December 9, 2022

Volume XII, Number 343

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Healthcare Regulatory Check-Up April 2022: Other Notable Developments

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.

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 146
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About this Author

James A. Cannatti III* practices at the intersection of today's most pertinent health care issues, including digital health, health IT policy, and fraud and abuse, including Anti-Kickback Statute/Stark Law matters. With more than 10 years of experience in the US Department of Health & Human Services’ (HHS) Office of Inspector General (OIG), most recently as Senior Counselor for Health Information Technology, James is well-attuned to the regulatory issues impacting the rapidly evolving digital health landscape, including:

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Emily J. Cook, McDermott Will Emery Law Firm, Health Care Attorney
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Emily J. Cook is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Los Angeles office.  She focuses her practice on Medicare provider certification, reimbursement and regulatory compliance.

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Gregory E. Fosheim Associate Chicago Healthcare  Healthcare Mergers & Acquisitions  Healthcare Regulatory & Compliance  Cannabis Industry
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Gregory E. Fosheim advises healthcare and life sciences clients across a variety of corporate, transactional and regulatory compliance matters. Working with hospitals, physician practice groups, clinical research programs, pharmaceutical companies, device manufacturers and others, Greg provides counsel on healthcare fraud and abuse risks, Medicare, Medicaid, and private payor billing, and clinical research and laboratory compliance in connection with federal grants, among other issues. Greg also provides regulatory due diligence support on healthcare transactions and collaborations,...

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Tony Maida Health Care Attorney McDermott WIll Law Firm
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Tony Maida is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s New York office.  Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal Anti-Kickback and Physician Self-Referral/Stark laws, false claims and overpayments, and government investigations.    He works closely with our health and white collar teams on criminal, civil, and administrative investigations and counseling clients on corporate transactions and compliance programs.

Tony previously served...

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Caroline Reignley Healthcare Attorney McDermott Will & Emery Washington, DC
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Caroline Reignley provides valuable counsel on healthcare regulatory and reimbursement law to her clients, including for-profit and nonprofit hospitals, health systems and physician groups.

She is particularly focused on advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding, licensure, accreditation and healthcare compliance matters.

Caroline also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statue. Her experience...

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