On March 27, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (HHSOIG) released a 53-page document, “Measuring Compliance Program Effectiveness: A Resource Guide.” Forty independent compliance professionals and staff from the HHS-OIG developed the guide during the Health Care Compliance Association’s (HCCA) Compliance Institute. The Guide summarizes the results and is aimed at helping organizations develop effective compliance programs.

Compliance programs went from voluntary to mandatory with the adoption of the Patient Protection and Affordable Care Act (generally referred to as the “ACA”) in 2010. The ACA requires that health care providers enrolled in Medicare, Medicaid, and other federally funded health care programs adopt a health care compliance plan. Section 6401 of the ACA specifically provides that health care providers must establish a compliance program that contains certain "core elements" as a condition of enrollment in government programs. HHS-OIG defined those core elements in a series of regulations and guidelines promulgated after the passage of the ACA. Those same elements form the backbone of the Guide.

Every health care organization should review the Guide as a starting point for assessing their compliance program’s effectiveness. The OIG is quick to point out, however, that the Guide is not a “checklist” to be applied wholesale to any given compliance program. Every healthcare organization will have different compliance needs, and therefore different compliance metrics. So beware, one size does NOT fill all!

The Guide breaks a compliance program down into seven core program elements and then describes more than 400 metrics that organizations can use to evaluate their compliance programs.

The compliance program elements include:

  • Standards, policies and procedures (62 possible metrics)
  • Compliance program administration (68 possible metrics) 
  • Screening and evaluation of employees, physicians, vendors, and other agents (40 possible metrics)
  • Communication, education, and training on compliance issues (49 possible metrics)
  • Monitoring, auditing, and internal reporting systems (77 possible metrics)
  • Discipline for non-compliance (34 possible metrics)
  • Investigations and remedial measures (71 possible metrics)

The compliance program elements, along with the many possible metrics for measuring each of those elements, present a rather daunting read. The FisherBroyles Pharmacy and Health Care Law team is available to assist you. We offer complete compliance reviews for pharmacies and health care entities across the U.S. and can help you determine the most effective metrics for your compliance program.