the london cia - health care compliance association · 10/30/2014 3 / the london cia 5 / what is a...
TRANSCRIPT
10/30/2014
1
The London CIA
Sharon Hager, JD
Heather Lovelace, MBA, CHC
November 7, 2014
/
Objectives
• To increase knowledge of the Saint Joseph London (SJL) Corporate
Integrity Agreement (CIA), specifically:
• Who is impacted
• What it is and what obligations are required
• When it was effective
• Where it is applicable
• Why it is being implemented
• How long it is effective
• What has to be done to operationalize it
• To increase understanding of the alleged issues that led to the CIA
and how to identify potential matters in other facilities
• To provide compliance leaders with lessons learned and increase
understanding of risk mitigation efforts to prevent a CIA
The London CIA 2
10/30/2014
2
/
History
• Initial investigation by SJL
• SJL self-disclosure to
government
• Whistleblower case filed
• Ensuing criminal and civil
government investigations
• Litigation
The London CIA 3
/
Settlement with the Government
• Effective January 22, 2014
• $16.5 million plus $295,000 in relators’ fees
• Resulted in the U.S. Department of Justice resolving all potential
civil claims brought, or that could have been brought, by the
federal government or the state of Kentucky arising out of the
past relationship with some cardiologists who no longer practice
at the hospital
• Agreement was reached without admission of a violation of the
law, in order to avoid the expense and uncertainty of prolonged
litigation
The London CIA 4
10/30/2014
3
/ The London CIA 5
/
What is a CIA?
• A negotiation between the U.S. Department of Health and Human
Services Office of Inspector General (OIG) and health care
providers as part of a settlement of investigations arising under
civil false claims statutes
• The health care provider consents to rigorous standards set forth
by the OIG
• The OIG agrees not to exclude the health care provider from
participation in Medicare, Medicaid and other federal health care
programs
• More information is available at:
http://oig.hhs.gov/compliance/corporate-integrity-
agreements/index.asp
The London CIA 6
10/30/2014
4
/
Comparing CIAs
• CIAs have many common elements, but each one addresses the
specific facts at issue
• CIA requirements are often tailored to accommodate and
recognize many of the elements of preexisting voluntary
compliance programs
• Some CIAs include language to have an outside consultant
monitor and mentor compliance; others are more quality-focused
The London CIA 7
/
CIA Terms
• Effective January 22, 2014
• Five-year term
• “Covered Persons” include:
• All owners, officers, directors, and employees of SJL; and
• All contractors, subcontractors, agents, and other persons who
provide patient care items or services or who perform billing or
coding functions on behalf of SJL
The London CIA 8
10/30/2014
5
/
CIA Overview
• Many board, administrative, compliance, education, policy,
independent review and other requirements
• Emphasis on compliance, peer review, quality, cardiac procedures,
cardiac surgeries, focused arrangements, and unallowable costs
• Will result in additional costs for each year of the five-year term
The London CIA 9
/
Managing a CIA
• Compliance Officer
• Compliance Committee
• Board review and oversight of the compliance program and CIA
• Must meet quarterly
• Must adopt resolution annually signed by each member of the
board summarizing its review and oversight of the CIA and
other requirements
• Physician Executive
• Medical Director of the Cardiac Catheterization Lab
The London CIA 10
10/30/2014
6
/
CIA Standards
• Code of Conduct
• Policies and Procedures
• Documentation of medical records
• Quality assessment and performance improvement
• Medical staff peer review
• Medical staff credentialing and privileging
• Management and oversight of cardiac cath lab
• Management and oversight of cardiac surgeries
• Anti-kickback and Stark
The London CIA 11
/
CIA Training
• General Training
• CIA requirements
• Compliance program
• Code of Conduct
• Specific Training
• Arrangements Training
• Board Training
• All Covered Persons must receive the applicable training within 30
days of becoming a member or within 90 days of the effective
date of the CIA
The London CIA 12
10/30/2014
7
/
CIA Oversight
• Engagements are required with:
• Peer Review Consultant
• Four Independent Review Organizations (IROs)
• Cardiac Procedures
• Cardiac Surgeries
• Arrangements
• Unallowable Costs
The London CIA 13
/
CIA Peer Review Consultant
• Be engaged within 60 days of the CIA effective date
• Evaluate processes related to medical staff peer review, medical
staff credentialing and privileging, and medical staff training and
discipline
• Report findings and recommendations to SJL and the OIG
• Assist in implementation of recommendations
• Monitor peer review recommendations and report findings to OIG
The London CIA 14
10/30/2014
8
/
CIA Independent Review Organizations
• Cardiac Procedures
• Cardiac Surgeries
• Arrangements
• Unallowable Costs
The London CIA 15
/
CIA Independent Review Organizations
• Be engaged each year of the five-year term
• Be engaged within 90 days of the CIA effective date
• Have expertise in medical necessity and appropriateness of
interventional cardiac procedures and established practice
guidelines of the American College of Cardiology
• Evaluate and analyze medical necessity of interventional cardiac
procedures
• File an annual report with the federal government
Cardiac Procedures
The London CIA 16
10/30/2014
9
/
CIA Independent Review Organizations
• Will sample 50 interventional cardiac procedures performed at SJL
and review for:
• Appropriateness of case selection
• Quality of procedure execution
• Proper response to intra-procedural problems
• Accurate assessment of procedure outcome
• Appropriateness of procedure management
Cardiac Procedures
The London CIA 17
/
CIA Independent Review Organizations
• Interventional cardiac procedures are defined as Percutaneous
Coronary Interventions (PCI), including but not limited to:
• Diagnostic cardiac catheterizations
• Percutaneous transluminal coronary angioplasties (PTCA)
• Balloon angioplasties
• Implantation of intracoronary stenting
• Any implantation of temporary or permanent pacemaker
devices
Cardiac Procedures
The London CIA 18
10/30/2014
10
/
CIA Independent Review Organizations
• Be engaged each year of the five-year term
• Be engaged within 90 days of the CIA effective date
• Have expertise in medical necessity and appropriateness of
cardiac surgeries
• File an annual report with the federal government
Cardiac Surgeries
The London CIA 19
/
CIA Independent Review Organizations
• Will sample 50 cardiac surgeries performed at SJL and review for:
• Appropriateness of case selection
• Quality of procedure execution
• Proper response time to intra-procedural problems
• Accurate assessment of procedure outcome
• Appropriateness of procedure management
• Cardiac surgeries are defined as coronary artery bypass graft
surgeries (CABGs)
Cardiac Surgeries
The London CIA 20
10/30/2014
11
/
CIA Independent Review Organizations
• Be engaged each year of the five-year term
• Be engaged within 90 days of the CIA effective date
• Have expertise in the requirements of the federal Stark Law and
Anti-Kickback Statute
• File an annual report with the federal government
Arrangements
The London CIA 21
/
CIA Independent Review Organizations
• Will review systems, processes, policies, and procedures:
• Relating to the initiation, review, approval, and tracking of
Arrangements
• With respect to creating and maintaining a centralized tracking
system for all existing and new Focused Arrangements
• For tracking remuneration to and from all parties to Focused
Arrangements
• For tracking service and activity logs to ensure the parties to
the Focused Arrangements are performing the services
required
Arrangements
The London CIA 22
10/30/2014
12
/
CIA Independent Review Organizations
• Will review systems, processes, policies, and procedures:
• Monitoring the use of leased space, medical supplies, medical
devices, equipment, and other patient care items consistent
with the terms of the Focused Arrangement
• Initiating Arrangements and that the business rationale/need is
specified
• For the internal review and approval of Arrangements
Arrangements
The London CIA 23
/
CIA Independent Review Organizations
• Will assess the Compliance Officer’s quarterly review of, and
reporting to, the Compliance Committee on:
• The Focused Arrangements Tracking System
• Review and approval process
• Other policies and procedures
• Review systems, policies, processes, and procedures for
implementing effective responses when suspected violations of
the Anti-Kickback Statute and Stark Law are discovered, including
disclosing Reportable Events and quantifying and repaying
overpayments when appropriate
Arrangements
The London CIA 24
10/30/2014
13
/
CIA Independent Review Organizations
• Will randomly select 50 Focused Arrangements at SJL and review
to determine whether:
• SJL has complied with the requirements
• The Focused Arrangement:
• Is in the centralized tracking system
• Was subject to the internal review and approval process
• The remuneration was tracked
Arrangements
The London CIA 25
/
CIA Independent Review Organizations
• Be engaged for each year of the five-year term
• Be engaged within 90 days of the CIA effective date
• Have expertise in the cost reporting requirements of SJL
• Review whether SJL has not charged to or sought payment from
federal or state payers for unallowable costs under the CIA and
settlement agreement
• Report its findings to OIG annually
• Typically is an accounting or audit firm
Unallowable Costs
The London CIA 26
10/30/2014
14
/
Early IRO Recommendations
• Personnel changes
• Restructure Quality Department
• Changes to composition of Credentials, Medical Staff Quality
Improvement Committee (MSQIC), and Medical Executive
Committee (MEC)
The London CIA 27
/
Other CIA Requirements
• New or renewed agreements
• Each party that meets the definition of a Covered Person must
complete Arrangements training, receive a copy of Code of
Conduct, Stark and Anti-Kickback policies
• Must include certification by the parties that they shall not
violate the Stark Law or Anti-Kickback statute with respect to
the arrangement
The London CIA 28
10/30/2014
15
/
Other CIA Requirements
• Within 90 days of the effective date, establish a Disclosure
Program (toll-free compliance hotline) and maintain a disclosure
log
• Within 30 days of discovery, SJL must notify OIG of any
investigation or legal proceeding involving allegations that SJL has
committed a crime or engaged in fraud
• Within 60 days of identification, SJL must repay any overpayments
to the appropriate payer
The London CIA 29
/
CIA Reportable Events
• Must notify OIG within 30 days of a reportable event:
• Substantial overpayment
• Violation of law
• Employment or contracting with an Ineligible Person
• Quality violation that results in imminent danger to health,
safety, or well-being of a health care program beneficiary
• Filing bankruptcy
The London CIA 30
10/30/2014
16
/
CIA – Changes to Business Units
• Within 30 days prior to the effective date, SJL must notify OIG of
any sale of its business, business units, or locations
• Within 30 days of the effective date, SJL must notify OIG of any
changes of locations or closures of business, business units, or
location related to furnishing of items or services that may be
reimbursed by federal health care programs
• At least 30 days prior to the effective date, SJL must notify OIG of
the purchase or establishment of new businesses, business units,
or locations
The London CIA 31
/
CIA – Reports
• Implementation Report
• Due to OIG within 120 days of
effective date
• Provides detailed summary of
work completed during first 90
days
The London CIA 32
10/30/2014
17
/
CIA – Reports
• Annual Report
• Due to OIG on March 22nd of each year beginning in 2015 and
ending in 2019
• Provides overview of status and findings of the IROs, all
compliance activities, and a detailed summary of work
completed for each year
The London CIA 33
/
Costs of the Investigation
• Some of the costs incurred throughout this process include:
• Self-disclosure and initial payment
• Outside physician expert review
• Outside legal fees
• Local, system, and national staff and leadership time
• Financial, relationship, and reputational harm
• Civil litigation
• Leadership turnover
• Unwind current physician agreements
The London CIA 34
10/30/2014
18
/
CIA – Costs Post-Settlement
• Additional annual costs incurred by the facility in order to comply
with the requirements of the CIA include:
• Peer Review Consultant
• IROs
• Cath Lab Medical Director
• Half-time CMO
• Full-time Compliance Officer and expenses
• Education/training
The London CIA 35
/
Negative Publicity
The London CIA 36
10/30/2014
19
/
Other Regulatory Considerations
• Ongoing
government
scrutiny
• Ongoing
litigation
• Significant
monetary
penalties daily
for non-
compliance with
CIA and potential
exclusion
The London CIA 37
/
Lesson Learned
• If something sounds too good to be true, it probably is (i.e., high
revenue from a service line)
• Expand data mining when looking for outliers
• Include medical necessity reviews as part of compliance
monitoring for high volume physicians
• Conduct thorough due diligence when acquiring physician
practices and include medical necessity reviews of specialists
• Don’t be afraid to walk away from a deal
• Make sure what is on paper is being practiced
The London CIA 38
10/30/2014
20
/
Risk Mitigation Efforts
• Centralization and standardization of compliance
• Compliance at the leadership table
• Data analytics and monitoring
• Due diligence
• Peer review
• Automation and standardization of the conflicts of interest
process
• Adherence to medical necessity criteria policy
The London CIA 39
/
Risk Mitigation Efforts
• Medical necessity/clinical appropriateness reviews
• Physician contracting and review procedures
• Physician compensation standards and review committee
• Non-monetary compensation database
• Physician-owned entity policy
• Disclosure of payments from business sources
The London CIA 40
10/30/2014
21
/
Questions
Sharon Hager, JD
Vice President and General Counsel
Catholic Health Initiatives
(502) 569-7974
Heather Lovelace, MBA, CHC
Corporate Responsibility Officer
Catholic Health Initiatives
(606) 330-6771
The London CIA 41