On November 20, 2020, the Department of Health and Human Services (HHS) published two rules that finalize reforms to several regulations governing fraud and abuse in the Medicare and Medicaid programs. The first rule, published by the HHS Office of Inspector General (OIG), focuses primarily on the Anti-Kickback Statute (AKS). The second rule, published by the Centers for Medicare & Medicaid Services (CMS), addresses the Physician Self-Referral Law, commonly referred to as the “Stark Law.” These final rules took effect on January 19, 2021.

Reviewed during this webinar are the newly finalized protections for value-based arrangements, as well as other important changes across a broad range of areas—from simplifying compliance to clarifying and redefining foundational concepts. Key topics include:

• The background of the proposed rules, including the transition towards value-based care and the HHS objective to remove roadblocks to care transformation that drove the amendments.
• The new protections for value-based care, which allow for the exchange of financial and other benefits in pursuit of care coordination, patient engagement, quality improvement and cost reduction.
• The revised protections regarding transfers of cybersecurity and electronic health record (EHR) technology.
  Other amendments to the AKS and Stark regulations that ease compliance burdens, clarify ambiguities and align with updates in other laws.
• The new or modified definitions for critical Stark Law concepts, such as “designated health services,” “commercially reasonable” and “fair market value.”

AAPM&R strongly recommends consultation with health care counsel experienced in the federal Stark Law and the AKS, as well as the applicable state’s fraud and abuse laws, prior to taking any actions in reliance on the final rules discussed in this webinar.  

Learning Objectives
After completing this enduring material, the participant should be able to:

• Develop an understanding of value-based care and value-based arrangements for which new Stark and Anti-Kickback Statute flexibilities will apply. 
• Develop an understanding of new Stark and Anti-Kickback Statute flexibilities to support engagement in value-based activities. 
• Learn about the revised protections regarding transfers of cybersecurity and electronic health record (EHR) technology.
• Discuss the other amendments to the AKS and Stark regulations. 
• Understand the new or modified definitions for critical Stark Law concepts.

Accreditation Statement
The American Academy of Physical Medicine and Rehabilitation is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Designation of Credit
The American Academy of Physical Medicine and Rehabilitation (AAPM&R) designates this enduring material for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. 

Financial Disclosures
AAPM&R requires all individuals who are in a position to control the content of an educational activity to disclose all relevant financial relationships with any commercial interest, which is any entity producing, marketing, re-selling or distributing health care goods or services consumed by, or used on, patients. Disclosures are made in written form prior to the start of the educational activity and any potential conflicts of interest that exist are resolved prior to the start of the activity through AAPM&R’s Conflict of Interest Disclosure and Resolution Policy Process. Individuals in a position to control content and their disclosed financial relationships are listed below.

Faculty
Robert Jasak, Esq.:Disclosed no relevant financial relationships. 
Cindy H. Moon, MPP, MPH: Board member, Semler Scientific.
Segun Dawodu, MD, MBA, JD: Disclosed no relevant financial relationships.

AAPM&R Medical Education Committee
John C. Cianca, MD: Ownership or partnership with Musculoskeletal Ultrasound Consultants, LLC.
Karen P. Barr, MD: Disclosed no relevant financial relationships.
Rachel A. Brakke Holman, MD: Disclosed no relevant financial relationships.
Joseph E. Burris, MD: Serves on the Speakers Bureau for, and received clinical research grants from Allergan.
David S. Cheng, MD: Disclosed no relevant financial relationships.
Theresa A. Gillis, MD: Disclosed no relevant financial relationships.
Kevin N. Hakimi, MD: Disclosed no relevant financial relationships.
Matthew T. Haas, MD: Disclosed no relevant financial relationships.
R.Samuel Mayer, MD: Royalties from Demos Medical Publishing.
Ameet S. Nagpal, MD MS MEd: Disclosed no relevant financial relationships.
Sunil Sabharwal, MD: Royalities from Demos Publishing; board member, American Board of Physical Medicine and Rehabilitation.
Sarah M. Smith, MD: Disclosed no relevant financial relationships.
Stephanie Tow, MD: Disclosed no relevant financial relationships.
Kevin R. VIncent, MD, PhD: Disclosed no relevant financial relationships.

AAPM&R CME Committee
Karen P. Barr, MD: Disclosed no relevant financial relationships.
Cherry C. Junn, MD: Disclosed no relevant financial relationships.
Sheryl R. Levin, MD: Disclosed no relevant financial relationships.
Kentaro Onishi, DO: Disclosed no relevant financial relationships.
Evan R. Peck, MD: Disclosed no relevant financial relationships.
Cynthia G. Pineda, MD: Disclosed no relevant financial relationships.
Patricia T. Tan, MD: Disclosed no relevant financial relationships.
Brionn K. Tonkin, MD: Disclosed no relevant financial relationships.
Kristin A. Wong, MD: Disclosed no relevant financial relationships.

No other planners, faculty or other individuals in control of content disclosed any relevant financial relationships.

FDA Disclosures
All faculty members for this activity have disclosed they do not intend to discuss or demonstrate any pharmaceutical or medical device for which FDA clearance has not been approved.