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
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
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
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
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
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
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
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
In response to the COVID-19 Public Health Emergency (PHE), CMS temporarily waived a significant number of Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements and conditions of participation pursuant...more
On April 29, 2022, CMS issued its final rule for Medicare Advantage (MA) and Part D plans with updates including reduced out-of-pocket costs for prescription drugs and improved consumer protections. CMS published the final...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
It has been almost two years since the Centers for Medicare & Medicaid Services (CMS) first issued blanket waivers of certain hospital conditions of participation allowing healthcare systems and hospitals to provide hospital...more
What is the Telehealth Extension and Evaluation Act? The Telehealth Extension and Evaluation Act would establish a two-year extension for certain COVID-19 emergency telehealth waivers. The legislation aims to extend the...more
Key Points- •HF 902 was signed into law on October 28, 2021 and requires employers to issue vaccine waivers to employees who: 1) refuse to receive a COVID-19 vaccine requirement and 2) submit a statement that the vaccine...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