Author:

Alayna Frauhiger

Journal of Regulatory Compliance Call for Papers: Spring 2021 Issue – Employment Issues in the Time of COVID-19

As the world grapples with the COVID-19 pandemic, the legal community has ramped up efforts to identify challenges and manage risks. In recognition of the employment implications of the COVID-19 pandemic, the Journal of Regulatory Compliance invites original submissions for publication in our Spring 2021 issue. The official Journal of Regulatory Compliance is a bi-annual …
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The DOJ Launches a National Nursing Home Initiative

On March 3, 2020, the Department of Justice (“DOJ”) launched a National Nursing Home Initiative to “coordinate and enhance civil and criminal efforts to pursue nursing homes and long-term care facilities that provide grossly substandard care to their residents.” The DOJ’s new initiative adds to its extensive efforts to combat elder abuse and financial fraud targeted at American seniors. The initiative will start with a focus on some of the worst nursing homes and enhance all civil and criminal efforts to pursue the nursing homes that provide grossly substandard care to their residents.

Congress Introduces the Smartwatch Data Act

On November 18th, 2019, Congress introduced the Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act, known as the Smartwatch Data Act. The Smartwatch Data Act was introduced by Democratic Senator Jacky Rosen and Republican Senator Bill Cassidy, due to Google’s desire to acquire fitness tracker manufacturer Fitbit in 2020. Since notice of this acquisition, privacy advocates have raised concerns about how Google will use personal health data collected through Fitbit devices. Therefore, this legislation aims to ensure that health data collected through fitness trackers, smartwatches, and health apps, cannot be sold without consumer consent.

Emerging Risks Associated with AI and Machine Learning

Today the healthcare industry is being transformed using the latest technology to meet the challenges it is facing in the 21st century. Technology helps healthcare organizations meet growing demands and deliver better patient care by operating more efficiently. As the world population continues to grow and age, artificial intelligence (AI) and machine learning will offer new and better ways to identify the disease and improve patient care.

CMS Modernizing the Physician Self-Referral and Anti-Kickback Regulations

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.

CMS Launched Pilot Project to Offer Individual Market Wellness Programs

Workplace wellness programs — efforts to get workers to lose weight, eat better, stress less and sleep more — are an $8 billion industry in the U.S. Recently, Centers for Medicare and Medicaid Services (CMS) launched a pilot project for states to implement health-contingent wellness programs in the individual market. The project is part of a mandate under the Affordable Care Act that added a provision to the Public Health Service Act calling for health-contingent wellness programs to be tested in the individual market through a pilot project operated by HHS, the Department of Labor and the Treasury Department.

CMS Issues New Rule to Tighten Provider Enrollment

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released its final rule with comments on Program Integrity Enhancements to the Provider Enrollment Process (“ The Program Integrity Enhancements”).  The final rule gives CMS the power to revoke Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollments of providers or suppliers who have an “affiliation” with previously sanctioned entities, even if those providers and suppliers aren’t directly violating any existing rules themselves. CMS says that this new authority will help to “stop fraud before it happens.”