Revised Code of Pharmaceutical Research and Manufacturers of America Takes Effect

On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective. The updates reflect fraud and abuse concerns voiced by the Department of Health and Human Services’ Office of Inspector General in its November 2020 Special Fraud Alert. While it is not a legal document, companies that adopt the code’s rules are more likely to comply with federal fraud and abuse laws like the Anti-Kickback Statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

CMS Mandate Blocked Nationwide

By Erin M. Duffy and Samantha Dalmass

A federal judge in New Orleans blocked the Interim Final Rule with Comment requiring the vaccination of all staff of health care facilities subject to the health and safety standards under the Medicare Conditions of Participation (“CoPs”) issued by the Centers for Medicare and Medicaid Services (“CMS”) earlier this month. The nationwide block was issued on November 30, 2021, less than one week before the December 6, 2021 deadline for all staff of covered facilities to have received at least their first dose of a two-dose COVID-19 vaccine series, and only one day after a federal court in Missouri blocked the CMS vaccination requirement in Missouri, Arkansas, Alaska, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.

Notwithstanding the broad authority of CMS to regulate the health and safety of facilities subject to Medicare CoPs, the order issued by the U.S. District Court for the Western District of Louisiana blocking implementation of the CMS mandate set forth in 86 Fed. Reg. 61555-01 (November 5, 2021) will remain in effect pending final resolution of the case. The Biden Administration will likely appeal to the Supreme Court, but in the meantime facilities covered by the mandate should plan accordingly and ensure they are prepared to implement the required plans and processes for vaccinating staff, providing exemptions and accommodations for those who are exempt, and tracking and documenting staff vaccinations.

Emergency Temporary Standard Issued for the Healthcare Industry by OSHA

On June 10, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration submitted for publication in the Federal Register its COVID-19 Emergency Temporary Standard (ETS), setting forth new mandatory safety requirements designed to protect workers from COVID-19. The much-anticipated ETS is generally applicable only to certain healthcare workplaces and imposes differing obligations with respect to vaccinated and unvaccinated employees in various contexts.

To read the full text of this Duane Morris Alert, please visit the firm website.