[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Notices]
[Pages 62482-62486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of New System

AGENCY: Department of Health and Human Services (HHS), Centers for 
Medicare & Medicaid Services (CMS).

ACTION: Notice of new System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system of records, called the 
``Privacy Accountability Database (PAD),'' HHS/CMS/OIS No. 09-70-0540. 
The primary purpose of the system of records is to aid CMS in tracking, 
reporting, and accounting the disclosures made from all CMS system of 
records as permitted by the Privacy Act of 1974 and The Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). 
Information retrieved from this system of records will be used to 
support regulatory, reimbursement, and policy functions performed 
within the agency or by a contractor or consultant; support constituent 
requests made to a Congressional representative; and support litigation 
involving the agency.
    We have provided background information about the proposed system 
in the SUPPLEMENTARY INFORMATION section, below. Although the Privacy 
Act requires only that the ``routine use'' portion of the system be 
published for comment, CMS invites comments on all portions of this 
notice. See ``Effective Dates'' section for comment period.

EFFECTIVE DATES: CMS filed a new system report with the Chair of the 
House Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Governmental Affairs, and the Administrator, Office 
of Information and Regulatory Affairs, Office of Management and Budget 
(OMB) on September 19, 2002. In any event, we will not disclose any 
information under a routine use until forty (40) calendar days after 
publication. We may defer implementation of this system of records or 
one or more of the routine use statements listed below if we receive 
comments that persuade us to defer implementation.

ADDRESSES: The public should address comments to: Director, Division of 
Data Liaison and Distribution (DDLD), CMS, Room N2-04-27, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850. Comments received will be 
available for review at this location, by appointment, during regular 
business hours, Monday through Friday from 9 a.m.-3p.m., eastern time 
zone.

FOR FURTHER INFORMATION CONTACT: Kimberly Elmo, Division of Data 
Liaison and Distribution (DDLD), CMS, Room N2-04-27, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850.

SUPPLEMENTARY INFORMATION:

I. Description of the New System of Records

A. Statutory and Regulatory Basis for System of Records

    42 CFR 401.101-401.148 and 1106(a) of the Social Security Act, 42 
U.S.C. 1306(a), 45 CFR 552a(c) of the Privacy Act and 45 CFR 164.528 of 
the Health Insurance Portability and Accountability Act.

B. Background

    CMS administers the Medicare, Medicaid, and the State Children's 
Health Insurance Program to accomplish its mission of ensuring health 
care security for beneficiaries. Accordingly, CMS possesses the 
nation's largest collection of health care data (consisting of over 60 
system of records), with information on over 74 million Americans. 
Having in place adequate electronic and procedural controls to address 
confidentiality will protect this personally identifiable data.
    Data files consisting of personally identifiable data are disclosed 
to various entities. These disclosures fall under exceptions of the 
Privacy Act, routine uses of the applicable system of record or are 
permitted by HIPAA. Privacy legislation requires CMS to track 
disclosures from each individual system of records. The PAD will 
provide the necessary tracking, reporting and accounting capabilities 
that CMS must have in place to be in compliance with the Privacy Act of 
1974 and HIPAA.

II. Collection and Maintenance of Data in the System

A. Scope of the Data Collected

    The PAD will contain information on disclosures of CMS data that 
fall under exceptions of the Privacy Act; routine uses of the 
applicable system of record or permitted by HIPAA that require 
tracking. This system may also contain the Medicare Health Insurance 
Claim Number, Social Security Number, or Railroad Retirement Board 
Number and a PAD tracking number for Medicare beneficiaries whose CMS 
data have been disclosed.
    The PAD will be implemented in phases. The initial fielding, 
scheduled to coincide with the April 14, 2003

[[Page 62483]]

HIPAA Privacy Rule compliance date, will capture and record applicable 
disclosure tracking information for enrollment and claims databases 
only (09-70-0536 Medicare Beneficiary Database and 09-70-0005 National 
Claims History National Medicare Utilization Database). These two 
databases contain the information most requested and, subsequently, 
serve as the source for the most frequently disclosed information. This 
phased implementation is based on architectural and technical 
limitations that exist in the CMS data center today. Modernization and 
reengineering initiatives are ongoing to increase cross-platform 
compatibility and integration. The PAD will incorporate accounting of 
additional databases as they are integrated into the new environment. 
This SOR will be republished as necessary.

B. Agency Policies, Procedures, and Restrictions on the Routine Use

    The Privacy Act permits us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such disclosure of data is known as a ``routine use.'' 
The government will only release PAD information that can be associated 
with an individual as provided for under ``Section III. Entities Who 
May Receive Disclosures Under Routine Use.'' Both identifiable and non-
identifiable data may be disclosed under a routine use. Identifiable 
data includes individual records with PAD information and identifiers. 
Non-identifiable data includes individual records with PAD information 
and masked identifiers or PAD information with identifiers stripped out 
of the file.
    CMS will only disclose the minimum personal data necessary to 
achieve the purpose of the PAD. CMS has the following policies and 
procedures concerning disclosures of information that will be 
maintained in the system. In general, disclosure of information from 
the SOR will be approved only for the minimum information necessary to 
accomplish the purpose of the disclosure after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data are being collected; e.g., tracking, reporting and 
accounting the disclosures made from all CMS systems of records as 
permitted by the Privacy Act and HIPAA.
    2. Determines that:
    a. The purpose for which the disclosure is to be made can only be 
accomplished if the record is provided in individually identifiable 
form;
    b. The purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring; 
and
    c. There is a strong probability that the proposed use of the data 
would, in fact, accomplish the stated purpose(s).
    3. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent unauthorized use of disclosure of the record;
    b. Remove or destroy at the earliest time all individually, 
identifiable information; and
    c. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

A. Entities That May Receive Disclosures Under Routine Use

    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the PAD without the consent of the individual 
to whom such information pertains. Each proposed disclosure of 
information under these routine uses will be evaluated to ensure that 
the disclosure is legally permissible, including but not limited to 
ensuring that the purpose of the disclosure is compatible with the 
purpose for which the information was collected. CMS proposes to 
establish the following routine use disclosures of information 
maintained in the system:
    1. To agency contractors, or consultants that have been contracted 
by the agency to assist in the performance of a service related to this 
system of records and that need to have access to the records in order 
to perform the activity.
    CMS contemplates disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing agency business 
functions relating to purposes for this system of records.
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and efficient operations. CMS must be 
able to give a contractor whatever information is necessary for the 
contractor to fulfill its duties. In these situations, safeguards are 
provided in the contract prohibiting the contractor from using or 
disclosing the information for any purpose other than that described in 
the contract and requires the contractor to return or destroy all 
information at the completion of the contract.
    2. To a Member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional Office made at the written 
request of the constituent about whom the record is maintained.
    Individuals sometimes request the help of a Member of Congress in 
resolving some issue relating to a matter before CMS. The Member of 
Congress then writes CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    3. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity; or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government;
is a party to litigation or has an interest in such litigation, and by 
careful review, CMS determines that the records are both relevant and 
necessary to the litigation.
    Whenever CMS is involved in litigation, or occasionally when 
another party is involved in litigation and CMS's policies or 
operations could be affected by the outcome of the litigation, CMS 
would be able to disclose information to the DOJ, court or adjudicatory 
body involved. A determination would be made in each instance that, 
under the circumstances involved, the purposes served by the use of the 
information in the particular litigation is compatible with a purpose 
for which CMS collects the information.

B. Additional Provisions Affecting Routine Use Disclosures

    In addition, CMS policy will be to prohibit release even of non-
identifiable data, except pursuant to one of the routine uses, if there 
is a possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the patient 
population is so small that individuals who are familiar with the 
enrollees could, because of the small size, use this information to 
deduce the identity of the beneficiary).

[[Page 62484]]

    This System of Records contains Protected Health Information as 
defined by the Department of Health and Human Services' regulation 
``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR parts 160 and 164, 65 FR 82462 as amended by 66 
FR 12434). Disclosures of Protected Health Information authorized by 
these routine uses may only be made if, and as, permitted or required 
by the ``Standards for Privacy of Individually Identifiable Health 
Information.''

IV. Safeguards

    The PAD system will conform to applicable law and policy governing 
the privacy and security of Federal automated information systems. 
These include but are not limited to: the Privacy Act of 1974, Computer 
Security Act of 1987, the Paperwork Reduction Act of 1995, the Clinger-
Cohen Act of 1996, and OMB Circular A-130, Appendix III, ``Security of 
Federal Automated Information Resources.'' CMS has prepared a 
comprehensive system security plan as required by OMB Circular A-130, 
Appendix III. This plan conforms fully to guidance issued by the 
National Institute for Standards and Technology (NIST) in NIST Special 
Publication 800-18, ``Guide for Developing Security Plans for 
Information Technology Systems.'' Paragraphs A-C of this section 
highlight some of the specific methods that CMS is using to ensure the 
security of this system and the information within it.

A. Authorized Users

    Personnel having access to the system have been trained in Privacy 
Act requirements. Employees who maintain records in the system are 
instructed not to release any data until the intended recipient agrees 
to implement appropriate administrative, technical, procedural, and 
physical safeguards sufficient to protect the confidentiality of the 
data and to prevent unauthorized access to the data. Records are used 
in a designated work area and system location is attended at all times 
during working hours.
    To ensure security of the data, the proper level of class user is 
assigned for each individual user level. This prevents unauthorized 
users from accessing and modifying critical data. The system database 
configuration includes five classes of database users:

--Database Administrator class owns the database objects (e.g., tables, 
triggers, indexes, stored procedures, packages) and has database 
administration privileges to these objects.
--Quality Control Administrator class has read and write access to key 
fields in the database;
--Quality Index Report Generator class has read-only access to all 
fields and tables;
--Policy Research class has query access to tables, but are not allowed 
to access confidential patient identification information; and
--Submitter class has read and write access to database objects, but no 
database administration privileges.

B. Physical Safeguards

    All server sites will implement the following minimum requirements 
to assist in reducing the exposure of computer equipment and thus 
achieve an optimum level of protection and security for the CMS system:
    Access to all servers is to be controlled, with access limited to 
only those support personnel with a demonstrated need for access. 
Servers are to be kept in a locked room accessible only by specified 
management and system support personnel. Each server is to require a 
specific log-on process. All entrance doors are identified and marked. 
A log is kept of all personnel who were issued a security card, key 
and/or combination, which grants access to the room housing the server, 
and all visitors are escorted while in this room. All servers are 
housed in an area where appropriate environmental security controls are 
implemented, which include measures implemented to mitigate damage to 
Automated Information Systems (AIS) resources caused by fire, 
electricity, water and inadequate climate controls.
    Protection applied to the workstations, servers and databases 
include:

--User Log-on--Authentication is to be performed by the Primary Domain 
Controller/Backup Domain Controller of the log-on domain.
--Workstation Names--Workstation naming conventions may be defined and 
implemented at the agency level.
--Hours of Operation--May be restricted by Windows NT. When activated 
all applicable processes will automatically shut down at a specific 
time and not be permitted to resume until the predetermined time. The 
appropriate hours of operation are to be determined and implemented at 
the agency level.
--Inactivity Lockout--Access to the NT workstation is to be 
automatically locked after a specified period of inactivity.
--Warnings--Legal notices and security warnings are to be displayed on 
all servers and workstations.
--Remote Access Security--Windows NT Remote Access Service (RAS) 
security handles resource access control. Access to NT resources is to 
be controlled for remote users in the same manner as local users, by 
utilizing Windows NT file and sharing permissions. Dial-in access can 
be granted or restricted on a user-by-user basis through the Windows NT 
RAS administration tool.

C. Procedural Safeguards

    All automated systems must comply with Federal laws, guidance, and 
policies for information systems security. These include, but are not 
limited to: The Privacy Act of 1974; the Computer Security Act of 1987; 
OMB Circular A-130, revised; Information Resource Management Circular 
10; HHS AIS Security Program; the CMS Information Systems 
Security Policy, Standards, and Guidelines Handbook; and other CMS 
systems security policies. Each automated information system should 
ensure a level of security commensurate with the level of sensitivity 
of the data, risk, and magnitude of the harm that may result from the 
loss, misuse, disclosure, or modification of the information contained 
in the system.

V. Effects of the New System on Individual Rights

    CMS proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will monitor the collection and reporting of PAD data. PAD 
information is submitted to CMS through standard systems. CMS will use 
a variety of onsite and offsite edits and audits to increase the 
accuracy of PAD data.
    CMS will take precautionary measures (see item IV., above) to 
minimize the risks of unauthorized access to the records and the 
potential harm to individual privacy or other personal or property 
rights of patients whose data are maintained in the system. CMS will 
collect only that information necessary to perform the system's 
functions. In addition, CMS will make disclosure from the proposed 
system only with consent of the subject individual, or his/her legal 
representative, or in accordance with an applicable exception provision 
of the Privacy Act.
    CMS, therefore, does not anticipate an unfavorable effect on 
individual privacy

[[Page 62485]]

as a result of maintaining this system of records.

    Dated: September 19, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
09-70-0540

System Name:
    Privacy Accountability Database (PAD), HHS/CMS/OIS.

Security Classification:
    Level 3, Privacy Act Sensitive.

System Location:
    HCFA Data Center, 7500 Security Boulevard, North Building, First 
Floor, Baltimore, Maryland 21244-1850. CMS contractors and agents at 
various locations.

Categories of Individuals Covered by the System:
    This system will contain the Medicare Health Insurance Claim (HIC) 
Number, Social Security Number, or Railroad Retirement Board Number for 
Medicare seneficiaries whose CMS data have been disclosed under 
exceptions of the Privacy Act, routine uses of the applicable system of 
record or are permitted by HIPAA. .

Categories of Records in the System:
    The PAD will contain information on disclosures of CMS data that 
fall under exceptions of the Privacy Act; routine uses of the 
applicable system of record or permitted by HIPAA that require 
tracking. This system may also contain the Medicare Health Insurance 
Claim (HIC) Number, Social Security Number, or Railroad Retirement 
Board Number for Medicare beneficiaries whose CMS data have been 
disclosed.

Authority for Maintenance of the System:
    42 CFR 401.101-401.148 and sec 1106(a) of the Social Security Act, 
42 U.S.C. 1306(a), 45 CFR 552a(c) of the Privacy Act and 45 CFR 164.528 
of the Health Insurance Portability and Accountability Act.

Purpose(s):
    The primary purpose of the systems of records is to aid CMS in 
tracking, reporting, and accounting the disclosures made from all CMS 
system of records as permitted by the Privacy Act of 1974 and The 
Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Routine Uses of Records Maintained in the System, Including Categories 
or Users and the Purposes of Such Uses:
    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the PAD without the consent of the individual 
to whom such information pertains. Each proposed disclosure of 
information under these routine uses will be evaluated to ensure that 
the disclosure is legally permissible, including but not limited to 
ensuring that the purpose of the disclosure is compatible with the 
purpose for which the information was collected. In addition, CMS 
policy will be to prohibit release even of non-identifiable data, 
except pursuant to one of the routine uses, if there is a possibility 
that an individual can be identified through implicit deduction based 
on small cell sizes (instances where the patient population is so small 
that individuals who are familiar with the enrollees could, because of 
the small size, use this information to deduce the identity of the 
beneficiary). Be advised, this System of Records contains Protected 
Health Information as defined by the Department of Health and Human 
Services' (HHS) regulation ``Standards for Privacy of Individually 
Identifiable Health Information'' (45 CFR parts 160 and 164, 65 FR 8462 
as amended by 66 FR 12434). Disclosures of Protected Health Information 
authorized by these routine uses may only be made if, and as, permitted 
or required by the ``Standards for Privacy of Individually Identifiable 
Health Information.''
    1. To agency contractors, or consultants that have been contracted 
by the agency to assist in the performance of a service related to this 
system of records and that need to have access to the records in order 
to perform the activity.
    2. To a Member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional Office made at the written 
request of the constituent about whom the record is maintained.
    3. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity; or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreedto represent the employee, or
    d. The United States Government; is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation.

Policies and Practices for Storing, Retrieving, Accessing, Retaining, 
and Disposing of Records in the System:
Storage:
    Records are stored on paper and magnetic media.

Retrievability:
    The Medicare records are retrieved by Health Insurance Claim 
Number, Social Security Number, or Railroad Retirement Board Number of 
the beneficiary and PAD tracking number.

Safeguards:
    CMS has safeguards for authorized users and monitors such users to 
ensure against excessive or unauthorized use. Personnel having access 
to the system have been trained in the Privacy Act and systems security 
requirements. Employees who maintain records in the system are 
instructed not to release any data until the intended recipient agrees 
to implement appropriate administrative, technical, procedural, and 
physical safeguards sufficient to protect the confidentiality of the 
data and to prevent unauthorized access to the data.
    In addition, CMS has physical safeguards in place to reduce the 
exposure of computer equipment and thus achieve an optimum level of 
protection and security for the CMS system. For computerized records, 
safeguards have been established in accordance with HHS standards and 
National Institute of Standards and Technology guidelines; e.g., 
security codes will be used, limiting access to authorized personnel. 
System securities are established in accordance with HHS, Information 
Resource Management Circular 10, Automated Information Systems 
Security Program; CMS Information Systems Security, Standards 
Guidelines Handbook and OMB Circular No. A-130 (revised) Appendix III.

Retention and Disposal:
    Records are disposed of in accordance with established CMS, Privacy 
Act and HIPAA retention guidelines. CMS will conduct periodic reviews 
to determine if these records are historical and should be placed in 
permanent files after established retention periods and administrative 
needs of CMS have elapsed.

    Note: The Department of Justice issued a directive in 1992 
prohibiting the destruction of Medicare claims/administrative 
records. Therefore, all Medicare claims-related/administrative data 
will be retained until the freeze is lifted.''


[[Page 62486]]



System Manager(s) and Address:

    Director, Division of Data Liaison and Distribution, Enterprise 
Databases Group, Office of Information Services, CMS, Room N2-04-27, 
7500 Security Boulevard, Baltimore, Maryland, 21244-1850.

Notification Procedure:

    For purpose of access, the subject individual should write to the 
system manager, who will require the system name, the subject 
individual's name (woman's maiden name, if applicable), social security 
number (SSN) (furnishing the SSN is voluntary, but it may make 
searching for a record easier and prevent delay), address, date of 
correspondence and control number.

Record Access Procedure:

    For purpose of access, use the same procedures outlined in 
Notification Procedures above. Requestors should also reasonably 
specify the record contents being sought. (These procedures are in 
accordance with Department regulation 45 CFR 5b.5(a)(2).)

Contesting Record Procedures:

    The subject individual should contact the system manager named 
above, and reasonably identify the record and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These procedures are in 
accordance with Department regulation 45 CFR 5b.7.)

Record Source Categories:

    CMS's National Claims History system of records, Enrollment 
Database system of records, Medicare Beneficiary Database system of 
records, and Medicaid Statistical Information System of records.

Systems Exempted from Certain Provisions of the Act:

    None.
[FR Doc. 02-25427 Filed 10-4-02; 8:45 am]
BILLING CODE 4120-03-P