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
This month’s bid protest roundup looks at two GAO protests from August. One examines the risks of using former federal employees to assist with proposal development when their prior access to non-public information might...more
Protesters and other litigants before the U.S. Court of Federal Claims have long encountered the complexities of jurisdiction under the Tucker Act. The Tucker Act, 28 U.S.C. § 1491, is the statute granting jurisdiction to the...more
On December 19, 2022, the U.S. Government Accountability Office (GAO) released a report titled, “Medicare: CMS Needs to Address Risks Posed by Provider Enrollment Waivers and Flexibilities” (GAO-23-105494). The report...more
In the seminal decision Blue & Gold Fleet, L.P. v. United States, the U.S. Court of Appeals for the Federal Circuit held that “a party who has the opportunity to object to the terms of a government solicitation containing a...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
The U.S. Government Accountability Office recently issued a decision in which it clarified the rules regarding bid protests that challenge an agency’s organizational conflict of interest waiver. As discussed below, the GAO’s...more
Vermont moves closer to launching the country’s first all-payer ACO; CMS approves Arizona’s 1115 waiver extension but rejects the State’s proposed work requirement and premiums for those earning below the FPL; and CMS issues...more
The Government Accountability Office (GAO) has exhibited little interest in evaluating the basis for agency decisions to waive organizational conflicts of interest (OCI). Where protesters have challenged agency waiver...more
HHS announces average premium price increases of 7.5% across HealthCare.gov; Michigan and Illinois launch the country’s first joint cloud-based, real-time Medicaid information management system; and the Marketplace carrier...more
Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which...more
The U.S. Government Accountability Office recently opened the door for government agencies to use their waiver authority under the Federal Acquisition Regulation, Subpart 9.5, during a protest to render academic a protester’s...more