Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

# AGENCY:

Department of Health and Human Services (HHS), Center 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, “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                               ( print 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                         *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 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 § 1110 of the Social Security Act (the Act), which authorizes research and demonstration projects under Social Security Act programs; § 1115 of the Act, which authorizes Medicaid demonstrations; and § 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 (§§ 235, 302(b) [amends section 1847(e) (42 United States Code (U.S.C.) §§ 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641, 646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act, §§ 121 and 122 of the Benefits Improvement and Protection Act of 2000, the Deficit Reduction Act of 1984, § 5007 of the Deficit Reduction Act of 2005, the Balanced Budget Act of 1997, § 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:                           ( print 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                           ( print 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 § 1110 of the Social Security Act (the Act), which authorizes research and demonstration projects under Social Security Act programs; § 1115 of the Act, which authorizes Medicaid demonstrations; and § 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 (§§ 235, 302 (b) [amends section 1847(e) (42 United States Code (U.S.C.) §§ 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641, 646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act, §§ 121 and 122 of the Benefits Improvement and Protection Act of 2000, the Deficit Reduction Act of 1984, § 5007 of the Deficit Reduction Act of 2005, the Balanced Budget Act of 1997, § 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                               ( print 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                               ( print 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.       ( print 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