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
While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning of the pandemic...more
As we enter the third year of the pandemic, life with COVID-19 has become the new “normal” for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more...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
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
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 & 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
On January 9, in its first Advisory Opinion of 2019 (OIG Advisory Opinion 19-01), the U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable opinion regarding an arrangement...more
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more
On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
In the fourth episode of our series on the national opioid crisis, Ruth Granfors and Tracy Lawless discuss how opioid treatment is reimbursed under Medicaid and other public programs...more
On April 18, 2017, President Donald Trump signed into law the “Buy American and Hire American” Executive Order (No. 13788). The Order requires agencies to do a wholesale evaluation of their compliance with “Buy American” laws...more
On December 29, 2016, CMS and OIG issued a Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model (the 2016 Notice). The 2016 Notice does not change or limit arrangements...more
McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on July 25, 2016, entitled, Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and...more
On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more
A distinguished panel of providers, consultants and IT firms convened on Tuesday, June 21st in New York at the Foley and Lardner LLP offices to share a discussion focused on the convergence of IT spend and new value based...more
Understandably, there is anticipation surrounding the April 1st start date for CMS’s newest bundled payment program, the Comprehensive Care for Joint Replacement (CJR) program. As participant hospitals consider gainsharing...more
On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) published a final rule regarding the waiver of several federal health care fraud and abuse laws with respect...more
On October 29th, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued its final rule (“Final Rule”) for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program (“Shared Savings...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more
Accountable Care Organizations (ACOs) can share costs of telehealth and remote patient monitoring services among their hospitals, providers/suppliers, and other ACO participants, according to federal regulations under the...more