Compliance Program Guidance

On September 8th, 1999, OIG published a solicitation notice seeking information and recommendations for developing formal guidance for individual and small group physician practices. On June 7th, 2000, the OIG released the Draft, Compliance Program Guidance for Individual and Small Group Physician Practices. The Draft was revised and released on September 25, 2000, and is available at www.hhs.gov/oig. Much of the guidance can also apply to other independent practitioners, such as psychologists, physical therapists, speech language pathologists, and occupational therapists.

The guidance identifies specific compliance risk areas, such as coding and billing; the provision of reasonable and necessary services; documentation; and improper inducements, kickbacks and self-referrals. The guidance includes several appendices outlining additional risk areas physicians should be familiar with, as well as basic information about criminal, civil and administrative statutes related to the federal health care programs. Information is also available about the OIG’s provider self-disclosure protocol, how to request an advisory opinion and Internet resources that may be useful to practices.

The OIG recognizes that there is no "one size fits all" compliance program, especially for physician practices. The applicability of these recommendations will depend on the circumstances of the particular practice. Each practice should undertake reasonable steps to respond to each of the seven elements of the guidance, depending on the size and resources of that practice. Compliance programs not only help to prevent fraudulent or erroneous claims, but they may also show that the practice is making a good faith effort to submit claims appropriately.

The OIG believes the great majority of providers are honest and committed to providing high quality medical care to Medicare beneficiaries. Under the law, providers are not subject to civil or criminal penalties for innocent errors, or even negligence. The government’s primary enforcement tool, the civil False Claims Act, covers only offenses that are committed with actual knowledge of the falsity of the claim, reckless disregard or deliberate ignorance of the truth or falsity of a claim. The False Claims Act simply does not cover mistakes, errors or negligence. The Office of Inspector General is very mindful of the difference between innocent errors ("erroneous claims") and reckless or intentional conduct ("fraudulent claims").

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