Recognizing the evolving landscape of care delivery and growth of telehealth, the U.S. Department of Health and Human Services (HHS) published a resource guide aimed at assisting telehealth providers in explaining the privacy and security risks to patients that engage in telehealth. The guide explains the risks in telehealth visits and ways to reduce these risks. Importantly, the guidance makes clear health care providers are not required by Health Insurance Portability and Accountability Act of 1996 (HIPAA) to provide this education. However, the goal is that the resource guide will help ..read more

On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued its 2024 Physician Fee Schedule final rule (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes to improve access to behavioral health care in Medicare’s history. These changes further the goals of CMS’s Behavioral Health Strategy as follows: For the first time, CMS allows Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs) to enroll in Medicare Part B and bill for their services. CMS expands billing flexibilities through the creation of n ..read more

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 Schedule final rule (2024 Final Rule) addresses billing scenarios and requests for clarifications on the appropriate use of these remote monitoring codes. The 2024 Final Rule clarifies CMS’ position on how it interprets certain requirements for these services. CMS rejected some of the proposals contained ..read more

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 strengthen privacy-preserving research and technologies, while developing guidelines for federal agencies. The provisions in this order will have a lasting impact on all facets of the health care industry that utilize or may in the future utilize AI models and systems. Prior to the release of the EO, the administration met w ..read more

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, with attendant potential pitfalls to navigate. The DPH’s new licensure regulations will permit requiring vaccines for a broad group of personnel, unless the individual declines the vaccine. Importantly, however, the new rules will also allow a hospital (or other DPH-licensed facility) to establish its own vaccination requirements that ..read more

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, applications opened. Eligible providers have until November 30, 2023 to submit their applications to CMS. As identified in the Scope section, CMS is accepting applications from Medicare-enrolled organizations located in the following states: Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, upstate New York, North Carolina, and Washington. The following ..read more

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 on the same topic and represents FDA’s current perspective. FDA is accepting comments and suggestions on this draft guidance for 60 days following publication. FDA’s Goal with the Draft Guidance. The draft guidance notes FDA’s goal of striking a balance between supporting health care professional (HCP) interest i ..read more

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance). This guidance updates previous guidance issued during the COVID-19 pandemic and is meant to provide clarity on current enforcement policies now that the public health emergency is declared over. Limited Modifications to Indications or Functionality. In its guidance, FDA announced that the administration does not intend to object to limited modifications to the indications o ..read more

On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert regarding the potential risks associated with compounded ketamine nasal spray. The October 10 warning notes that even though there has been widespread marketing for ketamine to treat psychiatric disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder), the FDA has not approved ketamine for any of these indications. Drug comp ..read more

A panel discussion moderated by Sofia Guerra of Bessemer Venture Partners aptly titled “The Great Leveling Out” provided some clear insights into how investors view the current state of play in digital health markets. Laura Veroneau, Managing Director of Optum Ventures, Andrew Adams, Managing Director of Oak HC/FT and Nick Richtt, Managing Director of JPMorgan, covered the topic from early stage to mature private equity (PE) financed to public strategic buyers. Capital Efficiency Not surprisingly with valuations and funding down sharply in 2023, investors are looking for companies wi ..read more