Privacy Act of 1974; Report of a New System of Records, 41807-41811 [E6-11637]
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Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Department of Health and
Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of
Records (SOR).
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AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
system titled, ‘‘Medicare Lifestyle
Modification Program (MLMP)
Demonstration, System No. 09–70–
0585.’’ The program is mandated by the
Consolidated Appropriations Act of
2001 (Public Law (Pub. L.) 106–554).
The MLMP Demonstration and
evaluation will test the feasibility and
cost effectiveness of proven and
intensive programs designed to reduce
or reverse the progression of
cardiovascular disease of patients at risk
for invasive treatment procedures. The
programs may reduce the incidence of
hospitalizations and invasive
procedures among patients with
substantial coronary occlusion.
The purpose of this system is to
collect and maintain demographic and
health related data on the target
population of Medicare beneficiaries
who are potential participants in the
MLMP Demonstration. We will also
collect certain identifying information
on Medicare providers who provide
services to such beneficiaries.
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, consultant or
other legal agent; (2) assist another
Federal or state agency with information
to contribute to the accuracy of CMS’s
proper payment of Medicare 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) assist
Quality Improvement Organizations; (4)
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; (5) support
litigation involving the agency; and (6)
combat fraud and abuse in certain
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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.
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 July
17, 2006. 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
comment to the CMS Privacy Officer,
Mail-stop N2–04–27, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. Comments received will be
available for review at this location by
appointment during regular business
hours, Monday through Friday from 9
a.m.–3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT:
Armen Thoumaian, Division of Health
Promotion & Disease Prevention
Demonstrations, Medicare
Demonstrations Program Group, Office
of Research, Development &
Information, Mail Stop S3–02–01,
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1849. He can be
reached by telephone at 410–786–6672,
or via e-mail at
Armen.Thoumaian@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
program is mandated by the
Consolidated Appropriations Act of
2001 (Public Law (Pub. L.) 106–554).
The MLMP demonstration and
evaluation will test the feasibility and
cost effectiveness of proven and
intensive programs designed to reduce
or reverse the progression of
cardiovascular disease of patients at risk
for invasive treatment procedures.
Research has provided evidence that
specific lifestyle changes can lead to a
decrease in the levels of cardiovascular
risk factors, resulting in lower morbidity
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and mortality associated with coronary
artery disease. Lifestyle modification
programs are increasingly becoming an
approach to the secondary prevention of
coronary disease morbidity. The
programs may reduce the incidence of
hospitalizations and invasive
procedures among patients with
substantial coronary occlusion.
Medicare currently pays for 12 weeks
of cardiac rehabilitation services for
Medicare patients who have a prior
diagnosis of myocardial infarction or
who have had a recent cardiac
revascularization procedure or both.
Coverage under the Medicare cardiac
rehabilitation benefit is more limited
than that contained in a comprehensive
lifestyle modification program. We are
investigating the benefits of coverage a
complete package of services offered
under an established, multi-site lifestyle
modification program.
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
the Consolidated Appropriations Act of
2001 (Public Law (Pub. L.) 106–554).
B. Collection and Maintenance of
Data in the System. This system will
collect and maintain individually
identifiable and other data collected on
Medicare beneficiaries who are
potential participants in the MLMP and
providers who provide services to such
beneficiaries. 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. It will also include
treatment, program participation, and
evaluation, survey, and research
information needed to evaluate the
program and develop research reports
on findings.
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
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which the information was collected.
Any such disclosure of data is known as
a ‘‘routine use.’’ The Government will
only release MLMP 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
MLMP.
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 demographic and
health related data on the target
population of Medicare beneficiaries
who are potential participants in the
MLMP Demonstration. We will also
collect certain identifying information
on Medicare providers who provide
services to such beneficiaries.
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
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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 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 MLMP
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper reimbursement for
services provided.
3. To assist Quality Improvement
Organizations (QIO) in connection with
the review of claims, or in connection
with studies or other review activities,
conducted pursuant to Part B of Title XI
of the Act and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
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QIOs will work to implement quality
improvement programs, provide
consultation to CMS, its contractors,
and to ensure that payment is only
made for medically necessary services.
QIOs will assist in related monitoring
and enforcement efforts, assist CMS and
intermediaries in program integrity
assessment, investigate beneficiary
complaints about quality of care, and
prepare summary information for
release to CMS.
4. 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 MLMP 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.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government,
is a party to litigation or has an interest
in such litigation, and, by careful
review, CMS determines that the
records are both relevant and necessary
to the litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, and occasionally when
another party is involved in litigation
and CMS policies or operations could be
affected by the outcome of the litigation,
CMS would be able to disclose
information to the DOJ, court or
adjudicatory body involved.
6. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a 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,
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remedy, or otherwise combat fraud or
abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual, grantee, cooperative
agreement or consultant relationship
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud and
abuse. CMS occasionally contracts out
certain of its functions 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.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
Other agencies may require MLMP
information for the purpose of
combating fraud 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
because of the small size, use of this
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information could allow for the
deduction of the identity of the
beneficiary).
IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations 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
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41809
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: July 14, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO. 09–70–0585
SYSTEM NAME:
‘‘Medicare Lifestyle Modification
Program (MLMP) Demonstration,’’ HHS/
CMS/ORDI.
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 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 Medicare beneficiaries who
are potential participants in the MLMP
Demonstration and providers who
provide services to such beneficiaries.
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/wellbeing, family and/or caregiver contact
information, and background
information relating to Medicare issues.
It will also include treatment, program
participation, and evaluation, survey,
and research information needed to
evaluate the program and develop
research reports on findings.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system
is given under the provisions of the
Consolidated Appropriations Act of
2001 (Public Law (Pub. L.) 106–554).
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PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to
collect and maintain demographic and
health related data on the target
population of Medicare beneficiaries
who are potential participants in the
MLMP Demonstration. We will also
collect certain identifying information
on Medicare providers who provide
services to such beneficiaries.
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, consultant or
other legal agent; (2) assist another
Federal or state agency with information
to contribute to the accuracy of CMS’s
proper payment of Medicare 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) assist
Quality Improvement Organizations; (4)
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; (5) support
litigation involving the agency; and (6)
combat fraud and abuse in certain
Federally-funded health benefits
programs.
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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 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
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benefits program funded in whole or in
part with Federal funds; and/or
c. Assist Federal/state Medicaid
programs within the state.
3. To assist Quality Improvement
Organizations (QIO) in connection with
the review of claims, or in connection
with studies or other review activities,
conducted pursuant to Part B of Title XI
of the Act and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
4. 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.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government, is
a party to litigation or has an interest in
such litigation, and, by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
6. 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 or
abuse in such program.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
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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
because of the small size, use of this
information could allow for the
deduction of 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.
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
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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, Office of Research,
Development & Information, Mail Stop
S3–02–01, 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, 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)).
sroberts on PROD1PC70 with NOTICES
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 Medicare
administrative and claims records,
patient medical charts, physician
VerDate Aug<31>2005
17:54 Jul 21, 2006
Jkt 208001
records, and via survey instruments
administered to beneficiaries and
providers.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E6–11637 Filed 7–21–06; 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, ‘‘Medicare Care
Management for High Cost Beneficiaries
(CMHCB), System No. 09–70–0580.’’
The program is authorized under
provisions of the Social Security Act (42
U.S.C. Section 1395b–1(a)), which gives
the Secretary the broad authority to,
‘develop and engage in experiments and
demonstration projects.’ The CMHCB
program seeks to improve beneficiary
self-care and provide beneficiaries and
their providers enhanced information
and support in order to increase
adherence to evidence-based care.
Improvements in these areas are
expected to generate savings to the
Medicare program to offset the costs of
the payments. Each CMHCB program is
an experimental design involving
assignment of beneficiaries to either an
intervention or control group.
The purpose of this system is to
collect and maintain demographic and
health related data on the target
population of Medicare beneficiaries
who are potential participants in the
CMHCB program. We will also collect
certain identifying information on
Medicare providers who provide
services to such beneficiaries.
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, consultant or
other legal agent; (2) assist another
Federal or state agency with information
to contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
enable such agency to administer a
Federal health benefits program, or to
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
41811
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 and abuse in certain Federallyfunded 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.
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 July
17, 2006. 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
comment to the CMS Privacy Officer,
Mail-stop N2–04–27, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. Comments received will be
available for review at this location by
appointment during regular business
hours, Monday through Friday from 9
a.m.–3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT:
Melissa Dehn, Division of Chronic Care
Improvement Programs, Provider Billing
Group, Center for Medicare
Management, Mail Stop C4–10–07,
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1849. She can be
reached by telephone at 410–786–5721,
or via e-mail at
Melissa.Dehn@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
CMHCB program pays monthly fees to
CMHCB sites for improving the
coordination of Medicare services
E:\FR\FM\24JYN1.SGM
24JYN1
Agencies
[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41807-41811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11637]
[[Page 41807]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
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, ``Medicare
Lifestyle Modification Program (MLMP) Demonstration, System No. 09-70-
0585.'' The program is mandated by the Consolidated Appropriations Act
of 2001 (Public Law (Pub. L.) 106-554). The MLMP Demonstration and
evaluation will test the feasibility and cost effectiveness of proven
and intensive programs designed to reduce or reverse the progression of
cardiovascular disease of patients at risk for invasive treatment
procedures. The programs may reduce the incidence of hospitalizations
and invasive procedures among patients with substantial coronary
occlusion.
The purpose of this system is to collect and maintain demographic
and health related data on the target population of Medicare
beneficiaries who are potential participants in the MLMP Demonstration.
We will also collect certain identifying information on Medicare
providers who provide services to such beneficiaries. 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, consultant or other legal agent; (2) assist
another Federal or state agency with information to contribute to the
accuracy of CMS's proper payment of Medicare 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) assist Quality Improvement Organizations; (4)
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; (5) support litigation involving the agency; and (6)
combat fraud 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.
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 July 17, 2006. 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 comment to the CMS Privacy
Officer, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. Comments received will be available for review at
this location by appointment during regular business hours, Monday
through Friday from 9 a.m.-3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT: Armen Thoumaian, Division of Health
Promotion & Disease Prevention Demonstrations, Medicare Demonstrations
Program Group, Office of Research, Development & Information, Mail Stop
S3-02-01, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244-1849. He can be reached by telephone at
410-786-6672, or via e-mail at Armen.Thoumaian@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The program is mandated by the Consolidated
Appropriations Act of 2001 (Public Law (Pub. L.) 106-554). The MLMP
demonstration and evaluation will test the feasibility and cost
effectiveness of proven and intensive programs designed to reduce or
reverse the progression of cardiovascular disease of patients at risk
for invasive treatment procedures. Research has provided evidence that
specific lifestyle changes can lead to a decrease in the levels of
cardiovascular risk factors, resulting in lower morbidity and mortality
associated with coronary artery disease. Lifestyle modification
programs are increasingly becoming an approach to the secondary
prevention of coronary disease morbidity. The programs may reduce the
incidence of hospitalizations and invasive procedures among patients
with substantial coronary occlusion.
Medicare currently pays for 12 weeks of cardiac rehabilitation
services for Medicare patients who have a prior diagnosis of myocardial
infarction or who have had a recent cardiac revascularization procedure
or both. Coverage under the Medicare cardiac rehabilitation benefit is
more limited than that contained in a comprehensive lifestyle
modification program. We are investigating the benefits of coverage a
complete package of services offered under an established, multi-site
lifestyle modification program.
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 the Consolidated
Appropriations Act of 2001 (Public Law (Pub. L.) 106-554).
B. Collection and Maintenance of Data in the System. This system
will collect and maintain individually identifiable and other data
collected on Medicare beneficiaries who are potential participants in
the MLMP and providers who provide services to such beneficiaries. 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. It
will also include treatment, program participation, and evaluation,
survey, and research information needed to evaluate the program and
develop research reports on findings.
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
[[Page 41808]]
which the information was collected. Any such disclosure of data is
known as a ``routine use.'' The Government will only release MLMP
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 MLMP.
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
demographic and health related data on the target population of
Medicare beneficiaries who are potential participants in the MLMP
Demonstration. We will also collect certain identifying information on
Medicare providers who provide services to such beneficiaries.
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 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 MLMP information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To assist Quality Improvement Organizations (QIO) in connection
with the review of claims, or in connection with studies or other
review activities, conducted pursuant to Part B of Title XI of the Act
and in performing affirmative outreach activities to individuals for
the purpose of establishing and maintaining their entitlement to
Medicare benefits or health insurance plans.
QIOs will work to implement quality improvement programs, provide
consultation to CMS, its contractors, and to ensure that payment is
only made for medically necessary services. QIOs will assist in related
monitoring and enforcement efforts, assist CMS and intermediaries in
program integrity assessment, investigate beneficiary complaints about
quality of care, and prepare summary information for release to CMS.
4. 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 MLMP 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.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government,
is a party to litigation or has an interest in such litigation, and, by
careful review, CMS determines that the records are both relevant and
necessary to the litigation and that the use of such records by the
DOJ, court or adjudicatory body is compatible with the purpose for
which the agency collected the records.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
6. To a CMS contractor (including, but not necessarily limited to,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
[[Page 41809]]
remedy, or otherwise combat fraud or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud and abuse. CMS occasionally contracts out certain of
its functions 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.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
Other agencies may require MLMP information for the purpose of
combating fraud 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
because of the small size, use of this information could allow for the
deduction of the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations 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.
Dated: July 14, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0585
SYSTEM NAME:
``Medicare Lifestyle Modification Program (MLMP) Demonstration,''
HHS/CMS/ORDI.
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 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 Medicare beneficiaries who are potential
participants in the MLMP Demonstration and providers who provide
services to such beneficiaries.
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. It will also include treatment, program participation, and
evaluation, survey, and research information needed to evaluate the
program and develop research reports on findings.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system is given under the
provisions of the Consolidated Appropriations Act of 2001 (Public Law
(Pub. L.) 106-554).
[[Page 41810]]
PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to collect and maintain demographic
and health related data on the target population of Medicare
beneficiaries who are potential participants in the MLMP Demonstration.
We will also collect certain identifying information on Medicare
providers who provide services to such beneficiaries. 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, consultant or other legal agent; (2) assist
another Federal or state agency with information to contribute to the
accuracy of CMS's proper payment of Medicare 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) assist Quality Improvement Organizations; (4)
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; (5) support litigation involving the agency; and (6)
combat fraud 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 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 assist Quality Improvement Organizations (QIO) in connection
with the review of claims, or in connection with studies or other
review activities, conducted pursuant to Part B of Title XI of the Act
and in performing affirmative outreach activities to individuals for
the purpose of establishing and maintaining their entitlement to
Medicare benefits or health insurance plans.
4. 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.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
6. To a CMS contractor (including, but not necessarily limited to,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures. 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
because of the small size, use of this information could allow for the
deduction of 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.
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
[[Page 41811]]
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, Office of Research, Development & Information, Mail Stop
S3-02-01, 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, 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. 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 Medicare administrative and claims
records, patient medical charts, physician records, and via survey
instruments administered to beneficiaries and providers.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E6-11637 Filed 7-21-06; 8:45 am]
BILLING CODE 4120-03-P