[Federal Register Volume 70, Number 174 (Friday, September 9, 2005)]
[Notices]
[Pages 53667-53672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

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

ACTION: Notice of a 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 create a new SOR titled, ``Data Collection 
Secondary to Coverage Decision (DCSCD) System, HHS/CMS/OCSQ, System No. 
09-70-0547.'' National Coverage Determinations (NCDs) are 
determinations by the Secretary with respect to whether or not a 
particular item or service is covered nationally under title XVIII of 
the Social Security Act (the Act) Sec.  1869(f)(1)(B). In order to be 
covered by Medicare, an item or service must fall within one or more 
benefit categories contained within Part A or Part B, and must not be 
otherwise excluded from coverage. Moreover, with limited exceptions, 
the expenses incurred for items or services must be ``reasonable and 
necessary for the diagnosis or treatment of illness or injury or to 
improve the functioning of a malformed body member,'' Sec.  
1862(a)(1)(A). CMS has determined that the evidence is adequate to 
conclude that certain identified diagnoses are reasonable and necessary 
in several patient groups where certain criteria for these patients 
have been met. The reasonable and necessary determination requires that 
patients meet the criteria and are consistent with the trials 
discussed. Collection of these data elements allows that determination 
to be made. We are particularly

[[Page 53668]]

interested in seeing evidence that would permit us to make a coverage 
or non-coverage decision, i.e., to move a diagnostic indication from 
coverage under a clinical trial or study to coverage or non-coverage 
based on definitive evidence of benefit, no benefit, or harm. If 
adequate new evidence is available, the decision may be changed to 
either ``coverage based on evidence of benefit,'' ``limited coverage'' 
or ``non-coverage based on evidence of harm or no benefit.''
    The purpose of this system is to collect and maintain data on 
patients to review determinations of ``reasonable and necessary'' with 
respect to whether or not a particular item or service is covered 
nationally under title XVIII of the Act Sec.  1869(f)(1)(B). 
Information retrieved from this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the agency or by a contractor or consultant; (2) assist another 
Federal or state agency with information to enable such agency to 
administer a Federal health benefits program, or to enable such agency 
to fulfill a requirement of Federal statute or regulation that 
implements a health benefits program funded in whole or in part with 
Federal funds; (3) to an individual or organization for a research 
project or in support of an evaluation project related to the 
prevention of disease or disability, the restoration or maintenance of 
health, or payment related projects; (4) support constituent requests 
made to a congressional representative; (5) support litigation 
involving the agency; and (6) combat fraud and abuse in certain health 
benefits programs. We have provided background information about the 
new system in the SUPPLEMENTARY INFORMATION section below. Although the 
Privacy Act requires only that CMS provide an opportunity for 
interested persons to comment on the proposed routine uses, CMS invites 
comments on all portions of this notice. See EFFECTIVE DATES section 
for comment period.

EFFECTIVE DATES: CMS filed a new SOR 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 09/01/2005. We will not disclose any information under a 
routine use until 30 days after publication. We may defer 
implementation of this SOR 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 the CMS Privacy 
Officer, Mail Stop 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.-3 p.m., eastern daylight time.

FOR FURTHER INFORMATION CONTACT: Rosemarie Hakim, Epidemiologist, 
Office of Clinical Standards and Quality, CMS, Mail Stop C1-09-06, 7500 
Security Boulevard, Baltimore, Maryland 21244-1849. Her telephone 
number is (410) 786-3934, or she can be reached via e-mail at 
<a href="/cdn-cgi/l/email-protection#fd8f959c969490bd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="74061c151f1d19341719075a1c1c075a131b02">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the case of ``limited coverage'', in NCDs 
for which additional evidence is required, CMS has determined that the 
evidence is adequate to conclude that the item or service improves net 
health outcomes only under specific circumstances. One of these 
circumstances is that the service is delivered in the context of 
specific data being collected. Coverage may be limited to providers who 
participate in and beneficiaries who are enrolled in a defined 
prospective data collection activity, when this data collection 
activity constitutes part of the evidence required to ensure that the 
item or service provided to that patient is reasonable and necessary.
    CMS is committed to ensuring that advances in medical technology 
are available for its Medicare beneficiaries while ensuring the care 
they receive is reasonable and necessary, which is a necessary 
condition for payment. The coverage with evidence development 
initiative is intended to enable Medicare to provide payment for items 
and services under conditions that help assure significant net benefits 
of the treatment for beneficiaries, and to give rise to additional 
information. This evidence will also assist doctors and patients in 
better understanding the risks, benefits and costs of alternative 
diagnostic and treatment options. Consequently, the linkage of coverage 
to data collection will also help to ensure that individual patients 
are receiving care that is reasonable and necessary given their 
specific clinical situation; systematic, protocol-driven data has the 
potential to increase the likelihood of improved health outcomes. Care 
provided under these protocols may lead to greater attention to 
appropriate patient evaluation and selection, as well as the 
appropriate application of the technology. These additional data may 
alter the course of patient treatment based on the best available 
evidence, and may lead a physician to reconsider the use of the item or 
service or otherwise alter a patient's management plan, potentially 
improving health outcomes. In addition, these additional data will be 
made available in some form to providers and practitioners to inform 
their decisions, monitor performance quality, benchmark and identify 
best practices. Collection of these data elements allows that 
determination to be made. We will also ensure that any future data 
collection system is consistent with the Standards for Privacy of 
Individually Identifiable Health Information and that all issues 
related to patient confidentiality, privacy, and compliance with other 
Federal laws will be resolved prior to the collection of any data.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for SOR

    The statutory authority for linking coverage decisions to the 
collection of additional data is derived from Sec. 1862 (a)(1)(A) of 
the Act, which states that Medicare may not provide payment for items 
and services unless they are ``reasonable and necessary'' for the 
treatment of illness or injury. In some cases, CMS will determine that 
an item or service is only reasonable and necessary when specific data 
collections accompany the provision of the service. In these cases, the 
collection of data is required to ensure that the care provided to 
individual patients will improve health outcomes.

B. Collection and Maintenance of Data in the System

    Information will be collected on individuals where CMS has 
determined that the evidence is adequate to conclude that certain 
identified diagnoses are reasonable and necessary in several patient 
groups where certain criteria for these patients have been met and the 
criteria are consistent with the trials reviewed. The collected 
information will contain, but is not limited to, name, address, 
telephone number, health insurance claim (HIC) number, geographic 
location, race/ethnicity, gender, and date of birth, as well as, 
background information relating to Medicare or Medicaid issues.

[[Page 53669]]

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

A. 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 DCSCD information that can be 
associated with an individual as provided for under ``Section III. 
Proposed Routine Use Disclosures of Data in the System.'' Both 
identifiable and non-identifiable data may be disclosed under a routine 
use.
    We will only collect the minimum personal data necessary to achieve 
the purpose of DCSCD. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from the system will be approved only 
to the extent necessary to accomplish the purpose of the disclosure and 
only after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected, e.g., to provide reimbursement 
for NCDs and assist in the collection of data on patients receiving an 
NCD for primary prevention to a data collection process to assure 
patient safety and protection and to determine that the NCD is 
reasonable and necessary.
    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 patient-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. The Privacy Act allows 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 compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    We contemplate 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 CMS function 
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 or consultant whatever information is 
necessary for the contractor or consultant to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor or consultant from using or disclosing the information 
for any purpose other than that described in the contract and requires 
the contractor or consultant to return or destroy all information at 
the completion of the contract.
    2. To another Federal or state agency to:
    a. Assist in the review determinations of ``reasonable and 
necessary'' with respect to whether or not a particular item or service 
is covered nationally under title XVIII of the Act Sec.  1869(f)(1)(B).
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds.
    Other Federal or state agencies in their administration of a 
Federal health program may require DCSCD information in order to assist 
in the review determinations of ``reasonable and necessary'' with 
respect to whether or not a particular item or service is covered 
nationally under title XVIII of the Act Sec.  1869(f)(1)(B).
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    The DCSCD data will provide for research or in support of 
evaluation projects, a broader, longitudinal, national perspective of 
the status of Medicare beneficiaries. CMS anticipates that many 
researchers will have legitimate requests to use this data in projects 
that could ultimately improve the care provided to Medicare 
beneficiaries and the policy that governs the care.
    4. 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.
    Beneficiaries sometimes request the help of a member of Congress in 
resolving an 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.
    5. 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 and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS' 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.
    6. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is

[[Page 53670]]

deemed reasonably necessary by CMS to prevent, deter, discover, detect, 
investigate, examine, prosecute, sue with respect to, defend against, 
correct, remedy, or otherwise combat fraud or abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship or 
grant with a third party to assist in accomplishing CMS functions 
relating to the purpose of combating fraud and abuse.
    CMS occasionally contracts out certain of its functions and makes 
grants when doing so would contribute to effective and efficient 
operations. CMS must be able to give a contractor or grantee whatever 
information is necessary for the contractor or grantee to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the contractor or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requiring the contractor or grantee to return or destroy all 
information.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    Other agencies may require DCSCD information for the purpose of 
combating fraud and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    This system contains Protected Health Information (PHI) as defined 
by HHS regulation ``Standards for Privacy of Individually Identifiable 
Health Information'' (45 CFR parts 160 and 164, 65 FR 82462 (12-28-00), 
subparts A and E. Disclosures of PHI 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.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine 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).

IV. Safeguards

    CMS has safeguards in place 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 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy.
    These laws and regulations include but are not limited to: The 
Privacy Act of 1974; the Federal Information Security Management Act of 
2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance 
Portability and Accountability Act of 1996; the E-Government Act of 
2002, the Clinger-Cohen Act of 1996; the Medicare Prescription Drug 
Improvement, and Modernization Act (MMA) of 2003, and the corresponding 
implementing regulations. OMB Circular A-130, Management of Federal 
Resources, Appendix III, Security of Federal Automated Information 
Resources also applies. Federal, HHS, and CMS policies and standards 
include but are not limited to: all pertinent National Institute of 
Standards and Technology publications; HHS Information System Program 
Handbook and the CMS Information Security Handbook.

V. Effects of the Proposed System of Records 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 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 as a result of information relating to 
individuals.

John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0547

SYSTEM NAME:
    ``Data Collection Secondary to Coverage Decision (DCSCD) System, 
HHS/CMS/OCSQ''.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 
Security Boulevard, North Building, First Floor, Baltimore, Maryland 
21244-1850 and at various co-locations of CMS contractors.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals where CMS has determined that the evidence is adequate 
to conclude that certain identified diagnoses are reasonable and 
necessary in several patient groups where certain criteria for these 
patients have been met and the criteria are consistent with the trials 
reviewed.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The data collection should include baseline patient 
characteristics. The collected information will contain, but is not 
limited to, name, address, telephone number, health insurance claim 
(HIC) number, geographic location, race/ethnicity, gender, and date of 
birth, as well as, background information relating to Medicare or 
Medicaid issues.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The statutory authority for linking coverage decisions to the 
collection of additional data is derived from Sec. 1862(a)(1)(A) of the 
Social Security Act (the Act), which states that Medicare may not 
provide payment for items and services unless they are ``reasonable and 
necessary'' for the treatment of illness or injury. In some cases, CMS 
will

[[Page 53671]]

determine that an item or service is only reasonable and necessary when 
specific data collections accompany the provision of the service. In 
these cases, the collection of data is required to ensure that the care 
provided to individual patients will improve health outcomes.

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system is to collect and maintain data on 
patients to review determinations of ``reasonable and necessary'' with 
respect to whether or not a particular item or service is covered 
nationally under title XVIII of the Act Sec.  1869(f)(1)(B). 
Information retrieved from this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the agency or by a contractor or consultant; (2) assist another 
Federal or state agency with information to enable such agency to 
administer a Federal health benefits program, or to enable such agency 
to fulfill a requirement of Federal statute or regulation that 
implements a health benefits program funded in whole or in part with 
Federal funds; (3) to an individual or organization for a research 
project or in support of an evaluation project related to the 
prevention of disease or disability, the restoration or maintenance of 
health, or payment related projects; (4) support constituent requests 
made to a congressional representative; (5) support litigation 
involving the agency; and (6) combat fraud and abuse in certain health 
benefits programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    The Privacy Act allows 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 compatible use of data is known as a ``routine 
use.'' We are proposing to establish the following routine use 
disclosures of information maintained in the system. Information will 
be disclosed:
    1. To agency contractors or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    2. To another Federal or state agency to:
    a. Assist in the review determinations of ``reasonable and 
necessary'' with re spect to whether or not a particular item or 
service is covered nationally under title XVIII of the Act Sec.  
1869(f)(1)(B).
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    4. 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.
    5. 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 and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    6. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.

Additional Provisions Affecting Routine Use Disclosures:
    This system contains Protected Health Information (PHI) as defined 
by Department of Health and Human Services (HHS) regulation ``Standards 
for Privacy of Individually Identifiable Health Information'' (45 Code 
of Federal Regulations (CFR) parts 160 and 164, 65 FR 82462 (12-28-00), 
subparts A and E). Disclosures of PHI 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.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine there is a 
possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the complaint 
population is so small that individuals who are familiar with the 
complainants could, because of the small size, use this information to 
deduce the identity of the complainant).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored electronically.

RETRIEVABILITY:
    The data is retrieved by an individual identifier i.e., name of 
beneficiary.

SAFEGUARDS:
    CMS has safeguards in place 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 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implements appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS; and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer

[[Page 53672]]

Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002; the Clinger-
Cohen Act of 1996; the Medicare Prescription Drug Improvement, 
Modernization Act (MMA) of 2003, and the corresponding implementing 
regulations. OMB Circular A-130, Management of Federal Resources, 
Appendix III, Security of Federal Automated Information Resources also 
applies. Federal, HHS, and CMS policies and standards include but are 
not limited to: all pertinent National Institute of Standards and 
Technology publications; HHS Information Systems Program Handbook and 
the CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    CMS will retain information for a total period of 10 years. All 
claims-related records are encompassed by the document preservation 
order and will be retained until notification is received from the 
Department of Justice.

SYSTEM MANAGER AND ADDRESS:
    Director, Office of Clinical Standards and Quality, CMS, Room S2-
26-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    For the purpose of access, the subject individual should write to 
the system manager who will require the system name, address, age, 
gender, and for verification purposes, the subject individual's name 
(woman's maiden name, if applicable).

RECORD ACCESS PROCEDURE:
    For the purpose of access, use the same procedures outlines 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).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above and reasonable identify the records 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:
    Records maintained in this system are derived from Carrier and 
Fiscal Intermediary Systems of Records, Common Working File System of 
Records, clinics, institutions, hospitals and group practices 
performing the procedures, and outside registries and professional 
interest groups.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 05-17845 Filed 9-8-05; 8:45 am]
BILLING CODE 4120-03-P


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