Solicitation of Information and Recommendations for Developing a Compliance Program Guidance for the Pharmaceutical Industry

AGENCY:

Office of Inspector General (OIG), HHS.

ACTION:

Notice.

SUMMARY:

This Federal Register notice seeks the input and recommendations of interested parties as the OIG develops a compliance program guidance for the pharmaceutical industry, especially those segments of the industry related to manufacturing, marketing or providing goods or services to Medicare, Medicaid and other Federal health care program beneficiaries. The pharmaceutical industry has experienced a number of instances of fraud and abuse and has expressed interest in increasing the awareness of the industry to assist in protecting against such conduct. In response to the industry's concerns, the OIG has written Advisory Opinions on a variety of industry-related issues and, in 1994, published a Special Fraud Alert relating to Prescription Drug Marketing Schemes. Also, in the early 1990s, the OIG's Office of Evaluation and Inspections issued reports relating to prescription drug promotional practices.

In an effort to provide further guidance, the OIG is soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop a compliance program guidance for the pharmaceutical industry to reduce the potential for fraud and abuse.

DATES:

To assure consideration, comments must be delivered to the address provided below by no later than 5 p.m. on August 10, 2001.

ADDRESSES:

Please mail or deliver your written comments, recommendations and suggestions to the following address:Department of Health and Human Services,Office of Inspector General,Attention: OIG-8-CPG,Room 5527 A, Cohen Building,330 Independence Avenue, SW.,Washington, DC 20201.

We do not accept comments by facsimile (FAX) transmission. In commenting, please refer to the file code OIG-8-CPG. Timely-filed comments will be available for public inspection as they are received, generally beginning approximately 3 weeks after receipt of a document, in Room 5541 of the Office of Inspector General at 330 Independence Avenue, S.W., Washington, D.C. 20201 on Monday through Friday of each week from 8 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT:

Mary E. Riordan or Nicole C. Hall, Office of Counsel to the Inspector General, (202) 619-2078.

SUPPLEMENTARY INFORMATION:

The development of compliance program guidances has become a major initiative of the OIG in its effort to engage the private health care industry in addressing and combating fraud and abuse. Over the past several years, the OIG has developed and issued compliance program guidances directed at various segments of the health care industry. These guidances are designed to provide clear direction and assistance to specific sections of the health care industry that are interested in reducing and eliminating fraud and abuse within their organizations.

The guidances have represented the culmination of the OIG's suggestions on how providers can most effectively establish internal controls and implement monitoring procedures to identify, correct and prevent fraudulent or wasteful activities. The suggestions contained in the guidances are not mandatory for providers, nor do they represent an exclusive discussion of the advisable elements of a compliance program.

The compliance program guidance for the pharmaceutical industry will be designed to reach segments of the health care industry which have not been covered by previous guidances, but which have recently been the subject of increasing scrutiny, such as pharmaceutical manufacturers and retail pharmacy chains. As the public debate about prescription drug costs and a potential expansion of the Medicare drug benefit continues, this scrutiny is likely to intensify.

Through this Federal Register notice, the OIG is seeking input from interested parties as the OIG considers developing a compliance program guidance directed at the pharmaceutical industry. The OIG will consider all comments, recommendations and suggestions received within the time frame indicated above.

We anticipate that the guidance for the pharmaceutical industry will contain the seven elements that we consider necessary for a comprehensive compliance program. These seven elements have been discussed in our previous guidances and include:

• The development of written policies and procedures;
• The designation of a compliance officer and other appropriate bodies;
• The development and implementation of effective training and education programs;
• The development and maintenance of effective lines of communication;
• The enforcement of standards through well-publicized disciplinary guidelines;
• The use of audits and other evaluation techniques to monitor compliance; and
• The development of procedures to respond to detected offenses and initiate corrective action.

The OIG would appreciate specific comments, recommendations and suggestions on (1) risk areas for the pharmaceutical industry, and (2) aspects of the seven elements contained in the previous guidances that may need to be modified to reflect the unique characteristics of the pharmaceutical industry. Detailed justifications and empirical data supporting any suggestions would be appreciated.

We request that any comments, recommendations and suggestions be submitted in a format that addresses the topics outlined above in a concise manner, rather than in the form of a comprehensive draft guidance that mirrors previous guidances.