False claims liability has typically turned on financial behaviors -- upcoding, submitting claims pursuant to Stark or anti-kickback violations, and other financial arrangements, activities and transactions. Rarely considered are the increasingly new liabilities associated with what Alice calls “quality fraud.” These are improper clinical behaviors including wasteful services, medical errors, over-use, under-use, failed medical necessity and violation of basic requirements for payment that turn on clinical compliance.  In addition, with the advent of value-based purchasing and significantly more reporting about quality, inaccurate or false reporting can create exposure as well. In “Quality Fraud: Gathering The Threads” Alice elucidates the multiple bases for quality fraud, what such fraud looks like as action, penalties associated with misbehaviors, the guidance the government has offered on point, and suggestions for avoiding these risks. Most providers-- including hospitals and physicians -- will have to update their compliance programs to address effectively these augmented perils.

The Health Insurance Portability and Accountability Act (HIPAA) and its regulations have existed for over twenty years. Although most health care providers are familiar with its requirements, most health care providers are less familiar with the ways in which HIPAA is enforced. They are likewise unaware of how HIPAA investigations are initiated, the processes they follow, nor the types of information the Department of Health and Human Services’ Office for Civil Rights (OCR) requires in the course of an investigation. Many also fear the imposition of stiff penalties, likely as a result of seeing headlines about multi-million dollar settlements by other providers. In “HIPAA Enforcement On the Books and In Practice: When It all Goes Wrong,” Dan addresses HIPAA enforcement, explaining both the regulatory provisions that govern it, and how that enforcement plays out in practice. In addition to explaining the enforcement rule and how the OCR actually employs it, Dan also offers practical guidance based on personal experience in helping clients navigate HIPAA breaches without having to pay penalties or enter into settlement agreements.

On December 20, 2022, the Department of Justice announced an almost $45 million settlement with BioTelemetry, Inc. and its subsidiary CardioNet, LLC to resolve allegations of False Claims Act violations arising from submitting claims to federal health care programs for cardiac monitoring tests. The claims were alleged to be false because a portion of the monitoring services were performed overseas. More specifically, CardioNet had sent certain tests for federal health care beneficiaries to be reviewed by technicians based in India. Medicare will not pay for services that are performed outside of the United States or United States territories (e.g., Guam, Puerto Rico). Because the services in question were performed in India, this rendered the claims false. The settlement arose from a whistleblower lawsuit brought by two former CardioNet employees. Dan has examined these issues and the complications associated with using offshore personnel to perform services in “The Lure of Foreign Shores: Outsourcing of Overseas Health Care Functions,”

In settlements and whistleblower cases around the country, the problems that can be created by a billing company (or as it is referred To in hospital world as ‘revenue cycle management’) have increased recently. Alice has addressed the major problems lurking here in the past in her article on billing company accountabilities. As we have reviewed more and more of these contracts for our clients, and have received more and more complaints about problems created in these relationships, we think it important to reassert issues that must be addressed in the contract for billing and collection services: (1) standards of performance, particularly with respect to timeliness of claims submission, collection rate, and aging of accounts receivable; (2) the obligation to bring billing concerns to management before going anywhere else; (3) getting a representation that the company and its personnel have not been whistleblowers in the past. There are plenty of other issues but those three are critical and frequently absent.