April 27, 2009

State Lists

GSA-EPLS

FDAOIG-LEIE

DOS-LSDP

DOS-LAPD

DOC-BIS

OFAC-SDN

� 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 12549 & 12689; 31 USC 6101 note; 48 CFR 9.404� Government-wide Nonprocurement Suspension and Debarment Common Rule (68 FR 66533)

� List of each Agency’s rules: http://www.epa.gov/isdc/reg.htm

� 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!

� 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

◦ https://www.desc.dla.mil/dcm/files/state%20suspension%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

� 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

� 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

� U.S. Sentencing Guidelines:

“ careful delegation of authority and due caredue caredue caredue care in hiring/screening employees”

� OIG Compliance Program Guidance:

“ employeesemployeesemployeesemployees, contractorscontractorscontractorscontractors and medical and clinical medical and clinical medical and clinical medical and clinical staff staff staff staff checked routinely (e.g. at least annually) against OIG LEIE and GSA EPLS”

� Federal Acquisition Regulation:

“review EPLS prior to prior to prior to 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

� 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

� 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

� 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

� 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

806-743-3950

millie.johnson@ttuhsc.edu

Robin Wilcox, CPA, CHC, CCEP

Associate Compliance Officer

University of Louisville

502-852-1371

robin.wilcox@louisville.edu