[Federal Register Volume 72, Number 68 (Tuesday, April 10, 2007)]
[Notices]
[Pages 17918-17924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

AGENCY: Department of Health and Human Services (HHS), Center for 
Medicare & Medicaid Services (CMS).

ACTION: Notice of a New System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system titled, ``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 demonstration, 
evaluation, and research studies administered by ORDI. Sixteen 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);
     ``End Stage Renal Disease Program Management and Medical 
Information System,'' System No. 09-70-0520, last published at 67 FR 
41244 (June 17, 2002);
     ``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

[[Page 17919]]

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 Dates section for comment 
period.

DATES: Effective Dates: 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 3, 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 [email protected].

SUPPLEMENTARY INFORMATION: The DERS system of records will serve as the 
constructive notice to the Medicare beneficiary population and health 
care communities on activities related to all demonstrations, 
evaluations, 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 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, evaluations, 
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:

[[Page 17920]]

    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 of disclosure of the record;
    b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
    c. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, 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 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

[[Page 17921]]

    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.

    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, evaluations, 
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

[[Page 17922]]

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 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

[[Page 17923]]

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. 
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, Ph.D., 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, Ph.D., 
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.

[[Page 17924]]

     Wisconsin Partnership Program. Contact: James 
Hawthorne, 410-786-6689.

 [FR Doc. E7-6693 Filed 4-9-07; 8:45 am]
BILLING CODE 4120-03-P