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.
Healthcare and life sciences lawyers will likely have plenty of work in 2022 thanks to pending legislative and regulatory actions throughout the healthcare, health insurance, and drug and device industries.
According to this Law360 article, surprise billing, abortion and drug pricing are some of the major issues facing lawmakers and regulators in the year ahead. McDermott Partner Michael Ryan noted that changes to the Medical Device User Fee Amendments (MDUFA) also could be in order.
As more employers mandate vaccines for their workforces, in-house legal departments are encountering a host of challenges, including understanding religious accommodations and minimizing litigation exposure. According to this article published in Law.com, employers should have the ability to navigate Americans with Disabilities Act (ADA) and Title VII-related accommodation requests. However, McDermott Partner Carole Spink said many employers have never encountered the current breadth of religious exemption requests from their workforces.
As companies consider whether or not to introduce vaccine mandates for employees, there is interest among some employers to increase health care premiums or impose financial penalties on employees who refuse vaccination. One major airline, for example, recently announced that unvaccinated employees enrolled in the company’s health plan would see a $200 monthly surcharge. However, according to McDermott Partner Judith Wethall in The Hill, financial penalties for the unvaccinated are legally complicated, and vaccine mandates likely pose less regulatory issues for employers to impose.
Mask Up, Vax Up: Illinois Governor Issues Immediate Face Covering Mandate for All, COVID-19 Vaccine Mandate for Healthcare, School and State Workers and Students
On August 26, 2021, Illinois Governor J.B. Pritzker issued Executive Order 2021-20 (the Order). The Order mandates that all individuals in Illinois who are at least two years old and who are medically able must wear face coverings indoors and in other specified settings.
In addition, the Order mandates COVID-19 vaccination for certain professionals in healthcare and education, as well as for students and state employees, subject to certain exemptions which require regular COVID-19 testing.
The full US Food and Drug Administration (FDA) approval of the Pfizer-BioNTech COVID-19 vaccine has led to vaccine mandates by both governments and businesses. More companies will implement their own vaccine requirements in light of the FDA approval, according to McDermott partner Michelle Strowhiro in this The Hill article.
“What employers are trying to balance right now is implementing the right safety standards for their workforce while also being cognizant of the fact that the labor market is so difficult and many employers are already struggling with having the right number of people on staff,” Strowhiro said.
Clinical laboratories continue to face challenges to obtain positive coverage decisions by government and private payers for new tests. According to McDermott+Consulting Senior Director Deborah Godes, payers require reasons to establish new coverage assays.
“[The] key to getting a positive coverage decision from payers is making a solid case through good quality evidence,” Godes notes in a recent Dark Report article. “Clinical laboratories need to demonstrate that a particular assay actually works as it is intended and also that it is used by clinicians to make decisions regarding patient care. ”
Not all payers will be persuaded by the same arguments. Each payer has its own coverage determination process, and clinical laboratories should be prepared to deal with each one individually.
“You need to determine what drives that payer’s denials and then present evidence to address those concerns,” Godes says.
President Biden’s July 9, 2021, Executive Order—which seeks to increase competition throughout the American economy—takes aim at prescription drug prices. In this article, published in Law360, McDermott partner Emily Jane Cook says Biden’s focus on drug prices is unsurprising given the “significant public interest and frustration” with drug costs.
The seismic, virtually overnight transformation of healthcare delivery as a result of the pandemic has flung open doors to innovation, as a diverse cross-section of digital health and life sciences stakeholders mobilize crisis resources; adjust operations for enhanced screening, sanitization and social distancing measures; harness telehealth capabilities to deliver healthcare remotely; and identify opportunities for smarter, better healthcare going forward.
Writing for The US-Israel Legal Review, partners from McDermott’s Health practice highlight the challenges and opportunities that digital health and life sciences operators and investors should consider as the industry charts a course through the post-pandemic changed healthcare landscape.
On December 16, 2020, the Equal Employment Opportunity Commission (EEOC) issued its first direct guidance for employers regarding COVID-19 vaccines approved or authorized by the Food and Drug Administration (FDA). Important takeaways from the guidance, as well as FAQs from the EEOC, are discussed in the attached link.