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
On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare until September 30, 2025. These were originally scheduled to end...more
The American Relief Act, 2025, signed into law on December 21, included a short-term extension of certain telehealth waivers that went into effect in the early days of the COVID-19 Public Health Emergency. These waivers, for...more
Congress narrowly avoided hurdling off the telehealth “cliff” Bradley previously reported on in this post with the passing of the American Relief Act, 2025 on December 21, 2024...more
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
This webinar will equip healthcare providers working via telemedicine with the invaluable information they'll need to know for a smooth transition toward compliance with the proposed rule changes. Join attorney Paul...more
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 Centers for Medicare & Medicaid Services (CMS) used its emergency waiver authority to relax many aspects of health care delivery during the federal Public Health Emergency for COVID-19 (PHE) to allow health care...more
Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as...more
President Biden announced that the COVID-19 national emergency and public health emergency (PHE) will expire on May 11, 2023. During the PHE, federal agencies were permitted to grant blanket waivers for certain health care...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
Historically viewed as recession-proof, 2023 is expected to be a challenging year for the healthcare industry as macroeconomic factors – inflation, high labor expenses, volatile markets, supply chain snarls and other issues –...more
On January 30, 2023, President Biden announced that both the COVID-19 national emergency and the public health emergency (PHE) will end May 11, 2023. This announcement has left many healthcare providers considering how the...more
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...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
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
As states roll back emergency provisions that allowed out-of-state providers to offer telehealth services during the COVID 19 pandemic, more permanent changes in interstate telehealth are under way. In April 2022, the...more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth...more
While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning of the pandemic...more
“The provision of health care services via telemedicine has been growing in popularity over the last several years. With the arrival of the COVID-19 pandemic, healthcare providers were able to rely on a variety of temporary...more
As we enter the third year of the pandemic, life with COVID-19 has become the new “normal” for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more...more
In response to the COVID-19 Public Health Emergency (the “PHE”), the Centers for Medicare and Medicaid Services (“CMS”) issued numerous “blanket waivers” to increase access to medical services, and ease the regulatory burden...more
As we covered in a prior Telehealth Update, many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (the...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
Takeaways: ..Telehealth greatly expanded during the COVID-19 pandemic, in large part due to regulatory waivers. Those regulatory waivers aren’t permanent, but lawmakers are evaluating ways to permanently expand some...more