Post on 16-Jun-2020
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Tips on Avoiding, Complying &
Negotiating CIA’sSusan E. Gillin, Esq. Sr Counsel (OIG/OCIG)
Lisa Rivera, Esq. Bass, Berry & SimsA. Michael Rosen, Esq. Co‐Founder, ProviderTrust, Inc
Susan E. Gillin Esq.
Sr. Counsel (OIG/OCIG)
Lisa Rivera, Esq.
Bass, Berry & Sims
Michael Rosen, Esq.
Co‐founder ProviderTrust
Your Speakers
Today’s Agenda
Main components
What is a CIA? What terms to negotiate
Role of a CCO/IRO
OIG’s perspective Exclusion monitoring & self disclosure
Operating under a CIA
How to succeed under a CIA –OIG’s perspective
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Part One
CIAs & Compliance Programs
• Compliance Officer• Management certifications• Training• Reportable events/self‐disclosure• Screening for excluded persons
CIAs:The OIG’s expectations for the minimum elementsof a compliance program
• Risk assessments• Audits• Stipulated penalties and exclusion
The OIG’s Perspective
Self‐Disclosure
Guidance Familiarize
CIAs are a form of compliance guidance
Self‐disclosure can help you avoid CIAs
Familiarizing yourself withrequirements helps
negotiations run smoothly
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Employee
Member of senior management
Reports to the Board
Not counsel to the company
Responsible for reporting requirements under CIA
Compliance Officer
Board Resolution and Management Certifications
• Increased accountability
• Board understands its responsibilities and has examined the compliance program
• Managers have responsibility for compliance in the areas under their supervision
Training
Training Plan language allows companies to determine how much training to give and to whom.
The provider and their counsel is in the best position to know how to mitigate risks and allocate compliance resources.
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Risk Assessments
• Recent addition to CIA model, but has been in numerous pharma CIAs
• Covers all federal health care program risks, regardless of covered conduct
• OIG expects the activities to be conducted by compliance, and not under attorney client privilege
• A CIA should position a company to better self‐police afterward
Audits• Independent Review Organizations conduct claims review
and arrangements reviews
• Companies should also be conducting internal reviews
• Reviews have become more targeted— OIG’s goal is that they address risks faced by the company going forward, not the covered conduct
• We are open to discussions mid‐CIA about how to make IRO reviews more relevant to changing risks
Screening
Whether your healthcare organization is under a CIA or not, you need to be monitoring for exclusions each month.
• Covers individuals and third party entities
• Current employees, contractors, and vendors as well as prospective individuals and entities
• The OIG‐ LEIE should be searched each month as well as SAM.gov(Best practice is to include available state Medicaid exclusion lists)
CIAs require Reportable Event and removal if you discover an excluded individual or entity. You must remove from any position involving federal health care programs.
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Part Two
Tips on Negotiating CIA’s
Living Under and in Compliance with a CIA
Negotiation Considerations
Scope ‐ addressing specific problems, with demonstrable focus
Degrees ‐ compare previous protocols to those proposed or seen in other cases
Prevention ‐measures in place, successes
Accountability ‐ staff training and accountability measures
Internal testing ‐ probes, sample size, extrapolation
Costs
Compliance Expert ‐ independent advisor
Independent Review Organizations (IRO)
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IRO
• OIG approval required• Contractor ‐ paid by provider, answers to the OIG• Qualified ‐ subject matter expertise• Reports ‐ not onsite every day• Reporting periods vary• Testing• Documents to provide or make available• Access ‐ systems, policies, procedures, Q&A, culture Explain the
process specify provider contact person(s)/designee(e) Request modification as appropriate
Complying with a CIA
• Get everyone on board
• Implement the CIA provisions and report to OIG Internal assessment‐ who will be signing certifications of compliance?‐ who will be responsible for implementation?‐ identify all systems and areas impacted, funnel information‐ identify all documents and electronic information impacted
• Develop a schedule or CIA compliance work plan, test it
Complying with a CIA
• Line up monitor or IRO
• Implement internal regular testing
• Follow up after every test, every IRO review Document tweaks and ongoing successes
• Anticipate ‐ past areas of concern, provider/industry vulnerabilities
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Violating a CIA Stipulated penalties
False Statements (certifications)
False Claims Act exposure
Exclusion
Recent enforcement efforts
Individuals at risk
Violating a CIA
Considerations:• nature/extent of violation• result of violation (quality of care
vs. reimbursement) • demonstrable corrective action • proper disclosure, transparency • historical pattern vs. new
conduct • period of time under scrutiny
Quality of Care CIAs
• Required in cases involving systemic failures of quality assurance systems and patient harm
• Have been used in SNFs, dental chains, hospitals, physician practices
• Quality‐related reviews:• Quality Monitors review quality of care on site• Peer review consultants review medical necessity of cardiac procedures• Claims reviews look for medical necessity of services and admissions
• Also contain the standard CIA provisions
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Part Two
Exclusion Monitoring: who, when and what
Pending Charges & Proposed Exclusions
If actual notice of offense covered by the exclusions statute, or that someone is proposed for exclusion, then the CIA removal requirement applies.
http://oig.hhs.gov/fraud/enforcement/cmp/cmpa.asp
What to do about SAM.gov?
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If a provider under a CIA is engaged in Federal health care program business with a contractor that is subject to a government‐wide debarment, what are the provider's obligations?
As a general rule, the suspension or debarment of a contractor by any Federal agency invokes the Ineligible Persons provisions of the CIA. The CIA requires reporting to OIG and removal from “responsibility for, or involvement with” the provider's “business operations related to the federal health care programs.”
You may access the EPLS at: http://www.epls.govand SAM at https://www.sam.gov.
SAM.gov
From the OIG Website
What is the difference between the LEIE and the General Services Administration's (GSA) Excluded Parties List
System (EPLS) and System for Award Management (SAM) websites?
GSA administers EPLS and SAM, both of which contain debarment actions taken by various Federal agencies, including exclusion actions taken by the OIG.
The List of Excluded Individuals/Entities contains only the exclusion actions taken by the OIG.
Stipulated Penalties
10‐03‐2014Florida Physician Pays IA Stipulated Penalty
06‐09‐2014Florida Medical Device Company Pays CIA Stipulated Penalty
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Exclusion for Material Breach
On March 7, 2014, OIG issued a Notice of Exclusion to Church Street Health Management (CSHM), pursuant to the Breach and Default provisions of CSHM's CIA, based on numerous material breaches of the CIA and CSHM's failure to cure those breaches.
CSHM LLC (March 7, 2014)
For excluded individuals, the protocol explains how to calculate damages:
OIG Self‐disclosure protocolApril 17, 2013
• For direct providers, the amount of the individual claims for items and services
• For services that are not separately billable, total costs of employment of the excluded individual, multiplied by the entity federal healthcare program payor mix
• A separate calculation must be included for each Federal health care program
Reportable Events/Self‐Disclosure
Under CIA, report all probable violations of civil, criminal, or administrative law related to Federal health care programs.
If not under a CIA, providers may report all potential fraud violations under OIG’s Self‐Disclosure Protocol
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Tips on Succeeding under a CIA: View from OIG
Tips from the OIG on how to succeed under a CIA
Don’t forget the basics
Don’t be afraid to ask your CIA monitor questions
Don’t rely on ”off‐the‐shelf” compliance policies and training
Don’t certify to 100% compliance, unless you are in fact, 100% compliant
Don’t try to "coach" your employees prior to a site visit
Tips continued
Don’t do all of your communication with OIG through outside counsel
Don’t argue your lack of liability
Don’t wait until the due date (or later) to ask for an extension
Don’t report an unworthy event
Don’t try to influence your IRO’s findings
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QuestionsAnswers&
Learn. Improve. Grow.
mrosen@providertrust.com
lriver@bassberry.com
susan.gillin@oig.hhs.gov