Webinar On The Healthcare Compliance Toolkit Best Practices

1. The Health Care Compliance Toolkit: Best Practices for Compensating and Contracting With Physician Presented by Joseph N. Wolfe, Esq.

2. Joseph Wolfe is a partner with Hall Render, the largest health care focused law firm in the country, now with offices nationwide. Hall Render attorneys provide advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a broad range of regulatory, operational and strategic matters. Mr. Wolfe regularly counsels clients on a national basis regarding compliance-focused physician compensation strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation and health care fair market value issues. Before attending law school at the University of Wisconsin, he served as a combat engineer in the United States Army. . Relevant presentations specific to health care contracting trends include: Right Sizing Your FMV and Commercial Reasonableness Process: Finding an Approach that Aligns with Industry Guidance and Developing Best Practices,and What Works for You - AHLA Webinar (March 7, 2018). • What Keeps You up at Night? Case Studies in Challenging Fair Market Value and Commercial Reasonableness Analyses - Physicians and Hospitals Law Institute (February 5, 2017) New Orleans, LA. • Fair Market Value and Commercial Reasonableness 101: Distinguishing Between Legal Requirements, Developing Best Practices and Dogma – AHLA Webinar (December 6, 2017). • A Fair Market Value Primer for Health Lawyers and Compliance Officers - Fraud and Compliance Institute (October 5, 2017) Baltimore, MD. • How to Use and Not Abuse MGMA and Other Survey Data in FMV Compliance Programs – Physicians and Hospitals Law Institute (February 1, 2017) Orlando, FL. • Acronym Soup: CJR, BPCI, OCM, MIPS, and APMs, What Do They Mean for FMV and Reasonableness in Compensation – AHLA Webinar (December 6, 2016). • Joseph N. Wolfe, Esq. MIPS and MACRA: What Healthcare Valuators Need to Know Now – BVR Webinar (November 29, 2016). • Strategies for Developing Compliant Physician Compensation Plans - AMGA Compensation Collaborative (November 10, 2016) New York, NY. • PhysicianCompensation Data: Questions and Answers for the Era of Value Based Reimbursement - AHLA Webinar (August 29, 2016). • Innovation Through Alignment: Strategies and Emerging Models for Successful AMC Physician Partnerships: AHLA AMC Conference (March 14-15, 2016) Washington, DC. • Exploring Gainsharing and ACO Compensation Trends - AMGA Annual Meeting (March 10, 2016) Orlando, FL. • Maintaining Compliance While Compensating Physicians for Quality and Cost Savings; HFMA, National Payment Innovation Summit (February 12, 2016) Memphis, TN. •

3. Agenda • Part I: Introductory Concepts – The Road to Compliance – The Enforcement Environment • Part II: Overview of the Regulatory Standards – Anti-Kickback – Stark Law – False Claims Act – Yates Memo • Part III: Case Studies • Part IV: Best Practices Toolkit 3

4. Part I: Introductory Concepts 4

5. The Road to Compliance The Current Climate: – More integration and financial relationships with referring physicians – More physician compensation arrangements that are tied to quality and/or value metrics – More alternative payment models (e.g., CJR, BPCI, MIPS and APMs, etc.) in the market – Despite reforms, the health care industry must still comply with a rigid and technical (mostly Stark Law) regulatory framework – Recent enforcement + disproportionate penalty structure = Enterprise Risk "Toolkit" of Considerations for Managing Risk: – Financial relationships must be defensible under the all applicable health care laws – Must focus on demonstrating the 3 Tenets of Defensibility: Fair market value ("FMV"), commercial reasonableness ("CR") and not taking into account ("TIA") referrals – Documentationand governanceprocesses (e.g., business planning, valuation, etc.) should support defensibility – For CMS Innovation Models (e.g., ACOs, BPCI, CCJR, etc.) focus on meeting the applicable technical requirements and the fraud and abuse waiver requirements – For cost-control models, must also focus on building in safeguards to ensure the models do not incentivize reductions in medically necessary services 5

6. Enforcement Environment: A Bit Hostile? • Enforcement (on both federal and state level) – IRS, DOJ, CMS, OIG, state AG, HRSA, OCR, ZPIC, MAC, MIC, etc. • Whistleblowers/qui tam relators • Civil claims, criminal liability, stiff penalties • Media and public scrutiny • Political focus on health care reform 6

7. Part II: Overview of the Regulatory Standards 7

8. Regulatory Framework • Federal Health Care Programs – Anti-Kickback Statute – Federal Stark Law – False Claims Act – Civil Monetary Penalties Law • EMTALA • HIPAA • Non-Profit and Tax Exemption Issues • Antitrust Compliance • State Law Issues 8

9. The Anti-Kickback Statute • Criminal Statute: – Prohibits paying "compensation" to induce items or services payable under federal health care programs – Intent is required (case law allows for inference of intent) – Broad and subjective statute Safe Harbors: – Protection requires strict compliance with all conditions of the applicable safe harbor – Safe harbor compliance is voluntary – Failure to comply with a safe harbor does not mean an arrangement is illegal – Arrangements that do not fit in a safe harbor must be evaluated on a case-by- case basis • 9

10. Stark's General Framework • If a Physician has a Financial Relationship with an Entity: – Then the Physician may not make a referral to that Entity for the furnishing of designated health services ("DHS") for which payment may be made under Medicare; and – The Entity may not bill Medicare, an individual, or another payor for the DHS performed pursuantto theprohibitedReferral… ... unlessthe arrangementfitssquarelywithina Starkexception • Threshold Compliance Statute: – Strictliability– no intentrequired.Civil (non-criminalstatute) – Triggeredby "technical"violations, inadvertenceanderror – Yourregulatory"Litmus Test" 16