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
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
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 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, 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
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
On September 27, 2022 and October 3, 2022, CMS announced additional resources and flexibilities available for Florida and South Carolina in response to the aftermath of Hurricane Ian. Following the President’s...more
On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more
On July 15, 2022, Department of Health and Human Services (HHS) Secretary Xavier Becerra again renewed the declaration of a Public Health Emergency (PHE) under the Public Health Service Act, averting a July 15, 2022,...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
On April 22, 2021 the Tennessee Justice Center and the National Health Law Program, representing thirteen (13) aggrieved Medicaid beneficiaries in the state of Tennessee, filed suit in the U.S. District Court for the District...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
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more
Effective July 25, 2020, the Department of Health and Human Services (HHS) renewed the COVID-19 public health emergency declaration. The declaration was initially issued on January 31, 2020, and renewed on April 26, 2020....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
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
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
On March 22, 2020, CMS announced a suite of four new tools intended to help states combat the coronavirus by allowing states to streamline enrollment into long-term care and home-based services and by expediting application...more
On March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services...more
Responding to the Coronavirus public health emergency, the Secretary of Health and Human Services (HHS) has waived certain requirements of the Medicare, Medicaid and Children’s Health Insurance Program (CHIP), including...more
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more