Privacy Act of 1974; Report of a New System of Records, 58442-58446 [05-19907]

Download as PDF 58442 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices Title System manager Evaluation of the Medicaid Demonstration for Improving Access to Care for Substance Abusing Pregnant Women. Evaluation of and External Quality Assurance for the Community Nursing Organization Demonstration ......... HHS/CMS/ORDI System No. 09–70–0063 09–70–0066 Dated: September 27, 2005. Charlene Brown, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. [FR Doc. 05–19906 Filed 10–5–05; 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), Centers 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 SOR titled ‘‘Medicare Care Management Performance Demonstration (MCMP),’’ System No. 09–70–0562. MCMP demonstration tests a payment methodology for physician practices that combines Medicare fee-for-service payments with performance-based payments for improvements in information technology systems, patient education, care management, and quality of care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. Mandated by Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), the MCMP Demonstration seeks to provide incentives for physicians to adopt and integrate information technology systems into their practices, and to improve quality as defined by key measurable outcomes. The primary purpose of the system is to establish a pay-for-performance three year pilot with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with VerDate Aug<31>2005 19:52 Oct 05, 2005 Jkt 208001 information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization 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 constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ‘‘Supplementary Information’’ section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ‘‘Effective Dates’’ section for comment period. EFFECTIVE DATES: CMS filed a new system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on September 27, 2005. In any event, we will not disclose any information under a routine use until 40 days after publication. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to: CMS Privacy Officer, Division of Privacy Compliance Data Development, CMS, 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 zone. FOR FURTHER INFORMATION CONTACT: Jody Blatt, Research Analyst, Division of Payment Policy, Medicare Demonstration Programs Group, Office of Research Development and Information, CMS, Mail Stop C4–17–27, PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 HHS/CMS/ORDI 7500 Security Boulevard, Baltimore, Maryland 21244–1850. The telephone number is (410) 786–6921 or e-mail jody.blatt@cms.hhs.gov. Section 649 of (MMA) requires the Secretary of Health and Human Services to ‘‘establish a pay-for-performance demonstration program with physicians to meet the needs of eligible beneficiaries through the adoption and use of health information technology and evidence-based outcomes measures.’’ The resulting demonstration, known as MCMP Demonstration, provides incentives to primary care physician practices for (1) clinical systems, which encompasses the implementation and use of information technology, patient education, and care management, and (2) clinical quality, which encompasses using evidence-based outcome measures. The objectives of the demonstration are to: (1) Promote continuity of care, (2) stabilize medical conditions, (3) reduce adverse health outcomes, and (4) prevent or minimize acute episodes of chronic conditions that require an emergency room visit or hospitalization. In the demonstration, payments will be made to physician practices that meet or exceed performance standards established by CMS. There will be two categories of performance payments. One payment will be made for clinical systems based on the number of patients who are Medicare beneficiaries with a chronic condition; and the other will be made for clinical quality based on the number of beneficiaries with the specific diseases of diabetes, congestive heart failure, or coronary artery disease. Payment for clinical quality will also be made for meeting standards on various screening measures. Payments can vary based on performance. The three year demonstration project will be launched in four states, with up to 2,800 physicians from solo and small to medium-sized group practices participating, including practices in both urban and rural areas. The project is expected to become operational in 2006, with physicians being paid in 2006, 2007, and 2008. It will operate in the same four states as initiated the Doctor’s Office Quality—Information Technology project (California, Utah, SUPPLEMENTARY INFORMATION: E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices Arkansas, and Massachusetts), thus allowing the Quality Improvement Organizations (QIOs) in those states to provide support to participating physicians. I. Description of the New System of Records A. Statutory and Regulatory Basis for System The authority for maintenance of this system is given under the provisions of Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108–173). B. Collection and Maintenance of Data in the System This system will maintain individually identifiable data collected on the Medicare expenditures of beneficiaries assigned to the participating physician practices. The data will consist of clinical quality measures collected from the individual physician practices participating in the demonstration. The collected information will contain: provider name, unique provider identification number, unique demonstration practice identification number, beneficiary health insurance claim number, and whether the beneficiary received the services described by the clinical measure and was counted in either the numerator and/or the denominator of the performance measure calculation for the physician. 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 MCMP 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 MCMP. 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: VerDate Aug<31>2005 19:52 Oct 05, 2005 Jkt 208001 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, e.g., to collect and maintain data on Medicare expenditures of the beneficiaries assigned to participating physician practices that is relevant to calculating physician based performance on clinical quality measures and making performance payments to participating physician practices. 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 information 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 individually 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. Entities Who May Receive Disclosures Under Routine Use 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 or consultants who have been engaged by the agency to assist in the performance of a service related to this system 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 58443 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 or consultant 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 or consultant from using or disclosing the information for any purpose other than that described in the contract and requires the contractor or consultant 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 MCMP 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 MCMP data will provide for research or in support of evaluation projects, a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policy that governs the care. 4. To a member of Congress or to a congressional staff member in response to an inquiry of the congressional office made at the written request of the constituent about whom the record is maintained. Beneficiaries sometimes request the help of a member of Congress in resolving an issue relating to a matter before CMS. The member of Congress then writes CMS, and CMS must be able E:\FR\FM\06OCN1.SGM 06OCN1 58444 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices to give sufficient information to be responsive to the inquiry. 5. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS’ policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 6. To a CMS contractor (including, but not necessarily limited to fiscal intermediaries and carriers) that assists in the administration of a CMSadministered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual relationship or grant with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud and abuse. CMS occasionally contracts out certain of its functions 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. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control VerDate Aug<31>2005 19:52 Oct 05, 2005 Jkt 208001 of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. Other agencies may require information for the purpose of combating fraud and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures This system contains Protected Health Information (PHI) as defined by HHS regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 Code of Federal Regulation Parts 160 and 164, 65 Fed. Reg. 82462 (12–28–00), Subparts A and E. Disclosures of PHI authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ In addition, our policy will be to prohibit release even of not directly identifiable information, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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 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 New System 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. CMS will take precautionary measures (see item IV. above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data is 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 maintaining this system. Dated: September 27, 2005. Charlene Brown, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. System No.: 09–70–0562 SYSTEM NAME: ‘‘Medicare Care Management Performance Demonstration (MCMP)’’ HHS/CMS/ORDI. SECURITY CLASSIFICATION: Level 3 Privacy Act Sensitive. SYSTEM LOCATION: This system is maintained at the Centers for Medicare & Medicaid E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244– 1850, and CMS contractors and agents at various locations. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: The data will be maintained on individual physicians participating in the demonstration. In order to collect this data and use it to determine incentive payments to physicians, the system will also maintain individually identifiable information on Medicare beneficiaries assigned to physicians participating in the demonstration. CATEGORIES OF RECORDS IN THE SYSTEM: The data will consist of clinical quality measures collected from physician participating in the demonstration. The collected information will contain provider name, unique provider identification number, unique demonstration practice identification number, beneficiary health insurance claim number (HICN), beneficiary demographic and diagnostic information relevant to the measure, and whether the beneficiary received the services described by the clinical measure and was counted in either the numerator and/or the denominator of the performance measure calculation for the physician. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The authority for maintenance of this system is given under the provisions of Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173). PURPOSE(S) OF THE SYSTEM: The primary purpose of the system is to establish a pay-for-performance three year pilot with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or VerDate Aug<31>2005 19:52 Oct 05, 2005 Jkt 208001 maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. Entities Who May Receive Disclosures Under Routine Use 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 or consultants who have been engaged by the agency to assist in the performance of a service related to this system and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS’s proper payment of Medicare benefits, b. Enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds, and/or c. Assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To a member of Congress or to a congressional staff member in response to an inquiry of the congressional office made at the written request of the constituent about whom the record is maintained. 5. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 58445 such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 6. To a CMS contractor (including, but not necessarily limited to fiscal intermediaries and carriers) that assists in the administration of a CMSadministered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures This system contains Protected Health Information (PHI) as defined by Department of Health and Human Services (HHS) regulation ‘‘Standards for Privacy of Individually Identifiable Health Information’’ (45 Code of Federal Regulations (CFR) Parts 160 and 164, 65 FR 82462 (12–28–00), Subparts A and E. Disclosures of PHI authorized by these routine uses may only be made if, and as, permitted or required by the ‘‘Standards for Privacy of Individually Identifiable Health Information.’’ In addition, our policy will be to prohibit release even of not directly identifiable information, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the beneficiary). E:\FR\FM\06OCN1.SGM 06OCN1 58446 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: CMS for adequate storage and security. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from the DOJ. STORAGE: All records are stored on magnetic media. RETRIEVABILITY: Information collected will be retrieved by the name or other identifying information of the participating provider, and may also be retrievable by HICN at the individual beneficiary record level. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E– Government Act of 2002, the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. Office of Management and Budget Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain identifiable information maintained in the MCMP system of records for a period of 6 years. Data residing with the designated claims payment contractor shall be returned to CMS at the end of the project, with all data then being the responsibility of VerDate Aug<31>2005 19:52 Oct 05, 2005 Jkt 208001 SYSTEM MANAGER AND ADDRESS: Director, Medicare Demonstration Program Group, Office of Research Development and Information, CMS, 7500 Security Boulevard, Mail stop C4– 17–27, 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, and for verification purposes, the subject individual’s name, provider identification number, and the patient’s medical record number. 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). RECORD SOURCE CATEGORIES: Information maintained in this system will be collected from physicians volunteering to participate in the MCMP Demonstration. Additional data will be collected from Medicare claims payment records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. 05–19907 Filed 10–5–05; 8:45 am] BILLING CODE 4120–03–P PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Philadelphia District, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 1 1/2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on Tuesday, October 11, 2005, from 8:30 a.m. to 5:30 p.m. and Wednesday, October 12, 2005, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Wyndham Philadelphia at Franklin Plaza, 17th and Race St., Philadelphia, PA 19103, 215–448–2000. For further hotel information and driving directions, go to https:// www.wyndham.com/hotels/PHLFP. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Judy Summers-Gates, Food and Drug Administration, rm. 900, U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215– 717–3008, FAX: 215–597–4660, email: judith.summersgates@fda.gov. For AdvaMed: Krystine McGrath, 202–434–7237, FAX: 202–783– 8750, kmcgrath@advamed.org; or Dia Black, 202–434–7231, FAX: 202–783–8750, e-mail: dblack@avamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number), and the registration fee of $350 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamed.org/ philadelphia. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Notices]
[Pages 58442-58446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19907]


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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), Centers for 
Medicare & Medicaid Services (CMS).

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

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new SOR titled ``Medicare Care 
Management Performance Demonstration (MCMP),'' System No. 09-70-0562. 
MCMP demonstration tests a payment methodology for physician practices 
that combines Medicare fee-for-service payments with performance-based 
payments for improvements in information technology systems, patient 
education, care management, and quality of care. Improvements in these 
areas are expected to generate savings to the Medicare program to 
offset the costs of the performance payments. Mandated by Section 649 
of the Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 (MMA), the MCMP Demonstration seeks to provide incentives for 
physicians to adopt and integrate information technology systems into 
their practices, and to improve quality as defined by key measurable 
outcomes.
    The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to promote the adoption 
and use of health information technology to improve the quality of 
patient care for chronically ill Medicare patients. Information 
retrieved from this system will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
agency or by a contractor or consultant; (2) assist another Federal or 
state agency with information to enable such agency to administer a 
Federal health benefits program, or to enable such agency to fulfill a 
requirement of Federal statute or regulation that implements a health 
benefits program funded in whole or in part with Federal funds; (3) 
assist an individual or organization 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 constituent requests made to a 
congressional representative; (5) support litigation involving the 
agency; and (6) combat fraud and abuse in certain health benefits 
programs. We have provided background information about the new system 
in the ``Supplementary Information'' section below. Although the 
Privacy Act requires only that CMS provide an opportunity for 
interested persons to comment on the proposed routine uses, CMS invites 
comments on all portions of this notice. See ``Effective Dates'' 
section for comment period.

EFFECTIVE DATES: CMS filed a new system report with the Chair of the 
House Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Governmental Affairs, and the Administrator, Office 
of Information and Regulatory Affairs, Office of Management and Budget 
(OMB) on September 27, 2005. In any event, we will not disclose any 
information under a routine use until 40 days after publication. We may 
defer implementation of this system or one or more of the routine use 
statements listed below if we receive comments that persuade us to 
defer implementation.

ADDRESSES: The public should address comments to: CMS Privacy Officer, 
Division of Privacy Compliance Data Development, CMS, 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 zone.

FOR FURTHER INFORMATION CONTACT: Jody Blatt, Research Analyst, Division 
of Payment Policy, Medicare Demonstration Programs Group, Office of 
Research Development and Information, CMS, Mail Stop C4-17-27, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. The telephone 
number is (410) 786-6921 or e-mail jody.blatt@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 649 of (MMA) requires the Secretary 
of Health and Human Services to ``establish a pay-for-performance 
demonstration program with physicians to meet the needs of eligible 
beneficiaries through the adoption and use of health information 
technology and evidence-based outcomes measures.'' The resulting 
demonstration, known as MCMP Demonstration, provides incentives to 
primary care physician practices for (1) clinical systems, which 
encompasses the implementation and use of information technology, 
patient education, and care management, and (2) clinical quality, which 
encompasses using evidence-based outcome measures. The objectives of 
the demonstration are to: (1) Promote continuity of care, (2) stabilize 
medical conditions, (3) reduce adverse health outcomes, and (4) prevent 
or minimize acute episodes of chronic conditions that require an 
emergency room visit or hospitalization.
    In the demonstration, payments will be made to physician practices 
that meet or exceed performance standards established by CMS. There 
will be two categories of performance payments. One payment will be 
made for clinical systems based on the number of patients who are 
Medicare beneficiaries with a chronic condition; and the other will be 
made for clinical quality based on the number of beneficiaries with the 
specific diseases of diabetes, congestive heart failure, or coronary 
artery disease. Payment for clinical quality will also be made for 
meeting standards on various screening measures. Payments can vary 
based on performance.
    The three year demonstration project will be launched in four 
states, with up to 2,800 physicians from solo and small to medium-sized 
group practices participating, including practices in both urban and 
rural areas. The project is expected to become operational in 2006, 
with physicians being paid in 2006, 2007, and 2008. It will operate in 
the same four states as initiated the Doctor's Office Quality--
Information Technology project (California, Utah,

[[Page 58443]]

Arkansas, and Massachusetts), thus allowing the Quality Improvement 
Organizations (QIOs) in those states to provide support to 
participating physicians.

I. Description of the New System of Records

A. Statutory and Regulatory Basis for System

    The authority for maintenance of this system is given under the 
provisions of Section 649 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173).

B. Collection and Maintenance of Data in the System

    This system will maintain individually identifiable data collected 
on the Medicare expenditures of beneficiaries assigned to the 
participating physician practices. The data will consist of clinical 
quality measures collected from the individual physician practices 
participating in the demonstration. The collected information will 
contain: provider name, unique provider identification number, unique 
demonstration practice identification number, beneficiary health 
insurance claim number, and whether the beneficiary received the 
services described by the clinical measure and was counted in either 
the numerator and/or the denominator of the performance measure 
calculation for the physician.

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 MCMP 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 MCMP. 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 
data on Medicare expenditures of the beneficiaries assigned to 
participating physician practices that is relevant to calculating 
physician based performance on clinical quality measures and making 
performance payments to participating physician practices.
    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 
information 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 individually 
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. Entities Who May Receive Disclosures Under Routine Use

    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 or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system 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 or 
consultant 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 or consultant from 
using or disclosing the information for any purpose other than that 
described in the contract and requires the contractor or consultant 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 MCMP 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 MCMP data will provide for research or in support of evaluation 
projects, a broader, longitudinal, national perspective of the status 
of Medicare beneficiaries. CMS anticipates that many researchers will 
have legitimate requests to use these data in projects that could 
ultimately improve the care provided to Medicare beneficiaries and the 
policy that governs the care.
    4. To a member of Congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    Beneficiaries sometimes request the help of a member of Congress in 
resolving an issue relating to a matter before CMS. The member of 
Congress then writes CMS, and CMS must be able

[[Page 58444]]

to give sufficient information to be responsive to the inquiry.
    5. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS' policies or operations 
could be affected by the outcome of the litigation, CMS would be able 
to disclose information to the DOJ, court or adjudicatory body 
involved.
    6. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship or 
grant with a third party to assist in accomplishing CMS functions 
relating to the purpose of combating fraud and abuse.
    CMS occasionally contracts out certain of its functions 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.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any state or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    Other agencies may require information for the purpose of combating 
fraud and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

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

IV. Safeguards

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

V. Effects of the New System 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.
    CMS will take precautionary measures (see item IV. above) to 
minimize the risks of unauthorized access to the records and the 
potential harm to individual privacy or other personal or property 
rights of patients whose data is 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 maintaining this system.

    Dated: September 27, 2005.
Charlene Brown,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
System No.: 09-70-0562

SYSTEM NAME:
    ``Medicare Care Management Performance Demonstration (MCMP)'' HHS/
CMS/ORDI.

SECURITY CLASSIFICATION:
    Level 3 Privacy Act Sensitive.

SYSTEM LOCATION:
    This system is maintained at the Centers for Medicare & Medicaid

[[Page 58445]]

Services (CMS) Data Center, 7500 Security Boulevard, North Building, 
First Floor, Baltimore, Maryland 21244-1850, and CMS contractors and 
agents at various locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The data will be maintained on individual physicians participating 
in the demonstration. In order to collect this data and use it to 
determine incentive payments to physicians, the system will also 
maintain individually identifiable information on Medicare 
beneficiaries assigned to physicians participating in the 
demonstration.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The data will consist of clinical quality measures collected from 
physician participating in the demonstration. The collected information 
will contain provider name, unique provider identification number, 
unique demonstration practice identification number, beneficiary health 
insurance claim number (HICN), beneficiary demographic and diagnostic 
information relevant to the measure, and whether the beneficiary 
received the services described by the clinical measure and was counted 
in either the numerator and/or the denominator of the performance 
measure calculation for the physician.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The authority for maintenance of this system is given under the 
provisions of Section 649 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (Public Law 108-173).

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to promote the adoption 
and use of health information technology to improve the quality of 
patient care for chronically ill Medicare patients. Information 
retrieved from this system will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
agency or by a contractor or consultant; (2) assist another Federal or 
state agency with information to enable such agency to administer a 
Federal health benefits program, or to enable such agency to fulfill a 
requirement of Federal statute or regulation that implements a health 
benefits program funded in whole or in part with Federal funds; (3) 
assist an individual or organization 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 constituent requests made to a 
congressional representative; (5) support litigation involving the 
agency; and (6) combat fraud and abuse in certain health benefits 
programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
A. Entities Who May Receive Disclosures Under Routine Use
    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 or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system and who need to have access to the records in order to perform 
the activity.
    2. To another Federal or state agency to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds, and/or
    c. Assist Federal/state Medicaid programs within the state.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    4. To a member of Congress or to a congressional staff member in 
response to an inquiry of the congressional office made at the written 
request of the constituent about whom the record is maintained.
    5. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, CMS determines that 
the records are both relevant and necessary to the litigation and that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    6. To a CMS contractor (including, but not necessarily limited to 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such program.
    7. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any state or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures
    This system contains Protected Health Information (PHI) as defined 
by Department of Health and Human Services (HHS) regulation ``Standards 
for Privacy of Individually Identifiable Health Information'' (45 Code 
of Federal Regulations (CFR) Parts 160 and 164, 65 FR 82462 (12-28-00), 
Subparts A and E. Disclosures of PHI authorized by these routine uses 
may only be made if, and as, permitted or required by the ``Standards 
for Privacy of Individually Identifiable Health Information.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine there is a 
possibility that an individual can be identified through implicit 
deduction based on small cell sizes (instances where the patient 
population is so small that individuals who are familiar with the 
enrollees could, because of the small size, use this information to 
deduce the identity of the beneficiary).

[[Page 58446]]

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

RETRIEVABILITY:
    Information collected will be retrieved by the name or other 
identifying information of the participating provider, and may also be 
retrievable by HICN at the individual beneficiary record level.

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

RETENTION AND DISPOSAL:
    CMS will retain identifiable information maintained in the MCMP 
system of records for a period of 6 years. Data residing with the 
designated claims payment contractor shall be returned to CMS at the 
end of the project, with all data then being the responsibility of CMS 
for adequate storage and security. All claims-related records are 
encompassed by the document preservation order and will be retained 
until notification is received from the DOJ.

SYSTEM MANAGER AND ADDRESS:
    Director, Medicare Demonstration Program Group, Office of Research 
Development and Information, CMS, 7500 Security Boulevard, Mail stop 
C4-17-27, 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, and for verification 
purposes, the subject individual's name, provider identification 
number, and the patient's medical record number.

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).

RECORD SOURCE CATEGORIES:
    Information maintained in this system will be collected from 
physicians volunteering to participate in the MCMP Demonstration. 
Additional data will be collected from Medicare claims payment records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 05-19907 Filed 10-5-05; 8:45 am]
BILLING CODE 4120-03-P
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