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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services 

# 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 off-label 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 NCI-sponsored clinical trials offer safeguards for patients to ensure appropriate patient evaluation and selection and                           ( print page 55134)                        reasonable use of cancer chemotherapy. We conclude that coverage for the off-label 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 anti-cancer 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.                           ( print page 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 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 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 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,                           ( print page 55136)                        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                               ( print page 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 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 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 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 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