Corporate Integrity Agreements American Health Lawyers Association 2001 Institute of Medicare and...

Corporate Integrity Corporate Integrity AgreementsAgreements

American Health Lawyers AssociationAmerican Health Lawyers Association

2001 Institute of Medicare and 2001 Institute of Medicare and Medicaid Payment IssuesMedicaid Payment Issues

Gary W. EilandGary W. Eiland

W. McKay “Mac” Henderson W. McKay “Mac” Henderson

March 29, 2001March 29, 2001

PurposePurpose

To establish provider compliance with To establish provider compliance with applicable rules and laws (and now with the applicable rules and laws (and now with the

provider’s internal policies and provider’s internal policies and procedures).procedures).

PurposePurpose

Generally, settlement of health care fraud Generally, settlement of health care fraud issues should have an accompanying issues should have an accompanying compliance agreement . . . aimed at compliance agreement . . . aimed at preventing future wrongdoing. . . . It is the preventing future wrongdoing. . . . It is the responsibility of HHS to negotiate an responsibility of HHS to negotiate an agreement where the Medicare or Medicaid agreement where the Medicare or Medicaid program is implicated.program is implicated.

Source: OIG/USAG Joint Report, Coordination of Fraud and Abuse Source: OIG/USAG Joint Report, Coordination of Fraud and Abuse Enforcement Programs (January 24, 1997)Enforcement Programs (January 24, 1997)

PurposePurpose

A global settlement agreement between a A global settlement agreement between a USAO and a provider or supplier entered USAO and a provider or supplier entered into for the purpose of resolving civil into for the purpose of resolving civil and/or criminal responsibility for past and/or criminal responsibility for past conduct, should not include within it any conduct, should not include within it any section designed to regulate future billing section designed to regulate future billing procedures and policies, unless those procedures and policies, unless those provisions have been reviewed by the provisions have been reviewed by the HHS Office of Counsel to the IG.HHS Office of Counsel to the IG.

Source: OIG/USAG Joint Report, Coordination of Fraud and Abuse Source: OIG/USAG Joint Report, Coordination of Fraud and Abuse Enforcement Programs (January 24, 1997)Enforcement Programs (January 24, 1997)

PenaltiesPenalties

Failure to timely Failure to timely implement the implement the compliance provisions compliance provisions of the CIAof the CIA

Failure to timely submit Failure to timely submit an implementation an implementation report or annual reportreport or annual report

Violations Triggering the Violations Triggering the Stipulated Penalties:Stipulated Penalties:

PenaltiesPenalties

Improper hiring/employing of Improper hiring/employing of ineligible personsineligible persons

Failure to grant access to information Failure to grant access to information required by the CIArequired by the CIA

Failure to comply with any obligation Failure to comply with any obligation of the CIAof the CIA

Violations Triggering the Violations Triggering the Stipulated Penalties:Stipulated Penalties:

ExclusionExclusion

Material breach is an independent basis for Material breach is an independent basis for exclusionexclusion

Material breach is defined to include:Material breach is defined to include: Failure to report material deficienciesFailure to report material deficiencies Failure to respond to stipulated penaltiesFailure to respond to stipulated penalties Failure to retain an IRO for review Failure to retain an IRO for review

obligationsobligations Repeated violations of CIARepeated violations of CIA

ExclusionExclusion

Stipulated penalties accrue for each Stipulated penalties accrue for each day of a violation, usually ranging day of a violation, usually ranging from $500 to $3,000 from $500 to $3,000

Providers are given an opportunity to Providers are given an opportunity to cure any violation that would result cure any violation that would result in exclusionin exclusion

Necessity of a CIANecessity of a CIA

Provider typically has already Provider typically has already negotiated settlement in principle with negotiated settlement in principle with the DOJ/USAOthe DOJ/USAO

OIG OIG quid pro quo quid pro quo for joining for joining settlement agreement and providing settlement agreement and providing release under OIG’s permissive release under OIG’s permissive exclusion and CMP authoritiesexclusion and CMP authorities


No statutory requirement for a CIANo statutory requirement for a CIA Duplicative of provider’s corporate Duplicative of provider’s corporate

compliance programcompliance program


Settlements without a CIA Settlements without a CIA No release of federal False Claims Act No release of federal False Claims Act

liabilityliability No release of OIG permissive exclusion No release of OIG permissive exclusion

authorityauthority

Negotiating with OIGNegotiating with OIG Potential for “standard draft”Potential for “standard draft” Understand OIG’s position on issuesUnderstand OIG’s position on issues

Demonstrate “how this problem will Demonstrate “how this problem will not happen again” not happen again”

Establish communicationsEstablish communications

Negotiating with OIGNegotiating with OIG

Prepare for negotiations Prepare for negotiations Involve client’s Involve client’s

compliance teamcompliance team Involve IRO in scope Involve IRO in scope

developmentdevelopment Involve legal advisor Involve legal advisor

on contractual issueson contractual issues

Negotiating with OIGNegotiating with OIG Present current Present current

compliance structurecompliance structure Use to reduce scope of Use to reduce scope of

IRO reviewIRO review Shift monitoring to Shift monitoring to

internal resources internal resources Present alternative to Present alternative to

address OIG concernsaddress OIG concerns

Negotiating with OIGNegotiating with OIG

Incorporate re-negotiation optionsIncorporate re-negotiation options Pick your battles- standard clausePick your battles- standard clause Frequently asked questionsFrequently asked questions Annual report checklistAnnual report checklist

Typical ProvisionsTypical Provisions

DefinitionsDefinitions Appointment of individual responsible Appointment of individual responsible

for compliancefor compliance Written standards such as policies and Written standards such as policies and

procedures and a code of conductprocedures and a code of conduct Training and education for employeesTraining and education for employees


Review measuresReview measures Validation reviewValidation review Reporting requirementsReporting requirements

Material deficiency Material deficiency defineddefined

Reporting material Reporting material deficiencydeficiency


Reporting of misconductReporting of misconduct Ineligible personsIneligible persons Inspection, audit, reviewInspection, audit, review Implementation reportImplementation report Confidential disclosureConfidential disclosure


Stipulated penaltiesStipulated penalties Claims reviewClaims review Third party billersThird party billers Dispute resolutionDispute resolution

Current TrendsCurrent Trends

OIG performing on-site OIG performing on-site auditsaudits OIG has authorization and OIG has authorization and

funding to conduct auditsfunding to conduct audits OIG using on-site audits to OIG using on-site audits to

re-audit providers whose re-audit providers whose annual reports appeared annual reports appeared insufficientinsufficient


Cost of CIA to an organizationCost of CIA to an organization Potential for modifying the Potential for modifying the

number of years for compliance number of years for compliance and billing engagementsand billing engagements

Allowing entities to reduce scope Allowing entities to reduce scope of IRO review in later yearsof IRO review in later years


Importance of OIG acknowledgement Importance of OIG acknowledgement of procedures and communication of procedures and communication with IRO (compliance vs. billing with IRO (compliance vs. billing engagements)engagements)

If IRO procedures deemed inadequate, If IRO procedures deemed inadequate, OIG will look to clientOIG will look to client

An agreement on coding criteria prior An agreement on coding criteria prior to initiation of billing revenueto initiation of billing revenue


Use of IRO for other Use of IRO for other engagementsengagements It all dependsIt all depends Disclose work in Disclose work in

annual/IRO reportannual/IRO report Audit worksheet and Audit worksheet and

overpayment formoverpayment form


“ “Often sample items cannot be located. Often sample items cannot be located. How missing sample items are handled How missing sample items are handled depends on the objectives of the audit and depends on the objectives of the audit and the characteristics being analyzed. The the characteristics being analyzed. The sampling plan must include a discussion of sampling plan must include a discussion of how missing sample items are to be how missing sample items are to be handled and the rationale.”handled and the rationale.”

Sampling Issues: Missing Sampling Issues: Missing RecordsRecords

Source: OIG Chapter 6-20, OAS Audit Policies and Procedures, OAS Source: OIG Chapter 6-20, OAS Audit Policies and Procedures, OAS Chapter 20-02, OAS Transmittal 96:04 (08-05-96)Chapter 20-02, OAS Transmittal 96:04 (08-05-96)


““The sampling plan must include a The sampling plan must include a discussion of how missing sampling discussion of how missing sampling items were handled and the items were handled and the rationale.”rationale.”

Sampling Issues: Missing RecordsSampling Issues: Missing Records

Source: OIG Provider Self-Disclosure Protocol, 63 Fed. Reg. 58399 Source: OIG Provider Self-Disclosure Protocol, 63 Fed. Reg. 58399 (October 20, 1998)(October 20, 1998)


““Question 18: When performing a billing Question 18: When performing a billing review, if supporting documentation for review, if supporting documentation for the unit that was randomly selected is not the unit that was randomly selected is not available, how should this unit be available, how should this unit be evaluated.”evaluated.”


Source: Frequently Asked Questions Related to OIG Corporate Integrity Source: Frequently Asked Questions Related to OIG Corporate Integrity Agreements (November 6, 2000)Agreements (November 6, 2000)

Current TrendsCurrent Trends““Answer 18: If the provider cannot Answer 18: If the provider cannot

produce supporting documentation for produce supporting documentation for a unit that was selected, this unit a unit that was selected, this unit should be considered an error in the should be considered an error in the amount paid. It is NOT permissible for amount paid. It is NOT permissible for the provider to remove this unit from the provider to remove this unit from the sample, to replace this unit with the sample, to replace this unit with spare or to consider that the service spare or to consider that the service was properly coded, billed, and was properly coded, billed, and reimbursed.”reimbursed.”

November 6, 2000


For the purpose of appraising Items included in the For the purpose of appraising Items included in the Claims Review and/or the Probe Sample, any Paid Claims Review and/or the Probe Sample, any Paid Claim for which Provider cannot produce any Claim for which Provider cannot produce any documentation (i.e., missing medical records) to documentation (i.e., missing medical records) to support the Paid Claim shall be reported as an support the Paid Claim shall be reported as an error and the total reimbursement received by error and the total reimbursement received by Provider for such Paid Claim shall be reported and Provider for such Paid Claim shall be reported and repaid as an Overpayment. Replacement sampling repaid as an Overpayment. Replacement sampling for Paid Claims with missing documentation is not for Paid Claims with missing documentation is not permitted.”permitted.”


Source:Source: Provision from Provision from recently proposed CIA (2001)recently proposed CIA (2001)


Proper “statistical” procedure would be to:Proper “statistical” procedure would be to: Determine the objectives of the audit and Determine the objectives of the audit and

the characteristics being analyzed the characteristics being analyzed Consider the facts and circumstances Consider the facts and circumstances

regarding the missing record(s)regarding the missing record(s) Identify the appropriate treatment for Identify the appropriate treatment for

purposes of the extrapolation purposes of the extrapolation



Variability of IRO implementationVariability of IRO implementation IRO fees related to samplingIRO fees related to sampling Issues related to sampling resultsIssues related to sampling results

Sampling IssuesSampling Issues


New options related to probe scopeNew options related to probe scope Probe sample of 30 claims and a Probe sample of 30 claims and a

statistically valid “Claims Review statistically valid “Claims Review Sample”Sample”

Two probe sample of 30 claimsTwo probe sample of 30 claims Probe sample of 50 claimsProbe sample of 50 claims


Probe Sample with Minimum Size of 30 Items:Probe Sample with Minimum Size of 30 Items:

The probe sample shall include at least 30 The probe sample shall include at least 30 items…. If no over payments are found in the items…. If no over payments are found in the probe sample, then a second probe sample, of probe sample, then a second probe sample, of at least 30 items, must be selected and at least 30 items, must be selected and received. …If no overpayments are found in received. …If no overpayments are found in this second probe sample, then the claims this second probe sample, then the claims review can be terminatedreview can be terminated..

Sample LanguageSample Language


Probe Sample with Minimum Size of Probe Sample with Minimum Size of 50 Items50 Items

If no overpayments are found in If no overpayments are found in this 50 item probe sample, then the this 50 item probe sample, then the claims review can be terminated claims review can be terminated with review of the probe sample.with review of the probe sample.

Sample LanguageSample Language


Trigger ClauseTrigger Clause Use 30 claim probeUse 30 claim probe If gross dollar overpayment does If gross dollar overpayment does

not exceed a 5% error rate, then a not exceed a 5% error rate, then a full statistical sample is not full statistical sample is not requiredrequired

This is not a standard clauseThis is not a standard clause


Scope and Intent of System Scope and Intent of System ReviewsReviews

System Review.System Review. The IRO shall review The IRO shall review billing and coding system and/or billing and coding system and/or operations and cost report preparation operations and cost report preparation process (the “System Review”)process (the “System Review”)


The system review can include:The system review can include: Review of billing system Review of billing system

procedures, controls, safeguards, procedures, controls, safeguards, etc., related to billing and codingetc., related to billing and coding

Review of systems and controls Review of systems and controls over preparation of cost reportsover preparation of cost reports

Report on system and weaknesses Report on system and weaknesses of the systemof the system


Retention of DraftsRetention of DraftsRetention of Records.Retention of Records. The IRO The IRO and Provider shall retain and make and Provider shall retain and make available to OIG upon request, all available to OIG upon request, all work papers, supporting work papers, supporting documentation and draft reports documentation and draft reports related to the engagementrelated to the engagement..


Becoming a more common Becoming a more common element in CIAs with nursing element in CIAs with nursing homes and other long term homes and other long term care providerscare providers

Potential for expansion to Potential for expansion to acute care facilitiesacute care facilities

Quality of Care Quality of Care InitiativeInitiative

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Corporate Integrity Agreements American Health Lawyers Association 2001 Institute of Medicare and...

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