Compliance programs are mandatory (pending final regulations) for all health care organizations post-Affordable Care Act. In some states, and for some provider/supplier types, compliance programs are already mandatory. In any event, compliance programs in health care organizations are crucial in today’s overregulated environment, with qui tam attorneys, whistleblowers, regulators, and payors seeking any potential excuse to recoup.
Compliance programs work as a set of internal controls that assist in preventing, detecting, and resolving illegal or unethical conduct/errors that may take place. In order to ensure compliance with all appropriate laws and regulations, radiology providers and suppliers should implement compliance programs that at a minimum meet all laws and regulations.
The elements of effective compliance programs are relatively straightforward and known. However, many organizations struggle to implement, execute, measure, and evaluate their compliance programs.
Recent extremely helpful compliance guidance has been issued by both the U.S Department of Justice (“DOJ”), and the HHS Office of Inspector General (“OIG”). Both compliance guidance resources should be considered by imaging providers/suppliers as they work to structure, implement, monitor, and evaluate effective compliance programs.
On February 8th, 2017, the DOJ, Criminal Division, Fraud Section, released the Evaluation of Corporate Compliance Programs (Guidance) (the “DOJ Guidance”). While not health care specific, the DOJ Guidance will assist the imaging community in analyzing whether their compliance programs are aligned with the newly issued DOJ Guidance. The DOJ Guidance focuses on specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to brings charges against the entity, etc. The factors used are commonly called the “Filip Factors” and include “the existence and effectiveness of the corporation’s pre-existing compliance program,” and the corporation’s remedial efforts “to implement an effective corporate compliance program or to improve the existing one.” The DOJ makes case-by-case evaluations of each entity’s corporate compliance program.
Some of the common question topics asked by the DOJ are similar to the OIG’s newly released compliance guidance (discussed below). The DOJ Guidance centers on:
- Analysis and Remediation of Underlying Misconduct;
- Senior and Middle Management;
- Autonomy and Resources;
- Policies and Procedures;
- Design and Accessibility;
- Operational Integration;
- Risk Assessment;
- Training and Communications;
- Confidential Reporting and Investigation;
- Incentives and Disciplinary Measures;
- Continuous Improvement, Periodic Testing and Review
- Third Party Management; and
- Mergers and Acquisitions (M&A).
On January 17, 2017, a group of compliance professionals and staff from the OIG gathered to discuss ways to measure the effectiveness of compliance programs. As a result of the meeting, on March 27, 2017, the OIG issued a resource guide to assist health organizations measure the effectiveness of their compliance programs (“Resource Guide”). The Resource Guide, interestingly, does not reference the DOJ’s new compliance guidance.
The Resource Guide contains questions that organizations can utilize to help measure the effectiveness of their current compliance programs. This list is not meant to be a checklist, nor is it meant to be a one size fits all approach. It is tailored to each individual organization’s needs.
The OIG promotes the establishment of compliance programs that are based on the OIG’s seven elements of effective compliance: (1) Standards, Policies, and Procedures; (2) Compliance Program Administration; (3) Screening and Evaluation of Employees, Physicians, Vendors, and Other Agents; (4) Communication, Education, and Training on Compliance Issues; (5) Monitoring, Auditing, and Internal Reporting Systems; (6) Discipline for Non-Compliance; and (7) Investigations and Remedial Measures.
The effectiveness of compliance programs, as opposed to the elements of a compliance program, has garnered little OIG guidance attention until now. A summary of the question topics covered in the Resource Guidance are:
- Standards, Policies, and Procedures;
- Compliance Program Administration;
- Screening and Evaluation of Employees, Physicians, Vendors and other Agents;
- Communication, Education, and Training on Compliance Issues;
- Monitoring, Auditing, and Internal Reporting Systems;
- Discipline for Non‐Compliance; and
- Investigations and Remedial Measures.
Each section has detailed implementation and evaluation steps that can assist imaging providers/suppliers as they evaluate the effectiveness of their own programs.
The DOJ’s Guidance and OIG’s Resource Guide are extremely helpful tools to assess the effectiveness of imaging organization’s compliance program. Many imaging examinations are costly (i.e., MRIs, CTs) and represent a large portion of claims paid to beneficiaries of Medicare and Medicaid programs. Imaging organizations can be at risk if an effective compliance program is not put in place.
Truly effective and well implemented compliance programs save money and prosecutions in the long-run, benefitting both the organization and the government. In light of recent guidance and enforcement actions, there is no better time to strengthen and evaluate your organizations compliance program.