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Pathology Services: Legal Compliance Update
Presented By:Bridget Cougevan, Esq.McDonald Hopkins LLC
600 Superior Avenue, East, Suite 2100Cleveland, OH 44114
216-348-5842 direct dial216-348-5474 facsimile
October 5, 2013
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COMPLIANCETopics Covered:• Recent Developments• Research Study Arrangements• Pathology Billing and Audit Activities• In-house laboratories • Account billing• EHR donations• HIPAA: HITECH Final Rule
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RECENT DEVELOPMENTS• Stark in-office ancillary services exception:– Removal of anatomic pathology professional and
technical services• Physician fee schedule• OPPS/APC fee schedule• Coding
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RESEARCH STUDY ARRANGEMENTS
• Privacy considerations– HIPPA– Institutional Review Boards
• Legal Issues– Data ownership– Publications– Inventions
• Material Transfer Agreements
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Pathology Billing and Audit Activities
• Medicare RACs, ZPICs• EHR Considerations
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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
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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
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HIPAA: HITECH Final Rule• Business Associates– Agreements
• Notice of Privacy Practices• Restrictions on disclosure of PHI• Security Breaches and Breach Notification• Enforcement
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Questions?
Contact InformationBridget Cougevan, Esq.McDonald Hopkins LLC
600 Superior Avenue, East, Suite 2100Cleveland, OH 44114
216-348-5842 direct dial216-348-5474 facsimile