1. Pathology Services: Legal Compliance Update Presented By: Bridget Cougevan, Esq. McDonald Hopkins LLC 600 Superior Avenue, East, Suite 2100 Cleveland, OH 44114 216-348-5842 direct dial 216-348-5474 facsimile bcougevan@mcdonaldhopkins.com October 5, 2013

2. COMPLIANCE Topics Covered: Recent Developments Research Study Arrangements Pathology Billing and Audit Activities In-house laboratories Account billing EHR donations HIPAA: HITECH Final Rule

3. RECENT DEVELOPMENTS Stark in-office ancillary services exception: – Removal of anatomic pathology professional and technical services Physician fee schedule OPPS/APC fee schedule Coding

4. RESEARCH STUDY ARRANGEMENTS Privacy considerations – HIPPA – Institutional Review Boards Legal Issues – Data ownership – Publications – Inventions Material Transfer Agreements

5. Pathology Billing and Audit Activities Medicare RACs, ZPICs EHR Considerations

6. ACCOUNT BILLING Account Billing/Client Billing Arrangements: Physician purchase professional and/or technical component pathology services at a discount and bill the payor. Typically excludes government work. Medicare Anti-Markup Regulations Other Payers State Prohibitions

7. EHR DONATIONS Stark law exception & AKS safe harbor – Permitted for a narrow range of donations – Must not take into account the volume/value of referrals – May not have protection after December 31, 2013 State Restrictions Donation Requirements

8. HIPAA: HITECH Final Rule Business Associates – Agreements Notice of Privacy Practices Restrictions on disclosure of PHI Security Breaches and Breach Notification Enforcement

9. Questions? Contact Information Bridget Cougevan, Esq. McDonald Hopkins LLC 600 Superior Avenue, East, Suite 2100 Cleveland, OH 44114 216-348-5842 direct dial 216-348-5474 facsimile bcougevan@mcdonaldhopkins.com