Author: ivan
I. Introduction
The Office of Inspector General (OIG) of the Department of Health and Human Services (DHHS) continues in its efforts to promote voluntarily implemented compliance programs...
Background
The creation of compliance program guidances is a major initiative of the OIG in its effort to engage the private health care community in combating...
Publication of the OIG Compliance Program Guidance for Nursing Facilities
AGENCY: Office of Inspector General (OIG), HHS. ACTION: Notice. SUMMARY: This Federal Register notice sets forth the recently issued Compliance Program Guidance for Nursing Facilities...
Endnotes
1. The term ‘‘Federal health care programs,’’ as defined in 42 U.S.C. 1320a– 7b(f), includes any plan or program that provides health benefits, whether directly,...
III. Conclusion
In today’s environment of increased scrutiny of corporate conduct and increasingly large expenditures for prescription drugs, it is imperative for pharmaceutical manufacturers to establish and...
II. Compliance Program Elements Reporting
Where the compliance officer, compliance committee, or a member of senior management discovers credible evidence of misconduct from any source and, after a reasonable inquiry,...
II. Compliance Program Elements H. Responding to Detected Problems and Developing Corrective Action Initiatives
Violation of a pharmaceutical manufacturer’s compliance program, failure to comply with applicable federal or state law, and other types of misconduct threaten the company’s status...
II. Compliance Program Elements G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
An effective compliance program should include clear and specific disciplinary policies that set out the consequences of violating the law or the pharmaceutical manufacturer’s code...
II. Compliance Program Elements F. Auditing and Monitoring
An effective compliance program should incorporate thorough monitoring of its implementation and an ongoing evaluation process. The compliance officer should document this ongoing monitoring, including...