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
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 May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...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
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
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
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
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
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
The Health and Human Services (HHS) Office of Inspector General (OIG) issued a Policy Statement on March 17, 2020 regarding the waiver of amounts owed by beneficiaries for services provided by telehealth. Recognizing the...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
- 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
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
The US Department of Health and Human Services recently announced the use of blanket waivers for healthcare providers under the Stark Law, and its Office of Inspector General noted it will exercise enforcement discretion in...more
On March 30, 2020, the Secretary of Health and Human Services issued blanket waivers of the Physician Self-Referral Law (“Stark Law”). As explained below, those waivers temporarily allow COVID-19 related payments and...more
The healthcare real estate industry finds itself in unchartered waters while grappling with the myriad issues created by the COVID-19 pandemic. Landlords are flooded with requests from tenants for rent relief as healthcare...more
On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative...more
As noted in our recent alert, the Centers for Medicare & Medicaid Services (“CMS”) recently issued “blanket waivers” concerning several Stark Law requirements in response to the COVID-19 pandemic. CMS enacted the Stark Law...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 what will be welcome news to the provider community, the Office of Inspector General (OIG) issued a policy statement on April 3, 2020, announcing that it will not impose administrative sanctions relating to the commission...more
Attached is a PDF issued by CMS regarding blanket waivers of the Stark Law in order to allow physicians and hospitals to adjust 18 different potential financial relationships in order to deal with the COVID-19 emergency. The...more
The Centers for Medicare & Medicaid Services (CMS) on March 30, 2020, issued blanket waivers of sanctions under the physician self-referral law (Stark Law), retroactive to March 1, 2020, in response to the COVID-19 pandemic...more