Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more
On September 13, 2024, the U.S. Trade Representative (USTR) announced that it has finalized the modifications to the Section 301 trade actions following the completion of its four-year statutory review in May 2024. As...more
On August 9, 2024, the U.S. Department of Justice published a final rule implementing new ADA requirements for accessible medical diagnostic equipment (MDE) used in hospitals, emergency departments, physicians’ offices,...more
The lazy, hazy days of summer are definitely not lazy or hazy when it comes to health planning in North Carolina. At this point in the year, the draft State Medical Facilities Plan (SMFP) has been published, and the summer...more
Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program got good news from The Centers for Medicare and Medicaid Services (CMS) related to widespread fraud involving urinary catheters that...more
Below is Part II of our New Jersey Statutory update. As you can see from the below, several statutes were passed imposing requirements on health insurance payers, including new requirements for prior authorization request and...more
On May 14, 2024, the Office of the United States Trade Representative (USTR) announced expansions to tariffs under § 301 of the Trade Act of 1974 (§ 301) on imports from China, including tariff increases on currently covered...more
The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more
Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, PFAS have several benefits, including resistance to grease, oil, water, heat and...more
Mark your calendar for the 2024 McGuireWoods Healthcare Private Equity and Finance Conference, and help us celebrate 20 years of bringing healthcare industry leaders together. This premier two-day healthcare...more
Disgraced Crypto Mogul Bankman-Fried Sentenced to 25 Years in Prison - On March 28, Judge Lewis Kaplan of the United States District Court for the Southern District of New York handed down a substantial term of...more
Former Healthcare Executives Convicted for Health Insurance Policy Fraud Scheme - Steven Dorfman, the former chief executive officer and owner of the Florida-based healthcare company Simple Health, and John Sand, a former...more
Studies have shown that persons with disabilities are not being afforded equal access to medical care, including routine examinations, due to a lack of medical diagnostic equipment (MDE). A lack of accessible MDE impacts the...more
On January 12, 2024, the U.S. Department of Justice (DOJ) published a notice of proposed rulemaking (NPRM) under Title II of the Americans with Disabilities Act (ADA) that would require accessible medical diagnostic equipment...more
This issue features articles on the firm’s Business Advisory Practice supporting Nervosave Therapeutics’ U.S. expansion; the USPTO’s forthcoming guidance on AI innovation protection; option pool sizes for life sciences...more
Taking advantage of the nearshoring effect, the Mexican Ministry of Finance and Public Credit (Secretaría de Hacienda y Crédito Público) issued a Decree that will provide tax benefits to key sectors of the export industry...more
Maintaining independence is fundamental for people living with disabilities. Having mobility options allows people with certain disabilities to go to doctor’s appointments, grocery shop, visits friends, and keep a sense of...more
The North Carolina Department of Health and Human Services Division of Health Service Regulation (DHSR) has published the draft 2024 State Medical Facilities Plan (SMFP), which was developed by the State Health Coordinating...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Kia and Hyundai Urged by Bipartisan Coalition of AGs to...more
A bipartisan coalition of eight AGs and the federal government settled with Phillips RS North America LLC (formerly known as Respironics Inc.), a medical equipment manufacturer, to resolve allegations that the company...more
Massachusetts AG Andrea Joy Campbell settled with Regional Home Care, Inc., a medical equipment supplier and service provider, to resolve allegations that the company’s billing and debt collection practices violated the...more
Maybe it is just us hardcopy application diehards, but this news hit us hard - The Centers for Medicare & Medicaid Services ("CMS") ended the National Supplier Clearinghouse ("NSC") and split the durable medical equipment,...more
The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
Seyfarth synopsis: The Spring 2022 Unified Regulatory Agenda is out with rulemakings on medical equipment, EV charging stations and fixed self-service transaction machines on the list of items to be addressed....more
The U.S. Justice Department’s COVID-related health care fraud crackdown continues to intensify. On a single day in September 2021, the Justice Department announced criminal charges against 138 defendants in 31 federal...more