pathology services: legal compliance update presented by: bridget cougevan, esq. mcdonald hopkins...

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

bcougevan@mcdonaldhopkins.com

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

bcougevan@mcdonaldhopkins.com