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
During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth...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
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
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
In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a...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
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...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
The OIG has indicated concern that patients suffering from opioid use disorder may experience difficulty accessing medication-assisted treatment (MAT), resulting in under-utilization of this intervention that offers what the...more
Federal and local governments have issued numerous waivers and provided significant funding in order to enable health care providers to combat the COVID-19 pandemic. These waivers and additional funding have given providers...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
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
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
In a Policy Statement released on April 3, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced that it will exercise its enforcement discretion and not impose...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
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
On March 17, 2020, OIG issued a policy statement titled, “Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Healthcare Program Beneficiaries for Telehealth Services...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
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19...more