1. Program Integrity & Labs
California Clinical Laboratory Association
2016 Annual Conference
Cybil Roehrenbeck, JD
Polsinelli, PC
Washington, DC

2. Today’s Agenda
Program Integrity Landscape
Government Scrutiny
Common Issues
Impact on Coverage
Q&A

3. Program Integrity Landscape
What is “program integrity”?
Source: mcolblog.com

4. Program Integrity Landscape

5. Government Scrutiny – OIG Review
The Office of Inspector General (OIG) releases a “work plan” on an annual basis to identify issues that they intend to watch, study, and audit.
The OIG work plan is an early indicator of areas on which the government intends to focus, and may give some insight into the government’s planned actions for the upcoming year.

6. Government Scrutiny – OIG Review
Highlights from 2016 OIG Work Plan:

7. Government Scrutiny – OIG Review
Source: OIG, “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2016: Year 2 of Baseline Data”

8. Government Scrutiny – OIG Review
OIG Special Fraud Alerts & Advisory Opinions – Kickbacks, Improper Arrangements, Self-Referrals….

9. Government Scrutiny – CMS review
Since 2010, CMS has dramatically increased the number of fraud investigators and expanded their enforcement powers and administrative remedies.
Source: CGSmedicare.com

10. Government Scrutiny – CMS Review
CMS has announced that new contracts – for Unified Program Integrity Contractors (UPICs) are going live.
Source: BNA Bloomberg 2016

11. Government Scrutiny
CMS has broad authority to suspend payments based on its findings, or while in the process of an audit, with few limitations:
Source: Office of Inspector General, U.S. Dept of Health & Human Services

12. Common Issues – Medical Necessity
Outside lab control
In lab control

13. Common Issues – Medical Necessity
Documentation requests – CMS parameters:
CMS Medicare Program Integrity Manual Ch. 3, , “Special Provisions for Lab Additional Documentation Requests”

14. Common Issues – Medical Necessity
Documentation requirements – CLIA v. Medicare

15. Common Issues
Panels
Kickbacks
Self-Referral

16. UPCOMING Common Issues - Affiliations
Source:

17. UPCOMING Common Issues - Affiliations

18. Impact on Medicare Coverage
Source: Centers for Medicare & Medicaid Services

19. Impact on Medicare Coverage
Source: Centers for Medicare & Medicaid Services

20. Impact on Medicare Coverage
Medicare coverage policies include program integrity provisions that can be later used as the basis for audits and recoupment. For example:

21. Counsel | Polsinelli PC
Q&A + Contact Information
Cybil G. Roehrenbeck
Counsel | Polsinelli PC
Washington, DC

22. Polsinelli provides this material for informational purposes only
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