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