False Claims Statutes

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. 

The False Claims Statutes were designed to prevent the government from paying for goods or services that were either not provided or not provided in compliance with government regulations. Federal and state False Claims Statutes make it a felony to ... 

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 regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, structure/function claims are permissible, while claims targeting specific diseases would not be permissible, unless reviewed by the FDA. A structure/function claim such as support of the immune system would be acceptable, while alleviates the common cold or flu would not be acceptable for Echinacea, because the claim would target a specific disease state (i.e cold or flu). In the United States, statute 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading thus, a structure/function claim must meet the criteria set forth in 403(r)(6). 

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