Privacy Act of 1974; Report of a New System of Records, 19711-19716 [E7-7404]

Download as PDF cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices Contact: Paul Boben, 410–786–6629 • Expansion of Coverage of Chiropractic Services Demonstration Contact: Carol Magee, 410–786–6611 • Frontier Extended Stay Clinic Demonstration Project Contact: Sid Mazumdar, 410–786–6673 • Home Health Agency Prospective Payment Demonstration Contact: J. Sherwood, 410–786–6651 • Impact of Payment Reform for Part B Covered Outpatient Drugs and Biologicals Contact: Usree Bandyopadhyay, 410–786– 6650 • Informatics for Diabetes Education and Telemedicine Demonstration (IDEATel) Contact: Diana Ayres: 410–786–7203 • Inhalation Drug Therapy Demonstration Contact: Debbie Vanhoven, 410–786–6625 • Life Masters Contact: Linda Colantino, 410–786–3343 • Low Vision Rehabilitation Demonstration Contact: James Coan, 410–786–9168 • Massachusetts Senior Care Options Contact: William Clark, 410–786–1484 • Medical Adult Day Care Services Demonstration Contact: Armen Thoumaian, PhD, 410– 786–6672 • Medicare + Choice Phase II—PPO Demonstration Contact: Debbie Vanhoven, 410–786–6625 • Medicare Advantage CCRC (Erickson) Demonstration Contact: Henry Bachofer, 410–786–0340 • Medicare Cancer Registry Record System Contact: Gerald Riley, 410–786–6699 • Medicare Care Management Performance Demonstration Contact: Jody Blatt, 410–786–6921 • Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project Contact: Linda Lebovic, 410–786–3402 • Medicare Coordinated Care Demonstration Contact: Cynthia Mason, 410–786–6680 • Medicare Drug Replacement Demonstration Contact: Jody Blatt, 410–786–6921 • Medicare Health Care Quality Demonstration Programs Contact: Cynthia Mason, 410–786–6680 • Medicare Home Health Independence Demonstration Contact: Armen Thoumaian, Ph.D., 410– 786–6672 • Medicare Hospital Gainsharing Demonstration Contact: Lisa Waters, 410–786–6615 • Medicare Preventive Services—Medicare Lifestyle Modification Program Demonstration Contact: Armen Thoumaian, PhD, 410– 786–6672 • Mercy Medicare Skilled Nursing Facility Payment Demonstration Contact: J. Sherwood, 410–786–6651 • Minnesota Senior Health Options Contact: Susan Radke, 410–786–4450 • Municipal Health Services Program Demonstration Contact: Michael Henesch, 410–786–6685 • New York Graduate Medical Education Demonstration Contact: Sid Mazumdar, 410–786–6673 • Nursing Home Value-Based Purchasing VerDate Aug<31>2005 15:39 Apr 18, 2007 Jkt 211001 Contact: Ronald Lambert, 410–786–6624 • PACE-for-Profit Demonstration Contact: Michael Henesch, 410–786–6685 • Payment Development, Implementation and Monitoring for the BIPA Disease Management Demonstration Contact: J. Sherwood, 410–786–6651 • Person-Level Medicaid Data System Contact: Dave Baugh, 410–786–7716 • Physician Group Practice Demonstration Contact: John Pilotte, 410–786–6658 • Premier Hospital Quality Incentive Demonstration Contact: Katharine Pirotte, 410–786–6774 • Rural Community Hospital Demonstration Contact: Sid Mazumdar, 410–786–6673 • Rural Hospice Demonstration: Quality Assurance Metrics Implementation Support Contact: Cindy Massuda, 410–786–0652 • Senior Risk Reduction Demonstration Contact: Pauline Lapin, 410–786–6883 • Social Health Maintenance Organization for Long-Term Care Demonstration Contact: Thomas Theis, 410–786–6654 • State-based Home Health Agency TPL Payments Contact: J. Sherwood, 410–786–6651 • United Mine Workers of America Demonstration Contact: Jason Petroski, 410–786–4681 • Utah Graduate Medical Education Contact: Sid Mazumdar, 410–786–6673 • Wisconsin Partnership Program Contact: James Hawthorne, 410–786–6689 [FR Doc. E7–7403 Filed 4–18–07; 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 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 establish a new system titled, ‘‘Post-Acute Care Payment Reform / Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC–CARE), System No. 09–70–0569.’’ The program is authorized under Section 5008 of the Deficit Reduction Act of 2005, which allows for the establishment of a demonstration program for purposes of understanding costs and outcomes across different post-acute care sites. The PAC–CARE will collect information that will enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post- PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 19711 acute care related costs in the Medicare program. Anticipated results of the PAC–CARE include a standardized assessment instrument for post-acute care patients and a proposal for siteneutral payment for post-acute care services. The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS’s proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accrediting organizations; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ‘‘Effective Dates’’ section for comment period. DATES: Effective Date: CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on April 13, 2007. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of E:\FR\FM\19APN1.SGM 19APN1 19712 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 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. The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Mail-stop N2–04–27, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.–3 p.m., eastern time. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Payment Research, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3–19–26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. She can be reached by telephone at 410–786–2583, or via e-mail at Shannon.Flood@cms.hhs.gov. Medicare beneficiaries frequently require postacute care for rehabilitation and recovery following a hospital stay. The level and length of care required varies with the individual patient and the condition(s) requiring hospitalization. The type of care ranges from outpatient therapy to multi-day stays in a variety of post-acute care settings. The PAC– CARE will study Medicare beneficiaries as they are discharged from participating hospitals and move among post-acute care settings. Patient functional assessments will be performed at regular intervals beginning at hospital discharge and continuing as patients move among post-acute care settings until the episode of care has completed. Cost data will be collected from the post-acute care settings, combined with other cost information collected by Medicare Fiscal Intermediaries or Carriers, and combined with claims and patient outcome data to develop a payment reform proposal. cprice-sewell on PROD1PC66 with NOTICES SUPPLEMENTARY INFORMATION: I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under Section 5008 of the Deficit Reduction Act of 2005. VerDate Aug<31>2005 15:39 Apr 18, 2007 Jkt 211001 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 require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC–CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. 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 PAC-CARE 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 PAC–CARE. 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, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 E:\FR\FM\19APN1.SGM 19APN1 cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 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 PAC–CARE information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The PAC–CARE data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that researchers may have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policies that govern their care. 4. To support Quality Improvement Organizations (QIO) in connection with 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. The QIO may use this data to support quality improvement activities and other QIO responsibilities as detailed in Title XI §§ 1151–1164. The QIO will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The QIO will assist state agencies in related monitoring and enforcement efforts, assist CMS and intermediaries in program integrity assessment, and prepare summary information for release to CMS. VerDate Aug<31>2005 15:39 Apr 18, 2007 Jkt 211001 5. To assist national accrediting organization(s) whose accredited facilities are presumed to meet certain Medicare requirements for inpatient hospital rehabilitation services (e.g., the Joint Commission for the Accreditation of Healthcare Organizations, the American Osteopathic Association, or the Commission on Accreditation of Rehabilitation Facilities). Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: a. Provide identifying information for post acute care facilities that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. At this time, CMS anticipates providing accrediting organizations with PAC–CARE information to enable them to target potential identified problems during the organization’s accreditation review process of the facility. 6. 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. 7. 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 19713 grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 8. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require PAC– CARE information for the purpose of combating fraud, waste, and abuse in such Federally funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information (PHI) as defined by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12–28–00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of E:\FR\FM\19APN1.SGM 19APN1 19714 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). cprice-sewell on PROD1PC66 with NOTICES IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the 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 VerDate Aug<31>2005 15:39 Apr 18, 2007 Jkt 211001 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: April 12, 2007. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09–70–0569 SYSTEM NAME: ‘‘Post-Acute Care Payment Reform/ Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC–CARE),’’ HHS/CMS/ ORDI. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244– 1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. submitted by beneficiaries and providers. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for this system is given under Section 5008 of the Deficit Reduction Act of 2005. PURPOSE(S) OF THE SYSTEM: The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS’s proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accrediting organizations; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. CATEGORIES OF RECORDS IN THE SYSTEM: ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: 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. Data will be collected from Medicare administrative and claims records, PAC–CARE site administrative data systems, patient medical charts, physician records, and via information 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1 cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS’s proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To support Quality Improvement Organizations (QIO) in connection with 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. 5. To assist national accrediting organization(s) whose accredited facilities are presumed to meet certain Medicare requirements for inpatient hospital rehabilitation services (e.g., the Joint Commission for the Accreditation of Healthcare Organizations, the American Osteopathic Association, or the Commission on Accreditation of Rehabilitation Facilities). Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: a. Provide identifying information for post acute care facilities that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. 6. 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 VerDate Aug<31>2005 15:39 Apr 18, 2007 Jkt 211001 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. 7. 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, waste, and abuse in such program. 8. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information (PHI) as defined by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12–28–00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ (See 45 CFR 164.512(a) (1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 19715 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 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. RETENTION AND DISPOSAL: Records will be retained until an approved disposition authority is obtained from the National Archives and Records Administration. All claimsrelated records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER AND ADDRESS: Director, Research and Evaluation Group, Office of Research Development E:\FR\FM\19APN1.SGM 19APN1 19716 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices & Information, Mail Stop C3–19–26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. ACTION: 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 (Outcome and Assessment Information Set, Inpatient Rehabilitation Facilities Patient Assessment Instrument, Long Term Care Minimum Data Set), postacute care site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7–7404 Filed 4–18–07; 8:45 am] BILLING CODE 4120–03–P Notice. ACTION: SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9067, e-mail: pamela.esposito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701, has requested that FDA withdraw approval of NADA 121– 200 for Tylosin 10 Premix (tylosin), NADA 129–159 for TYLAN 40 Sulfa-G (tylosin and sulfamethazine), and NADA 137–484 for Swine Guard-BN (pyrantel). All are intermediate premixes used to manufacture Type C medicated feeds. This action is requested because the products are no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115 Withdrawal of approval of applications, notice is given that approval of NADA 121–200, NADA 129–159, and NADA 137–484, and all supplements and amendments thereto, are hereby withdrawn, effective April 30, 2007. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–7461 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES cprice-sewell on PROD1PC66 with NOTICES Food and Drug Administration Food and Drug Administration [Docket No. 2007N–0077] [Docket No. 2007N–0078] Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, AGENCY: SUMMARY: The Food and Drug Administration (FDA) has withdrawn approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9067; e-mail: pamela.esposito@fda.hhs.gov. PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 80524, has requested that FDA withdraw approval of NADA 141–040 for DURALEASE (estradiol benzoate), a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency and NADA 141–041 for CELERIN-C (estradiol benzoate), a similar product used in suckling beef calves for increased rate of weight gain. This action is requested because the products are no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115, notice is given that approval of NADA 141–040 and NADA 141–041 and all supplements and amendments thereto, were withdrawn as of September 29, 2006. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. SUPPLEMENTARY INFORMATION: Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. 07–1941 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration, HHS. HHS. VerDate Aug<31>2005 Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate Notice. 15:39 Apr 18, 2007 Jkt 211001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Notices]
[Pages 19711-19716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7404]


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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).

-----------------------------------------------------------------------

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system titled, ``Post-Acute 
Care Payment Reform / Continuity of Assessment Report and Evaluation 
Demonstration and Evaluation (PAC-CARE), System No. 09-70-0569.'' The 
program is authorized under Section 5008 of the Deficit Reduction Act 
of 2005, which allows for the establishment of a demonstration program 
for purposes of understanding costs and outcomes across different post-
acute care sites. The PAC-CARE will collect information that will 
enable CMS to better understand the relationships among patient needs, 
post-acute care placement, patient outcomes, and post-acute care 
related costs in the Medicare program. Anticipated results of the PAC-
CARE include a standardized assessment instrument for post-acute care 
patients and a proposal for site-neutral payment for post-acute care 
services.
    The purpose of this system is to collect and maintain demographic, 
health, and health resource use related data on the target population 
of Medicare beneficiaries who require treatment in a designated acute 
care or post-acute care facility. We will also collect certain 
identifying information on Medicare providers who provide services to 
such beneficiaries. Information retrieved from this system may be 
disclosed to: (1) Support regulatory, reimbursement, and policy 
functions performed within the agency or by a contractor, grantee, 
consultant or other legal agent; (2) assist another Federal or state 
agency with information to contribute to the accuracy of CMS's proper 
payment of Medicare benefits, enable such agency to administer a 
Federal health benefits program, or to enable such agency to fulfill a 
requirement of Federal statute or regulation that implements a health 
benefits program funded in whole or in part with Federal funds; (3) 
support an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects; (4) support the functions of Quality Improvement 
Organizations; (5) support the functions of national accrediting 
organizations; (6) support litigation involving the agency; and (7) 
combat fraud, waste, and abuse in certain Federally-funded health 
benefits programs. We have provided background information about the 
new system in the SUPPLEMENTARY INFORMATION section below. Although the 
Privacy Act requires only that CMS provide an opportunity for 
interested persons to comment on the proposed routine uses, CMS invites 
comments on all portions of this notice. See ``Effective Dates'' 
section for comment period.

DATES: Effective Date: CMS filed a new SOR report with the Chair of the 
House Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Homeland Security & Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on April 13, 2007. To ensure that all 
parties have adequate time in which to comment, the new system will 
become effective 30 days from the publication of

[[Page 19712]]

the notice, or 40 days from the date it was submitted to OMB and the 
Congress, whichever is later. We may defer implementation of this 
system or one or more of the routine use statements listed below if we 
receive comments that persuade us to defer implementation.

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

FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Payment 
Research, Research and Evaluation Group, Office of Research Development 
& Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be 
reached by telephone at 410-786-2583, or via e-mail at 
Shannon.Flood@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: Medicare beneficiaries frequently require 
post-acute care for rehabilitation and recovery following a hospital 
stay. The level and length of care required varies with the individual 
patient and the condition(s) requiring hospitalization. The type of 
care ranges from outpatient therapy to multi-day stays in a variety of 
post-acute care settings. The PAC-CARE will study Medicare 
beneficiaries as they are discharged from participating hospitals and 
move among post-acute care settings. Patient functional assessments 
will be performed at regular intervals beginning at hospital discharge 
and continuing as patients move among post-acute care settings until 
the episode of care has completed. Cost data will be collected from the 
post-acute care settings, combined with other cost information 
collected by Medicare Fiscal Intermediaries or Carriers, and combined 
with claims and patient outcome data to develop a payment reform 
proposal.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for SOR

    The statutory authority for this system is given under Section 5008 
of the Deficit Reduction Act of 2005.

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 require treatment in 
a designated acute care or post-acute care facility. We will also 
collect certain identifying information on Medicare providers who 
provide services to such beneficiaries. The collected information will 
include, but is not limited to: Medicare claims and eligibility data, 
name, address, telephone number, health insurance claims number, race/
ethnicity, gender, date of birth, provider name, unique provider 
identification number, medical record number, as well as clinical, 
demographic, health/well-being, family and/or caregiver contact 
information, and background information relating to Medicare issues. 
Data will be collected from Medicare administrative and claims records, 
PAC-CARE site administrative data systems, patient medical charts, 
physician records, and via information submitted by beneficiaries and 
providers.

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 PAC-CARE 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 PAC-CARE.
    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, health, and health resource use related data on the target 
population of Medicare beneficiaries who require treatment in a 
designated acute care or post-acute care facility. 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

[[Page 19713]]

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 PAC-CARE information in order to 
support evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper reimbursement for services provided.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    The PAC-CARE data will provide for research or support of 
evaluation projects and a broader, longitudinal, national perspective 
of the status of Medicare beneficiaries. CMS anticipates that 
researchers may have legitimate requests to use these data in projects 
that could ultimately improve the care provided to Medicare 
beneficiaries and the policies that govern their care.
    4. To support Quality Improvement Organizations (QIO) in connection 
with 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.
    The QIO may use this data to support quality improvement activities 
and other QIO responsibilities as detailed in Title XI Sec. Sec.  1151-
1164.
    The QIO will work to implement quality improvement programs, 
provide consultation to CMS, its contractors, and to state agencies. 
The QIO will assist state agencies in related monitoring and 
enforcement efforts, assist CMS and intermediaries in program integrity 
assessment, and prepare summary information for release to CMS.
    5. To assist national accrediting organization(s) whose accredited 
facilities are presumed to meet certain Medicare requirements for 
inpatient hospital rehabilitation services (e.g., the Joint Commission 
for the Accreditation of Healthcare Organizations, the American 
Osteopathic Association, or the Commission on Accreditation of 
Rehabilitation Facilities). Information will be released to these 
organizations for only those facilities that they accredit and that 
participate in the Medicare program and if they meet the following 
requirements:
    a. Provide identifying information for post acute care facilities 
that have an accreditation status with the requesting deemed 
organization;
    b. Submission of a finder file identifying beneficiaries/patients 
receiving post acute care services;
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access; and
    d. Upon completion of a signed data exchange agreement or a CMS 
data use agreement.
    At this time, CMS anticipates providing accrediting organizations 
with PAC-CARE information to enable them to target potential identified 
problems during the organization's accreditation review process of the 
facility.
    6. 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.
    7. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud, waste, and abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual, grantee, 
cooperative agreement or consultant relationship with a third party to 
assist in accomplishing CMS functions relating to the purpose of 
combating fraud, waste, and abuse. CMS occasionally contracts out 
certain of its functions or makes grants or cooperative agreements when 
doing so would contribute to effective and efficient operations. CMS 
must be able to give a contractor, grantee, consultant or other legal 
agent whatever information is necessary for the agent to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the agent from using or disclosing the information for any 
purpose other than that described in the contract and requiring the 
agent to return or destroy all information.
    8. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud, 
waste, or abuse in, a health benefits program funded in whole or in 
part by Federal funds, when disclosure is deemed reasonably necessary 
by CMS to prevent, deter, discover, detect, investigate, examine, 
prosecute, sue with respect to, defend against, correct, remedy, or 
otherwise combat fraud, waste, or abuse in such programs.
    Other agencies may require PAC-CARE information for the purpose of 
combating fraud, waste, and abuse in such Federally funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise authorized by these routine uses may only be made 
if, and as, permitted or required by the ``Standards for Privacy of 
Individually Identifiable Health Information.'' (See 45 CFR 
164.512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of

[[Page 19714]]

the routine uses or if required by law, if we determine there is a 
possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the patient 
population is so small that individuals could, because of the small 
size, use this information to deduce the identity of the beneficiary).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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: April 12, 2007.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
SYSTEM NO. 09-70-0569

System Name:
    ``Post-Acute Care Payment Reform/Continuity of Assessment Report 
and Evaluation Demonstration and Evaluation (PAC-CARE),'' HHS/CMS/ORDI.

Security Classification:
    Level Three Privacy Act Sensitive Data.

System Location:
    Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 
Security Boulevard, North Building, First Floor, Baltimore, Maryland 
21244-1850 and at various co-locations of CMS agents.

Categories of Individuals Covered by the System:
    This system will collect and maintain individually identifiable and 
other data collected on Medicare beneficiaries who require treatment in 
a designated acute care or post-acute care facility. We will also 
collect certain identifying information on Medicare providers who 
provide services to such beneficiaries.

Categories of Records in the System:
    The collected information will include, but is not limited to: 
Medicare claims and eligibility data, name, address, telephone number, 
health insurance claims number, race/ethnicity, gender, date of birth, 
provider name, unique provider identification number, medical record 
number, as well as clinical, demographic, health/well-being, family 
and/or caregiver contact information, and background information 
relating to Medicare issues. Data will be collected from Medicare 
administrative and claims records, PAC-CARE site administrative data 
systems, patient medical charts, physician records, and via information 
submitted by beneficiaries and providers.

Authority for Maintenance of the System:
    The statutory authority for this system is given under Section 5008 
of the Deficit Reduction Act of 2005.

Purpose(s) of the System:
    The purpose of this system is to collect and maintain demographic, 
health, and health resource use related data on the target population 
of Medicare beneficiaries who require treatment in a designated acute 
care or post-acute care facility. We will also collect certain 
identifying information on Medicare providers who provide services to 
such beneficiaries. Information retrieved from this system may be 
disclosed to: (1) Support regulatory, reimbursement, and policy 
functions performed within the agency or by a contractor, grantee, 
consultant or other legal agent; (2) assist another Federal or state 
agency with information to contribute to the accuracy of CMS's proper 
payment of Medicare benefits, enable such agency to administer a 
Federal health benefits program, or to enable such agency to fulfill a 
requirement of Federal statute or regulation that implements a health 
benefits program funded in whole or in part with Federal funds; (3) 
support an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects; (4) support the functions of Quality Improvement 
Organizations; (5) support the functions of national accrediting 
organizations; (6) support litigation involving the agency; and (7) 
combat fraud, waste, and abuse in certain Federally-funded health 
benefits programs.

Routine Uses of Records Maintained in the System, Including Categories 
or Users and the Purposes of Such Uses:
    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees, who have been 
engaged by the agency to assist in the performance of a service related 
to this collection and

[[Page 19715]]

who need to have access to the records in order to perform the 
activity.
    2. To another Federal or state agency to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits;
    b. Enable such agency to administer a Federal health benefits 
program, or, as necessary, to enable such agency to fulfill a 
requirement of a Federal statute or regulation that implements a health 
benefits program funded in whole or in part with Federal funds; and/or
    c. Assist Federal/state Medicaid programs within the state.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    4. To support Quality Improvement Organizations (QIO) in connection 
with 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.
    5. To assist national accrediting organization(s) whose accredited 
facilities are presumed to meet certain Medicare requirements for 
inpatient hospital rehabilitation services (e.g., the Joint Commission 
for the Accreditation of Healthcare Organizations, the American 
Osteopathic Association, or the Commission on Accreditation of 
Rehabilitation Facilities). Information will be released to these 
organizations for only those facilities that they accredit and that 
participate in the Medicare program and if they meet the following 
requirements:
    a. Provide identifying information for post acute care facilities 
that have an accreditation status with the requesting deemed 
organization;
    b. Submission of a finder file identifying beneficiaries/patients 
receiving post acute care services;
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access; and
    d. Upon completion of a signed data exchange agreement or a CMS 
data use agreement.
    6. 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.
    7. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud, waste, and abuse in such program.
    8. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud, 
waste, or abuse in, a health benefits program funded in whole or in 
part by Federal funds, when disclosure is deemed reasonably necessary 
by CMS to prevent, deter, discover, detect, investigate, examine, 
prosecute, sue with respect to, defend against, correct, remedy, or 
otherwise combat fraud, waste, or abuse in such programs.
    B. Additional Provisions Affecting Routine Use Disclosures
    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise authorized by these routine uses may only be made 
if, and as, permitted or required by the ``Standards for Privacy of 
Individually Identifiable Health Information.'' (See 45 CFR 164.512(a) 
(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals could, because of the small size, use this information to 
deduce the identity of the beneficiary).

Policies and Practices for Storing, Retrieving, Accessing, Retaining, 
and Disposing of Records in the System:
Storage:
    All records are stored on electronic media.

Retrievability:
    The collected data are retrieved by an individual identifier; e.g., 
beneficiary name or HICN.

Safeguards:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against unauthorized use. Personnel having access to 
the system have been trained in the Privacy Act and information 
security requirements. Employees who maintain records in this system 
are instructed not to release data until the intended recipient agrees 
to implement appropriate management, operational and technical 
safeguards sufficient to protect the confidentiality, integrity and 
availability of the information and information systems and to prevent 
unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations may apply but are not limited to: the Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: all pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

Retention and Disposal:
    Records will be retained until an approved disposition authority is 
obtained from the National Archives and Records Administration. 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, Research and Evaluation Group, Office of Research 
Development

[[Page 19716]]

& Information, Mail Stop C3-19-26, 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 (Outcome and Assessment Information Set, Inpatient 
Rehabilitation Facilities Patient Assessment Instrument, Long Term Care 
Minimum Data Set), post-acute care site administrative data systems, 
patient medical charts, physician records, and via information 
submitted by beneficiaries and providers.

Systems Exempted From Certain Provisions of the Act:
    None.
[FR Doc. E7-7404 Filed 4-18-07; 8:45 am]
BILLING CODE 4120-03-P
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