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
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...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
The novel Coronavirus (“COVID-19”) pandemic has brought about unprecedented applications of certain federal healthcare laws and regulations, including the federal physician self-referral law (the “Stark Law”) and the federal...more
HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more
As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more
The Centers for Medicare & Medicaid Services and the US Department of Health and Human Services Office of Inspector General have provided additional guidance and clarification on the application of Stark Law blanket waivers...more
The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods...more
For private equity transactions going forward during the COVID-19 crisis, and for those occurring several years after it’s over, private equity investors will need to perform additional due diligence to evaluate whether and...more
The COVID-19 pandemic has created the need for flexibility in physician arrangements during the public health emergency. In response to that need, the Centers for Medicare and Medicaid Services (“CMS”) issued Stark waivers,...more
Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services...more
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...more
The Centers for Medicare & Medicaid Services (CMS) issued Blanket Waivers of certain requirements of the Physician Self-Referral Law (Stark Law). The purpose for the Blanket Waivers is to provide the flexibility providers...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket...more
As discussed in detail in a prior post, U.S. Health and Human Services Secretary Alex M. Azar II (the Secretary) issued blanket waivers of sanctions under the federal Physician Self-Referral Law (Section 1877 of the Act),...more
Bricker attorneys Beth Kastner, Shannon DeBra and Claire Turcotte will explore how COVID-19 has—at least temporarily—changed Stark and Anti-Kickback compliance for health care providers. Topics to be discussed include: ...more
On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued additional guidance explaining the scope and application of the Stark Law blanket waivers to certain financial relationships. CMS issued the Stark...more
While health care providers continue to focus on the challenges of treating COVID-19 patients and complying with newly-issued state government "reopening" orders, now is the time to begin planning for a successful transition...more
On April 21, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released “Explanatory Guidance” related to the March 30, 2020 Blanket Waivers of Section 1877(g) of the Social Security Act (information about those...more
On March 30, 2020, the Secretary of the U.S. Department of Health and Human Services issued a "blanket waiver" impacting the physician self-referral law known as the Stark Law. The blanket waiver—which is retroactively...more
As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under...more
- Federal emergency authorities targeting COVID-19 provide important protections to businesses for certain actions in connection with the national response to the public health crisis. - The protections include immunity...more
The Blanket Waivers that the Center of Medicare and Medicaid services issued under the Stark Law apply only to financial relationships and referrals that are related to the national emergency that is the COVID-19 outbreak in...more
The following is a list of categories of the Stark Law Blanket Waivers permitting deviations from the provisions of the Stark Law where necessary for a COVID-19 purpose. See Background on CMS Stark Law Waiver. The definition...more
The Centers for Medicare & Medicaid Services published at the end of March new blanket waivers under the federal physician self-referral law (commonly known as the Stark Law) in response to the COVID-19 pandemic. The waivers...more
Stark and the AKS - The Physician Self-Referral Law, commonly referred to as “Stark,” prohibits physicians from referring Medicare and/or Medicaid patients to receive “designated health services” (DHS), including clinical...more