Privacy Act of 1974; Report of a New System of Records, 41450-41454 [E6-11579]
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rwilkins on PROD1PC63 with NOTICES_1
41450
Federal Register / Vol. 71, No. 140 / Friday, July 21, 2006 / Notices
description of what elements the ‘‘behavioral
health services (including medication
services)’’ encompass, and how they are
different (or the same) as services in the
currently approved State plan. It is not clear
whether this is an expansion of coverage or
a different payment methodology for school
providers. Absent such information, SPA 05–
06 did not comply with the requirements of
section 1902(a)(10) of the Act to provide for
medical assistance as defined in section
1905(a) of the Act.
Section 1902(a)(2) of the Act provides that
the State plan must assure adequate funding
for the non-Federal share of expenditures
from State or local sources for the amount,
duration, scope, or quality of care and
services available under the plan. Section
1902(a)(30)(A) of the Act requires that State
plans provide for payment for care and
services available under the plan that is
‘‘consistent with economy, efficiency, and
quality of care.’’ In order to assess
compliance with these provisions, State
officials were asked to provide information
related to Alaska’s funding mechanisms for
payments, and the net State and local
expenditures that are incurred. Nor did
Alaska respond to requests for any transfers
of funds between providers and State or local
governments, and information as to whether
the providers keep 100 percent of the total
computable funds given as Medicaid
payments.
According to a flow chart provided by the
State, the Medicaid agency pays the schools
100 percent of the claimed amount. A
quarterly bill for the State match is then
submitted to school providers who transfer to
the Medicaid agency the State share of the
services provided. This transfer of funds is
made after the schools have been reimbursed
for the services they provide, and is
effectively a refund by the schools for part of
their Medicaid payments. As a result of this
refund, the net expenditure by the State
Medicaid agency is wholly federally funded.
In light of this refund arrangement, we
cannot conclude that the proposed payment
rate reflects the net expenditure by the State
for Medicaid services provided by schools,
and that the net non-Federal share meets the
requirements of section 1902(a)(2) of the Act.
Moreover, the refund is an indication that the
full payment amount is not required to
ensure Medicaid beneficiaries’ access to the
providers’ services. The result is that
proposed payments under this section of the
plan would not be in compliance with the
requirement under section 1902(a)(30)(A) of
the Act that payment rates must be consistent
with economy, efficiency, and quality of care.
Finally, the proposed SPA does not comply
with the general provisions of section
1902(a), including section 1902(a)(4) of the
Act, as implemented in part by Federal
regulations at 42 CFR section 430.10. This
regulation requires that States include in
their State plans all information necessary for
CMS to determine whether the plan can be
approved to serve as a basis for Federal
financial participation. As discussed above,
Alaska did not provide information that
would more precisely identify the covered
services or the non-Federal funding source.
Therefore the proposed SPA does not comply
with this requirement.
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For the reasons cited above, and after
consultation with the Secretary, as required
by Federal regulations at 42 CFR 430.15(c)(2),
Alaska SPA 05–06 was disapproved.
I am scheduling a hearing on your request
for reconsideration to be held on August 29,
2006, at the Blanchard Plaza Building, 2201
Sixth Avenue, 11th Floor Conference Room,
Seattle, WA 98121, to reconsider the decision
to disapprove SPA 05–06. If this date is not
acceptable, we would be glad to set another
date that is mutually agreeable to the parties.
The hearing will be governed by the
procedures prescribed by Federal regulations
at 42 CFR part 430.
I am designating Ms. Kathleen ScullyHayes as the presiding officer. If these
arrangements present any problems, please
contact the presiding officer at (410) 786–
2055. In order to facilitate any
communication which may be necessary
between the parties to the hearing, please
notify the presiding officer to indicate
acceptability of the hearing date that has
been scheduled, and provide names of the
individuals who will represent the State at
the hearing.
Sincerely,
Mark B. McClellan, M.D., PhD.
Section 1116 of the Social Security Act
(42 U.S.C. 1316; 42 CFR 430.18)
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program)
Dated: July 14, 2006.
Mark B. McClellan,
Administrator.
[FR Doc. E6–11577 Filed 7–20–06; 8:45 am]
BILLING CODE 4120–01–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
system titled, ‘‘Medicare Chiropractic
Coverage Demonstration and Evaluation
(MCCDE), System No. 09–70–0577.’’
The demonstration entitled, ‘‘Expansion
of Coverage of Chiropractic Services
Demonstration’’ was established under
provisions of Section 651 (d) of the
Medicare Prescription Drug,
Improvement, and Modernization Act
(MMA) of 2003 (Public Law (Pub. L.)
108–173). The MCCDE will focus on
selected beneficiaries, residing within
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the four demonstration regions or their
respective control regions, who have
Medicare chiropractic-eligible diagnoses
[i.e., neuromusculoskeletal conditions
(NMS)]. The system will contain:
Demographic information from
Medicare enrollment files; Medicare
claims data on utilization of NMSrelated Medicare services with
associated costs, for demonstration
participants and their matched, nonparticipant controls; and participant
satisfaction survey data for the subset
randomly surveyed. The MCCDE has
four goals: (1) To determine whether
eligible beneficiaries who use
chiropractic services under the
demonstration use a lesser overall
amount of items and services for which
payment is made under the Medicare
program than eligible beneficiaries who
do not use such services; (2) to
determine the cost of providing
payment for chiropractic services under
the Medicare program; (3) to further
determine whether the demonstration
achieves budget neutrality, and if not,
the amount of any cost excess to be
recouped by Medicare from the
chiropractic profession; and (4) finally,
to ascertain the satisfaction of eligible
beneficiaries participating in the
demonstration projects and their
perceived quality of care received.
The primary purpose of the system is
to collect and maintain individually
identifiable information on
beneficiaries, physicians, participating
chiropractors, and providers of service
participating in the demonstration and
evaluation program. Information
retrieved from this system may be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor, consultant or grantee; (2)
assist another Federal or state agency
with information to contribute to the
accuracy of CMS’s proper payment of
Medicare benefits, enable such agency
to administer a Federal health benefits
program, or to enable such agency to
fulfill a requirement of Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support litigation
involving the agency; and (5) combat
fraud and abuse in certain Federallyfunded health benefits programs. We
have provided background information
about the new system in the
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SUPPLEMENTARY INFORMATION section
below.
Although the Privacy Act requires
only that CMS provide an opportunity
for interested persons to comment on
the proposed routine uses, CMS invites
comments on all portions of this notice.
See ‘‘Effective Dates’’ section for
comment period.
DATES: Effective Date: CMS filed a new
SOR report with the Chair of the House
Committee on Government Reform and
Oversight, the Chair of the Senate
Committee on Homeland Security &
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on July
14, 2006. To ensure that all parties have
adequate time in which to comment, the
new system will become effective 30
days from the publication of the notice,
or 40 days from the date it was
submitted to OMB and the Congress,
whichever is later. We may defer
implementation of this system or one or
more of the routine use statements listed
below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address
comment to the CMS Privacy Officer,
Mail-stop N2–04–27, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. Comments received will be
available for review at this location by
appointment during regular business
hours, Monday through Friday from 9
a.m.–3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT:
Carol Magee, Division of Beneficiary
Research, Research and Evaluation
Group, Office of Research Development
and Information, CMS, Mail Stop
C3–19–07, 7500 Security Boulevard,
Baltimore, Maryland 21244–1849. Her
telephone number is (410) 786–6611,
and her e-mail is
Carol.Magee@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Medicare demonstration being
evaluated by MCCDE is entitled,
‘‘Expansion of Coverage of Chiropractic
Services Demonstration’’ and was
established under Section 651 of the of
the MMA, for the purpose of evaluating
the feasibility and advisability of
providing additional Medicare coverage
for chiropractic services, beyond the
usual covered care allowed for spinal
manipulation to correct spinal
subluxation. The two-year
demonstration, operates within four
geographic regions (two rural and two
urban, with one including a health
professional shortage area (HPSA) and
one a non-HPSA area, respectively in
each). For the demonstration, CMS has
approved an expanded list of NMS
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conditions, all typical among users of
chiropractic, as well as various
additional diagnostic tests, which may
be billed without physician approval to
Part B Medicare by participating
chiropractors. Participation in this
expanded payment demonstration is
determined individually by chiropractic
provider practices and any Medicare
Advantage Plans located within the four
regions. Congress has mandated budget
neutrality; consequently, any overall
excess costs to Medicare, within this
two-year span of expanded chiropractic
coverage, must be subsequently
recouped by Medicare from the
chiropractic profession.
The MCCDE to enable conduct of the
mandated evaluation of this chiropractic
demonstration will acquire and
aggregate data relative to beneficiaries
receiving chiropractic services. The
beneficiary survey data will address
patient satisfaction and quality of care
issues, while the relevant abstracted
Medicare claims file data elements on
NMS diagnoses, services, and costs will
enable determination of costs and
utilization patterns, and of
demonstration budget neutrality.
Additionally the evaluation will address
cost aspects relative to the potential for
expansion of chiropractic coverage to
the national Medicare program.
I. Description of the Proposed System of
Records
A. Statutory and Regulatory Basis for
SOR. The statutory authority for this
system is given under the Section 651
of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173).
B. Collection and Maintenance of Data
in the System. This system will
maintain individually-identifiable and
other data collected by CMS and its
contractors on Medicare participants
and providers of service in the
chiropractic coverage demonstration,
and on selected beneficiaries as nonparticipant controls, in order to analyze
relevant data for the mandated
evaluation and as means to select and
contact participant beneficiaries for the
survey.
Information collected will include,
but is not limited to, beneficiary health
insurance claim number, beneficiary
identification code, beneficiary name
and address, race/ethnicity, gender type,
date of birth, diagnostic code(s),
relevant procedural codes and dates of
service, dates of admissions and
discharges, diagnostic review group,
unique provider identification number,
as well as self-reported survey
information regarding health status,
demographic utilization issues, and
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satisfaction with care relating to
chiropractic services.
II. Agency Policies, Procedures, and
Restrictions on the Routine Use
A. The Privacy Act permits us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such disclosure of data is known as
a ‘‘routine use.’’ The Government will
only release MCCDE 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
MCCDE.
CMS has the following policies and
procedures concerning disclosures of
information that will be maintained in
the system. Disclosure of information
from the system will be approved only
to the extent necessary to accomplish
the purpose of the disclosure and only
after CMS:
1. Determines that the use or
disclosure is consistent with the reason
that the data is being collected; e.g., to
collect and maintain individually
identifiable information on
beneficiaries, physicians, participating
chiropractors, and providers of service
participating in the demonstration and
evaluation program.
2. Determines that:
a. The purpose for which the
disclosure is to be made can only be
accomplished if the record is provided
in individually identifiable form;
b. The purpose for which the
disclosure is to be made is of sufficient
importance to warrant the effect and/or
risk on the privacy of the individual that
additional exposure of the record might
bring; and
c. There is a strong probability that
the proposed use of the data would in
fact accomplish the stated purpose(s).
3. Requires the information recipient
to:
a. Establish administrative, technical,
and physical safeguards to prevent
unauthorized use of disclosure of the
record;
b. Remove or destroy, at the earliest
time, all patient-identifiable
information; and
c. Agree to not use or disclose the
information for any purpose other than
the stated purpose under which the
information was disclosed.
4. Determines that the data are valid
and reliable.
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III. Proposed Routine Use Disclosures
of Data in the System
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To agency contractors, consultants,
or grantees, who have been engaged by
the agency to assist in the performance
of a service related to this collection and
who need to have access to the records
in order to perform the activity.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual or similar agreement
with a third party to assist in
accomplishing CMS function relating to
purposes for this system.
CMS occasionally contracts out
certain of its functions when doing so
would contribute to effective and
efficient operations. CMS must be able
to give a contractor, consultant, or
grantee whatever information is
necessary for the contractor, consultant,
or grantee to fulfill its duties. In these
situations, safeguards are provided in
the contract prohibiting the contractor,
consultant, or grantee from using or
disclosing the information for any
purpose other than that described in the
contract and requires the contractor,
consultant, or grantee to return or
destroy all information at the
completion of the contract.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits;
b. Enable such agency to administer a
Federal health benefits program, or, as
necessary, to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; and/or
c. Assist Federal/state Medicaid
programs within the state.
Other Federal or state agencies, in
their administration of a Federal health
program, may require MCCDE
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper reimbursement for
services provided.
3. To an individual or organization for
a research project or in support of an
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evaluation project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment related projects.
The MCCDE data will provide for
research or support of evaluation
projects and a broader, longitudinal,
national perspective of the status of
Medicare beneficiaries. CMS anticipates
that many researchers will have
legitimate requests to use these data in
projects that could ultimately improve
the care provided to Medicare
beneficiaries and the policies that
govern their care.
4. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
such litigation, and, by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, and occasionally when
another party is involved in litigation
and CMS policies or operations could be
affected by the outcome of the litigation,
CMS would be able to disclose
information to the DOJ, court or
adjudicatory body involved.
5. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual, grantee, cooperative
agreement or consultant relationship
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud and
abuse. CMS occasionally contracts out
certain of its functions or makes grants
or cooperative agreements when doing
so would contribute to effective and
efficient operations. CMS must be able
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to give a contractor, grantee, consultant
or other legal agent whatever
information is necessary for the agent to
fulfill its duties. In these situations,
safeguards are provided in the contract
prohibiting the agent from using or
disclosing the information for any
purpose other than that described in the
contract and requiring the agent to
return or destroy all information.
6. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
Other agencies may require MCCDE
information for the purpose of
combating fraud and abuse in such
Federally-funded programs.
B. Additional Provisions Affecting
Routine Use Disclosures.
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, Subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164.512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
because of the small size, use of this
information could allow for the
deduction of the identity of the
beneficiary).
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
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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 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.
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V. Effects of the Proposed System of
Records on Individual Rights
CMS proposes to establish this system
in accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
Data in this system will be subject to the
authorized releases in accordance with
the routine uses identified in this
system of records.
CMS will take precautionary
measures to minimize the risks of
unauthorized access to the records and
the potential harm to individual privacy
or other personal or property rights of
patients whose data are maintained in
this system. CMS will collect only that
information necessary to perform the
system’s functions. In addition, CMS
will make disclosure from the proposed
system only with consent of the subject
individual, or his/her legal
representative, or in accordance with an
applicable exception provision of the
Privacy Act. CMS, therefore, does not
anticipate an unfavorable effect on
individual privacy as a result of
information relating to individuals.
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Dated; July 13, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO. 09–70–0577
SYSTEM NAME:
‘‘Medicare Chiropractic Coverage
Demonstration and Evaluation
(MCCDE),’’ HHS/CMS/ORDI.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid
Services (CMS) Data Center, 7500
Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244–
1850 and at various co-locations of CMS
agents as follows:
• Brandeis University, 415 South
Street, Waltham, Massachusetts
002454–9110.
• Battelle Institute, Suite 200, 6115
Falls Road, Baltimore, Maryland 21209.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
This system will maintain
individually-identifiable and other data
collected by CMS and its contractors on
Medicare participants and providers of
service in the chiropractic coverage
demonstration, and on selected
beneficiaries as non-participant
controls, in order to analyze relevant
data for the mandated evaluation and as
means to select and contact participant
beneficiaries for the survey.
CATEGORIES OF RECORDS IN THE SYSTEM:
Information collected will include,
but is not limited to, beneficiary health
insurance claim number (HICN),
beneficiary identification code,
beneficiary name and address, race/
ethnicity, gender type, date of birth,
diagnostic code(s), relevant procedural
codes and dates of service, dates of
admissions and discharges, diagnostic
review group, unique provider
identification number (UPIN), as well as
self-reported survey information
regarding health status, demographic
utilization issues, and satisfaction with
care relating to chiropractic services.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system
is given under the Section 651 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is
to collect and maintain individually
identifiable information on
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41453
beneficiaries, physicians, participating
chiropractors, and providers of service
participating in the demonstration and
evaluation program. Information
retrieved from this system may be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor, consultant or grantee; (2)
assist another Federal or state agency
with information to contribute to the
accuracy of CMS’s proper payment of
Medicare benefits, enable such agency
to administer a Federal health benefits
program, or to enable such agency to
fulfill a requirement of Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support litigation
involving the agency; and (5) combat
fraud and abuse in certain Federallyfunded health benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To agency contractors, consultants,
or grantees, who have been engaged by
the agency to assist in the performance
of a service related to this collection and
who need to have access to the records
in order to perform the activity.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits;
b. enable such agency to administer a
Federal health benefits program, or, as
necessary, to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; and/or
c. assist Federal/state Medicaid
programs within the state.
3. To an individual or organization for
a research project or in support of an
evaluation project related to the
prevention of disease or disability, the
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restoration or maintenance of health, or
payment related projects.
4. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. any employee of the agency in his
or her official capacity, or
c. any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. the United States Government, is a
party to litigation or has an interest in
such litigation, and, by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
5. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such program.
6. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
B. Additional Provisions Affecting
Routine Use Disclosures.
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164.512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
VerDate Aug<31>2005
17:59 Jul 20, 2006
Jkt 208001
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
because of the small size, use of this
information could allow for the
deduction of the identity of the
beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records will be stored
electronically and on hard copy.
RETRIEVABILITY:
The collected data are retrieved by an
individual identifier; e.g., beneficiary
name or HICN.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: The Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
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.
CMS will retain information for a total
period not to exceed 25 years. All
Frm 00040
Fmt 4703
Sfmt 4703
SYSTEM MANAGER AND ADDRESS:
Director, Office of Research,
Development, and Information, CMS,
Mail Stop C3–20–11, 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, employee identification number,
tax identification number, national
provider number, and for verification
purposes, the subject individual’s name
(woman’s maiden name, if applicable),
HICN, and/or SSN (furnishing the SSN
is voluntary, but it may make searching
for a record easier and prevent delay).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Data sources will include Medicare
claims for beneficiaries with relevant
neuromusculoskeletal conditions
diagnoses, and responses from the
survey instrument administered to
participant beneficiaries. The collected
information from Medicare claims and
enrollment data and the survey
instrument, will include all of the data
elements that reside within the
Medicare National Claims History File
and the Medicare Enrollment Data Base,
as well as the self-reported beneficiary
survey responses.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
RETENTION AND DISPOSAL:
PO 00000
claims-related records are encompassed
by the document preservation order and
will be retained until notification is
received from DOJ.
[FR Doc. E6–11579 Filed 7–20–06; 8:45 am]
BILLING CODE 4120–03–P
E:\FR\FM\21JYN1.SGM
21JYN1
Agencies
[Federal Register Volume 71, Number 140 (Friday, July 21, 2006)]
[Notices]
[Pages 41450-41454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11579]
-----------------------------------------------------------------------
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 system titled, ``Medicare
Chiropractic Coverage Demonstration and Evaluation (MCCDE), System No.
09-70-0577.'' The demonstration entitled, ``Expansion of Coverage of
Chiropractic Services Demonstration'' was established under provisions
of Section 651 (d) of the Medicare Prescription Drug, Improvement, and
Modernization Act (MMA) of 2003 (Public Law (Pub. L.) 108-173). The
MCCDE will focus on selected beneficiaries, residing within the four
demonstration regions or their respective control regions, who have
Medicare chiropractic-eligible diagnoses [i.e., neuromusculoskeletal
conditions (NMS)]. The system will contain: Demographic information
from Medicare enrollment files; Medicare claims data on utilization of
NMS-related Medicare services with associated costs, for demonstration
participants and their matched, non-participant controls; and
participant satisfaction survey data for the subset randomly surveyed.
The MCCDE has four goals: (1) To determine whether eligible
beneficiaries who use chiropractic services under the demonstration use
a lesser overall amount of items and services for which payment is made
under the Medicare program than eligible beneficiaries who do not use
such services; (2) to determine the cost of providing payment for
chiropractic services under the Medicare program; (3) to further
determine whether the demonstration achieves budget neutrality, and if
not, the amount of any cost excess to be recouped by Medicare from the
chiropractic profession; and (4) finally, to ascertain the satisfaction
of eligible beneficiaries participating in the demonstration projects
and their perceived quality of care received.
The primary purpose of the system is to collect and maintain
individually identifiable information on beneficiaries, physicians,
participating chiropractors, and providers of service participating in
the demonstration and evaluation program. Information retrieved from
this system may be disclosed to: (1) Support regulatory, reimbursement,
and policy functions performed within the agency or by a contractor,
consultant or grantee; (2) assist another Federal or state agency with
information to contribute to the accuracy of CMS's proper payment of
Medicare benefits, enable such agency to administer a Federal health
benefits program, or to enable such agency to fulfill a requirement of
Federal statute or regulation that implements a health benefits program
funded in whole or in part with Federal funds; (3) support an
individual or organization for a research project or in support of an
evaluation project related to the prevention of disease or disability,
the restoration or maintenance of health, or payment related projects;
(4) support litigation involving the agency; and (5) combat fraud and
abuse in certain Federally-funded health benefits programs. We have
provided background information about the new system in the
[[Page 41451]]
SUPPLEMENTARY INFORMATION section below.
Although the Privacy Act requires only that CMS provide an
opportunity for interested persons to comment on the proposed routine
uses, CMS invites comments on all portions of this notice. See
``Effective Dates'' section for comment period.
DATES: Effective Date: CMS filed a new SOR report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Homeland Security & Governmental Affairs, and the
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB) on July 14, 2006. To ensure that all
parties have adequate time in which to comment, the new system will
become effective 30 days from the publication of the notice, or 40 days
from the date it was submitted to OMB and the Congress, whichever is
later. We may defer implementation of this system or one or more of the
routine use statements listed below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address comment to the CMS Privacy
Officer, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. Comments received will be available for review at
this location by appointment during regular business hours, Monday
through Friday from 9 a.m.-3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT: Carol Magee, Division of Beneficiary
Research, Research and Evaluation Group, Office of Research Development
and Information, CMS, Mail Stop C3-19-07, 7500 Security Boulevard,
Baltimore, Maryland 21244-1849. Her telephone number is (410) 786-6611,
and her e-mail is Carol.Magee@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The Medicare demonstration being evaluated
by MCCDE is entitled, ``Expansion of Coverage of Chiropractic Services
Demonstration'' and was established under Section 651 of the of the
MMA, for the purpose of evaluating the feasibility and advisability of
providing additional Medicare coverage for chiropractic services,
beyond the usual covered care allowed for spinal manipulation to
correct spinal subluxation. The two-year demonstration, operates within
four geographic regions (two rural and two urban, with one including a
health professional shortage area (HPSA) and one a non-HPSA area,
respectively in each). For the demonstration, CMS has approved an
expanded list of NMS conditions, all typical among users of
chiropractic, as well as various additional diagnostic tests, which may
be billed without physician approval to Part B Medicare by
participating chiropractors. Participation in this expanded payment
demonstration is determined individually by chiropractic provider
practices and any Medicare Advantage Plans located within the four
regions. Congress has mandated budget neutrality; consequently, any
overall excess costs to Medicare, within this two-year span of expanded
chiropractic coverage, must be subsequently recouped by Medicare from
the chiropractic profession.
The MCCDE to enable conduct of the mandated evaluation of this
chiropractic demonstration will acquire and aggregate data relative to
beneficiaries receiving chiropractic services. The beneficiary survey
data will address patient satisfaction and quality of care issues,
while the relevant abstracted Medicare claims file data elements on NMS
diagnoses, services, and costs will enable determination of costs and
utilization patterns, and of demonstration budget neutrality.
Additionally the evaluation will address cost aspects relative to the
potential for expansion of chiropractic coverage to the national
Medicare program.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR. The statutory authority
for this system is given under the Section 651 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L.
108-173).
B. Collection and Maintenance of Data in the System. This system
will maintain individually-identifiable and other data collected by CMS
and its contractors on Medicare participants and providers of service
in the chiropractic coverage demonstration, and on selected
beneficiaries as non-participant controls, in order to analyze relevant
data for the mandated evaluation and as means to select and contact
participant beneficiaries for the survey.
Information collected will include, but is not limited to,
beneficiary health insurance claim number, beneficiary identification
code, beneficiary name and address, race/ethnicity, gender type, date
of birth, diagnostic code(s), relevant procedural codes and dates of
service, dates of admissions and discharges, diagnostic review group,
unique provider identification number, as well as self-reported survey
information regarding health status, demographic utilization issues,
and satisfaction with care relating to chiropractic services.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The Government will only release MCCDE 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 MCCDE.
CMS has the following policies and procedures concerning
disclosures of information that will be maintained in the system.
Disclosure of information from the system will be approved only to the
extent necessary to accomplish the purpose of the disclosure and only
after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected; e.g., to collect and maintain
individually identifiable information on beneficiaries, physicians,
participating chiropractors, and providers of service participating in
the demonstration and evaluation program.
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if the record is provided in individually identifiable
form;
b. The purpose for which the disclosure is to be made is of
sufficient importance to warrant the effect and/or risk on the privacy
of the individual that additional exposure of the record might bring;
and
c. There is a strong probability that the proposed use of the data
would in fact accomplish the stated purpose(s).
3. Requires the information recipient to:
a. Establish administrative, technical, and physical safeguards to
prevent unauthorized use of disclosure of the record;
b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
c. Agree to not use or disclose the information for any purpose
other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
[[Page 41452]]
III. Proposed Routine Use Disclosures of Data in the System
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, consultants, or grantees, who have been
engaged by the agency to assist in the performance of a service related
to this collection and who need to have access to the records in order
to perform the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS function
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant, or grantee whatever information
is necessary for the contractor, consultant, or grantee to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the contractor, consultant, or grantee from using or
disclosing the information for any purpose other than that described in
the contract and requires the contractor, consultant, or grantee to
return or destroy all information at the completion of the contract.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies, in their administration of a
Federal health program, may require MCCDE information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
The MCCDE data will provide for research or support of evaluation
projects and a broader, longitudinal, national perspective of the
status of Medicare beneficiaries. CMS anticipates that many researchers
will have legitimate requests to use these data in projects that could
ultimately improve the care provided to Medicare beneficiaries and the
policies that govern their care.
4. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
5. To a CMS contractor (including, but not necessarily limited to,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud and abuse. CMS occasionally contracts out certain of
its functions or makes grants or cooperative agreements when doing so
would contribute to effective and efficient operations. CMS must be
able to give a contractor, grantee, consultant or other legal agent
whatever information is necessary for the agent to fulfill its duties.
In these situations, safeguards are provided in the contract
prohibiting the agent from using or disclosing the information for any
purpose other than that described in the contract and requiring the
agent to return or destroy all information.
6. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
Other agencies may require MCCDE information for the purpose of
combating fraud and abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures.
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, Subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR
164.512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
because of the small size, use of this information could allow for the
deduction of the identity of the beneficiary).
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
[[Page 41453]]
appropriate management, operational and technical safeguards sufficient
to protect the confidentiality, integrity and availability of the
information and information systems and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the Proposed System of Records on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights of patients whose data are
maintained in this system. CMS will collect only that information
necessary to perform the system's functions. In addition, CMS will make
disclosure from the proposed system only with consent of the subject
individual, or his/her legal representative, or in accordance with an
applicable exception provision of the Privacy Act. CMS, therefore, does
not anticipate an unfavorable effect on individual privacy as a result
of information relating to individuals.
Dated; July 13, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0577
SYSTEM NAME:
``Medicare Chiropractic Coverage Demonstration and Evaluation
(MCCDE),'' HHS/CMS/ORDI.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850 and at various co-locations of CMS agents as follows:
Brandeis University, 415 South Street, Waltham,
Massachusetts 002454-9110.
Battelle Institute, Suite 200, 6115 Falls Road, Baltimore,
Maryland 21209.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
This system will maintain individually-identifiable and other data
collected by CMS and its contractors on Medicare participants and
providers of service in the chiropractic coverage demonstration, and on
selected beneficiaries as non-participant controls, in order to analyze
relevant data for the mandated evaluation and as means to select and
contact participant beneficiaries for the survey.
CATEGORIES OF RECORDS IN THE SYSTEM:
Information collected will include, but is not limited to,
beneficiary health insurance claim number (HICN), beneficiary
identification code, beneficiary name and address, race/ethnicity,
gender type, date of birth, diagnostic code(s), relevant procedural
codes and dates of service, dates of admissions and discharges,
diagnostic review group, unique provider identification number (UPIN),
as well as self-reported survey information regarding health status,
demographic utilization issues, and satisfaction with care relating to
chiropractic services.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system is given under the Section
651 of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (Pub. L. 108-173).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is to collect and maintain
individually identifiable information on beneficiaries, physicians,
participating chiropractors, and providers of service participating in
the demonstration and evaluation program. Information retrieved from
this system may be disclosed to: (1) Support regulatory, reimbursement,
and policy functions performed within the agency or by a contractor,
consultant or grantee; (2) assist another Federal or state agency with
information to contribute to the accuracy of CMS's proper payment of
Medicare benefits, enable such agency to administer a Federal health
benefits program, or to enable such agency to fulfill a requirement of
Federal statute or regulation that implements a health benefits program
funded in whole or in part with Federal funds; (3) support an
individual or organization for a research project or in support of an
evaluation project related to the prevention of disease or disability,
the restoration or maintenance of health, or payment related projects;
(4) support litigation involving the agency; and (5) combat fraud and
abuse in certain Federally-funded health benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, consultants, or grantees, who have been
engaged by the agency to assist in the performance of a service related
to this collection and who need to have access to the records in order
to perform the activity.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. assist Federal/state Medicaid programs within the state.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the
[[Page 41454]]
restoration or maintenance of health, or payment related projects.
4. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. any employee of the agency in his or her official capacity, or
c. any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. the United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
5. To a CMS contractor (including, but not necessarily limited to,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
6. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures.
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR
164.512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
because of the small size, use of this information could allow for the
deduction of the identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records will be stored electronically and on hard copy.
RETRIEVABILITY:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HICN.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain information for a total period not to exceed 25
years. All claims-related records are encompassed by the document
preservation order and will be retained until notification is received
from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Office of Research, Development, and Information, CMS,
Mail Stop C3-20-11, 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, employee
identification number, tax identification number, national provider
number, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable), HICN, and/or SSN (furnishing the
SSN is voluntary, but it may make searching for a record easier and
prevent delay).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These procedures are in
accordance with Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Data sources will include Medicare claims for beneficiaries with
relevant neuromusculoskeletal conditions diagnoses, and responses from
the survey instrument administered to participant beneficiaries. The
collected information from Medicare claims and enrollment data and the
survey instrument, will include all of the data elements that reside
within the Medicare National Claims History File and the Medicare
Enrollment Data Base, as well as the self-reported beneficiary survey
responses.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E6-11579 Filed 7-20-06; 8:45 am]
BILLING CODE 4120-03-P