Durable medical equipment industry; compliance program guidance,

[Federal Register: August 7, 1998 (Volume 63, Number 152)]

[Notices]

[Page 42409-42410]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07au98-124]

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.

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.

\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.

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. 98-20965Filed8-6-98; 8:45 am]

BILLING CODE 4150-04-P