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Stark + AKS Proposed Regulations

This hub includes information developed by AHLA, as well as government and other resources, to help our members and the public stay abreast of new developments to the two highly anticipated final rules to reform the Stark Law and Anti-Kickback Statute regulations. This hub will be updated once the final rules are released with information on upcoming webinars, podcasts, and articles.

​Just Released

AHLA News & Analysis

​From HHS

AHLA Podcasts

Fraud and Abuse: What to Expect from the Final Stark/AKS Rules (Speaking of Health Law Podcast, August 24, 2020)
In this episode of our monthly series on fraud and abuse issues, Matthew Wetzel, Associate General Counsel, Compliance Officer, GRAIL, Joe Wolfe, Partner, Hall Render Killian Heath & Lyman PC, and Kristin Carter, Partner, Baker Donelson Bearman Caldwell & Berkowitz PC, discuss the eagerly anticipated final rules reforming the Stark Law and Anti-Kickback Statute. The podcast dives into when the rules might be released and what they might look like. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.

Stark and AKS Proposed Rules: Questions Answered (Speaking of Health Law Podcast, December 3, 2019)
Building on their enormously popular October webinar on the Stark and AKS proposed rules, Robert Homchick, Partner, Davis Wright Tremaine LLP, and Julie Kass, Principal, Baker Donelson Bearman Caldwell & Berkowitz PC talk with Mark Ryberg, Principal, SullivanCotter to answer important questions about the rules and dig deeper into issues such as distinctions between the CMS and OIG approach to certain definitions, what is a value-based purpose, and downside/upside risk definitions. From AHLA's Fraud and Abuse Practice Group. Sponsored by SullivanCotter.

Acting IG Joanne Chiedi on AKS Reform, Technology, and the Future of Enforcement (Speaking of Health Law Podcast, November 21, 2019)
Acting Inspector General Joanne Chiedi speaks to AHLA CEO David Cade about the OIG’s goals in proposing Anti-Kickback Statute reforms and how the agency plans to move forward in its enforcement efforts. Chiedi talks about emerging technology and the future of data analytics and how technology can improve health care. The podcast also discusses how OIG intends to address information blocking and interoperability. Sponsored by GlassRatner, a B. Riley Financial company.

HHS Deputy Secretary Hargan Talks to AHLA on Stark, AKS Proposed Regs (Speaking of Health Law Podcast, October 10, 2019)
HHS Deputy Secretary Eric Hargan speaks to AHLA CEO David Cade about the newly unveiled Stark and Anti-Kickback Statute proposed regulations. Hargan discusses how the proposed rules are a central feature of the agency’s broader effort to advance value-based care and reduce regulatory burdens that impede care coordination. The podcast describes the key revisions to the fraud and abuse regulations including proposed new safe harbors and exceptions, updates to existing exemptions, and definitions of commercial reasonableness, volume and value of referrals, and fair market value. Hargan also talks about next steps and the agency’s priorities for regulatory reform. Sponsored by GlassRatner, a B. Riley Financial company.

AHLA Webinars

Potential Operational Implications of the Stark Law Proposed Rule for Health Care Entities

Recorded on 03/26/2020  |  Purchase On-Demand Recording
On October 17, 2019, CMS published a proposed rule that would make significant changes to the Stark Law. If finalized, this rule would modify fundamental concepts under the Stark Law including definitions, exceptions, and various “special rules” designed by CMS. In this session we will discuss some of the most significant proposed changes to the Stark Law and discuss ways in which they will create opportunities and challenges for hospitals, group practices, providers in value-based care arrangements, and other health care entities.

Federal False Claims Act: A Year in Review

Recorded on 02/27/2020  |  Purchase On-Demand Recording
Federal False Claims Act recoveries remained at an all-time high in 2019 as the United States government continues the fight against fraud. Last year saw a slew of new case law and announcements from the DOJ and some new enforcement priorities. “A Year in Review” will update you on the current regulatory enforcement environment, including: 

  • Important regulatory, compliance, and enforcement activity during 2019; 
  • Noteworthy settlements and lessons learned over the past year;
  • Continuing developments with the Stark Law, the Anti-Kickback Statute, and the False Claims Act; and
  • Proactive compliance activities to protect your organization in 2020 and beyond.

Health Information Technology Implications of the AKS and Stark NPRM

Recorded on 11/19/2019  |  Available In AHLA's Health Law Archive (with a subscription)
On October 9, CMS and OIG issued two highly anticipated proposed rules to reform the Stark Law and Anti-Kickback Statute (AKS) regulations. The rules are part of the agencies’ broader efforts to address perceived regulatory barriers to innovation and move toward a more affordable, high quality, value-based health care system, while maintaining important protections for patients and programs. Join leading industry experts and representatives from CMS and OIG for an AHLA webinar that will focus on the proposed regulatory changes affecting health information technology, including the creation of a new Stark exception/Anti-Kickback safe harbor for the donation of cybersecurity technology, and the potential extension or elimination of the sunset date for the electronic health record donation rules. CMS and OIG will discuss proposals for both the Stark exceptions and the Anti-Kickback safe harbors. The webinar will also cover health information technology implications of the other regulatory proposals, which are part of the NPRM.

The Stark Proposed Rule: Exploring the New FMV, Commercial Reasonableness and Volume or Value Guidance

Recorded on 11/12/2019  |  Available In AHLA's Health Law Archive (with a subscription)
On October 9, CMS issued a highly anticipated proposed rule aimed at modernizing and streamlining the Federal Stark Regulations. The proposed rule contains extensive guidance on three critical regulatory requirements, fair market value, commercial reasonableness, and the prohibition on “taking into account” the volume or value of a physician’s referrals. Notably, CMS proposed modifications to the FMV definition, a new definition for commercial reasonableness, and a bright-line standard for circumstances where compensation will be considered to “take into account” the volume or value of referrals. Join leading industry experts, including the Chief Legal Officer for CMS, for an AHLA webinar that will focus on the proposed rule and this important Stark guidance.

This webinar is sponsored by:

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Stark and AKS Proposed Rules: What You Need to Know

Recorded on 10/24/2019  |  Available In AHLA's Health Law Archive (with a subscription)

On October 9, CMS and OIG issued two highly anticipated proposed rules to reform the Stark Law and Anti-Kickback Statute (AKS) regulations. The rules are part of the agencies’ broader efforts to remove regulatory barriers to innovation and move toward a more affordable, high quality, value-based health care system, while maintaining important protections for patients. Join leading industry experts and representatives from CMS and OIG for an AHLA webinar that will analyze key provisions of the proposed rules such as new, permanent exceptions to the Stark Law for value-based arrangements that would apply broadly to care provided to all patients, as well as the clarifications and guidance on key statutory terms. Speakers will also examine elements of the AKS proposed rule including the three new safe harbors for remuneration exchanged between or among eligible participants; for all innovation models that CMS sponsors; and for donating cybersecurity technology and services.

This webinar is sponsored by:

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