April 27, 2009 OIG S FDA t - a L t E e IE Lists DOS-LAPD OF D A GSA-EPLS -BIS O C C S- - O LS S D D D P N

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1 April 27, 2009 FDA State Lists DOS-LAPD OIG-LEIE DOS-LSDP GSA-EPLS OFAC-SDN DOC-BIS

2 Exclusion Authority Statutes (SSA) 42 USC 1320a-7 and 42 USC 1320c-5 Impact of Exclusion No payment by a federal health care program for items/services provided/ordered/directed/prescribed by an excluded individual/entity Includes Management/Administrative Services DHHS OIG Authority to exclude from federal health care programs Maintains list of excluded individuals and entities(leie) Impose CMPs for violations 42 USC 1320a-7a(a) Excluded Parties List Service EO & 12689; 31 USC 6101 note; 48 CFR Government-wide Nonprocurement Suspension and Debarment Common Rule (68 FR 66533) List of each Agency s rules: Federal Agencies & their Contractors Prohibited from Employing/Contracting with those on the LEIE Federal Grants, Cooperative Agreements, Contracts What it Does and Does Not Include Entities debarred, suspended, proposed for debarment, excluded or disqualified under the nonprocurement common rule, etc. Accuracy of information NOT guaranteed!

3 See 42 CFR 1002 State Initiated Exclusion from Medicaid Does Not Require Publication of Exclusion List State Exclusion Lists Texas Medicaid Exclusion List New York List of Providers Not Allowed to Order/Bill nsion%20and%20debarment%20websites.doc CMS Letter to State Medicaid Agencies Office of Foreign Assets Control (OFAC) Administers and Enforces Economic and Trade Sanctions based on US Foreign Policy & National Security Enforces economic sanctions that prevent trade or financial transactions and other prohibited dealings Specially Designated Nationals List (SDN) OFAC publication listing terrorist, drug traffickers, those with ties to certain countries US citizens and permanent residents are prohibited from doing business (trade and financial transactions) with those on the SDN

4 BIS Lists Denied Persons List: Those Denied Export Privileges Unverified Lists: Parties who BIS was unable to verify in a prior transaction - Raises a red flag to resolve before conducting any transactions Entity List: Those whose presence in a transaction may require an export license under EAR Includes those formally listed on General Order No. 3 State Department Debarred List : Those barred under ITAR (defense items/info) Nonproliferation Sanctions FDA Debarment List 21 USC 335a Individuals restricted from receiving investigational drugs, bioloigics or devices based on FDA determination. Cannot work for a drug manufacturer in any capacity Disqualified, Restricted and Assurances List for Clinical Investigators ORI PHS Administrative Actions List

5 Part of an Effective Compliance Program (FSG) Due diligence Knew or should have know standard Limited Substantial Authority Individuals Fair Credit Reporting Act - Employees Internal v. External Agency State Laws

6 U.S. Sentencing Guidelines: careful delegation of authority and due care in hiring/screening employees OIG Compliance Program Guidance: employees, contractors and medical and clinical staff checked routinely (e.g. at least annually) against OIG LEIE and GSA EPLS Federal Acquisition Regulation: review EPLS prior to contract award Research Applicable Government Lists Identify Risk Populations Select Routine Check Intervals Consider What Other Departments Are Doing Decide In-House or Vendor Database Search Apply Verification Procedures for Potential Matches Initiate Appropriate Action on Verified Matches Document Policies & Procedures

7 Federal Lists - OIG / GSA / FDA - OFAC / DOC / DOS Populations: - All University Employees (Semi-Annual), plus all New Employees at Time of Hire - Affiliated Research Personnel (Semi-Annual) - Commercial A/P Vendors $1,000 + (Annual), plus all New Contractors/Subs Prior to Award - Procurement Card Vendors $1,000 + (Annual) (Templates #1 & #2) All Applicable Lists Included in Database Variables Included in System Checks (Full Name, Address, DOB, SSN/TIN) Auto Elimination of Non-Matches In Future Search Results Data Security and Record Retention System Administrator Feature Allows CO to View All Departmental Searches/Results Annual vs. Per Search $ Fee

8 Name/Date of Birth per VOD Summary Report Social Security Number Date of Birth per Federal Agency Records Address / Action Date Analysis Certification Form Template #3 Verification Procedures Template #4 Potential Match Review Sheet Template #5 Employee/Affiliate Certification Form Name per VOD Summary Report Tax Identification Number / SSN Address Review - City/State Per Federal Agency Record - Central Contractor Registration Review Certification Form Template #6 Verification Procedures Template #7 Potential Match Review Sheet Template #8 Vendor Certification Form

9 Finding Federal Agency Lists/Resources Understanding List Nuances/Pitfalls Deciding if Government Agency Contact is Necessary Determining Specific Action Necessary for Verified Matches Initial Check Background Checks Employees, Students and Residents Volunteers GSA EPLS List Check Annual Reviews Batch run against on-line databases Employees (including Residents), Vendors and Contractors Matches Referred to Institutional Compliance Office Template #9 Process for Contracts/Purchasing

10 Vendor Contractual Language Temporary Employees Volunteers Students who are not Employees Loss of Employee s Licensure Millie Johnson, JD, CPC, CCEP Institutional Compliance Officer Texas Tech University Health Sciences Center millie.johnson@ttuhsc.edu Robin Wilcox, CPA, CHC, CCEP Associate Compliance Officer University of Louisville robin.wilcox@louisville.edu