Since mid-2020, many pharmaceutical manufacturers have introduced policies that scope their offering of 340B pricing, including limiting contract pharmacy arrangements and requiring covered entities to submit claims data. These policies have generated a good deal of attention generally, and a significant number of covered entities have made attendant complaints to the Health Resources and Services Administration (HRSA).
Pete Enko
Healthcare clients depend on Pete for his valued advice in health law, information management, privacy and security matters. He frequently counsels clients on contracting, research compliance, fraud and abuse, managed-care, medical staffing, Medicare/Medicaid, patient care, operational and transactional issues.
Healthcare Perspectives on Data Privacy Day 2021
The pandemic of 2020 tested the mettle of our nation’s healthcare system in many unexpected and profound ways. As healthcare delivery was being rapidly restructured to accommodate COVID-19 diagnosis and treatment and socially-distanced care, bad actors simultaneously began to exploit the increased number of vulnerabilities in health information systems created by telehealth platforms, patient portals and the inattention of stressed, overworked staff. The result was an unprecedented number of cyberattacks culminating in an alert from the Cybersecurity and Infrastructure Security Agency (CISA) on October 28, 2020 addressing the plague of ransomware activity targeting the healthcare and public health sector.
Health Law & Innovation Virtual Series – Pharmacy Trends 2021: What to Watch Out for After The Year That Was
Please join Husch Blackwell as we go virtual with our Health Law Conference. The series will include a range of important topics relevant to the healthcare industry and will be moderated by Curt Chase, leader of the firm’s Healthcare, Life Sciences and Education team; Hal Katz, American Bar Association, Health Law Section, Chair; and Tom Shorter, American Health Law Association, President-Elect Designate. The webinar programs will be offered every Thursday through November 19.
Federal Government Raises Alarms Over Cyberattacks Against Hospitals
The combination of a significant increase in COVID-19 cases, political tensions in the final days of a national election season, and law enforcement’s focus on election security created an opportunity for cybercriminals to target the computer networks of America’s healthcare and public health (HPH) sector. That opportunity has come to fruition this week.
On October 28, 2020 the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS) published Alert AA20-302A (Alert) describing ransomware activity that has targeted the HPH sector. In the Alert, CISA, FBI and HHS assess that cybercriminals are targeting the HPH sector with TrickBot and BazarLoader malware, which are frequently followed by ransomware attacks, data theft, and disruption of healthcare services.
OIG Tags Higher Education Grantees Receiving NIH Awards
COVID-19 is not the sole focus of the Department of Health and Human Services (“HHS”) these days. On May 15th, the Office of Inspector General (“OIG”) announced that it added to its Work Plan a “Review of Institutions of Higher Education Grantees Receiving National Institutes of Health Awards” to address areas of potential risk at institutions of higher education (“IHE”).
Another notch in the hacking holster: Cyber outlaws hit Anthem hard
Having no need to brandish bandanas to obscure identity or firearms to force entry, it was reported Wednesday that cyber bandits, in a sophisticated and well-orchestrated robbery, recently waltzed into the IT vaults of Anthem, the second-largest U.S. health insurer, and walked off with personally identifiable information on about 80 million current and former members, a population that comprises Anthem customers, employees and its CEO, Joseph R. Swedish. The haul is reported to have included names, birthdates, social security numbers, medical identification numbers, street and email addresses and employee income data. Fortunately, there’s no indication at this point that credit-card numbers, claims information, test results or diagnostic codes were compromised as part of the crime. That said, to minimize the potential harm, Anthem has called in the FBI and is notifying affected individuals and offering free credit and identity-theft monitoring.
Interoperability 2017 – Will the latest government plan be the golden spike that connects the EHR rails?
Seemingly picking up where we left off in our recent white paper and Advisory Board article, the Obama administration released a 166-page draft plan January 30th intended to drive providers and patients toward a common set of electronic clinical information and a commitment to more fully connected EHR systems by the end of 2017.
After a slow start, generic pharmaceutical companies now accelerate their use of inter partes review patent challenges
When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references. Id. at Paper 43; March 19, 2013.