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
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
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
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) 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
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
The Big Picture - On January 4, the Centers for Medicare & Medicaid Services (CMS) issued a new State Medicaid Director (SMD) letter on how states can make expanded use of ILOS authority, including to address social...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
In this episode, Foley partner Anil Shankar discusses California’s new Medicaid wavier called CalAIM, (California Advancing and Innovating Medi-Cal, the multiyear care delivery and payment reform initiative led by the...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
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
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
Editor’s Note: In a new expert perspective prepared for the Robert Wood Johnson Foundation’s State Health and Value Strategies program, reproduced below, Manatt Health outlines the time-limited targeted enrollment...more
More than 13 million people were enrolled in Medi-Cal in California in September 2021, making it the largest Medicaid program in the nation. In December 2021, the Centers for Medicare & Medicaid Services (CMS) approved the...more
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more
On January 22, 2022, Georgia and the Georgia Department of Community Health filed suit against the Centers for Medicare & Medicaid Services (CMS) seeking to prevent the rescission of the central aspects of Georgia’s 1115...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
This just in – as previously discussed, on January 4, 2021 CMS Administrator Seema Verma sent a letter (available here) to State Medicaid Directors requesting they sign a Letter of Agreement “as soon as possible” establishing...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
A quick, timely update for our reader. As reported in our previous posts on the recently approved Tennessee waiver, in likely anticipation of the Biden Administration withdrawing the newly approved, but controversial waiver,...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more