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
Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81. The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more
WHAT: The Office of Management and Budget (OMB) recently issued an update to its initial guidance on implementing the Build America, Buy America (BABA) provisions of the Bipartisan Infrastructure Law. This is the third set of...more
Almost a year to the day after the Build America Buy America Act (BABA) became law, the federal Office of Management and Budget (OMB) has published its “Final Guidance for Grants and Agreements” intended to implement BABA’s...more
On August 14, 2023, the Office of Management and Budget (OMB) released a pre-publication version of final guidance implementing the Build America, Buy America Act (BABAA).The guidance adds a new Part 184 in 2 C.F.R. and...more
The Build America, Buy America Act generally requires that non-federal government infrastructure projects that benefit from federal government funding impose requirements for the use of domestic iron and steel and...more
The White House issued final guidance this week governing the procurement preferences required by the Build America, Buy America Act, or BABA, for infrastructure projects. In addition to providing definitions for key terms...more
This article discusses compliance “Buy America” provisions in federal procurement laws and how the Federal Acquisition Regulations (FAR) implement some of those commitments in government contracts. It also outlines the...more
Case Studies for Build America, Buy America Infrastructure Projects – Review of recent changes to government procurement and Buy America laws relating to infrastructure projects. Includes case studies covering construction...more
More than a year has passed since Congress enacted the Build America, Buy America Act (“BABA”)—a sweeping change to domestic sourcing requirements for federally funded infrastructure projects. BABA, which was included as part...more
On February 15, 2023, the White House Office of Management and Budget (OMB) approved a final rule that would increase certain U.S. Department of State fees for visa services. This is the final step prior to publication of the...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
It has been two months since President Biden issued his Buy American Executive Order on January 25, 2021. But it would seem we still have more questions than answers: What specific actions will agencies take to promote the...more
On January 25, President Biden signed an Executive Order that contemplates increasing the domestic content thresholds and price preferences for domestic goods under the Buy American Act ("BAA," 41 U.S.C. §§ 8301-8305). The...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
On March 22, 2020, CMS announced a suite of four new tools intended to help states combat the coronavirus by allowing states to streamline enrollment into long-term care and home-based services and by expediting application...more
COVID-19 Grips Federal Policymakers. Like the rest of the country, lawmakers and regulators spent much of this week grappling with the effects of the COVID-19 virus. Below is a quick rundown of the various responses from...more
The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more
This edition of the Cozen O’Connor Maritime and Infrastructure Federal Update highlights: (i) the unprecedented nature of the recent Jones Act waiver, (ii) available infrastructure funding through the TIGER program, (iii)...more
On April 18, 2017, Donald Trump signed a Presidential Executive Order on Buy American and Hire American (EO). As we reported at the time, Section 3 of the EO directed the heads of all federal agencies to, among other things:...more
Final ACO Fraud Waiver Under OMB Review – The White House Office of Management and Budget (OMB) reported on September 9, 2015, that it began its review of the final rule (CMS-1439-F; RIN 0938-AR30), titled “Medicare Shared...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more