Privacy Act of 1974; Report of a New System of Records, 41807-41811 [E6-11637]

Download as PDF Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ‘‘Medicare Lifestyle Modification Program (MLMP) Demonstration, System No. 09–70– 0585.’’ The program is mandated by the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106–554). The MLMP Demonstration and evaluation will test the feasibility and cost effectiveness of proven and intensive programs designed to reduce or reverse the progression of cardiovascular disease of patients at risk for invasive treatment procedures. The programs may reduce the incidence of hospitalizations and invasive procedures among patients with substantial coronary occlusion. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the MLMP Demonstration. 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) assist Quality Improvement Organizations; (4) 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; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 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. 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 July 17, 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 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: Armen Thoumaian, Division of Health Promotion & Disease Prevention Demonstrations, Medicare Demonstrations Program Group, Office of Research, Development & Information, Mail Stop S3–02–01, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. He can be reached by telephone at 410–786–6672, or via e-mail at Armen.Thoumaian@cms.hhs.gov. SUPPLEMENTARY INFORMATION: The program is mandated by the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106–554). The MLMP demonstration and evaluation will test the feasibility and cost effectiveness of proven and intensive programs designed to reduce or reverse the progression of cardiovascular disease of patients at risk for invasive treatment procedures. Research has provided evidence that specific lifestyle changes can lead to a decrease in the levels of cardiovascular risk factors, resulting in lower morbidity PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 41807 and mortality associated with coronary artery disease. Lifestyle modification programs are increasingly becoming an approach to the secondary prevention of coronary disease morbidity. The programs may reduce the incidence of hospitalizations and invasive procedures among patients with substantial coronary occlusion. Medicare currently pays for 12 weeks of cardiac rehabilitation services for Medicare patients who have a prior diagnosis of myocardial infarction or who have had a recent cardiac revascularization procedure or both. Coverage under the Medicare cardiac rehabilitation benefit is more limited than that contained in a comprehensive lifestyle modification program. We are investigating the benefits of coverage a complete package of services offered under an established, multi-site lifestyle modification program. 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 the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106–554). 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 are potential participants in the MLMP and providers who provide services to such beneficiaries. Data will be collected from Medicare administrative and claims records, patient medical charts, physician records, and via survey instruments administered to beneficiaries and providers. 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. It will also include treatment, program participation, and evaluation, survey, 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 E:\FR\FM\24JYN1.SGM 24JYN1 41808 Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices sroberts on PROD1PC70 with NOTICES which the information was collected. Any such disclosure of data is known as a ‘‘routine use.’’ The Government will only release MLMP 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 MLMP. 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 MLMP Demonstration. 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 VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 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 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 MLMP information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To assist Quality Improvement Organizations (QIO) in connection with the review of claims, or in connection with studies or other review activities, conducted pursuant to Part B of Title XI of the Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 QIOs will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to ensure that payment is only made for medically necessary services. QIOs will assist in related monitoring and enforcement efforts, assist CMS and intermediaries in program integrity assessment, investigate beneficiary complaints about quality of care, and prepare summary information for release to CMS. 4. 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 MLMP 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. 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 deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, E:\FR\FM\24JYN1.SGM 24JYN1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices 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 MLMP information for the purpose of combating fraud 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 Fed. Reg. 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 because of the small size, use of this VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 information could allow for the deduction of 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 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 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 41809 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: July 14, 2006. John R. Dyer, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09–70–0585 SYSTEM NAME: ‘‘Medicare Lifestyle Modification Program (MLMP) Demonstration,’’ 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 are potential participants in the MLMP Demonstration and providers who provide services to such beneficiaries. CATEGORIES OF RECORDS IN THE SYSTEM: Data will be collected from Medicare administrative and claims records, patient medical charts, physician records, and via survey instruments administered to beneficiaries and providers. 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/wellbeing, family and/or caregiver contact information, and background information relating to Medicare issues. It will also include treatment, program participation, and evaluation, survey, 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 the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106–554). E:\FR\FM\24JYN1.SGM 24JYN1 41810 Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices 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 are potential participants in the MLMP Demonstration. 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) assist Quality Improvement Organizations; (4) 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; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain Federally-funded health benefits programs. sroberts on PROD1PC70 with NOTICES 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 VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 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 Quality Improvement Organizations (QIO) in connection with the review of claims, or in connection with studies or other review activities, conducted pursuant to Part B of Title XI of the Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 4. 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. 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 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 because of the small size, use of this information could allow for the deduction of 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 E:\FR\FM\24JYN1.SGM 24JYN1 Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices 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. 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 S3–02–01, 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)). sroberts on PROD1PC70 with NOTICES CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicare administrative and claims records, patient medical charts, physician VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 records, and via survey instruments administered to beneficiaries and providers. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6–11637 Filed 7–21–06; 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 Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). 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 establish a new system titled, ‘‘Medicare Care Management for High Cost Beneficiaries (CMHCB), System No. 09–70–0580.’’ The program is authorized under provisions of the Social Security Act (42 U.S.C. Section 1395b–1(a)), which gives the Secretary the broad authority to, ‘develop and engage in experiments and demonstration projects.’ The CMHCB program seeks to improve beneficiary self-care and provide beneficiaries and their providers enhanced information and support in order to increase adherence to evidence-based care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the payments. Each CMHCB program is an experimental design involving assignment of beneficiaries to either an intervention or control group. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the CMHCB 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 41811 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 and abuse in certain Federallyfunded 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. 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 July 17, 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 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: Melissa Dehn, Division of Chronic Care Improvement Programs, Provider Billing Group, Center for Medicare Management, Mail Stop C4–10–07, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. She can be reached by telephone at 410–786–5721, or via e-mail at Melissa.Dehn@cms.hhs.gov. SUPPLEMENTARY INFORMATION: The CMHCB program pays monthly fees to CMHCB sites for improving the coordination of Medicare services E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41807-41811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11637]



[[Page 41807]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


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

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

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

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system titled, ``Medicare 
Lifestyle Modification Program (MLMP) Demonstration, System No. 09-70-
0585.'' The program is mandated by the Consolidated Appropriations Act 
of 2001 (Public Law (Pub. L.) 106-554). The MLMP Demonstration and 
evaluation will test the feasibility and cost effectiveness of proven 
and intensive programs designed to reduce or reverse the progression of 
cardiovascular disease of patients at risk for invasive treatment 
procedures. The programs may reduce the incidence of hospitalizations 
and invasive procedures among patients with substantial coronary 
occlusion.
    The purpose of this system is to collect and maintain demographic 
and health related data on the target population of Medicare 
beneficiaries who are potential participants in the MLMP Demonstration. 
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) assist Quality Improvement Organizations; (4) 
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; (5) support litigation involving the agency; and (6) 
combat fraud 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.

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 July 17, 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 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: Armen Thoumaian, Division of Health 
Promotion & Disease Prevention Demonstrations, Medicare Demonstrations 
Program Group, Office of Research, Development & Information, Mail Stop 
S3-02-01, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1849. He can be reached by telephone at 
410-786-6672, or via e-mail at Armen.Thoumaian@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: The program is mandated by the Consolidated 
Appropriations Act of 2001 (Public Law (Pub. L.) 106-554). The MLMP 
demonstration and evaluation will test the feasibility and cost 
effectiveness of proven and intensive programs designed to reduce or 
reverse the progression of cardiovascular disease of patients at risk 
for invasive treatment procedures. Research has provided evidence that 
specific lifestyle changes can lead to a decrease in the levels of 
cardiovascular risk factors, resulting in lower morbidity and mortality 
associated with coronary artery disease. Lifestyle modification 
programs are increasingly becoming an approach to the secondary 
prevention of coronary disease morbidity. The programs may reduce the 
incidence of hospitalizations and invasive procedures among patients 
with substantial coronary occlusion.
    Medicare currently pays for 12 weeks of cardiac rehabilitation 
services for Medicare patients who have a prior diagnosis of myocardial 
infarction or who have had a recent cardiac revascularization procedure 
or both. Coverage under the Medicare cardiac rehabilitation benefit is 
more limited than that contained in a comprehensive lifestyle 
modification program. We are investigating the benefits of coverage a 
complete package of services offered under an established, multi-site 
lifestyle modification program.

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 the Consolidated 
Appropriations Act of 2001 (Public Law (Pub. L.) 106-554).
    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 are potential participants in 
the MLMP and providers who provide services to such beneficiaries. Data 
will be collected from Medicare administrative and claims records, 
patient medical charts, physician records, and via survey instruments 
administered to beneficiaries and providers. 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. It 
will also include treatment, program participation, and evaluation, 
survey, 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

[[Page 41808]]

which the information was collected. Any such disclosure of data is 
known as a ``routine use.'' The Government will only release MLMP 
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 MLMP.
    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 MLMP 
Demonstration. 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 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 MLMP information in order to 
support evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper reimbursement for services provided.
    3. To assist Quality Improvement Organizations (QIO) in connection 
with the review of claims, or in connection with studies or other 
review activities, conducted pursuant to Part B of Title XI of the Act 
and in performing affirmative outreach activities to individuals for 
the purpose of establishing and maintaining their entitlement to 
Medicare benefits or health insurance plans.
    QIOs will work to implement quality improvement programs, provide 
consultation to CMS, its contractors, and to ensure that payment is 
only made for medically necessary services. QIOs will assist in related 
monitoring and enforcement efforts, assist CMS and intermediaries in 
program integrity assessment, investigate beneficiary complaints about 
quality of care, and prepare summary information for release to CMS.
    4. 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 MLMP 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.
    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,

[[Page 41809]]

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 MLMP information for the purpose of 
combating fraud 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 Fed. Reg. 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 
because of the small size, use of this information could allow for the 
deduction of 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: July 14, 2006.
 John R. Dyer,
 Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0585

SYSTEM NAME:
    ``Medicare Lifestyle Modification Program (MLMP) Demonstration,'' 
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 are potential 
participants in the MLMP Demonstration and providers who provide 
services to such beneficiaries.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Data will be collected from Medicare administrative and claims 
records, patient medical charts, physician records, and via survey 
instruments administered to beneficiaries and providers. 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. It will also include treatment, program participation, and 
evaluation, survey, 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 the Consolidated Appropriations Act of 2001 (Public Law 
(Pub. L.) 106-554).

[[Page 41810]]

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 are potential participants in the MLMP Demonstration. 
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) assist Quality Improvement Organizations; (4) 
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; (5) support litigation involving the agency; and (6) 
combat fraud 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 assist Quality Improvement Organizations (QIO) in connection 
with the review of claims, or in connection with studies or other 
review activities, conducted pursuant to Part B of Title XI of the Act 
and in performing affirmative outreach activities to individuals for 
the purpose of establishing and maintaining their entitlement to 
Medicare benefits or health insurance plans.
    4. 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.
    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. 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 
because of the small size, use of this information could allow for the 
deduction of 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

[[Page 41811]]

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. 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 
S3-02-01, 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, patient medical charts, physician records, and via survey 
instruments administered to beneficiaries and providers.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. E6-11637 Filed 7-21-06; 8:45 am]
BILLING CODE 4120-03-P
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