Compliance Policies Table of Contents Policy Page Policy Title # Number 001 Compliance Plan 2 001.1 Corporate Integrity Agreement 6 002 Compliance Communication and Internal Reporting 11 003 Compliance Hotline Disclosure 14 004 Compliance Risk Assessment 16 005 Compliance Officer and Committee 19 006 Board of Directors Obligation 21 007 CIA Management Certification Process 22 008 Training and Education 25 009 Document Retention 29 010 Focus Arrangement 33 011 Compliance Focus Arrangement Tracking System 37 012 Government Investigations 41 013 Subpoenas and Search Warrants 49 014 OIG Reporting Requirements 51 015 Claims Submission and Overpayment Procedures 58 016 Compliance Audit and Monitoring 61 017 Ineligible Persons-Entities Screening 63 018 Consequences of Non-Compliance 66 019 Fair Market Value Assessment 68 020 Monitoring Guidance for Remuneration Paid Under Arrangement 021 Conflict of Interest 75 72
Policy #: 1 Page 1 of 4 Procedure Name: Compliance Plan Policy: The Regent Care Management Services, LP Compliance Plan Policy (Plan Policy) which includes Regent Care Management Services, LP and its managed nursing homes (collectively Regent Care) has been designed to provide a clear statement of the Compliance Department s departmental policy with related procedural steps for internal department operations included in the Corporate Integrity Agreement (CIA) Compliance. These policies supersede any current Regent Care compliance related policies, at a minimum for the duration of Regent Care s CIA. Purpose: The Plan Policy provides guidance to Regent Care s Compliance Department in its efforts to ensure that Regent Care conducts its business in compliance with federal/state healthcare rules and regulations by implementing an effective compliance program. The Plan Policy and related Regent Care CIA policies provide a foundation for the Compliance Department to structure a program that effectively: Enhances a culture that promotes prevention, detection, and resolution of instances of noncompliance with federal and state laws, public and private requirements, and Regent Care s administrative policies; Articulates and demonstrates Regent Care s commitment to its Compliance Program; Maintains a process for disseminating information and guidance on applicable federal and state statutes, regulations, Regent Care policy and other requirements; Maintains an infrastructure throughout Regent Care system to support the Compliance Program; Educates and informs employees of the importance of compliance processes and procedures; Provides advance notice of, and expectations for employees regarding compliance processes and procedures, and the repercussions associated with non-compliance; Assists Regent Care in complying with federal, state and local rules and regulations; Mitigates penalties and sanctions that may be imposed for non-compliance; Provides a means and method for Regent Care to monitor the strengths and weaknesses of compliance documentation processes for all s; Provides a means of preventing and detecting any noncompliant business practices; Provides a protocol for responding to any regulatory investigation or audit; and Provides employees a means by which to report or address concerns or issues regarding potential noncompliance within Regent Care. The Compliance Plan is derived from the HHS Office of Inspector General s (OIG) Compliance Program Guidance for Nursing Facilities (65 Fed. Reg. 14289 (March 16, 2000). The Plan includes the seven elements prescribed by the OIG: 1. Implementing written policies, procedures, and standards of conduct; 2. Designating a Compliance Officer and compliance committee; 3. Conducting effective training and education; 4. Developing effective lines of communication; 5. Enforcing standards through well-publicized disciplinary guidelines; 2
Policy #: 1 Procedure Name: Compliance Plan 6. Conducting internal monitoring and auditing; and 7. Responding promptly to detected offenses and developing corrective action. 3 Procedures: I. Compliance Program Plan, Policies And Procedures: Regent Care has established compliance standards and procedures, including a Code of Conduct and Ethics, to be followed by its employees and agents that are reasonably capable of reducing the prospect of illegal and wrongful conduct under federal health care requirements and Regent Care s CIA. The Compliance Plan and related CIA policies and procedures are specific to the mission, vision, values and goals, organizational history, lines of business and culture of Regent Care. II. Compliance Officer and Compliance Committee: The Board of Directors will assure sufficient resources are available to effectively implement the Compliance Plan. The roles and responsibilities of the Compliance Committee and Compliance Officer are outlined in Policy #005, titled Compliance Officer & Compliance Committee. A. Compliance Committee: The Board of Directors will approve a Compliance Committee (Committee), which shall be responsible for the oversight and supervision of the Compliance Plan. The Committee has the responsibility to coordinate compliance efforts and implement any and all compliance policies and procedures in accordance with the directives outlined in the Compliance Plan. B. Compliance Officer: The Compliance Officer has the responsibility to administer and manage all tasks related to establishing, monitoring, and updating the Compliance Plan. III. Staff Education And Training: A. Regent Care will communicate its Compliance Plan standards and procedures to all staff and agents. Education is provided through mandatory training programs and by disseminating publications that explain in a practical manner the requirements of compliance. B. Compliance training is a component of the Personnel Orientation Program for new employees, agents and the members of Boards of Directors. As an integral part of the CIA Training Plan, an annual Compliance Education and Training Plan is developed in response to the level of risk a staff member or agent possesses, or may encounter. Additional training is provided for those individuals working with billing, coding and accounting processes. C. Evaluation of management and staff promotion and adherence to the Compliance Plan and any other compliance issues, is a component of an individual s annual performance appraisal. Attendance records of staff orientation and annual update education must be retained. The Page 2 of 4
Policy #: 1 Procedure Name: Compliance Plan Human Resources Director or his/her designee must ensure that annual performance appraisals are based in part on receipt of compliance information as offered by the company. IV. Effective Communication with the Compliance Officer and Reporting Structure: Regent Care maintains the Compliance Hotline for confidential reporting of real or potential problems. All calls, written and verbal reports will be documented, including how they were triaged and, as appropriate, investigated and what actions were taken. Regent Care shall clearly communicate to all staff and agents that hotline reporting is confidential and anonymous; to the extent permitted by law, and that the Regent Care has a non-retaliation policy. Regent Care s disclosure policy is described in Policy 002, titled Compliance Communication and Internal Reporting Policies. Regent Care s hotline policy is described in Policy 003, titled Compliance Disclosure Policy. V. Consistent Enforcement And Discipline: Through its systematic reporting, monitoring and auditing systems, Regent Care will investigate and remediate identified systematic and staff/agent problems. Regent Care shall discipline individuals responsible for the failure to prevent or detect compliance or legal violation and individuals who commit such violations. VI. Auditing and Risk Evaluation Regent Care is taking steps to achieve compliance with its compliance standards, i.e., by utilizing monitoring and auditing systems designed to detect criminal conduct by its staff or agents, and by having in place and publicizing a reporting system whereby Regent Care staff and agents can report criminal conduct or other misconduct by others within the organization without fear of retribution. Regent Care s auditing and monitoring policy is described in Policy 016, titled Compliance Audit and Monitoring Policy. A. Auditing: 1. Regent Care conducts risk-based audits at least annually. 2. Compliance Department personnel are permitted to review all relevant areas of corporate operations. 3. Compliance Department personnel have access to, and support from, senior management. 4. Individuals conducting audits shall be independent of the operational area to be audited. B. Monitoring: 1. Regent Care s monitoring activity provides an ongoing review of internal coding, billing, marketing and contracting practices to assure that Regent Care policies and procedures have been properly followed. 2. Regent Care conducts monitoring on a regular basis. 3. Regent Care s monitoring activities focus on compliance concerns and performance measures. 4 Page 3 of 4
Policy #: 1 Procedure Name: Compliance Plan VII. Response and Prevention Regent Care staff and agents shall be oriented to the correct procedure to follow in the event of a detected violation or government investigation. Regent Care s policy addressing response to suspected violations is described in Policy 018, titled Consequences of Non-Compliance to Code of Conduct & Ethics and RMS Policies and Procedures. 5 Page 4 of 4
Policy #: 1.1 Procedure Name: Corporate Integrity Agreement 6 Purpose: It is the intent of this policy to aid those associated with Regent Care Management Services, LP and its managed nursing homes (collectively, Regent Care) and all Covered Persons and Arrangements Covered Persons in achieving the highest standards of integrity and quality services to our residents. This Policy and all Regent Care Compliance Policies enacted following the effective date (October 19, 2015) of, the Corporate Integrity Agreement (Regent Care s CIA) supersede any duplicative policy statements currently in place and apply to all Covered Persons and Arrangements Covered Persons, at a minimum during the period of Regent Care s CIA, which is five (5) years from the effective date. Covered Persons and Arrangements Covered Persons are defined as follows: 1. Covered Persons: a. All owners, officers, directors, and employees of Regent Care; and b. All contractors, subcontractors, agents, and other persons who furnish patient care items or services or who perform billing or coding functions on behalf of Regent Care excluding vendors whose sole connection with Regent Care is selling or otherwise providing medical supplies or equipment to Regent Care. Notwithstanding the above, this term does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours during a Reporting Period, except that any such individuals shall become Covered Persons at the point when they work more than 160 hours during a Reporting Period. 2. Arrangements Covered Persons includes each Covered Person who is involved with the development, approval, management, or review of Regent Care s Arrangements. The leadership of Regent Care and Regent Care s Compliance Department are dedicated to complying with Regent Care s CIA, laws, regulations, and any requirements of federal, state, and private payor plans with which we work as well as to the highest standard of professional responsibility and quality of care. Policy: Regent Care hereby establishes a Compliance Policy consisting of standards for all Covered Persons and Arrangements Covered Persons, with the specific intent of identifying, preventing, and correcting certain actions that may be considered non-compliant, fraudulent, or abusive. Procedure: 1. The Compliance Department is responsible for the identification of all Covered Persons and Arrangements Covered Persons for the purpose of this agreement. The Chief Compliance Officer (CCO) will work collaboratively with the following individuals to create and maintain a list of both Covered Persons and Arrangements Covered Persons: Page 1 of 5
Policy #: 1.1 Procedure Name: Corporate Integrity Agreement 7 a. President or designee to identify all owners, officers, and directors of Regent Care; b. Human Resource Director to identify all employees who work more than 160 hours in a year; c. Chief Financial Officer to identify contractors, subcontractors, agents, and other persons who furnish patient care items or services or who perform billing or coding functions on behalf of Regent Care. The list will be updated as needed for the term of this Agreement by the individuals listed above and reported to the CCO. 2. Regent Care will engage an Independent Review Organization (IRO) for the duration of this Agreement as per Regent Care s CIA. a. The IRO will have appropriate qualifications to perform Systems Review and Arrangements Review; b. The CCO will serve as the main Regent Care contact for the IRO to monitor and assist in the IRO s work and implement the recommendations in the IRO s reports; c. The CCO will ensure the retention of all work papers, documentation, correspondence, and draft reports related to the IRO reviews; and d. The CCO will report to the OIG within 15 days of any change to the contracted IRO. 3. The following non-exclusive list of issues and conduct, together with the standards set forth in the Regent Care Code of Conduct and Ethics, present common compliance concerns that skilled nursing care providers frequently encounter. This list provides some, but not all, issues that Covered Persons and Arrangements Covered Persons may encounter. If any Regent Care personnel, including a Covered Person or Arrangement Covered Person become aware of such issues, he/she shall notify the CCO immediately. a. Payments and Discounts: It is prohibited by law to receive payments, discounts, or gifts that may be considered remuneration in exchange for the purchase, lease, ordering, or recommending of any goods, facilities, services, or items reimbursed by federal or state health care programs. b. Anti-Kickback Regulations: Regent Care staff or agents shall not knowingly and willfully solicit, offer to pay, or actually pay or receive, any remuneration, directly, indirectly, overtly, covertly, in cash and/or in return for: 1) Referring an individual to Regent Care or a person for the furnishing, or arranging for the furnishing, of any item or service for which payment may be made, in whole or in part, under any state or federal healthcare program. Page 2 of 5
Policy #: 1.1 Procedure Name: Corporate Integrity Agreement 8 2) Purchasing, leasing, ordering, or arranging for, or recommending the purchasing, leasing, or ordering of any good(s), facility, service or item for which payment may be made in whole or in part, under any federal or state healthcare program. 3) Specific safe harbors are excluded from this prohibition. An example of a safe harbor agreement would be a volume purchasing and/or group purchasing discount agreement. Regent Care management shall consult with the Chief Executive Officer (CEO) or Chief Compliance Officer before signing or offering any agreement or arrangement based upon safe harbor compliance. 4) Remuneration may include, however but is not limited to: a) Bribes, b) Rebates, c) Kickback payments, and d) Gifts in lieu of payments. c. Kickbacks: It is prohibited by law to make or receive payments in any form that can be considered a kickback in exchange for the use or recommendations of supplies, services, goods, facilities, or items reimbursed by federal or state healthcare programs. This includes knowingly and willfully offering, paying, soliciting or receiving money or other benefits, directly or indirectly, in return for (1) patient referrals or (2) purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a federal health care program. d. Loans, Rebates or Services: The offer or delivery of loans rebates, or services, or payments of any kind, in any way connected to patient referrals, are prohibited. e. Entertainment: Business dealings may include a shared meal or similar social occasion that may be proper business activities. More extensive entertainment may not be consistent with organizational policy and should be reviewed and pre-approved by the Compliance Officer. f. Gifts: Employees of Regent Care may not receive any gift they believe is offered in an attempt to influence decisions or actions related to: (1) patient referrals, (2) purchasing, leasing, ordering, or arranging for, or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a federal health care program. Employees should return such gifts and report the incident to the Compliance Officer. Token promotional items, such as pens or pencils marked with the donor s name are not considered inappropriate when given in individual or limited quantities. Page 3 of 5
Policy #: 1.1 Procedure Name: Corporate Integrity Agreement 9 g. Billing: Regent Care bears the responsibility to accurately bill for actual services rendered in a timely fashion. Billing activities are expected to maintain the highest standard of integrity honesty, and diligence in the performance of these important duties. Regent Care is committed to accuracy in our financial dealings. False, inaccurate, or questionable claims, coding, or billing should be reported immediately to the Central Billing Office Manager and/or the Compliance Officer. The Office of Inspector General identified specific areas of risk in the billing and cost reporting process. Examples of potentially fraudulent or abusive practices include: 1) Claiming reimbursement for services that were not rendered or provided as claimed; 2) Submitting claims for equipment, medical supplies, and services, including but not limited to, rehabilitation therapy that is not medically necessary; 3) Submitting claims to Medicare Part A for residents who are not eligible for Part A coverage; 4) Filing duplicate claims; 5) Failure to identify and refund credit balances in a timely manner; 6) Submitting claims for items or services that have not been ordered; 7) Knowingly billing for substandard or inadequate care; 8) Providing misleading information about a resident s medical condition on Minimum Data Sets, or otherwise providing inaccurate information used to determine the Resource Utilization Group (RUG) assigned to residents; 9) Upcoding the level of service provided; 10) Billing for individual items or services when they are either billed at a facility per diem rate or are the type of item or service that must be billed as unit and may not be unbundled; 11) Billing residents for items or services that are included in a per diem rate or otherwise covered by a third party payor; 12) Forging physician or beneficiary signatures on documents used to verify that services were ordered and/or provided; 13) Failing to maintain sufficient documentation to establish that the services were ordered and/or provided; and 14) Submitting false cost reports. h. Patient Referrals: Regent Care is in the business of providing the delivery of appropriate nursing, rehabilitation, and long term care services. Residents serviced by Regent Care may be referred to other organizations or providers as is medically necessary for the treatment of their conditions. The resident or the resident s guardian or other responsible party should make the choice of provider with guidance from his or her physician as to what providers are qualified and medically appropriate Page 4 of 5
Policy #: 1.1 Procedure Name: Corporate Integrity Agreement 10 a. Referrals to or from Regent Care by providers who have a financial relationship with the organization may be made only if specific provisions of the law (Stark Law exceptions and/or Anti-Kickback Statute safe harbors) are met. Any referral or pattern of referrals that are questionable should be brought to the attention of the Compliance Officer, who is obligated to review that action with advice from Regent Care s Counsel. i. Compliance Hotline: Regent Care maintains a Compliance Hotline to enable individuals to disclose to the Compliance Officer any identified issues or questions associated with Regent Care s policies, conduct, practices, or procedures with respect to a federal health care program believed by the individual to be a potential violation of the law. The Compliance Officer or the Compliance Officer s designee will investigate reports. The Compliance Hotline number is 877-245-6675 and the Hotline website is reportlineweb.com/regent. j. Retaliation or Retribution: Retaliation or retribution of any kind against those reporting fraudulent or abusive activity or even suspected compliance violations will not be tolerated. Employees, who feel they are the targets of retaliation or retribution should report such conduct immediately to their supervisor or the Compliance Officer, follow grievance procedures in Regent Care s Employee Handbook and Human Resources Policies and Procedures manual and/or contact the Compliance Officer to file a formal report that will be reviewed by administration. k. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. Page 5 of 5
Policy #: 2 Procedure Name: Compliance Communication and Internal Reporting 11 Purpose: As required by the Disclosure Program section of Regent Care s Corporate Integrity Agreement (CIA), an effective means of communicating with the Compliance Officer and reporting compliance issues and questions is hereby established and made available to all Regent Care personnel and Covered Persons. Prior to Regent Care s CIA, Regent Care established and maintained a Compliance Officer and a Compliance Hotline. This Policy and Procedure is established to continue and to strengthen reporting of compliance issues to the Compliance Department. Policy: 1. All personnel and Covered Persons, via the Regent Care Code of Conduct and otherwise, have been notified that they have free and unrestrained access to the Compliance Officer for reporting appropriate concerns and questions with regard to legal compliance involving Regent Care. 2. The identity of those reporting compliance and integrity issues, concerns, or questions will be kept confidential within the organization. The Compliance Officer or Regent Care Counsel may have a need to discuss the report with the reporting individual. 3. Individuals may report compliance concerns or ask compliance questions anonymously either by oral or written means. 4. Individuals reporting compliance issues should be aware that regardless of Regent Care s internal policy of protecting identities, their identity may have to be released to federal or state agencies conducting investigations, and may become public in the process of those investigations from federal and state sources. 5. Individuals reporting compliance issues are entitled to be informed as to the correction or investigation of the issues they report, and may be so informed by the Compliance Officer in confidential meetings. 6. The Compliance Officer will maintain regular office hours during which reports may be made in person. 7. In addition, Regent Care s Compliance Hotline is available 24 hours per day, either by telephone or internet website. The Compliance Hotline allows individuals to anonymously report specific concerns and ask compliance questions, and will ask the caller to provide his or her name and telephone number only if the caller wants to speak with the Compliance Officer personally. Callers will be instructed as to the specific information required to conduct a meaningful investigation. The Compliance Hotline number: 877-245-6675 and website: www.reportlineweb.com/regent, will be posted conspicuously and provided in writing to each Covered Person, employee, associated medical care provider, and others as appropriate. Page 1 of 3
Policy #: 2 Procedure Name: Compliance Communication and Internal Reporting 12 8. Corporate leaders, Administrators and other facility management receiving complaints from staff should forward those to the Compliance Officer and maintain anonymity of the complainant if asked to do so. Supervisors should also seek to resolve and answer any concerns. 9. A log shall be maintained by the Compliance Department listing all complaints, the nature of the complaint, date and time received; receipt by call, personal visit, or written means, the nature of the investigation to be performed; and results of the investigation. As appropriate, based on the nature and scope of complaints received, the Compliance Officer shall seek the guidance of senior management and Counsel of the organization. 10. No Regent Care personnel making a report in good faith will suffer any retaliation or retribution whatsoever as a result of such report. 11. The Compliance Officer will also make quarterly reports to the Compliance Committee that shall include a description of any material compliance complaints, as well as the investigation and resolution of such complaints. 12. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. Page 2 of 3
s and Regent Care Management Services, LP Compliance Concern Reporting Chain Addendum CIA Policy #002 13 YOUR IMMEDIATE SUPERVISOR IS YOUR PRIMARY REPORTING OPTION Employee Supervisor OR YOU MAY REPORT TO ONE OF THESE RESOURCES Administrator Human Resources IF YOU ARE UNCOMFORTABLE REPORTING LOCALLY, YOU MAY REPORT TO RESOURCES RMS COMPLIANCE OFFICER (409) 763-6000 Ext 1016 THE REGENT CARE HOTLINE (anonymous/confidential) 1-877-245-6675 reportlineweb.com/regent Page 3 of 3
Policy #: 3 Procedure Name: Compliance Hotline Disclosure Purpose: As required by Regent Care s Corporate Integrity Agreement (CIA), Regent Care is committed to the timely identification and resolution of all compliance issues that may either impact a federal or state healthcare program, or that potentially violates criminal, civil, or administrative law, or adversely affects employees, patients, or the organization. Regent Care has an established disclosure mechanism for any and all Covered Persons and Regent Care personnel to report problems and concerns and to ask questions, including a Compliance Hotline (1-877-245-6675) and online address: reportlineweb.com/regent. All Covered Persons and Regent Care personnel, as well as residents and the public are encouraged to report problems and concerns and ask questions either anonymously or in confidence via the disclosure process when they deem appropriate. This mechanism establishes an avenue for Covered Persons and other interested parties to report suspected illegal or unethical conduct, or a violation of Regent Care s CIA occurring within the organization in the event other resolution channels are ineffective or the caller wishes to remain anonymous. Policy: 1. Regent Care will continue to maintain its Compliance Hotline that all Covered Persons and Regent Care personnel may use to report problems, concerns and questions, either anonymously or in confidence. 2. Personnel who report problems and concerns in good faith via the Compliance Hotline will be protected from any form of retaliation or retribution. 3. Regent Care has contracted its Compliance Hotline service to an external hotline resource, which provides 24-hour/7 day per week service. A live person who has been trained to respond and record concerns from callers and electronically submit the report to Regent Care s Compliance Officer. Procedure: 1. Upon receipt of a disclosure, the Compliance Officer (or designee) will gather all relevant information from the disclosing individual. a. The Compliance Officer (or designee) will make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. b. The Compliance Officer will also determine whether the disclosure is sufficiently specific so that it reasonably: i. Permits a determination of the appropriateness of the alleged improper practice; ii. Provides an opportunity for taking corrective action. 14 Page 1 of 2
Policy #: 3 Procedure Name: Compliance Hotline Disclosure c. If the Compliance Officer determines that the disclosure is sufficiently specific, Regent Care will conduct an internal review of the allegations set forth in the disclosure and ensures that proper follow-up is conducted. 2. The Compliance Department shall maintain a disclosure log and will record each disclosure in this log. The disclosure log may include: a. Summary of each disclosure received (including anonymous disclosures), b. Status of the respective internal reviews, and c. Corrective action taken in response to the internal reviews. 3. The Compliance Officer s general responsibilities related to the operation of the Compliance Hotline include ensuring that all calls are addressed appropriately, as well as in accordance with these and all related policies and procedures. Other responsibilities may include the following: a. Ensuring proper functioning of the Compliance Hotline; b. Establishing reporting and records maintenance procedures; c. Conducting appropriate investigations and follow-up; d. Referring calls when appropriate; and e. Providing feedback as appropriate. 4. The Compliance Officer will publicize the existence of the Compliance Hotline via periodic e-mails to employees and by posting the information in prominent common areas. 5. The Compliance Officer will communicate any matter deemed potentially unlawful to the appropriate party. 6. The Compliance Officer will report quarterly to the Compliance Committee regarding reports made via the Compliance Hotline, and may include the following information: a. Total number of calls received, acted upon, and general results from the operation of the Compliance Hotline; and b. Recommendations for system-wide improvements or corrective actions arising from the results of the operation and related investigations. 7. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. 15 Page 2 of 2
Policy #: 4 Page 1 of 3 Procedure Name: Compliance Risk Assessment Policy: This Policy outlines Regent Care s risk assessment and internal review process to facilitate compliance with the requirements of Regent Care s CIA and with the requirements of federal health care programs. Definitions: 1. Arrangements shall mean every arrangement or transaction that: a. Involves, directly or indirectly, the offer, payment, solicitation, or receipt of anything of value; and is between Regent Care and any actual or potential source of health care business or referrals to Regent Care or any actual or potential recipient of health care business or referrals from Regent Care. The term source of health care business or referrals shall mean any individual or entity that refers, recommends, arranges for, orders, leases, or purchases any good, facility, item, or service for which payment may be made in whole or in part by a Federal health care program and the term recipient of health care business or referrals shall mean any individual or entity: I. To whom Regent Care refers an individual for the furnishing or arranging for the furnishing of any item or service, or II. From whom Regent Care purchases, leases or orders or arranges for or recommends the purchasing, leasing, or ordering of any good, facility, item, or service for which payment may be made in whole or in part by a Federal health care program; or III. Is between Regent Care and a physician (or a physician s immediate family member (as defined at 42 C.F.R. 411.351)) who makes a referral (as defined at 42 U.S.C. 1395nn(h)(5)) to Regent Care for designated health services (as defined at 42 U.S.C. 1395nn(h)(6)). 2. Focus Arrangements means every Arrangement that: a. Is between Regent Care and any actual source of health care business or referrals to or from Regent Care and involves, directly or indirectly, the offer, payment, or provision of anything of value; or b. Is between Regent Care and any physician (or a physician s immediate family member) (as defined at 42 C.F.R. 411.351)) who makes a referral (as defined at 42 U.S.C. 1395nn(h)(5)) to Regent Care for designated health services (as defined at 42 U.S.C. 1395nn(h))(6)). Any Arrangement that satisfies the requirements of 42 C.F.R. 411.356 (ownership or investment interests), 42 C.F.R. 411.357(g) (remuneration unrelated to the provision of designated health services); 42 C.F.R. 411.357(i) (payments by a physician for items and services); 42 C.F.R. 411.357(k) (non-monetary compensation); 42 C.F.R. 411.357(m) (medical staff incidental benefits), 42 C.F.R. 411.357(o) (compliance training), 42 C.F.R. 411.357(q) 16
Policy #: 4 Page 2 of 3 Procedure Name: Compliance Risk Assessment (referral services), 42 C.F.R. 411.357(s) (professional courtesy), 42 C.F.R. 357(u) (communitywide health information systems), or any exception to the prohibitions of 42 U.S.C. 1395nn that does not require a written agreement shall not be considered a Focus Arrangement. Procedure: 1. The risk assessment and internal review process are conducted under the direction of the Compliance Officer. The Compliance Department and facility leaders shall: a. Identify and prioritize risks, b. Develop internal audit work plans related to the identified risk areas, c. Implement the internal audit work plans, d. Develop corrective action plans in response to the results of any internal audits performed, and e. Track the implementation of the corrective action plans in order to assess the effectiveness of such plans. 2. The annual compliance risk assessment is conducted by the Compliance Department; department staff is knowledgeable in fraud, waste and abuse, and compliance issues. The compliance risk assessment team may review the following topics: a. Kickbacks and inducements; b. Self-referrals; c. Employee screening; d. Quality of care; e. Residents rights; f. Admission processes, specifically those that might reveal discrimination or improper denial of access to care; g. Management of residents financial affairs, and any evidence of failure to safeguard the finances of patients; and h. Billing and cost reporting. 3. Results of the risk assessment will be prioritized by the Compliance Officer in collaboration with leadership and utilized to develop an annual compliance work plan that will outline: a. Prioritized risk areas; b. Description of issues; c. Mitigation activities; d. Responsible persons; and e. Reporting date. 4. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. 17
Policy #: 4 Procedure Name: Compliance Risk Assessment Revisions are communicated and distributed to all Covered Persons. 18 Page 3 of 3
Policy #: 5 Procedure Name: Compliance Officer & Committee Policy: Regent Care maintains a Compliance Program developed and implemented by the Compliance Officer and overseen by the Compliance Committee. Procedure: 1. The Compliance Officer s position and responsibilities are consistent with the requirements in Regent Care s Corporate Integrity Agreement (CIA): a. The Compliance Officer is a member of the senior management of Regent Care, overseeing all of Regent Care s compliance programs, and granted authority to design, implement, and revise Regent Care s compliance programs. b. The Compliance Officer reports directly to the Regent Care President and CEO, and the Compliance Officer is not subordinate to Regent Care s Counsel or Chief Financial Officer. c. The Compliance Officer is responsible for, without limitation: i. Developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in Regent Care s CIA and with Federal/State health care program requirements; ii. iii. iv. Making quarterly reports regarding compliance matters directly to the Regent Care Boards of Directors (the Compliance Officer is authorized to report on such matters to the Board of Directors at any time); Maintaining written documentation of his/her reports to the Board of Directors; and Monitoring the day-to-day compliance activities engaged in by Regent Care as well as for any reporting obligations created under Regent Care s CIA. d. The Compliance Officer does not have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Regent Care. These responsibilities are carried out by Regent Care s Counsel. e. The Compliance Officer may have limited noncompliance job responsibilities which are not expected to interfere with the Compliance Officer s ability to perform the duties outlined in Regent Care s CIA or in this Policy. f. Regent Care will report to OIG, in writing, any changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer s ability to perform the duties necessary to meet the obligations in Regent Care s CIA, within five days after such a change. 19 Page 1 of 2
Policy #: 5 Procedure Name: Compliance Officer & Committee 2. The Compliance Committee s composition responsibilities are consistent with the requirements in Regent Care s CIA: a. The Compliance Committee is chaired by the Compliance Officer, and comprises the following members of senior management: [e.g., senior executives of relevant departments, such as finance, clinical, operations and human resources]; b. The Compliance Committee supports the Compliance Officer in fulfilling his/her responsibilities by performing the following actions: i. Assisting in the analysis of Regent Care s risk areas by evaluating and approving risk assessment plans proposed by Certifying Employees, as described in Policy 007 entitled Management Certifications ; ii. Overseeing monitoring of internal and external audits and investigations brought to the Committee s review by the Compliance Officer. c. The Compliance Committee meets quarterly, and keeps a record of the minutes of its meetings available to OIG upon request. The Compliance Officer is authorized to convene the Compliance Committee for meetings in addition to the scheduled quarterly meetings, as the Compliance Officer deems necessary. 3. Regent Care will report to OIG, in writing, any changes in the composition of the Compliance Committee, or any actions or changes that would affect the Compliance Committee s ability to perform the duties necessary to meet the obligations in Regent Care s CIA, within 15 days after such a change. 4. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. 20 Page 2 of 2
Policy #: 6 Procedure Name: Board of Directors Obligation Policy: The Board of Directors of Regent Care Management Services, LP (Board) is responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of Regent Care s Corporate Integrity Agreement (CIA). As required by Regent Care s CIA, the Board includes several independent members. The Compliance Department will maintain a copy of current Board membership. Procedure: 1. As required by Regent Care s CIA, the Board is responsible for the following: a. Meeting at least quarterly to review and oversee Regent Care s compliance program, including the performance of the Compliance Officer and Compliance Committee; b. Adopting a resolution, signed by each member of the Board summarizing its review and oversight of Regent Care s compliance with Federal/State health care program requirements and the obligations of Regent Care s CIA. At minimum, the resolution must include the following language: The Board of Directors has made a reasonable inquiry into the operations of Regent Care s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Regent Care has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the CIA. If the Board is unable to provide such a conclusion in the resolution, the Board will include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at Regent Care; and c. Submitting to the Office of Inspector General (OIG) a description of the documents and other materials that the Board reviewed, as well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and in support of making the resolution above during each Reporting Period (1 year). 2. Regent Care will report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board s ability to perform the duties necessary to meet the obligations in Regent Care s CIA, within 15 days after such a change. 3. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. 21 Page 1 of 1
Policy #: 7 Page 1 of 3 Procedure Name: CIA Management Certification Process Policy: In addition to the responsibilities set forth in Regent Care s Corporate Integrity Agreement (CIA) for all Covered Persons, certain Regent Care employees (Certifying Employees) must monitor and oversee activities within their areas of authority and shall annually certify that the applicable Regent Care department is in compliance with applicable Federal/State health care program requirements and with the obligations of Regent Care s CIA. Procedure: 1. The Certifying Employees include the following: President; Chief Administrative Officer; Chief Financial Officer; Northern Regional Directors; Southern Regional Directors; Clinical Services Director; Administrator and Director of Nursing of El Paso; Administrator and Director of Nursing of Kingwood; Administrator and Director of Nursing of Laredo; Administrator and Director of Nursing of League City; Administrator and Director of Nursing of San Antonio; Administrator and Director of Nursing of Oakwell Farms; Administrator and Director of Nursing Regent Care at Medical Center; Administrator and Director of Nursing of San Marcos; Administrator and Director of Nursing of The Woodlands; Administrator and Director of Nursing of Woodway; Administrator and Director of Nursing of Reno; Administrator and Director of Nursing Harbourview at South Shore; 2. For each Reporting Period during Regent Care s CIA, each Certifying Employee shall sign a certification (Management Certification) that states: I have been trained on and understand the compliance requirements and responsibilities as 22
Policy #: 7 Page 2 of 3 Procedure Name: CIA Management Certification Process they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Regent Care policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Regent Care is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States. 3. If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. 4. At the direction of the Compliance Officer, and at a time consistent with compiling data for each Reporting Year as defined by the Compliance Officer, the President, Chief Administrative Officer, Chief Financial Officer, each Regional Director of Operations, and each Facility Administrator and Director of Nursing may require their direct subordinates to submit documentation to support their individual department s compliance with applicable Federal/State health care program requirements and with the obligations of Regent Care s CIA. Such documentation shall be compiled per each Certifying Employee s area of oversight and be assessed to ensure all department reporting, and may include, at a minimum, the following data: a. Results of operational assessments; and b. Written reports of monitoring activities and independent audits. 5. The Compliance Officer is responsible for collaborating with management on the development of a timeline and report methodology for the collection of data and other reports to support the Management Certifications for each Reporting Period. a. Each Certifying Employee will (1) develop a list of all direct reports, (2) outline the types of reports, data, or other supporting documentation to be utilized for the certification process, (3) outline the deadlines for the submission of reports, and (4) submit this information to the Compliance Officer to present to the Compliance Committee for review and approval. b. The Compliance Committee will make a determination on approval of each Certifying Employee s proposed process and notify the Certifying Employee upon the Committee s approval. c. The Certifying Employee will maintain documentation of such assessments for the duration of Regent Care s CIA. 23
Policy #: 7 Procedure Name: CIA Management Certification Process 6. Certifying Employees who do not comply with this certifying process are subject to disciplinary action, up to and including termination. 7. This Policy is assessed by the Compliance Officer at least annually, and updated accordingly. Revisions are communicated and distributed to all Covered Persons. 24 Page 3 of 3
Policy #: 8 Procedure Name: Training and Education 25 Policy: Regent Care is committed to maintaining an effective compliance training and education program. Pursuant to Regent Care s Corporate Integrity Agreement (CIA), Regent Care has developed a written plan (Training Plan) that outlines the steps taken to ensure that all Covered Persons and Arrangements Covered Persons receive adequate training in accordance with Regent Care s CIA regarding, among other things, Regent Care s CIA requirements, Regent Care s compliance program, and the requirements of federal health care programs. Definitions: 1. Covered Persons includes: a. All owners, officers, directors, and employees of Regent Care; and b. All contractors, subcontractors, agents, and other persons who furnish patient care items or services or who perform billing or coding functions on behalf of Regent Care excluding vendors whose sole connection with Regent Care is selling or otherwise providing medical supplies or equipment to Regent Care. Notwithstanding the above, this term does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours annually, except that any such individuals shall become Covered Persons at the point when they work more than 160 hours annually. 2. Arrangements Covered Persons includes each Covered Person who is involved with the development, approval, management, or review of Regent Care s arrangements. Procedure: All training is provided in person and/or using computer-based training. If Regent Care chooses to provide computer-based training, it shall make available appropriately qualified and knowledgeable staff or trainers to answer questions or provide additional information to the individuals receiving such training. 1. The Compliance Officer maintains a list of knowledgeable training instructors to answer questions and provide additional information to the individuals receiving training. 2. The Compliance Officer is responsible for developing and maintaining training documentation to include records of training, qualification of trainers, training materials, and certifications of training by individuals who receive training. Page 1 of 4
Policy #: 8 Procedure Name: Training and Education 26 Training for Covered Persons and Arrangements Covered Persons: 1. Covered Persons receive General Training, comprising training on the following topics: a. The requirements agreed to by Regent Care in Regent Care s CIA; and b. Regent Care s compliance program, including the Code of Conduct. 2. Arrangements Covered Persons receive Specific Training, lasting at least sixty (60) minutes and comprising training on the following topics: a. Arrangements that potentially implicate the Anti-Kickback Statute or the Stark Law, as well as the regulations and guidance documents related to these laws; b. Regent Care s policies, procedures, and other requirements relating to its arrangements, including: i. The Focus Arrangements Tracking System; ii. The internal review and approval process for arrangements; and iii. The tracking of remuneration to and from sources of health care business or referrals; c. The personal obligation of each individual involved in the development, approval, management, or review of Regent Care s arrangements to know the applicable legal requirements and Regent Care s policies and procedures; d. The legal sanctions under the Anti-Kickback Statute and the Stark Law; and e. Examples of violations of the Anti-Kickback Statute and the Stark Law. 3. All newly-employed Covered Persons and Arrangements Covered Persons receive training within 30 days after beginning their employment and annually thereafter. 3. Each individual who is required to attend General or Specific Training must certify, in writing or in electronic form, that he or she has received the required training. a. The certification must specify the type of training received and the date received. b. The Compliance Officer (or designee) must retain the certifications, along with all course materials. 4. Attendance at training is a condition of continued employment. Failure to attend training will result in a disciplinary action, up to and including termination. Page 2 of 4