Under Federal Rule of Civil Procedure 23(b)(3), a district court may certify a damages class if “the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that
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IP 101 for Emerging Healthy F&B Companies
Intellectual property protection is essential for emerging companies in the healthy food and beverage (“F&B”) space to attract investors and stand out from competitors. To gain a competitive edge, companies should understand and be intentional about building their intellectual property…
Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program.
The guidance published in the 2024 Physician Fee…
Massachusetts: Proceed With Caution – New Vaccination Criteria for Hospitals and Other Licensed Health Facilities
Following public hearings and at least 78 public comments, at the end of October, hospitals and other facilities licensed by the Massachusetts Department of Public Health (DPH) will have new flexibility to require both flu and COVID-19 vaccinations for personnel,…
New Biden EO on AI Oversight, Development, and Use: Implications for the Health Care Industry
On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used in the health care industry. The order seeks to…
HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long partnership between the Office of Inspector General (OIG) and…
NLRB’s New Rule Sings “Come Together, Right Now”
On October 26, 2023, the National Labor Relations Board (NLRB or the “Board”) issued its long-awaited final rule (the “New Rule”) addressing the standard for determining joint-employer status under the National Labor Relations Act (NLRA). The new rule…
White House Issues Extensive AI Executive Order
As has been widely reported, the White House issued a comprehensive and sweeping (some might say overly broad) Executive Order on October 30 about “the Safe, Secure, and Trustworthy Development, and Use of Artificial Intelligence.” Interest in Artificial Intelligence (AI)…
CMS’ Making Care Primary (MCP) Model: Applications Due November 30, 2023
By Clara Greaney & James Miles
The Centers for Medicare and Medicaid Services’ (CMS) new program Making Care Primary (MCP), is anticipated to begin July 1, 2024.
In a previous blog post Foley breaks down major highlights of the new model.
On September 5, 2023,…
FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on its website. This guidance supersedes its 2014 draft guidance…