| Appreciating the Anti-Kickback Statute's 1/3 Income Rule for ASC Investments and a Recent Case Involving Not Meeting the Personal Service & Management Contracts Safe Harbor
Presenter: Rachel Rose, JD, MBA
Time: 56.46 minutes
Description: It is imperative to appreciate the risk and reputational, financial, and legal costs of not complying with federal fraud, waste, and abuse laws. Rachel Rose, Attorney at Law, discusses AKS safe harbors, Stark Law exceptions, and EKRA safe harbors, which should be squarely met for compliance.
Objectives:
- Discuss AKS, Physician Self-Referral Law (Stark Law), and EKRA nuances.
- Recognize safe harbors and exceptions to understand what is required in general.
- Study the AKS safe harbor – ASC investments and the one third of income requirement (42 C.F.R. § 1001.952(r)(3)(i)).
- Examine the AKS safe harbor – personal services and management contracts (42 C.F.R. §1001.952(d)).
- Explore recent seventh circuit opinion involving 42 C.F.R. §1001.952(d) and HIPAA.
- Review compliance considerations.
Key Topics:
- HHS OIG STATEMENT
- AKS, Stark Law, and EKRA – Similarities and Differences
- The Anti-Kickback Statute (1972)
- Stark Law – General Items
- New Stark Law and AKS Final Rules (Dec. 2, 2020, effective Jan. 19, 2021)
- Eliminating Kickbacks in Recovery of 2018 (EKRA)
- EKRA Highlights
- Safe Harbors and Exceptions – What is Required in General?
- According to HHS-OIG…
- 2 Key Questions and Answers
- EKRA (7 Safe Harbors)
- AKS Safe Harbor – ASC Investments and the One Third of Income Requirement
- 42 C.F.R. § 1001.952(r)(3)(i)
- Surgeon Owned
- Single Specialty ASC
- Multi-Specialty ASC
- Hospital/Physician Owned ASC
- The Practice Income Test - Determining “Income” Related to the 1/3 of Income Requirement – OIG FAQ
- Drilling Down Further
- OIG Emphasizes the Inquiry Is “Facts and Circumstances Based”
- Two More OIG Opinions
- AKS Safe Harbor – Personal Services and Management Contracts
- Personal Services and Management Contracts and Outcomes-Based Payment Arrangements
- Stop Ill. Health Care Fraud, LLC v. Sayeed , Nos. 22-3295 and 23-1943
(7th Cir. May 2, 2024)
- Background
- Compliance Considerations – Conclusion
- HHS-OIG Guidance 2023
- Justice Manual Corporate Compliance
- Compliance Considerations
Speaker Rachel V. Rose, JD, MBA - Principal. https://www.rvrose.com/ Ms. Rose has a unique background. Throughout her career, she has accumulated knowledge in a multitude of fields, with an emphasis on various facets of healthcare. Her experiences include:
- working on Wall Street and at one of the "Big Four" consulting firms;
- producing for the Chairman of the Reform and Oversight Committee on Capitol Hill;
- interning at the Department of Health and Human Services;
- compiling policy papers at the Royal College of Nursing in London;
- consultative work as a top performing representative for the pharmaceutical and medical device industry;
- clerking for the Honorable Linda R. Allan (6th Judicial Circuit, FL).
Prior to opening her law firm, she was Director of Business Development and Assistant General Counsel for a healthcare advisory company. She is extensively published and presents on a variety of healthcare, False Claims Act and securities law topics including: cybersecurity, qui tam, physician reimbursement, ICD-10, access to care, anti-kickback and Stark laws, U.S. Supreme Court cases impacting the medical device industry, international comparative healthcare laws, and the HIPAA/the HITECH Act.
Presently, she is the immediate past-chair of the Federal Bar Association's Corporate and Associations Counsel Division (2014-2016), one of eighteen lawyers, who serves on the Federal Bar Association's Government Relations Committee. Ms. Rose has co-authored The American Bar Association's books - The ABCs of ACOs and What Are International HIPAA Considerations?, as well as being a co-editor of American Health Lawyers Association’s Enterprise Risk Management Handbook (2nd Edition). Ms. Rose is also an Affiliated Member of the Baylor College of Medicine's Center for Health Policy and Medical Ethics, where she teaches bioethics and is on the University of Houston Law School's Healthcare Law Advisory Board.
Education
- Bachelor of Arts- History (The Pennsylvania State University)
- Master of Business Administration (Vanderbilt University)
- Doctorate of Jurisprudence (Stetson University College of Law); Editor, The Journal of International Law and Aging
Honors and Awards
- National Scribes Award
- The William F. Blews Pro Bono Service Award
- Federal Bar Association Fellow
- Named to Texas Bar College
- National Women Trial Lawyers Association - Top 25,, 2018 and 2019
- Houstonia Magazine's Top Lawyers- Healthcare Law, 2018 and 2019
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