Privacy Act of 1974; Report of a Modified or Altered System of Records, 67143-67148 [E6-19506]

Download as PDF Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a Modified or Altered System of Records Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of a Modified or Altered System of Records (SOR). sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ‘‘Inpatient Rehabilitation Facilities (IRF) Patient Assessment Instrument (IRF– PAI),’’ System No. 09–70–1518, last published at 66 Federal Register 56681 (November 9, 2001). Information maintained in this system will continue to contain clinical assessment information for all Medicare Part A feefor-service patients receiving the services of a Medicare approved IRF. This information will be useful in developing core measures that provide meaningful information on patient characteristics and outcomes across post-acute care settings and will be used by CMS to fulfill its responsibility for validating surveys conducted by accrediting agencies. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09–70–0521. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will modify existing routine use number 2 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs relating to assessing and improving IRF quality of care. The modified routine use will be renumbered as routine use number 4. We will delete routine use number 5 authorizing disclosure to support VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ‘‘prior written consent’’ of the data subject. We will broaden the scope of published routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ‘‘waste’’ which refers increasingly more to specific beneficiary or recipient practices that result in unnecessary cost to federally-funded health benefit programs. CMS proposes to broaden the scope of the disclosure requirement for routine use number 5, authorizing disclosure to national accrediting organizations that have been approved by CMS for deeming authority for Medicare requirements for home health services. 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: (1) Provide identifying information for IRFs that have an accreditation status with the requesting accrediting organization that has been granted deeming authority by CMS, (2) submission of a finder file identifying beneficiaries/patients receiving IRF services, (3) safeguard the confidentiality of the data and prevent unauthorized access, and (4) upon completion of a signed data exchange agreement or a CMS data use agreement. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS’s intention to disclose individualspecific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108–173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to support the IRF prospective payment system (PPS) for payment of the IRF Medicare Part A fee-for-services furnished by the IRF to Medicare beneficiaries. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 67143 a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, for evaluating and monitoring the quality of IRF health care and contribute to the accuracy of health insurance operations; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support the functions of Quality Improvement Organizations; (5) assist other insurers; (6) support the functions of national accrediting organizations; (7) support litigation involving the Agency; and (8) combat fraud, waste, and abuse in certain health care programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period. DATES: Effective Dates: CMS filed a modified or altered system 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 November 14, 2006. To ensure that all parties have adequate time in which to comment, the modified system, including routine uses, will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless CMS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, CMS, Room N2–04–27, 7500 Security Boulevard, Baltimore, Maryland 21244– 1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.–3 p.m., Eastern Time zone. FOR FURTHER INFORMATION CONTACT: Georgia Johnson, Division of Continuing Care Providers, Survey and Certification Group, Center for Medicaid and State Operations, CMS, Mail Stop S2–12–25, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. She can also be reached by telephone at 410–786–6859, E:\FR\FM\20NON1.SGM 20NON1 67144 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices or via e-mail at Georgia.Johnson@cms.hhs.gov. SUPPLEMENTARY INFORMATION: I. Description of the Modified or Altered System of Records A. Statutory and Regulatory Basis for SOR Authority for maintenance of the system is given under section 1886 (j) (2) (D) of the Social Security Act authorizing the secretary to collect the data necessary to establish and administer the payment system. B. Collection and Maintenance of Data in the System The IRF–PAI will be completed on all Medicare Part A fee-for-service patients who receive services under Part A from an IRF, it may also be completed on Medicare Advantage enrollees. Records in this system will include, but are not limited to, name, address, date of birth, gender, ethnicity, social security number, health insurance claim number, Medicaid number, patient identification number, patient history, diagnosis, and functional prognosis. sroberts on PROD1PC70 with NOTICES II. Agency Policies, Procedures, and Restrictions on Routine Uses A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a ‘‘routine use.’’ The government will only release IRF–PAI 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 IRF–PAI. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from this system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, e.g, to support the IRF prospective payment system (PPS) for payment of the IRF Medicare Part A fee-for-services furnished by the IRF to Medicare beneficiaries. 2. Determines that: VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 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 indivdual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a ‘‘routine use.’’ The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To support agency contractors, consultants, or grantees who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS’ 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. Improve the state survey process for investigation of complaints related to health and safety or quality of care and to implement a more outcome oriented survey and certification program. Other Federal or state agencies in their administration of a Federal health program may require IRF–PAI 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 research on the utilization of inpatient rehabilitation services as well as evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for understanding and improving payment projects. The IRF–PAI data will provide for research or in support of evaluation projects, a broader, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policy that governs the care. 4. To support 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 E:\FR\FM\20NON1.SGM 20NON1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices 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 insurance companies, third party administrators (TPA), employers, self-insurers, managed care organizations, other supplemental insurers, non-coordinating insurers, multiple employer trusts, group health plans (i.e., health maintenance organization (HMO) or a competitive medical plan (CMP)) with a Medicare contract, or a Medicare-approved health care payment plan (HCPP), directly or through a contractor, and other groups providing protection for their enrollees. Information to be disclosed shall be limited to Medicare entitlement data. In order to receive the information, they must agree to: a. Certify that the individual about whom the information is being provided is one of its insured or employees, or is insured and/or employed by another entity for whom they serve as a third party administrator; b. Utilize the information solely for the purpose of processing the individual’s insurance claims; and c. Safeguard the confidentiality of the data and prevent unauthorized access. Other insurers, CMP, HMO and HCPP may require IRF–PAI information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper payment for services provided. 6. 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 IRFs that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving IRF 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. VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 At this time, CMS anticipates providing accrediting organizations with IRF–PAI information to enable them to target potential identified problems during the organization’s accreditation review process of the facility. 7. To support the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS’ policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 8. To assist 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, or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual relationship or grant 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 and makes grants when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor or grantee whatever information is necessary for the contractor or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor or grantee from using or disclosing the information for any purpose other than that PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 67145 described in the contract and requiring the contractor or grantee to return or destroy all information. 9. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require IRF–PAI information for the purpose of combating fraud, waste, and abuse in such federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information (PHI) as defined by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12–28–00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ (See 45 CFR 164–512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against 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 E:\FR\FM\20NON1.SGM 20NON1 67146 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent NIST publications; the DHHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Modified System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system’s functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. sroberts on PROD1PC70 with NOTICES Dated: November 8, 2006. John R. Dyer, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09–70–0521 SYSTEM NAME: ‘‘Inpatient Rehabilitation Facilities Patient Assessment Instrument (IRF– PAI),’’ HHS/CMS/CMSO. VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: The Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244– 1850 and at various contractor sites and at CMS Regional Offices. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: The IRF–PAI will be completed on all Medicare Part A fee-for-service patients who receive services under Part A from an IRF, it may also be completed on Medicare Advantage enrollees. CATEGORIES OF RECORDS IN THE SYSTEM: Records in this system will include, but are not limited to, name, address, date of birth, gender, ethnicity, social security number (SSN), health insurance claim number (HICN), Medicaid number, patient identification number, patient history, diagnosis, and functional prognosis. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for maintenance of the system is given under section 1886(j)(2)(D) of the Social Security Act authorizing the secretary to collect the data necessary to establish and administer the payment system. PURPOSE(S) OF THE SYSTEM: The primary purpose of this modified system is to support the IRF prospective payment system (PPS) for payment of the IRF Medicare Part A fee-for-services furnished by the IRF to Medicare beneficiaries. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, for evaluating and monitoring the quality of IRF health care and contribute to the accuracy of health insurance operations; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support the functions of Quality Improvement Organizations (QIO); (5) assist other insurers; (6) support the functions of national accrediting organizations; (7) support litigation involving the Agency; (8) combat fraud, waste, and abuse in certain health care programs. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. The Privacy Act allows us to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a ‘‘routine use.’’ The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To support agency contractors, consultants, or grantees who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS’ 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. Improve the state survey process for investigation of complaints related to health and safety or quality of care and to implement a more outcome oriented survey and certification program. 3. To an individual or organization for research on the utilization of inpatient rehabilitation services as well as evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for understanding and improving payment 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 insurance companies, third party administrators (TPA), employers, self-insurers, managed care organizations, other supplemental insurers, non-coordinating insurers, multiple employer trusts, group health plans (i.e., health maintenance organization (HMO) or a competitive medical plan (CMP)) with a Medicare E:\FR\FM\20NON1.SGM 20NON1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices contract, or a Medicare-approved health care payment plan (HCPP), directly or through a contractor, and other groups providing protection for their enrollees. Information to be disclosed shall be limited to Medicare entitlement data. In order to receive the information, they must agree to: a. Certify that the individual about whom the information is being provided is one of its insured or employees, or is insured and/or employed by another entity for whom they serve as a third party administrator; b. Utilize the information solely for the purpose of processing the individual’s insurance claims; and c. Safeguard the confidentiality of the data and prevent unauthorized access. 6. 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 IRFs that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving IRF 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. 7. To support the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 8. To assist 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, or abuse in such program. 9. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information (PHI) as defined by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12–28– 00), disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ (See 45 CFR 164– 512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on magnetic media. RETRIEVABILITY: The Medicare records are retrieved by the HICN and SSN. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 67147 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 DHHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain identifiable IRF–PAI data for a total period of 15 years. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER(S) AND ADDRESS: Director, Survey and Certification Group, Center for Medicaid and State Operations, CMS, Mail Stop C3–20–01, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual’s name (woman’s maiden name, if applicable), and SSN. Furnishing the SSN is voluntary, but it E:\FR\FM\20NON1.SGM 20NON1 67148 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices may make searching for a record easier and prevent delay. RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORDS PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the records and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Information for this system is collected from the Inpatient Rehabilitation Facilities—Patient Assessment Instrument. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6–19506 Filed 11–17–06; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration sroberts on PROD1PC70 with NOTICES Delegation of Authority Notice is hereby given that I have delegated to the Administrator, Health Resources and Services Administration (HRSA), with authority to re-delegate, the authority vested in the Secretary of Health and Human Services under Title III, Part B, Section 319F–4, titled ‘‘Covered Countermeasure Process,’’ of the Public Health Service Act, as amended, by the Public Readiness and Emergency Preparedness Act of 2006 (Pub. L. 109–148), only insofar as it pertains to the compensation program. This delegation shall be exercised under the Department’s existing delegation of authority and policy on regulations. This delegation is effective upon signature. In addition, I hereby affirmed and ratified any actions taken by the HRSA Administrator or other HRSA officials which involved the exercise of this authority prior to the effective date of this delegation. This delegation is effective upon date of signature. VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 Dated: November 8, 2006. Michael O. Leavitt, Secretary. [FR Doc. 06–9264 Filed 11–17–06; 8:45 am] BILLING CODE 4165–15–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute: Circulating Biomarkers of Cardiovascular Risk in the NHLBI’s Framingham Heart Study National Heart, Lung, and Blood Institute, NIH, HHS. ACTION: Notice. AGENCY: SUMMARY: National Heart, Lung, and Blood Institute (NHLBI) seeks partners in a biomarker consortium to promote research on novel serum/plasma/urine biomarkers of cardiovascular disease (CVD) and related risk factors including atherosclerosis, obesity, insulin resistance, hypertension, and metabolic syndrome. An immediate consequence of this project will be the development of new diagnostic tests to identify individuals at high risk for CVD and its risk factors at a time when intervention is most feasible. A downstream result of the identification of novel biomarkers of CVD (and its risk factors) will be the discovery of disease promoting pathways, which may serve as new therapeutic targets for treating and preventing our nation’s leading cause of death. Background: Despite steady declines in CVD mortality, CVD remains the leading cause of death in the developed world. The NHLBI’s Framingham Heart Study (FHS) has been instrumental in the identification and elucidation of key modifiable risk factors for CVD, which in turn have facilitated modern approaches to the prevention and treatment of CVD. Because of its prospective study design, the NHLBI’s FHS is ideally positioned to enable identification of novel risk factors for CVD. The availability of frozen serum/ plasma/urine samples from over 7000 FHS participants in the Offspring and Third Generation cohorts, in concert with new high-throughput quantitative biomarker technology available from commercial collaborators, provides a unique opportunity to explore the biochemical signatures of key CVD phenotypes. In addition, by the end of 2007 genotyping of 550k SNPs will be completed in nearly all the FHS participants as part of the NHLBI’s SHARe project and these data will PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 permit analysis of the associations of gene variants with biomarker levels. Scientific Scope: The proposed study will measure 150 or more evolving and novel biomarkers from the FHS in 7000 FHS subjects for whom subclinical and clinical CVD and its risk factors have been carefully characterized. Analyses will be conducted for association of biomarkers—individually and collectively—with clinically relevant phenotypes. The aims of the project are to: 1. Identify the biochemical signature of atherosclerosis as determined by: (a) Aortic and coronary calcification on CT (data available in 3500 people), (b) aortic plaque burden by MRI (n=2000), (c) carotid intimal-medial thickness by ultrasound (n=3500), (d) clinical atherosclerotic CVD (n=500), and (e) the dynamic balance between arterial calcification and bone demineralization (n=3500). 2. Identify the biochemical signature of metabolic syndrome components including (a) systolic and diastolic blood pressure (n=7000), (b) obesity (n=7000) and visceral adiposity by CT (n=3500), (c) dyslipidemia (n=7000), and (d) impaired fasting glucose, diabetes, and insulin resistance. Biomarkers for this project will be selected by expert consensus on the basis of (a) a careful review of the literature for biomarkers of atherosclerosis and metabolic syndrome, and (b) genes implicated in atherosclerosis and metabolic syndrome (and their constituent components and pathways), or showing evidence of association with the phenotypes of interest. Technology: As part of this project, new quantitative tests will be developed to measure circulating biomarker levels using antibody sandwich assays and/or proteomic approaches that are amenable to high throughput application. Critical to this project is the implementation of methods to measure large numbers of biomarkers with minimal sample volume; proteomic, bead-linked immunoassays, and nanotechnology methods may be necessary to accomplish this aim. Pathways to be studied include but are not limited to: Adhesion/chemoattraction, adipokines, cytokines, growth factors, heat shock proteins, inflammation, lipoproteins, neurohormones, thrombosis/ fibrinolysis, and vascular calcification. Demonstrated rigorous assay validation using non-FHS samples will be necessary before FHS biospecimens can be used for this project. Study Sample: The NHLBI’s FHS is community-based[N1], which should contribute to the generalizability of E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Pages 67143-67148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19506]



[[Page 67143]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a Modified or Altered System of 
Records

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

ACTION: Notice of a Modified or Altered System of Records (SOR).

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

SUMMARY: In accordance with the Privacy Act of 1974, we are proposing 
to modify or alter an existing SOR, ``Inpatient Rehabilitation 
Facilities (IRF) Patient Assessment Instrument (IRF-PAI),'' System No. 
09-70-1518, last published at 66 Federal Register 56681 (November 9, 
2001). Information maintained in this system will continue to contain 
clinical assessment information for all Medicare Part A fee-for-service 
patients receiving the services of a Medicare approved IRF. This 
information will be useful in developing core measures that provide 
meaningful information on patient characteristics and outcomes across 
post-acute care settings and will be used by CMS to fulfill its 
responsibility for validating surveys conducted by accrediting 
agencies. We propose to assign a new CMS identification number to this 
system to simplify the obsolete and confusing numbering system 
originally designed to identify the Bureau, Office, or Center that 
maintained information in the Health Care Financing Administration 
systems of records. The new assigned identifying number for this system 
should read: System No. 09-70-0521.
    We propose to modify existing routine use number 1 that permits 
disclosure to agency contractors and consultants to include disclosure 
to CMS grantees who perform a task for the agency. CMS grantees, 
charged with completing projects or activities that require CMS data to 
carry out that activity, are classified separate from CMS contractors 
and/or consultants. The modified routine use will remain as routine use 
number 1. We will modify existing routine use number 2 that permits 
disclosure to Peer Review Organizations (PRO). Organizations previously 
referred to as PROs will be renamed to read: Quality Improvement 
Organizations (QIO). Information will be disclosed to QIOs relating to 
assessing and improving IRF quality of care. The modified routine use 
will be renumbered as routine use number 4.
    We will delete routine use number 5 authorizing disclosure to 
support constituent requests made to a congressional representative. If 
an authorization for the disclosure has been obtained from the data 
subject, then no routine use is needed. The Privacy Act allows for 
disclosures with the ``prior written consent'' of the data subject. We 
will broaden the scope of published routine uses number 7 and 8, 
authorizing disclosures to combat fraud and abuse in the Medicare and 
Medicaid programs to include combating ``waste'' which refers 
increasingly more to specific beneficiary or recipient practices that 
result in unnecessary cost to federally-funded health benefit programs.
    CMS proposes to broaden the scope of the disclosure requirement for 
routine use number 5, authorizing disclosure to national accrediting 
organizations that have been approved by CMS for deeming authority for 
Medicare requirements for home health services. 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: (1) Provide identifying information for 
IRFs that have an accreditation status with the requesting accrediting 
organization that has been granted deeming authority by CMS, (2) 
submission of a finder file identifying beneficiaries/patients 
receiving IRF services, (3) safeguard the confidentiality of the data 
and prevent unauthorized access, and (4) upon completion of a signed 
data exchange agreement or a CMS data use agreement.
    We are modifying the language in the remaining routine uses to 
provide a proper explanation as to the need for the routine use and to 
provide clarity to CMS's intention to disclose individual-specific 
information contained in this system. The routine uses will then be 
prioritized and reordered according to their usage. We will also take 
the opportunity to update any sections of the system that were affected 
by the recent reorganization or because of the impact of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Pub. L. 108-173) provisions and to update language in the 
administrative sections to correspond with language used in other CMS 
SORs.
    The primary purpose of this modified system is to support the IRF 
prospective payment system (PPS) for payment of the IRF Medicare Part A 
fee-for-services furnished by the IRF to Medicare beneficiaries. 
Information maintained in this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the Agency or by a contractor, consultant, or a CMS grantee; (2) 
assist another Federal and/or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent, 
for evaluating and monitoring the quality of IRF health care and 
contribute to the accuracy of health insurance operations; (3) support 
research, evaluation, or epidemiological projects related to the 
prevention of disease or disability, or the restoration or maintenance 
of health, and for payment related projects; (4) support the functions 
of Quality Improvement Organizations; (5) assist other insurers; (6) 
support the functions of national accrediting organizations; (7) 
support litigation involving the Agency; and (8) combat fraud, waste, 
and abuse in certain health care programs. We have provided background 
information about the modified system in the SUPPLEMENTARY INFORMATION 
section below. Although the Privacy Act requires only that CMS provide 
an opportunity for interested persons to comment on the modified or 
altered routine uses, CMS invites comments on all portions of this 
notice. See Effective Dates section for comment period.

DATES: Effective Dates: CMS filed a modified or altered system 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 November 
14, 2006. To ensure that all parties have adequate time in which to 
comment, the modified system, including routine uses, will become 
effective 30 days from the publication of the notice, or 40 days from 
the date it was submitted to OMB and Congress, whichever is later, 
unless CMS receives comments that require alterations to this notice.

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

FOR FURTHER INFORMATION CONTACT: Georgia Johnson, Division of 
Continuing Care Providers, Survey and Certification Group, Center for 
Medicaid and State Operations, CMS, Mail Stop S2-12-25, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850. She can also be reached by 
telephone at 410-786-6859,

[[Page 67144]]

or via e-mail at Georgia.Johnson@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Description of the Modified or Altered System of Records

A. Statutory and Regulatory Basis for SOR

    Authority for maintenance of the system is given under section 1886 
(j) (2) (D) of the Social Security Act authorizing the secretary to 
collect the data necessary to establish and administer the payment 
system.

B. Collection and Maintenance of Data in the System

    The IRF-PAI will be completed on all Medicare Part A fee-for-
service patients who receive services under Part A from an IRF, it may 
also be completed on Medicare Advantage enrollees. Records in this 
system will include, but are not limited to, name, address, date of 
birth, gender, ethnicity, social security number, health insurance 
claim number, Medicaid number, patient identification number, patient 
history, diagnosis, and functional prognosis.

II. Agency Policies, Procedures, and Restrictions on Routine Uses

A. Agency Policies, Procedures, and Restrictions on the Routine Use

    The Privacy Act permits us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such disclosure of data is known as a ``routine use.'' 
The government will only release IRF-PAI 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 IRF-PAI. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from this system will be approved 
only to the extent necessary to accomplish the purpose of the 
disclosure and only after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected, e.g, to support the IRF 
prospective payment system (PPS) for payment of the IRF Medicare Part A 
fee-for-services furnished by the IRF to Medicare 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 
indivdual's consent if the information is to be used for a purpose that 
is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To support agency contractors, consultants, or grantees who have 
been engaged by the agency to assist in the performance of a service 
related to this collection and who need to have access to the records 
in order to perform the activity.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing CMS function 
relating to purposes for this system.
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and efficient operations. CMS must be 
able to give a contractor, consultant or grantee whatever information 
is necessary for the contractor or consultant to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor, consultant or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requires the contractor, consultant or grantee to return or destroy 
all information at the completion of the contract.
    2. To assist another Federal and/or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' 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. Improve the state survey process for investigation of complaints 
related to health and safety or quality of care and to implement a more 
outcome oriented survey and certification program.
    Other Federal or state agencies in their administration of a 
Federal health program may require IRF-PAI 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 research on the utilization 
of inpatient rehabilitation services as well as evaluation or 
epidemiological projects related to the prevention of disease or 
disability, the restoration or maintenance of health, or for 
understanding and improving payment projects.
    The IRF-PAI data will provide for research or in support of 
evaluation projects, a broader, national perspective of the status of 
Medicare beneficiaries. CMS anticipates that many researchers will have 
legitimate requests to use these data in projects that could ultimately 
improve the care provided to Medicare beneficiaries and the policy that 
governs the care.
    4. To support 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

[[Page 67145]]

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 insurance companies, third party administrators (TPA), 
employers, self-insurers, managed care organizations, other 
supplemental insurers, non-coordinating insurers, multiple employer 
trusts, group health plans (i.e., health maintenance organization (HMO) 
or a competitive medical plan (CMP)) with a Medicare contract, or a 
Medicare-approved health care payment plan (HCPP), directly or through 
a contractor, and other groups providing protection for their 
enrollees. Information to be disclosed shall be limited to Medicare 
entitlement data. In order to receive the information, they must agree 
to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a third party 
administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's insurance claims; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    Other insurers, CMP, HMO and HCPP may require IRF-PAI information 
in order to support evaluations and monitoring of Medicare claims 
information of beneficiaries, including proper payment for services 
provided.
    6. 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 IRFs that have an 
accreditation status with the requesting deemed organization;
    b. Submission of a finder file identifying beneficiaries/patients 
receiving IRF 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 IRF-PAI information to enable them to target potential identified 
problems during the organization's accreditation review process of the 
facility.
    7. To support the Department of Justice (DOJ), court or 
adjudicatory body when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS' policies or operations 
could be affected by the outcome of the litigation, CMS would be able 
to disclose information to the DOJ, court or adjudicatory body 
involved.
    8. To assist a CMS contractor (including, but not necessarily 
limited to fiscal intermediaries and carriers) that assists in the 
administration of a CMS-administered health benefits program, or to a 
grantee of a CMS-administered grant program, when disclosure is deemed 
reasonably necessary by CMS to prevent, deter, discover, detect, 
investigate, examine, prosecute, sue with respect to, defend against, 
correct, remedy, or otherwise combat fraud, waste, or abuse in such 
program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship or 
grant 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 and makes 
grants when doing so would contribute to effective and efficient 
operations. CMS must be able to give a contractor or grantee whatever 
information is necessary for the contractor or grantee to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the contractor or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requiring the contractor or grantee to return or destroy all 
information.
    9. To assist another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud, 
waste, or abuse in, a health benefits program funded in whole or in 
part by Federal funds, when disclosure is deemed reasonably necessary 
by CMS to prevent, deter, discover, detect, investigate, examine, 
prosecute, sue with respect to, defend against, correct, remedy, or 
otherwise combat fraud, waste, or abuse in such programs.
    Other agencies may require IRF-PAI information for the purpose of 
combating fraud, waste, and abuse in such federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise authorized by these routine uses may only be made 
if, and as, permitted or required by the ``Standards for Privacy of 
Individually Identifiable Health Information.'' (See 45 CFR 164-
512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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

[[Page 67146]]

information systems and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent NIST 
publications; the DHHS Information Systems Program Handbook and the CMS 
Information Security Handbook.

V. Effects of the Modified System of Records on Individual Rights

    CMS proposes to modify this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will take precautionary measures to minimize the risks of 
unauthorized access to the records and the potential harm to individual 
privacy or other personal or property rights of patients whose data are 
maintained in the system. CMS will collect only that information 
necessary to perform the system's functions. In addition, CMS will make 
disclosure from the proposed system only with consent of the subject 
individual, or his/her legal representative, or in accordance with an 
applicable exception provision of the Privacy Act. CMS, therefore, does 
not anticipate an unfavorable effect on individual privacy as a result 
of information relating to individuals.

    Dated: November 8, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0521

SYSTEM NAME:
    ``Inpatient Rehabilitation Facilities Patient Assessment Instrument 
(IRF-PAI),'' HHS/CMS/CMSO.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    The Centers for Medicare & Medicaid Services (CMS) Data Center, 
7500 Security Boulevard, North Building, First Floor, Baltimore, 
Maryland 21244-1850 and at various contractor sites and at CMS Regional 
Offices.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The IRF-PAI will be completed on all Medicare Part A fee-for-
service patients who receive services under Part A from an IRF, it may 
also be completed on Medicare Advantage enrollees.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Records in this system will include, but are not limited to, name, 
address, date of birth, gender, ethnicity, social security number 
(SSN), health insurance claim number (HICN), Medicaid number, patient 
identification number, patient history, diagnosis, and functional 
prognosis.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of the system is given under section 
1886(j)(2)(D) of the Social Security Act authorizing the secretary to 
collect the data necessary to establish and administer the payment 
system.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this modified system is to support the IRF 
prospective payment system (PPS) for payment of the IRF Medicare Part A 
fee-for-services furnished by the IRF to Medicare beneficiaries. 
Information maintained in this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the Agency or by a contractor, consultant, or a CMS grantee; (2) 
assist another Federal and/or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent, 
for evaluating and monitoring the quality of IRF health care and 
contribute to the accuracy of health insurance operations; (3) support 
research, evaluation, or epidemiological projects related to the 
prevention of disease or disability, or the restoration or maintenance 
of health, and for payment related projects; (4) support the functions 
of Quality Improvement Organizations (QIO); (5) assist other insurers; 
(6) support the functions of national accrediting organizations; (7) 
support litigation involving the Agency; (8) combat fraud, waste, and 
abuse in certain health care programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To support agency contractors, consultants, or grantees who have 
been engaged by the agency to assist in the performance of a service 
related to this collection and who need to have access to the records 
in order to perform the activity.
    2. To assist another Federal and/or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' 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. Improve the state survey process for investigation of complaints 
related to health and safety or quality of care and to implement a more 
outcome oriented survey and certification program.
    3. To an individual or organization for research on the utilization 
of inpatient rehabilitation services as well as evaluation or 
epidemiological projects related to the prevention of disease or 
disability, the restoration or maintenance of health, or for 
understanding and improving payment 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 insurance companies, third party administrators (TPA), 
employers, self-insurers, managed care organizations, other 
supplemental insurers, non-coordinating insurers, multiple employer 
trusts, group health plans (i.e., health maintenance organization (HMO) 
or a competitive medical plan (CMP)) with a Medicare

[[Page 67147]]

contract, or a Medicare-approved health care payment plan (HCPP), 
directly or through a contractor, and other groups providing protection 
for their enrollees. Information to be disclosed shall be limited to 
Medicare entitlement data. In order to receive the information, they 
must agree to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a third party 
administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's insurance claims; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    6. 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 IRFs that have an 
accreditation status with the requesting deemed organization;
    b. Submission of a finder file identifying beneficiaries/patients 
receiving IRF 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.
    7. To support the Department of Justice (DOJ), court or 
adjudicatory body when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    8. To assist a CMS contractor (including, but not necessarily 
limited to fiscal intermediaries and carriers) that assists in the 
administration of a CMS-administered health benefits program, or to a 
grantee of a CMS-administered grant program, when disclosure is deemed 
reasonably necessary by CMS to prevent, deter, discover, detect, 
investigate, examine, prosecute, sue with respect to, defend against, 
correct, remedy, or otherwise combat fraud, waste, or abuse in such 
program.
    9. To assist another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any State or local governmental agency), that 
administers, or that has the authority to investigate potential fraud, 
waste, or abuse in, a health benefits program funded in whole or in 
part by Federal funds, when disclosure is deemed reasonably necessary 
by CMS to prevent, deter, discover, detect, investigate, examine, 
prosecute, sue with respect to, defend against, correct, remedy, or 
otherwise combat fraud, waste, or abuse in such programs.
    B. Additional Provisions Affecting Routine Use Disclosures. To the 
extent this system contains Protected Health Information (PHI) as 
defined by HHS regulation ``Standards for Privacy of Individually 
Identifiable Health Information'' (45 CFR parts 160 and 164, subparts A 
and E) 65 FR 82462 (12-28-00), disclosures of such PHI that are 
otherwise authorized by these routine uses may only be made if, and as, 
permitted or required by the ``Standards for Privacy of Individually 
Identifiable Health Information.'' (See 45 CFR 164-512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals could, because of the small size, use this information to 
deduce the identity of the beneficiary).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored on magnetic media.

RETRIEVABILITY:
    The Medicare records are retrieved by the HICN and SSN.

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 DHHS 
Information Systems Program Handbook and the CMS Information Security 
Handbook.

RETENTION AND DISPOSAL:
    CMS will retain identifiable IRF-PAI data for a total period of 15 
years. All claims-related records are encompassed by the document 
preservation order and will be retained until notification is received 
from DOJ.

SYSTEM MANAGER(S) AND ADDRESS:
    Director, Survey and Certification Group, Center for Medicaid and 
State Operations, CMS, Mail Stop C3-20-01, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual should write to the 
system manager who will require the system name, HICN, address, date of 
birth, and gender, and for verification purposes, the subject 
individual's name (woman's maiden name, if applicable), and SSN. 
Furnishing the SSN is voluntary, but it

[[Page 67148]]

may make searching for a record easier and prevent delay.

RECORD ACCESS PROCEDURE:
    For purpose of access, use the same procedures outlined in 
Notification Procedures above. Requestors should also specify the 
record contents being sought. (These procedures are in accordance with 
department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above, and reasonably identify the records and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These Procedures are in 
accordance with Department regulation 45 CFR 5b.7).

RECORDS SOURCE CATEGORIES:
    Information for this system is collected from the Inpatient 
Rehabilitation Facilities--Patient Assessment Instrument.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. E6-19506 Filed 11-17-06; 8:45 am]
BILLING CODE 4120-03-P
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