Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55137 

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 CMSadministered 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 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 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). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored electronically. 

RETRIEVABILITY: 

The data are retrieved by an 

individual identifier i.e., name of 

beneficiary or provider. 

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 EGovernment Act of 2002; the ClingerCohen 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 

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. 05–18488 Filed 9–19–05; 8:45 am] 

BILLING CODE 4120–03–P 

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). 

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 

55138 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

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 rhakim@cms.hhs.gov. 

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. 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 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: 

55140 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

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 CMSadministered 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 EGovernment Act of 2002, the ClingerCohen 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. 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 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 CMSadministered 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. 

55142 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

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 EGovernment Act of 2002; the ClingerCohen 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission of OMB Review; Comment 

Request 

Title: Compassion Capital Fund 

Evaluation. 

OMB No.: New Collection. 

Description: This proposed 

information collection activity is for two 

rounds of surveys to be completed by 

faith-based and community 

organizations participating in two 

studies within the Compassion Capital 

Fund (CCF) evaluation project. The first 

survey will be conducted as a baseline 

survey and the second will be a followup survey conducted several months 

later. 

The CCF evaluation is an important 

opportunity to examine the 

effectiveness of the Compassion Capital 

Fund in meeting its objective of 

improving the capacity of faith-based 

and community organizations. The 

evaluation includes three distinct 

studies: a random assignment impact 

study, an outcome study, and a 

retrospective study. This notice pertains 

to the impact and outcome studies. The 

impact study will involve up to 1,000 

faith-based and community 

organizations that seek services from 

CCF-funded intermediary organizations. 

Information will be collected from these 

faith-based and community-based 

organizations to assess change and 

improvement in various areas of 

capacity. The study design includes the 

random assignment of faith-based and 

community organizations to either a 

treatment group that receives capacitybuilding services from a CCF 

intermediary grantee or to a control 

group that does not. The impact of the 

services provided by intermediaries, 

primarily through sub-awards and/or 

technical assistance (TA), will be 

determined by comparing the changes 

in organizational and service capacity of 

the recipient organizations with those of 

the control group. 

The outcome study will examine 

changes and improvements in a 

representative sample of about 750 

faith-based and community 

organizations served by all CCF 

intermediaries operating in FY2005 and 

FY2006, except those already part of the 

impact study. The survey instruments 

will be used to track changes in the 

faith-based and community 

organizations’ organizational capacity 

between baseline and follow-up. 

Respondents: The respondents for 

both studies will be faith-based and 

community organizations that seek subawards or TA from CCF intermediary 

grantees. The baseline survey will be 

primarily self-administered and is 

expected to be completed as part of the 

intermediary’s sub-award application or 

TA request process. The follow-up 

survey also will be primarily selfadministered and contain questions 

similar to those in the baseline survey 

as well as additional questions related 

to services received from the 

intermediary or other organizations. It is 

expected that the follow-up survey will 

be administered approximately 12 

months after the baseline survey. As 

needed to increase response rates, the 

survey will be administered by 

telephone to organizations that do not 

initially return a completed survey.