[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Pages 67133-67137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a Modified or Altered System

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

ACTION: Notice of a Modified or Altered System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act, we are 
proposing to modify or alter an existing SOR titled, ``Medicare-Cancer 
Registry Record System (MCR), System No. 09-70-0042,'' established at 
53 FR 38082 (September 29, 1988), and most recently modified at 65 FR 
37792 (June 16, 2000). We propose to assign a new CMS identification 
number to this system to simplify the obsolete and confusing numbering 
system originally designed to identify the Bureau, Office, or Center 
that maintained information in the Health Care Financing Administration 
systems of records. The new assigned identifying number for this system 
should read: System No. 09-70-0509.
    We propose to modify existing routine use number 2 that permits 
disclosure to agency contractors and consultants to include disclosure 
to CMS grantees who perform a task for the agency. CMS grantees, 
charged with completing projects or activities that require CMS data to 
carry out that activity, are classified separately from CMS contractors 
and/or consultants. The modified routine use will be renumbered as 
routine use number 1. We will delete routine use number 3 authorizing 
disclosure to support constituent requests made to a congressional 
representative. If an authorization for the disclosure has been 
obtained from the data subject, then no routine use is needed. The 
Privacy Act allows for disclosures with the ``prior written consent'' 
of the data subject.
    We propose to broaden the scope of the disclosure provisions of 
this system by adding a routine use to permit the release of 
information to another Federal or state agency to contribute to the 
accuracy of CMS' proper payment of Medicare benefits, to enable such 
agency to administer a Federal health benefits program, and/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, to evaluate and to monitor the 
amount and kinds of services received by Medicare beneficiaries 
contracting cancer. The added routine use will be numbered as routine 
use number 2.
    We will further broaden the scope of this system by including the 
section titled ``Additional Circumstances Affecting Routine Use 
Disclosures,'' that addresses ``Protected Health Information (PHI)'' 
and ``small cell size.'' The requirement for compliance with HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' applies whenever the system collects or maintains PHI. 
This system may contain PHI. In addition, our policy to prohibit 
release if there is a possibility that an individual can be identified 
through ``small cell size'' will apply to the data disclosed from this 
system.
    We are modifying the language in the remaining routine uses to 
provide a proper explanation as to the need for the routine use and to 
provide clarity to CMS's intention to disclose individual-specific 
information contained in this system. The routine uses will then be 
prioritized and reordered according to their usage. We will also take 
the opportunity to update any sections of the system that were affected 
by the

[[Page 67134]]

recent reorganization or because of the impact of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Pub. L. 108-173) provisions and to update language in the 
administrative sections to correspond with language used in other CMS 
SORs.
    The primary purpose of the system of records is to link individual-
level data from the Surveillance, Epidemiology, and End Results (SEER) 
tumor registry system, operated by the National Cancer Institute (NCI), 
with Medicare enrollment and claims data. This linked file will greatly 
enhance CMS's and NCI's ability to understand and evaluate the amount 
and kinds of services received by Medicare beneficiaries contracting 
cancer. Information retrieved from this system of records will also be 
disclosed to: (1) Support regulatory, reimbursement, and policy 
functions performed within the agency or by a contractor, consultant or 
grantee; (2) assist another Federal or state agency to conduct 
activities related to this system; (3) support research, evaluation, or 
epidemiological projects related to the prevention of disease or 
disability, or the restoration or maintenance of health, and for 
payment related projects; and (4) support litigation involving the 
agency. 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 routine uses, CMS invites comments 
on all portions of this notice. See ``Effective Dates'' section for 
comment period.

DATES: Effective Dates: CMS filed a modified or altered system report 
with the Chair of the House Committee on Government Reform and 
Oversight, the Chair of the Senate Committee on Homeland Security & 
Governmental Affairs, and the Administrator, Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB) on November 
9, 2006. To ensure that all parties have adequate time in which to 
comment, the modified system, including routine uses, will become 
effective 30 days from the publication of the notice, or 40 days from 
the date it was submitted to OMB and Congress, whichever is later, 
unless CMS receives comments that require alterations to this notice.

ADDRESSES: The public should address comments to: CMS Privacy Officer, 
Division of Privacy Compliance, Enterprise Architecture and Strategy 
Group, Office of Information Services, CMS, Room N2-04-27, 7500 
Security Boulevard, Baltimore, MD 21244-1850. Comments received will be 
available for review at this location, by appointment, during regular 
business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time 
zone.

FOR FURTHER INFORMATION CONTACT: Gerald Riley, Social Science Research 
Analyst, Division of Health Systems Research, Research and Evaluations 
Group, Office of Research, Development and Information, CMS, Mail Stop 
C3-20-11, 7500 Security Boulevard, Baltimore, MD 21244-1850. He can 
also be reached by telephone at 410-786-6699, or via e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Description of the Modified or Altered System of Records

A. Statutory and Regulatory Basis for System

    Authority for the collection and maintenance of this system is 
given under the provisions of section 1875(a) of the Social Security 
Act (42 U.S.C. 139511(a)) and sections 301 and 410-416 of the Public 
Health Service Act (42 U.S.C. 241 and 285-285a-5).

B. Collection and Maintenance of Data in the System

    The system collects and maintains information on Medicare 
beneficiaries diagnosed with cancer in 12 geographic areas of the 
United States. Data is collected from 12 Surveillance, Epidemiology, 
and End Results (SEER) program cancer registries linked with Medicare 
enrollment and claims data. The areas covered by the 12 registries are 
Iowa, Utah, Hawaii, New Mexico, Connecticut, New Jersey, California, 
Louisiana, Kentucky, Atlanta, Detroit, and western Washington.

II. Agency Policies, Procedures, and Restrictions on Routine Use

    A. 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 MCR 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 MCR. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from this system will be approved 
only to the extent necessary to accomplish the purpose of the 
disclosure and only after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected, e.g., to understand and 
evaluate the amount and kinds of services received by Medicare 
beneficiaries contracting cancer.
    2. Determines:
    a. That the purpose for which the disclosure is to be made can only 
be accomplished if the record is provided in individually identifiable 
form;
    b. That the purpose for which the disclosure is to be made is of 
sufficient importance to warrant the potential effect and/or risk on 
the privacy of the individual that additional exposure of the record 
might bring; and
    c. That 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; and
    b. Remove or destroy at the earliest time all patient-identifiable 
information.
    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 support agency contractors, consultants, or grantees, who 
have been engaged by the agency to assist in the performance of a 
service related to this collection 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

[[Page 67135]]

would contribute to effective and efficient operations. CMS must be 
able to give a contractor, consultant or grantee 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, consultant or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requires the contractor, consultant or grantee to return or destroy 
all information at the completion of the contract.
    2. To assist another Federal or state agency to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. 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, and/or
    c. Evaluate and monitor the amount and kinds of services received 
by Medicare beneficiaries contracting cancer.
    Other Federal or state agencies in their administration of a 
Federal health program may require MCR information in order to support 
evaluations and monitoring of services received and reimbursement for 
services provided.
    3. To assist an individual or organization for research, evaluation 
or epidemiological projects related to the prevention of disease or 
disability, or the restoration or maintenance of health, and for 
payment related projects.
    The collected data will provide the research, evaluation and 
epidemiological projects a broader, longitudinal, national perspective 
of the data. CMS anticipates that many researchers will have legitimate 
requests to use these data in projects that could ultimately improve 
the care provided to Medicare patients and the policy that governs the 
care. CMS understands the concerns about the privacy and 
confidentiality of the release of data for a research use. Disclosure 
of data for research and evaluation purposes may involve aggregate data 
rather than individual-specific data.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with another Federal agency to assist in accomplishing CMS 
functions relating to purposes for this system of records.
    4. To support 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.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise 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.'' (See 45 CFR 164-
512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, 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 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 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 may apply 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; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

V. Effects of the Modified System of Records on Individual Rights

    CMS proposes to modify 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.


[[Page 67136]]


    Dated: November 8, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0509

SYSTEM NAME:
    ``Medicare-Cancer Registry Record System (MCR),'' HHS/CMS/ORDI.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    The Centers for Medicare & Medicaid Services (CMS) Data Center, 
7500 Security Boulevard, North Building, First Floor, Baltimore, 
Maryland 21244-1850 and South Building, Baltimore, Maryland 21244-1850.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The system collects and maintains information on Medicare 
beneficiaries diagnosed with cancer in 12 geographic areas of the 
United States.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system collects and maintains data from 12 Surveillance, 
Epidemiology, and End Results (SEER) program cancer registries linked 
with Medicare enrollment and claims data. The areas covered by the 12 
registries are Iowa, Utah, Hawaii, New Mexico, Connecticut, New Jersey, 
California, Louisiana, Kentucky, Atlanta, Detroit, and Western 
Washington State.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for the collection and maintenance of this system is 
given under the provisions of section 1875(a) of the Social Security 
Act (42 United States Code (U.S.C.) 139511(a)) and sections 301 and 
410-416 of the Public Health Service Act (42 U.S.C. 241 and 285-285a-
5).

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of the system of records is to link individual-
level data from the Surveillance, Epidemiology, and End Results (SEER) 
tumor registry system, operated by the National Cancer Institute (NCI), 
with Medicare enrollment and claims data. This linked file will greatly 
enhance CMS's and NCI's ability to understand and evaluate the amount 
and kinds of services received by Medicare beneficiaries contracting 
cancer. Information retrieved from this system of records will also be 
disclosed to: (1) Support regulatory, reimbursement, and policy 
functions performed within the agency or by a contractor, consultant or 
CMS grantee; (2) assist another Federal agency to conduct activities 
related to this system; (3) support research, evaluation, or 
epidemiological projects related to the prevention of disease or 
disability, or the restoration or maintenance of health, and for 
payment related projects; and (4) support litigation involving the 
agency.

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 support agency contractors, consultants, or grantees, who 
have been engaged by the agency to assist in the performance of a 
service related to this collection and who need to have access to the 
records in order to perform the activity.
    2. To assist another Federal or state agency to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. 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, and/or
    c. Evaluate and monitor the amount and kinds of services received 
by Medicare beneficiaries contracting cancer.
    3. To assist an individual or organization for research, evaluation 
or epidemiological projects related to the prevention of disease or 
disability, or the restoration or maintenance of health, and for 
payment related projects.
    4. To support 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.
    B. Additional Provisions Affecting Routine Use Disclosures. To the 
extent this system contains Protected Health Information (PHI) as 
defined by HHS regulation ``Standards for Privacy of Individually 
Identifiable Health Information'' (45 CFR parts 160 and 164, subparts A 
and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are 
otherwise 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'' (See 45 CFR 164-512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, 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 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 on paper and magnetic disk.

RETRIEVABILITY:
    Magnetic media records are retrieved by the name of the employees 
or other authorized individual and/or card key number. Paper records 
are retrieved alphabetically by name.

SAFEGUARDS:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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.

[[Page 67137]]

These laws and regulations may apply 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; the HHS 
Information Systems Program Handbook and the CMS Information Security 
Handbook.

RETENTION AND DISPOSAL:
    Records are maintained in a secure storage area with identifiers as 
long as needed for program research. Records will be disposed 3 years 
after research is completed.

SYSTEM MANAGER AND ADDRESS:
    Director, Division of Health Systems Research, Research and 
Evaluations Group, Office of Research Development and Information.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual should write to the 
system manager who will require the system name, assigned card key 
number, and building/secure area, and for verification purposes, the 
subject individual's name (woman's maiden name, if applicable), and 
SSN. Furnishing the SSN is voluntary, but it may make searching for a 
record easier and prevent delay.

RECORD ACCESS PROCEDURE:
    For purpose of access, use the same procedures outlined in 
Notification Procedures above. Requestors should also specify the 
record contents being sought. (These procedures are in accordance with 
department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above, and reasonably identify the records and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These procedures are in 
accordance with department regulation 45 CFR 5b.7).

RECORDS SOURCE CATEGORIES:
    Surveillance, Epidemiology, and End Results (SEER) program cancer 
registry records and Medicare enrollment and claims files.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. E6-19504 Filed 11-17-06; 8:45 am]
BILLING CODE 4120-03-P