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 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
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
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
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
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
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
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
The Center for Medicare and Medicaid Innovation (CMMI) is launching a long awaited new oncology model, the Enhancing Oncology Model (EOM). EOM is a successor to the Oncology Care Model (OCM), which ended June 30, 2020 after a...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
For health care providers, particularly long term care providers, COVID-19 has brought unprecedented challenges. In response to those challenges, both the federal and state governments have responded over the course of the...more
Since the COVID-19 public health emergency was initiated in Arkansas in March 2020, Governor Asa Hutchinson has repeatedly renewed the emergency order, maintaining the public health emergency for fourteen (14) months. ...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
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
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
According to an April 13, 2020 Press Release issued by the National Association of ACOs (“NAACOS”), a recent NAACOS survey shows that 56% of the survey-participating at-risk accountable care organizations (“ACOs”) – i.e.,...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
On May 12, 2020 the Centers for Medicare & Medicaid Services (CMS) issued additional 1135 blanket waivers which are applicable to a wide variety of health care providers. These COVID-19 Emergency Declaration Blanket Waivers...more
As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis. In many respects, the attention is well deserved: 1. Nursing homes traditionally...more
As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced an additional expansion of telehealth services, widening provider access to its 62 million Medicare beneficiaries. It also strongly...more
This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well. The Centers...more
In times of emergency, the Secretary of Health and Human Services (the "Secretary") has authority to issue temporary waivers or modifications of certain Medicare, Medicaid, CHIP, and HIPAA requirements. The Centers for...more
On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the...more
Following President Trump’s declaration of a national emergency related to COVID-19 on March 13, 2020, CMS has been swiftly approving states’ requests for flexibilities for their Medicaid programs as they continue to battle...more