Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 1) - Diagnosing Health Care
#WorkforceWednesday: Employee Privacy and COVID-19, CMS Vaccine Mandate on Hold, Independent Contractor Classification - Employment Law This Week®
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
CMS Vaccine Rule for Health Care Workers - Employment Law This Week®
#WorkforceWednesday: Vaccine Mandate Compliance for Large Employers, Unionized Employers, and Health Care Providers - Employment Law This Week®
Podcast: No Surprises Act: Considerations for Plans and Providers - Diagnosing Health Care
DOL Clarifies Timing of Lifetime Income Disclosures in Benefit Statements
Information Blocking: How Will the New Rule Impact the Health Care Industry?
COVID-19 Hospice How-To Series: Recent Developments Regarding Telehealth, Virtual Visits, and Medicare Audits and Appeals
On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. ...more
Welcome to the Akin Intelligence September-October recap. Around the one-year anniversary of the AI Executive Order, the White House announced that agencies had carried out their directives. Members of Congress introduced a...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate...more
Hemp product producers and sellers must consider a large number of legal and regulatory compliance risks each day. Are their inputs and plant material coming from legally compliant sources? Are their products,...more
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” - To the dismay of the medical...more
The COVID-19 pandemic has been particularly devasting to people with disabilities. Recent studies indicate that they are three times as likely to die from the virus as the general population. But as the pharmaceutical...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
This week in Washington: House Minority Leader Kevin McCarthy announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package; Senate Appropriations Committee releases...more
On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more
This week in Washington: Washington is relatively quiet because of Election Day on Tuesday, Nov. 3rd. Grassley, Hassan Introduce Bipartisan Legislation to Increase Transparency and Accountability within the Federal Government...more
Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more
The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered “high risk” as sources of foodborne illness. The proposed rule would apply to entities...more
On August 20, 2020, the United States Drug Enforcement Administration (“DEA”) issued an interim final rule (“IFR”) pertaining to the classifications of marijuana and hemp under the federal Controlled Substances Act (“CSA”) in...more
Court Dismisses Beef “Product of the USA” Lawsuit - A New Mexico federal court has dismissed allegations that several food companies falsely labeled beef as a “Product of the USA” because the cattle were raised in other...more
On August 21, 2020, nearly two years after the passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill), the Drug Enforcement Administration (DEA or the Agency) published an interim final rule that, according to...more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
December 19th, 2019, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater...more
With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
Hemp production is a large and growing industry in the United States. Even before Congress’ passage of the Agriculture Improvement Act of 2018 (better known as the 2018 Farm Bill), the Hemp Business Journal estimated that...more
Since late February 2019, the U.S. Department of Agriculture (USDA) has been promising to publish guidelines regarding hemp production. Aside from the obvious importance of these guidelines to hemp farmers, the guidelines are...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Issues Interim Rule On Hemp Production - The U.S. Department of Agriculture (USDA) has issued an interim final rule “specifying the rules and regulations to produce hemp.” The...more
On October 31, 2019 the U.S. Department of Agriculture (USDA) published an Interim Final Rule (84 FR 58522) establishing the U.S. Domestic Hemp Production Program and outlining a regulatory framework for monitoring hemp...more