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
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
With the COVID-19 Public Health Emergency (PHE) ending on May 11th, providers and practitioners must carefully consider the dates when various telehealth waivers and flexibilities end. This requires understanding the...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
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
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...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
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
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
On July 7, 2022, the Centers for Medicare and Medicaid Services (CMS) released its proposed 2023 Medicare Physician Fee Schedule (PFS) rule. The rule, if enacted as proposed, will: Create three new permanent telehealth...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
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
Companies who feel the Public Health Emergency (PHE) waivers and exceptions have rendered telemedicine “immune” from compliance oversight might be surprised to learn what federal regulators have in the works. The Office of...more
In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a...more
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more
As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. The Public Health...more
On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. This follows on the heels of...more
The Secretary of Health and Human Services announced a renewal of the nationwide public health emergency ("PHE") late on Thursday, July 23, 2020. The announcement came just two days before the then-current PHE designation was...more
As most are aware, the telehealth industry has experienced a major expansion during the COVID-19 pandemic. The volume of telehealth claim lines in April 2020 alone reportedly increased more than 8,000% versus April of 2019,...more
Caring for Recipients, Protecting the Workforce and Supporting Provider Sustainability - Examine the Immediate Issues and Opportunities Facing Long-Term Care Providers—and Look Ahead at How to Build a Stronger Future—at a...more
Acting under its broad authority granted under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), in an April 21, 2020 release the Centers for Medicare and Medicaid Services (“CMS”) announced an even...more
To ensure Medicare beneficiaries have access to necessary care without risking exposure to COVID-19, the Centers for Medicare & Medicaid Services (CMS) has further expanded telehealth services and relaxed certain requirements...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