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HCCA - Part D Conference Tips for Conducting Internal Investigations Howard J. Young, Esq. Sep. 11, 2006 Baltimore, MD
HCCA - Part D Conference
Tips for Conducting Internal Investigations
Howard J. Young, Esq.
Sep. 11, 2006Baltimore, MD
nternal Investigations – CMS Mandated
Chapter 9 Part D Program to Control FWA• Prompt follow-up investigation procedures in
response to hotline inquires and other complaints (§50.2.4.2 and §50.2.7.1)
• Sponsor should initiate “reasonable inquiry immediately, but no later than two weeks from date potential misconduct is identified.”
Reasonable Inquiry”
Section 50.2.7.1 states:• A reasonable inquiry includes a preliminary
investigation of the matter by the Part D Compliance Officer and/or Special Investigative Unit (SIU) for the Sponsor. In the event that the Sponsor does not have either the time or the resources to investigate the potential misconduct, it should refer the matter to the MEDIC within two weeks of the date the potential misconduct is identified . . .
elf-Reporting of Potential Fraud
Regulations state that self-reporting is “voluntary” (42 CFR § 423(b)(4)(vi)(H)), but is a critical element of FWA compliance program.• Report potential fraud of sponsor, first tier and
downstream entities• Challenging to monitor and investigate potential fraud
at downstream and first tier levels• If you verify “potential fraud”, report to MEDIC
promptly, but no later than 60 days from determination and sooner if discovered at 1st tier or downstream entities. Also consider reporting to OIG or DOJ. (§ 50.2.8.2)
ractical Effect of FWA Guidance –stablish a Plan for Investigations
CMS and its contractors “will investigate all cases as potentially fraudulent and will refer to law enforcement as warranted.”Unless willing to allow MEDIC to conduct the “internal investigation”, you must have an internal investigation plan and process in place, with adequate staffing, resources, and access to qualified legal counsel.Time to establish or assess investigation protocols is now, not when the first potential issue arises.
onsiderations for Establishing nternal Investigation Protocols
Roles and ResponsibilitiesTime frames for actionInvolvement of Legal Counsel – attorney-client and “attorney work product” protectionsInformation gathering and interview considerationsDocumenting Investigatory FindingsRegulatory and Legal Analysis
reate a Written Investigative Work Plan
Lead roles and responsibilities• Compliance, SIU, legal counsel (be specific)
Tasks Time frames and deadlinesComment fieldReview and revise periodically throughout investigationInclude assessment of corrective actionsAvoid listing legal conclusions/findings
stablishing a “Control Group”
Internal investigations may involve sensitive information and require exercise of considerable judgmentDetermine which personnel will assistNeed people with expertise, professional independence, discretion, authorityIf “high risk” area (potential legal violations, considerable dollars at issue), involve legal counselKeep group small if possible
Use of Legal Counsel
Investigation of high risk areas should involve legal counsel to protect organization and individualsCommunications with counsel must be kept confidential to maintain attorney-client privilege Communications seeking legal advice protected; underlying facts are NOT protectedAttorneys may supervise investigatory work of others -protected by “Work Product” doctrine (e.g., hire forensic consultants)Use of Internal vs. External Counsel
Role of Compliance Officer/SIU
Initial fact finding to assess credibility of complaint – document date of discovery and initial stepsGather background information – what was known, by whom and when?Assess whether to engage counselApprise senior management at appropriate timesEnsure timely investigation ensues – managing resources effectively
nformation/Fact Gathering
Ensure documents are secured and preserved intact• Memo to employees – do not destroy/alter• Emails/voicemails/electronic data presents challenges
to preserveAssess who may have relevant informationDetermine who should gather documents• Independence, reliability, organized
Relevance - Err on side of over-inclusiveness at gathering stageDocument controls – bate stamping, security, system to establish source of documentsDocument review – relevance, privilege, “hot documents”
mployee/Contractor Interviews
Information gathered is “confidential” but may be shared with management and/or governmentIf very sensitive (e.g., potential criminal violation), apprise of access to their own counselTwo people should conduct interviews (note-taker) and to avoid “he said/she said”Interview notes – protected by privilege/work product protections? If not an attorney, avoid legal conclusions in notesAccess to downstream contractor personnel – look to terms of contract
Assessing Investigative Findings
Systemic problems or isolated?Legal/regulatory violation?Intentional, negligent, or inadvertent?Assessing whether organization “should have known” of violation (reckless)First Tier or downstream entities – responsibility to share findings and allow comment?Documenting findings (is less more?)
haring Findings
Senior management reportBoard of Directors (Compliance/Audit Committee or full Board)• Oral presentation• Power Point or investigative report?
Reporting findings to MEDICWhat if you can’t meet 60 day reporting time frame?If no report to MEDIC, document rationaleShare with affected employees, contractors?What you share, form of report, etc. may itself become subject to scrutiny, so choose carefully
Content of Report
Chapter 9 - Section 50.2.8.3• Provider data (billing
#, tax I.D., address)• Item or service
involved• Place of service• Nature of allegation• Timeframe• Description of
investigation and findings
• Date of Part D Service, drug codes, etc.
• Beneficiary names, HIC #• Contact information of
complainant• Documents re: prior
sanctions and/or “compliance history” and corrective actions, if any
• Not an all-inclusive list• MEDIC may request
more information
