On April 20, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) released a compliance guidance document created through the joint efforts of the OIG, the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA). The document’s purpose is to assist governing boards of health care entities in their oversight of compliance plans. While the intended audience is governing boards, the document offers anyone with a compliance role insight and ideas for improving compliance within their laboratory or other health care organization. According to a press release, the 19-page document is an educational resource that will benefi compliance officers auditors and legal counsel in addition to the boards to which they report. It’s intended to provide practical ideas, tools and tips that can be adapted for organizations of all sizes. The introduction explains: “A critical element of effective oversight is the process of asking the right questions of management to determine the adequacy and effectiveness of the organization’s compliance program, as well as the performance of those who develop and execute that program and to make compliance a responsibility for all levels of management.” The guidance […]
On April 20, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) released a compliance guidance document created through the joint efforts of the OIG, the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA). The document’s purpose is to assist governing boards of health care entities in their oversight of compliance plans.
While the intended audience is governing boards, the document offers anyone with a compliance role insight and ideas for improving compliance within their laboratory or other health care organization. According to a press release, the 19-page document is an educational resource that will benefi compliance officers auditors and legal counsel in addition to the boards to which they report. It’s intended to provide practical ideas, tools and tips that can be adapted for organizations of all sizes. The introduction explains: “A critical element of effective oversight is the process of asking the right questions of management to determine the adequacy and effectiveness of the organization’s compliance program, as well as the performance of those who develop and execute that program and to make compliance a responsibility for all levels of management.” The guidance also explains the interrelationship between and individual importance of the following compliance-related functions: compliance, legal, internal audit, human resources, and quality improvement.
The areas of focus addressed in the guidance include: expectations for board oversight, compliance roles, reporting to the board, identifying and auditing risk areas, and encouraging accountability. The document recommends using existing guidance materials available to boards and compliance professionals as “benchmarks” for evaluating the effectiveness of their compliance plans—including the Federal Sentencing Guidelines, OIG compliance program guidance and Corporate Integrity Agreements (CIA). While a CIA is an agreement that entities enter into once they have already gotten in trouble, the measures negotiated into these agreements “may be helpful resources for Boards seeking to evaluate their organizations’ compliance programs.”
Suggestions for facilitating management’s compliance reporting directly to governing boards include use of dashboards and executive sessions. The document also discusses methods for keeping tabs on current compliance risks, including sources such as compliance hotlines and internal audits as well as “professional organization publications, OIG-issued guidance, consultants, competitors, or news media.” “When failures or problems in similar organizations are publicized, Board members should ask their own management teams whether there are controls and processes in place to reduce the risk of, and to identify, similar misconduct or issues within their organizations,” the document advises.
It’s worth noting that among the top risk areas highlighted, the first issue mentioned is referral relationships and arrangements—an issue of significant relevance to laboratories particularly in light of last year’s fraud alert and current enforcement efforts targeting such relationships. Other risk areas highlighted were billing, privacy breaches and quality-related events.
Highlighting the potential for “new incentives and compliance risks” created by current health care reform efforts, the guidance notes: “New payment models have also incentivized consolidation among health care providers and more employment and contractual relationships (e.g., between hospitals and physicians).” Laboratory compliance professionals should heed the guidance’s suggestion that “Boards of entities that have financial relationships with referral sources or recipients should ask how their organizations are reviewing these arrangements for compliance with the physician self-referral (Stark) and anti-kickback laws.”
Increasing transparency was also highlighted, with the availability of data from CMS on quality measures, payment data and the Sunshine rule providing public access to more information than ever before. The OIG and its collaborators encourage boards to “consider all the beneficial uses of this newly available information” for evaluating compliance and establishing benchmarks. Finally, boards are urged to consider and employ measures to incentivize compliant behavior and create a culture of compliance, while conducting self-evaluations and, when necessary, self-reporting non-compliance and repaying overpayments.
The resource, “Practical Guidance for Health Care Governing Boards on Compliance Oversight,” can be found on the OIG’s website.
Takeaway: A new guidance document provides not just governing boards but all individuals involved in compliance with helpful tips for improving compliance, evaluating effectiveness and adapting compliance plans to a changing health care environment focused on quality and value.
