P o l i c i e s a n d P o l i t i c s contact the company accused of the allegations. The next step in the process to date has been the negotiation of a settlement, since no company has yet chosen the alternative option of a trial. This entire legal process often takes several years and includes extensive probing of company records, interviews with witnesses, and other gathering of evidence. There are strong and clear incentives for a company to settle a case rather than risk a criminal conviction which could lead to its being excluded from selling to the government. When an agreement is reached, it is incorporated into a Corporate Integrity Agreement (CIA). A CIA spells out the conduct, policies and procedures by which a company must satisfy the government that it will operate in compliance with the applicable laws and regulations. Compliance with a CIA includes auditing by an independent third party, which then delivers reports to company management and to the government. Included in CIAs has been an agreement that the company will create and implement a Compliance Program. In May 2003, the HHS OIG provided a Guidance that set forth seven major features of a compliance program. These include the designation of a compliance officer within the company to oversee an internal compliance program, the development and implementation of written policies and procedures, extensive and documented training, monitoring, specific mechanisms for employees to report violations, and annual reports to the OIG. Some of the most notable cases that have set precedents for CIAs include allegations that a company increased reimbursement from Medicaid or avoided paying rebates to Medicaid. Cases have involved alleged kickbacks to physicians and other medical professionals, as well as the failure to report malfunctions of a medical 4 7
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