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###### Department of Health and Human Services

###### Office of Inspector General 

# AGENCY:

Office of Inspector General (OIG), HHS. 

# ACTION:

Notice and comment period. 

# SUMMARY:

In accordance with the provisions of the Privacy Act of 1974, the Office of Inspector General (OIG) is amending an existing system of records, entitled “Health Care Program Violations.” This system of records maintains certain health care sanction records for the purpose of making sanction decisions publically available. In order to assure the proper identification of sanctioned individuals, we are amending the category of records maintained in the system to include individual Social Security numbers (SSNs). The purpose of maintaining SSNs is to provide another field of identification which may be entered by those querying the system; these SSNs will not be accessible by users of the system. In addition, in the future, entities listed in the system will be able to be queried by their Employer Identification number (EIN). 

This notice also makes other amendments to the system of records that include more specifically describing the categories of individuals covered by the system; adding a routine use for disclosure of information as required by the Federal Acquisition Streamlining Act of 1994; revising the routine use for disclosure of information in the event of litigation; and explaining the method of retrievability for electronic records. Additional minor technical changes include revising the period of record retention for paper records; adding a retention period for electronic records; and changing the point of contact for the record notification procedure. 

# DATES:

*Effective date:*                         This revision will become effective, without further notice, on March 29, 2001, unless comments received on or before that date result in a contrary determination.                     

*Comment date:*                         Comments on this revision will be considered if we receive them at the address provided below no later than 5 p.m. on March 14, 2001.                     

# ADDRESSES:

Please mail or deliver written comments to the following address: Office of Inspector General, Department of Health and Human Services, Attention: OIG-52-N, 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-52-N. 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 a.m. to 4:30 p.m. 

# FOR FURTHER INFORMATION CONTACT:

Joel Schaer, OIG Regulations Officer, (202) 619-0089. 

# SUPPLEMENTARY INFORMATION:

## I. Background 

### A. The Federal Health Care Program Violations System of Records 

Under current law, individuals and entities must be excluded from participation in Federal health care programs in accordance with section 1128 of the Social Security Act (42 U.S.C. 1320a-7) for certain types of convictions, and may be excluded for other reasons, including licensure board actions, other Federal or State agency actions, and quality of care violations. In conjunction with this authority, the “Health Care Program Violations” system of records, maintained by the OIG, serves as a source of public information on all individuals or entities excluded from Federal health care programs. This system of records also provides the organizations responsible for licensing, certifying or otherwise approving the health-related activities of individuals and entities with the information they may need to make decisions. The system of records also allows health care employers to check on the exclusion status of new and current employees and contractors. This is of particular importance to hospitals and other health care entities, which are subject to civil money penalties, as authorized by Public Law 105-33, for hiring or contracting with excluded individuals and entities. Finally, the system of records serves as a fraud deterrent by virtue of public knowledge of its very existence, and provides the OIG with a means of analyzing trends and impact in fraud and abuse detection and enforcement. 

                    Procedural information regarding the “Health Care Program Violations” system of records was last published in the                     **Federal Register**                     on August 26, 1982 (47 FR 37693).                           ( print page 9866)    

### B. Content of, and Querying, the Records System 

                    Information from paper case files, found in the Civil and Administrative Investigative Files of the Inspector General system of records (47 FR 43099, September 30, 1982), is extracted and compiled into a master List of Excluded Individuals/Entities (LEIE). This list contains the Social Security numbers (SSNs) of most individuals excluded from participation in Federal health care programs by the OIG. The SSNs are not published on the LEIE and are not accessible to the general public. In the near future, the list will also contain the EINs of entities excluded by the OIG from participation in the Federal health care programs.[1] 

The LEIE is transmitted and made available electronically to other Federal agencies and organizations that are required by law to take action based upon the exclusions imposed by the OIG. In addition, the LEIE is available to the general public on the OIG's web site at http://www.dhhs.gov/​progorg/​oig. The on-line searchable database allows users to obtain information regarding excluded individuals and entities sorted by: 
    - The legal bases for the exclusion;
    - The types of individuals and entities excluded by the OIG; and
    - The States where excluded individuals reside or entities do business at the time of their exclusions.

Users may also query the database in order to ascertain whether a particular individual or entity is currently excluded from program participation by submitting the pertinent information regarding the subject. Users may have the data sorted by name, profession or specialty, city, state, zip code or sanction type. Users may input information in any of these fields and will receive a list of currently excluded individuals and entities which meet the criteria entered. 

## II. Amendment to the System of Records 

The following summarizes the major changes being proposed: 

### A. Categories of Records in the System 

This amendment to the system of records will include individual SSNs and EINs within the category of records in the Health Care Program Violations system as another field of identification. The OIG has received numerous comments from users of the LEIE that those querying the system should be able to input the SSN of an excluded individual as part of their search. The commenters believe inclusion of this additional search field is necessary to produce more reliable identification on the query match, and to ensure that no individuals are erroneously determined to be excluded because of the inability to get accurate information. In many cases, the queries are being received from health care providers who are considering hiring or contracting with an individual or entity and want to know if that particular individual or entity is excluded. As such, these health care providers already have the SSN of a particular individual. 

The purpose of including individual SSNs (and EINs, if applicable) in this system is to allow individuals querying the LEIE to use SSNs and EINs as specific search fields. However, the SSNs maintained in the system will not be accessible by those using an SSN for identification. The OIG will include fields where a user may input SSN or EIN information. The individual SSNs or EINs will not be retrievable through the LEIE. In order to use the SSN or EIN search field, the individual entering the query must have the full name and the 9 digits of an individual's SSN. The query will either affirm a match or state that no match exists; the LEIE will not verify the SSN or EIN. It is ultimately the recipient's responsibility to verify the information before using it as the basis for any formal action. 

### B. Categories of Individuals Covered by the System 

The current description of the individuals covered by this system is being revised to more specifically describe the categories of providers, contractors, grantees and other individuals that are now in the system of records. This revised description more accurately reflects the categories of individuals, permitting retrieval of information on some additional key individuals who are not described in the current outdated description. In addition, the revised description brings this systems notice into conformity with the categories of sanctioned individuals covered in the Civil and Administrative Files of the OIG system of records. 

### C. Routine Uses 

In the system of records, under “Routine Use,” a new paragraph 1.d. is being added to provide for disclosures required by the Federal Acquisition Streamlining Act of 1994, Public Law 103-355. The disclosures set forth under this routine use provide the information necessary for other Federal agencies and their agents to enforce debarments, suspensions and exclusions, as required by law. This routine use provision provides essential information to other Federal agencies with respect to individuals and entities barred from participating in Federal procurement and non-procurement programs or activities. 

In addition, paragraph 3 under “Routine Use” is revised to outline the necessary disclosures made in the course of litigation involving the Department, its employees, or the United States. It is essentially the same type of disclosure provision found in most Federal systems of records and is necessary to the effective administration of justice in such proceedings. In addition, this revision brings this systems notice into conformity with the similar routine use used in the Civil and Administrative Investigative Files of the OIG system of records. 

### D. Retrievability 

The method for retrieving records is expanded to include both paper and electronic records, including a revised list of the types of information that can be used to retrieve the records. This revision also sets forth instructions on how to indirectly access the database on public records through the Internet; this information was absent from the existing outdated description. 

### E. Other Minor Revisions 

Other minor changes are also being made to clarify certain provisions and bring the system of records notice into conformity with organizational, legislative and policy changes. They include: 
    - Records Retention—The retention period for paper records is being expanded from 5 years to 6 years to bring it into conformity with the retention period established for records of OIG by the National Archives and Records Administration. In addition, the retention period for electronic records is included.
    - Notification Procedure—The notification procedure is revised to provide a point of contact for media inquiries and a new point of contact for written notification requests. Information on how to request records electronically is also included.

Dated: February 2, 2001. 

Michael F. Mangano, 

Acting Inspector General. 

##                         HHS                                                  OS                                                  OIG 09-90-0101                     

### System name:

Health Care Program Violations.

### Security classification:

                        None.                              ( print page 9867)    

### System location:

This system is located in the Office of Inspector General, Department of Health and Human Services, 330 Independence Avenue, SW., Washington, DC 20201. The database for this system, known as the List of Excluded Individuals/Entities (LEIE), is on a local area network in the Wilber H. Cohen Building, 330 Independence Avenue, SW., Washington, D.C. The system is operated by the Office of Inspector General. 

### Categories of individuals and entities covered by the system:

Individuals and entities covered by this system are employees and former employees, HHS grantees, contractors, sub-contractors and their employees; employees of State agencies and Medicare carriers and intermediaries; Medicare and Medicaid providers; recipients under programs administered or funded by the Federal and State programs; and others involved in health care. It includes individuals and entities who have been excluded from participation in the Medicare, Medicaid, and all Federal health care programs as defined in section 1128B(f) of the Social Security Act. The individuals would include physicians, nurses, pharmacists, dentists, therapists, suppliers and private citizens receiving Federal payments for the furnishing of items or services covered by any Federal or private program. 

### Categories of records in the system:

The Health Care Program Violations System contains public information on individuals and entities which have been excluded from participation in the Medicare, Medicaid, and all other Federal health care programs (after August 1997, in accordance with Pub. L. 105-33), including names, publicly available Social Security numbers, individual Social Security numbers (and Employer Identification numbers, if applicable), aliases and “doing-business-as,” addresses, and other available unique identifiers related to fraud, waste and abuse; occupations and specialties, and institutional affiliations; type and date of exclusion. 

### Authority for maintenance of the system:

5 U.S.C. App. 3. 

### Purposes:

The Health Care Program Violations System is used to protect program beneficiaries and to reduce fraud and abuse in Federal health care programs by providing a clearinghouse of public information on individuals and entities excluded from health care programs. 

### Routine uses of records maintained in the system, including categories of users and purposes of such uses: 

1. Information maintained by this system may be disclosed, as a routine use, to Federal, State, local, public and private agencies and organizations, as follows:

a. Agencies or organizations which reimburse or regulate individuals or entities with respect to the furnishing of health-related services or items. 

b. Agencies or organizations which license, certify, or otherwise regulate the health-related activities of individuals and entities which provide health care services or items, to alert them to possibly disqualifying actions, practices or conditions.

c. Agencies or organizations charged with investigating or prosecuting possible violations indicated in items a and b.

d. Agencies and their agents or representatives enforcing debarments, suspensions and exclusions under the Federal Acquisition Streamlining Act of 1994.

e. Upon written request, agencies and/or their contractors or organizations seeking information in connection with the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the awarding of a contract, or the issuance of a license, grant or other benefit by the requesting agency, to the extent that the record is relevant and necessary to the requesting agency's decision on the matter.

f. Professional and business organizations concerned with standards and conduct of individuals and entities engaged in providing health care items and services.

g. Scholars or other researchers investigating trends and characteristics in the health care field.

2. Disclosure may be made to a Congressional office from the record of an individual or entity in response to an inquiry from the Congressional office made at the request of that individual or entity.

3. In the event of litigation, information from the system of records may be disclosed to the Department of Justice, to a judicial or administrative tribunal, opposing counsel, and witnesses, in the course of proceedings involving HHS, any HHS employee (where the matter pertains to the employee's official duties), or the United States, or any agency thereof where the litigation is likely to affect HHS, or HHS is a party or has an interest in the litigation and the use of the information is relevant and necessary to the litigation.

### Policies and practices for storing, retrieving, revealing, retaining, and disposing of records in the system:

### Storage:

Paper records, which includes program exclusion case files, are kept in files and file folders. Electronic records are stored on hard or floppy disks and tapes.

### Retrievability:

The agency retrieves records from files indexed alphabetically by geographic region. Both paper records and electronic records are retrievable by agency-assigned internal case control numbers, name, personal identifier fields such as date of birth, UPIN, Social Security or Employer Identification number, address, specialty/occupation, program violated, date of exclusion, and type of exclusion.

                        Indirect access to the database on public records fields is available to the general public on the OIG's Internet site (                        *http://www.dhhs.gov/​progorg/​oig*).                    

### Safeguards:

Paper records are stored in secured cabinets behind a locked door with access limited to authorized personnel. Computer based records are available only to authorized users and are safeguarded in accordance with the provisions of the National Bureau of Standards Federal Information Processing Standards 41 and 31, and the HHS Information Processing Standards, HHS ADP Systems Manual, Part 6, “ADP Systems Security.” All computer tapes are password protected prohibiting unauthorized access.

### Retention and disposal:

The OIG maintains the hardcopy records and files for one year, after which they are transferred to the Federal Records Center for an additional 5 years. The electronic records system is maintained for an indefinite period of time.

### System manager(s) and address:

The Systems Manager is an employee of Office of Investigations, Office of Inspector General, Department of Health and Human Services, 330 Independence Avenue, SW., Washington, DC 20201. The OIG web site is managed by the Office of Information Technology, Office of Inspector General, at this same address.

### Notification Procedure:

                        An individual who wishes to be notified whether the system contains a record should make a request electronically to the OIG web site at http://www.dhhs.gov/​progorg/​oig.      ( print page 9868)    Media inquiries should be directed to the HHS/OIG External Affairs Office, 330 Independence Avenue, SW., Washington, DC 20201. Requests for written documentation should be submitted in writing, together with a printout from the OIG web site identifying the individual or entity, to the Office of Investigations, Health Care Administrative Sanctions, Room N2-01-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.                    

### Record access procedure:

Same as notification procedure. 

### Contesting record procedures:

An individual who wishes to contest the record procedures should contact the Office of Health Care Administrative Sanctions, Office of Investigations, Office of Inspector General, Department of Health and Human Services, Room N2-01-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. The individual or entity should reasonably identify the record and specify the information to be contested, the corrective action sought and the reasons for the correction, with supporting documentation.

### Record source categories:

The sources are Government and private agencies and organizations. 

### Systems exempted from certain provisions of the Act:

None.

# Footnotes

1.                             Some individuals may also be referenced by EINs in addition to their SSN.                    
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[FR Doc. 01-3419 Filed 2-9-01; 8:45 am] 

BILLING CODE 4152-01-P