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 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
On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...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
Hospital at Home (“HaH”) programs received renewed interest during the COVID-19 pandemic as a way to relieve hospital capacity issues and allow patients to receive effective care outside of the traditional hospital setting....more
The North Carolina Division of Health Service Regulation (“DHSR”) has issued guidance to Adult Care Home (ACH), Family Care Home (FCH), and Skilled Nursing Facility (SNF) providers regarding temporary waivers or modification...more
Hurricane Helene has left unprecedented devastation across western North Carolina, impacting the lives of residents and staff in long-term care facilities. Dozens of facilities are coping with flooding, property damage, power...more
South Carolina Governor Henry McMaster declared a State of Emergency on September 25, 2024, to prepare for Hurricane Helene. On September 29, 2024, the Federal Emergency Management Agency (FEMA) issued a Federal Major...more
North Carolina Governor Roy Cooper declared a State of Emergency on September 25, 2024, due to the impending impact of Tropical Storm Helene (Helene). On September 28, 2024, a Federal Major Disaster Declaration (FEMA-4827-DR)...more
On August 15, 2024, the United States District Court for the Northern District of Texas vacated a Medicare regulation excluding from the Medicare DSH payment days attributable to inpatients covered by a section 1115 waiver...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
Where has the time gone? We have hit the one-year mark since the end of the COVID-19 public health emergency (PHE). Yes, you read that correctly. One year! One of the long-term consequences of the PHE was the shift in when...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
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
On Tuesday, January 16, 2024, Governor Kathy Hochul released the SFY 2025 New York State Executive Budget (“Executive Budget”). While still subject to legislative approval, the Executive Budget incorporates the recently...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
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
Throughout 2021 and 2022, states have been seeking to include or have successfully included medical respite to Medicaid 1115 waivers. These experimental Medicaid-reimbursed programs are reviewed and approved by the Secretary...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
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
On January 30, 2023, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023. The PHE was enacted on January 27, 2020, to provide flexibility to healthcare providers and payors...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