Privacy Act of 1974; Report of a Modified System of Records, 47045-47050 [07-4076]
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47045
Federal Register / Vol. 72, No. 162 / Wednesday, August 22, 2007 / Notices
the forms, their requests for approval are
evaluated. There is no cost to
respondents other than their time to
participate.
Estimated Annualized Burden Hours:
Section name
Data type
Number of respondents
Number of responses per
respondent
Average burden response
(in hours)
84.11 .................................................
84.33 .................................................
84.35 .................................................
84.41 .................................................
84.43 .................................................
84.257 ...............................................
84.1103 .............................................
Total ...........................................
Applications ......................................
Labeling ............................................
Modifications ....................................
Reporting ..........................................
Record Keeping ...............................
Labeling ............................................
Labeling ............................................
...........................................................
43
43
43
43
43
43
43
........................
8
8
8
8
8
8
8
........................
86
2
66
23
46
3
3
........................
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–16591 Filed 8–21–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institute for Occupational
Safety and Health (NIOSH) Advisory
Board on Radiation and Worker Health
(ABRWH or Advisory Board)
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following committee meeting:
Name: Advisory Board on Radiation and
Worker Health, National Institute for
Occupational Safety and Health.
Audio Conference Call Time and Date: 11
a.m.–4 p.m., EST, Tuesday, September 4,
2007.
Place: Audio Conference Call via FTS
Conferencing. The USA toll free dial in
number is 1–866–643–6504 with a pass code
of 9448550.
Status: Open to the public, but without a
public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
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program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to the
CDC. NIOSH implements this responsibility
for CDC. The charter was issued on August
3, 2001, renewed at appropriate intervals,
most recently, August 3, 2007, and will
expire on August 3, 2009.
Purpose: This Advisory Board is charged
with (a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters To Be Discussed: The agenda for
the conference call includes: Report of Board
Member Votes Recorded Since the Last Board
Meeting; Update on Rocky Flats Follow-Up
Actions; Update on SC&A Review of TBD
6000 and General Steel Industries Appendix;
Report on SC&A Contract Talks for FY08;
Discussions of Initial Steps for a Board
Contractor for FY09 and Beyond; Report on
Privacy Act ‘‘Clearance’’ Procedures; Update
on Letters to DOE and DOL on Chapman
Valve; Work Group Updates; Status of and
Plans for Future Board Activities; and Board
Working Time.
The agenda is subject to change as
priorities dictate.
Recommended changes to the agenda from
the Office of General Counsel resulted in the
Federal Register notice being published less
that fifteen days before the date of the
meeting.
Because there is not a public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
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Total burden
hours
29,584
688
22,704
7,912
15,824
1,032
1,032
78,776
and should be submitted to the contact
person below well in advance of the meeting.
Contact Person for More Information: Dr.
Lewis V. Wade, Executive Secretary, NIOSH,
CDC, 4676 Columbia Parkway, Cincinnati,
OH 45226, Telephone 513.533.6825, Fax
513.533.6826.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: August 16, 2007.
Michael Tropauer,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–16557 Filed 8–21–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers For Medicare & Medicaid
Services
Privacy Act of 1974; Report of a
Modified System of Records
Department of Health and
Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
AGENCY:
Notice of a Modified System of
Records (SOR).
ACTION:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we propose to modify an existing
system titled, ‘‘National Emphysema
Treatment Trial (NETT), System No. 09–
70–0531,’’ established at 65 Federal
Register 47995 (August 4, 2000). We
propose to modify existing routine use
number 1 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
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projects or activities that require CMS
data to carry out that activity, are
classified separate from CMS
contractors and/or consultants. The
modified routine use will remain as
routine use number 1. We will delete
routine use number 4 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 will broaden the scope of routine
uses number 5 and 6, authorizing
disclosures to combat fraud and abuse
in the Medicare and Medicaid programs
to include combating ‘‘waste’’ which
refers to specific beneficiary or recipient
practices that result in unnecessary cost
to all federally-funded health benefit
programs. Additionally, we will
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’’ apply
when ever the system collects or
maintain 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 individualspecific 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
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 collect and maintain data
that will allow CMS to provide secure
data on participants in the randomized
phase of the study, pay claims, and to
monitor and evaluate the clinical trial.
Information retrieved from this system
of records will also be disclosed to: (1)
Support regulatory, reimbursement and
policy functions performed within the
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agency or by a contractor, consultant, or
CMS grantee; (2) assist another Federal
or state agency to enable such agency to
administer a Federal health benefits
program, or 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) 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; (4) support
litigation involving the agency; and (5)
combat fraud, waste, and abuse in
certain health benefits programs. We
have provided background information
about the new 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 DATE
section for comment period.
CMS filed a modified
system report with the Chair of the
House Committee on Government
Reform and Oversight, the Chair of the
Senate Committee on Homeland
Security and Governmental Affairs, and
the Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on
August 10, 2007. To ensure that all
parties have adequate time in which to
comment, the modified SOR, including
routine uses, will become effective 40
days from the publication of the notice,
or from the date it was submitted to
OMB and the Congress, whichever is
later, unless CMS receives comments
that require alterations to this notice.
EFFECTIVE DATE:
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, 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.–3 p.m., Eastern Time zone.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Joanna Baldwin, Health Insurance
Specialist, Division of Medical and
Surgical Services, Coverage and
Analysis Group, Office of Clinical
Standards and Quality, CMS, Room C1–
10–25, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850. Her
telephone number is (410) 786–7205.
She can be reached by telephone at 410–
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786–7205 or e-mail
Joanna.Baldwin@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Description of the Proposed System of
Records
A. Statutory and Regulatory Basis for
SOR
The statutory authority for this system
is given under the provisions of Section
1862(a) (1) (A) of the Social Security
Act, and 42 U.S.C. 1395, which states
that Medicare must provide coverage for
items and services that are ‘‘reasonable
and necessary for the diagnosis or
treatment of illness or injury or to
improve the functioning of a malformed
body member.’’
B. Collection and Maintenance of Data
in the System
This system will collect and maintain
individually identifiable and other data
collected on Medicare beneficiaries and
providers participating in the study.
Data will be collected from Medicare
administrative and claims records,
patient medical charts, physician
records, and via survey instruments
administered to beneficiaries and
providers. The collected information
will include, but is not limited to
Medicare claims and eligibility data,
name, address, telephone number,
health insurance claims number, race/
ethnicity, gender, date of birth, provider
name, unique provider identification
number, medical record number, as well
as clinical, demographic, health/wellbeing, family and/or caregiver contact
information, and background
information relating to Medicare issues.
II. Agency Policies, Procedures, and
Restrictions on Routine Uses
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 NETT 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
NETT.
CMS has the following policies and
procedures concerning disclosures of
information that will be maintained in
the system. Disclosure of information
from the system will be approved only
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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
collect and maintain data that will allow
CMS to provide secure data on
participants in the randomized phase of
the study, pay claims, and to monitor
and evaluate the clinical trial.
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.
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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, consultants
or CMS 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
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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, consultant or CMS
grantees 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 CMS grantees from using
or disclosing the information for any
purpose other than that described in the
contract and requires the contractor,
consultant or CMS grantees to return or
destroy all information at the
completion of the contract.
2. To 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. assist Federal/state Medicaid
programs within the state.
Other Federal or state agencies, in
their administration of a Federal health
program, may require NETT information
in order to support evaluations and
monitoring of Medicare claims
information of beneficiaries, including
proper reimbursement for services
provided.
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 NETT data will provide for
research or support of evaluation
projects and a broader, longitudinal,
national perspective of the status of
Medicare beneficiaries. CMS anticipates
that many researchers will have
legitimate requests to use these data in
projects that could ultimately improve
the care provided to Medicare
beneficiaries and the policies that
govern their care.
4. 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
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47047
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.
5. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste, and abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual, grantee, cooperative
agreement or consultant relationship
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud,
waste, and abuse.
CMS occasionally contracts out
certain of its functions or makes grants
or cooperative agreements when doing
so would contribute to effective and
efficient operations. CMS must be able
to give a contractor, grantee, consultant
or other legal agent whatever
information is necessary for the agent to
fulfill its duties. In these situations,
safeguards are provided in the contract
prohibiting the agent from using or
disclosing the information for any
purpose other than that described in the
contract and requiring the agent to
return or destroy all information.
6. 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, waste, 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,
waste, and abuse in such programs.
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Other agencies may require NETT
information for the purpose of
combating fraud, waste, and abuse in
such Federally-funded programs.
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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 of 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 EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
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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 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 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
this 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.
Dated: August 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO.:
09–70–0531.
SYSTEM NAME:
‘‘National Emphysema Treatment
Trial (NETT),’’ HHS/CMS/OCSQ.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
Data.
SYSTEM LOCATION:
CMS Data Center, 7500 Security
Boulevard, North Building, First Floor,
Baltimore, Maryland 21244–1850 and at
various other contractor locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
This system will collect and maintain
individually identifiable and other data
collected on Medicare beneficiaries and
providers participating in the study.
CATEGORIES OF RECORDS IN THE SYSTEM:
Data will be collected from Medicare
administrative and claims records,
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patient medical charts, physician
records, and via survey instruments
administered to beneficiaries and
providers. The collected information
will include, but is not limited to
Medicare claims and eligibility data,
name, address, telephone number,
health insurance claims number, race/
ethnicity, gender, date of birth, provider
name, unique provider identification
number, medical record number, as well
as clinical, demographic, health/wellbeing, family and/or caregiver contact
information, and background
information relating to Medicare issues.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system
is given under the provisions of Section
1862(a)(1)(A) of the Social Security Act,
and 42 U.S.C. 1395, which states that
Medicare must provide coverage for
items and services that are ‘‘reasonable
and necessary for the diagnosis or
treatment of illness or injury or to
improve the functioning of a malformed
body member.’’
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system of
records is to collect and maintain data
that will allow CMS to provide secure
data on participants in the randomized
phase of the study, pay claims, and to
monitor and evaluate the clinical trial.
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
or state agency to enable such agency to
administer a Federal health benefits
program, or 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) 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; (4) support
litigation involving the agency; and (5)
combat fraud, waste, 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
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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, consultants
or CMS 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 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. assist Federal/state Medicaid
programs within the state.
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 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.
5. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste, and abuse in such program.
6. 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
VerDate Aug<31>2005
16:26 Aug 21, 2007
Jkt 211001
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, waste, and abuse in such
programs.
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 electronic
media.
RETRIEVABILITY:
The collected data are retrieved by an
individual identifier; e.g., beneficiary
name or HICN, and unique provider
identification number.
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
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
47049
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 EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: All pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain information for a total
period not to exceed 25 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, Division of Medical and
Surgical Services, Coverage and
Analysis Group, Office of Clinical
Standards and Quality, CMS, Room C4–
10–10, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, employee identification number,
tax identification number, national
provider number, and for verification
purposes, the subject individual’s name
(woman’s maiden name, if applicable),
HICN, and/or 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 reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5 (a)
(2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
E:\FR\FM\22AUN1.SGM
22AUN1
47050
Federal Register / Vol. 72, No. 162 / Wednesday, August 22, 2007 / Notices
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:
The data collected and maintained in
this system are retrieved from Medicare
enrollment records, Medicare
beneficiaries or proxies, and medical
providers (such as physicians, medical
facilities, home health care providers)
for a sample of enrollees.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 07–4076 Filed 8–21–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: National Survey of Child and
Adolescent Well-Being—Second Cohort
(NSCAW II).
OMB No.: 0970–0202.
Description: The Department of
Health and Human Services (HHS)
intends to collect data on a new sample
of children and families for the National
Survey of Child and Adolescent WellBeing (NSCAW). The NSCAW was
authorized under Section 427 of the
Personal Responsibility and Work
Opportunities Reconciliation Act of
1996. The original survey began in
November 1999 with a national sample
of 5,501 children, ages 0–14, who had
been the subject of investigation by
Child Protective Services during the
baseline data collection period, which
extended from November 1999 through
April 2000. Direct assessments and
interviews were conducted with the
children themselves, their primary
caregivers, their caseworkers, and, for
school-aged children, their teachers;
agency directors also were interviewed
at baseline. Follow-up data collections
were conducted 12 months, 18 months,
and 36 months post-baseline, and a fifth
data collection is currently under way.
The NSCAW is the only source of
nationally representative, firsthand
information about the functioning and
well-being, service needs, and service
utilization of children and families who
come to the attention of the child
welfare system. Information is collected
about children’s cognitive, social,
emotional, behavioral, and adaptive
functioning, as well as family and
community factors that are likely to
influence their functioning. Family
service needs and service utilization
also are addressed in the data collection.
The current data collection plan calls
for selecting a new cohort of 5,700
children and families and repeating the
data collection procedures used in the
original study. Selection of a new cohort
will allow the comparison of
characteristics of children who are
entering the child welfare system today
with those who entered prior to the
implementation of the Adoption and
Safe Families Act and prior to the
advent of the Child and Family Services
Review process. The data collection will
follow the same format as that used in
previous rounds of data collection, and
will employ, with only modest
revisions, the same instruments that
have been used in previous rounds.
Currently, HHS intends to collect
baseline data and one follow-up 18
months later, with future follow-up
rounds contingent on funding
availability. Data from NSCAW are
made available to the research
community through licensing
arrangements from the National Data
Archive on Child Abuse and Neglect at
Cornell University.
Respondents: 5,700 Children and
their associated permanent or foster
caregivers, caseworkers, and teachers; in
addition, an administrator will be
interviewed in each location from
which children are sampled.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
jlentini on PROD1PC65 with NOTICES
Child Interview ...............................................................................................
Permanent Caregiver Interview .....................................................................
Foster Caregiver Interview ............................................................................
Caseworker Interview ....................................................................................
Teacher Questionnaire ..................................................................................
Agency Questionnaire ...................................................................................
Estimated Total Annual Burden
Hours: 25,472.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
VerDate Aug<31>2005
16:26 Aug 21, 2007
Jkt 211001
Number of
responses per
respondent
5,700
3,800
1,990
5,700
3,000
97
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
Average
burden hours
per response
1
1
1
1
1
1
1.2
2.0
1.5
1.0
.75
1.0
Total burden
hours
6,840
7,600
2,985
5,700
2,250
97
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: August 15, 2007.
Brendan C. Kelly,
Reports Clearance Officer.
[FR Doc. 07–4110 Filed 8–21–07; 8:45 am]
BILLING CODE 4184–07–M
E:\FR\FM\22AUN1.SGM
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Agencies
[Federal Register Volume 72, Number 162 (Wednesday, August 22, 2007)]
[Notices]
[Pages 47045-47050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4076]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers For Medicare & Medicaid Services
Privacy Act of 1974; Report of a Modified System of Records
AGENCY: Department of Health and Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a Modified System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we propose to modify an existing system titled, ``National
Emphysema Treatment Trial (NETT), System No. 09-70-0531,'' established
at 65 Federal Register 47995 (August 4, 2000). We propose to modify
existing routine use number 1 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
[[Page 47046]]
projects or activities that require CMS data to carry out that
activity, are classified separate from CMS contractors and/or
consultants. The modified routine use will remain as routine use number
1. We will delete routine use number 4 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 will broaden the scope of routine uses number 5 and 6,
authorizing disclosures to combat fraud and abuse in the Medicare and
Medicaid programs to include combating ``waste'' which refers to
specific beneficiary or recipient practices that result in unnecessary
cost to all federally-funded health benefit programs. Additionally, we
will 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'' apply
when ever the system collects or maintain 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 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 collect and
maintain data that will allow CMS to provide secure data on
participants in the randomized phase of the study, pay claims, and to
monitor and evaluate the clinical trial. 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 or state agency to enable such agency to administer a
Federal health benefits program, or 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)
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; (4) support
litigation involving the agency; and (5) combat fraud, waste, and abuse
in certain health benefits programs. We have provided background
information about the new 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 DATE section for comment period.
EFFECTIVE DATE: CMS filed a modified system report with the Chair of
the House Committee on Government Reform and Oversight, the Chair of
the Senate Committee on Homeland Security and Governmental Affairs, and
the Administrator, Office of Information and Regulatory Affairs, Office
of Management and Budget (OMB) on August 10, 2007. To ensure that all
parties have adequate time in which to comment, the modified SOR,
including routine uses, will become effective 40 days from the
publication of the notice, or from the date it was submitted to OMB and
the 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, 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.-3 p.m.,
Eastern Time zone.
FOR FURTHER INFORMATION CONTACT: Joanna Baldwin, Health Insurance
Specialist, Division of Medical and Surgical Services, Coverage and
Analysis Group, Office of Clinical Standards and Quality, CMS, Room C1-
10-25, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Her
telephone number is (410) 786-7205. She can be reached by telephone at
410-786-7205 or e-mail Joanna.Baldwin@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under the
provisions of Section 1862(a) (1) (A) of the Social Security Act, and
42 U.S.C. 1395, which states that Medicare must provide coverage for
items and services that are ``reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member.''
B. Collection and Maintenance of Data in the System
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries and providers
participating in the study. Data will be collected from Medicare
administrative and claims records, patient medical charts, physician
records, and via survey instruments administered to beneficiaries and
providers. The collected information will include, but is not limited
to Medicare claims and eligibility data, name, address, telephone
number, health insurance claims number, race/ethnicity, gender, date of
birth, provider name, unique provider identification number, medical
record number, as well as clinical, demographic, health/well-being,
family and/or caregiver contact information, and background information
relating to Medicare issues.
II. Agency Policies, Procedures, and Restrictions on Routine Uses
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 NETT 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 NETT.
CMS has the following policies and procedures concerning
disclosures of information that will be maintained in the system.
Disclosure of information from the system will be approved only
[[Page 47047]]
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 collect and maintain
data that will allow CMS to provide secure data on participants in the
randomized phase of the study, pay claims, and to monitor and evaluate
the clinical trial.
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, consultants or CMS 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 would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant or CMS grantees 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 CMS grantees from
using or disclosing the information for any purpose other than that
described in the contract and requires the contractor, consultant or
CMS grantees to return or destroy all information at the completion of
the contract.
2. To 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. assist Federal/state Medicaid programs within the state.
Other Federal or state agencies, in their administration of a
Federal health program, may require NETT information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
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 NETT data will provide for research or support of evaluation
projects and a broader, longitudinal, national perspective of the
status of Medicare beneficiaries. CMS anticipates that many researchers
will have legitimate requests to use these data in projects that could
ultimately improve the care provided to Medicare beneficiaries and the
policies that govern their care.
4. 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.
5. 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, waste, and abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud, waste, and abuse.
CMS occasionally contracts out certain of its functions or makes
grants or cooperative agreements when doing so would contribute to
effective and efficient operations. CMS must be able to give a
contractor, grantee, consultant or other legal agent whatever
information is necessary for the agent to fulfill its duties. In these
situations, safeguards are provided in the contract prohibiting the
agent from using or disclosing the information for any purpose other
than that described in the contract and requiring the agent to return
or destroy all information.
6. 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,
waste, 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, waste, and abuse in such programs.
[[Page 47048]]
Other agencies may require NETT information for the purpose of
combating fraud, waste, and abuse in such Federally-funded programs.
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 of
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 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 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 this 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.
Dated: August 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
System No.:
09-70-0531.
System Name:
``National Emphysema Treatment Trial (NETT),'' HHS/CMS/OCSQ.
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850 and at various other contractor
locations.
Categories of Individuals Covered By the System:
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries and providers
participating in the study.
Categories of Records In the System:
Data will be collected from Medicare administrative and claims
records, patient medical charts, physician records, and via survey
instruments administered to beneficiaries and providers. The collected
information will include, but is not limited to Medicare claims and
eligibility data, name, address, telephone number, health insurance
claims number, race/ethnicity, gender, date of birth, provider name,
unique provider identification number, medical record number, as well
as clinical, demographic, health/well-being, family and/or caregiver
contact information, and background information relating to Medicare
issues.
Authority For Maintenance of the System:
The statutory authority for this system is given under the
provisions of Section 1862(a)(1)(A) of the Social Security Act, and 42
U.S.C. 1395, which states that Medicare must provide coverage for items
and services that are ``reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member.''
Purpose(s) of the System:
The primary purpose of the system of records is to collect and
maintain data that will allow CMS to provide secure data on
participants in the randomized phase of the study, pay claims, and to
monitor and evaluate the clinical trial. 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 or state agency to enable such agency to administer a
Federal health benefits program, or 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)
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; (4) support
litigation involving the agency; and (5) combat fraud, waste, 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
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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, consultants or CMS 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 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. assist Federal/state Medicaid programs within the state.
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 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.
5. 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, waste, and abuse in such program.
6. 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, waste, and abuse in such programs.
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 electronic media.
Retrievability:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HICN, and unique provider identification number.
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.
Retention and Disposal:
CMS will retain information for a total period not to exceed 25
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, Division of Medical and Surgical Services, Coverage and
Analysis Group, Office of Clinical Standards and Quality, CMS, Room C4-
10-10, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Notification Procedure:
For purpose of access, the subject individual should write to the
system manager who will require the system name, employee
identification number, tax identification number, national provider
number, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable), HICN, and/or 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 reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5 (a) (2).)
Contesting Record Procedures:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested.
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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:
The data collected and maintained in this system are retrieved from
Medicare enrollment records, Medicare beneficiaries or proxies, and
medical providers (such as physicians, medical facilities, home health
care providers) for a sample of enrollees.
Systems Exempted From Certain Provisions of the Act:
None.
[FR Doc. 07-4076 Filed 8-21-07; 8:45 am]
BILLING CODE 4120-03-P