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
The short-term spending bill President Donald Trump signed into law last month included the extension of several telehealth waivers by entering a new termination date of Sept. 30 into the existing law. These waivers, called...more
On March 13, the NCAA issued guidance in the form of a Q&A defining the scope of the eligibility waiver it previously approved on December 23, 2024, for student-athletes who have competed at non-NCAA institutions, such as...more
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
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
In an informational bulletin, the Centers for Medicare & Medicaid Services (CMS) announced it will further extend waivers for “unwinding” under Section 1902(e)(14)(A) of the Social Security Act until June 30, 2025. The...more
Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more
In Short - The Situation: In 2020, a cruise ship in Australian waters, the Ruby Princess, experienced a COVID‑19 outbreak that resulted in an Australian class action. Part of the class were passengers subject to...more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...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
On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...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
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur...more
On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...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
With less than two weeks left until the end of the federal COVID-19 Public Health Emergency (PHE), which is set to expire on May 11, 2023, the Department of Health and Human Services (HHS) is preparing to transition certain...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
Summary - The U.S. International Trade Commission (USITC) is soliciting public comment on the proposed expansion of a June 2022 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property...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 Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...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