OneWorld Community Health Centers Policy and Procedure

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1 TITLE: Corporate Compliance Program and Policy APPLICABLE STANDARDS: RI , HR EC , EC OBJECTIVE: To establish guidelines to ensure professional and ethical behavior for each employee, contractor and agent of the Center. PROGRAM: The Compliance Program consists of several components: this Compliance Policy, which sets out the general structure, purpose and commitment of the Compliance Program, and which is to be adopted by the Center as an expression of continuing commitment to compliance and a mandate to implement the Compliance Program; Procedures supporting compliance; and Compliance Plans developed and focused on specific activities identified after a risk analysis is performed. Goals The goals of the Compliance Program are to: a. Foster an understanding of and commitment to compliance. b. Detect and prevent illegal and improper behavior and thereby reduce the risk of sanction for noncompliance. c. Assure prompt investigation and response to reported illegal or improper conduct and prevent recurrence. d. Assure that each person associated with the Center carrying out tasks which have the potential to violate applicable laws or regulations: i. is aware of and committed to carry out his or her job in accordance with applicable laws and regulations and the terms of the Compliance Program; ii. has the required level of training and experience necessary to carry out his or her job in accordance with applicable laws and regulations and the Compliance Program; and iii. has a method to report areas of potential noncompliance with applicable laws and regulations. e. Preserve and enhance the reputation of practitioners of the Center as ethical providers of health care. f. Preserve the attorney-client privilege to the maximum extent possible as a tool for helping to protect and defend the Center. Accountability This Policy and all related documents and activities shall be implemented by, and be the accountability of the Chief Executive Officer of the Center who shall be designated as and hereafter referred to as the "Center Compliance Officer." As Center Compliance Officer, the Chief Executive Officer will assume the managerial and administrative tasks involved in establishing this Policy and shall perform the following functions in collaboration with Center practitioners, staff and outside resource persons to: Revised: 7-13 Page 1 of 24

2 1. Ensure the billing, monitoring and fraud prevention system described in the Policy is functioning effectively. 2. Ensure that all practitioners are updated by internal or external staff regarding any change in the billing practice or other pertinent compliance updates. 3. Arrange for regular monitoring and period external audits of billing and other compliance risk areas. 4. Assure compliance with this policy and associated procedures and Compliance Plans. 5. Make disclosures and tender repayments when errors are discovered. 6. Establish a reporting system and see that suspected misconduct is investigated. The Role of Legal Counsel The Center has engaged Baird Holm, LLP as Legal Counsel for compliance. Legal Counsel may be asked from time to time to: 1. Conduct legal analyses of risk areas identified in connection with the Compliance Program and provide legal opinions with respect to those risk areas, 2. Respond to specific concerns and provide legal opinions in connection with those concerns, 3. Conduct or oversee investigations based on specifically identified problem areas and render legal advice based on the results of those investigations, 4. If requested, conduct educational programs concerning risk areas identified by the Center Compliance Officer or others, and 5. Retain outside consultants and auditors to review specific areas of compliance concern. The Compliance Program shall be conducted in such a way as to preserve the attorney-client privilege and protection of information under the attorney work product doctrine to the greatest extent possible with respect to all activities conducted by legal counsel. All questions and concerns regarding compliance with the standards set forth in this Policy shall be directed to the Center Compliance Officer. All employees and agents of the Center must fully cooperate and assist the Center Compliance Officer as required in the exercise of his or her duties. If an employee, contractor or agent of the Center is uncertain whether specified conduct is prohibited, the employee, contractor or agent must contact the Center Compliance Officer for guidance prior to engaging in such conduct. Preventing Individuals Involved In Illegal Activities From Exercising Discretionary Authority No individuals who have been convicted of health care related crimes or who have been excluded from Federal health care programs will be allowed to occupy positions within the Center as either an employee or a contractor. The effect of an OIG exclusion from Federal health care programs is that no Federal health care program payment may be made for items or services furnished by excluded individuals or entities, or directed by an excluded provider (42 C.F.R ). This prohibition against Federal program payment extends to payment for administrative and management services not directly related to patient care, but that are a necessary component of providing items and services to federal program beneficiaries. Revised: 7-13 Page 2 of 24

3 (See the Screening, Evaluation and Disciplinary Procedure.) Training and Education Programs 1. Employee Handbooks All employees, including all practitioner employees, will receive an employee handbook, this Policy, the Code of Conduct and other information necessary to ensure compliance with these standards. Each employee must sign and return an acknowledgment form which states that the employee has read and understands these provisions. Each employee will be required to review these compliance standards and sign and return a new acknowledgment form, which states that the employee has reviewed and understands the provisions of this Policy and the Code of Conduct. If any employee has questions regarding this Policy or his or her obligations, he or she should contact the Center Compliance Officer or his or her supervisor immediately. (See the Code of Conduct and the Education, Training and Communication Procedure.) 2. Employee Training Education and training shall be ongoing activities. All employees and practitioners of the Center are required to participate in designated education and training programs. Training should include reinforcement of compliance policies and standards of conduct, disciplinary policies, detection of suspected compliance issues and reporting. All employees of the Center are required to attend an initial comprehensive training session within sixty (60) days following the adoption of this Policy to be followed by periodic updates. The full cooperation of all employees is expected. All new employees will be required to complete a training program as part of their orientation to their employment. Some employees may receive specialized training as a result of the areas in which they are employed. This specialized training may focus on more complex compliance topics or on areas deemed to be high-risk and/or high priority. As new developments or concerns arise, additional training sessions may be required for some or all employees. Education and training records will be maintained for all providers and non-provider personnel as part of human resources files and attendance lists and content outlines for training will be maintained as part of compliance records. The Center Compliance Officer will see that the scheduling, content and overall effectiveness of compliance education and training is evaluated on an ongoing basis. Revised: 7-13 Page 3 of 24

4 (See the Education, Training, and Communications Procedure.) 3. Employee Supervision The promotion of and adherence to the standards and policies set forth in this Policy shall be an element in evaluating the performance of all employees. (See the Education, Training, and Communications Procedure.) 4. Training and Contractors and Other Agents of the Center Contractors and agents of the Center shall receive compliance orientation and training when their role or responsibilities have compliance implications. Such training shall, at minimum, include distribution and acknowledgment of this Compliance Policy and the Code of Conduct. To the extent that it is practical and pertinent, contractors and other agents may be included in employee training and education programs. Training and education of contractors and other agents shall be documented in the same manner as all other employee education and training. (See the Education, Training, and Communications Procedure.) Risk Assessment, Monitoring And Auditing Systems 1. Risk Assessment Risk assessment involves the identification of areas of legal risk to the Center and an analysis of those risks. The analysis should consider both the significance of the risk and its likelihood or frequency. A risk that does not have a significant effect on the Center and that has a low likelihood of occurrence generally does not warrant concern. A risk with high potential liability and/or a high likelihood or frequency of occurrence demands particular attention. In some cases, risk assessment will require monitoring, auditing and/or legal review of activities. Individual Compliance Plans that include targeted standards and procedures will be developed based upon risk assessment. Risk assessment will ordinarily be performed in the following ways: a. In response to the risk areas identified for provider practices in the OIG Compliance Program Guidance for Individual and Small Group Practices, risks identified in the current OIG Work Plan and risks identified in the Centers for Medicare and Medicaid Services (CMS) Comprehensive Medicaid Integrity Plan and any subsequently published work plans related to Medicaid-related compliance. b. As compliance audits designed or approved by the Center Compliance Officer and initiated by or under authority of Legal Counsel. c. As a result of ongoing monitoring or auditing activities. d. As a by-product of actual investigations. Revised: 7-13 Page 4 of 24

5 e. In response to national trends and publicity regarding areas of industry exposure, government enforcement program priorities and changes in law and regulation as applied to the Center. Risk assessment is an ongoing and vital part of the Compliance Program. Results of risk assessment activity will be used in the design of individual Compliance Plans. Specific compliance plans will be prepared and adopted based on risk assessment activities, based on the judgment and priorities established by the Center Compliance Officer in consultation with Center practitioners and Legal Counsel. 2. Risk Assessment Tool Based on the risk assessment, the Center Compliance Officer, in consultation with Legal Counsel, will consider and determine the need for compliance plans in at least the following substantive areas: a. Medicare, Medicaid and commercial billing issues, for example coding, medical necessity, billing for non-covered services as if covered and Central documentation. b. Kickbacks, inducements and self-referrals. c. Advance beneficiary notices. d. Medicare regulations governing FQHCs. e. Rules governing tax-exempt organizations. (See the Risk Assessment Tool) 3. Monitoring Monitoring is not auditing, but rather a proactive approach to identify problems at an early stage. Monitoring should be conducted on selected risk areas on a daily basis and integrated into the routine activities of the Center. All monitoring of billing shall be concurrent, that is, it shall be performed on current bills which are corrected as necessary before they are submitted. Retrospective audits of billing shall not be performed without the approval of the Center Compliance Officer in consultation with Legal Counsel when necessary. Monitoring procedures will be implemented which are designed to detect billing inaccuracies or other instances of potential misconduct as quickly as possible. Periodic random samplings of billing documents and medical records will be checked and reviewed by external reviewers to ensure proper coding and compliance with applicable billing rules. Results of the reviews shall be provided to the Center Compliance Officer for further evaluation. In addition, special attention will be given to (i) reviewing the reasons given for Medicare or Medicaid claim denials and claim denials by other third party payors, (ii) reviewing frequent billings of certain procedure codes, and (iii) analyzing other facts that may suggest inappropriate conduct. (See the Monitoring and Auditing Procedure.) 4. Audits Revised: 7-13 Page 5 of 24

6 Audits or legal reviews are more formal and more comprehensive than monitoring activities and are generally arranged through Legal Counsel in order to assist Legal Counsel in advising the Center on matters of legal risk. The Center shall engage Legal Counsel to undertake compliance reviews in areas of risk, as identified from time to time by the Center Compliance Officer or Center practitioners. Legal Counsel shall be asked to analyze such areas and report back to the Center Compliance Officer. Legal Counsel and the Center Compliance Officer shall jointly determine the appropriate consultants to assist Legal Counsel in carrying out such duties. The results of audits shall be included in a written report and presented to the Center Compliance Officer by Legal Counsel. (See the Monitoring and Auditing Procedure.) 5. Contracts All contracts and other arrangements with hospitals, private physician groups, dental or behavioral health groups, laboratories, referral sources and other entities will be reviewed by the Center s Legal Counsel to verify that each is in compliance with applicable law. (See the Contracting Procedure.) 6. Internal Investigations The Center Compliance Officer shall receive disclosures and reports from employees who are engaging in or have information regarding suspected misconduct and shall see that any reports of suspected misconduct are promptly and thoroughly investigated. Records of suspected misconduct and any subsequent investigation shall be confidentially retained by the Center Compliance Officer. Employees allegedly involved in the misconduct shall be removed from their current work activity until the investigation is completed. The Center shall take steps to prevent the destruction of documents or other evidence relevant to the investigation. If the investigation reveals that misconduct did occur, corrective actions shall be immediately initiated. If the Center has received overpayments, it shall make prompt repayment of such sums to the appropriate health care program and to beneficiaries in the case of co-payments. The Center shall take appropriate disciplinary action to cure the problems identified by the investigation and to prevent such problems from recurring. No employee, contractor or agent who reports suspected misconduct to the Center may be retaliated against or otherwise disciplined for the reason of making such a report. The Center Compliance Officer may consult with Legal Counsel in order to maximize the possibility that disclosures and other reports relating to the Center s compliance with the law will be encompassed within the attorney-client privilege and/or the protections of the attorney work product doctrine. (See the Litigation, Investigation, and Legal Process Procedure.) Revised: 7-13 Page 6 of 24

7 7. Governmental Investigations The Center may be subject to governmental investigations. If a governmental agent appears at the Center unannounced, the procedure set forth in the Litigation, Investigation, and Legal Process Policy should be followed. (See the Litigation, Investigation, and Legal Process Procedure.) 8. Reporting All employees, contractors and agents shall be informed that they are required to report suspected misconduct in accordance with the Reporting Procedure. All complaints and reports will be held in confidence. (See the Reporting and Internal Investigation Procedure.) Code of Conduct Introduction The Center has adopted a Compliance Program. The Compliance Program is a voluntary undertaking as part of a continuing effort to ensure compliance with all statutory and regulatory requirements which relate to the operations of the Center. The Compliance Program s goals include the detection and prevention of violations of civil and criminal statutes and regulations, in order to minimize the legal risks connected with operations. The purpose of this Code of Conduct is to assure that employees and agents are aware of the Compliance Program and Policies and are accountable to follow these standards of conduct. Scope of the Code of Conduct This Code of Conduct applies to the conduct of all employees, contractors and agents of the Center. Those persons considered agents for the purpose of this Policy include students and contractors having compliancerelated responsibilities. Code of Conduct Each employee, contractor and agent of the Center is expected and required to comply with each of the following duties and to assure that his or her behavior and activity is consistent with the requirements of this Code of Conduct. Become and Remain Educated and Informed Regarding Legal Aspects of Responsibilities Revised: 7-13 Page 7 of 24

8 Each employee, contractor and agent is expected to be sufficiently knowledgeable about the legal aspects of his or her responsibilities and activities to be able to avoid inadvertent violation of statutes and regulations. At minimum, this expectation requires the individual to attend orientation, training and educational opportunities offered by the Center. It is further expected that each employee and agent will pursue a reasonable amount of self-education through reading or attendance at seminars and conferences outside the Center. Finally, each employee, contractor and agent is expected to notify the Center Compliance Officer whenever he or she has a question or has identified a need for additional information or education in regard to compliance matters. Report Conduct Suspected To Be Illegal Each employee, contractor and agent is expected to report conduct that is known or suspected to be illegal or in violation of Center policy. The identity of reporting individuals and the content of reports shall be treated as confidential information and shall be disclosed only to persons within the Center charged with investigative and enforcement responsibilities, to others with a legitimate need to know or to governmental agents during investigations upon a showing of proper authority. (See the Reporting and Internal Investigation Procedure.) Comply With Law and Avoid Engaging In Illegal or Potentially Illegal Conduct Each employee, contractor and agent is expected to comply with applicable laws related to his or her job responsibilities and refrain from knowingly participating in illegal activities or failing to meet affirmative legal duties. An important step in meeting this duty is being sufficiently informed about the law affecting the individual s responsibilities to be able to identify potential legal issues and seek guidance as required. Adhere To The Compliance Plans Each employee, contractor and agent is expected to read and be familiar with the content of any Compliance Plans applicable to the responsibilities of such individual. These will be distributed to appropriate individuals. It is further the responsibility of each employee and agent to seek consultation and assistance whenever the requirements of a Compliance Plan are unclear to the individual. Carry Out Duties In An Ethical Manner Each employee, contractor and agent is expected to carry out his or her duties in furtherance of the commitment of the Center to conduct itself, through the actions of its employees, contractors and agents, in an ethical manner and not merely to avoid violations of law. Every employee, contractor and agent is expected to be loyal to OneWorld, to avoid using his/her position for personal gain and to avoid conflicts of interests. All patients will be provided care with respect and dignity. Every employee, contractor and agent is expected to follow OneWorld policies regarding confidentiality. Every employee, contractor and agent will be treated with respect and dignity. Revised: 7-13 Page 8 of 24

9 I certify that: Employee/Agent Certification 1. I have read and understand the OneWorld Community Health Centers, Inc. Code of Conduct and any compliance policies, procedures and plans applicable to my responsibilities. 2. I pledge to act in compliance with the Code of Conduct and any compliance policies applicable to my responsibilities. 3. I will report any conduct which I believe to be illegal or to violate compliance policies or compliance plans using any of the methods outlined in the Reporting and Internal Investigation Policy. 4. I will seek advice from the Center Compliance Officer concerning appropriate actions that I may need to take in order to comply with the Code of Conduct. 5. I understand that failure to comply with these obligations will result in termination of my ability to provide on-site supervision of students at the center. Revised: 7-13 Page 9 of 24

10 Print name: Signed Date Revised: 7-13 Page 10 of 24

11 Procedures 1. Screening Procedures a. Selection of employees, students and contractors shall require each individual seeking to affiliate with the Center, through employment or contract, to certify in writing that he or she has not been subject to sanctions or exclusions under the Medicare or Medicaid Programs and has not been convicted of violation of other laws. In addition, the Center shall review the current OIG/GSA Government lists of excluded and debarred individuals and entities to independently verify whether such individuals have been subject to sanctions or exclusions under the Medicare or Medicaid Programs. Individuals found to be the subject of current sanctions or exclusions or who have been convicted of other violations of the law shall not be hired or contracted with, without the express written approval of the Center Compliance Officer, after consultation with Legal Counsel. b. Upon commencement of employment or affiliation, all employees, contractors and agents of the Center shall, as part of their orientation process, execute the Employee/Contractor/Agent Certification. c. Designated personnel of the Center shall annually review the HHS-OIG s List of Excluded Individuals and Entities and the General Services Administration s List of Parties Debarred from Federal Programs in order to determine whether any employees or agents of the Center have been subject to sanctions or exclusions under the Medicare and Medicaid Programs. In the event that individuals are included in such reports, such individuals shall not be permitted to continue their affiliation with the Center without the express written approval of the Center Compliance Officer, after consultation with Legal Counsel. d. In the case of agents of the Center, termination of affiliation shall mean termination of contracts and agreements for cause on the ground of breach of a material condition and termination of informal relationships with students or vendors up to and including denying access to Center facilities, personnel and patients. e. Employees shall be subject to applicable disciplinary policies and procedures in the event of violation of the Code of Conduct, Compliance Procedures or Compliance Plans. 2. Litigation, Investigation, and Legal Process Procedure The following procedure shall be followed in the event of investigations and other requests for information. a. Investigations. If a government official arrives at or makes a telephone contact with the Center for the purpose of conducting any type of inspection or investigation or gathering of information or records, the following steps should be followed as applicable: i. Employees. A. Immediately notify the Center Compliance Officer. In the case of telephone inquiries, refer the caller to the Center Compliance Officer; do not answer questions or disclose Revised: 7-13 Page 11 of 24

12 written information in any form. In the case of on-site inspections, ask the agent(s) for an explanation (preferably written) of the purpose and scope of the inspection. If the investigation is non-routine, i.e., not a survey inspection, ask the agent(s) for a copy of the warrant authorizing the search. In all cases, ask the agent(s) for identification. B. Ask the agent(s) to delay the search while waiting for the Center Compliance Officer or his or her designee to arrive. If they proceed without waiting, be sure that someone accompanies the agents until the Compliance Officer arrives. In the case of a search pursuant to a warrant, the agents do not have to agree to wait. If the search is warrantless, the Center representative may consent to the search but insist upon delaying the inspection until the Center Compliance Officer arrives. C. Make sure that any verbal statement made to agent(s) is accurate. Avoid making broad statements that are technically incorrect and could be construed as misrepresentations, such as, No, we never billed under that CPT code under those circumstances. D. Maintain an attitude of respect and cooperation with the agents. Such an attitude will avoid unnecessarily creating ill will which could have an adverse effect on the Center s position, but will also result in a greater likelihood of preserving rights and property during the search. ii. Center Compliance Officer. A. Ask who or what is the subject of the investigation, the nature of the investigation, whether the investigation is civil or criminal, and ask how long the investigation is expected to take. The Center Compliance Officer should also request an exit conference and an official report. B. Call Legal Counsel for the Center immediately. Explain what is happening and fax a copy of the search document or any other writing purporting to authorize the search. Legal Counsel will determine whether to come to the search site and be present throughout the search. C. Designate someone to be in charge of the search situation; usually the Center Compliance Officer and/or Operations Director. This individual will remain with the agents and monitor the search process. The search should not extend to areas outside those specified in the warrant. Avoid directly or indirectly permitting the search to go beyond the scope of the warrant. If the materials being searched are susceptible to disarray or damage, e.g., computer files, ask the agents for permission to assign employees to assist in locating information. D. If it appears that the search will be extensive, send all nonessential employees home or reassign to other areas to minimize inappropriate or inaccurate disclosures. A search warrant does not authorize the interrogation of employees. However, employees may be contacted by agents at home for informal interviews in connection with a governmental investigation. The Center may not forbid employees from talking to agents, however, employees should be informed that, absent a subpoena, they do not have to talk to agents if they do not so choose. If an employee chooses to talk to agents, he or she may place any condition on the interview that he or she desires, such as having an attorney and/or a representative of the Center, or anyone else present. Revised: 7-13 Page 12 of 24

13 E. If records or other items are seized by agents, inventory and ask for copies of every record seized before the originals are removed. Ask agents for their list of all documents seized. F. Do not answer questions or permit questioning of employees until legal counsel, or if unavailable, until the Center Compliance Officer arrives. b. Requests for Records or Testimony. i. Routine Requests For Records. This Procedure does not address so-called routine requests for patient records from other health care providers, insurance companies, and the like. If, in the course of handling an apparently routine request, a question arises with respect to the identity of the requestor, or the purpose of the request, then this Procedure should be followed to the extent it is applicable. ii. Subpoenas, Depositions and Other Requests. Any employee or agent of the Center receiving a subpoena, a request for a deposition or other request for information, formal or informal, shall report such subpoenas and requests (other than routine requests as described above or subpoenas for medical records) to his or her immediate supervisor who shall convey such report to the Center Compliance Officer. Subpoenas for medical records shall be received and handled by medical records personnel according to Center procedures. The Center Compliance Officer, in consultation with Legal Counsel, if necessary, shall verify the nature of and authority for the subpoena or request and determine the appropriate scope of response. c. Information for Employees and Agents. Employees contractors and agents of the Center should be aware of and consider the following information: i. No employee, contractor or agent will be retaliated against solely for cooperating in any lawful investigation in an appropriate and truthful manner. (See Reporting and Internal Investigation Policy). Any employee, contractor or agent who believes that he or she has been retaliated against because of reports or participation in an investigation should report this belief to his or her supervisor or to the Center Compliance Officer. Non-retaliation protections do not protect employees who knowingly provide false information or who may be subject to discipline for unrelated performance issues. ii. Employees, contractors and agents should verify the identity and authority of parties requesting information before participating in any voluntary interviews. iii. Remember that investigators cannot compel disclosure of information without a subpoena or court order. iv. Confidential patient information or employee, contractor and agent information may not be disclosed without the patient s or employee s, contractor s or agent s consent unless the disclosure is subject to exceptions such as a court order. Employees, contractors and agents are strongly urged to seek consultation from the Center Compliance Officer or in his/her absence, advice from personal legal counsel before releasing such confidential information. 3. Education, Training, and Communications Procedure Revised: 7-13 Page 13 of 24

14 a. Orientation programs shall include an overview of the Center Compliance Program and the Code of Conduct for all employees, practitioners and students. Such orientation will include presentations regarding corporate ethics, which may be limited to the Code of Conduct for some positions and may be more extensive, for others. It shall be the responsibility of the supervisor to assure that this orientation requirement is met within his or her areas of responsibility. b. Training sessions will be provided for individuals connected with Medicare/Medicaid billing, including practitioners, and training sessions in connection with other Compliance Plan subjects as identified from time to time. c. Periodic update and refresher sessions for employees and practitioners will be provided. d. Written introductory materials shall ordinarily be used to inform vendors and contractors of the Compliance Program, unless the contractor is affiliated with the Center on a full-time basis, in which case, he or she is expected to attend orientation with employees. e. The Center Compliance Officer shall see that complete and accurate training records containing the following information are established and maintained: i. Training announcements and communications. ii. Content outlines, including time frames. iii. Copies of handout materials and resources used. iv. Attendance records of the course name, date, times, and names of individual attendees. v. All other communications pursuant to this Policy. f. The Center Compliance Officer shall assure that periodic evaluations of training effectiveness are conducted. Such evaluation may include, but shall not be limited to participant evaluations of the programs. 4. Reporting and Internal Investigation Procedure a. Reports must be made in writing to the Center Compliance Officer or through the Compliance reporting line and/or other reporting procedures. b. Information regarding the obligation to report and the means of reporting shall be consistently communicated throughout the Center through orientation and training sessions, public relations publications such as newsletters and posters and other means developed from time to time. c. Employees, contractors and agents are not required by this or any other policy to report anything other than firsthand knowledge. Firsthand knowledge as used in this policy means information gained as a result of direct observation or contact, or direct admission of the person engaged in the violation, but does not include information relayed by a third party. d. All employees, contractors and agents making reports are encouraged to disclose their identity, recognizing that anonymity may hamper complete and timely investigation. e. All reports of wrongdoing, however received, shall be investigated according to the following procedure: i. The Center Compliance Officer shall establish and develop a written record for each report. ii. No promises will be made to the party making the report or witnesses providing supporting information about the report by the Center Compliance Officer or anyone else in regard to his or her culpability or what steps may be taken by the Center in response to the report. Revised: 7-13 Page 14 of 24

15 iii. The Center Compliance Officer shall conduct an initial assessment of each report to determine whether the report has merit and warrants further investigation. A written record will be established for each report at the time of initial assessment. iv. The Center Compliance Officer shall determine whether the alleged wrongdoing is a violation of state or federal law or administrative regulation; is a violation of policy, procedure or plan connected with the Compliance Program; is a violation of other administrative policy; poses a risk to the general public or otherwise puts the Center at risk of economic injury or injury to reputation. v. If the Center Compliance Officer, after consultation with Legal Counsel when appropriate, believes that the allegation, if true, constitutes a violation of statute or regulation, the matter shall be immediately reviewed by the Center Compliance Officer and Legal Counsel for consideration and determination of appropriate action, including further investigation, corrective action, disciplinary action and government reporting. vi. If it is determined that the matter is not likely to involve serious legal consequences or is outside the scope of the Compliance Program, then it shall be referred to the appropriate function for resolution. Minor infractions of rules will ordinarily be referred to the individual s supervisor for the necessary and appropriate discipline. f. Following the investigation, the Center Compliance Officer shall document the findings of the investigation and complete a written record which shall include the following information, conclusions and recommendations: i. The report or other information that triggered the investigation; ii. The findings of the investigation; iii. Whether a violation of law or policy appears to have occurred; iv. The desirability and need to make any disclosures to a government agency or a third party; v. Recommendations for corrective action with respect to ongoing practices; vi. Recommended disciplinary measures to be taken against employees or agents of the Center; and vii. All final actions, including decisions to take no action. viii. The final report shall be signed by and placed in a permanent file maintained by the Center. g. No one involved in the process of receiving and investigating reports shall communicate any information about a report or investigation, including the fact that a report has been received or an investigation is ongoing, to anyone within the Center who is not involved in the investigatory process. h. All records relating to reports of potential wrongdoing shall be retained and preserved in accordance with policy governing record retention. 5. Record Creation, Retention and Destruction Procedure a. Employees and agents of the Center are encouraged to avoid creating unnecessary documents, and to use restraint in copying and circulating documents. b. Records compiled by the Center shall retain records for periods required by federal or state statute and regulation and by Center policy in a safe and secure manner. Revised: 7-13 Page 15 of 24

16 c. Retention periods may be extended beyond the period defined by statute or regulation based upon a risk management analysis of the advisability of retaining a particular category of record for a longer period. d. When there is an express or implied requirement of retention for a particular category of record, but no defined time period under statute or regulation, the retention period shall be three years in keeping with the standard federal retention period defined by the Paperwork Reduction Act of 1980 and the Uniform Preservation of Private Business Records Act, unless otherwise determined by the Records Custodian. e. The Center shall establish operating procedures governing retention periods for records which include at least the following provisions: i. Appointment of a position within the Center that is responsible for records issues. ii. A list of current pertinent records retention requirements and a provision for periodic updating. iii. Designation and maintenance of safe and secure storage areas for retained records and an accurate and understandable system of labeling stored records to prevent unauthorized access and minimize the risk of loss. iv. Establishment of a system for dating and flagging records for destruction on a regular schedule, including a provision for defeating the destruction schedule by polling for objections to destruction in the event that a record is the subject of actual or threatened litigation or investigation. v. When a record or category of records is scheduled for destruction, the responsible manager shall send a memorandum soliciting objections containing the following information to appropriate employees and to the Center Compliance Officer: a description of records scheduled for destruction; a statement of the retention period required by law, if any, and at the time period during which the records have been retained; the person to contact with objections and a deadline, after which records will be destroyed; and a affirmative acknowledgement that the individual receiving the memo has no objection. vi. If no objections are received by the scheduled deadline, the designated records may be destroyed on schedule. The responsible manager will follow-up with individuals who did not respond before authorizing record destruction. vii. The records shall be destroyed in the course of ordinary business and in a manner preserving confidentiality. Large volume shredding will be performed by a reputable company capable of meeting the standards set forth in this policy. Individual Center employees will be responsible for appropriately shredding small volumes of documents provided that all requirements of this policy are met. f. The following categories of compliance-related records shall be established and retained: i. Documentation of efforts to comply with applicable Federal health program requirements; including copies of all written communications with carrier representatives and regulators and documentation of oral communications. ii. Records of all risk assessment activities and internal and external audits and monitoring activities iii. An updated binder of historical and current regulatory guidance pertinent to Center billing categories, as well as general billing and coding guidance. iv. Current copies of all compliance policies and plans. Revised: 7-13 Page 16 of 24

17 Frequently Performed/ Occurring Subject to multiple recent changes Subject of regulatory guidance* Reporting line issue Identified by internal or external audit Identified by Comp. Officer, Committee or Management Identified by regulations in a specific case Previously identified as a priority by Committee Totals OneWorld Community Health Centers v. Documentation of all compliance-related reports received through the reporting process and a report of investigations and disposition of such reports. g. In the event of change in organization structure, i.e. merger, contractual arrangements shall be made for the disposition of the medical records. 6. Monitoring and Auditing Procedure The Center Compliance Officer, in consultation with Legal Counsel, shall develop an overall plan for compliance monitoring and auditing which shall include but not be limited to the following areas: a. Monitoring of ongoing activities selected in connection with risk assessment activities. b. Periodic (internal or external) audits of internal and external relationships. c. Monitoring and auditing of compliance concerns reported by employees or agents of the Center or raised through routine regulatory inquiry or correspondence. 7. Risk Assessment Tool List all compliance priorities under consideration and check each column that applies. For example: Outpatient Billing. Check column "a" for high volume and column "b" because outpatient billing is specifically addressed in the OIG's Supplemental Compliance Program Guidance, plus any other columns that apply. Total the number of columns checked on the far right-hand "Totals" column. Risk Area Revised: 7-13 Page 17 of 24

18 *OIG Annual Work Plan, Compliance Program Guidance, Special Fraud Alerts or Advisory Bulletins Select a short list of priorities (5 to 8) that resulted in the highest totals in the first round and analyze further to create a final list. If any of the priority areas from the first round are quick and easy fixes, select them as a priority. Among the remaining priorities, which will be more costly and time consuming to resolve, give priority to those which: represent the greatest financial exposure in terms of potential repayment obligations; involve severe penalties, e.g., Stark, anti-kickback or tax-exempt issues arising under contracts with providers and other referral sources; and pertain to any specific and current focus by regulators of the Center. This Risk Assessment Tool may be used to identify priorities for study and development of Compliance Plans and may also be effectively used by specific functions, e.g., billing, to develop specific compliance priorities. Ongoing Evaluation of the Compliance Program a. The Center will conduct an annual review of its Compliance Program elements as well as an assessment of the overall success of the program. The following Compliance Program elements will be individually reviewed and evaluated: i. Designation of a Center Compliance Officer. This aspect involves review of the Center "structure" to conduct compliance activities, reporting relationships and interpersonal relationships among Center personnel with compliance responsibilities. ii. Development of Compliance Policies and Procedures, Including Standards of Conduct. This includes a review of policies and procedures for accuracy, readability and updating plus an evaluation of policy and standards knowledge and compliance. Review of this element also includes the development and use of a risk assessment tool. iii. Developing Open Lines of Communication. Evaluation here requires an assessment of reporting line effectiveness and use, review of investigations and reports of investigations and review and evaluation of methods for conveying ongoing compliance information within the Center. iv. Appropriate Training and Education. Current compliance training offered to employee, contractors and agents of the Center should be inventoried, both general and specific to Revised: 7-13 Page 18 of 24

19 individual roles and duties; evaluate and update content; review personnel evaluations of training programs; review compliance with education requirements and assess compliance education. v. Internal Monitoring and Auditing. Plans for programs should be reviewed and monitoring and auditing results and reports evaluated, including evaluation of the use of external auditors. Trends in error rates should be assessed. vi. Response to Detected Deficiencies. Review the Center's response to deficiencies detected through audits or other means in terms of timeliness of investigation and correction, the quality and effectiveness of corrective action plans and the results of monitoring to determine whether corrective action was effective. vii. Enforcement of Disciplinary Standards. Review the consistency of required background education and disciplinary standards pertinent to compliance. Consider whether Center employees and agents are notified and periodically reminded of the standards of conduct and disciplinary consequences for infractions. b. Annual reviews of Compliance Program elements and overall effectiveness will be initiated and planned by the Center Compliance Officer working with Legal Counsel and technical consultants as appropriate. The evaluation process need not be highly technical or performed by external consultants. However, it will be planned and conducted in a manner designed to gather objective information and to detect areas requiring correction, improvement and/or further development. c. Patient Safety Report to Board of Directors d. Following review of all Compliance Program elements and overall effectiveness, the Center Compliance Officer will develop goals and improvement plans for the Compliance Program that respond to the findings and conclusion of the review. Advance Beneficiary Notice (ABN) Procedure The medical necessity requirement (42 U.S.C. 1395y(a)(1)(a)) prohibits Medicare and Medicaid from reimbursing for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning or malformed body member. If an order is received for a test to be performed on a patient for which Medicare reimbursement will be sought, it must be accompanied by medical information documenting medical necessity in the form of a narrative description of the symptoms or an appropriate code. The ABN provides a method of informing the patient that this denial may occur and documenting that the patient has been so informed. If an ABN is not obtained prior to collection of the specimen or performance of the diagnostic test, the patient cannot be billed for services denied by Medicare. If the patient is informed that the test may be covered by Medicare and if an ABN is obtained, the patient may be billed if the service is denied by Medicare. An ABN should be obtained when the provider is aware that services to be furnished to a patient will not or may not be covered except where the Medicare beneficiary handbook expressly states that the test is not covered or the non-covered status of the test is generally known, i.e., most screening tests. Revised: 7-13 Page 19 of 24

20 Obtaining an Advanced Beneficiary Notice (ABN) a. ABNs may be obtained when a practitioner is aware that the services to be furnished to a patient will not be covered. b. To be valid, a patient or patient representative must be notified in writing at or prior to performance of the service. Ideally, this should be done by the ordering practitioner. c. Providers are not required to submit claims for non-covered services, but the patient may request that the provider submit a claim for reimbursement. If requested, claims will be submitted for potentially non-covered services, but a signed ABN will be obtained so that if payment is denied, the beneficiary may be billed for the service. d. An ABN should only be obtained when there is a reasonable basis for the belief that a service is noncovered either by its nature or because it is not medically necessary for the patient at that time. It is not acceptable to use a blanket ABN for each patient to cover the possibility that a service may be regarded as non-covered. Therefore, patients may not be asked to sign an ABN for any and all services. e. The basis for believing that a service may not be covered must be documented on the ABN form. f. The ABN must be obtained prior to providing the service. g. The ABN must designate the service that the provider believes will not be covered. h. The ABN must be signed by the patient or patient representative and must be dated to show that the ABN was obtained prior to performing the service. i. The signed ABN must be maintained and must be available for audit by the Medicare carrier. j. An ABN for a service for a mentally incompetent patient in a nursing home may be signed by a representative of the nursing home or his or her representative who signs for the beneficiary on other matters. The following individuals are allowed to sign for the beneficiary (42 CFR ): i. legal guardian; ii. relative or other person who receives Social Security or other benefits on behalf of the beneficiary; iii. relative or other person who arranges treatments for the beneficiary; and iv. a representative of the nursing home. k. Standing Orders. An ABN is required at the outset of treatment for a non-covered service and is effective as long as no new services are specified in the standing order. If new services are provided, then a new ABN is necessary. l. Patient Refusal. A beneficiary has the choice to either refuse or obtain the service. He or she does not have the choice to obtain the service, but refuse to sign an ABN and be responsible for payment if the service is non-covered. If the beneficiary demands that a service be performed, but refuses to sign the ABN, a second person should witness the refusal and document this and their signature on the ABN statement. A note to the patient file should indicate the two persons present who witnessed the patient refusal. If only one person is present in the physical location with the patient, the second witness may be contacted by telephone to witness the refusal and then sign the note later. If the beneficiary refuses the service, the provider should be notified and such refusal documented on the requisition. Revised: 7-13 Page 20 of 24

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