Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs). These penalty increases cover a broad range of health care violations, including the Stark Law, the Anti-Kickback Statute, the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA). The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) recently announced these “adjustments” to account for inflation – in one case, accounting for more than 40 years of inflation. In particular, the new FCA penalties are nearly double, and CMPs for both the Stark Law and the Anti-Kickback Statute have increased approximately fifty percent.
Please join Arent Fox partner Erin Muellenberg on Friday, September 16, from 1:30-2:30 PM Eastern for an AHLA educational call on the Implications of Escobar: Credentialing and Peer Review Compliance Issues and Risks.
Every state and territory in the US, except Alabama, New Mexico, and South Dakota, have data breach notification statutes, and most of them apply to any person, business, or government agency that acquires, owns, or licenses computerized data that includes personal identifiable information of individuals who reside within that jurisdiction.
This survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes.
To view and download the full survey, click here.
Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state. Although the changes do not affect the NP scope of practice, they do reflect an attempt to modernize the BRN’s regulatory approach toward NP certification. The public may send written comments on the proposed changes to the BRN by September 19, 2016. The BRN also will hold a public hearing on the proposed amendments on September 19, 2016, at 9:00 a.m., in Sacramento.
On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the administrative dispute resolution process applicable to all covered entities and drug manufacturers participating in the 340B Drug Pricing Program. Comments on the Proposed Rule are due on or before October 11, 2016.
Please join Arent Fox LLP on Friday, September 16th, for an engaging program where Arent Fox counsel Lanhee Chen and senior government relations director Sonja Nesbit will discuss the fate of the Affordable Care Act given the current political environment and the upcoming presidential election. This will be an interactive discussion between our two health policy authorities who will present different ideas and perspectives on the future of this important and oft-debated piece of legislation.
About the Panel
- DEA will not reschedule marijuana unless the FDA determines the drug has a medical use.
- DEA’s new research policy will hopefully facilitate future necessary medical research.
* The following alert was originally published in Health Law360. To read it on the Health Law360 website, click here.
The Federal Trade Commission asserted its data security authority in two recent back-to-back enforcement actions, only a day apart from each other.
Today, the US Department of Health & Human Services’ Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois’ largest healthcare system) will pay a record $5.5 million settlement for violating HIPAA. The violations include failure to properly assess risks and limit access to electronic PHI (for example, an unencrypted laptop was left in an employee’s unlocked vehicle overnight); failure to have in place business associate agreements; and three data breaches, compromising the records of four million patients. With this record settlement (and other recent settlements setting previous record highs), OCR hopes to send covered entities a strong message that they must conduct comprehensive risk analyses and risk management to keep electronic PHI secure.
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