[Federal Register: April 19, 2007 (Volume 72, Number 75)]
[Notices]
[Page 19705-19711]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap07-36]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a new system of records (SOR).
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[[Page 19706]]
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled, ``Master
Demonstration, Evaluation, and Research Studies (DERS) for the Office
of Research, Development and Information (ORDI),'' System No. 09-70-
0591. This notice serves as the Master system for all demonstrations,
evaluation, and research studies administered by ORDI. Fifteen existing
ORDI demonstration, evaluation, and research studies will be included
under this notice and the separate, existing systems of records notices
for those studies will be deleted upon the effective date of this
notice. DERS will become effective 30 days from the publication of the
notice in the Federal Register, or 40 days from the date submitted to
OMB and the Congress, whichever is later.
With the publication of this master system, ORDI will only be
deleting the systems of records listed below as separate stand alone
notices to the public. Retention and destruction of the data contained
in these systems will follow the schedules listed in this DERS system
notice. The existing ORDI systems of records to be included under DERS
and which will be deleted by this notice are as follows:
``Municipal Health Services Program System No. 09-70-
0022,'' 65 Federal Register (FR) 37792 (June 16, 2000);
``Monitoring of the Home Health Agency Prospective Payment
Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000);
``Person-Level Medicaid Data System, System No. 09-70-
0507'' last published at 71 FR 60726 (October 16, 2006);
``Medicare Cancer Registry Record System,'' System No. 09-
70-0509, last published at 71 FR 67133 (November 20, 2006);
``Evaluations of the Medicaid Reform Demonstrations,''
System No. 09-70-0523, last published at 71 FR 60540 (October 13,
2006);
``MMA Section 641 Prescription Drug Benefit
Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587
(June 10, 2004);
``Medicare Physician Group Practice Demonstration,''
System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005);
``Cancer Prevention and Treatment Demonstration for Ethnic
and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR
57602 (October 3, 2005);
``Medicare Care Management Performance Demonstration,''
System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005);
``Rural Hospice Demonstration,'' System No. 09-70-0563,
last published at 71 FR 57968 (October 2, 2006);
``Medicare Chiropractic Coverage Demonstration and
Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450
(July 21, 2006);
``Low Vision Rehabilitation Demonstration,'' System No.
09-70-0582, last published at 71 FR 58621 (October 4, 2006);
``Medicare Lifestyle Modification Program Demonstration,''
System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006);
``Competitive Bidding for Clinical Laboratory Services,''
System No. 09-70-0589, last published at 71 FR 60713 (October 16,
2006); and
``Senior Risk Reduction Demonstration and Evaluation,''
System No. 09-70-0592, last published at 71 FR 60718 (October 16,
2006).
The purpose of this system is to document, track, monitor,
evaluate, and conduct ORDI-administered demonstration, evaluation, and
research studies. 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
CMS grantee; (2) assist another Federal or state agency with
information to contribute to the accuracy of CMS's payment of Medicare
benefits, enable such agency to administer a Federal health benefits
program, or to enable such agency to fulfill a requirement of Federal
statute or regulation that implements a health benefits program funded
in whole or in part with Federal funds; (3) support an individual or
organization for a research project or in support of an evaluation
project related to the prevention of disease or disability, the
restoration or maintenance of health, or payment related projects; (4)
support litigation involving the agency; and (5) combat fraud, waste
and abuse in certain Federally-funded health benefits programs. We have
provided background information about the new system in the
SUPPLEMENTARY INFORMATION section below. Although the Privacy Act
requires only that CMS provide an opportunity for interested persons to
comment on the proposed routine uses, CMS invites comments on all
portions of this notice. See ``Effective Date'' section for comment
period.
DATES: Effective Date: CMS filed a new SOR report with the Chair of the
House Committee on Oversight and Government Reform, 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 April 12, 2007. 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 send comments to: CMS Privacy Officer,
Division of Privacy Compliance, Enterprise Architecture and Strategy
Group, Office of Information Services, CMS, Room 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 zone.
FOR FURTHER INFORMATION CONTACT: James Beyer, Division of Research and
Information Dissemination, Information and Methods Group, Office of
Research Development and Information, Mail Stop C3-24-01, Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD
21244-1849. He can be reached by telephone at 410-786-6693, or via e-
mail at James.Beyer@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The DERS system of records will serve as the
constructive notice to the Medicare beneficiary population and health
care communities on activates related to all demonstrations,
evaluation, and research studies administered by ORDI. The
consolidation of the existing multiple notices into one master notice
will serve the public interest by providing a single clear and concise
format, a plain language notification easily understood, a central
point of contact for access and correction of record information, and a
new web based service to provide detailed information on each separate
ORDI project. ORDI currently has 43 active projects and an additional 8
future projects anticipated to be included under DERS. An electronic
web based list of current and each new demonstration, evaluation, and
research studies administered by ORDI will be made accessible via the
CMS public Web site. In addition to the Web based information and
notification, other methods of direct notification, CMS will
[[Page 19707]]
publish timely modification and updates to DERS as required keeping our
Medicare community as informed as possible.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for maintenance of this system is given
under the provisions of Sec. 1110 of the Social Security Act (the
Act), which authorizes research and demonstration projects under Social
Security Act programs; Sec. 1115 of the Act, which authorizes Medicaid
demonstrations; and Sec. 402 of the Social Security Amendments of 1967
(42 U.S.C. 1395b-1), which authorizes waivers of Medicaid and Medicare
provisions under certain demonstrations. Many of the individual studies
and demonstrations are specifically mandated in other legislation
(Sec. Sec. 235, 302 (b) [amends section 1847(e) (42 United States Code
(U.S.C.) Sec. Sec. 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641,
646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act,
Sec. Sec. 121 and 122 of the Benefits Improvement and Protection Act
of 2000, the Deficit Reduction Act of 1984, Sec. 5007 of the Deficit
Reduction Act of 2005, the Balanced Budget Act of 1997, Sec. 222 of
the Consolidated Appropriations Act of 2001, and Conference Report No.
106-1033 for the Consolidated Appropriations Act of 2001. This system
also covers all demonstrations, evaluation, and research studies
administered by ORDI that may be authorized or mandated by future
legislation.
B. Collection and Maintenance of Data in the System
The system will collect and maintain records related to Medicare
beneficiaries, Medicaid recipients, and physician and providers of
services who voluntarily participate in demonstrations, evaluation, and
research studies administered by ORDI. In addition, Medicare enrollment
data, claims data or provider enrollment information currently
maintained in existing systems of records will be used in
demonstrations, evaluation, and research studies administered by ORDI.
Examples include, but are not limited to: provider name, unique
provider identification number, unique demonstration practice
identification number, beneficiary name, health insurance claim number,
beneficiary demographic and diagnostic information relevant to the
project, types and costs of health services used, and measures of the
quality of health care received.
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 DERS 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 DERS.
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 document, track,
monitor, evaluate, and conduct ORDI-administered research,
demonstration, and evaluation activities.
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 or disclosure of the record;
b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
c. Agree to not use or disclose the information for any purpose
other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
III. Proposed Routine Use Disclosures of Data in the System
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, consultants or grantees, who have been
engaged by the agency to assist in the performance of a service related
to this collection and who need to have access to the records in order
to perform the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS 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 to give a contractor, consultant or grantee whatever information
is necessary for the contractor or consultant to fulfill its duties. In
these situations, safeguards are provided in the contract prohibiting
the contractor, consultant or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requires the contractor, consultant or grantee to return or destroy
all information at the completion of the contract.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies, in their administration of a
Federal health program, may require DERS 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
[[Page 19708]]
evaluation project related to the prevention of disease or disability,
the restoration or maintenance of health, or payment related projects.
The DERS 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, waste or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud, waste and abuse. CMS occasionally contracts out
certain of its functions or makes grants or cooperative agreements when
doing so would contribute to effective and efficient operations. CMS
must be able to give a contractor, grantee, consultant or other legal
agent whatever information is necessary for the agent to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the agent from using or disclosing the information for any
purpose other than that described in the contract and requiring the
agent to return or destroy all information.
6. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste or abuse in, a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs.
Other agencies may require DERS information for the purpose of
combating fraud, waste and abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR
164.512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that an
individual could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. Personnel having access to
the system have been trained in the Privacy Act and information
security requirements. Employees who maintain records in this system
are instructed not to release data until the intended recipient agrees
to implement appropriate management, operational and technical
safeguards sufficient to protect the confidentiality, integrity and
availability of the information and information systems and to prevent
unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: all pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the Proposed System of Records on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights of patients whose data are
maintained in this system. CMS will collect only that information
necessary to perform the system's functions. In addition, CMS will make
disclosure from the proposed system only with consent of the subject
individual, or his/her legal representative, or in accordance with an
applicable exception provision of the Privacy Act. CMS, therefore, does
not anticipate an unfavorable effect on individual privacy as a result
of information relating to individuals.
[[Page 19709]]
Dated: March 28, 2007.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0591
SYSTEM NAME:
``Master Demonstration, Evaluation, and Research Studies for the
Officer of Research, Development and Information (DERS),'' HHS/CMS/
ORDI.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850 and at various co-locations of CMS agents.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The system will collect and maintain records related to Medicare
beneficiaries, Medicaid recipients, and physician and providers of
services who voluntarily participate in demonstrations, evaluation, and
research studies administered by ORDI. In addition, Medicare enrollment
data, claims data or provider enrollment information currently
maintained in existing systems of records will be used in
demonstrations, evaluation, and research studies administered by ORDI.
CATEGORIES OF RECORDS IN THE SYSTEM:
The collected information will include, but is not limited to:
provider name, unique provider identification number, unique
demonstration practice identification number, beneficiary name, health
insurance claim number (HICN), beneficiary demographic and diagnostic
information relevant to the project, types and costs of health services
used, and measures of the quality of health care received.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for maintenance of this system is given
under the provisions of Sec. 1110 of the Social Security Act (the
Act), which authorizes research and demonstration projects under Social
Security Act programs; Sec. 1115 of the Act, which authorizes Medicaid
demonstrations; and Sec. 402 of the Social Security Amendments of 1967
(42 U.S.C. 1395b-1), which authorizes waivers of Medicaid and Medicare
provisions under certain demonstrations. Many of the individual studies
and demonstrations are specifically mandated in other legislation
(Sec. Sec. 235, 302 (b) [amends section 1847(e) (42 United States Code
(U.S.C.) Sec. Sec. 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641,
646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act,
Sec. Sec. 121 and 122 of the Benefits Improvement and Protection Act
of 2000, the Deficit Reduction Act of 1984, Sec. 5007 of the Deficit
Reduction Act of 2005, the Balanced Budget Act of 1997, Sec. 222 of
the Consolidated Appropriations Act of 2001, and Conference Report No.
106--1033 for the Consolidated Appropriations Act of 2001. This system
also covers all demonstrations, evaluation, and research studies
administered by ORDI that may be authorized or mandated by future
legislation.
PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to document, track, monitor,
evaluate, and conduct ORDI-administered demonstration, evaluation, and
research studies. 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
CMS grantee; (2) assist another Federal or state agency with
information to contribute to the accuracy of CMS's payment of Medicare
benefits, enable such agency to administer a Federal health benefits
program, or to enable such agency to fulfill a requirement of Federal
statute or regulation that implements a health benefits program funded
in whole or in part with Federal funds; (3) support an individual or
organization for a research project or in support of an evaluation
project related to the prevention of disease or disability, the
restoration or maintenance of health, or payment related projects; (4)
support litigation involving the agency; and (5) combat fraud, waste
and abuse in certain federally-funded health benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To 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 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, waste 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,
waste or abuse in, a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to
[[Page 19710]]
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud, waste or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR
164.512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that an
individual could, because of the small size, use this information to
deduce the identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored on electronic media.
RETRIEVABILITY:
The collected data are retrieved by the name or other identifying
information of the participating provider or beneficiary, and may also
be retrieved by a distinct identifier such as the HICN, at the
individual beneficiary level.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against 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 information maintained in the DERS
system of records for a period of 5 years after the end of the
research, demonstration, or evaluation project. Data residing with the
designated claims payment contractor shall be returned to CMS at the
end of the project, with all data then being the responsibility of CMS
for adequate storage and security. 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:
Deputy Director, Office of Research Development and Information,
Mail Stop C3-18-07, CMS, 7500 Security Boulevard, Baltimore, MD 21244-
1849.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager who will require the system name, employee
identification number, tax identification number, national provider
number, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable), HICN, and/or SSN (furnishing the
SSN is voluntary, but it may make searching for a record easier and
prevent delay).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These procedures are in
accordance with Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Data will be collected from Medicare administrative and claims
records, patient medical charts, and physician records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
Appendix A. Current ORDI run Demonstration, Evaluation and Research
Activities
The following is a listing of the current ORDI run
demonstration, evaluation and research activities at CMS, with the
appropriate contact person. A perpetual list of current
demonstrations and evaluations will be made accessible through the
CMS public Web site (http://www.cms.hhs.gov). The list will be
amended for each new project that is implemented.
1. ORDI Run Demonstration, Evaluation and Research Activities
Bundled Case-Mix Adjusted Payment System for End Stage
Renal Disease Services Demonstration
Contact: Henry Bachofer, 410-786-0340
Cancer Prevention and Treatment Demonstration for Ethnic
and Racial Minorities
Contact: Diane Merriman, 410-786-7237
Consumer Directed Chronic Outpatient Services
Contact: Pauline Lapin, 410-786-6883
Cost-effectiveness of Daily versus Conventional
Hemodialysis for the Medicare Population
Contact: Penny Mohr, 410-786-6502
Data Collection and Administering the Medicare Health
Improvement Survey
Contact: David Bott, 410-786-0249
Design and Implementation of a Beneficiary Survey on Access
to Selected Prescriptions and Biologicals
Contact: Penny Mohr, 410-786-6502
Disease Management for Severely Chronically Ill Medicare
Beneficiaries
Contact: J. Sherwood, 410-786-6651
End Stage Renal Disease (ESRD) Disease Management
Demonstration
Contact: Sid Mazumdar, 410-786-6673
Evaluation of Care Management for High Cost Beneficiaries
Demonstration
Contact: David Bott, 410-786-0249
Evaluation of Second Phase of Oncology Demonstration
Program
Contact: James Menas, 410-786-4507
Evaluation of the Medicare Preferred Provider Organization
Demonstration
Contact: Victor McVicker, 410-786-6681
Evaluation of the State Medicaid Reform Demonstrations
[[Page 19711]]
Contact: Paul Boben, 410-786-6629
Expansion of Coverage of Chiropractic Services
Demonstration
Contact: Carol Magee, 410-786-6611
Frontier Extended Stay Clinic Demonstration Project
Contact: Sid Mazumdar, 410-786-6673
Home Health Agency Prospective Payment Demonstration
Contact: J. Sherwood, 410-786-6651
Impact of Payment Reform for Part B Covered Outpatient
Drugs and Biologicals
Contact: Usree Bandyopadhyay, 410-786-6650
Informatics for Diabetes Education and Telemedicine
Demonstration (IDEATel)
Contact: Diana Ayres: 410-786-7203
Inhalation Drug Therapy Demonstration
Contact: Debbie Vanhoven, 410-786-6625
Life Masters
Contact: Linda Colantino, 410-786-3343
Low Vision Rehabilitation Demonstration
Contact: James Coan, 410-786-9168
Massachusetts Senior Care Options
Contact: William Clark, 410-786-1484
Medical Adult Day Care Services Demonstration
Contact: Armen Thoumaian, PhD, 410-786-6672
Medicare + Choice Phase II--PPO Demonstration
Contact: Debbie Vanhoven, 410-786-6625
Medicare Advantage CCRC (Erickson) Demonstration
Contact: Henry Bachofer, 410-786-0340
Medicare Cancer Registry Record System
Contact: Gerald Riley, 410-786-6699
Medicare Care Management Performance Demonstration
Contact: Jody Blatt, 410-786-6921
Medicare Clinical Laboratory Services Competitive Bidding
Demonstration Project
Contact: Linda Lebovic, 410-786-3402
Medicare Coordinated Care Demonstration
Contact: Cynthia Mason, 410-786-6680
Medicare Drug Replacement Demonstration
Contact: Jody Blatt, 410-786-6921
Medicare Health Care Quality Demonstration Programs
Contact: Cynthia Mason, 410-786-6680
Medicare Home Health Independence Demonstration
Contact: Armen Thoumaian, Ph.D., 410-786-6672
Medicare Hospital Gainsharing Demonstration
Contact: Lisa Waters, 410-786-6615
Medicare Preventive Services--Medicare Lifestyle
Modification Program Demonstration
Contact: Armen Thoumaian, PhD, 410-786-6672
Mercy Medicare Skilled Nursing Facility Payment
Demonstration
Contact: J. Sherwood, 410-786-6651
Minnesota Senior Health Options
Contact: Susan Radke, 410-786-4450
Municipal Health Services Program Demonstration
Contact: Michael Henesch, 410-786-6685
New York Graduate Medical Education Demonstration
Contact: Sid Mazumdar, 410-786-6673
Nursing Home Value-Based Purchasing
Contact: Ronald Lambert, 410-786-6624
PACE-for-Profit Demonstration
Contact: Michael Henesch, 410-786-6685
Payment Development, Implementation and Monitoring for the
BIPA Disease Management Demonstration
Contact: J. Sherwood, 410-786-6651
Person-Level Medicaid Data System
Contact: Dave Baugh, 410-786-7716
Physician Group Practice Demonstration
Contact: John Pilotte, 410-786-6658
Premier Hospital Quality Incentive Demonstration
Contact: Katharine Pirotte, 410-786-6774
Rural Community Hospital Demonstration
Contact: Sid Mazumdar, 410-786-6673
Rural Hospice Demonstration: Quality Assurance Metrics
Implementation Support
Contact: Cindy Massuda, 410-786-0652
Senior Risk Reduction Demonstration
Contact: Pauline Lapin, 410-786-6883
Social Health Maintenance Organization for Long-Term Care
Demonstration
Contact: Thomas Theis, 410-786-6654
State-based Home Health Agency TPL Payments
Contact: J. Sherwood, 410-786-6651
United Mine Workers of America Demonstration
Contact: Jason Petroski, 410-786-4681
Utah Graduate Medical Education
Contact: Sid Mazumdar, 410-786-6673
Wisconsin Partnership Program
Contact: James Hawthorne, 410-786-6689
[FR Doc. E7-7403 Filed 4-18-07; 8:45 am]
BILLING CODE 4120-03-P