[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55137-55142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18489]


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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, ``Carotid Artery 
Stenting (CAS) System, System No. 09-70-0556.'' 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) section 1869(f) 
(1) (B). In order to be covered by Medicare, an item or service must 
fall within one

[[Page 55138]]

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.'' 
section 1862(a) (1) (A). CMS has determined that the evidence is 
adequate to conclude that CAS with embolic protection is reasonable and 
necessary to symptomatic patients who are at high risk for carotid 
endarterectomy (CEA), have significant comorbidities, or have anatomic 
risk factors. 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.
    The purpose of this system is to collect and maintain data on 
patients to review determinations of ``reasonable and necessary'' with 
respect to CAS in patients who are at high risk for CEA. 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 modified 
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 DATE: 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 September 13, 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 comment 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. She can be reached 
by telephone at (410) 786-3934, or via email at [email protected].

SUPPLEMENTARY INFORMATION: Each year about 700,000 people in the United 
States experience a new or recurrent stroke. About 500,000 of these are 
first attacks and 200,000 are recurrent attacks. The term stroke refers 
to a ``group of cerebrovascular disorders in which part of the brain is 
transiently or permanently affected by ischemia or hemorrhage, or in 
which one or more blood vessels of the brain are primarily affected by 
a pathologic process, or both.'' There are three main categories of 
strokes: Cerebral infarction (greater than 80%), intracerebral 
hemorrhage, and subarachnoid hemorrhage. Of the cerebral infarctions, 
``20% to 30% are due to atherothrombosis or thromboembolism from the 
extracranial or intracranial vessels.''
    Risk factors for stroke include advanced age, male gender, 
hypertension, history of stroke or transient ischemic attack, atrial 
fibrillation, valvular heart disease, diabetes mellitus, carotid artery 
stenosis, hypercoagulable conditions, and cigarette smoking. 
Hypertension is ``the single most important risk factor for both 
ischemic and hemorrhage stroke.'' Awareness of stroke warning signs is 
important since ``the inability of patients and bystanders to recognize 
stroke symptoms and to quickly access the emergency medical system are 
the largest barriers to effective acute stroke therapy.''
    Prevention of stroke remains important and includes among others, 
treatment of hypertension and diabetes mellitus; smoking cessation; 
limiting alcohol intake; control of diet and obesity; antiplatelet 
drugs or anticoagulants for atrial fibrillation and appropriate acute 
myocardial infarctions; antiplatelet drugs for symptomatic carotid or 
vertebrobasilar atherosclerosis; and CEA for specifically defined 
populations of patients with symptomatic carotid artery stenosis. CEA 
is a surgical procedure used to prevent stroke in which the surgeon 
removes fatty deposits or ulcerated and stenotic plaques from the 
carotid arteries, the two main arteries in the neck supplying blood to 
the brain. Although carotid artery stenosis is an important risk 
factor, it was estimated that ``approximately 20% and 45% of strokes in 
the territory of symptomatic and asymptomatic carotid arteries with 70% 
to 99% stenosis, respectively, are unrelated to carotid stenosis.'' In 
these patients, optimal medical therapy would be most important since 
CEA does not reduce lacunar and cardio embolic strokes. CAS is 
performed with a catheter, usually inserted through the femoral artery, 
and threaded up to the carotid artery beyond the area of narrowing. A 
distal embolic protection device or filter is usually placed first to 
catch emboli or debris that may dislodge during the procedure. A self-
expandable or balloon-expandable, metal mesh stent is then placed to 
widen the stenosis and the protection device is removed.
    On June 18, 2004, CMS began an NCD process for CAS with distal 
embolic protection for patients at high risk for CEA. Previously, 
Medicare covered percutaneous transluminal angioplasty (PTA) of the 
carotid artery concurrent with stent placement in accordance with the 
Food and Drug Administration (FDA) approved protocols governing 
Category B Investigational Device Exemption clinical trials and in FDA 
required post approval studies. Effective July 1, 2001, PTA of the 
carotid artery, when provided solely for the purpose of carotid artery 
dilation concurrent with carotid stent placement, is considered to be a 
reasonable and necessary service only when provided in the context of 
such a clinical trial, and therefore is considered a covered service 
for the purposes of these trials. Effective October 12, 2004, Medicare 
covered PTA of the carotid artery concurrent with the placement of an 
FDA-approved carotid stent for an FDA-approved indication when 
furnished in accordance with FDA-approved protocols governing post-
approval studies.

[[Page 55139]]

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 name, address, telephone number, Health 
Insurance Claim Number (HICN), geographic location, race/ethnicity, 
gender, and date of birth, as well as background information relating 
to Medicare or Medicaid issues.

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 CAS 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 CAS. 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 collect and maintain 
data on patients to review determinations of ``reasonable and 
necessary'' with respect to CAS in patients who are at high risk for 
CEA.
    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 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.
    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 CAS in patients who are at high risk for 
CEA.
    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 CAS information in order to assist 
in the review determinations of ``reasonable and necessary'' with 
respect to CAS in patients who are at high risk for CEA.
    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 CAS 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 these 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:

[[Page 55140]]

    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 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 CAS 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 Code of Federal Regulations 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 Modernization Act 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.

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.

Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
SYSTEM NO. 09-70-0556

SYSTEM NAME:
    ``Carotid Artery Stenting (CAS) System,'' HHS/CMS/OCSQ.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

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

[[Page 55141]]

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 name, address, 
telephone number, Health Insurance Claim Number (HICN), 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 section 1862(a)(1)(A) of 
the Social Security 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.

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 CAS in patients who are at high risk for carotid 
endarterectomy. 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 to:
    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 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 respect to carotid artery stenting in patients who are 
at high risk for carotid endarterectomy.
    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, 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.
    B. Additional Provisions Affecting Routine Use Disclosures: This 
system contains Protected Health Information (PHI) as defines 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.

[[Page 55142]]

RETRIEVABILITY:
    The data are 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 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 Modernization Act 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 DOJ.

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 reasonably 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. 05-18489 Filed 9-19-05; 8:45 am]
BILLING CODE 4120-03-P