[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42409-42410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


Solicitation of Information and Recommendations for Developing 
OIG Compliance Program Guidance for the Durable Medical Equipment 
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 into the OIG's development of a 
compliance program guidance for the durable medical equipment (DME) 
industry, its providers and suppliers. Many providers and provider 
organizations have expressed an interest in better protecting their 
operations from fraud and abuse. Previously, the OIG has developed 
compliance program guidances for hospitals, clinical laboratories and 
home health agencies. In order to provide clear and meaningful guidance 
to those segments of the health care industry involved in the supply 
and distribution of DME, we are soliciting comments, recommendations 
and other suggestions from concerned parties and organizations on how 
best to develop compliance program guidance and reduce fraud and abuse 
within the DME industry.

DATES: To assure consideration, comments must be delivered to the 
address provided below by no later than 5 p.m. on September 21, 1998.

ADDRESSES: Please mail or deliver your written comments, 
recommendations and suggestions to the following address:
    Office of Inspector General, Department of Health and Human 
Services, Attention: OIG-3-CPG, Room 5246, Cohen Building, 330 
Independence Avenue, SW, Washington, DC 20201.
    We do not accept comments by facsimile (FAX) transmission. In 
commenting, please refer to file code OIG-3-CPG. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, in Room 5541 of the Office of Inspector General at 330 
Independence Avenue, SW, Washington, DC, on Monday through Friday of 
each week from 8:00 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Christine Saxonis, Office of Counsel 
to the Inspector General, (202) 619-2078, or Joel Schaer, Office of 
Counsel to the Inspector General, (202) 619-0089.

SUPPLEMENTARY INFORMATION: The creation of compliance program guidance 
has become a major initiative of the OIG in its effort to engage the 
private health care community in addressing and fighting fraud and 
abuse. Recently, the OIG has developed and issued compliance program 
guidance directed at various segments of the health care industry.\1\ 
This guidance is 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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    \1\ 62 FR 9435 (March 3, 1997) for clinical laboratories and 63 
FR 8987 (February 23, 1998) for hospitals. The guidances can also be 
found on the OIG web site at http:/www.dhhs.gov/progorg/oig.
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    The guidances represent the OIG's suggestions on how providers can 
best establish internal controls and monitoring to correct and prevent 
fraudulent activities. The contents of the guidances should not be 
viewed as mandatory for providers or as an exclusive discussion of the 
advisable elements of a compliance program.
    In an effort to formalize the process by which the OIG receives 
public comments in connection with compliance program guidances, we are 
seeking, through this Federal Register notice, formal input from all 
interested parties as the OIG begins developing compliance program 
guidance directed at the DME industry, its providers and suppliers. The 
OIG will give consideration to all comments, recommendations and 
suggestions

[[Page 42410]]

submitted and received by the time frame indicated above.
    We anticipate that the DME guidance 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;
    <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 to initiate corrective action.
    We would appreciate specific comments, recommendations and 
suggestions on (1) risk areas for the DME industry, and (2) aspects of 
the seven elements contained in previous guidances that may need to be 
modified to reflect the unique characteristics of the DME industry. 
Detailed justifications and empirical data supporting suggestions would 
be appreciated. We are also hopeful that any comments, recommendations 
and input be submitted in a format that addresses the above topics in a 
concise manner, rather than in the form of comprehensive draft guidance 
that mirrors previous guidance.

    Dated: July 28, 1998.
June Gibbs Brown,
Inspector General.
[FR Doc. 98-20965 Filed 8-6-98; 8:45 am]
BILLING CODE 4150-04-P