The Compliance Program Paper
A brief description of the elements of a compliance program
The Office of the Inspector General (OIG), Department of Health and Human Services, developed the Compliance Program Guidance for Pharmaceutical Manufacturers in 2003 (Miola, 2007). The seven elements of a compliance program are:
• Establish policies, procedure, and controls; this element is meant to detect and prevent unethical conduct; henc
e, reduce the likelihood of misconduct.
• Exercise effective compliance and ethics oversight; this element requires the involvement of an organization’s various layers of management in the compliance and ethics processes to ensure the effectiveness of the programs.
• Exercise due diligence and avoid delegation of authority to unethical individuals; in accordance with this element, organizations should avoid delegating significant authority to individuals with a reputation of associating with illegal activities or behavior inconsistent with the ethics program.
• Communicate and educate employees on compliance and ethics programs; under this element, an organization is obligated to communicate regularly and in a practical manner, the acceptable procedures and standards, and other aspects of the compliance and ethics programs.
• Monitor and audit compliance and ethics programs for effectiveness; this element gives the organization the responsibility of ensuring that the employees appropriately follow the compliance and ethics programs.
• Ensure consistent promotion of the program and enforcement violations; this element provides that an organization should constantly promote the value and importance of compliance and ethics programs.
• Appropriately respond to incidents and take steps to prevent future incidents; under this element, organizations are obligated to appropriately investigate instances of suspected compliance and ethics violations.
The Office of the Inspector General negotiates the Corporate Integrity with healthcare professionals and other entities as part of the settlement of the Federal health care program investigations arising under a variety of civil false claims statutes (Miola, 2007). Each of the CIAs is enforced to address the specific facts of the case presented. On the other hand, a compliance program is enforced to forester a culture of compliance to ethics that begins at the executive level and spreads throughout the organization (Miola, 2007).
Preference
I would rather operate under a compliance program since our company can tailor it to meet the specific needs of our business. The compliance program can be organized to satisfy the requirements of an organization; hence, it is ideal when an organization has unique needs and goals.
Violation of the prohibition against self-referrals
The self- referrals law is designed to prevent/limit physicians from referring patients for clinical laboratory services under the Medicare Program to institutions in which the physician or a relative has a financial interest (Miola, 2007). For instance, John suffers from a medical condition and goes to see Peter, his personal …
