The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
Seyfarth Synopsis: On December 26, 2023, the Federal Motor Carrier Safety Administration (“FMCSA”) announced they would be accepting comments from the public in response to multiple petitions requesting waivers from the...more
On June 1, 2022, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would modify its requirements for water quality certification under Clean Water Act (CWA) Section 401 (the “Proposed Rule”). The...more
In a rapid and remarkable response to COVID-19, The Centers for Medicare & Medicaid Services (CMS) has altered a wide range of coverage and payment rules applicable to hospitals, practitioners and suppliers. In an interim...more
We are still reviewing the just-released draft waiver from Oklahoma, but wanted to share with our readers in the meantime. As we’ve discussed... we expected Oklahoma to be the first-mover after release of the Trump...more
CalRecycle Study Makes Recommendations to Local Agencies - The California Department of Resources Recycling and Recovery released a draft report of cost impacts to local agencies to implement Senate Bill 1383 and reduce...more
Multi-state coalition’s lawsuit challenges Trump EPA withdrawal of California Clean Air Act waiver. EPA formally announced its decision to withdraw California’s 2013 Clean Air Act waiver, which allowed the state to set its...more
With cybercrime on the rise, organizations have increasingly found themselves subject to litigation or regulatory investigations related to breaches. Documents and information created before breaches, such as security...more
Continuing threats to the supply chain pose increasing risks to our national security. The new interim Federal Acquisition Regulation (FAR) rule published on August 13, 2019, seeks to address certain of these threats by...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series...more
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on July 25, 2016, entitled, Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and...more
Alaska - House Brings Medicaid Expansion Lawsuit to State Supreme Court - The Alaska House of Representatives has filed an appeal to the State Supreme Court seeking reinstatement of its lawsuit against Governor Bill...more
Vermont posted a draft 1332 waiver proposal for public comment on February 8, 2016. Vermont proposes to eliminate the ACA requirement that small employers enroll through a Small Business Health Options Program (SHOP) web...more