Historically, the HHS Office of Inspector General (“OIG”) has been the only agency authorized to exclude individuals and entities from Federal healthcare programs. According to a recent HHS announcement, however, the Centers for Medicare & Medicaid Services (“CMS”) has also been granted exclusion authority.
The exclusion authority will significantly expand CMS’s existing program-integrity powers and will allow CMS to not only deny, suspend, revoke or terminate Medicare enrollment but to also prevent healthcare providers from participating in the Federal healthcare programs altogether.
HHS has not yet published any guidance describing how CMS and OIG will divide or coordinate their exclusion responsibilities. At this time, it is also unclear whether CMS will adopt OIG’s existing exclusion standards or if CMS will develop a separate enforcement approach. The expanded authority may be particularly significant in False Claims Act settlements and self-disclosures, where parties have historically addressed exclusion-related issues with OIG. Going forward, resolutions may require CMS involvement or additional assurances addressing both agencies’ authority.
The consequences of exclusion from Federal healthcare programs for a healthcare organization are enormous. Excluded individuals and entities lose their ability to submit claims for reimbursement to federally funded healthcare programs and can become subject to numerous additional actions (e.g., licensing sanctions, contract terminations).
Given these developments, healthcare organizations should closely monitor forthcoming CMS and OIG guidance and prepare for a more coordinated and expanded Federal enforcement posture.
