Content Detail

• Content META

  Title	Corporate Integrity Agreement Advisory and Independent Services prev next
  ID	3327861
  External ID	7221585754
  Author	Unknown
  Published Date	Oct. 17, 2024, 8:17 a.m.
  Summary	Overview The US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) has primary oversight responsibility for, and significant enforcement authority within, government
  Tags	None
  URL	https://www.lexology.com/library/detail.aspx?g=961ef859-27b6-487a-a829-18fa90ebed23
  Sentiment	Negative: 0.03689    Neutral: 0.92134    Positive: 0.04177
  Relevance	0.00429

• Content Details

  Content ID	1706412
  Key	a5d230aa-dd08-4121-aa91-20c3ad384ab5
  Content	Overview The US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) has primary oversight responsibility for, and significant enforcement authority within, government healthcare programs including Medicare and Medicaid. The OIG also periodically reports to Congress on its key initiatives. OIG’s enforcement authority includes the ability to exclude organizations entirely from participation in government healthcare programs. If excluded, an entity must reapply to participate in federal healthcare programs. Many commercial insurers refuse to interact with excluded providers. Criminal violations result in mandatory exclusion from government healthcare programs. Civil violations are typically investigated and resolved under the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and other state and federal healthcare fraud, waste, and abuse (FWA) laws. The OIG is given more leniency in exclusion for civil violations, including permissive authority to exclude providers if certain conditions are met. When the OIG resolves civil healthcare fraud allegations, it often requires the target organization to enter into a corporate integrity agreement (CIA) to avoid exclusion from participation in federal healthcare programs. CIAs typically have five-year terms, and the OIG tailors the obligations of each CIA to address the problematic conduct identified. Over time, CIA blueprints have evolved across segments of the healthcare industry. CIAs establish an array of compliance and ethics program obligations, including in areas such as: Compliance and Ethics Program Design and Effectiveness; Governing Body Oversight; Executive Leadership; Key Controls and Functions; Review Procedures; Operational Transparency; and Accountability. Across the life sciences, payer, and provider sectors, BRG’s CIA Advisory and Independent Services team has served as advisor to the compliance team before and after an organization enters into a CIA, as the board’s independent compliance expert, and as an independent review organization (IRO). Key CIA Obligations COMPLIANCE AND ETHICS PROGRAM DESIGN AND EFFECTIVENESS In 1998, the OIG published its first iteration of the “Seven Elements of an Effective Compliance Program,” which drew upon the US Sentencing Guidelines for Organizations, in its “Compliance Program Guidance for Hospitals.” The seven elements constitute the foundational controls and elements of a compliance and ethics program. Other federal and state agencies have adopted the same framework. Over more than twenty years, the OIG’s compliance and ethics program guidance has evolved significantly. In 2023, the OIG published its General Compliance Program Guidance, which reflects the agency’s commitment to modernizing and improving the accessibility of its public guidance. The OIG will next publish new or revised guidance for key industry segments segments. While the guidance is voluntary, it informs the obligations that CIAs impose. GOVERNING BODY OVERSIGHT CIAs create significant obligations for governing bodies (e.g., boards of directors and trustees, collectively “boards”). To ensure that the board’s oversight is objective, CIAs often require at least one board member to be independent. Boards must also review and oversee: The organization’s compliance with CIA obligations and federal healthcare program requirements; and The design, implementation, and operational effectiveness of the compliance and ethics program. At minimum, a CIA typically requires the board to meet at least quarterly to review the organization’s compliance and ethics program, including the performance of the compliance officer and compliance committee, and submit to the OIG a description of the materials the board reviewed. Some CIAs require the board to engage an independent firm with expertise in compliance with federal healthcare program requirements. The board’s compliance expert must review the effectiveness of the organization’s compliance and ethics program in some or all the CIA’s Annual Reporting Periods and draft a Program Review Report that must be included in the corresponding Annual Report. EXECUTIVE LEADERSHIP Compliance Officer CIAs routinely require the appointment of a compliance officer who is an employee and a member of senior management, reports to the organization’s chief executive officer, and has a reporting line to the board. The compliance officer must not report to the organization’s general counsel or chief financial officer or have any responsibilities that involve serving as legal counsel, supervising legal functions for the organization, or any other noncompliance responsibilities that, in the OIG’s discretion, may interfere with the compliance officer’s duties under the CIA. Compliance Committee The compliance committee must meet at least quarterly and is responsible for, among other things, implementing and overseeing the risk assessment and internal review process and supporting the compliance officer in the performance of their duties. CIAs require the organization to appoint a compliance committee chaired by the compliance officer and composed of members of senior management who best enable the organization to meet the CIA’s requirements. KEY CONTROLS AND FUNCTIONS CIAs mandate that compliance and ethics programs establish or continue to maintain the key controls and functions described in the “Seven Elements.” Written Standards Organizations subject to a CIA must develop and implement written policies and procedures addressing: The operation of the organization’s compliance and ethics program, including compliance with the CIA and federal healthcare program requirements; A review and approval process for all transactions with potential referral sources to ensure such arrangements comply with FWA laws; and The identification, quantification, and repayment of overpayments to the organization by federal healthcare programs. Training and Education CIAs now require the organization to develop a Training Plan for all employees and contractors. CIAs usually include board training obligations as well. That curriculum must cover the board’s corporate governance responsibilities and review and oversight of the compliance and ethics program. The board training must include a discussion of the OIG’s guidance on governing body responsibilities and address the specific responsibilities of healthcare governing body members, including risks, oversight areas, and approaches to conducting effective oversight of a healthcare organization. The compliance committee is responsible for reviewing the Training Plan and board training at least annually and updating it as necessary. The organization must maintain, and provide to the OIG upon request, all materials and records verifying that required training was provided. Risk Assessment and Internal Review Procedures Consistent with compliance and ethics program guidance from the OIG and other federal and state agencies, organizations under a CIA must develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with the organization’s participation in federal healthcare programs. The annual risk assessment and internal review process must: Identify and prioritize risks; Develop and implement work or audit plans related to the identified risk areas, as appropriate; Develop corrective action plans in response to the results of any internal audits performed; and Track the implementation and assess the effectiveness of the work or audit plans and any corrective actions undertaken. Disclosure Program CIAs require organizations to establish a disclosure program that includes a reporting mechanism for anonymous, confidential communications. It is a critical control that must be maintained and enhanced as the compliance and ethics program matures. The organization must appropriately publicize the disclosure program to its employees, contractors, and other business partners, for example with periodic email reminders and informational posters in common areas. The organization must prohibit retaliating against employees and contractors for using the disclosure program. The compliance officer, or their designee, must conduct a review of each disclosure received. Such reviews must include gathering the relevant information from the disclosing individual and ensuring that appropriate follow-up is conducted. Within two business days of each disclosure, the compliance officer or designee must start a record of each disclosure in a written disclosure log—even those not related to potential violations of law, regulation, or federal healthcare program rules. Ineligible Persons Screening Organizations operating under a CIA must screen all employees and contractors against Exclusion Lists and remove those who are excluded from federal healthcare programs. If the organization determines that an employee or contractor is excluded from participation in federal healthcare programs, it must remove the individual from any position for which their compensation is paid, or for which any items or services furnished, ordered, or prescribed by the individual are paid, by any federal healthcare program from which the employee or contractor is excluded. REVIEW PROCEDURES – INDEPENDENT REVIEW ORGANIZATION CIAs frequently require the organization to engage a firm to conduct auditing as an IRO. The IRO performs different types of reviews depending on the organization’s industry sector and the problematic conduct discovered during investigation. The organization must select an IRO that has evaluated and certified its professional independence and objectivity with respect to the reviews, and has the appropriate experience for the specific audits required by the CIA. OPERATIONAL TRANSPARENCY – PROMPT AND PERIODIC REPORTING OBLIGATIONS CIAs impose significant reporting obligations on organizations. For example, an entity must submit to the OIG an implementation report detailing its progress with implementing the CIA’s requirements, and comprehensive annual reports thereafter. Additionally, an organization must notify the OIG in writing within thirty days after determining that a Reportable Event has occurred. CIAs define Reportable Events as a substantial overpayment; a matter a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to federal healthcare programs; the employment of or contacting with an individual or entity excluded from participating in federal healthcare programs; or a bankruptcy petition by the entity. ACCOUNTABILITY – MANAGEMENT AND BOARD CERTIFICATIONS CIAs mandate that key members of senior management monitor compliance within the divisions or departments for which they are responsible and annually certify that their division or department complies with the requirements of the CIA and applicable federal healthcare programs. Similarly, the board must annually adopt a resolution approved by each board member regarding the board’s review and oversight of the organization’s compliance and ethics program. The OIG envisions a comprehensive sub-certification process to enable members of senior management to certify their department’s compliance fully and truthfully. The organization must develop and implement a written process for management and the board to follow when completing the required certifications and sub- certifications. Anyone required to certify but unable to do so must provide the OIG with a written explanation of their reasoning. Services Offered ADVISORY SERVICES Compliance and Ethics Program Assessments BRG’s CIA Advisory and Independent Services team performs efficient and comprehensive compliance and ethics program assessments, enabling the organization to accelerate the development of its program in anticipation of resolving an enforcement action that could lead to a CIA. BRG’s experts focus on evolving best practices, and corporate culture and values, to enable our clients to exceed the expectations of key stakeholders including the OIG, the US Department of Justice, and the Centers for Medicare & Medicaid Services. CIA Readiness CIA obligations are rigorous, and failure to fulfill them has serious ramifications. Before a pending investigation is resolved, organizations increasingly are engaging advisors to assist their senior management teams to prepare for implementing capabilities often required by CIAs. Our CIA experts advise boards and management teams regarding their upcoming obligations and collaborate with management to develop the requisite compliance and ethics program infrastructure, including policies and procedures, education and training plans, disclosure programs, risk assessment processes, and auditing, testing, and monitoring plans. CIA Implementation BRG’s experts bring years of experience leading organizations through CIAs, including as advisors, board members, and members of executive leadership teams. In collaboration with outside counsel, our team often advises and assists the organization’s compliance and legal departments in timely fulfilling the organization’s CIA obligations, including developing the required certification process and implementation and annual reports. INDEPENDENT SERVICES The Board’s Independent Compliance Expert The board’s compliance expert must be independent. Our seasoned governance advisors ensure that the organization’s governing body receives optimal education on its fiduciary duties and oversight responsibilities—generally and with respect to compliance and ethics, as well as quality of care programs. Many CIAs require the board’s independent compliance expert to perform program effectiveness reviews and draft corresponding reports to the OIG. Our team has served in this role across all key sectors in the healthcare industry. We have extensive experience in performing the required effectiveness reviews, developing comprehensive reports, and interacting with OIG officials. Independent Review Organization BRG is a leader in sophisticated healthcare data analytics. Combined with our preeminent auditing capabilities, we are well positioned to efficiently perform any reviews required by a CIA. Our team has conducted reviews in various industry settings to assess coding and reimbursement accuracy and has produced comprehensive review reports to the OIG. These engagements have included analyzing the policies, procedures, and billing practices associated with the operations of durable medical equipment companies, large multisystem hospitals, long-term care facilities, and physician practices, among others.
  Content Reference URL	None

• Publisher

  Publisher Name	Lexology (#2656)
  Publisher URL	https://www.lexology.com/
  Description	None
  Trust Flow Score	30
  Citation Flow Score	48

• Data Source

  Data Source Name	Quantexa News (#5)
  Data Source Type	news
  Data Source URL	https://app.aylien.com/dashboard
  Description	Welcome to Quantexa News API — the most powerful way to aggregate, filter, and integrate global news data into your apps and models.
  Weight	10