Privacy Act of 1974; Report of a New System of Records, 57602-57607 [05-19676]

Download as PDF 57602 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices following class of employees as an addition to the SEC: following class of employees as an addition to the SEC: Department of Energy (DOE) employees or DOE contractor or subcontractor employees who worked as radiographers from May 1948 to March 1949 in support of Line 1 operations at the Iowa Army Ammunition Plant and who were employed for a number of work days aggregating at least 250 work days, occurring under this employment in combination with work days of employment occurring within the parameters (excluding aggregate work day requirements) established for other classes of employees included in the SEC. This designation became effective on September 24, 2005, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on September 24, 2005, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 513–533–6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV. Department of Energy (DOE) employees or DOE contractor or subcontractor employees who worked in uranium enrichment operations or other radiological activities at the Y–12 facility in Oak Ridge, Tennessee from March 1943 through December 1947 and who were employed for a number of work days aggregating at least 250 work days, either solely under this employment or in combination with work days of employment occurring within the parameters (excluding aggregate work day requirements) established for other classes of employees included in the SEC. This designation became effective on September 24, 2005, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on September 24, 2005, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 513–533–6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV. Dated: September 26, 2005. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 05–19673 Filed 9–30–05; 8:45 am] Dated: September 26, 2005. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 05–19674 Filed 9–30–05; 8:45 am] BILLING CODE 4163–19–P BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Centers for Medicare & Medicaid Services Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort Privacy Act of 1974; Report of a New System of Records Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Y–12 facility, in Oak Ridge, Tennessee as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 25, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). AGENCY: SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new system titled, ‘‘Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities (CPTD) System, System No. 09–70–0560.’’ Section 122 of the Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Public Law (Pub. L.) 106–554) grants CMS the PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 authority to award at least nine cooperative agreement demonstration projects that will identify methods to reduce disparities in early cancer screening, diagnosis, and treatment for Black, Hispanic, Asian American and Pacific Islander, and American Indian (including Alaskan Native, Eskimo, and Aleut) Medicare beneficiary populations. Demonstration sites will use the best available scientific evidence to identify promising models of cancer screening, diagnosis and treatment interventions to promote health and appropriate utilization of Medicare covered services, eliminate disparities in cancer detection and treatment among ethnic and racial populations of Medicare beneficiaries, and provide information to improve the effectiveness of the Medicare program. The purpose of this system is to collect and maintain demographic and cancer health-related data on Medicare target population beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and Racial Minorities. This system will enable CMS to enroll eligible participants in the demonstration project; randomize participants into intervention and control groups; reimburse demonstration site service claims; and develop, maintain and analyze/evaluate research information showing the potential impact of providing cancer screening, diagnosis and treatment facilitation services to underserved Medicare 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 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 engaged in the performance activities of the demonstration or in 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 constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY E:\FR\FM\03OCN1.SGM 03OCN1 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 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 DATES section for comment period. DATES: 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 Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on September 26, 2005. In any event, we will not disclose any information under a routine use until 40 days after publication. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comment to the CMS Privacy Officer, Mail-stop N2–04–27, 7500 Security Boulevard, Baltimore, Maryland 21244– 1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.–3 p.m., eastern time. FOR FURTHER INFORMATION CONTACT: C. Diane Merriman, Project Officer, Division of Health Promotion and Disease Prevention Demonstrations, Office of Research Development and Information, CMS, Mail Stop S3–07–04, 7500 Security Boulevard, Baltimore, Maryland 21244–1849, telephone number (410) 786–7237, e-mail Diane.Merriman@cms.hhs.gov. SUPPLEMENTARY INFORMATION: Section 122 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106–554) requires CMS to design and implement at least nine demonstration projects in specific target populations for the purpose of developing models and evaluating methods that: (1) Improve the quality of items and services provided to target individuals in order to facilitate reduced disparities in early detection and treatment of cancer; (2) improve clinical outcomes, satisfaction, quality of life, and appropriate use of Medicare-covered services and referral patterns among those target individuals with cancer; (3) eliminate disparities in the rate of preventive cancer screening measures; and (4) promote collaboration with community-based organizations to ensure cultural competency of health care professionals and linguistic access for persons with limited English proficiency. Each of the following four VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 legislatively-mandated target populations are required to be the subject of two separate demonstration projects: American Indians (including Alaskan Natives, Eskimos and Aleuts); Asian Americans and Pacific Islanders; Blacks; and Hispanics. If the initial demonstration evaluation indicates that these projects (1) reduce Medicare expenditures; or (2) do not increase Medicare expenditures, reduce ethnic and racial health disparities, and increase beneficiary and health care provider satisfaction, the existing demonstration projects will continue, and the number of demonstration projects may be expanded in the future. 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 122 of the Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106–554). B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable demographic and cancer health-related data collected on Medicare target population beneficiaries who voluntarily enroll in the CPTD for Ethnic and Racial Minorities. The system will maintain information on two populations: (1) Medicare beneficiaries belonging to a defined ethnic or racial minority group who do not have a current diagnosis of cancer before enrollment in the demonstration project; and (2) Medicare beneficiaries belonging to a defined ethnic or racial minority who have been diagnosed with cancer before enrollment in the demonstration project. The collected information will contain name, address, telephone number, Medicare health insurance claim (HIC) number, race/ethnicity, gender type, and date of birth, as well as background information relating to Medicare issues. It will also include cancer screening, diagnosis, treatment, project enrollment and evaluation, survey and research information needed to administer the demonstration project and develop research reports on the demonstration 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 57603 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 CPTD 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 CPTD. 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 cancer health-related data on Medicare target population beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and Racial Minorities. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. E:\FR\FM\03OCN1.SGM 03OCN1 57604 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 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, grantees, consultants or other legal agents who have been engaged by the agency to assist in the performance of a service related to this system of records 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, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to purposes for this system or records. 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, 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 requires the agent 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 CPTD 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 engaged in or assisting in the enrollment, screening, diagnosis, treatment, evaluation, or research efforts relative to beneficiary participation in the CPTD for Ethnic and Racial Minorities (including summary analyses demonstrating the impact of the demonstration project), and other activities reasonably necessary to fulfill the provisions of the demonstration VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 project and ensure appropriate use of Medicare trust funds and program funds, as well as 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, the reduction of healthcare disparities, or payment related projects. The CPTD 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 a Member of Congress or to a congressional staff member in response to an inquiry of the congressional office made at the written request of the constituent about whom the record is maintained. Beneficiaries sometimes request the help of a Member of Congress in resolving an issue relating to a matter before CMS. The Member of Congress then writes to CMS, and CMS must be able to give sufficient information to be responsive to the inquiry. 5. 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. 6. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMSadministered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. Other agencies may require CPTD information for the purpose of combating fraud and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures 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, 65 FR 82462 (12–28–00), Subparts A and E). Disclosures of PHI 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.’’ In addition, our policy will be to prohibit release even of not directly identifiable information, 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 E:\FR\FM\03OCN1.SGM 03OCN1 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees 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 include but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. 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 (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 VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 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: August 30, 2005. John R. Dyer, Chief Operating Officer, Centers for Medicare & Medicaid Services. System No. 09–70–0560 SYSTEM NAME: ‘‘Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities (CPTD),’’ 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 demographic and cancer health-related data collected on Medicare target population beneficiaries who voluntarily enroll in the Cancer Prevention and Treatment Demonstration (CPTD) for Ethnic and Racial Minorities. The system will maintain information on two populations: (1) Medicare beneficiaries belonging to a defined ethnic or racial minority group who do not have a current diagnosis of cancer before enrollment in the demonstration project; and (2) Medicare beneficiaries belonging to a defined ethnic or racial minority who have been diagnosed with cancer before enrollment in the demonstration project. CATEGORIES OF RECORDS IN THE SYSTEM: The collected information will contain name, address, telephone number, health insurance claim (HIC) number, race/ethnicity, gender type, and date of birth, as well as background information relating to Medicare issues. It will also include cancer screening, diagnosis, treatment, project enrollment and evaluation, survey and research information needed to administer the demonstration project and develop PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 57605 research reports on the demonstration findings. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for this system is given under the provisions of Section 122 of the Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106–554). PURPOSE(S) OF THE SYSTEM: The purpose of this system is to collect and maintain demographic and cancer health-related data on Medicare target population beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and Racial Minorities. This system will enable CMS to enroll eligible participants in the demonstration project; randomize participants into intervention and control groups; reimburse demonstration site service claims; and develop, maintain and analyze/evaluate research information showing the potential impact of providing cancer screening, diagnosis and treatment facilitation services to underserved Medicare 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 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 engaged in the performance activities of the demonstration or in 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 constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain 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 E:\FR\FM\03OCN1.SGM 03OCN1 57606 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices known as a ‘‘routine use.’’ We are proposing to establish the following routine use disclosures of information maintained in the system. Information will be disclosed to: 1. To agency contractors, grantees, consultants or other legal agents who have been engaged by the agency to assist in the performance of a service related to this system of records 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 engaged in or assisting in the enrollment, screening, diagnosis, treatment, evaluation, or research efforts relative to beneficiary participation in the CPTD for Ethnic and Racial Minorities (including summary analyses demonstrating the impact of the demonstration project), and other activities reasonably necessary to fulfill the provisions of the demonstration project and ensure appropriate use of Medicare trust funds and program funds, as well as 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 a Member of Congress or to a congressional staff member in response to an inquiry of the congressional office made at the written request of the constituent about whom the record is maintained. 5. 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 VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 the purpose for which the agency collected the records. 6. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMSadministered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures: This system contains Protected Health Information as defines by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 CFR Parts 160 and 164, 65 Federal Register 82462 (12–28–00), Subparts A and E). Disclosures of Protected Health Information 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.’’ In addition, our policy will be to prohibit release even of not directly identifiable information, 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 complaint population is so small that individuals who are familiar with the complainants could, because of the small size, use this information to deduce the identity of the complainant). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored electronically. Some input may be generated in hardcopy, such as eligibility, enrollment, initial cancer status and followup assessment information before transcription to electronic media. All claims-related records are encompassed PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 by the document preservation order and will be retained until notification is received from the Department of Justice. RETRIEVABILITY: The collected data are retrieved by an individual identifier; e.g., beneficiary name or HIC number. 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 include but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain information for a total period not to exceed 25 years. Data residing with the designated demonstration project site agent shall be returned to CMS at the end of the demonstration period, with all data then being the responsibility of CMS for adequate storage and security. SYSTEM MANAGER AND ADDRESS: Director, Office of Research Development and Information, CMS, Room C3–20–11, 7500 Security Boulevard, Baltimore, Maryland 21244– 1850. E:\FR\FM\03OCN1.SGM 03OCN1 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices NOTIFICATION PROCEDURE: For the purpose of access, the subject individual should write to the system manager who will require the system name, address, age, gender type, and, for verification purposes, the subject individual’s name (woman’s maiden name, if applicable). care funds. The duration of the grant is 12 months. Statutory Authority: This award will be made pursuant to the Child Care and Development Block Grant Act of 1990 as amended (CCDBG Act); section 418 of the Social Security Act; Consolidated Appropriations Act, 2001 (Pub. L. 106–554). FOR FURTHER INFORMATION CONTACT: RECORD ACCESS PROCEDURE: Shannon Rudisill, Director of Technical Assistance, Child Care Bureau, at 202– 205–8051. 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)). Dated: September 27, 2005. Joan E. Ohl, Commissioner, Administration on Children, Youth and Families. [FR Doc. 05–19650 Filed 9–30–05; 8:45 am] BILLING CODE 4184–01–P 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). SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P–0376] Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. None. Notice. [FR Doc. 05–19676 Filed 9–30–05; 8:45 am] ACTION: BILLING CODE 4120–03–P SUMMARY: The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Canada’s Original ICEBERG Water Corp., to market a product designated as ‘‘Canada’s Original Iceberg Water’’ that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility. DATES: This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the test product into interstate commerce, but not later than January 3, 2006. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2371. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17 concerning temporary permits to facilitate market testing of foods deviating from the requirements of the standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is giving notice that a temporary permit DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Administration on Children, Youth, and Families; Notice of Award of NonCompetitive Grant Administration on Children, Youth and Families, ACF, HHS. ACTION: Award announcement. AGENCY: SUMMARY: The Administration on Children, Youth and Families herein announces an urgent grant award to the National Association of Child Care Resource and Referral Agencies (NACCRRA) to provide technical assistance to reestablish the operations of the resource and referral agencies in Mississippi and Louisiana whose operations have been disrupted by Hurricane Katrina. This grant will help to re-establish child care referral services so that families along the Gulf Coast can find child care. This grant will also support local and Statewide inventories of child care need and availability. The amount of the proposed grant to NACCRRA is $99,500 in FY 2005 child VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 57607 has been issued to Canada’s Original ICEBERG Water Corp., 23 Lesmill Rd., suite 304, Toronto, Ontario Canada, M3B–3P6. The permit covers limited interstate marketing tests of products identified as ‘‘Canada’s Original Iceberg Water’’ that deviate from the U.S. standard of identity for bottled water (§165.110 (21 CFR 165.110)) in that the source of the water is an iceberg. The test product meets all the requirements of the standard with the exception of the source definition. The purpose of this permit is to test the product throughout the United States, in order to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility. This permit provides for the temporary marketing of 500,000 cases of the 24 x 500 milliliter bottles and 500,000 cases of the 12 x 1 liter bottles, totaling 1 million cases per year. The total fluid quantity covered by this application is 12 million liters (3,170,065 gallons). The test product will be manufactured for Canada’s Original ICEBERG Water Corp., by Discovery Springs, Daniel’s Point Rd., Trepassey, Newfoundland, Canada A0A–4B0. Canada’s Original ICEBERG Water Corp. will distribute the test products throughout the United States. The information panel of the labels will bear nutrition labeling in accordance with 21 CFR 101.9. The bottled water will be manufactured in accordance with the quality standards in §165.110 and the requirements for processing and bottling of bottled drinking water in 21 CFR part 129. This permit is effective for 15 months, beginning on the date the food is introduced or caused to be introduced into interstate commerce, but not later than January 3, 2006. Dated: September 22, 2005. Barbara Schneeman, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. 05–19728 Filed 9–30–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0394] Food and Drug Administration’s Communication of Drug Safety Information; Public Hearing AGENCY: Food and Drug Administration, HHS. E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57602-57607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


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

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

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

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to create a new system titled, ``Cancer 
Prevention and Treatment Demonstration for Ethnic and Racial Minorities 
(CPTD) System, System No. 09-70-0560.'' Section 122 of the Medicare, 
Medicaid, and State Children's Health Insurance Program (SCHIP) 
Benefits Improvement and Protection Act of 2000 (BIPA) (Public Law 
(Pub. L.) 106-554) grants CMS the authority to award at least nine 
cooperative agreement demonstration projects that will identify methods 
to reduce disparities in early cancer screening, diagnosis, and 
treatment for Black, Hispanic, Asian American and Pacific Islander, and 
American Indian (including Alaskan Native, Eskimo, and Aleut) Medicare 
beneficiary populations. Demonstration sites will use the best 
available scientific evidence to identify promising models of cancer 
screening, diagnosis and treatment interventions to promote health and 
appropriate utilization of Medicare covered services, eliminate 
disparities in cancer detection and treatment among ethnic and racial 
populations of Medicare beneficiaries, and provide information to 
improve the effectiveness of the Medicare program.
    The purpose of this system is to collect and maintain demographic 
and cancer health-related data on Medicare target population 
beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and 
Racial Minorities. This system will enable CMS to enroll eligible 
participants in the demonstration project; randomize participants into 
intervention and control groups; reimburse demonstration site service 
claims; and develop, maintain and analyze/evaluate research information 
showing the potential impact of providing cancer screening, diagnosis 
and treatment facilitation services to underserved Medicare 
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 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 engaged in the performance activities of the 
demonstration or in 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 constituent requests made to a congressional representative; 
(5) support litigation involving the agency; and (6) combat fraud and 
abuse in certain health benefits programs. We have provided background 
information about the new system in the Supplementary

[[Page 57603]]

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 Dates section for comment period.

DATES: 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 Governmental Affairs, and the Administrator, Office of Information 
and Regulatory Affairs, Office of Management and Budget (OMB) on 
September 26, 2005. In any event, we will not disclose any information 
under a routine use until 40 days after publication. We may defer 
implementation of this system or one or more of the routine use 
statements listed below if we receive comments that persuade us to 
defer implementation.

ADDRESSES: The public should address comment to the CMS Privacy 
Officer, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850. Comments received will be available for review at 
this location by appointment during regular business hours, Monday 
through Friday from 9 a.m.-3 p.m., eastern time.

FOR FURTHER INFORMATION CONTACT: C. Diane Merriman, Project Officer, 
Division of Health Promotion and Disease Prevention Demonstrations, 
Office of Research Development and Information, CMS, Mail Stop S3-07-
04, 7500 Security Boulevard, Baltimore, Maryland 21244-1849, telephone 
number (410) 786-7237, e-mail Diane.Merriman@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 122 of the Medicare, Medicaid, and 
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 
106-554) requires CMS to design and implement at least nine 
demonstration projects in specific target populations for the purpose 
of developing models and evaluating methods that: (1) Improve the 
quality of items and services provided to target individuals in order 
to facilitate reduced disparities in early detection and treatment of 
cancer; (2) improve clinical outcomes, satisfaction, quality of life, 
and appropriate use of Medicare-covered services and referral patterns 
among those target individuals with cancer; (3) eliminate disparities 
in the rate of preventive cancer screening measures; and (4) promote 
collaboration with community-based organizations to ensure cultural 
competency of health care professionals and linguistic access for 
persons with limited English proficiency. Each of the following four 
legislatively-mandated target populations are required to be the 
subject of two separate demonstration projects: American Indians 
(including Alaskan Natives, Eskimos and Aleuts); Asian Americans and 
Pacific Islanders; Blacks; and Hispanics. If the initial demonstration 
evaluation indicates that these projects (1) reduce Medicare 
expenditures; or (2) do not increase Medicare expenditures, reduce 
ethnic and racial health disparities, and increase beneficiary and 
health care provider satisfaction, the existing demonstration projects 
will continue, and the number of demonstration projects may be expanded 
in the future.

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 122 of the Medicare, Medicaid, and State 
Children's Health Insurance Program (SCHIP) Benefits Improvement and 
Protection Act of 2000 (BIPA) (Pub. L. 106-554).

B. Collection and Maintenance of Data in the System

    This system will collect and maintain individually identifiable 
demographic and cancer health-related data collected on Medicare target 
population beneficiaries who voluntarily enroll in the CPTD for Ethnic 
and Racial Minorities. The system will maintain information on two 
populations: (1) Medicare beneficiaries belonging to a defined ethnic 
or racial minority group who do not have a current diagnosis of cancer 
before enrollment in the demonstration project; and (2) Medicare 
beneficiaries belonging to a defined ethnic or racial minority who have 
been diagnosed with cancer before enrollment in the demonstration 
project. The collected information will contain name, address, 
telephone number, Medicare health insurance claim (HIC) number, race/
ethnicity, gender type, and date of birth, as well as background 
information relating to Medicare issues. It will also include cancer 
screening, diagnosis, treatment, project enrollment and evaluation, 
survey and research information needed to administer the demonstration 
project and develop research reports on the demonstration 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 CPTD 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 CPTD.
    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 cancer health-related data on Medicare target 
population beneficiaries who voluntarily enroll in the CPTD Project for 
Ethnic and Racial Minorities.
    2. Determines that:
    a. The purpose for which the disclosure is to be made can only be 
accomplished if the record is provided in individually identifiable 
form;
    b. The purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring; 
and
    c. There is a strong probability that the proposed use of the data 
would in fact accomplish the stated purpose(s).
    3. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent unauthorized use or disclosure of the record;
    b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
    c. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected.

[[Page 57604]]

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, grantees, consultants or other legal 
agents who have been engaged by the agency to assist in the performance 
of a service related to this system of records 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, grantee, 
cooperative agreement or consultant relationship with a third party to 
assist in accomplishing CMS functions relating to purposes for this 
system or records. 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, 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 requires 
the agent 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 CPTD 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 engaged in or assisting in the 
enrollment, screening, diagnosis, treatment, evaluation, or research 
efforts relative to beneficiary participation in the CPTD for Ethnic 
and Racial Minorities (including summary analyses demonstrating the 
impact of the demonstration project), and other activities reasonably 
necessary to fulfill the provisions of the demonstration project and 
ensure appropriate use of Medicare trust funds and program funds, as 
well as 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, the reduction 
of healthcare disparities, or payment related projects.
    The CPTD 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 a Member of Congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    Beneficiaries sometimes request the help of a Member of Congress in 
resolving an issue relating to a matter before CMS. The Member of 
Congress then writes to CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    5. 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.
    6. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual, grantee, 
cooperative agreement or consultant relationship with a third party to 
assist in accomplishing CMS functions relating to the purpose of 
combating fraud and abuse. CMS occasionally contracts out certain of 
its functions or makes grants or cooperative agreements when doing so 
would contribute to effective and efficient operations. CMS must be 
able to give a contractor, grantee, consultant or other legal agent 
whatever information is necessary for the agent to fulfill its duties. 
In these situations, safeguards are provided in the contract 
prohibiting the agent from using or disclosing the information for any 
purpose other than that described in the contract and requiring the 
agent to return or destroy all information.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    Other agencies may require CPTD information for the purpose of 
combating fraud and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    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, 65 FR 82462 (12-28-00), 
Subparts A and E). Disclosures of PHI 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.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, 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

[[Page 57605]]

based on small cell sizes (instances where the patient population is so 
small that individuals who are familiar with the enrollees 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 include 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 (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 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: August 30, 2005.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
System No. 09-70-0560

SYSTEM NAME:
    ``Cancer Prevention and Treatment Demonstration for Ethnic and 
Racial Minorities (CPTD),'' 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 
demographic and cancer health-related data collected on Medicare target 
population beneficiaries who voluntarily enroll in the Cancer 
Prevention and Treatment Demonstration (CPTD) for Ethnic and Racial 
Minorities. The system will maintain information on two populations: 
(1) Medicare beneficiaries belonging to a defined ethnic or racial 
minority group who do not have a current diagnosis of cancer before 
enrollment in the demonstration project; and (2) Medicare beneficiaries 
belonging to a defined ethnic or racial minority who have been 
diagnosed with cancer before enrollment in the demonstration project.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The collected information will contain name, address, telephone 
number, health insurance claim (HIC) number, race/ethnicity, gender 
type, and date of birth, as well as background information relating to 
Medicare issues. It will also include cancer screening, diagnosis, 
treatment, project enrollment and evaluation, survey and research 
information needed to administer the demonstration project and develop 
research reports on the demonstration findings.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The statutory authority for this system is given under the 
provisions of Section 122 of the Medicare, Medicaid, and State 
Children's Health Insurance Program (SCHIP) Benefits Improvement and 
Protection Act of 2000 (BIPA) (Pub. L. 106-554).

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system is to collect and maintain demographic 
and cancer health-related data on Medicare target population 
beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and 
Racial Minorities. This system will enable CMS to enroll eligible 
participants in the demonstration project; randomize participants into 
intervention and control groups; reimburse demonstration site service 
claims; and develop, maintain and analyze/evaluate research information 
showing the potential impact of providing cancer screening, diagnosis 
and treatment facilitation services to underserved Medicare 
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 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 engaged in the performance activities of the 
demonstration or in 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 constituent requests made to a congressional representative; 
(5) support litigation involving the agency; and (6) combat fraud and 
abuse in certain 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

[[Page 57606]]

known as a ``routine use.'' We are proposing to establish the following 
routine use disclosures of information maintained in the system. 
Information will be disclosed to:
    1. To agency contractors, grantees, consultants or other legal 
agents who have been engaged by the agency to assist in the performance 
of a service related to this system of records 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 engaged in or assisting in the 
enrollment, screening, diagnosis, treatment, evaluation, or research 
efforts relative to beneficiary participation in the CPTD for Ethnic 
and Racial Minorities (including summary analyses demonstrating the 
impact of the demonstration project), and other activities reasonably 
necessary to fulfill the provisions of the demonstration project and 
ensure appropriate use of Medicare trust funds and program funds, as 
well as 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 a Member of Congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    5. 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.
    6. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    B. Additional Provisions Affecting Routine Use Disclosures:
    This system contains Protected Health Information as defines by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 Federal Register 82462 (12-
28-00), Subparts A and E). Disclosures of Protected Health Information 
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.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, 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 complaint 
population is so small that individuals who are familiar with the 
complainants could, because of the small size, use this information to 
deduce the identity of the complainant).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored electronically. Some input may be generated 
in hardcopy, such as eligibility, enrollment, initial cancer status and 
followup assessment information before transcription to electronic 
media. All claims-related records are encompassed by the document 
preservation order and will be retained until notification is received 
from the Department of Justice.

RETRIEVABILITY:
    The collected data are retrieved by an individual identifier; e.g., 
beneficiary name or HIC number.

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 include but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    CMS will retain information for a total period not to exceed 25 
years. Data residing with the designated demonstration project site 
agent shall be returned to CMS at the end of the demonstration period, 
with all data then being the responsibility of CMS for adequate storage 
and security.

SYSTEM MANAGER AND ADDRESS:
    Director, Office of Research Development and Information, CMS, Room 
C3-20-11, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

[[Page 57607]]

NOTIFICATION PROCEDURE:
    For the purpose of access, the subject individual should write to 
the system manager who will require the system name, address, age, 
gender type, and, for verification purposes, the subject individual's 
name (woman's maiden name, if applicable).

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).

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 05-19676 Filed 9-30-05; 8:45 am]
BILLING CODE 4120-03-P
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