What Keeps You Up at Night? Issues of Fraud and Abuse Compliance Series Don’t Let This CIA Sneak Up On You: What You Need to Know About Corporate Integrity Agreements
What is a Corporate Integrity Agreement? 2
Today’s Speakers Thomas E. Zeno T +1 513 361 1202 thomas.zeno@squiresanders.com Elizabeth A. Mills T +1 513 361 1203 elizabeth.mills@squiresanders.com Elizabeth E. Trende T +1 614 365 2728 elizabeth.trende@squiresanders.com 3
What is a CIA? • Result of Criminal conviction Deferred prosecution agreement Civil settlement Investigation by HHS – Office of Inspector General • OIG accepts CIA in exchange for not seeking exclusion from health care programs • Although common elements, specifically tailored to problems of settlement 4
Source of CIA • DOJ and OIG work together on health care matters • OIG Agents often involved in investigations • OIG Counsel provide agency support • Settlements are signed by DOJ and OIG 5
OIG Role in CIAs Only OIG • Has authority to release exclusion authorities • Negotiates terms of CIAs With individuals With entities • Drafts CIAs • Signs CIAs • Administers (enforces) CIAs Using administrative process 6
OIG Role in Exclusions • Delegated by Secretary of HHS to OIG • OIG excludes thousands of individuals and entities annually • Exclusions process allows for engagement with the OIG in advance of exclusion • Due process protections allow for administrative and judicial appeal (sometimes) after implementation • Department of Justice NOT involved in the OIG’s decision making process 7
Effect of Exclusion by OIG • No Payments for items or services furnished, ordered or prescribed by the excluded individual or entity 8
A Rosetta Stone for Exclusions • Section 1128 of the Social Security Act Is the same as • Section 1128 of the Act Is the same as • 42 U.S.C. § 1320a-7 9
More on Exclusion http://www.squiresanders.com/what_keeps_ you_up_at_night_fraud_and_abuse_compli ance_webinar_series_part_ii/ http://www.squiresanders.com/files/Publication/8fe2d243-8cf0- 45bf-9251- d33be521ea26/Presentation/PublicationAttachment/eb2c3a71- 10 bdff-485c-9f96-d43e31a89724/Rx_for_Health_Care_Fraud.pdf
CIA Guidance https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp 11
CIA Basics • OIG executed its first 4 CIAs in 1994 Initial CIAs only required provider to attend training and certify completion to OIG • OIG has entered into more than 200 CIAs/IAs in the last 5 years • Majority of agreements are 5 years • Contain standard provisions 12
Navigant Report 13
Terms of CIA • Most terms are standard 40 to 60 pages • Compliance program Written Standards Compliance Officer Board of Directors training and involvement • Policies and procedures • Training Covered Persons Compliance training for all Contractors too? Who is not a Covered Person matters 14
Terms of CIA – Selecting an IRO • Independent Review Organization (IRO) must meet qualifications specified in CIA • Independence and objectivity requirements • OIG can require removal of IRO if has reason to believe the IRO: Does not possess the required qualifications Is not independent and objective Has failed in its responsibilities under the CIA 15
Terms of CIA – IRO (con’t) • Independent Review Organization review Annual Arrangements Transaction Review CIA specifies number of Agreements to be reviewed by IRO Database important Expensive and difficult Annual Performance/Claims Review Discovery sample If greater than 5% error rate, additional sampling and Systems Review required 16
Terms of CIA – IRO (con’t) • Considerations for effective relationship Need to be able to live with the result Set expectations on both sides IRO 17
Terms of CIA – OIG Monitor • OIG Monitor Assigned by OIG All notifications and reports required under CIA to be submitted to Monitor Communication with Monitor encouraged by OIG 18
Terms of CIA (con’t) • Ineligible Person screening procedures Prevent hiring and contracting with excluded persons • Reportable Events Definition is important Mandatory Substantial Overpayment “Matter a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program…” Employment of or contracting with a Covered Person who is an Ineligible Person 19
Terms of CIA (con’t) • Written notice of CIA to health care clients • Implementation Report and Annual Report • Notifications to OIG regarding locations • Annual reviews by Compliance Officer • Board oversight and certifications • Compliance Officer certification 20
Terms of CIA (con’t) • OIG inspection, audit and review rights • Stipulated Penalties • Material Breach = Exclusion Administrative appeal - final 21
Terms of CIA (con’t) • Purchase or Sale - Mandatory Transfer of Terms Binding on new acquisition Remains binding if unit sold Binding on successor organization Waivable by OIG 22
Terms – Quality of Care CIAs • Reportable Event Violation of one or more instances of immediate danger to health, safety or well-being Places beneficiary in high-risk situation • Independent Quality Monitor Specific issue Overall quality 23
Engaging with the OIG • Earlier the better During negotiations about settlement • Make contact through USAO or DOJ Attorney • Mandatory exclusion CANNOT be waived by the OIG under any circumstances • Fruitful discussion depends on facts Is damage – Financial only? Personal injury? HIPAA? Is settlement – Civil only? Criminal conviction? 24
Engaging with the OIG (con’t) • Don’t expect much negotiation • Discussions with OIG primarily forward-looking Focused on current and future compliance program Opportunity to discuss corporation, subsidiaries, and/or individuals 25
Alternative to a CIA? • Sometimes Certification of Compliance Agreement (CCA) Maintain Compliance Program Report overpayments, reportable events, and ongoing investigations and legal proceedings Provide annual reports regarding the entity’s compliance activities during term of CCA 26
Trends in CIAs • Church Street Health Management Entered into civil settlement agreement with the DOJ on January 20, 2010 Paid more than $24 million in penalties and fines and entered into a 5 year CIA with the OIG CIA contained standard penalty provisions for breaches of the agreement In 2012, OIG issued Notice of Material Breach and Intent to Exclude Notice to CSHM CSHM unable to resolve all of the breaches within 30 day cure period OIG required CSHM to divest a subsidiary as a condition for the parent to avoid exclusion 27
Trends in CIAs (con’t) • GlaxoSmithKline 2012 settlement – largest on record $3 billion $1 billion criminal; $2 billion civil 122 page CIA “Integrity Champions” responsible to implement Document off label requests Targets plans for sales Shifts from volume based compensation Bonus and incentive three year claw back Posting of study results, even discontinued ones Posting of grants and charitable giving 28
Trends in CIAs (con’t) • Next generation of CIAs February 23, 2012 Pharmaceutical Compliance Roundtable August 7, 2012 Roundtable with representatives from 32 companies that have entered into CIAs since 2009 Included hospitals, ambulance companies, medical device manufacturers, physician practices, labs, home health agencies and SNFs 29
Light At The End of The Tunnel 30
Three Things That Can Help • Compliance • Compliance • Compliance 31
Compliance • Now is the time to ensure robust compliance • Proactive adoption of practices now in CIAs • Keep a kudos file • Explain cost benefit analysis Cost of compliance v. cost of CIA Specific examples in your industry 32
CIA Guidance https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp 33
Thank You for Joining Our Webinar Join Us for Our Next Call in This Series … • Proper Recordkeeping in a Heightened Enforcement Environment – Spring 2013 34
Thank You for Joining Our Webinar Contact us with other topics, questions or issues: • Tom Zeno: thomas.zeno@squiresanders.com • Elizabeth Mills: elizabeth.mills@squiresanders.com • Emy Trende: elizabeth.trende@squiresanders.com 35
What Keeps You Up at Night? Issues of Fraud and Abuse Compliance Series
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