Privacy Act of 1974; Report of a New System of Records, 67709-67713 [05-22192]
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
Proximal Anastomotic Assist Devices
Surgeons use proximal AADs in
CABG procedures to avoid the need to
clamp the aorta when attaching a
harvested vessel to it. If a proximal AAD
is not used, the surgeon must use a
clamp to stop the flow of blood to a
segment of the aorta while the harvested
vessel is surgically attached. Using a
clamp can cause calcified plaque
particles to dislodge from the aorta and
travel through the blood stream to the
brain, risking neurological dysfunction
or stroke.
The proper geographic market in
which to analyze the effects of the
proposed transaction on the market for
proximal AADs is the United States.
Proximal AADs are medical devices that
must be approved by the FDA before
being marketed in the United States. As
with other medical devices, the clinical
testing and regulatory approval process
for proximal AADs can be costly and
time-consuming, preventing proximal
AADs approved outside of the United
States but not approved within the
United States from serving as a
competitive alternative for U.S.
consumers.
There are currently three firms in the
U.S. market for proximal AADs, making
it a highly concentrated market. The
evidence indicates that J&J and
Guidant’s manual proximal AADs are
each others’ closest competitors.
Medtronic also participates in the
market with an automatic device that it
recently launched in the United States.
A fourth firm, St. Jude Medical,
removed its automatic device,
Symmetry, from the market last year
amidst reports of device failures. J&J’s
proximal AAD, eNclose, was
developed and is manufactured by
Novare; J&J and Novare have a
distribution agreement making J&J the
sole distributor of eNclose in the
United States.
As with the other medical devices
discussed, entry into the market for
proximal AADs is difficult, costly, and
time-consuming. Additionally, the
alleged safety concerns regarding St.
Jude’s Symmetry device have resulted
in greater scrutiny of proximal AADs by
the FDA. The increased scrutiny is
likely to substantially increase the cost
of developing a proximal AAD. In
addition, it appears that the publicity
surrounding Symmetry’s removal from
the market has dampened physician
enthusiasm for these devices. These
developments, along with the declining
number of overall U.S. CABG
procedures, decrease the likelihood of
entry into this market.
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The proposed acquisition is likely to
cause significant competitive harm in
the market for proximal AADs by
eliminating competition between J&J
and Guidant and reducing the number
of competitors in the market from three
to two. The evidence has also shown
that J&J and Guidant’s products are
likely each others’ closest competitors
in the proximal AAD market because
they are more similar to each other than
to Medtronic’s product. The proposed
acquisition is therefore likely to enable
the combined J&J/Guidant to raise prices
for proximal AADs unilaterally.
The proposed acquisition’s
anticompetitive effects in the market for
proximal AADs are remedied by the
proposed Consent Agreement’s
requirement that J&J terminate its
distribution agreement with Novare for
Novare’s proximal AAD, eNclose. It is
anticipated that it will take Novare no
more than two months to find a new
distribution partner for eNclose.
Appointment of an Interim Monitor and
a Divestiture Trustee
The proposed Consent Agreement
contains a provision that allows the
Commission to appoint an interim
monitor to oversee J&J’s compliance
with all of its obligations and
performance of its responsibilities
pursuant to the Commission’s Decision
and Order. The interim monitor is
required to file periodic reports with the
Commission to ensure that the
Commission remains informed about
the status of the divestitures, about the
efforts being made to accomplish the
divestitures, and the provision of
services and assistance during the
transition period for the EVH
divestiture.
Finally, the proposed Consent
Agreement contains provisions that
allow the Commission to appoint a
divestiture trustee if any or all of the
above remedies are not accomplished
within the time frames required by the
Consent Agreement. The divestiture
trustee may be appointed to accomplish
any and all of the remedies required by
the proposed Consent Agreement that
have not yet been fulfilled upon
expiration of the time period allotted for
each.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Decision
and Order or to modify its terms in any
way.
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67709
By direction of the Commission, with
Chairman Majoras and Commissioner
Harbour recused.
Donald S. Clark,
Secretary.
[FR Doc. 05–22165 Filed 11–7–05; 8:45 am]
BILLING CODE 6750–01–P
GOVERNMENT ACCOUNTABILITY
OFFICE
Advisory Council on Government
Auditing Standards; Notice of Meeting
The Advisory Council on Government
Auditing Standards will meet Monday,
December 5, 2005, from 8:30 a.m. to 5
p.m., in room 7C13 of the Government
Accountability Office building, 441 G
Street, NW., Washington, DC.
The Advisory Council on Government
Auditing Standards will hold a meeting
to discuss issues that may impact
government auditing standards. The
meeting is open to the public. Council
discussions and reviews are open to the
public. Members of the public will be
provided an opportunity to address the
Council with a brief (five minute)
presentation on Monday afternoon.
Any interested person who plans to
attend the meeting as an observer must
contact Sharon Chase, Council
Assistant, 202–512–9406. A form of
picture identification must be presented
to the GAO Security Desk on the day of
the meeting to obtain access to the GAO
Building. For further information,
please contact Ms. Chase. Please check
the Government Auditing Standards
Web page (https://www.gao.gov/govaud/
ybk01.htm) one week prior to the
meeting for a final agenda.
Jeanette M. Franzel,
Director, Financial Management and
Assurance.
[FR Doc. 05–22205 Filed 11–7–05; 8:45 am]
BILLING CODE 1610–02–P
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) Centers for
Medicare & Medicaid Services (CMS).
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
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SOR titled, ‘‘Medicare Prescription Drug
Plan Finder (MPDPF) System, HHS/
CMS/CBC, System No. 09–70–0564.’’
Under the provisions of Section 101 of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173), CMS
has provided the participants of
eligibility transactions a query and
response solution in a single data center
using a three-tier architecture.
Enterprise Business Services (EBS), the
user interface, will have the
responsibility of receiving identifying
information on Medicare beneficiaries
for processing eligibility requests and
enrollment assistance with the Medicare
Prescription Drug Benefit Program.
These inbound messages will be sent to
EBS for processing of the eligibility
request and for securing the information
from the CMS Community Based
Organization/Customer Service
Representative (CBO/CSR) Data Store,
and for sending an available plan option
response back via the internet. EBS will
capture the identifying information and
enrollment selection, and transmit it to
the selected Medicare Prescription Drug
Plan (PDP) or Medicare Advantage
Prescription Drug Plan (MAPD). This
initiative will streamline and facilitate
drug benefit eligibility determination
and the enrollment process.
The primary purpose of this system is
to provide a Web accessible inquiry
system that will provide a mechanism to
support an individual beneficiary’s
efforts in performing drug benefit
eligibility queries and to enroll them
into selected plans. Information in this
system will also be used to: (1) Support
regulatory and policy functions
performed within the Agency or by a
contractor or consultant; (2) assist PDPs
and MAPDs directly or through the
Enterprise Business Services; (3)
support constituent requests made to a
Congressional representative; and (4)
support litigation involving the Agency
related to this system. We have
provided background information about
the proposed system in the
‘‘Supplementary Information’’ section
below. Although the Privacy Act
requires only that the Aroutine use’’
portion of the system be published for
comment, CMS invites comments on all
portions of this notice. See EFFECTIVE
DATES section for comment period.
EFFECTIVE DATES: CMS filed a new
system report with the Chair of the
House Committee on Government
Reform and Oversight, the Chair of the
Senate Committee on Governmental
Affairs, and the Administrator, Office of
Information and Regulatory Affairs,
Office of Management and Budget
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(OMB) on November 1, 2005. To ensure
that all parties have adequate time in
which to comment, the new SOR,
including routine uses, will become
effective 40 days from the publication of
the notice, or from the date it was
submitted to OMB and the Congress,
whichever is later, unless CMS receives
comments that require alterations to this
notice.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Privacy Compliance Data
Development, CMS, 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
daylight time.
FOR FURTHER INFORMATION CONTACT:
Thomas Dudley, Division of Website
Project Management, Beneficiary
Information Services Group, Center for
Beneficiary Choices, CMS, Mail Stop
S1–01–26, 7500 Security Boulevard,
Baltimore, Maryland, 21244–1850. His
telephone number is 410–786–1442, or
e-mail at Thomas.Dudley@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
public version of the toll will use
knowledge based authentication (KBA),
to provide the end user access to
personalized information about their
drug benefit eligibility and enrollment.
KBA allows a user to access the system
based on what they know without the
need for a user id/password. To
successfully authenticate, the user will
need to provide the following
information: Health Insurance Claim
Number (HICN), Date of Birth, Last
Name, Type of Enrollment, Effective
date of enrollment, and Zip Code. This
information will then be validated in
the CMS Data Center. All data elements
must match to successfully authenticate
the user. If the authentication fails, the
user will be taken directly to the default
route and asked to respond to a series
of questions in lieu of authentication.
They will not be provided with ‘‘retry’’
options. If successfully authenticated,
Part D and Part C information will be
retrieved from the data center and
passed to MPDPF.
CMS has planned to provide the
participants of eligibility transactions a
query and response solution in a single
data center using a three-tier
architecture. EBS, the user interface,
will have the responsibility of receiving
identifying information on Medicare
beneficiaries for processing eligibility
requests and enrollment assistance with
the Medicare Prescription Drug Benefit
Program. These inbound messages will
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be sent to EBS for processing of the
eligibility request and for securing the
information from the CMS CBO/CSR
Data Store, and for sending a response
back via the internet.
The drug benefit itself is very
complex. The user must self-identify
him/herself into one of 4 categories in
order to get the options applicable in
his/her circumstances (full dual subsidy
eligible; full subsidy eligible; partial
subsidy eligible; no subsidy eligible).
CMS knows from prior education and
consumer research efforts that it is
extremely difficult for persons with
Medicare to understand the nuances of
these options and to accurately
categorize them. This presents a
challenge for both the direct beneficiary
user and those assisting the beneficiary
(CSRs and CBOs). However, CMS data
systems contain information that can
easily provide the user’s categorization
and then enable the drug benefit tool to
accurately present only those options
that are applicable to his/her unique
circumstances. This is the primary
driver for the development of the
eligibility query.
A secondary, but also essential, driver
is to provide an efficient means for users
to explore their drug benefit choices. We
need to ensure that we provide tools
that can encourage the maximum
number of Medicare beneficiaries to use
self-service options given the volume of
inquiries we are projecting and the
extraordinary costs for servicing those
calls. To meet the varying needs of
different end-users, two different
versions of the MPDPF will be
developed: one tool will be used for the
Public (including CBOs, and
beneficiaries) and the other tool will be
dedicated to CSR staffing the call
centers that service 1–800–Medicare.
I. Description of the Proposed System of
Records
A. Statutory and Regulatory Basis for
the System
Authority for this system is given
under the provisions of Section 101 of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Public Law 108–173).
This new prescription drug benefit
program was enacted into law on
December 8, 2003, amended Title XVIII
of the Social Security Act (the Act), and
codified at Title 42 Code of Federal
Regulations (CFR) Parts 403, 411, 417
and 423 by establishing a new Medicare
‘‘Part D’’ Prescription Drug Benefit
program. Part D of Title XVIII of the Act,
as amended by the MMA, and its
implementing regulations at 42 CFR
Parts 403, 411, 417 and 423.
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B. Collection and Maintenance of Data
in the System
Information collected for this system
will include but is not limited to,
individuals who voluntarily access and
who successfully validate information
required by the Web-based Application
Systems maintained by CMS.
Information collected for this system
will include, but is not limited to, last
name, gender, HICN, telephone number,
geographic location, type of enrollment
(Medicare Part A or Part B), and
effective date of enrollment in Part A
and Part B.
II. Agency Policies, Procedures, and
Restrictions on the Routine Use
A. Agency Policies, Procedures, and
Restrictions on the Routine Use
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 MPDPF
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 MPDPF. 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
provide a Web accessible inquiry system
that will provide a mechanism to
support an individual beneficiary’s
efforts in performing drug benefit
eligibility queries and to enroll them
into selected plans.
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).
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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, or
consultants who have been contracted
by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this system
and who need to have access to the
records in order to assist CMS.
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 functions relating
to purposes for this system.
CMS occasionally contracts out
certain of its functions when this would
contribute to effective and efficient
operations. CMS must be able to give a
contractor whatever information is
necessary for the contractor to fulfill its
duties. In these situations, safeguards
are provided in the contract prohibiting
the contractor from using or disclosing
the information for any purpose other
than that described in the contract and
to return or destroy all information at
the completion of the contract.
2. To Medicare Prescription Drug
Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD)
directly or through the Enterprise
Business Services, a CMS intermediary
for the administration of Title XVIII of
the Act.
PDPs and MAPDs require MPDPF
information in order to establish the
validity of evidence or to verify the
accuracy of information presented by
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67711
the individual, as it concerns the
individual’s entitlement to Part D
benefits under the Medicare
Prescription Drug Benefit Program.
3. To a Member of Congress or to a
Congressional staff member in response
to an inquiry of the Congressional office
made at the written request of the
constituent about whom the record is
maintained.
Individuals sometimes request the
help of a Member of Congress in
resolving some issue relating to a matter
before CMS. The Member of Congress
then writes CMS, and CMS must be able
to give sufficient information to be
responsive to the inquiry.
4. To the Department of Justice (DOJ),
court or adjudicatory body when
a. The Agency or any component
thereof; or
b. Any employee of the Agency in his
or her official capacity; or
c. Any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee; or
d. The United States Government;
is a party to litigation or has an interest
in such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation. Whenever CMS is involved in
litigation, or occasionally when another
party is involved in litigation and CMS’s
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. A determination would be
made in each instance that, under the
circumstances involved, the purposes
served by the use of the information in
the particular litigation is compatible
with a purpose for which CMS collects
the information.
B. Additional Provisions Affecting
Routine Use Disclosures. 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 PHI 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.’’
In addition, our policy will be to
prohibit release even of not directly
identifiable information, 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
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that individuals who are familiar with
the enrollees 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 include 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; 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
the system. CMS will collect only that
information necessary to perform the
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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 the
disclosure of information relating to
individuals.
PURPOSE(S) OF THE SYSTEM:
SYSTEM NAME:
The primary purpose of this system is
to provide a Web accessible inquiry
system that will provide a mechanism to
support an individual beneficiary’s
efforts in performing drug benefit
eligibility queries and to enroll them
into selected plans. Information in this
system will also be used to: (1) Support
regulatory and policy functions
performed within the Agency or by a
contractor or consultant; (2) assist PDPs
and MAPDs directly or through the
Enterprise Business Services; (3)
support constituent requests made to a
Congressional representative; and (4)
support litigation involving the Agency
related to this system.
‘‘Medicare Prescription Drug Plan
Finder (MPDPF) System, HHS/CMS/
CBC’’
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
Dated: October 27, 2005.
Charlene Frizzera,
Deputy Chief Operating Officer, Centers for
Medicare & Medicaid Services.
09–70–0564
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive
SYSTEM LOCATION:
Centers for Medicare & Medicaid
Services (CMS) Data Center, 7500
Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244–
1850, and at various contractor
locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Information collected for this system
will include but is not limited to,
individuals who voluntarily access and
who successfully validate information
required by the Web-based Application
Systems maintained by CMS.
CATEGORIES OF RECORDS IN THE SYSTEM:
Information collected for this system
will include, but is not limited to, last
name, gender, Health Insurance Claim
Number (HICN), telephone number,
geographic location, type of enrollment
(Medicare Part A or Part B), and
effective date of enrollment in Part A
and Part B.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for this system is given
under the provisions of Section 101 of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Public Law 108–173).
This new prescription drug benefit
program was enacted into law on
December 8, 2003, amended Title XVIII
of the Social Security Act (the Act), and
codified at Title 42 Code of Federal
Regulations (CFR) parts 403, 411, 417
and 423 by establishing a new Medicare
‘‘Part D’’ Prescription Drug Benefit
program. Part D of Title XVIII of the Act,
as amended by the MMA, and its
implementing regulations at 42 CFR
Parts 403, 411, 417 and 423.
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Fmt 4703
Sfmt 4703
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, or
consultants who have been contracted
by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this system
and who need to have access to the
records in order to assist CMS.
2. To Medicare Prescription Drug
Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD)
directly or through the Enterprise
Business Services, a CMS intermediary
for the administration of Title XVIII of
the Act.
3. To a Member of Congress or to a
congressional staff member in response
to an inquiry of the congressional office
made at the written request of the
constituent about whom the record is
maintained.
4. To the Department of Justice (DOJ),
court or adjudicatory body when
a. The Agency or any component
thereof; or
b. any employee of the Agency in his
or her official capacity; or
c. any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee; or
d. The United States Government;
Is a party to litigation or has an
interest in such litigation, and by careful
review, CMS determines that the
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records are both relevant and necessary
to the litigation.
B. Additional Provisions Affecting
Routine Use Disclosures. 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 PHI 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.’’
In addition, our policy will be to
prohibit release even of not directly
identifiable information, 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 who are familiar with
the enrollees 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:
RETENTION AND DISPOSAL:
Records are maintained in a secure
storage area with identifiers. Disposal
occurs 6 years and 3 months from the
time the individual accesses the
MPDPF.
SYSTEM MANAGER AND ADDRESS:
Director, Beneficiary Information
Services Group, Center for Beneficiary
Choices, CMS, Mail Stop S1–01–26,
7500 Security Boulevard, Baltimore,
Maryland, 21244–1850.
NOTIFICATION PROCEDURE:
STORAGE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, HICN, and for verification
purposes, the subject individual’s name
(woman’s maiden name, if applicable).
Computer diskette and on magnetic
storage media.
RETRIEVABILITY:
Information can be retrieved by the
individual identifiable information of
the beneficiary.
RECORD ACCESS PROCEDURE:
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 include 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
VerDate Aug<31>2005
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; HHS Information Systems
Program Handbook and the CMS
Information Security Handbook.
16:11 Nov 07, 2005
Jkt 208001
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.)
RECORD SOURCE CATEGORIES:
Sources of information contained in
this records system include data
collected from the initial voluntary
inquiry made by or on behalf of the
individual and validated through the
Medicare Beneficiary Database.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
67713
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 05–22192 Filed 11–7–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0226]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
013
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 013’’ (Recognition List
Number: 013), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII of this
document for the effective date of the
recognition of standards announced in
this document.
ADDRESSES: Submit written requests for
single copies on a 3.5’’ diskette of
‘‘Modifications to the List of Recognized
Standards, Recognition List Number:
013’’ to the Division of Small
Manufacturers, International and
Consumer Assistance, Center for
Devices and Radiological Health (HFZ–
220), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850.
Send two self-addressed adhesive labels
to assist that office in processing your
requests, or FAX your request to 301–
443–8818. Submit written comments
concerning this document, or
recommendations for additional
standards for recognition, to the contact
person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments
by e-mail: standards@cdrh.fda.gov. This
document may also be accessed on
FDA’s Internet site at https://
www.fda.gov/cdrh/fedregin.html. See
section VI of this document for
electronic access to the searchable
E:\FR\FM\08NON1.SGM
08NON1
Agencies
[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67709-67713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22192]
=======================================================================
-----------------------------------------------------------------------
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) Centers 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
[[Page 67710]]
SOR titled, ``Medicare Prescription Drug Plan Finder (MPDPF) System,
HHS/CMS/CBC, System No. 09-70-0564.'' Under the provisions of Section
101 of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) (Pub. L. 108-173), CMS has provided the participants
of eligibility transactions a query and response solution in a single
data center using a three-tier architecture. Enterprise Business
Services (EBS), the user interface, will have the responsibility of
receiving identifying information on Medicare beneficiaries for
processing eligibility requests and enrollment assistance with the
Medicare Prescription Drug Benefit Program. These inbound messages will
be sent to EBS for processing of the eligibility request and for
securing the information from the CMS Community Based Organization/
Customer Service Representative (CBO/CSR) Data Store, and for sending
an available plan option response back via the internet. EBS will
capture the identifying information and enrollment selection, and
transmit it to the selected Medicare Prescription Drug Plan (PDP) or
Medicare Advantage Prescription Drug Plan (MAPD). This initiative will
streamline and facilitate drug benefit eligibility determination and
the enrollment process.
The primary purpose of this system is to provide a Web accessible
inquiry system that will provide a mechanism to support an individual
beneficiary's efforts in performing drug benefit eligibility queries
and to enroll them into selected plans. Information in this system will
also be used to: (1) Support regulatory and policy functions performed
within the Agency or by a contractor or consultant; (2) assist PDPs and
MAPDs directly or through the Enterprise Business Services; (3) support
constituent requests made to a Congressional representative; and (4)
support litigation involving the Agency related to this system. We have
provided background information about the proposed system in the
``Supplementary Information'' section below. Although the Privacy Act
requires only that the Aroutine use'' portion of the system be
published for comment, CMS invites comments on all portions of this
notice. See EFFECTIVE DATES section for comment period.
EFFECTIVE DATES: CMS filed a new system report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Governmental Affairs, and the Administrator, Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB) on November 1, 2005. To ensure that all parties have adequate
time in which to comment, the new SOR, including routine uses, will
become effective 40 days from the publication of the notice, or from
the date it was submitted to OMB and the Congress, whichever is later,
unless CMS receives comments that require alterations to this notice.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Privacy Compliance Data Development, CMS, 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 daylight time.
FOR FURTHER INFORMATION CONTACT: Thomas Dudley, Division of Website
Project Management, Beneficiary Information Services Group, Center for
Beneficiary Choices, CMS, Mail Stop S1-01-26, 7500 Security Boulevard,
Baltimore, Maryland, 21244-1850. His telephone number is 410-786-1442,
or e-mail at Thomas.Dudley@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The public version of the toll will use
knowledge based authentication (KBA), to provide the end user access to
personalized information about their drug benefit eligibility and
enrollment. KBA allows a user to access the system based on what they
know without the need for a user id/password. To successfully
authenticate, the user will need to provide the following information:
Health Insurance Claim Number (HICN), Date of Birth, Last Name, Type of
Enrollment, Effective date of enrollment, and Zip Code. This
information will then be validated in the CMS Data Center. All data
elements must match to successfully authenticate the user. If the
authentication fails, the user will be taken directly to the default
route and asked to respond to a series of questions in lieu of
authentication. They will not be provided with ``retry'' options. If
successfully authenticated, Part D and Part C information will be
retrieved from the data center and passed to MPDPF.
CMS has planned to provide the participants of eligibility
transactions a query and response solution in a single data center
using a three-tier architecture. EBS, the user interface, will have the
responsibility of receiving identifying information on Medicare
beneficiaries for processing eligibility requests and enrollment
assistance with the Medicare Prescription Drug Benefit Program. These
inbound messages will be sent to EBS for processing of the eligibility
request and for securing the information from the CMS CBO/CSR Data
Store, and for sending a response back via the internet.
The drug benefit itself is very complex. The user must self-
identify him/herself into one of 4 categories in order to get the
options applicable in his/her circumstances (full dual subsidy
eligible; full subsidy eligible; partial subsidy eligible; no subsidy
eligible). CMS knows from prior education and consumer research efforts
that it is extremely difficult for persons with Medicare to understand
the nuances of these options and to accurately categorize them. This
presents a challenge for both the direct beneficiary user and those
assisting the beneficiary (CSRs and CBOs). However, CMS data systems
contain information that can easily provide the user's categorization
and then enable the drug benefit tool to accurately present only those
options that are applicable to his/her unique circumstances. This is
the primary driver for the development of the eligibility query.
A secondary, but also essential, driver is to provide an efficient
means for users to explore their drug benefit choices. We need to
ensure that we provide tools that can encourage the maximum number of
Medicare beneficiaries to use self-service options given the volume of
inquiries we are projecting and the extraordinary costs for servicing
those calls. To meet the varying needs of different end-users, two
different versions of the MPDPF will be developed: one tool will be
used for the Public (including CBOs, and beneficiaries) and the other
tool will be dedicated to CSR staffing the call centers that service 1-
800-Medicare.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for the System
Authority for this system is given under the provisions of Section
101 of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) (Public Law 108-173). This new prescription drug
benefit program was enacted into law on December 8, 2003, amended Title
XVIII of the Social Security Act (the Act), and codified at Title 42
Code of Federal Regulations (CFR) Parts 403, 411, 417 and 423 by
establishing a new Medicare ``Part D'' Prescription Drug Benefit
program. Part D of Title XVIII of the Act, as amended by the MMA, and
its implementing regulations at 42 CFR Parts 403, 411, 417 and 423.
[[Page 67711]]
B. Collection and Maintenance of Data in the System
Information collected for this system will include but is not
limited to, individuals who voluntarily access and who successfully
validate information required by the Web-based Application Systems
maintained by CMS. Information collected for this system will include,
but is not limited to, last name, gender, HICN, telephone number,
geographic location, type of enrollment (Medicare Part A or Part B),
and effective date of enrollment in Part A and Part B.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. Agency Policies, Procedures, and Restrictions on the Routine Use
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 MPDPF 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 MPDPF. 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 provide a Web
accessible inquiry system that will provide a mechanism to support an
individual beneficiary's efforts in performing drug benefit eligibility
queries and to enroll them into selected plans.
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, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this system and who need to have access to the records
in order to assist CMS.
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 functions
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when this
would contribute to effective and efficient operations. CMS must be
able to give a contractor whatever information is necessary for the
contractor to fulfill its duties. In these situations, safeguards are
provided in the contract prohibiting the contractor from using or
disclosing the information for any purpose other than that described in
the contract and to return or destroy all information at the completion
of the contract.
2. To Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through the Enterprise
Business Services, a CMS intermediary for the administration of Title
XVIII of the Act.
PDPs and MAPDs require MPDPF information in order to establish the
validity of evidence or to verify the accuracy of information presented
by the individual, as it concerns the individual's entitlement to Part
D benefits under the Medicare Prescription Drug Benefit Program.
3. To a Member of Congress or to a Congressional staff member in
response to an inquiry of the Congressional office made at the written
request of the constituent about whom the record is maintained.
Individuals sometimes request the help of a Member of Congress in
resolving some issue relating to a matter before CMS. The Member of
Congress then writes CMS, and CMS must be able to give sufficient
information to be responsive to the inquiry.
4. To the Department of Justice (DOJ), court or adjudicatory body
when
a. The Agency or any component thereof; or
b. Any employee of the Agency in his or her official capacity; or
c. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee; or
d. The United States Government;
is a party to litigation or has an interest in such litigation, and by
careful review, CMS determines that the records are both relevant and
necessary to the litigation. Whenever CMS is involved in litigation, or
occasionally when another party is involved in litigation and CMS's
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. A determination would be made in each
instance that, under the circumstances involved, the purposes served by
the use of the information in the particular litigation is compatible
with a purpose for which CMS collects the information.
B. Additional Provisions Affecting Routine Use Disclosures. 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 PHI 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.''
In addition, our policy will be to prohibit release even of not
directly identifiable information, 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
[[Page 67712]]
that individuals who are familiar with the enrollees 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 include 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; 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 the system. CMS will collect only that information
necessary to perform the system's functions. In addition, CMS will make
disclosure from the proposed system only with consent of the subject
individual, or his/her legal representative, or in accordance with an
applicable exception provision of the Privacy Act. CMS, therefore, does
not anticipate an unfavorable effect on individual privacy as a result
of the disclosure of information relating to individuals.
Dated: October 27, 2005.
Charlene Frizzera,
Deputy Chief Operating Officer, Centers for Medicare & Medicaid
Services.
09-70-0564
SYSTEM NAME:
``Medicare Prescription Drug Plan Finder (MPDPF) System, HHS/CMS/
CBC''
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive
SYSTEM LOCATION:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850, and at various contractor locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Information collected for this system will include but is not
limited to, individuals who voluntarily access and who successfully
validate information required by the Web-based Application Systems
maintained by CMS.
CATEGORIES OF RECORDS IN THE SYSTEM:
Information collected for this system will include, but is not
limited to, last name, gender, Health Insurance Claim Number (HICN),
telephone number, geographic location, type of enrollment (Medicare
Part A or Part B), and effective date of enrollment in Part A and Part
B.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for this system is given under the provisions of Section
101 of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) (Public Law 108-173). This new prescription drug
benefit program was enacted into law on December 8, 2003, amended Title
XVIII of the Social Security Act (the Act), and codified at Title 42
Code of Federal Regulations (CFR) parts 403, 411, 417 and 423 by
establishing a new Medicare ``Part D'' Prescription Drug Benefit
program. Part D of Title XVIII of the Act, as amended by the MMA, and
its implementing regulations at 42 CFR Parts 403, 411, 417 and 423.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this system is to provide a Web accessible
inquiry system that will provide a mechanism to support an individual
beneficiary's efforts in performing drug benefit eligibility queries
and to enroll them into selected plans. Information in this system will
also be used to: (1) Support regulatory and policy functions performed
within the Agency or by a contractor or consultant; (2) assist PDPs and
MAPDs directly or through the Enterprise Business Services; (3) support
constituent requests made to a Congressional representative; and (4)
support litigation involving the Agency related to this system.
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, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this system and who need to have access to the records
in order to assist CMS.
2. To Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through the Enterprise
Business Services, a CMS intermediary for the administration of Title
XVIII of the Act.
3. To a Member of Congress or to a congressional staff member in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
4. To the Department of Justice (DOJ), court or adjudicatory body
when
a. The Agency or any component thereof; or
b. any employee of the Agency in his or her official capacity; or
c. any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee; or
d. The United States Government;
Is a party to litigation or has an interest in such litigation, and
by careful review, CMS determines that the
[[Page 67713]]
records are both relevant and necessary to the litigation.
B. Additional Provisions Affecting Routine Use Disclosures. 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 PHI 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.''
In addition, our policy will be to prohibit release even of not
directly identifiable information, 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 who are familiar with the
enrollees 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:
Computer diskette and on magnetic storage media.
RETRIEVABILITY:
Information can be retrieved by the individual identifiable
information of the beneficiary.
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 include 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; HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
Records are maintained in a secure storage area with identifiers.
Disposal occurs 6 years and 3 months from the time the individual
accesses the MPDPF.
SYSTEM MANAGER AND ADDRESS:
Director, Beneficiary Information Services Group, Center for
Beneficiary Choices, CMS, Mail Stop S1-01-26, 7500 Security Boulevard,
Baltimore, Maryland, 21244-1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager who will require the system name, HICN, and for
verification purposes, the subject individual's name (woman's maiden
name, if applicable).
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.)
RECORD SOURCE CATEGORIES:
Sources of information contained in this records system include
data collected from the initial voluntary inquiry made by or on behalf
of the individual and validated through the Medicare Beneficiary
Database.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-22192 Filed 11-7-05; 8:45 am]
BILLING CODE 4120-03-P