What Keeps You Up at Night? Issues of Fraud and Abuse Compliance - - PowerPoint PPT Presentation

▶
what keeps you up at night
SMART_READER_LITE
LIVE PREVIEW

What Keeps You Up at Night? Issues of Fraud and Abuse Compliance - - PowerPoint PPT Presentation

Aug 11, 2023 210 likes •587 views

What Keeps You Up at Night? Issues of Fraud and Abuse Compliance Series Dont Let This CIA Sneak Up On You: What You Need to Know About Corporate Integrity Agreements What is a Corporate Integrity Agreement? 2 Todays Speakers Thomas

slide-1
SLIDE 1

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

slide-2
SLIDE 2

2

What is a Corporate Integrity Agreement?

slide-3
SLIDE 3

3

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

slide-4
SLIDE 4

4

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

slide-5
SLIDE 5

5

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
slide-6
SLIDE 6

6

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

slide-7
SLIDE 7

7

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

slide-8
SLIDE 8

8

Effect of Exclusion by OIG

  • No Payments for items or services furnished,
  • rdered or prescribed by the excluded individual
  • r entity
slide-9
SLIDE 9

9

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
slide-10
SLIDE 10

10

More on Exclusion

http://www.squiresanders.com/files/Publication/8fe2d243-8cf0- 45bf-9251- d33be521ea26/Presentation/PublicationAttachment/eb2c3a71- bdff-485c-9f96-d43e31a89724/Rx_for_Health_Care_Fraud.pdf http://www.squiresanders.com/what_keeps_ you_up_at_night_fraud_and_abuse_compli ance_webinar_series_part_ii/

slide-11
SLIDE 11

11

CIA Guidance

https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp

slide-12
SLIDE 12

12

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
slide-13
SLIDE 13

13

Navigant Report

slide-14
SLIDE 14

14

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

slide-15
SLIDE 15

15

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
slide-16
SLIDE 16

16

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

slide-17
SLIDE 17

17

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

slide-18
SLIDE 18

18

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
slide-19
SLIDE 19

19

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

slide-20
SLIDE 20

20

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

slide-21
SLIDE 21

21

Terms of CIA (con’t)

  • OIG inspection, audit and review rights
  • Stipulated Penalties
  • Material Breach = Exclusion
  • Administrative appeal - final
slide-22
SLIDE 22

22

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
slide-23
SLIDE 23

23

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
slide-24
SLIDE 24

24

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?
slide-25
SLIDE 25

25

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

slide-26
SLIDE 26

26

Alternative to a CIA?

  • Sometimes Certification of Compliance

Agreement (CCA)

  • Maintain Compliance Program
  • Report overpayments, reportable events, and
  • ngoing investigations and legal proceedings
  • Provide annual reports regarding the entity’s

compliance activities during term of CCA

slide-27
SLIDE 27

27

Trends in CIAs

  • Church Street Health Management
  • Entered into civil settlement agreement with the DOJ
  • n 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

slide-28
SLIDE 28

28

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
slide-29
SLIDE 29

29

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

slide-30
SLIDE 30

30

Light At The End of The Tunnel

slide-31
SLIDE 31

31

Three Things That Can Help

  • Compliance
  • Compliance
  • Compliance
slide-32
SLIDE 32

32

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
slide-33
SLIDE 33

33

CIA Guidance

https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp

slide-34
SLIDE 34

34

Thank You for Joining Our Webinar

Join Us for Our Next Call in This Series …

  • Proper Recordkeeping in a Heightened

Enforcement Environment – Spring 2013

slide-35
SLIDE 35

35

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
slide-36
SLIDE 36

What Keeps You Up at Night?

Issues of Fraud and Abuse Compliance Series