[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60718-60722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc06-42]
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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).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled, ``Senior Risk
Reduction Demonstration and Evaluation (SRRDE), System No. 09-70-
0592.'' The program is authorized under provisions of the Social
Security Act (42 U.S.C. 1395b-1(a)), which gives the Secretary the
broad authority to, ``develop and engage in experiments and
demonstration projects.'' The goal of the SRRDE is to determine whether
risk reduction programs that have been developed and tested in the
private sector can also be tailored to and work well with Medicare
beneficiaries to improve their health and reduce avoidable health care
utilization. The specific aims of the demonstration and evaluation are
to: (1) Determine whether a senior risk reduction service provided by
Medicare will be accepted by beneficiaries, achieve high participation
rates, and be viewed positively by beneficiaries; (2) reduce health
risk factors, improve health behaviors, improve functioning, and
prevent disability; and (3) save money for Medicare.
The purpose of this system is to collect and maintain demographic
and health related data on the target population of non-
institutionalized Medicare beneficiaries between the ages of 67 and 74
who are potential participants in the SRRDE 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 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 October 6, 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 comments to the CMS Privacy
Officer, Division of Privacy Compliance, Enterprise Architecture and
Strategy Group, Office of Information Services, 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: Pauline Lapin, Division of Health
Promotion & Disease Prevention Demonstrations, Medicare Demonstrations
Program Group, Office of Research Development & Information, Mail Stop
S3-06-24, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at
410-786-6883, or via e-mail at Pauline.Lapin@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Behavioral lifestyle choices with respect to
diet, physical activity, alcohol, and tobacco use are associated with
the leading causes of morbidity and mortality in the United States.
Recent research suggests that well-structured risk reduction programs
can achieve significant improvements in a population's risk profile.
Successful programs are founded on solid behavior change theory, use
tailored interventions, are personalized and sufficiently intensive,
and are delivered with adequate social supports. The SRRDE program will
be tailored to the needs, concerns, and learning styles of seniors. The
goal is to develop personalized materials and instruments, followed by
interventions tailored to the risks presented by the participants.
CMS will offer risk reduction services to non-institutionalized
Medicare beneficiaries between the ages of 67 and 74. The demonstration
requires random selection of beneficiaries from across the United
States as well as from communities that have exemplary Information and
Referral/Assistance programs for seniors. Medicare will assign
approximately 15,000-17,000 randomly selected beneficiaries to each
site for recruitment. Medicare's inclusion criteria for beneficiaries
eligible for the demonstration and evaluation are as follows: they must
be a Medicare fee-for-service beneficiary enrolled in both Parts A and
B, they may be dual eligible for both Medicare and Medicaid, and
Medicare must be their primary payer. Medicare's exclusion criteria for
beneficiaries to participate in the demonstration and evaluation are as
follows: they cannot be currently enrolled in a Medicare Health Plan;
they cannot be enrolled in a hospice or End State Renal Disease (ESRD)
program; cannot currently be participating in another CMS
demonstration; cannot have residence in an institution for 100 days or
the past 12 months; cannot have the inability to participate in self-
care activities due to severe dementia or other serious mental illness;
and cannot have had initial enrollment into Medicare before the age of
65.
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
402(a)(1)(B) and (a)(2) of the Social Security Amendments of 1967,
Public Law No. 90-248, as amended, 42 United States Code Sec. 1395b-
1(a)(1)(B) and (a)(2).
[[Page 60719]]
B. Collection and Maintenance of Data in the System
This system will collect and maintain individually identifiable and
other data collected on non-institutionalized Medicare beneficiaries
between the ages of 67 and 74 who are potential participants in the
SRRDE program. 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. Data will be
collected from Medicare administrative and claims records, SRRDE site
administrative data systems, patient medical charts, and physician
records.
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 SRRDE 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 SRRDE.
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 non-
institutionalized Medicare beneficiaries between the ages of 67 and 74
who are potential participants in the SRRDE program.
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 support agency contractors, consultants or grantees, who have
been engaged by the agency to assist in the performance of a service
related to this collection and who need to have access to the records
in order to perform the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS function
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant or grantee whatever information
is necessary for the contractor or consultant to fulfill its duties. In
these situations, safeguards are provided in the contract prohibiting
the contractor, consultant or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requires the contractor, consultant or grantee to return or destroy
all information at the completion of the contract.
2. To assist another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies, in their administration of a
Federal health program, may require SRRDE information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To 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.
The SRRDE 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 researchers may
have legitimate requests to use these data in projects that could
ultimately improve the care provided to Medicare beneficiaries and the
policies that govern their care.
4. To support the Department of Justice (DOJ), court or
adjudicatory body when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
5. To assist a CMS contractor (including, but not necessarily
limited
[[Page 60720]]
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, 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, 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 assist 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 SRRDE information for the purpose of
combating fraud, waste, and abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164.512(a)
(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors 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: October 4, 2006.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0592
System Name:
``Senior Risk Reduction Demonstration and Evaluation (SRRDE),''
HHS/CMS/ORDI.
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 non-institutionalized Medicare beneficiaries
between the ages of 67 and 74 who are potential participants in the
SRRDE program.
Categories of Records in the System:
The collected information will include, but is not limited to:
Medicare claims and eligibility data, name, address, telephone number,
health insurance claims number (HICN), 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. Data will be collected from Medicare
administrative and claims records, SRRDE site administrative data
systems,
[[Page 60721]]
patient medical charts, and physician records.
Authority for Maintenance of the System:
The statutory authority for this system is given under section 402
(a)(1)(B) and (a)(2) of the Social Security Amendments of 1967, Public
Law 90-248, as amended, 42 United States Code 1395b-1(a)(1)(B) and
(a)(2).
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 non-
institutionalized Medicare beneficiaries between the ages of 67 and 74
who are potential participants in the SRRDE 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 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 support agency contractors, consultants or grantees, who have
been engaged by the agency to assist in the performance of a service
related to this collection and who need to have access to the records
in order to perform the activity.
2. To assist another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
3. To 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. To support the Department of Justice (DOJ), court or
adjudicatory body when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
5. To assist 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, or abuse in such
program.
6. To assist 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 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164.512(a)
(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
All records are stored on electronic media.
Retrievability:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HICN.
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.
[[Page 60722]]
These laws and regulations may apply but are not limited to: The
Privacy Act of 1974; the Federal Information Security Management Act of
2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance
Portability and Accountability Act of 1996; the E-Government Act of
2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of
2003, and the corresponding implementing regulations. OMB Circular A-
130, Management of Federal Resources, Appendix III, Security of Federal
Automated Information Resources also applies. Federal, HHS, and CMS
policies and standards include but are not limited to: all pertinent
National Institute of Standards and Technology publications; the HHS
Information Systems Program Handbook and the CMS Information Security
Handbook.
Retention and Disposal:
CMS will retain information for a total period not to exceed 10
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
S3-06-24, 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, SRRDE site administrative data systems, patient medical
charts, and physician records.
Systems Exempted from Certain Provisions of the Act:
None.
[FR Doc. E6-17055 Filed 10-13-06; 8:45 am]
BILLING CODE 4120-03-P