involved the scope of the government’s authority to dismiss False Claims Act (“FCA”) qui tam actions) made its way to the United States Supreme Court (“SCOTUS”).  Now, however, following SCOTUS ..read more

In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”). In United States, et al., ex rel. Hart v. McKesson Corp, the Court found that to act willfully, a defendant must have knowledge that their conduct is unlawful, even if the defendant is unaware of the AKS specifically. This means that a defendant must have a “bad purpose” or intent to do something the law forbids, but does not need to be aware of the ..read more

On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. The HTI-1 Final Rule finalizes statutory requirements required by the 21stCentury Cures Act (Cures Act) to issue policies on information blocking and the ONC Health IT Certification Program (Certification Program). In addition, the HTI-1 Final Rule’s predictive decision support ..read more

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes recommendations to conduct annual internal risk assessments, to consider quality of care as a component of the compliance program, and to emphasize the importance of a board’s and executive leadership’s oversight of compliance. Starting ..read more

Last week, the Office for Civil Rights (“OCR”) announced a settlement with Lafourche Medical Group (“LMG”), a Louisiana medical group, for a 2021 phishing attack and breach that affected the protected health information (“PHI”) of 34,862 individuals. In addition to paying $480,000 to OCR, LMG agreed to a corrective action plan that will include implementing security measures to protect electronic PHI, developing written policies and procedures to comply with HIPAA rules, and training staff members. Through a phishing attack, in March 2021, a hacker gained access to an owner’s email account. Th ..read more

On November 8, 2023, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security discussed the impact of artificial intelligence (AI) on the healthcare sector in the Committee’s second AI hearing in nine days. The hearing comes as the White House and Congressional leaders seek to quickly respond to AI threats, mitigate its dangers, and harness its potential for American industry. Senators discussed the recent Executive Order issued by the White House to guide AI regulation and innovation across all sectors, including in the ..read more

Last week, the Office for Civil Rights (“OCR”) issued two pieces of guidance on the privacy and security of protected health information (“PHI”) when using telehealth services. One of the documents is intended to help health care providers explain to patients, in plain language, the privacy and security risks of using remote communication technologies for telehealth (the “Provider Telehealth Guidance”). The other provides tips to patients on how to safeguard their PHI when using video apps and other technologies for telehealth (the “Patient Telehealth Guidance”). The COVID-19 public health eme ..read more

On September 14, 2023, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule updating Section 504 of the Rehabilitation Act of 1973 (“Section 504”). The new rule entitled Discrimination on the Basis of Disability in Health and Human Service Programs or Activities(the “Proposed Rule”) is the first major regulatory update to Section 504 in nearly 50 years.  Section 504 prohibits discrimination against individuals on the basis of disability in programs and activities that receive Federal financial assistance (“FFA”) or are conducted by a Federal agency.  Sec ..read more

On September 1, 2023, the U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (“CMS”) issued a much anticipated and contested proposed rule that seeks to establish minimum staffing level requirements for nursing homes.  The proposed rule represents the first time the federal government has proposed comprehensive nationwide nursing home staffing requirements, although various states have already enacted their own staffing requirements. Proposed Staffing Standard – 3.0 HPRD Under the proposed rule nursing homes would have to, at a minimum ..read more

On July 21, 2023, the Department of Health Care Access and Information of the California Health and Human Services Agency released a Notice of Proposed Rulemaking (the “Proposed Rule”) with regulations that would implement new financial and ownership transparency requirements for skilled nursing facilities (“SNFs”) in California. Senate Bill 650, which was signed into law in October 2021 and codified at Section 128734.1 of the California Health and Safety Code, requires organizations that operate, conduct, own, manage, or maintain a SNF to file annual consolidated financial reports w ..read more