ARTICLE
21 November 2024

One Year In: The OIG's General Compliance Program Guidance

November 6, 2024, marked one year since the Office of Inspector General (OIG) released its General Compliance Program Guidance (GCPG).
United States Food, Drugs, Healthcare, Life Sciences

November 6, 2024, marked one year since the Office of Inspector General (OIG) released its General Compliance Program Guidance (GCPG). Issued 15 years since OIG's last updates to the previous compliance program guidance documents, the GCPG is the go-to resource for healthcare organizations navigating the complicated system of compliance and regulatory requirements.

GCPG Builds on Previous OIG Guidance

The GCPG provides a framework for healthcare organizations to build robust, adaptable compliance programs. Many healthcare organizations are familiar with the OIG's seven elements of an effective compliance program. The GCPG delves deeper into the seven foundational elements, which are now articulated with greater specificity to reflect the current healthcare environment, including recommendations to use data analytics and carefully develop incentive plans to ensure they don't encourage risky or noncompliant behavior.

What We've Learned

The GCPG's one-year anniversary is an opportune moment to reflect on the significant updates integrated into the OIG's compliance infrastructure and to highlight several important considerations for all entities who are building or improving their compliance programs.

After a year of helping health centers assess and revise their compliance programs using the GCPG (and even helping several organizations that don't see patients directly, such as primary care associations which support health centers), here's what we've learned:

  • A significant addition to the GCPG is the emphasis on proactive risk assessments. Healthcare organizations are encouraged to conduct these assessments annually, a practice that is instrumental in identifying potential vulnerabilities before they escalate into costly legal and ethical lapses. This shift towards a more preventative stance by the OIG underscores the importance of mitigating compliance risks rather than just focusing on responding and recovering from them.
  • The role of leadership is magnified in the GCPG. It highlights that an organization's commitment to compliance is reflected in the actions and attitudes of its executive team and board members. Their active involvement in overseeing and championing compliance initiatives is now seen as a critical component of a successful program.
  • Furthermore, the GCPG focuses on the importance of a functioning staff-level compliance committee, whose purpose should be to aid and support the compliance officer in implementing, operating, and monitoring the organizational compliance program. The compliance committee should work in partnership with the compliance officer to ensure that the organization's compliance program is comprehensive, effective, and adapted to current regulations and expectations.
  • Small healthcare entities are still expected to have compliance programs in place but the OIG recognizes the compliance programs may be adapted for the entity's size. While the scope of such compliance programs may be different (e.g., conducting targeted chart reviews instead of a full-blown risk assessment), all concepts from GCPG and the seven elements of compliance would still apply.

Looking Ahead

The OIG announced1 that it will publish its first industry segment-specific CPG (ICPG) addressing nursing facilities in late 2024. OIG intends to publish its next ICPGs, addressing Medicare Advantage, hospitals, and clinical laboratories, in 2025.

We'll be reviewing the ICPGs with an eye on how they are likely to affect health centers. For example, because Medicare Advantage plans regularly include compliance program activities in their contracts with health centers, once the Medicare Advantage ICPG is issued, we expect to see contract revisions to align with the ICPG. In addition, health centers may find hospitals making changes to contracting, referral or other processes based upon the hospital ICPG.

Feldesman's Premium Plan subscribers have access to more practical tips for enhancing their compliance programs based on GCPG in the November issue of our Premium Insights newsletter.

Footnote

1 https://oig.hhs.gov/compliance/compliance-guidance/

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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