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
Many healthcare providers received waivers and exceptions due to the COVID-19 pandemic, but now with the emergency declaration set to expire sometime in the new year, providers need to ask themselves: What did I change in my...more
Last year, the Oklahoma legislature joined a growing number of states in taking direct aim at the opioid crisis by enacting legislation designed to combat the forgery of paper prescriptions. More than a year and a half after...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
Hospitals operating in regions affected by the recent hurricanes and other natural disasters may be able to obtain temporary regulatory relief. During times of disasters and emergencies, CMS can provide some flexibility...more
On March 6, 2017, President Trump signed the highly anticipated and revised Executive Order (EO), "Protecting The Nation From Foreign Terrorist Entry Into The United States." The new order rescinds the previous EO issued at...more
On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more
In our last post, we discussed the Visa Waiver Program Improvement and Terrorist Prevention Act of 2015 (the “Act”). It prevents a citizen of one of 38 VWP countries (Australia, Italy, Japan, Switzerland, etc.) who is also a...more