Important New Compliance Resources

By Adrienne Dresevic, Esq. and Clinton Mikel, Esq. of The Health Law Partners, P.C.

Compliance programs will be mandatory, pending final regulations, for all healthcare organizations post-Affordable Care Act. In some states, and for some provider/supplier types, compliance programs are already mandatory. They are crucial for healthcare organizations 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 US 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.

DOJ Guidance

On February 8, the DOJ released their “Evaluation of Corporate Compliance Programs.” While not healthcare specific, the DOJ guidance will assist the imaging community in analyzing their own compliance programs. The DOJ guidance focuses on specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to bring 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:

1. Analysis and Remediation of Underlying Misconduct
2. Senior and Middle Management
3. Autonomy and Resources
4. Policies and Procedures
   • Design and Accessibility
   • Operational Integration
5. Risk Assessment
6. Training and Communications
7. Confidential Reporting and Investigation
8. Incentives and Disciplinary Measures
9. Continuous Improvement, Periodic Testing, and Review
10. Third Party Management
11. Mergers and Acquisitions (M&A)

OIG-HCCA Guidance

On January 17, 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, the OIG issued the publication, “Measuring Compliance Program Effectiveness: A Resource Guide.” The OIG resource guide does not reference the DOJ’s new compliance guidance.

The OIG 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
7. Investigations and Remedial Measures

Each section of the resource guide 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 organizations’ compliance programs. Many imaging exams are costly (ie, 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.

Radiology providers and suppliers should measure the effectiveness of their compliance programs and target activities such as auditing of billing practices (ie, Medicare and Medicaid billing), referral relationships and marketing practices, HIPAA training for employees, etc.

Truly effective and well implemented compliance programs save money and prosecutions in the long-run, benefiting 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.

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Adrienne Dresevic, Esq. is a Founding Shareholder of The Health Law Partners, P.C., a nationally recognized healthcare law firm with offices in Michigan and New York. Practicing in all areas of healthcare law, she devotes a substantial portion of her practice to providing clients with counsel and analysis regarding compliance, Stark Law, Anti-Kickback Statute, and compliance related issues. Ms. Dresevic serves on the American Bar Association Health Law Section’s Council, which serves as the voice of the national health law bar within the ABA. Ms. Dresevic also serves as the ABA Health Law Section’s Co-Chair of the Physicians Legal Issues Conference Committee, Vice Chair of the Programs Committee (Executive Leadership), and Vice Chair of the Sponsorship Committee. She is licensed to practice law in Michigan and New York, and can be contacted at adresevic@thehlp.com. 

Clinton Mikel, Esq. graduated from the University of Michigan Law School. Practicing healthcare law, he concentrates in Stark, fraud/abuse, telehealth/telemedicine, compliance, and the corporate and financial aspects of healthcare practice.

The authors are members of The Health Law Partners, P.C. and may be reached at (248) 996-8510 or (212) 734-0128, or at www.thehlp.com.