Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55133 

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 establish a new 

SOR titled, ‘‘Anti-Cancer Chemotherapy 

for Colorectal Cancer (CRC) System, 

System No. 09–70–0554.’’ National 

Coverage Determinations (NCD) 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 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). 

Under authority of section 1861(t)(2) 

of the statute, Medicare provides 

coverage for Food and Drug 

Administration (FDA) approved 

indications for anticancer 

chemotherapeutic agents and for other 

indications that are in the specific 

approved compendia listed below. 

Increased understanding of the biology 

of cancer and emerging technologies is 

making possible new approaches in 

treating cancer. To ensure that 

beneficiaries have access to the most 

appropriate cancer treatments, it is 

imperative that adequate clinical trial 

data for off-label uses be made available 

to patients and providers for clinical 

decision-making and to policy-making. 

CMS has determined that Medicare will 

cover the use of oxaliplatin (Eloxatin), 

irinotecan (Camptosar), cetuximab 

(ErbituxTM), or bevacizumab 

(AvastinTM), in clinical trials identified 

by CMS and sponsored by the National 

Cancer Institute (NCI). 

The purpose of this system is to 

provide reimbursement for CRCs and 

assist in the collection of data on 

patients receiving CRC as a new or 

emerging cancer treatment regimen to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC is reasonable and 

necessary. 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 system 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. to 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, she can also 

be reached via e-mail at 

rhakim@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: CMS has 

determined that oxaliplatin, irinotecan, 

cetuximab, and bevacizumab are 

Medicare covered for the FDA-approved 

and compendia-supported use in 1st 

and/or 2nd line treatment of advanced 

colorectal cancer. The off-label use of 

irinotecan for the treatment of non-small 

cell lung cancer is supported in one of 

the approved drug compendia; therefore 

this off-label use is covered by 

Medicare. No other off-label use for 

irinotecan, oxaliplatin, cetuximab, or 

bevacizumab appears as supported in 

the approved drug compendia. Off-label 

coverage of these agents is therefore 

determined by the Medicare contractors 

based on their review of the medical 

literature. During our NCD review of the 

medical literature, we found studies of 

off-label indications for these agents that 

varied widely in quality. 

At the request of CMS, NCI identified 

high priority clinical trials studying offlabel uses of the four agents that are the 

subject of this national coverage 

determination review. It was agreed that 

the selected trials should address 

questions likely to lead to important 

changes in therapy and that by covering 

the use of these agents in selected trials; 

we will: 

• Offer consistent national coverage 

for these specific trials, 

• Ensure continued advancement in 

knowledge for the appropriate use of 

these agents, 

• Accelerate the development of 

evidence for new or emerging cancer 

treatment regimens for these agents, 

• Ensure beneficiaries rapid access to 

promising new uses of approved 

technologies under controlled clinical 

trial conditions, 

• Serve as a potential model for 

additional coverage expansions in 

clinical trials for other anti-cancer 

chemotherapeutic agents, 

• Encourage industry to invest in 

studies that will expand knowledge base 

for patient and doctor discussions. 

Although we did not find sufficient 

evidence to support coverage of off-label 

use of cancer chemotherapy for all 

persons who have cancer, a sufficient 

inference of benefit can be drawn to 

support limited coverage in the context 

of an NCI-sponsored clinical trial that 

provides rigorous safeguards for 

patients. We base this inference on the 

evidence discussed above regarding the 

benefits of chemotherapy for labeled 

uses. We further believe that NCIsponsored clinical trials offer safeguards 

for patients to ensure appropriate 

patient evaluation and selection and 

55134 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

reasonable use of cancer chemotherapy. 

We conclude that coverage for the offlabel use of cancer chemotherapy could 

provide clinical benefits to Medicare 

beneficiaries with cancer, and that those 

benefits are likely to be present in the 

context of a clinical trial that assures 

informed individualized analysis and 

evaluation of the response to 

chemotherapy and patient health status, 

as well as an adequate plan for data and 

safety monitoring. 

The proposed policy does not obviate 

the need for contractors to continue to 

review the medical literature and 

determine the conditions under which 

off-label indications of FDA-approved 

drugs and biologicals used in anticancer chemotherapeutic regimens for 

medically accepted indications are 

reasonable and necessary (Sec. 

1861(t)(2)(B)(ii)(II)). Contractors will not 

infer from this NCD that any other uses 

of these drugs should not be approved. 

This policy also does not withdraw 

Medicare coverage for items and 

services that may be covered according 

to the existing national coverage policy 

for Routine Costs in a Clinical Trial 

(National Coverage Determination 

Manual, section 310.1). Routine costs 

will continue to be covered as well as 

other items and services provided as a 

result of coverage of these specific trials 

in this NCD. Specific reimbursements 

will be determined as the protocols are 

completed and the trials begin. 

In addition to covering these specific 

NCI trials, we are interested in 

establishing other processes to identify 

appropriate trials for which we may 

provide coverage. We are also interested 

in identifying additional means of 

gathering evidence outside of a clinical 

trial setting for use in decision-making 

such as registries and analyses of 

routinely collected electronic data. 

Therefore, we will shortly begin a 

process to develop appropriate guidance 

(Medicare Prescription Drug 

Improvement, Modernization Act of 

2003 section 731) that will include an 

Open Door Forum and an expert panel 

convened by the Institute of Medicine 

and will result in the publication of a 

draft guidance document. We encourage 

broad public participation in this 

process. 

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 provisions 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 

The data collection should include 

baseline patient characteristics. The 

collected information will also contain, 

but is not limited to, 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 CRC 

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 CRC. CMS has the following 

policies and procedures concerning 

disclosures of information that will be 

maintained in the system. Disclosure of 

information from the SOR 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 CRCs and 

assist in the collection of data on 

patients receiving CRC as a new or 

emerging cancer treatment regimens to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC 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 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. 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55135 

2. To another Federal or state agency 

to: 

a. Provide reimbursement for CRCs 

and assist in the collection of data on 

patients receiving CRC as a new or 

emerging cancer treatment regimens to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC is reasonable and 

necessary. 

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 CRC information 

in order to provide reimbursement for 

CRCs and assist in the collection of data 

on patients receiving CRC as a new or 

emerging cancer treatment regimens to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC is reasonable and 

necessary. 

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 CRC 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 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 CRC 

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, 

55136 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 

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. 09–70–0554 

SYSTEM NAME: 

‘‘Anti-Cancer Chemotherapy for 

Colorectal Cancer (CRC) 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: 

CMS will cover the use of oxaliplatin 

(Eloxatin), irinotecan (Camptosar), 

cetuximab (ErbituxTM), or bevacizumab 

(AvastinTM), on all Medicare 

beneficiaries who are in clinical trials 

identified by CMS and sponsored by the 

National Cancer Institute. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The data collection should include 

baseline patient characteristics. The 

collected information will also contain, 

but is not limited to, 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 

provide reimbursement for CRCs and 

assist in the collection of data on 

patients receiving CRC as a new or 

emerging cancer treatment regimens to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC is reasonable and 

necessary. 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: 

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. 

2. To another Federal or state agency 

to: 

a. Provide reimbursement for CRCs 

and assist in the collection of data on 

patients receiving CRC as a new or 

emerging cancer treatment regimens to a 

data collection process to assure patient 

safety and protection and to determine 

that the CRC is reasonable and 

necessary, 

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 

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