Privacy Act of 1974; Report of a New System of Records, 72733-72737 [E7-24788]
Download as PDF
Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices
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
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 will be retained for a period
of 10 years after the demonstration and
evaluation project has completed. 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 Advocacy and
Special Initiatives, Disabled and Elderly
Health Programs Group, Center for
Medicaid and State Operations, Mail
Stop S2–14–26, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244–1849.
NOTIFICATION PROCEDURE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, 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).
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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
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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.
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:
Data will be collected from Medicaid
administrative and claims records, and
from grantee progress reports.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–24786 Filed 12–20–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers For Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of a New System of
Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
system titled, ‘‘Home and CommunityBased Alternatives (CBA) to Psychiatric
Residential Treatment Facilities (PRTF)
Demonstration (CBA–PRTF), System
No. 09–70–0594.’’ The demonstration,
created by section 6063 of the Deficit
Reduction Act of 2005 (Pub. L. 109–
171), allows up to 10 states (as defined
for purposes of title XIX of the Social
Security Act (the Act)) to provide home
and community-based services to youth
as alternatives to PRTFs. The purpose of
the demonstration is to test the
effectiveness in improving or
maintaining a child’s functional level
and cost effectiveness of providing
coverage of home and community-based
alternatives to psychiatric residential
treatment for children enrolled in the
Medicaid program under title XIX of the
Act.
The purpose of this system is to
collect and maintain individually
identifiable information on Medicaid
recipients, and providers of services
who voluntarily participate in the
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72733
national evaluation of the CBA–PRTF.
Information retrieved from this system
may be disclosed to: (1) Support
regulatory, reimbursement, and policy
functions performed within the agency
or by a contractor, grantee, or
consultant; (2) assist another Federal or
state agency with information to
contribute to the accuracy of CMS’s
proper payment of Medicaid benefits,
enable such agency to administer a
Federal health benefits program, or to
enable such agency to fulfill a
requirement of Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support litigation
involving the agency; and (5) combat
fraud, waste, and abuse in certain
Federally-funded 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
Dates’’ section for comment period.
DATES: Effective Date: CMS filed a new
SOR report with the Chair of the House
Committee on Government Reform and
Oversight, the Chair of the Senate
Committee on Homeland Security &
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on
December 14, 2007. To ensure that all
parties have adequate time in which to
comment, the new system will become
effective 30 days from the publication of
the notice, or 40 days from the date it
was submitted to OMB and the
Congress, whichever is later. We may
defer implementation of this system or
one or more of the routine use
statements listed below if we receive
comments that persuade us to defer
implementation.
ADDRESSES: The public should address
comments to the CMS Privacy Officer,
Division of Privacy Compliance,
Enterprise Architecture and Strategy
Group, Mail-stop N2–04–27, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850. Comments
received will be available for review at
this location by appointment during
regular business hours, Monday through
Friday from 9 a.m.–3 p.m., eastern time.
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices
Effie
Shockley, Division of Advocacy and
Special Initiatives, Disabled and Elderly
Health Programs Group, Center for
Medicaid and State Operations, Mail
Stop S2–14–26, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244–1849.
She can be reached by telephone at 410–
786–8639, or via e-mail at
Effie.Shockley@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
demonstration, created by section 6063
of the Deficit Reduction Act of 2005
(Pub. L. 109–171), allows up to 10 states
(as defined for purposes of title XIX of
the Act) to provide home and
community-based services to youth as
alternatives to PRTFs. The purpose of
the demonstration is to test the
effectiveness in improving or
maintaining a child’s functional level
and cost effectiveness of providing
coverage of home and community-based
alternatives to psychiatric residential
treatment for children enrolled in the
Medicaid program under title XIX of the
Act. Participating states will acquire
approved functional outcomes on
participants across the following life
domains: community living, school
functioning, juvenile justice, family
functioning, alcohol and other drug use,
mental health, social support, program
satisfaction and environmental
variables. The overall evaluation must
directly address the two primary
questions posed in the statutes: Does the
provision of home and communitybased services to youth under this
demonstration (1) result in the
maintenance or improvement in a
child’s functional status; and (2) on
average, cost no more than anticipated
aggregate PRTF expenditures in the
absence of the demonstration?
FOR FURTHER INFORMATION CONTACT:
I. Description of the Proposed System of
Records
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A. Statutory and Regulatory Basis for
SOR
The statutory authority for this system
is given under Section 6063 of the
Deficit Reduction Act of 2005.
B. Collection and Maintenance of Data
in the System
This system will collect and maintain
individually identifiable and other data
collected on Medicaid recipients, and
providers of services who voluntarily
participate in the national evaluation of
the CBA–PRTF. The collected
information will include, but is not
limited to: name, address, telephone
number, health insurance claims
number, race/ethnicity, gender, date of
birth, patient medical charts, physician
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Jkt 214001
records, community living, school
functioning, juvenile justice activity,
alcohol and other drug use, mental
health, social support, family
functioning outcomes, program
satisfaction and changes in the patient’s
environment.
II. Agency Policies, Procedures, and
Restrictions on the 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 CBA–PRTF 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 CBA–PRTF.
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
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 individually
identifiable information on Medicaid
recipients, and providers of services
who voluntarily participate in the
national evaluation of the CBA–PRTF.
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
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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 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
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 another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicaid 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 CBA–PRTF
information in order to support
evaluations and monitoring of Medicaid
claims information of beneficiaries,
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices
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 CBA–PRTF data will provide for
research or support of evaluation
projects and a broader, longitudinal,
national perspective of the status of
Medicaid beneficiaries. CMS anticipates
that researchers may have legitimate
requests to use these data in projects
that could ultimately improve the care
provided to Medicaid 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 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
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Jkt 214001
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, or abuse in such programs.
Other agencies may require CBA–
PRTF 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 Fed. Reg.
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
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72735
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
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 Proposed System of
Records on Individual Rights
CMS proposes to establish this system
in accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
Data in this system will be subject to the
authorized releases in accordance with
the routine uses identified in this
system of records.
CMS will take precautionary
measures 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.
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices
Dated: December 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO. 09–70–0594
SYSTEM NAME:
• ‘‘Home and Community-Based
Alternatives (CBA) to Psychiatric
Residential Treatment Facilities (PRTF)
Demonstration (CBA–PRTF),’’ HHS/
CMS/CMM.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid
Services (CMS) Data Center, 7500
Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244–
1850 and at various co-locations of CMS
agents.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
This system will collect and maintain
individually identifiable and other data
collected on Medicaid recipients, and
providers of services who voluntarily
participate in the national evaluation of
the CBA–PRTF.
CATEGORIES OF RECORDS IN THE SYSTEM:
The collected information will
include, but is not limited to: name,
address, telephone number, health
insurance claims number (HICN), race/
ethnicity, gender, date of birth, patient
medical charts, physician records,
community living, school functioning,
juvenile justice activity, alcohol and
other drug use, mental health, social
support, family functioning outcomes,
program satisfaction and changes in the
patient’s environment.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system
is given under Section 6063 of the
Deficit Reduction Act of 2005.
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PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to
collect and maintain individually
identifiable information on Medicaid
recipients, and providers of services
who voluntarily participate in the
national evaluation of the CBA–PRTF.
Information retrieved from this system
may be disclosed to: (1) Support
regulatory, reimbursement, and policy
functions performed within the agency
or by a contractor, grantee, or
consultant; (2) assist another Federal or
state agency with information to
contribute to the accuracy of CMS’s
proper payment of Medicaid benefits,
enable such agency to administer a
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Jkt 214001
Federal health benefits program, or to
enable such agency to fulfill a
requirement of Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support litigation
involving the agency; and (5) combat
fraud, waste, and abuse in certain
Federally-funded health benefits
programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To agency contractors, 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 another Federal or state agency
to:
a. contribute to the accuracy of CMS’s
proper payment of Medicaid 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
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Fmt 4703
Sfmt 4703
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
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, or 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 Fed. Reg. 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).
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
SYSTEM MANAGER AND ADDRESS:
Director, Division of Advocacy and
Special Initiatives, Disabled and Elderly
Health Programs Group, Center for
Medicaid and State Operations, Mail
Stop S2–14–26, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244–1849.
STORAGE:
All records are stored on electronic
media.
RETRIEVABILITY:
The collected data are retrieved by the
name or other identifying information of
the participating provider or
beneficiary, and may be retrieved by a
distinct identifier such as the HICN, at
the individual beneficiary level.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations 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.
mstockstill on PROD1PC66 with NOTICES
Records will be retained for a period
of 10 years after the demonstration and
evaluation project has completed. All
claims-related records are encompassed
by the document preservation order and
will be retained until notification is
received from DOJ.
18:37 Dec 20, 2007
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, 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.
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:
Data will be collected from Medicaid
administrative and claims records,
patient medical charts, and physician
records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–24788 Filed 12–20–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
RETENTION AND DISPOSAL:
VerDate Aug<31>2005
NOTIFICATION PROCEDURE:
Jkt 214001
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
72737
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on February 20, 2008, from 8 a.m
to 5 p.m.
Location: National Labor College,
Lane Kirkland Center, Solidarity Hall,
10000 New Hampshire Avenue, Silver
Spring, MD, 301–431–6400.
Contact Person: Teresa A. Watkins,
Center for Drug Evaluation and
Research, HFD–21, Food and Drug
Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane,
Rm. 1093) Rockville, MD 20857, 301–
827–7001, fax: 301–827–6776, e-mail:
teresa.watkins@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512545. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
the new drug application (NDA) 22–150,
icatibant solution for injection
(proposed tradename FIRAZYR), by
Jerini, for the proposed indication of
treatment of attacks of hereditary
angioedema.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 5, 2008.
Oral presentations from the public will
be scheduled between approximately
12:30 p.m. and 1:30 p.m. Those desiring
to make formal oral presentations
E:\FR\FM\21DEN1.SGM
21DEN1
Agencies
[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72733-72737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers For Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of a New System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled, ``Home and
Community-Based Alternatives (CBA) to Psychiatric Residential Treatment
Facilities (PRTF) Demonstration (CBA-PRTF), System No. 09-70-0594.''
The demonstration, created by section 6063 of the Deficit Reduction Act
of 2005 (Pub. L. 109-171), allows up to 10 states (as defined for
purposes of title XIX of the Social Security Act (the Act)) to provide
home and community-based services to youth as alternatives to PRTFs.
The purpose of the demonstration is to test the effectiveness in
improving or maintaining a child's functional level and cost
effectiveness of providing coverage of home and community-based
alternatives to psychiatric residential treatment for children enrolled
in the Medicaid program under title XIX of the Act.
The purpose of this system is to collect and maintain individually
identifiable information on Medicaid recipients, and providers of
services who voluntarily participate in the national evaluation of the
CBA-PRTF. Information retrieved from this system may be disclosed to:
(1) Support regulatory, reimbursement, and policy functions performed
within the agency or by a contractor, grantee, or consultant; (2)
assist another Federal or state agency with information to contribute
to the accuracy of CMS's proper payment of Medicaid benefits, enable
such agency to administer a Federal health benefits program, or to
enable such agency to fulfill a requirement of Federal statute or
regulation that implements a health benefits program funded in whole or
in part with Federal funds; (3) support an individual or organization
for a research project or in support of an evaluation project related
to the prevention of disease or disability, the restoration or
maintenance of health, or payment related projects; (4) support
litigation involving the agency; and (5) combat fraud, waste, and abuse
in certain Federally-funded 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 Dates'' section for comment period.
DATES: Effective Date: CMS filed a new SOR report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Homeland Security & Governmental Affairs, and the
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB) on December 14, 2007. To ensure that all
parties have adequate time in which to comment, the new system will
become effective 30 days from the publication of the notice, or 40 days
from the date it was submitted to OMB and the Congress, whichever is
later. We may defer implementation of this system or one or more of the
routine use statements listed below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address comments to the CMS Privacy
Officer, Division of Privacy Compliance, Enterprise Architecture and
Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. Comments received will be available for review at
this location by appointment during regular business hours, Monday
through Friday from 9 a.m.-3 p.m., eastern time.
[[Page 72734]]
FOR FURTHER INFORMATION CONTACT: Effie Shockley, Division of Advocacy
and Special Initiatives, Disabled and Elderly Health Programs Group,
Center for Medicaid and State Operations, Mail Stop S2-14-26, Centers
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
MD 21244-1849. She can be reached by telephone at 410-786-8639, or via
e-mail at Effie.Shockley@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The demonstration, created by section 6063
of the Deficit Reduction Act of 2005 (Pub. L. 109-171), allows up to 10
states (as defined for purposes of title XIX of the Act) to provide
home and community-based services to youth as alternatives to PRTFs.
The purpose of the demonstration is to test the effectiveness in
improving or maintaining a child's functional level and cost
effectiveness of providing coverage of home and community-based
alternatives to psychiatric residential treatment for children enrolled
in the Medicaid program under title XIX of the Act. Participating
states will acquire approved functional outcomes on participants across
the following life domains: community living, school functioning,
juvenile justice, family functioning, alcohol and other drug use,
mental health, social support, program satisfaction and environmental
variables. The overall evaluation must directly address the two primary
questions posed in the statutes: Does the provision of home and
community-based services to youth under this demonstration (1) result
in the maintenance or improvement in a child's functional status; and
(2) on average, cost no more than anticipated aggregate PRTF
expenditures in the absence of the demonstration?
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under Section 6063
of the Deficit Reduction Act of 2005.
B. Collection and Maintenance of Data in the System
This system will collect and maintain individually identifiable and
other data collected on Medicaid recipients, and providers of services
who voluntarily participate in the national evaluation of the CBA-PRTF.
The collected information will include, but is not limited to: name,
address, telephone number, health insurance claims number, race/
ethnicity, gender, date of birth, patient medical charts, physician
records, community living, school functioning, juvenile justice
activity, alcohol and other drug use, mental health, social support,
family functioning outcomes, program satisfaction and changes in the
patient's environment.
II. Agency Policies, Procedures, and Restrictions on the 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 CBA-PRTF 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 CBA-PRTF.
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 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
individually identifiable information on Medicaid recipients, and
providers of services who voluntarily participate in the national
evaluation of the CBA-PRTF.
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 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 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 another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicaid
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 CBA-PRTF information in order to
support evaluations and monitoring of Medicaid claims information of
beneficiaries,
[[Page 72735]]
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 CBA-PRTF data will provide for research or support of
evaluation projects and a broader, longitudinal, national perspective
of the status of Medicaid beneficiaries. CMS anticipates that
researchers may have legitimate requests to use these data in projects
that could ultimately improve the care provided to Medicaid
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, or abuse in such programs.
Other agencies may require CBA-PRTF 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 Fed. Reg. 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 Proposed System of Records on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will take precautionary measures 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.
[[Page 72736]]
Dated: December 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0594
SYSTEM NAME:
``Home and Community-Based Alternatives (CBA) to
Psychiatric Residential Treatment Facilities (PRTF) Demonstration (CBA-
PRTF),'' HHS/CMS/CMM.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850 and at various co-locations of CMS agents.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
This system will collect and maintain individually identifiable and
other data collected on Medicaid recipients, and providers of services
who voluntarily participate in the national evaluation of the CBA-PRTF.
CATEGORIES OF RECORDS IN THE SYSTEM:
The collected information will include, but is not limited to:
name, address, telephone number, health insurance claims number (HICN),
race/ethnicity, gender, date of birth, patient medical charts,
physician records, community living, school functioning, juvenile
justice activity, alcohol and other drug use, mental health, social
support, family functioning outcomes, program satisfaction and changes
in the patient's environment.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system is given under Section 6063
of the Deficit Reduction Act of 2005.
PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to collect and maintain individually
identifiable information on Medicaid recipients, and providers of
services who voluntarily participate in the national evaluation of the
CBA-PRTF. Information retrieved from this system may be disclosed to:
(1) Support regulatory, reimbursement, and policy functions performed
within the agency or by a contractor, grantee, or consultant; (2)
assist another Federal or state agency with information to contribute
to the accuracy of CMS's proper payment of Medicaid benefits, enable
such agency to administer a Federal health benefits program, or to
enable such agency to fulfill a requirement of Federal statute or
regulation that implements a health benefits program funded in whole or
in part with Federal funds; (3) support an individual or organization
for a research project or in support of an evaluation project related
to the prevention of disease or disability, the restoration or
maintenance of health, or payment related projects; (4) support
litigation involving the agency; and (5) combat fraud, waste, and abuse
in certain Federally-funded health benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, 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 another Federal or state agency to:
a. contribute to the accuracy of CMS's proper payment of Medicaid
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,
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, or 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 Fed. Reg. 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).
[[Page 72737]]
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 the name or other identifying
information of the participating provider or beneficiary, and may be
retrieved by a distinct identifier such as the HICN, at the individual
beneficiary level.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations 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 will be retained for a period of 10 years after the
demonstration and evaluation project has completed. 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 Advocacy and Special Initiatives, Disabled
and Elderly Health Programs Group, Center for Medicaid and State
Operations, Mail Stop S2-14-26, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, MD 21244-1849.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager who will require the system name, 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. 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:
Data will be collected from Medicaid administrative and claims
records, patient medical charts, and physician records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E7-24788 Filed 12-20-07; 8:45 am]
BILLING CODE 4120-03-P