Alerts

Government contractors may wish to seek further legal review of all diversity and inclusion training materials used.

This post explains steps that Illinois LLCs and their majority members can take to protect otherwise privileged communications from disclosure to minority members in advance of and during litigation.

The US Environmental Protection Agency has proposed to amend its pesticide regulations to exempt from FIFRA, the federal pesticide statute, certain pesticidal substances (PIPs) created in plants using biotechnology.

On September 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it streamlined the federal Clinical Laboratory Improvement Amendments (CLIA) certification process for laboratories applying to perform COVID-19 testing.

Effective January 1, 2021, California employers must provide significantly expanded family and medical leave under state law. 

Substantial funding for precision agriculture is anticipated as part of FCC 5G Fund to support next generation wireless services.

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a violation of the Food, Drug, and Cosmetic Act (FDCA).

Last month, in Pharmaceutical Care Management Association v. Tufte et al. No. 18-2926 (8th Cir. August 7, 2020), the United States Court of Appeals for the Eighth Circuit invalidated legislation in North Dakota on the grounds that it was preempted by ERISA.

Headlines that Matter for Companies and Executives in Regulated Industries

As we previously reported, Maryland has passed several employment laws that go into effect on October 1, 2020.

HHS has finalized the CARES Act provider reporting and recoupment rules and they are different from those put forth in the proposed form. Providers should take careful note — the new requirements are significant and detailed.

In a decision with potentially far-reaching consequences for class actions, a divided panel of the U.S. Court of Appeals for the Eleventh Circuit held that the ubiquitous practice of awarding a class representative an “incentive” payment as part of a class action settlement is impermissible.

In recent years, the US health care system has experienced unprecedented challenges, an increasing pace of change, and ever-growing complexity.

SB 1159 expands the presumption of workers’ compensation liability for employees who contract COVID-19 due to a workplace outbreak.

Yesterday, the US Department of Labor’s Wage and Hour Division proposed a new rule designed to “bring clarity and consistency to the determination of who’s an independent contractor under the Fair Labor Standards Act.”

On September 18, 2020, under the authority of the Center for Medicare and Medicaid Innovation, CMS finalized the new Radiation Oncology Alternative Payment Model (Model), with a new payment methodology for radiation therapy (RT) services.

Following up on the recent New York State Executive Order the New York City Department of Health and Mental Hygiene issued an alert advising providers that all point-of-care COVID-19 test results must be reported electronically via the New York State Electronic Clinical Laboratory Reporting.

Adding to various paid sick leave requirements that employers must navigate in the COVID-19 environment, California has once again expanded its state law paid sick leave mandates. 

Headlines that Matter for Companies and Executives in Regulated Industries

On September 14, 2020, the Department of Homeland Security (DHS) through Customs and Border Protection (CBP) issued new withhold release orders (WRO) aimed at entities involved in the importation, downstream manufacturing, and/or sale of certain apparel, cotton, hair products, and computer parts.

The Centers for Medicare and Medicaid Services (CMS) has withdrawn its proposed Medicaid Fiscal Accountability Regulation (MFAR), according to a September 14, 2020, announcement via Twitter by Administrator Seema Verma.

Multiple members of Congress issued a letter to HHS Secretary Alex Azar on September 14, 2020, urging him to use his authority to compel pharmaceutical manufacturers to comply with the laws and regulations governing the 340B Drug Pricing Program.

The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for prescription drugs under both the Medicare Part B and Medicare Part D program

Prop 65 Counsel: What To Know

The amended statute will benefit some businesses in California while leaving others wishing for more exemptions and more clarity.