[Federal Register: November 20, 2006 (Volume 71, Number 223)]
[Notices]
[Page 67133-67137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no06-67]
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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
gerald.riley@cms.hhs.gov.
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