Recently, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, which provides a mechanism for industry and academia to access and research cannabis (including marijuana and other cannabis-derived products) without violating the Controlled Substances Act. This legislation creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. It also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration that contain cannabidiol or marijuana for commercial sale. The legislation also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment,” which may be of significant interest for healthcare providers.
FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
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.
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 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.
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.
We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.
Jennifer Geetter and Dale Van Demark wrote this bylined article on how companies must manage and govern their use of digital healthcare information assets. “Organizations will need to design and implement digital governance structures that … include additional components and organizational stakeholders, in order to meet the business and strategic demands of the digital health revolution,” the authors wrote.