[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55133-55137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18488]



[[Page 55133]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


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

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

ACTION: Notice of a new System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to 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[reg]), irinotecan 
(Camptosar[reg]), 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 
[email protected].

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

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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.

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    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,

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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[supreg]), 
irinotecan (Camptosar[supreg]), 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

[[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