Following a year of significant regulatory changes and market realignments, the health care landscape in North and South Carolina continues to undergo significant transformation driven by federal policy shifts, state...more
4/9/2025
/ Artificial Intelligence ,
Certificate of Need ,
Children's Health Insurance Program (CHIP) ,
Health Insurance ,
Healthcare Reform ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
Private Equity ,
Proposed Legislation ,
Tort Reform
The Eliminating Kickbacks in Recovery Act (EKRA), 18 U.S.C. § 220, is a criminal statute that prohibits knowingly and willfully soliciting or receiving remuneration for referring patients to recovery homes, clinical treatment...more
The Physician Self-Referral Law (the “Stark Law”) and Anti-Kickback Statute (“AKS”) are two of the most prominent healthcare fraud and abuse laws in the United States. The Stark Law and AKS have been in place for many years...more
On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of Excellence, a federally...more
On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule (the “Rule”) that enables adult consumers (18 years of age or older) with perceived mild to moderate hearing impairment to purchase certain...more
On October 24, 2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, (the “SUPPORT Act”). Section 1822 of the SUPPORT Act contains the...more
On April 20, 2022, the Centers for Medicare & Medicaid Services (CMS) released new data on Medicare-enrolled hospitals and nursing homes that merged, consolidated, became acquired, or had changes of ownership from 2016 to...more
As in the previous fiscal year, we expect the federal government to direct much of its fraud and abuse law enforcement activities at the health care industry. The federal government has many civil, criminal, and...more
As the COVID-19 pandemic progressed, the U.S. Food and Drug Administration (FDA) sought to provide timely guidance to the relevant stakeholders to support continuity and response efforts. Notwithstanding, on August 19, 2020,...more
On September 17, 2021, the Department of Health and Human Services (HHS) Secretary Xavier Becerra announced a three-pronged response from HHS following Texas’ passage of SB 8, which is a law that became effective on September...more
Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more
The U.S. Food and Drug Administration (FDA) has faced many operational challenges during the COVID-19 pandemic. Early on, the FDA temporarily postponed routine surveillance facility inspections, conducting mission-critical...more
2020 was an historical year in the health care industry with the global COVID-19 pandemic being the most impactful issue for most of the year. As we enter 2021, we are tracking the following issues which will have an impact...more
As hospitals and healthcare providers/systems (collectively, “Healthcare Providers”) across the nation have been reacting to spiking COVID-19 cases, an increased, imminent cybercrime threat targeting Healthcare Providers has...more
11/2/2020
/ Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Ransomware
Health care spending in the United States reached $3.6 trillion in 2018 and is projected to reach $6.2 trillion by 2028. With such a large amount of money concentrated in the health care industry, it is no wonder why private...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act. On April 24, 2020, the President signed into law the Paycheck Protection Program and Health Care Enhancement...more
Over the past several months, the United States Food and Drug Administration (FDA) has issued several guidance documents and guidelines to regulate the importation and distribution of respirators for medical purposes during...more
A recent nationwide recall of a series of non-Food and Drug Administration (FDA)-approved stem cell products that have infected at least 12 patients has raised serious questions concerning legal exposure to providers that use...more