Anti-kickback Statute

Most of the recent regulatory enforcement activity by the government pertaining to health care has focused on violahons of the False Claims Statutes, the Prescription Drug Marketing Act, or the Anti-kickback Statute. 

Table 23.1 Regulatory Safe Harbors Exempt from Anti-kickback Statutes...

Each violation of the Anti-kickback Statute carries the potential for a 25,000 criminal fine, a civil fine, or up to 5 years imprisonment, or all of these. The court may also impose repayment of the amount of losses sustained by the government. Additionally, exclusion from participation in all Medicare and Medicaid programs is required for individuals or corporations convicted of violating the Anti-kickback Statute. 

Under the direction of the chief compliance officer and the corporate compliance committee, each organization should develop written compliance policies that pertain to the organization s practices that may be at risk for noncompliance. The policy should clearly delineate the organization s commitment to comply with all federal and state standards, with an emphasis on preventing fraud and abuse. The compliance plan should address, at a minimum, the False Claims Act, the Anti-kickback Statutes, physician self-referral laws, and laws regarding bribery and improper gifts. Once the plan is developed, it should be reviewed and approved by the organization s board of directors. 

The anti-kickback statutes are intended to prevent overuse of and overcharging for medical products that are subject to government reimbursement either under Medicaid or Medicare (or other government-reimbursed health care programs). They prohibit any activity in which a medical products company may try to persuade, other than with sound therapeutic arguments, a physician or another health care provider or facility to use a particular product. 

Many companies, in their internal training, include information about the anti-kickback statute. The Office of the Inspector General in the Department of Health and Human Services (HHS) enforces the antikickback law. HHS administers the Medicaid and Medicare programs. Any serious violations are referred for potential criminal prosecution to the Department of Justice administrative sanctions also are possible. 

USA Federal Anti-Kickback Statute 42 U.S.C. 1320a-7b (www.gpoaccess.govv/uscode). 

Another federal law that applies to the marketing of medical products is the so-called anti-kickback law. This law, which dates from 1972, is not part of the FD C Act instead, it relates to Medicaid and Medicare statutes. 

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