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
Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
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
California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care...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
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...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) 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
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
The Biden administration gave its stamp of approval last week to Colorado’s novel waiver under Section 1332 of the Affordable Care Act (ACA) to require premium reductions in a public option program, a first-of-its-kind plan...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
The Coronavirus (COVID-19) pandemic continues to disrupt communities and businesses around the world. This unprecedented crisis has also focused major scrutiny on force majeure (FM) clauses in contracts, as parties struggle...more
As a follow up to our legal alert posted on April 7, 2020, the Federal Communications Commission ("FCC") announced that it is accepting applications for its $200 million COVID-19 Telehealth Program as of April 13, 2020. As a...more
Update 04.10.2020: The FCC has launched an online portal explaining the application process for grants from the $200 million in funding to support telehealth services described in this client update. The FCC will begin...more
The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more
As we previously reported, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) (“CARES Act”) on March 27, 2020. We recently provided guidance on how the CARES Act...more
Topics to be presented: HIPAA, Telehealth, and Other Compliance Flexibilities Presented by Patricia A. Markus Stark Waivers and Medicare Advance Payments Presented by Lester J. Perling Compliance and Enforcement ...more
On March 13, 2020, when President Trump declared a national emergency under the Stafford Act, the Secretary of Health and Human Services utilized his authority to take particular actions, such as temporarily waiving or...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 a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...more
In the midst of the Coronavirus (COVID-19) pandemic, healthcare providers and suppliers will need to make decisions on how to ensure compliance with existing federal fraud and abuse laws while taking swift action to avoid...more
The COVID-19 emergency presents an unprecedented need to communicate quickly and effectively from a distance. Telehealth and telecommunications applications more broadly are poised to address the potentially crushing demand...more