The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security of the US drug supply chain. When finalized and effective, these licensing regulations will pre-empt state and local licensing standards, requirements and regulations that are different from these federal requirements.
On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s initiatives have not yet been implemented, President Biden reiterated his administration’s focus on nursing home reform during his March 1, 2022, State of the Union address. Accordingly, the efforts described in the Fact Sheet provide stakeholders with a peek into the regulatory crystal ball of the governmental efforts that may be forthcoming, either through new laws, regulatory action, policy changes, enforcement activities or subregulatory guidance.
The Federal Civil Penalties Inflation Adjustment Act of 2015 directs the US Department of Labor (DOL) to make annual inflation adjustments to specified Employee Retirement Income Security Act (ERISA) violations. The increased penalties generally apply to reporting and disclosure failures if the penalty is assessed after January 15, 2022, and if the violation occurred after November 2, 2015.
Many employers will likely encourage vaccination rather than mandate it. In this Ladders article, McDermott Partner Michelle Strowhiro notes the administrative burdens associated with tracking mandatory employee vaccination.
On March 22, 2022, the US Occupational Safety and Health Administration (OSHA) announced a limited reopening of the rulemaking record for the COVID-19 emergency temporary standard for the healthcare industry, originally published on June 21, 2021 (the Healthcare ETS). OSHA will hold an informal public hearing to gather additional information from healthcare industry stakeholders. With the announcement, OSHA reaffirmed its plans to publish a permanent COVID-19 safety standard (i.e., regulation) for the healthcare industry later this year.
The federal government’s COVID-19 vaccine mandate has spurred an uptick in religious exemption requests. In this Politico article, McDermott Partner Michelle Strowhiro explains how some workers are copying and pasting exemption documents from anti-vaccine websites.
“The religious exemption is not a tough standard for a worker to submit,” Strowhiro said. “There can be a level of people making things up, unfortunately.”
On March 17, 2022, New York State’s Commissioner of Health ended the designation of COVID-19 as an airborne infectious disease that presents a serious risk of harm to public health under the New York Health and Essential Rights (HERO) Act. As of that date, private sector employers in New York State are no longer required to implement their workforce safety plans.
Congressional inaction may prevent a more robust federal government COVID-19 response, according to this Washington Post article. A $15 billion COVID-19 funding bill recently collapsed in Congress, potentially crippling testing, treatment and vaccine access. McDermott+Consulting’s Rodney Whitlock said not enough “spadework” was done to get compromises across the finish line.
A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.
“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.
COVID-19 has not only accelerated dramatic shifts within the healthcare industry, but it has also become a catalyst for change in workforce strategies. In this special report, McDermott Partner Michael Peregrine offers perspective about key trends and priorities for the human capital committee to consider as it plans for the upcoming year and beyond.
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