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November 2, 2020
Arent Fox Partner Kay Georgi will speak at the Passport to Proficiency Series on the Export Administration Regulations event.
October 6, 2020 - October 8, 2020
Partner Karen Carr will serve as a panel speaker at the 2020 FDLI Annual Conference in October. Karen’s session is titled “Emerging Technologies: Regulatory Oversight of Intentional Genomic Alterations in Animals.”
September 30, 2020 - October 2, 2020
Health Care Partner Rachel Hold-Weiss will present effective compliance activities in the hospice and palliative care industry twice during Hospice Fundamentals’ Fall Virtual Compliance Workshop.
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.
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).
BMW and two of its subsidiaries will pay $18 million to end allegations from the U.S. Securities and Exchange Commission that the carmaker inflated its reported retail sales in the U.S. through misleading disclosures, the agency announced.
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.
As we previously reported, Maryland has passed several employment laws that go into effect on October 1, 2020.
September 23, 2020 12:00 PM - 1:30 PM
Health Care Partner Anne Murphy will moderate a panel discussion on the state of behavioral health care in an upcoming webinar hosted by the Boston Bar Association.
SB 1159 expands the presumption of workers’ compensation liability for employees who contract COVID-19 due to a workplace outbreak.
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.
In recent years, the US health care system has experienced unprecedented challenges, an increasing pace of change, and ever-growing complexity.
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.”
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. 
September 14, 2020 - September 18, 2020
Health Care Partner Stephanie Trunk will participate in an External Counsel Fireside Chat at Informa Connect’s virtual Medicaid Drug Rebate Program on Friday, September 18, 2020. She will also host an in-depth on-demand session on reimbursement and contract strategy.
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.
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 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
On September 10, former US State Department lawyers filed a joint amicus brief in the Supreme Court encouraging the justices to reverse a DC Circuit court decision altering the FSIA.
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.