RESPONSIBLE REPORTING OF AND RESPONDING TO COMPLIANCE / ETHICS CONCERNS
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1 Page 1 of 10 RESPONSIBLE REPORTING OF AND RESPONDING TO COMPLIANCE / ETHICS CONCERNS 1. Purpose 1.1 This policy provides guidance regarding the internal reporting of compliance and ethics concerns. The provisions of this policy set forth expectations for the individuals reporting the concern, and for the organization responding to the concern. 1.2 Secondly, this policy outlines the Kaiser Permanente (KP) standards involved in the investigation and formulation of corrective action for any violation of a State or Federal law, regulatory requirement, contractual obligation or organizational policy or procedure. 1.3 Additionally, any form of retaliation can undermine the reporting process; therefore, this policy aims to protect employees and staff from retaliation when they make a good faith report. 1.4 Lastly, this policy supplements the Regional Compliance Program s policy , Prevention, Detection, and Correction of Fraud, Waste, and Abuse. 2. Scope 2.1 This policy applies to all employees of Kaiser Foundation Health Plan, Inc. (KFHP), Kaiser Foundation Hospitals (KFH), and the Hawaii Permanente Medical Group, Inc. (HPMG), collectively Kaiser Permanente, and contractors, vendors, or other individuals or entities who provide direct patient care items or services, or perform billing, coding or prescription benefit management 2.2 Definitions 2.3 Compliance and Ethics Concern - suspected wrongdoing, including non-compliance or unethical behavior 2.4 Non-compliance. Not acting in accordance with externally and/or internally established standards. Non-compliance can be intentional or unintentional. Individuals can act with deliberate intent to violate the law or internal policy. Conversely, individuals unaware or unclear on established standards may not be aware they are in violation
2 Page 2 of KP Compliance Hotline- a national toll-free telephone line accessible by all employees, physicians, vendors, and contractors twenty-four (24) hours a day, seven (7) days a week, to report problems and concerns anonymously or otherwise. 2.6 Good Faith - honest and sincere intention. 2.7 Internal Reporting - using internal channels to report concerns; includes, but is not limited to reports to individuals such as a supervisor, manager, local/regional/national administrator, a department such as Compliance, Quality, Human Resources, Environmental Health and Safety, Security; as well as systems such as the Kaiser Permanente Compliance Hotline. 2.8 Open Door Policy willingness of managers and supervisors to meet with anyone who has a concern or problem to report. 2.9 Responsible Reporting - individual responsibility to report compliance and ethics concerns or potential misconduct Retaliation - intentional and unwarranted harm to an individual s professional standing. It includes, but is not limited to, preventing advancement, harassment, disciplinary action, demotion, termination or damage to reputation Investigator - the individual assigned to investigate the case and may include the Department Manager or Supervisor Special Investigator - an individual other than the Department Manager or Supervisor and may include for example, the Regional Compliance Officer the Privacy & Security Officer, or investigator from the National Special Investigations Unit (NSIU) Compliance Reportable Event - anything that involves a substantial overpayment or a matter that a responsible person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized. A Compliance Reportable Event may be the result of an isolated event or a series of occurrences. 3. Responsible Reporting of Identified Concerns 3.1 Responsible Reporting Provisions - To support good faith reporting by employees and staff, the has set expectations for individuals and departments to maintain an open door policy regarding reporting, has publicized and supported the national KP Compliance Hotline for anonymous reporting.
3 Page 3 of Duty to Report All employees and physicians have a duty and a responsibility to report actual or potential compliance/ethics concerns and misconduct using the designated processes and systems. Employees and staff are also encouraged to report close calls so the organization may learn from the situations Reporting Channels Employees and staff are encouraged to report to any of the following persons or systems: The immediate supervisor, the immediate supervisor s manager or the department manager Any senior manager or medical director Any regional or national officer or staff in Human Resources, Compliance, and Quality Departments Legal counsel A member of the Board of Directors The KP Compliance Hotline at Publication of the KP Compliance Hotline The KP Compliance Hotline is publicized but not limited to by the following methods: Principles of Responsibility (Code of Conduct) General Compliance Training Compliance is Everybody s Business (pamphlet) Posters in work areas KP Compliance Hotline pens Badge tag Lanyard (Badge Ribbon) Anonymity Reports may be made anonymously and confidentially through the KP Compliance Hotline. 3.2 Responsible Reporting Procedures Open Communication All levels of management shall maintain an open line of communication with any employee or staff or other individual regarding discussion of potential misconduct or compliance/ethics concerns. When a report is received the manager, in a timely manner, shall: Acknowledge the person for reporting the concern, Investigate the reported concern as expeditiously as possible while ensuring that the investigation is thorough, balanced, objective, and documented,
4 Page 4 of Consult with representatives from the Compliance Office and as needed from the Human Resources, Legal or other appropriate departments, Take appropriate corrective action to address actual events or substantiated allegations, Prepare reports, as appropriate, for senior leaders, committees or the Board, Information may be shared with the reporting person as appropriate and when allowable under the law KP Compliance Hotline ( ) The National KP Compliance Hotline is managed by an outside vendor on behalf of Kaiser Permanente. In each Region, the Compliance Officer and designated staff shall: Review each report and determine the appropriate individual to lead the investigation, Assign the investigation to an individual responsible for review and follow-up, Monitor timeliness of the investigation, Consult as appropriate on the investigation, Refer final report to a compliance leader to validate closure, Enter findings and close report in TrakWeb, Kaiser Permanente s Investigative Case Management tracking system. (refer to Appendix 1 & 2) 3.3 Non-Retaliation Any form of retaliation against a staff or physician who reports in good faith is strictly prohibited. Leaders protect employees and staff from retaliation, disciplinary or job action related to reporting by following established procedures for disciplinary action against any employee or staff that commits or condones retaliation Employees and staff may communicate up the chain of command or directly with their Human Resources representative if they believe that retaliation has occurred Employees and staff shall use the KP Compliance Hotline to file a report if they believe that retaliation has occurred. 3.4 Self Reporting
5 Page 5 of Employees and staff may not be exempt from consequences of their behavior by making a report; but self-reporting may be taken into account when determining the appropriate course of action, providing the following requirements are met: The person self-reporting does so as soon as he/she realizes that he/she has been involved in an occurrence or event covered by this policy There is no evidence of gross negligence, fraud, waste, abuse, or willful misconduct, reckless disregard of ethical or compliant standards of conduct, or criminal intent/conduct The person involved participates fully in the investigation and follow-up action(s) as appropriate. 4. Responding to Reported Concerns 4.1 Responding to Reported Concerns All reports of alleged violations received through the Kaiser Permanente Compliance Hotline or through direct referrals to the National Compliance Officer (NCO) shall be immediately investigated by an NCO Case Manager as specified in this policy All compliance reports of alleged violations received through the Compliance Office shall be immediately investigated in coordination with Compliance Office staff. 4.2 Responding to Reported Concerns Procedure Investigating The investigation should be initiated within two weeks of receiving the complaint or report, or shall commence as soon as reasonably possible The investigator shall consult the Regional Compliance Officer or Legal Counsel. Depending on the circumstances, the Regional Compliance Officer or Legal Counsel will assume responsibility for directing the investigation depending on the type and severity of the alleged non-compliance or suspected violation A competent reviewer shall complete an objective review Procedure for Review includes but is not limited to the following:
6 Page 6 of 10 Interview the reporting individual and others who may have knowledge of the alleged problem or incident, Review applicable laws, regulations, and contracts, Principles of Responsibility, Kaiser Permanente or third party payor policies that may be relevant in determining if a violation has occurred, Determine whether violations of applicable laws, regulations, contracts, Principles of Responsibility, Kaiser Permanente or third party payor policies have occurred, If the initial review results in a finding that the allegation of non-compliance or violation was unsubstantiated, the review shall be closed If the initial investigation results in a finding that the allegation of non-compliance or violation was substantiated, the investigator shall proceed to identify the individuals who have engaged in non-compliant activities and determine the full scope and nature of the incident, the frequency and duration of its occurrence, and its potential implications. If financial implication is identified, investigator must further identify overpayments received from any government or private third party payor If the investigator identifies that a potential or actual violation of a law, regulation, contract, Principles of Responsibility, or third party payor policy has occurred, the investigator shall notify the Regional Compliance Officer and when appropriate, send a copy of the investigation documents to the Regional Compliance Officer Corrective Action On violations not referred to the Regional Compliance Officer, the investigator shall consult with the department manager for appropriate corrective action On violations that were referred to the Regional Compliance Office, the investigator and department manager, as required, shall consult with the Regional Compliance Officer for corrective action Circumstances that formed the basis for the investigation shall be reviewed to determine whether similar problems have been uncovered.
7 Page 7 of Appropriate corrective action shall be determined and may include but not limited to: establishing a corrective action plan with timeframes and clear accountability for full implementation, creating or revising policies and/or procedures, distribution of current, relevant Federal and State standards, regulations and news bulletins, process improvement in systems design (to include use of quality improvement tools), periodic assessments, reporting to the government, to include refunding overpayments, as applicable, education, disciplinary action In cases of Compliance Reportable Events or when violations of prior agreements with the government the Compliance Department shall: Notify the OIG, in writing, within 30 days after making the determination that the Compliance Reportable Event exists; Provide a complete description of the Compliance Reportable Event including the relevant facts, persons involved, and legal and Federal health care program authorities implicated; Provide a description of actions taken to correct the Compliance Reportable Event; and Communicate any further steps to take in order to address the Compliance Reportable Event and prevent it from recurring Record Maintenance
8 Page 8 of The investigation records may contain documentation of the alleged violation, a description of the investigative process, copies of interview notes and key documents, a log of witnesses interviewed and documents reviewed, the results of the investigation (including any disciplinary action taken), and the corrective action implemented All documents related to the investigation shall be retained in accordance with the Business Records Retention Policy. 5. Responsibilities The Regional Compliance Department shall be responsible for ensuring that this policy is current and accurate. 6. Maintenance This policy shall be reviewed annually and revised as necessary. 7. References KP National Compliance Office Policy, NCO-2, Code of Conduct KP National Compliance Office Policy, NCO-3, Non Retaliation KP National Compliance Office Policy, NCO-4, Reporting Compliance and Ethics Concerns KP National Policy, NCO-5, Business Records Retention KP Policy, , Complaints about Privacy Practices Office of Inspector General Compliance Program for Individual and Small Physician Practices, 65 FR (Oct. 5, 2000) Office of Inspector General Compliance Program Guidance for Hospitals, 63 FR (Feb. 23, 1998) Office of Inspector General Self-Disclosure Protocol, 63 FR (Oct. 30, 1998) Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (42 C.F.R (b)(4)(vi)(H) Quest RFP-MQD
9 Page 9 of Implementation 8.1 Effective Dates This policy becomes effective upon approval by the approving authorities. 8.2 Distribution Upon approval, this policy shall be distributed to all process stakeholders and affected departments As applicable, affected entities, departments, and individuals may prepare and implement procedures consistent with this policy and as necessary conduct appropriate education to assure consistent and uniform implementation This policy is accessible on the KP Hawaii Intranet. 9. Appendices 9.1 Appendix 1 National Compliance Hotline Overview 9.2 Appendix 2 Sarbanes-Oxley Investigations 10. Endorsement and Approval
10 Page 10 of 10 Contacts: Endorsed By: Susan VonEssen, Regional Compliance Officer Natalie A. Doxtator, Regulatory Compliance Consultant Sylvia Shimonishi, Manager, Pharmacy Compliance Compliance Operations and Scope of Practice Workgroup Medicare/Medicaid Managed Care Compliance Workgroup Date: 12/01/06 Date: 12/04/06 Date: 12/08/06 Approved By: Compliance Committee Date: 12/11/06 Next Review Date: 12/11/07
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