The COVID-19 pandemic has raised concern among health care leaders about the preparedness of acute care systems to adapt to and manage large-scale environmental disruptions. Current physician compensation models do not align...more
The Situation: As the outbreak of the novel coronavirus disease (COVID-19) continues, telemedicine platforms are ideally situated to coordinate care and minimize exposure, while advancing access to care.
The Action:...more
The Situation: States have historically required close physician supervision of physician assistants, including, among other things, onerous chart review requirements, co-location of physicians on-site where physician...more
The Situation: The Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") released an advisory opinion providing new insight into the evaluation of fraud and abuse risks of per-click fee...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more
With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more
3/25/2019
/ ACOs ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Exceptions ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U.S. Food and Drug Administration. They discuss how the FDA is addressing the...more
The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more
11/8/2018
/ Administrative Procedure Act ,
Affordable Care Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Final Rules ,
Medicare Advantage ,
Overpayment ,
Overpayment Recovery Time Limits ,
Social Security Act ,
Vacated
Jones Day’s Ann Hollenbeck and Courtney Carrell discuss an unexpected False Claims Act action as a private equity firm faces FCA liability. They also discuss the implications to consider when Uber, Lyft, and other rideshare...more
The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses.
The Development: The U.S. Food and Drug...more
On February 16, 2018, the University of North Texas settled with the Department of Justice for more than $13 million based upon a self-reported failure to accurately measure, track, and pay researchers for effort spent on...more
The Bipartisan Budget Act of 2018, signed into law on February 9, 2018, imposes changes on health care fraud and abuse laws that appear to reflect Congress's desire to reduce the draconian threat of strict liability under the...more
The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more
12/6/2017
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Medicare ,
MedPAC ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more