Health Law Scan

The new Civil Cyber-Fraud Initiative of the US Department of Justice’s use of the punitive False Claims Act (FCA) and its whistleblower provisions has some important legal and risk management considerations for the health industry. Because enforcement will initially occur largely through civil investigations applying the FCA in the broadest possible way, healthcare organizations should undertake a priority assessment of their cybersecurity status to ensure that their practices can withstand hacks, whistleblowers, and government scrutiny.

The HHS Office of Inspector General (OIG) recently announced its Office of Audit Services plans to conduct a nationwide review of hospice eligibility, focusing on those Medicare hospice beneficiaries who haven't had an inpatient hospital stay or an ER visit in certain periods prior to their start of hospice care.  

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.

Biometrics are physical or behavioral human characteristics that can be used to digitally identify a person to grant access to systems, devices, or data. Examples of biometric identifiers are fingerprints, facial geometry scans, and voice prints, as each are considered unique to the individual. Unlike a Social Security number, a person’s biometric data generally cannot be altered.

The US Department of Health and Human Services, Office of Inspector General (OIG) recently transmitted a memorandum to the Center for Medicaid and CHIP Services detailing the findings of the Massachusetts state auditor's report on the commonwealth’s controls around dual-eligible hospice patients and weaknesses related to election statements and potential MassHealth overpayments for curative items and services related to hospice patients that should have been covered by the hospices.

Members of our labor and employment group published a LawFlash discussing the US Equal Employment Opportunity Commission (EEOC) updates on its COVID-19 guidance, detailing its view of employer obligations under Title VII when evaluating religious objections to COVID-19 vaccination mandates and requests for accommodation based on pregnancy under the Americans with Disabilities Act and the Pregnancy Discrimination Act. These updates may be of interest to healthcare employers as they continue to navigate through vaccine mandates.

The Centers for Medicare and Medicaid Services (CMS) announced that it had restarted the Targeted Probe and Educate (TPE) audit process, effective September 1, 2021. More recently, the Medicare Administrative Contractors for hospice have targeted “claims with revenue code 0656 [General Inpatient Care] greater than or equal to 7 days submitted with dates of service on or after January 1, 2020” for active, pre-pay medical review.

Members of our labor, employment and benefits team published a LawFlash covering Texas Governor Greg Abbott’s recently issued Executive Order No. GA-40 (EO GA-40), which purports to prohibit vaccine mandates, but in reality expands the scope of mandatory exemptions to such mandates.

Ransomware attacks are increasing in their severity and sophistication, with healthcare companies being significant targets. Ransomware actors often target businesses believed to have fewer resources to invest in cyber protection, as well as those holding sensitive data, in the hopes that they will be more likely to make a quick ransom payment.

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.