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Pathology Services: Legal Compliance Update

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. COMPLIANCE. Topics Covered :

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Pathology Services: Legal Compliance Update

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  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

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