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
At the onset of the COVID-19 PHE, CMS was permitted to issue several temporary emergency statutory and regulatory waivers to help providers appropriately respond to the pandemic. On May 1, 2023, the Secretary released a memo...more
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in...more
On March 30, 2020, the U.S. Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFC) introducing temporary regulatory waivers and new rules to promote flexibility in the American health care system...more
Last week CMS issued a new round of regulatory waivers and rule changes in response to the COVID-19 public health emergency, including its Interim Final Rule with comment period, CMS-5531-IFC. The key changes relax certain...more
As we described in a prior blog post, the Centers for Medicare & Medicaid Services (“CMS”) published multiple COVID-19 Blanket Waivers for Health Care Providers. CMS announced another round of Blanket Waivers on April 30 ...more
On April 30, 2020, CMS issued several new and revised blanket waivers for health care providers retroactively effective March 1, 2020, through the end of the emergency declaration. CMS’s authority to grant blanket waivers...more
As part of sweeping exemptions aimed at facilitating all levels of healthcare during the coronavirus public health emergency, the Centers for Medicare and Medicaid Services (CMS) has been issuing waivers for a wide range of...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