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.
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.
Because widespread, rapid COVID-19 testing remains unavailable in many locations, universities have had to find innovative ways to implement testing, tracing and isolation protocols to reduce the risk of transmission among students, faculty and staff. There is no one perfect protocol—all universities are in unchartered waters. But there are a few key components university administrators may want to consider and address.
The US Departments of Labor, Health and Human Services, and Treasury issued a second set of answers to frequently asked questions. The tri-agency FAQs (Part 43) clarify important health and welfare provisions under the Families First Coronavirus Response Act (FFCRA), which became law on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020. Both laws addressed Coronavirus (COVID-19) testing and prevention coverage, as well as expansion of telehealth service availability.
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration, finding the right partner is crucial for success, particularly at the highly scrutinized intersection of healthcare and technology. This post explores the factors to address when evaluating service providers and vendors for your next telemedicine collaboration.
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