Privacy Act of 1974; Report of a Modified or Altered System of Records, 75175-75180 [E5-7486]
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Federal Register / Vol. 70, No. 242 / Monday, December 19, 2005 / Notices
scientific misconduct by fabricating
study research records for 15 subjects,
including the patient interview data, the
forms tracking data, and the medical
record extraction data in a study on the
management of cerebral aneurysms. The
research was supported by National
Institute of Neurological Disorders and
Stroke (NINDS), National Institutes of
Health (NIH), career development award
K23 NS02159.
In a final decision dated November
23, 2005, the HHS Debarring Official, on
behalf of the Secretary of HHS, issued
the final debarment notice based on the
PHS findings of scientific misconduct
finding. The following actions have
been implemented for a period of three
(3) years, beginning on November 23,
2005:
(1) Ms. Grol has been debarred from
any contracting or subcontracting with
any agency of the United States
Government and from eligibility for or
involvement in nonprocurement
programs of the United States
Government as defined in the
debarment regulations at 45 CFR part
76; and
(2) Ms. Grol is prohibited from serving
in any advisory capacity to PHS,
including but not limited to service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Division of Research
Investigations, Office of Research
Integrity, 5515 Security Lane, Suite 700,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal,
Acting Director, Office of Research Integrity.
[FR Doc. E5–7470 Filed 12–16–05; 8:45 am]
BILLING CODE 4160–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers For Medicare & Medicaid
Services
Privacy Act of 1974; Report of a
Modified or Altered System of Records
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of a Modified or Altered
System of Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to modify or alter an
existing SOR, titled ‘‘Non-Medicare
Beneficiary Workers’ Compensation
(WC) Set-aside File (WCSAF),’’ System
No. 09–70–0537, last published at 67 FR
36892 (May 28, 2002). We propose to
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expand the scope of this system to
include non-Medicare beneficiaries
whose applications for a WC
Arrangement have not been approved
(denied) as submitted. The disclosure
provisions contained in published
routine use number 2 and 3 are deemed
to be duplicative of each other and as
such require corrective action. This
modified routine use will now be
number 2 and will authorize disclosure
to ‘‘another Federal and/or state agency,
agency of a state government, an agency
established by state law, or its fiscal
agent.’’
We are modifying the language in the
remaining routine uses to provide
clarity to CMS’s intention to disclose
individual-specific information
contained in this system. The routine
uses will then be prioritized and
reordered according to their usage. We
will also take the opportunity to update
any sections of the system that were
affected by the recent reorganization
and to update language in the
administrative sections to correspond
with language used in other CMS SORs.
The primary purpose of the nonMedicare beneficiary WCSAF is to
maintain a file of individuals who were
injured while employed; are not
currently Medicare beneficiaries; whose
WC Settlement included a WC Medicare
Set-aside Arrangement that is intended
to pay for future medical expenses in
place of future Medicare benefits; and
was approved or not approved (denied)
by CMS as submitted. The information
retrieved from this system will be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor or consultant; (2) another
Federal and/or state agency, agency of a
state government, an agency established
by state law, or its fiscal agent to
contribute to the accuracy of CMS’
proper payment of Medicare benefits,
enable such agency to administer a
Federal health benefits program, or
enable such agency to fulfill a
requirement of a Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) an
individual or organization for research,
evaluation or epidemiological projects
related to the prevention of disease or
disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects; (4) support constituent
requests made to a Congressional
representative; (5) support litigation
involving the agency; and (6) combat
fraud and abuse in health benefits
programs funded in whole or in part by
Federal funds. We have provided
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background information about the
modified system in the SUPPLEMENTARY
INFORMATION section, below. Although
the Privacy Act requires only that the
‘‘routine use’’ portion of the system be
published for comment, CMS invites
comments on all portions of this notice.
See EFFECTIVE DATE section for comment
period.
EFFECTIVE DATE: CMS filed a modified or
altered SOR 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 December 13, 2005. We will
not disclose any information under a
routine use until 30 days after
publication. We may defer
implementation of this system or one or
more of the routine use statements listed
below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address
comment to the CMS Privacy Officer,
Mail Stop N2–04–27, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. Comments received will be
available for review at this location, by
appointment, during regular business
hours, Monday through Friday from 9
a.m.–3 p.m., eastern daylight time.
FOR FURTHER INFORMATION CONTACT:
Donna Kettish, Division of Medicare
Secondary Payer Policy Operations,
Financial Services Group, Office of
Financial Management, CMS, Mail stop
C3–14–16, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850. She
can be reached by telephone at (410)
786–5462, or via e-mail at
Donna.Kettish@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Notice for
this system, ‘‘Non Medicare Beneficiary
Workers’ Compensation Set-aside File,’’
System No. 09–70–0537, was most
recently published in full at 67 Federal
Register 36892 (May 28, 2002). CMS is
responsible for safeguarding the fiscal
integrity of the Medicare Program. The
Health Insurance Portability and
Accountability Act of 1996 established
the ‘‘Medicare Integrity Program,’’
enabling CMS to competitively award
contracts with entities to promote the
integrity of the Medicare Program. The
Coordination of Benefit Contractor
(COBC) is one of those specialized
contractors hired to increase efficiency
and effectiveness by ensuring that the
appropriate payer makes benefit
payments by coordinating Medicare and
other benefit payments.
The Electronic Correspondence
Referral System (ECRS) is currently
used to transfer data between CMS’s
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Medicare contractors and the COBC to
establish Medicare Secondary Payer
(MSP) periods of coverage on CMS’s
Common Working File (CWF) and to
update CWF with the results of a CMS
review of a WC Medicare Set-aside
Arrangement Proposal. The CWF is a
CMS system, containing Medicare
beneficiary eligibility information that is
used for verification and validation
purposes to ensure Medicare claims are
paid properly and by the appropriate
payer. The WC Case Control System is
used to control the receipt of WC
Medicare Set-aside Arrangement
Proposals and tracking of each proposal
through the review process to
establishment of the MSP period of
coverage via ECRS. ECRS is also used to
transmit WC Medicare Set-aside
Arrangement data from CMS Regional
Offices (RO) to the COBC for Medicare
beneficiaries and non-Medicare
beneficiaries who have an approved or
denied WC Medicare Set-aside
Arrangement to cover future medical
costs resulting from an injury incurred
while employed. If the injury results in
disability payments from the Social
Security Administration, there is a
reasonable expectation that the injured
individual will also be eligible for
Medicare benefits some time after the
WC settlement is made.
The ROs or a CMS contractor will
transmit the WC Medicare Set-aside
Arrangement information via ECRS, or
the WC Case Control System, for nonMedicare beneficiaries once they
approve or deny the arrangement. The
COBC will maintain ECRS and WC Case
Control System transmitted data in the
WCSAF for future matching purposes.
The COBC will ‘‘match’’ non-beneficiary
WCSAF data against the file it receives
each month of new Medicare eligibles to
identify any non-beneficiaries with
impending Medicare entitlement. Once
a match occurs, the existence of a WC
Medicare Set-aside Arrangement will be
reflected on the new beneficiary’s CWF
record and a Lead Medicare Contractor
will be assigned for monitoring
expenditures from the WC Medicare
Set-aside Arrangement.
CMS is drawn into a civil action
resulting from a WC claim in a
consulting position to ensure that a legal
settlement involving an injured worker
considers Medicare’s interest with
respect to future claims. CMS RO
approval of a WC Medicare Set-aside
Arrangement helps direct the treatment
of future disorders or health claims by
the injured worker, ensuring he/she is
adequately covered for long-term care
resulting from their WC injury, first by
the WC Medicare Set-aside Arrangement
and then by Medicare if necessary.
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I. Description of the Modified or
Altered System of Records
A. Statutory and Regulatory Basis for
SOR
Section 1862 (b)(2) of the Social
Security Act (the Act) requires that
Medicare payment may not be made for
any item or service to the extent that
payment has been made under a WC
law or plan. This section of the Act and
Title 42 Code of Federal Regulations
(CFR) 411.46 require CMS to exclude
payments once the injured individual
becomes a Medicare beneficiary when
payment should be made from WC
funds that are always primary to
Medicare payment.
B. Collection and Maintenance of Data
in the System
The WCSAF includes standard data
for identification including the name,
address, date of birth, Social Security
Number, date of the WC injury/incident,
injury diagnosis code(s), effective date
and amount of the WC Medicare Setaside Arrangement. In addition, data
will be included to enable CMS to
manage the WC Medicare Set-aside
Arrangement information when it
becomes part of the beneficiary’s record
on the CWF. These data include the WC
carrier, the administrator of the Setaside Arrangement, and the attorney
that prepared the arrangement.
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 WCSAF
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 WCSAF. CMS has the
following policies and procedures
concerning disclosures of information
that will be maintained in the system.
Disclosure of information from this
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
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that the data are being collected; e.g.,
ensuring that benefit payments are made
by the appropriate payer by
coordinating Medicare and other benefit
payments.
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 that have been contracted
by the agency to assist in the
performance of a service related to this
system and that need to have access to
the records in order to perform the
activity.
CMS contemplates 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 agency business
functions 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
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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 requires
the contractor to return or destroy all
information at the completion of the
contract.
2. To another Federal and/or state
agency, agency of a state government, an
agency established by state law, or its
fiscal agent 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.
Other Federal or state agencies in
their administration of a Federal health
program may require WCSAF
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper payment for services
provided. Releases of information
would be allowed if the proposed use(s)
for the information proved compatible
with the purpose for which CMS
collects the information.
WCSAF data may be released to the
State only on those injured individuals
who are not currently Medicare
beneficiaries but who have a WC
Medicare Set-aside Arrangement that is
intended to pay for future medical
expenses in place of future Medicare
benefits that has been approved, or
denied, by CMS.
3. To an individual or organization for
research, evaluation or epidemiological
projects related to the prevention of
disease or disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects.
The WCSAF data will provide the
research and evaluations a broader,
longitudinal, national perspective of the
status of injured individuals that are not
currently Medicare beneficiaries but
have a WC Medicare Set-aside
Arrangement that is intended to pay for
future medical expenses in place of
future Medicare benefits that has been
approved, or denied, by CMS.
4. 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.
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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.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity; or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation.
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.
6. To a CMS contractor (including, but
not necessarily limited to intermediaries
and carriers) that assists in the
administration of a CMS-administered
health benefits program, or to a grantee
of a CMS-administered grant program,
when disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such program.
CMS contemplates 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 the purpose of combating fraud and
abuse.
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
(like ensuring that 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
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the record might bring and those stated
in II.B, above), 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.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
Other State agencies in their
administration of a Federal health
program may require WCSAF
information for the purpose of
preventing, deterring, discovering,
detecting, investigating, examining,
prosecuting, suing with respect to,
defending against, correcting,
remedying, or otherwise combating such
fraud and abuse in such programs.
Releases of information would be
allowed if the proposed use(s) for the
information proved compatible with the
purpose for which CMS collects the
information.
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, 65 FR 82462 (12–28–00),
Subparts A and E. 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.’’
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 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
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users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: the Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
V. Effects of the Modified or Altered
System of Records on Individual Rights
CMS proposes to modify 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 (see item IV above) 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
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anticipate an unfavorable effect on
individual privacy as a result of
information relating to individuals.
Dated: December 12, 2005.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for
Medicare & Medicaid Services.
SYSTEM NO. 09–70–0537
SYSTEM NAME:
‘‘Non-Medicare Beneficiary Workers’
Compensation (WC) Set-aside File,
(WCSAF).’’
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive.
SYSTEM LOCATION:
Group Health Incorporated, 25
Broadway, New York, New York 10004.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The system of records will contain
data on non-Medicare beneficiaries that
receive an approval or a denial by the
Centers for Medicare & Medicaid
Services (CMS) of the adequacy of a WC
Medicare Set-aside Arrangement, as part
of a WC settlement that is intended to
pay for future medical expenses in place
of future Medicare benefits.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system of records will contain
the individual-level identifying data
including, but not limited to, name,
address, date of birth, social security
number (SSN), date of the WC injury/
incident, injury diagnosis code(s),
effective date and amount of the WC
Medicare Set-aside Arrangement. In
addition, data will be included to enable
CMS to manage the WC Medicare Setaside Arrangement information when it
becomes part of a beneficiary’s record
on the Common Working File. These
data include the WC carrier, the
administrator of the WC Medicare Setaside Arrangement, and the attorney
that prepared the arrangement.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Section 1862(b)(2) of the Social
Security Act (the Act) requires that
Medicare payment may not be made for
any item or service to the extent that
payment has been made under a WC
law or plan. This section of the Act and
Title 42 Code of Federal Regulation
(CFR) 411.46 require CMS to exclude
payments once the injured individual
becomes a Medicare beneficiary when
payment should be made from WC
funds that are always primary to
Medicare payment.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the nonMedicare beneficiary WCSAF is to
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maintain a file of individuals who were
injured while employed; are not
currently Medicare beneficiaries; whose
WC Settlement included a WC Medicare
Set-aside Arrangement that is intended
to pay for future medical expenses in
place of future Medicare benefits; and
was approved or not approved (denied)
by CMS as submitted. The information
retrieved from this system will be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor or consultant; (2) another
Federal and/or state agency, agency of a
state government, an agency established
by state law, or its fiscal agent to
contribute to the accuracy of CMS’
proper payment of Medicare benefits,
enable such agency to administer a
Federal health benefits program, or
enable such agency to fulfill a
requirement of a Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) an
individual or organization for research,
evaluation or epidemiological projects
related to the prevention of disease or
disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects; (4) support constituent
requests made to a Congressional
representative; (5) support litigation
involving the agency; and (6) combat
fraud and abuse in health benefits
programs funded in whole or in part by
Federal funds.
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 that have been contracted
by the agency to assist in the
performance of a service related to this
system and that need to have access to
the records in order to perform the
activity.
2. To another Federal and/or state
agency, agency of a state government, an
agency established by state law, or its
fiscal agent to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
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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.
3. To an individual or organization for
research, evaluation or epidemiological
projects related to the prevention of
disease or disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects.
4. 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.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity; or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government; is
a party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation.
6. To a CMS contractor (including, but
not necessarily limited to intermediaries
and carriers) that assists in the
administration of a CMS-administered
health benefits program, or to a grantee
of a CMS-administered grant program,
when disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such program.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
B. Additional Provisions Affecting
Routine Use Disclosures:
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
VerDate Aug<31>2005
18:59 Dec 16, 2005
Jkt 208001
Health Information’’ (45 CFR Parts 160
and 164, 65 FR 82462 (12–28–00)),
Subparts A and E. 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.’’
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 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:
All records are stored on magnetic
media.
RETIEVABILITY:
The records are retrieved
alphabetically by the name and/or SSN
of the subject of the records.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: The Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
75179
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 identifiable WCSAF
data for a period of 6 years and 3
months unless the injured individual
becomes a Medicare beneficiary prior to
that period of time. When either of these
criteria is met, the information stored on
the injured individual will be deleted
from the WCSAF. All claims-related
records are encompassed by the
document preservation order and will
be retained until notification is received
from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Medicare
Secondary Payer Policy Operations,
Financial Services Group, Office of
Financial Management, CMS, Mail Stop
C3–14–16, 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, and for verification purposes, the
subject individual’s name (woman’s
maiden name, if applicable), address,
date of birth, date of WC injury/
incident, diagnosis, effective date and
amount of the WC Medicare Set-aside
Arrangement. (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).
RECORD SOURCE CATEGORIES:
The Electronic Correspondence
Referral System, Workers Comp Case
E:\FR\FM\19DEN1.SGM
19DEN1
75180
Federal Register / Vol. 70, No. 242 / Monday, December 19, 2005 / Notices
Control System, Medicare contractors
and the Coordination of Benefit
Contractor, Common Working File, CMS
Regional Offices, an agency of a State
government, Medicare beneficiaries and
non-Medicare beneficiaries that have an
approved or denied WC Medicare Setaside arrangement to cover future
medical costs resulting from an injury
incurred while employed and the Social
Security Administration.
SYSTEMS EXEMPTED FROM CERTAIN PROVISION
OF THE ACT:
None.
[FR Doc. E5–7486 Filed 12–16–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Sanction Policies Task Order.
OMB No.: New Collection.
Description: This study is designed to
determine how local welfare offices
implement sanction policies in the
Temporary Assistance for Needy
Families program. This study will
survey local welfare staff to gather indepth qualitative information on how
workers interpret the policies and apply
them in specific instances. The results
of this study should give the
Administration for Children and
Families (ACF) a better understanding
of possible outcomes of various sanction
policies, which in turn will help ACF
design a research program to study the
effect of sanctions.
Respondents: A maximum of 324
welfare staff in local welfare offices.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per respondent
Average
burden
hours per response
Total burden
hours
In-person Survey and Telephone Interviews ...................................................
324
1
.85
275
Estimated Total Annual Burden
Hours: 275.
In compliance with the requirements
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
VerDate Aug<31>2005
18:59 Dec 16, 2005
Jkt 208001
Dated: December 12, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–24174 Filed 12–16–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1980N–0208]
Biological Products; Bacterial
Vaccines and Toxoids; Implementation
of Efficacy Review; Anthrax Vaccine
Adsorbed; Final Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00032
Fmt 4703
The final order on categorization
of AVA is effective December 19, 2005.
FOR FURTHER INFORMATION CONTACT:
Kathleen Swisher, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
DATES:
Table of Contents
The Food and Drug
Administration (FDA) proposed, among
other things, to classify Anthrax Vaccine
Adsorbed (AVA) on the basis of findings
and recommendations of the Panel on
Review of Bacterial Vaccines and
Toxoids (the Panel) on December 13,
1985. The Panel reviewed the safety,
efficacy, and labeling of bacterial
vaccines and toxoids with standards of
potency, bacterial antitoxins, and
immune globulins. After the initial final
rule and final order was vacated by the
United States District Court for the
District of Columbia on October 27,
2004, FDA published a new proposed
rule and proposed order on December
29, 2004. The purpose of this final order
is to categorize AVA according to the
evidence of its safety and effectiveness,
SUMMARY:
PO 00000
thereby determining if it may remain
licensed and on the market; issue a final
response to recommendations made in
the Panel’s report, and; respond to
comments on the previously published
proposed order. The final rule and final
order concerning bacterial vaccines and
toxoids other than AVA is published
elsewhere in this issue of the Federal
Register.
Sfmt 4703
I. Introduction
II. Background
A. General Description of the
‘‘Efficacy Review’’ for Biological
Products Licensed Before July 1972
B. The December 1985 Proposal
C. Additional Proceedings Following
the December 1985 Proposal
III. Categorization of Anthrax Vaccine
Adsorbed—Final Order
A. Efficacy of Anthrax Vaccine
Adsorbed
B. Safety of Anthrax Vaccine
Adsorbed
C. The Panel’s General Statement:
Anthrax Vaccine, Adsorbed,
Description of Product
D. The Panel’s Specific Product
E:\FR\FM\19DEN1.SGM
19DEN1
Agencies
[Federal Register Volume 70, Number 242 (Monday, December 19, 2005)]
[Notices]
[Pages 75175-75180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7486]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers For Medicare & Medicaid Services
Privacy Act of 1974; Report of a Modified or Altered System of
Records
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of a Modified or Altered System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to modify or alter an existing SOR, titled
``Non-Medicare Beneficiary Workers' Compensation (WC) Set-aside File
(WCSAF),'' System No. 09-70-0537, last published at 67 FR 36892 (May
28, 2002). We propose to expand the scope of this system to include
non-Medicare beneficiaries whose applications for a WC Arrangement have
not been approved (denied) as submitted. The disclosure provisions
contained in published routine use number 2 and 3 are deemed to be
duplicative of each other and as such require corrective action. This
modified routine use will now be number 2 and will authorize disclosure
to ``another Federal and/or state agency, agency of a state government,
an agency established by state law, or its fiscal agent.''
We are modifying the language in the remaining routine uses to
provide clarity to CMS's intention to disclose individual-specific
information contained in this system. The routine uses will then be
prioritized and reordered according to their usage. We will also take
the opportunity to update any sections of the system that were affected
by the recent reorganization and to update language in the
administrative sections to correspond with language used in other CMS
SORs.
The primary purpose of the non-Medicare beneficiary WCSAF is to
maintain a file of individuals who were injured while employed; are not
currently Medicare beneficiaries; whose WC Settlement included a WC
Medicare Set-aside Arrangement that is intended to pay for future
medical expenses in place of future Medicare benefits; and was approved
or not approved (denied) by CMS as submitted. The information retrieved
from this system will be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor or consultant; (2) another Federal and/or state agency,
agency of a state government, an agency established by state law, or
its fiscal agent to contribute to the accuracy of CMS' proper payment
of Medicare benefits, enable such agency to administer a Federal health
benefits program, or enable such agency to fulfill a requirement of a
Federal statute or regulation that implements a health benefits program
funded in whole or in part with Federal funds; (3) an individual or
organization for research, evaluation or epidemiological projects
related to the prevention of disease or disability, the restoration or
maintenance of health, or for understanding and improving payment
projects; (4) support constituent requests made to a Congressional
representative; (5) support litigation involving the agency; and (6)
combat fraud and abuse in health benefits programs funded in whole or
in part by Federal funds. We have provided background information about
the modified system in the Supplementary Information section, below.
Although the Privacy Act requires only that the ``routine use'' portion
of the system be published for comment, CMS invites comments on all
portions of this notice. See Effective Date section for comment period.
EFFECTIVE DATE: CMS filed a modified or altered SOR 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 December 13, 2005. We will not disclose
any information under a routine use until 30 days after publication. We
may defer implementation of this system or one or more of the routine
use statements listed below if we receive comments that persuade us to
defer implementation.
ADDRESSES: The public should address comment to the CMS Privacy
Officer, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. Comments received will be available for review at
this location, by appointment, during regular business hours, Monday
through Friday from 9 a.m.-3 p.m., eastern daylight time.
FOR FURTHER INFORMATION CONTACT: Donna Kettish, Division of Medicare
Secondary Payer Policy Operations, Financial Services Group, Office of
Financial Management, CMS, Mail stop C3-14-16, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850. She can be reached by telephone at
(410) 786-5462, or via e-mail at Donna.Kettish@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Notice for this system, ``Non Medicare
Beneficiary Workers' Compensation Set-aside File,'' System No. 09-70-
0537, was most recently published in full at 67 Federal Register 36892
(May 28, 2002). CMS is responsible for safeguarding the fiscal
integrity of the Medicare Program. The Health Insurance Portability and
Accountability Act of 1996 established the ``Medicare Integrity
Program,'' enabling CMS to competitively award contracts with entities
to promote the integrity of the Medicare Program. The Coordination of
Benefit Contractor (COBC) is one of those specialized contractors hired
to increase efficiency and effectiveness by ensuring that the
appropriate payer makes benefit payments by coordinating Medicare and
other benefit payments.
The Electronic Correspondence Referral System (ECRS) is currently
used to transfer data between CMS's
[[Page 75176]]
Medicare contractors and the COBC to establish Medicare Secondary Payer
(MSP) periods of coverage on CMS's Common Working File (CWF) and to
update CWF with the results of a CMS review of a WC Medicare Set-aside
Arrangement Proposal. The CWF is a CMS system, containing Medicare
beneficiary eligibility information that is used for verification and
validation purposes to ensure Medicare claims are paid properly and by
the appropriate payer. The WC Case Control System is used to control
the receipt of WC Medicare Set-aside Arrangement Proposals and tracking
of each proposal through the review process to establishment of the MSP
period of coverage via ECRS. ECRS is also used to transmit WC Medicare
Set-aside Arrangement data from CMS Regional Offices (RO) to the COBC
for Medicare beneficiaries and non-Medicare beneficiaries who have an
approved or denied WC Medicare Set-aside Arrangement to cover future
medical costs resulting from an injury incurred while employed. If the
injury results in disability payments from the Social Security
Administration, there is a reasonable expectation that the injured
individual will also be eligible for Medicare benefits some time after
the WC settlement is made.
The ROs or a CMS contractor will transmit the WC Medicare Set-aside
Arrangement information via ECRS, or the WC Case Control System, for
non-Medicare beneficiaries once they approve or deny the arrangement.
The COBC will maintain ECRS and WC Case Control System transmitted data
in the WCSAF for future matching purposes. The COBC will ``match'' non-
beneficiary WCSAF data against the file it receives each month of new
Medicare eligibles to identify any non-beneficiaries with impending
Medicare entitlement. Once a match occurs, the existence of a WC
Medicare Set-aside Arrangement will be reflected on the new
beneficiary's CWF record and a Lead Medicare Contractor will be
assigned for monitoring expenditures from the WC Medicare Set-aside
Arrangement.
CMS is drawn into a civil action resulting from a WC claim in a
consulting position to ensure that a legal settlement involving an
injured worker considers Medicare's interest with respect to future
claims. CMS RO approval of a WC Medicare Set-aside Arrangement helps
direct the treatment of future disorders or health claims by the
injured worker, ensuring he/she is adequately covered for long-term
care resulting from their WC injury, first by the WC Medicare Set-aside
Arrangement and then by Medicare if necessary.
I. Description of the Modified or Altered System of Records
A. Statutory and Regulatory Basis for SOR
Section 1862 (b)(2) of the Social Security Act (the Act) requires
that Medicare payment may not be made for any item or service to the
extent that payment has been made under a WC law or plan. This section
of the Act and Title 42 Code of Federal Regulations (CFR) 411.46
require CMS to exclude payments once the injured individual becomes a
Medicare beneficiary when payment should be made from WC funds that are
always primary to Medicare payment.
B. Collection and Maintenance of Data in the System
The WCSAF includes standard data for identification including the
name, address, date of birth, Social Security Number, date of the WC
injury/incident, injury diagnosis code(s), effective date and amount of
the WC Medicare Set-aside Arrangement. In addition, data will be
included to enable CMS to manage the WC Medicare Set-aside Arrangement
information when it becomes part of the beneficiary's record on the
CWF. These data include the WC carrier, the administrator of the Set-
aside Arrangement, and the attorney that prepared the arrangement.
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 WCSAF 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 WCSAF. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from this 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 are being collected; e.g., ensuring that benefit
payments are made by the appropriate payer by coordinating Medicare and
other benefit payments.
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 that have been contracted
by the agency to assist in the performance of a service related to this
system and that need to have access to the records in order to perform
the activity.
CMS contemplates 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 agency business
functions 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
[[Page 75177]]
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 requires the contractor to return or destroy all
information at the completion of the contract.
2. To another Federal and/or state agency, agency of a state
government, an agency established by state law, or its fiscal agent 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.
Other Federal or state agencies in their administration of a
Federal health program may require WCSAF information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper payment for services provided. Releases
of information would be allowed if the proposed use(s) for the
information proved compatible with the purpose for which CMS collects
the information.
WCSAF data may be released to the State only on those injured
individuals who are not currently Medicare beneficiaries but who have a
WC Medicare Set-aside Arrangement that is intended to pay for future
medical expenses in place of future Medicare benefits that has been
approved, or denied, by CMS.
3. To an individual or organization for research, evaluation or
epidemiological projects related to the prevention of disease or
disability, the restoration or maintenance of health, or for
understanding and improving payment projects.
The WCSAF data will provide the research and evaluations a broader,
longitudinal, national perspective of the status of injured individuals
that are not currently Medicare beneficiaries but have a WC Medicare
Set-aside Arrangement that is intended to pay for future medical
expenses in place of future Medicare benefits that has been approved,
or denied, by CMS.
4. 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.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity; or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation.
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.
6. To a CMS contractor (including, but not necessarily limited to
intermediaries and carriers) that assists in the administration of a
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
CMS contemplates 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 the purpose of combating fraud and abuse.
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 (like
ensuring that 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 those stated in II.B, above), 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.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
Other State agencies in their administration of a Federal health
program may require WCSAF information for the purpose of preventing,
deterring, discovering, detecting, investigating, examining,
prosecuting, suing with respect to, defending against, correcting,
remedying, or otherwise combating such fraud and abuse in such
programs. Releases of information would be allowed if the proposed
use(s) for the information proved compatible with the purpose for which
CMS collects the information.
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, 65 FR 82462 (12-28-00), Subparts A and E. 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.''
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 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
[[Page 75178]]
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 Modified or Altered System of Records on Individual
Rights
CMS proposes to modify 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 (see item IV above) 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 information relating to
individuals.
Dated: December 12, 2005.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0537
System Name:
``Non-Medicare Beneficiary Workers' Compensation (WC) Set-aside
File, (WCSAF).''
Security Classification:
Level 3 Privacy Act Sensitive.
System Location:
Group Health Incorporated, 25 Broadway, New York, New York 10004.
Categories of Individuals Covered by the System:
The system of records will contain data on non-Medicare
beneficiaries that receive an approval or a denial by the Centers for
Medicare & Medicaid Services (CMS) of the adequacy of a WC Medicare
Set-aside Arrangement, as part of a WC settlement that is intended to
pay for future medical expenses in place of future Medicare benefits.
Categories of Records in the System:
This system of records will contain the individual-level
identifying data including, but not limited to, name, address, date of
birth, social security number (SSN), date of the WC injury/incident,
injury diagnosis code(s), effective date and amount of the WC Medicare
Set-aside Arrangement. In addition, data will be included to enable CMS
to manage the WC Medicare Set-aside Arrangement information when it
becomes part of a beneficiary's record on the Common Working File.
These data include the WC carrier, the administrator of the WC Medicare
Set-aside Arrangement, and the attorney that prepared the arrangement.
Authority for Maintenance of the System:
Section 1862(b)(2) of the Social Security Act (the Act) requires
that Medicare payment may not be made for any item or service to the
extent that payment has been made under a WC law or plan. This section
of the Act and Title 42 Code of Federal Regulation (CFR) 411.46 require
CMS to exclude payments once the injured individual becomes a Medicare
beneficiary when payment should be made from WC funds that are always
primary to Medicare payment.
Purpose(s) of The System:
The primary purpose of the non-Medicare beneficiary WCSAF is to
maintain a file of individuals who were injured while employed; are not
currently Medicare beneficiaries; whose WC Settlement included a WC
Medicare Set-aside Arrangement that is intended to pay for future
medical expenses in place of future Medicare benefits; and was approved
or not approved (denied) by CMS as submitted. The information retrieved
from this system will be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor or consultant; (2) another Federal and/or state agency,
agency of a state government, an agency established by state law, or
its fiscal agent to contribute to the accuracy of CMS' proper payment
of Medicare benefits, enable such agency to administer a Federal health
benefits program, or enable such agency to fulfill a requirement of a
Federal statute or regulation that implements a health benefits program
funded in whole or in part with Federal funds; (3) an individual or
organization for research, evaluation or epidemiological projects
related to the prevention of disease or disability, the restoration or
maintenance of health, or for understanding and improving payment
projects; (4) support constituent requests made to a Congressional
representative; (5) support litigation involving the agency; and (6)
combat fraud and abuse in health benefits programs funded in whole or
in part by Federal funds.
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 that have been contracted
by the agency to assist in the performance of a service related to this
system and that need to have access to the records in order to perform
the activity.
2. To another Federal and/or state agency, agency of a state
government, an agency established by state law, or its fiscal agent to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
[[Page 75179]]
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.
3. To an individual or organization for research, evaluation or
epidemiological projects related to the prevention of disease or
disability, the restoration or maintenance of health, or for
understanding and improving payment projects.
4. 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.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity; or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government; is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation.
6. To a CMS contractor (including, but not necessarily limited to
intermediaries and carriers) that assists in the administration of a
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures:
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR Parts 160 and
164, 65 FR 82462 (12-28-00)), Subparts A and E. 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.''
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 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:
All records are stored on magnetic media.
Retievability:
The records are retrieved alphabetically by the name and/or SSN of
the subject of the records.
Safeguards:
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
Retention and Disposal:
CMS will retain identifiable WCSAF data for a period of 6 years and
3 months unless the injured individual becomes a Medicare beneficiary
prior to that period of time. When either of these criteria is met, the
information stored on the injured individual will be deleted from the
WCSAF. All claims-related records are encompassed by the document
preservation order and will be retained until notification is received
from DOJ.
System Manager And Address:
Director, Division of Medicare Secondary Payer Policy Operations,
Financial Services Group, Office of Financial Management, CMS, Mail
Stop C3-14-16, 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, and for verification
purposes, the subject individual's name (woman's maiden name, if
applicable), address, date of birth, date of WC injury/incident,
diagnosis, effective date and amount of the WC Medicare Set-aside
Arrangement. (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).
Record Source Categories:
The Electronic Correspondence Referral System, Workers Comp Case
[[Page 75180]]
Control System, Medicare contractors and the Coordination of Benefit
Contractor, Common Working File, CMS Regional Offices, an agency of a
State government, Medicare beneficiaries and non-Medicare beneficiaries
that have an approved or denied WC Medicare Set-aside arrangement to
cover future medical costs resulting from an injury incurred while
employed and the Social Security Administration.
Systems Exempted From Certain Provision of the Act:
None.
[FR Doc. E5-7486 Filed 12-16-05; 8:45 am]
BILLING CODE 4120-03-P