Fed. Reg. Notices — Notice of a New System of Records…

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). 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, “Competitive Bidding for Clinical Laboratory Services (CBCLS), System No. 09-70-0589.” The demonstration project is mandated by section 302(b) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003

(MMA)(Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The CBCLS demonstration and evaluation seek to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. Independent, hospital, and physician office laboratories providing non-patient Medicare Part B laboratory services will be required to participate in the demonstration. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Information retrieved from this system may be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;

(4)support litigation involving the agency; and

(5)combat fraud, 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 Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on October 6, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time. FOR FURTHER INFORMATION CONTACT: Linda Lebovic, Division Payment Policy Demonstrations, Medicare Demonstrations Program Group, Office of Research, Development & Information, Mail Stop C4-17-27, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-3402, or via e-mail at *Linda.Lebovic@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: The demonstration is mandated by section 302(b) of the MMA (Pub. L. 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Act. The CBCLS demonstration and evaluation seek to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. Independent, hospital, and physician office laboratories providing Medicare Part B clinical laboratory services to non-patient beneficiaries will be required to participate. The demonstration and its evaluation include all clinical laboratory services paid under the Clinical Laboratory Fee Schedule (except pap smears and colorectal cancer screening tests) for Medicare Part B fee-for-service beneficiaries who live in the demonstration area. The payment basis determined for each competitive acquisition area will be substituted for payment under the existing Clinical Laboratory Fee Schedule. The MMA requires laboratories to comply with the regulations under the Clinical Laboratory Improvement Amendments as mandated under section 353 of the Public Health Service Act. Beneficiary access to laboratory services and laboratory quality will be monitored throughout the demonstration. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under the provisions of section 302(b) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 (Pub. L. 108-173). B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Data will be collected from Medicare administrative and claims records, patient medical charts, and physician records. The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, background information relating to Medicare issues, and research information needed to evaluate the program and develop research reports on findings. 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 CBCLS 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 CBCLS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected; *e.g.* , to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the CBCLS program. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. 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 function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor, consultant, or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require CBCLS 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 CBCLS 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 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 CBCLS 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 excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Prescription Drug Improvement, and 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: October 4, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0589 System Name “Competitive Bidding for Clinical Laboratory Services (CBCLS),” HHS/CMS/ORDI. Security Classification Level Three Privacy Act Sensitive Data. System Location 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 This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Categories of Records in the System: The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number (HICN), race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, background information relating to Medicare issues, and research information needed to evaluate the program and develop research reports on findings. Authority for Maintenance of the System: The statutory authority for this system is given under the provisions of section 302(b) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 (Pub. L. 108-173). Purpose(s) of the System: The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Information retrieved from this system may be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;

(4)support litigation involving the agency; and

(5)combat fraud, 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 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 an individual identifier; *e.g.* , beneficiary name or HICN. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. Retention and Disposal: CMS will retain information for a total period not to exceed 10 years. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager and Address: Division Payment Policy Demonstrations, Medicare Demonstrations Program Group, Office of Research, Development & Information, Mail Stop C4-17-27, Centers for Medicare & Medicaid Services, 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 (Common Working File, Carrier Medicare Claims Record, Intermediary Medicare Claims Records), patient medical charts, and physician records. Systems Exempted from Certain Provisions of the Act: None. [FR Doc. E6-17052 Filed 10-13-06; 8:45 am] BILLING CODE 4120-03-P 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). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Senior Risk Reduction Demonstration and Evaluation (SRRDE), System No. 09-70-0592.” The program is authorized under provisions of the Social Security Act (42 U.S.C. 1395b-1(a)), which gives the Secretary the broad authority to, “develop and engage in experiments and demonstration projects.” The goal of the SRRDE is to determine whether risk reduction programs that have been developed and tested in the private sector can also be tailored to and work well with Medicare beneficiaries to improve their health and reduce avoidable health care utilization. The specific aims of the demonstration and evaluation are to:

(1)Determine whether a senior risk reduction service provided by Medicare will be accepted by beneficiaries, achieve high participation rates, and be viewed positively by beneficiaries;

(2)reduce health risk factors, improve health behaviors, improve functioning, and prevent disability; and

(3)save money for Medicare. The purpose of this system is to collect and maintain demographic and health related data on the target population of non-institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;

(4)support litigation involving the agency; and

(5)combat fraud, 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 Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on October 6, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time. FOR FURTHER INFORMATION CONTACT: Pauline Lapin, Division of Health Promotion & Disease Prevention Demonstrations, Medicare Demonstrations Program Group, Office of Research Development & Information, Mail Stop S3-06-24, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-6883, or via e-mail at *Pauline.Lapin@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: Behavioral lifestyle choices with respect to diet, physical activity, alcohol, and tobacco use are associated with the leading causes of morbidity and mortality in the United States. Recent research suggests that well-structured risk reduction programs can achieve significant improvements in a population's risk profile. Successful programs are founded on solid behavior change theory, use tailored interventions, are personalized and sufficiently intensive, and are delivered with adequate social supports. The SRRDE program will be tailored to the needs, concerns, and learning styles of seniors. The goal is to develop personalized materials and instruments, followed by interventions tailored to the risks presented by the participants. CMS will offer risk reduction services to non-institutionalized Medicare beneficiaries between the ages of 67 and 74. The demonstration requires random selection of beneficiaries from across the United States as well as from communities that have exemplary Information and Referral/Assistance programs for seniors. Medicare will assign approximately 15,000-17,000 randomly selected beneficiaries to each site for recruitment. Medicare's inclusion criteria for beneficiaries eligible for the demonstration and evaluation are as follows: they must be a Medicare fee-for-service beneficiary enrolled in both Parts A and B, they may be dual eligible for both Medicare and Medicaid, and Medicare must be their primary payer. Medicare's exclusion criteria for beneficiaries to participate in the demonstration and evaluation are as follows: they cannot be currently enrolled in a Medicare Health Plan; they cannot be enrolled in a hospice or End State Renal Disease

(ESRD)program; cannot currently be participating in another CMS demonstration; cannot have residence in an institution for 100 days or the past 12 months; cannot have the inability to participate in self-care activities due to severe dementia or other serious mental illness; and cannot have had initial enrollment into Medicare before the age of 65. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under section 402(a)(1)(B) and (a)(2) of the Social Security Amendments of 1967, Public Law No. 90-248, as amended, 42 United States Code § 1395b-1(a)(1)(B) and (a)(2). B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on non-institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, SRRDE site administrative data systems, patient medical charts, and physician records. 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 SRRDE 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 SRRDE. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected; *e.g.* , to collect and maintain demographic and health related data on the target population of non-institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. 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 support agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor 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 assist 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 SRRDE information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To 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. The SRRDE 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 researchers may 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 support 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 assist 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 assist 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 SRRDE 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 individuals 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 excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the 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: October 4, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0592 System Name: “Senior Risk Reduction Demonstration and Evaluation (SRRDE),” 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: This system will collect and maintain individually identifiable and other data collected on non-institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. Categories of Records in the System: The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number (HICN), race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, SRRDE site administrative data systems, patient medical charts, and physician records. Authority for Maintenance of the System: The statutory authority for this system is given under section 402 (a)(1)(B) and (a)(2) of the Social Security Amendments of 1967, Public Law 90-248, as amended, 42 United States Code 1395b-1(a)(1)(B) and (a)(2). Purpose(s) of the System: The purpose of this system is to collect and maintain demographic and health related data on the target population of non-institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;

(4)support litigation involving the agency; and

(5)combat fraud, 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 support 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 assist 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 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. To support 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 assist 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 assist 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 individuals 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 an individual identifier; *e.g.* , beneficiary name or HICN. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. Retention and Disposal: CMS will retain information for a total period not to exceed 10 years. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager and Address: Director Office of Research Development & Information, Mail Stop S3-06-24, Centers for Medicare & Medicaid Services, 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, SRRDE site administrative data systems, patient medical charts, and physician records. Systems Exempted from Certain Provisions of the Act: None. [FR Doc. E6-17055 Filed 10-13-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a Modified or Altered System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a Modified or Altered System of Records (SOR). SUMMARY: In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, “Medicare Current Beneficiary Survey (MCBS),” System No. 09-70-6002, last published at 66 **Federal Register** 15496 (March 19, 2001). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center of the Health Care Financing Administration that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0519. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the “prior written consent” of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain a research database for CMS and other researchers that is capable of producing data sets suitable for both longitudinal and cross-sectional analysis to be used to:

(1)Produce projections for current programs and proposed program changes,

(2)produce national level estimates of health care expenditures by the aged and disabled, and

(3)provide a research database that can be used to provide guidance to program management and policies. The information retrieved from this system of records will also be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee;

(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)assist 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; and

(4)support litigation involving the agency. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period. EFFECTIVE DATE: CMS filed a modified or altered SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on October 6, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address 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: William Long, Social Science Research Analyst, Division of Survey Management and Data Release, Information and Methods Group, Office of Research, Development and Information, CMS, Mail Stop C3-20-11, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. He can also be reached by telephone at 410-786-7927, or via e-mail at *William.Long@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: CMS has previously published SOR notice on this system at 66 **Federal Register**

(FR)15496 (March 19, 2001), and 55 FR 35957 (September 4, 1990). MCBS is an ongoing, multi-purpose survey for use by all components of CMS, by the Department, and by others concerned with Medicare policy. The core of the MCBS concept is a series of interviews of a representative sample of the Medicare population regarding: their patterns of use and cost of health services over time; their sources of coverage and payment; their assets and income; their demographic characteristics; their health and functional status; their health and work history; and their family support. The same beneficiaries will be interviewed repeatedly over several years to observe changes in health care use with changes in coverage, and to observe processes that occur over time, such as institutionalization or spending down of assets. I. Description of the Modified or Altered System of Records A. Statutory and Regulatory Basis for SOR Authority for maintenance of the system is given under section 1875 of the Social Security Act (42 United States Code 1395ll). B. Collection and Maintenance of Data in the System Records in this system will be maintained on a random sample of persons enrolled for hospital insurance and/or supplemental medical benefits under the Medicare program. Records in this system will include, but are not limited to, name, social security number, health insurance claim number, age, gender, ethnicity, education, military service history, income data, marital status, medical utilization and cost data, prescription drug usage and cost data, health and functional status, health insurance coverage, medical condition status, household composition data, and medical provider names. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release MCBS 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 MCBS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from this system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, *e.g.* , to maintain a research database for CMS and other researchers that is capable of producing data sets suitable for both longitudinal and cross-sectional analysis to be used to:

(1)Produce projections for current programs and proposed program changes,

(2)produce national level estimates of health care expenditures by the aged and disabled, and

(3)provide a research database that can be used to provide guidance to program management and policies. 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 support agency contractors, consultants, or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor 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 MCBS information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To assist 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 MCBS data will provide for research or in support of evaluation projects, a broader, 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 policy that governs the care. 4. To support 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. 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 individuals 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 excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Modified or Altered System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: October 4, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0519 SYSTEM NAME: “Medicare Current Beneficiary Survey (MCBS),” HHS/CMS/ORDI. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: The Centers for Medicare & Medicaid Services

(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various contractor sites and at CMS Regional Offices. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Records in this system will be maintained on a random sample of persons enrolled for hospital insurance and/or supplemental medical benefits under the Medicare program. CATEGORIES OF RECORDS IN THE SYSTEM: Records in this system will include, but are not limited to, name, social security number (SSN), health insurance claim number (HICN), age, gender, ethnicity, education, military service history, income data, marital status, medical utilization and cost data, prescription drug usage and cost data, health and functional status, health insurance coverage, medical condition status, household composition data, and medical provider names. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for maintenance of the system is given under section 1875 of the Social Security Act (42 United States Code 1395ll). PURPOSE(S) OF THE SYSTEM: The primary purpose of this modified system is to collect and maintain a research database for CMS and other researchers that is capable of producing data sets suitable for both longitudinal and cross-sectional analysis to be used to:

(1)Produce projections for current programs and proposed program changes,

(2)produce national level estimates of health care expenditures by the aged and disabled, and

(3)provide a research database that can be used to provide guidance to program management and policies. The information retrieved from this system of records will also be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee;

(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)assist 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; and

(4)support litigation involving the agency. 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 support 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 assist 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 support 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. 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 individuals 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 computer diskette and magnetic storage media. RETRIEVABILITY: Information can be retrieved by the name and HICN of the beneficiary. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications, the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records will be maintained for 10 years after the final action of the research project is complete. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER(S) AND ADDRESS: Deputy Director, Office of Research, Development and Information, CMS, Mail Stop C3-20-01, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), and 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 specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b(a)(2)). CONTESTING RECORDS PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the records 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: Information contained in these records will be obtained from the Medicare enrollment records, Medicare bill records, Medicare provider records, Medicare beneficiaries and/or their representatives, and Medicare carriers and intermediaries. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6-17057 Filed 10-13-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a Modified or Altered System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a modified or altered system of records (SOR). SUMMARY: In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, “Person-Level Medicaid Data System (PMDS),” System No. 09-70-0033, established at 49 **Federal Register**

(FR)47573 (December 5, 1984) and last modified at 65 FR 37792 (June 16, 2000). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0507. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 3 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the “prior written consent” of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of information to other Federal and State agencies to:

(1)Contribute to the accuracy of CMS' proper payment of Medicare benefits; and

(2)enable such agency to administer a Federal health benefits program, and/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. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain individually-identifiable data to study Medicaid use and expenditures in order to increase CMS' understanding of the Medicaid and Medicare programs and to improve CMS' ability to conduct program evaluation, strengthen program management, evaluate policy alternatives, conduct and evaluate demonstration projects, and advise States in the area of Medicaid financing. The information retrieved from this system of records will also be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or grantee;

(2)assist another Federal and/or State agency;

(3)support an individual or organization for research, evaluation or epidemiological projects; and

(4)support litigation involving the agency. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period. EFFECTIVE DATE: CMS filed a modified or altered SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on October 6, 2006. To ensure that all parties have adequate time in which to comment, the modified system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern daylight time. FOR FURTHER INFORMATION CONTACT: Dave Baugh, Division of State Program and Research, Research and Evaluation Group, Office of Research, Development and Information, CMS, Mail Stop C3-20-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. He can also be reached by telephone at 410-786-7716, or via e-mail at *David.Baugh@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: Enacted under the authority of section 1902(a)(6) of the Social Security Act (the Act) (42 United States Code (U.S.C.) 1396(a)(6)), this section provides that a State plan for medical assistance must provide that the State agency will make such report, in such form and containing such information, as the Secretary may from time to time require, and comply with such provisions as the Secretary may from time to time find necessary to assure the correctness and verification of such reports. To this end we have created a records system using Medicaid data which has greatly improved CMS' ability to conduct program evaluation and has strengthened program management. I. Description of the Modified or Altered System of Records A. Statutory and Regulatory Basis for SOR Authority for maintenance of the system is given under § 1902(a)(6) of the Act (42 U.S.C. 1396(a)(6)). B. Collection and Maintenance of Data in the System PMDS contains information on persons enrolled in the Medicaid program under either Federal or State provisions. Information collected includes but is not limited to data from 5 State Medicaid agencies (California, Georgia, Michigan, New York, and Tennessee) showing claims submitted for covered medical services, provider characteristics, name, address, phone number, date of birth, social security number, health insurance claim number, gender and ethnicity. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release PMDS 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 PMDS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from this system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, *e.g.* , to study Medicaid use and expenditures in order to increase CMS' understanding of the Medicaid and Medicare programs and to improve CMS' ability to conduct program evaluation, strengthen program management, evaluate policy alternatives, conduct and evaluate demonstration projects, and advise States in the area of Medicaid financing. 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 support agency contractors, consultants, or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor 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 assist another Federal or State agency: a. To contribute to the accuracy of CMS's proper payment of Medicare benefits, b. To enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds. Other Federal or State agencies in their administration of a Federal health program may require PMDS information in order to support evaluations and monitoring of reimbursement for services provided. 3. To assist an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects. The collected data will provide the research, evaluation and epidemiological projects a broader, longitudinal, national perspective of the data. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare patients and the policy that governs the care. CMS understands the concerns about the privacy and confidentiality of the release of data for a research use. Disclosure of data for research and evaluation purposes may involve aggregate data rather than individual-specific data. 4. To support 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. 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 individuals 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 excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Modified System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures ( *see* item IV above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: October 4, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0507 SYSTEM NAME: “Person-Level Medicaid Data System (PMDS),” HHS/CMS/ORDI. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: The Centers for Medicare & Medicaid Services

(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various contractor sites and at CMS Regional Offices. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: PMDS contains information on persons enrolled in the Medicaid program under either Federal or State provisions, as well as health care providers. CATEGORIES OF RECORDS IN THE SYSTEM: Information collected includes but is not limited to data from 5 State Medicaid agencies (California, Georgia, Michigan, New York, and Tennessee) showing claims submitted for covered medical services, provider characteristics, name, address, phone number, date of birth, social security number (SSN), health insurance claim number (HICN), unique provider identification number, gender and ethnicity. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for maintenance of the system is given under section 1902(a)(6) of the Social Security Act (42 United States Code 1396(a)(6)). PURPOSE(S) OF THE SYSTEM: The primary purpose of this modified system is to collect and maintain individually-identifiable data to study Medicaid use and expenditures in order to increase CMS' understanding of the Medicaid and Medicare programs and to improve CMS' ability to conduct program evaluation, strengthen program management, evaluate policy alternatives, conduct and evaluate demonstration projects, and advise States in the area of Medicaid financing. The information retrieved from this system of records will also be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or grantee;

(2)assist another Federal and/or State agency;

(3)support an individual or organization for research, evaluation or epidemiological projects; and

(4)support litigation involving the agency. 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: 5. To support 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. 6. To assist another Federal or State agency: a. To contribute to the accuracy of CMS's proper payment of Medicare benefits, b. To 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. 7. To assist an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects. 8. To support 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. 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 individuals could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on magnetic tape and computer disk. RETRIEVABILITY: Enrollment records are retrieved by Medicaid and Medicare identification numbers. Provider records are retrieved by Medicaid and Medicare provider identification numbers. Claims records contain both enrollee and provider identification numbers. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain information for a total period of 6 years and 3 months. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER(S) AND ADDRESS: Deputy Director, Office of Research, Development and Information, CMS, Mail Stop C3-20-11, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), and 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 specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORDS PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the records 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: Medicaid and Medicare enrollment, claims, and provider records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6-17058 Filed 10-13-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects *Title:* Child Care and Development Fund Plan for States/Territories for FY 2008-2009. *OMB No.:* 0970-0114. *Description:* The Child Care and Development Fund

(CCDF)Plan (the Plan) for States and Territories is required from each CCDF Lead Agency in accordance with Section 658E of the Child Care and Development Block Grant Act of 1990, as amended (Pub. L. 101-508, Pub. L. 104-193, and 42 U.S.C. 9858). The implementing regulations for the statutorily required Plan are set forth at 45 CFR 98.10 through 98.18. The Plan, submitted on the ACF-118, is required biennially, and remains in effect for two years. The Plan provides ACF and the public with a description of, and assurance about, the State's or the Territory's child care program. The ACF-118 is currently approved through June 30, 2008, making it available to States and Territories needing to submit Plan Amendments through the end of the FY 2007 Plan Period. However, in July 2007, States and Territories will be required to submit their FY 2008-2009 Plans. Consistent with the statute and regulations, ACF requests extension of the ACF-118 with minor corrections and modifications. The Tribal Plan (ACF-118A) is not affected by this notice. *Respondents:* State and Territorial CCDF Lead Agencies. *Annual Burden Estimates:* Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ACF-118 56 .5 162.57 4,552 *Estimated Total Annual Burden Hours:* 4,552. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L'Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-Mail address: *infocollection@acf.hhs.gov.* All requests should be identified by the title of the information collection. The Department specifically requests comments on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: October 11, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06-8689 Filed 10-13-06; 8:45 am]

Notices. Notice of a New System of Records (SOR)