ADVAMED CODE 2022 UPDATES

The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (2022 Code) on March 18, 2022. The 2022 Code will become effective on June 1, 2022.

In general, the Code updates focus on value-based care arrangements and address the integration of medical technology across products and services. The updates reflect medical device industry efforts to adjust compliance programs to address OIG’s preclusion of medical device companies from taking advantage of the new value-based safe harbors (except in limited circumstances involving digital health technology). Highlights from the 2022 Code updates include the following:

• An emphasis on data-driven devices and solutions. The 2022 Code acknowledges the expanding role of data analytics and technology in the medical technology industry and updates guidance throughout to consider virtual events and related issues.

• Updated guidance on company-conducted programs, meetings, education and training for value-based care arrangements. The Code underscores that companies have a legitimate need to educate and train healthcare professionals on how to incorporate and use their medical technologies, as defined by the 2022 Code. Meetings with healthcare professionals to discuss value-based solutions, services or other arrangements may be permissible with appropriate safeguards. Arrangements that advance value-based care may include product trainings and education activities. HEALTHCARE REGULATORY CHECK-UP 13

• Addition and expansion of certain defined terms, including “medical technology,” “value-based care” and “virtual.” Updates to definitions reflect OIG’s efforts to modernize the Code. Definitions are similar to terminology used in the AKS value-based enterprise safe harbor provisions concerning digital health (see, e.g., 42 CFR § 1001.952(ee)(14)(ii), defining “Digital health technology”). However, the 2022 Code takes a broader approach, as certain arrangements may still be permissible under a facts and circumstances analysis even if criteria for a particular safe harbor are not met.

Our recent On the Subject includes a chart that may be helpful when reviewing the updated Code. It identifies changes made to each section and provides a comparison to earlier versions of the Code.

THE BIDEN ADMINISTRATION’S REGULATORY FOCUS ON NURSING HOMES

Shortly before the State of the Union address on March 1, 2022, the Biden Administration issued a fact sheet outlining its policy priorities for nursing home reforms. The fact sheet can be seen as a reaction to two related areas of concern for the administration: perceived quality problems in nursing homes emphasized by the COVID-19 pandemic, and the perceived increasing role of private equity investment in nursing homes. This fact sheet came on the heels of a January 2022 OIG report finding that CMS has provided inadequate oversight and enforcement of state and federal nursing home requirements. It will reverse several Trump-era policies that relaxed infection control requirements prior to the pandemic.

In the fact sheet, the Biden Administration cited to several studies that found worse outcomes and lower quality in private- equitybacked facilities. The fact sheet also emphasized ongoing impacts of the pandemic and other emergencies, such as evacuations in response to wildfires and hurricanes.

The fact sheet’s most significant policy proposals include minimum staffing requirements; an “accelerated” phase-out of rooms with three or more residents; increased funding for inspections and higher penalties, particularly for repeat offenders; heightened emergency preparation requirements; measures to improve nurse and aide staffing; and the creation of transparent databases for nursing home corporate ownership. The fact sheet also outlined new funding opportunities and incentive programs, technical assistance programs and other “carrot” measures aimed at improving nursing home quality. The fact sheet indicated that the administration plans to take action within a year on many of these measures, although precise dates and methods of implementation have yet to be determined.

Reactions to the fact sheet have been mixed. While some advocates strongly supported the administration’s proposals, question s remain as to how reforms can be implemented without increased funding, particularly for Medicaid recipients. Some critics have noted that the proposals do not do enough to address staffing shortages. Others have raised concerns that reforms tied to Medicare and Medicaid could push nursing homes to go fully private or accept fewer patients to comply with staffing ratios and roommate limitations.

Evie Atwater, Carole M. Becker, Kristina Dipano, Dexter Golinghorst, Adetoro Olugbemi also contributed to this article.