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The Sarbanes-Oxley (SOX) Act of 2002 (Public Law 107-204) was designed to protect the interests of investors and enhance corporate oversight and accountability of public traded companies.  Specifically, SOX mandates auditing, quality control, ethics, detailed/timely disclosures and independent /informed authentication of all financial statements. To date, there are only two provisions of SOX that apply directly to HealthCare (Non-Profit) Organizations — whistleblower protections and retention of all documentation pertinent to an investigation. However, the healthcare…
What is an expectation to privacy?  The Fourth Amendment provides this constitutional right. An expectation of privacy is related to, but is not the same as, a right to privacy, a much broader concept which is found in many privacy laws. In general, one cannot have a reasonable expectation of privacy in things held out to the public. But, what about email and other electronic communications/information? The Stored Communications Act (SCA) was enacted in 1986 to…
The March 18, 2019 post of Legal Topics in Healthcare provided a definition of Cooperation Credit when undergoing a False Claims Act (FCA), HIPAA Investigation or the like.  In 2015, Deputy Attorney General Yates issued a memorandum detailing a policy on “individual accountability”.  The memo, Individual Accountability for Corporate Wrongdoing, is known as the “Yates Memo.” This memo essentially limited the availability of cooperation credit to only those organizations that provide the…
On August 17, 2018, the Centers for Medicare and Medicaid Services (CMS) announced that it is adding a sub-section (3.2) into Chapter 3 of its Medicare Program Integrity Manual (MPIM, Publication 100-08) entitled “Verifying Potential Errors and Taking Corrective Actions,” The new section references Medicare’s Targeted Probe and Educate (TPE) Program, first initiated as a pilot in 2016. The initial pilot focused only on nursing home and inpatient claims. The pilot has now been…
Qui Tam lawsuits are what we also refer to as whistleblower suits, whereby a private individual assists the government with the prosecution of illegal activities and can receive all or part of any penalty imposed. In healthcare, these usually involve False Claims Act (FCA) allegations directly against a provider. But the provider is not always at the center of these types of Qui Tam suits. One of the longest running Qui Tam cases that still…
Nearly every aspect of modern life has a virtual or electronic component.  Today, most of us choose every day to share information online at the click of a button. And for many consumers, sharing health care information is no exception. This alone underscores how significantly things have changed since over the past decade. We live in an interconnected world of technology and privacy, and nothing about concern over the lack of respecting boundaries is unexpected. …
In 2017, President Trump issued a call to action that led to the declaration of a nationwide public health emergency regarding the opioid crisis. In response, the Office for Civil Rights (OCR) issued guidance on how HIPAA allows information sharing to address the opioid crisis. OCR’s guidance, released in October 2017, addresses when and how healthcare providers can share a patient’s health information with his or her family members, friends, and legal personal representatives when…