Changing Telehealth Rules
PODCAST: Williams Mullen's Benefits Companion - Health Plan Transparency Requirements
PODCAST: Williams Mullen's Benefits Companion - Group Health Plan Service Provider Compensation Disclosure Requirements
Podcast: What's New for Insurers in Mental Health Parity Compliance - Diagnosing Health Care
PODCAST: Williams Mullen's Benefits Companion - Employee Retention Tax Credit Expansion
Department of Labor Imposes Additional Requirement on Employer-Provided Health Services
COVID-19 Relief in 2021: What Small Businesses Need to Know
On-Demand Webinar | Navigating Leave and Disability Protection Laws During COVID-19: A Practical Guide for California Employers
COVID-19 in the Workplace - PPP Update, COVID Plans from the Biden Transition Team, Higher Education Relief Package Provision, COVID WARN Act Developments
PODCAST: Williams Mullen's Benefits Companion - New Round of COVID-19 Relief Expands Assistance for Employers
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more
On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...more
Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...more
Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the Consolidated Appropriations Act of 2023...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) went into effect with US President Joe Biden’s signing of the Consolidated Appropriations Act, 2023. This legislation will profoundly change the way cosmetic...more
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more
There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023 (you can find our blog...more
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug,...more
The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on January 27 to recommend that Congress grant states the ability to limit Medicaid coverage for drugs and biologicals approved under the FDA’s accelerated...more
340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more
The dust from the 2022 Midterm Elections has settled and the 118th Congress has begun. Republicans were successfully able to flip control of the House and now have a 222-212 majority with one vacancy to be filled. Democratic...more
As part of the Consolidated Appropriations Act, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This is the first major reform of cosmetics regulation since the Federal...more
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more
Buried within the thousands of pages of the Consolidated Appropriations Act of 2023 is the most significant statutory expansion to the U.S. Food and Drug Administration’s (FDA) authority over cosmetics since 1938...more
Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more
As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA),...more
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more