HEALTHCARE COMPLIANCE I
Kpatel
InternalInvestigations.pptxInternal Investigations
Chapter 11
Learning Objectives
Situations requiring investigation or audit
Steps in conducting an internal investigation
Interviewing employees and third parties
Reviewing documents and records
Contents of a thorough investigation report
Sources of a government investigation
Responses to a government investigation
When to conduct an internal compliance audit
Taking advantage of attorney-client privilege
Introduction
An organization conducts an internal investigation to discover whether a violation of law has occurred or is likely to occur.
Internal sign or report that a violation has occurred
Organization learns that a government agency has launched an investigation
As a preventive measure, the organization conducts periodic audits
Investigations in a Compliance Program
Key component of an effective compliance program
Discover problems before a government agency learns of them
Opportunity to control resolution of the problems
Once government initiates its an inquiry, the organization is compelled to conduct its own parallel investigation
Multi-Step Investigation Procedure
Use trained, trusted employees to carry out the investigation
Consider using an attorney and a consultant
Fit the investigation to the suspected misconduct
Investigative techniques: personnel interviews, records and document reviews
Report based on investigation findings
After the investigation is complete
Use Trained, Trusted Employees
Starts with the Compliance Officer. Other staff should be ….
Trained in investigation techniques
Knowledgeable about area where misconduct suspected, but preferably not working there
People of good judgment and discretion
Willing to make hard decisions
Able to maintain confidentiality
Consider Using an Attorney
For all but trivial incidents, consult an attorney
For serious matters, conduct investigation under the guidance of an attorney
Take advantage of work-client or work-product privileges whenever possible
Attorney will direct the investigation, communicate with top management, and control information flows about the events
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Consider Using a Consultant
If the organization lacks the time, the experienced personnel, or the expertise to carry out the investigation
Consultant performs work that is channeled through the attorney
Consultant lacks close relationship with the organization
Consultant duties should be carefully defined
Fit the Investigation to the Suspected Misconduct
As the investigation proceeds and the gravity of the misconduct is revealed, efforts can be scaled up or down.
Investigative techniques should be discussed with management and the attorney.
Anticipate effects of the investigation on workforce morale and productivity.
Focus of the Investigation
Nature and scope of the problem incident
Statutes and regulations related to the incident
Clarity or ambiguity of the relevant standards
Knowledge and intent of the persons involved
Prior incidents with same department or employees
Exactly how the incident took place
Possible actions to mitigate or prevent the problem
Investigative Techniques: Personnel Interviews
Current/former employees, customers.
Patients, providers, vendors, payors, & other third parties
Logistics of the interview process
Legal implications of personnel interviews
Warnings to interviewees
Caution when interviewing third parties with no allegiance to the organization
Training in interview skills
Investigative Techniques: Document Reviews
Bills, claims, cost reports, financial statements, clinical records, policies and procedures, internal & external communications, and compliance program materials
Unique issues in reviewing electronic data
Employee warnings against destruction or modification of documents or records
Store collected documents in secure locations
Report Based on Investigation Findings (I)
Attorney oversees preparation of report that includes these elements ….
Facts discovered by investigators
Facts sought but still unknown
Laws implicated by the revealed facts
Attorney analysis of facts in light of the laws
Specific facts indicating cause of the incident
Report Based on Investigation Findings (II)
Detailed description of non-compliant incident
Incident’s impact on safety and quality of care
Time period during which incident occurred
Identity of persons involved in incident
Identity of persons who should have detected or reported the incident
Financial and legal enormity of the issue
After the Report Is Completed
Determine corrective action needed to fix the problems identified – personnel changes, retraining, or discipline, modify policies and procedures, reallocate resources, revise work processes, reorganize departments, and modify the compliance program
Whether to disclose investigation results to government authorities and repay monies wrongly received
Agency-Driven Investigation Inquiry
Agency suspects non-compliant behavior that violates laws and costs the government money.
It wants to learn more to determine the scope of the non-compliance.
Organization must take the matter seriously and move quickly.
Responding will consume time and money.
Sources of the Inquiry
Center for Medicare and Medicaid Services
Office of the Inspector General (DHHS)
Office of Civil Rights (DHHS)
Department of Justice
Solicitor’s Office (DOL)
State attorneys general
Legal Forms of the Inquiry
An inquiry can take several legal forms. The organization’s attorney can explain them.
Informal inquiry
Subpoena duces tecum
Search warrant
Formal legal action
Informal Inquiry
Letter, phone call, or personal visit
Concerning the organization or a business partner
Carefully consider and manage the response
Caution employees on their rights and responsibilities
Subpoena Duces Tecum
Order to produce documents or other tangible evidence
Work activities targeted, documents sought, number of years, how soon needed (days or weeks)
Prelude to a more formal and invasive investigation
Immediately contact legal counsel
Search Warrant
Issued by judge upon showing of “probable cause”
Investigator shows up demanding documents immediately
Follow pre-planned protocol during this often traumatic event
Ask for warrant copy and contact legal counsel
Record details of the search
No interference, no document destruction
Formal Legal Action
Criminal complaint filed with a court charging a violation of law. If judge finds “probable cause”, will issue a summons.
Organization is now a “defendant”.
Civil complaint does not require probable cause and states a claim for relief from misconduct or damages caused.
Government action preceded by one of three information-gathering methods.
Responses to the Inquiry
Protect integrity of related evidence
Identify areas that are targets of the inquiry
Designate one person to manage the response
Expert legal counsel is essential (in-house, ad hoc engagement, permanently retained)
Leverage fully the protections of the attorney-client relationship
Organization-Initiated Internal Audit
Conducted to make sure an existing compliance program and policies are operating at peak effectiveness.
An audit is a formal, systematic investigation intended to assess compliance with legal standards and identify existing or potential compliance violations.
Baseline vs Routine Audits
An initial audit by an organization establishes a baseline of compliance effectiveness for future audits.
After that, routine audits are conducted on a regular schedule (monthly, quarterly, semi-annual, annual).
Audits may target diverse areas of the organization at risk of non-compliance.
Scope of Audits
Direct audits to areas of highest legal risk and potential impact on the organization.
Based on prior audit reports, public and private payor correspondence, claims denials, and data analysis.
Based also on public sources: OIG compliance guidance and work plans, RAC priorities, CMS CERT reports, and Health Care Fraud and Abuse Control Program annual reports.
Type of Audit
Range of activities studied (an entire process vs just one part of the process)
Rough conclusions from a small sample vs statistically valid results from a more comprehensive, sophisticated survey
Review of documents or analysis of data
Audit type depends on its purpose
Other Audit Characteristics
Personnel conducting the audit
Audit standards (recognized benchmarks)
Reporting audit results
Debriefing among investigators
Final report on operational shortcomings
Legal counsel reports on violations
Basic Audit Techniques
Personnel interviews
Document review
Data sampling
Basic Sampling Process
Time period from which sample taken
Population of items to be sampled
Sample plan (sample size, and item selection)
Execution of sample plan
Determining extent of non-compliance
Evaluate Results & Correct Problems
Non-compliance without legal violations
Significant violation with major repercussions
Appropriate employee discipline and behavior correction
Policies and procedures changed or replaced
New education and training of employees
Attorney-Related Protections
Attorney-client privilege
Work product privilege
Self-evaluation privilege
Advice of counsel
