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In late November, the Centers for Medicare and Medicaid Services and the Office of the Inspector General released their final rules revising the Physician Self-Referral Law (the “
Stark Law”) and the Anti-Kickback Statute. The changes are sweeping and while they are generally designed to facilitate coordinated care, some of the changes will impact providers more broadly. Most provisions of the final rules are effective on January 19, 2021. The following is a brief overview of the hundreds of pages of rules and commentary:
The Stark Law Final Rule
New Value-Based Exceptions: New exceptions were created to permit compensation arrangements in the context of value-based arrangements designed to coordinate and improve the quality of care for patients and to lower costs.
Tuesday, December 22, 2020
OVERVIEW
On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Law. As part of these final rules, the agencies liberalized the requirements under the existing exception and safe harbor for donations of electronic health record items and services, and created a new exception and safe harbor to allow donations of cybersecurity technology and related services.
IN DEPTH
On November 20, 2020, the US Department of Health & Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (collectively, AKS Rule) in connection with HHS’s Regulatory Sprint to Coordinated Care. As part of the Stark Rule and the AKS
January 7, 2021
- CA US
Mentorhealth
Phone:8003851607
Overview:In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician employment agreements on behalf of health systems, hospitals and medical groups. He will explain key provisions and potential pitfalls in both types of agreements.Why you should Attend: Given the substantial awards and settlements in recent enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to more innovative compensation structures, they must manage their compliance and enterprise risk by ensuring their physician employment arrangements are defensible under the Stark Law.Areas Covered in the Session:Provide a general Stark Law overviewExamine critical components of Stark a
January 5, 2021
- CA US
Mentorhealth
Phone:8003851607
Overview:
In this session Mr. Wolfe will provide an overview of the Stark Law, including its technical requirements and key tenets of defensibility. He will also discuss best practices for structuring evaluating and structuring new compensation models. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
Why you should Attend: As health care organizations redesign their compensation plans, they must be sure the process they follow and the models the new models they develop are defensible under the Stark Law. In this webinar Mr. Wolfe will discuss developing best practices and how to evaluate whether a new compensation model is compliant with Stark s technical requirements and key tenets of defensibility.
Wednesday, December 23, 2020
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well.
Continued Progress on Non-COVID Priorities…
Besides the obvious scientific, technical, and regulatory work that FDA and other stakeholders have been doing all year to mount a comprehensive response to the emergence of SARS-CoV-2 as a pandemic pathogen, the agency’s work on other high-priority human drug and biological product regulatory programs continued during 2020. FDA has demonstrated a fairly impressive ability to manage a huge number of competing priorities, even as certain areas like pre-approval inspections and re-inspections of facilities seeking removal from an import alert have suffered in the face of travel restrict