[Federal Register Volume 66, Number 112 (Monday, June 11, 2001)]
[Notices]
[Pages 31246-31247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


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

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice.

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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.\1\ Also, in the early 
1990s, the OIG's Office of Evaluation and Inspections issued reports 
relating to prescription drug promotional practices.\2\
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    \1\ The Advisory Opinions and the Special Fraud Alert can be 
found on the OIG web site at http://www.hhs.gov/oig.
    \2\ The reports issued by the Office of Evaluation and 
Inspections also can be found on the OIG web site.
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    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

[[Page 31247]]

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.\3\ 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.
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    \3\ The OIG has issued compliance program guidance for the 
following nine industry sectors: hospitals, clinical laboratories, 
home health agencies, durable medical equipment suppliers, third-
party medical billing companies, hospices, Medicare+Choice 
organizations offering coordinated care plans, nursing facilities, 
and individual and small group physician practices. The compliance 
program guidances for these industry sectors can be found on the OIG 
web site at http://www.hhs.gov/oig or by calling the OIG Public 
Affairs office at (202) 619-1343.
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    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:
    <bullet> The development of written policies and procedures;
    <bullet> The designation of a compliance officer and other 
appropriate bodies;
    <bullet> The development and implementation of effective training 
and education programs;
    <bullet> The development and maintenance of effective lines of 
communication;
    <bullet> The enforcement of standards through well-publicized 
disciplinary guidelines;
    <bullet> The use of audits and other evaluation techniques to 
monitor compliance; and
    <bullet> 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.

    Dated: May 31, 2001.
Michael F. Mangano,
Acting Inspector General,
[FR Doc. 01-14598 Filed 6-8-01; 8:45 am]
BILLING CODE 4152-01-U