1. AHCA Compliance Webinar: Session 3 Dealing With Excluded Individuals/Entities Designing and Implementing A Corporate Compliance Program: Hiring or Contracting With Excluded Individuals and Entities These materials have been prepared by Poyner Spruill LLP for informational purposes only and are not legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship.

2. AHCA Webinar Series: Where We’ve Been In October 2008, Session 1, we began with: –What is a compliance program –Elements of an effective program –Corporate philosophy statements –Role of Board of Directors/Owners Examining “mechanics” or “structure” of compliance programs first, then moving into “substance” or laws making up the program We’ll be doing this monthly through November 2009 Prior webinars, materials and updates to the 2000 AHCA compliance manual are posted on AHCA website (www.ahca.org)

3. Session Two, November 2008 We covered: –Compliance officers and compliance committees –How they work, what are their responsibilities –Who should be on them –Their role in “structure” of compliance program operation –Discussion with actual providers (large/small) were shared What works and maybe what doesn’t Challenges they’ve faced with officers & committees Successes they recommend to other providers

4. Today: Excluded Individuals/Entities I’ll explain impact of not understanding the OIG’s exclusion authority and what happens if you employ, contract with or “do business with” excluded individuals/entities OIG will explain more about the exclusion program, what it addresses and the process by which providers can determine if individual/entity is excluded Cheri Battee, provider, will walk us through an actual “sample” check using a tool her company developed You – questions and answers

5. The Rules on Exclusion OIG can or must exclude individuals/entities: –Convicted of a program-related crime (patient abuse included) –Who submit false or fraudulent, or otherwise improper, claims –Or submit claims during period of exclusion To any “Federal Health Care program” –Medicaid, Medicare, Tricare and VA are main LTC ones –But, also, Maternal/Child Health Grant, Social Services block grants to states, & State Children’s Health Insurance OIG excludes individuals, entities (corporation, partnership, LLC, etc.) and in any profession related to health care, not just the nurses/doctors

6. The Basic Rule on Exclusion No payment will be made by any Federal health care program for any items or services furnished, ordered or prescribed by excluded individual or entity –Includes services/items “directed by” (M.D. directs an order) –Whether billed separately, bundled, per cost reports, fee schedules or a PPS system –And even where the Federal payment is made to another provider or supplier who is not excluded, if provided/directed/ordered by the excluded individual or entity –Includes administrative/management services not directly related to patient care, but that are necessary component of providing items or services to program beneficiaries

7. Once Exclusion Occurs, You May Not: Employ, contract with, allow them to direct the ordering or delivery of services or supplies, undertake certain administrative duties, utilization reviews, MDS reviews Whether or not direct care activities If any part of that task is reimbursed by Federal program Even if you don’t submit the claim yourself Example: your contractor has excluded employee who performs some task that is reimbursable Some LIMITED exceptions Rule is very broad & can be complex

8. The Exclusion Status of Others You are charged by law with knowing the exclusion status of employees and contractors Not required by law with checking the OIG database But, there are sanctions (later) if you “knew or should have known” of exclusion & submit the claim anyway OIG materials—”affirmative duty” to check status With online, available OIG database, no reason to argue the “know or should have known” standard So – CHECK THE DATABASE ! New hires/contracts and periodically for existing ones

9. So, What Are The Consequences of “Doing Business With” Excluded Individuals/Entities? For the excluded individual/entity submitting claims: –$10,000 fine for each item/service claimed or “caused to be” claimed (i.e, by another entity) –Plus treble damages = amount claimed for each item/service –Extension of existing exclusion period Reinstatement is not automatic after exclusion Also potentially amounts to a false claim under Federal False Claims Act –Separate basis for administrative sanctions or exclusion

10. So, What Are The Consequences of “Doing Business With” Excluded Individuals/Entities? For the provider who employs/contracts with excluded individual or entity: –Civil money penalties of up to $10,000 for each item or service furnished by the excluded individual/entity –Plus CMP of three times the amount claimed for each item or service –In extreme cases, exclusion from Federal health care programs Note—some states have parallel state laws

11. So, Ken’s Easy Rule Remember real goal: no role in Federal health care at all The “10-foot pole” Rule Just don’t go there and when in doubt, don’t My clients: “But she’s so important to our bottom line” Response: Maybe she’s “too creative” And, “are you prepared for the consequences?” “But, the exceptions” – very, very narrow You’ll need to seek advisory opinion in most cases to assess whether you can proceed What message does that send public & government?

12. OFFICE OF INSPECTOR GENERAL EXCLUSIONS

13. Exclusions Implementing exclusions for over 30 years Over 3,100 individuals and entities excluded in FY 2008 Over 44,000 individuals and entities currently excluded Referrals received from various sources, including licensing boards, United States Attorney’s offices, Medicaid Fraud Control Units and Medicaid State Agencies Referrals reviewed to determine if there is a basis for exclusion http://oig.hhs.gov/fraud/exclusions.asp

14. Exclusions continued  Mandatory – must be processed  Permissive – option to process or close http://oig.hhs.gov/fraud/exclusions/authorities.asp

15. Effect of Exclusion Remedial in purpose –Protection of Federal health care programs and beneficiaries Improper payment Improper/abusive practices No further program remuneration Government-wide debarment OPM debarment Does NOT effect ability to receive benefits as a beneficiary

16. Reinstatement Excluded until reinstated by OIG, regardless of the length of exclusion imposed EXAMPLES:  A doctor who is excluded under section 1128(a)(1) for the minimum period of 5 years is eligible to apply for reinstatement 120 days before the 5-year period expires  A nurse who is excluded under section 1128(b)(4) is eligible to apply reinstatement once the license has been returned to active status by the licensing board

17. Reinstatement continued  Excluded individuals and entities must submit a written request for reinstatement  The excluded individual or entity must complete a reinstatement application and sign an authorization which allows the OIG to request information from employers  An investigation is conducted based on the information provided in the completed application  Average processing time is 90-120 days

18. Reinstatement continued OIG notifies the individual or entity of the decision on reinstatement by letter Reinstated individuals and entities are removed from the LEIE If reinstatement is denied, the individual or entity may request a review If reinstatement is denied, the individual or entity is eligible to apply again in 1 year

19. Withdrawal Basis for exclusion is reversed or vacated Reinstated back to date of exclusion EXAMPLE:  A pharmacist excluded under section 1128(a)(4) has his conviction overturned on appeal

20. Waiver Waiver may be granted for mandatory exclusions (except 1128(a)(2) patient abuse/neglect) if the subject is the –Sole community physician –Sole source of essential specialized services in a community Waiver may be granted for permissive exclusions if –OIG determines that imposition of exclusion is not in the public’s interest

21. Waiver continued Requires a written request from the individual administering the Federal or State health care program Applies to a limited geographical area Exclusion remains in effect elsewhere

22. List of Excluded Individuals/Entities LEIE  Individuals and entities currently excluded  Downloadable site available since September 1995  Online searchable site available since March 1999  Both updated monthly http://exclusions.oig.hhs.gov/

23. Information Contained in the LEIE The LEIE contains only exclusion actions currently in effect The LEIE contains only exclusion actions taken by the OIG The LEIE does NOT contain actions taken by any other agencies

26. Contact Joann M. Francis, Investigations Analyst Exclusions Staff Office of Investigations Office of Inspector General Suite 210 7175 Security Boulevard Baltimore, MD 21244 (410) 281-3069 joann.francis@oig.hhs.gov