S ark L aw aw An A t n i-kickbac b k S atut u e an an d Fal F se Cl C aims A c A t E f n orcement Jay y P. P A n A sti t n i e, e JD R adma m p

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1 Stark Law, Anti-kickback Statute and False Claims Act Enforcement Jay P. Anstine, JD HCCA Physician Practice Compliance Conference Philadelphia, PA October 17-19, 19, Roadmap Fraud and Abuse laws The Big Three - Background - Trends in enforcement Managing Self-Referral Compliance Legislative & Regulatory Update Questions? 2 1

2 Fraud and Abuse Background Stark 101 Refresher (42 U.S.C. 1395nn) The Stark Laws prohibit physicians from referring Medicare patients for DHS to an entity with which the physician (or immediate family) has a financial relationship with unless an exception applies. 3 Fraud and Abuse Background Three Types of Exceptions: Exceptions for compensation arrangements; Exceptions for ownership arrangements; Exceptions for both compensation and ownership arrangements. 4 2

3 Fraud and Abuse Background Stark Penalties Spectrum Denial of payment; Refund of amounts collected from improperly submitted claims; CMP up to $15,000 for each improper claim submitted; Up to 3x the amounts for each item/service claimed; Exclusion from Federal health programs; CMP up to $100k for arrangements/schemes. 5 Fraud and Abuse Background Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) Felony offense to knowingly and willfully solicit, offer, or pay for referrals of patients for items or services reimbursable by Medicare, Medicaid or other Federal health care programs. The statute prohibits the offer or solicitation of payment not only of money but also of anything of value in exchange for referrals. 6 3

4 Fraud and Abuse Background Safe Harbors Authorized by DHHS Arrangements conditionally permitted 7 Fraud and Abuse Background Penalties under the AKS include: Up to five years in prison; Criminal fines up to $25,000; Civil penalties up to $50,000;and Exclusion from participation in Federal health care programs. 8 4

5 Fraud and Abuse Background False Claims Act (31 U.S.C. 3729) Prohibits anyone from knowingly filing a false or fraudulent claim for payments to Medicare, Medicaid or other federally funded health care programs. 9 Fraud and Abuse Background Penalties include: A civil money penalty of between $5,500 and $11,000; Plus potential treble damages (3x) for each item/service claim. 10 5

6 Enforcement Trends-Legislation Fraud Enforcement and Recovery Act ( FERA ) Expands whistleblower protections and provider liability Contains a new provision creating liability for knowingly and improperly avoiding an obligation to pay the Government (e.g. retention of payment ) Patient Protection/Affordable Care Act ( PPACA ) Stark Law & Physician Ownership Changes Compliance Programs Mandatory? 11 Enforcement Trends-Settlements Big Dollar Settlements Continue Pfizer Inc. Eli Lilly Allergan City/State of NY Forest Pharm Boston Scientific = $2.3 Billion = $1.4 Billion = $600 Million = $540 Million = $313 Million = $296 Million 12 6

7 Enforcement Trends-Settlements Traditional healthcare providers back in the spotlight McAllen Hospitals- $27. 5 Million -Alleged sham medical director/lease agreements Lourdes Medical Center- $7.9 Million -Alleged inflation of charges to increase outlier payments San Mateo County Medical Center-$6.8 Million -Alleged false bed counts to increase DSH payments Covenant Medical Center-$4.5 Million -Alleged hospital overpaid physicians 13 Enforcement Trends-OIG OIG Activity Advisory Opinions-Volume Opinions Opinions Opinions Opinions Opinions 2010? Trends? 14 7

8 Self-Referral Compliance Managing Self-Referral Compliance Operational challenges Steps to improve compliance Note: References to Owner-Referral meant to include government-payer patients only. 15 Self-Referral Compliance: Operational Challenges The Human Factor Tools: Education Software 16 8

9 Self-Referral Compliance: Operational Challenges Staff Turnover Tools: Education Constant Consistent Multi-faceted Approach 17 Self-Referral Compliance: Operational Challenges Managing Compliance=Balancing Act Competing interests/parties Tools: Staff (internal and external) Patients Physician Owners Board Members Diplomacy Skills 18 9

10 Steps to Improve Compliance Scheduling Scheduling a multi-step approach Documentation! Cross-checking schedules Patient reminder calls Leverage Registration Staff 19 Steps to Improve Compliance Registration Registration.a different animal. Unscheduled exams Leverage software Edits to guard against the human factor 20 10

11 Steps to Improve Compliance Billing Billing can supply a final check Leverage software reports Further review? Disable charge? 21 Steps to Improve Compliance Key Elements Key Compliance Program Elements Education Auditing & Monitoring Investigating/Responding to Reports 22 11

12 Legislative & Regulatory Update Stark Law Changes-PPACA Revised Self-Disclosure Protocol New disclosure requirements In-Office Imaging (MRI, CT. and PET only) Physician-Owned Hospitals Compliance Programs-Mandatory? 23 Questions? Jay P. Anstine, JD Director, Corporate Compliance The Imaging Center Fort Collins, CO