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HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology Monday, February 8, 2021
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others.
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HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records Friday, February 5, 2021
In this fifth installment of our blog series covering the changes, we dive into (i) the new AKS safe harbor and Stark Law exception for cybersecurity technology and related services, and (ii) the significant changes to the existing safe harbor and exception for electronic health records (EHR) technology.
Cybersecurity Technology and Related Services
In the face of mounting concerns about the financial losses and risks to patients caused by cyberattacks against hospitals and other health care providers, the agencies finalized a new safe harbor and a new exception for donations of cybersecurity technology and services. The health care industry – particularly hospitals – should welcome this new flexibility to donate cybersecurity technology and services to physic
“Full Financial Risk”
A. Overview of Key Safe Harbors and Exceptions
An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. Stakeholders must navigate the requirements under both regulatory regimes for arrangements that potentially implicate each law. Although a number of commenters sought a unified set of requirements between Stark Law and AKS requirements, CMS and OIG rejected this approach, noting the different purposes of each law. In general, CMS provides more flexibility for Stark Law exceptions, given its strict liability standard. In contrast, OIG felt it was appropriate for the AKS which is an intent-based law to serve as “backstop” protection for arrangements that implicate both laws. The six safe harbors and exceptions set forth by OIG and CMS are as follows:
Tuesday, February 2, 2021
On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse landscape for “value-based” arrangements:
(i) The HHS Office of the Inspector General (OIG) published a Final Rule that introduces new safe harbor protections under the federal Anti-Kickback Statute (AKS) for certain coordinated care and risk-sharing value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions (AKS Final Rule).
(ii) The HHS Centers for Medicare & Medicaid Services (CMS) published a Final Rule that finalizes similar exceptions to the Physician Self-Referral Law (Stark Law) for certain value-based compensation arrangements between or among physicians, providers, and suppliers (Stark Final Rule, and together with the AKS Final
Note from the Editors
Digital technologies have transformed almost every aspect of the health care and life sciences industry from electronic health records and telemedicine, to diagnostics and therapeutics augmented by artificial intelligence, and to remote clinical trials. The year 2020 witnessed the COVID-19 pandemic catalyzing unprecedented levels of digital health innovation and adoption. The digital health industry is entering 2021 with optimism for even greater advancement, reductions in regulatory burdens, and continued widespread adoption of digital health technologies. In the Industry Insights contribution for this issue, several of our digital health experts briefly summarize the major advancements in four key digital health areas that took place over 2020, as well as expectations for 2021.