Notices. Notice of a New System of Records
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/register/2007/07/02/07-3219A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6712-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Privacy Act of 1974; New System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC). ACTION: Notice of a New System of Records. SUMMARY: In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention
(CDC)is proposing to establish a new system of records (SOR), 09-20-0170, “National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER.” The purpose of the system is to limit access to those biological agents and toxins listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, to those individuals who have a legitimate need to handle or use such agents or toxins, and who are not identified as restricted persons by the U.S. Attorney General. NSAR is a single web-based information management system shared by CDC and the U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) that tracks the possession, use and transfer of select agents and toxins that could pose a severe threat to public health and safety, to the health and safety of animals, and to the safety of plants or animal and plant products. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. DATES: *Effective Date:* CDC filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on June 25, 2007. CDC invites interested parties to submit comments on the proposed routine uses. To ensure that all parties have adequate time in which to comment, the new system will be effective 30 days from the publication of this notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later, unless CDC receives comments that persuade us to defer implementation. ADDRESSES: Comments should be addressed to the CDC Privacy Act Officer at the address listed below. Comments received will be available for review at this location by appointment during regular business hours from 8 a.m. to 4:30 p.m., Monday through Friday in the CDC Roybal Facility, Building 21, Room 8125, Atlanta, Georgia. FOR FURTHER INFORMATION CONTACT: Betsey S. Dunaway, Privacy Act Officer, Office of the Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Building 21, Room 8125, Mailstop D-74, Atlanta, Georgia 30333,
(404)639-4642. SUPPLEMENTARY INFORMATION: CDC proposes to establish a new system of records within its Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER): 09-20-0170, “National Select Agent Registry (NSAR)/ Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER.” An important component of the nation's overall terrorism deterrence policy, the Division of Select Agents and Toxins
(DSAT)in the Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER) within the CDC regulates the possession, use, and transfer of biological agents and toxins (select agents) that could pose a severe threat to public health and safety. A select agent is defined as a virus, bacteria, fungus or toxin that could pose a severe threat to public health and safety, to animal or plant health; or animal or plant products. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires entities to register with the U.S. Department of Health and Human Services
(HHS)if they possess, use, or transfer select agents that could pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002 requires that facilities handling select agents that could pose a severe threat to animal or plant health; or animal or plant products register with the USDA. Within HHS, the DSAT is responsible for registering entities and personnel who either possess or are applying for approval to possess, use or transfer select agents that could pose a severe threat to public health and safety. Within the USDA, APHIS has a similar responsibility for registering entities and personnel handling agents that pose a severe threat to animal or plant health; or animal or plant products. The Acts require safeguards and security measures that will adequately protect these agents. This includes controlling access and screening of entities and personnel through security risk assessments conducted by the U.S. Attorney General. The Acts also require the establishment of a national database of registered entities. While some entities register for select agents regulated only by HHS, others for select agents regulated only by USDA, there are a number of entities registering for select agents that can pose a severe threat to public health and safety, to animal health, or to animal products (“overlap” select agents). Since DSAT and APHIS coordinate regulatory activities for those overlap select agents that would be regulated by both agencies, the Acts require that a single national database be established. This new Privacy Act system of records notice
(SORN)describes the records and processes that enable DSAT to fulfill HHS' requirements; APHIS will be publishing a similar SORN to address how USDA will fulfill theirs. B. Collection and Maintenance of Data in the System CDC will only collect the minimum amount of personal data necessary to achieve the purpose of this system, which is to limit access to the select agents listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, to those individuals who have a legitimate need to handle or use such agents, and who are not identified as a restricted person by the U.S. Attorney General. The data elements required are: name, address, date of birth, job title, and the name of the institution that would be housing the select agent(s). Entities handling select agents must appoint a Responsible Official within their organization who certifies that the entity meets federal requirements for handling select agents such as having security measures in place to protect the select agents they possess from theft, loss and unauthorized access, and safety measures to prevent the release of agents. DSAT's SOR includes personal information on those individuals who have access or who have applied to have access to select agents, and the list of select agents to which they have access or would have access. II. 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 compatible disclosure of data is known as a “routine use.” The government will only release select agent information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” We will only collect the minimum personal data necessary to achieve the purpose of this system. CDC has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the SOR will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CDC: A. Determines that the use or disclosure is consistent with the reason that the data are being collected, e.g., to limit access to select agents to those individuals who have a legitimate need to handle or use select agents and who are not identified as a restricted person by the U.S. Attorney General. *B. DETERMINES THAT:* 1. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; 2. 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 3. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). C. Requires the information recipient to: 1. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; 2. Remove or destroy at the earliest time all identifiable information; and 3. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. D. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System 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 compatible disclosure 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: A. Records may be disclosed to contractors to handle program work overflow duties, performing many of the same functions as DSAT employees. Contractors are required to maintain Privacy Act safeguards with respect to such records. These functions include conducting regulatory oversight of individuals and entities that possess, use, or transfer select agents, including the review of registration applications, conducting inspections of registered facilities or facilities requesting registration, and maintaining this information pertaining to individuals and entities that possess, use, and/or transfer select agents. DSAT contracts out certain functions when doing so would contribute to efficient and effective operations of the agency. DSAT must be able to give a contractor the information necessary for the contractor to fulfill its duties. Safeguards are provided in the contract prohibiting the contractor from using or disclosing the information for any purpose other than that described in the Statement of Work and requires the contractor to return or destroy all information at the contract's completion. B. Records may be disclosed to health departments and other public health or cooperating medical authorities to deal more effectively with outbreaks and conditions of public health significance. When outbreaks or other conditions of public health significance that might have been caused by exposure to select agents (either accidental or otherwise) occur, CDC's sharing of information on those individuals and organizations registered to possess select agents could prove beneficial to the health department's investigation. C. Personal information from this system may be disclosed as a routine use to assist the recipient Federal agency in making a determination concerning an individual's trustworthiness to access select agents; to any Federal or State agency where the purpose in making the disclosure is to prevent access to select agents for use in domestic or international terrorism or for any criminal purpose; or to any Federal or State agency to protect the public health and safety with regard to the possession, use, or transfer of select agents. Based on the provisions of the Acts, the Attorney General has the authority and responsibility to conduct electronic database checks (i.e., the security risk assessments) on the Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals requesting access to select agents. The Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS), has been delegated authority for conducting these security risk assessments. Therefore, the information must be shared with the CJIS for them to conduct a security risk assessment to ensure that individuals requesting access to select agents are not identified as a restricted person based on criteria established in the U.S.A. Patriot Act. This is compatible with the overall purpose of the system—that only trustworthy individuals are granted access. Other Federal or State agencies may require the information DSAT possesses on individuals with access to select agents and the institutions at which those agents are housed to aid in their investigations of domestic or international terrorism or for any other criminal purpose. The purpose of the system is to be certain that only individuals who have a legitimate need to handle or use such select agents have access to them; this routine use is compatible in that this disclosure is done to prevent access to select agents for terrorism or other criminal purposes. State emergency planners may need this identifiable information to fulfill their responsibilities. The overall purpose of this SOR is to protect the public health and safety. Federal and State agency emergency responders may require DSAT's identifiable information if select agents are accidentally released or otherwise used inappropriately with the ultimate goal of protecting the public's health and safety. Records may also be shared with the Department of Transportation to ensure that the transfer of select agents is done safely and in compliance with their regulations—a use in line with CDC's purpose of safely transferring select agents for which it has responsibility. D. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual. When a constituent requests a congressional office to facilitate obtaining information from this CDC system, it is compatible to provide such information, since this is in line with the overall purpose of the Privacy Act which is to provide access to the subject individual of the records the government has on him or her. E. In the event of litigation where the defendant is:
(a)The Department, any component of the Department, or any employee of the Department in his or her official capacity;
(b)the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or
(c)any Department employee in his or her individual capacity where the Justice Department has agreed to represent such employee, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected. Whenever CDC is involved in litigation dealing with the DSAT, and CDC policies or operations could be affected by the outcome of the litigation, CDC must be able to disclose identifiable information to the Department of Justice so that an effective defense could be presented. IV. Safeguards The CDC/DSAT has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel with access to the system have been trained in Privacy Act and information security requirements. Employees maintaining records 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 and HHS 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 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 CDC policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications and the HHS Information Systems Program Handbook. V. Effects of the Proposed System of Records on Individual Rights CDC proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CDC 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 individuals whose data are maintained in the system. CDC will collect only that information necessary to perform the system's purpose. In addition, CDC will make disclosures from the 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. CDC, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: June 22, 2007. James D. Seligman, Chief Information Officer, Office of the Director, Centers for Disease Control and Prevention. Privacy Act System NO. 09-20-0170 System Name: National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER. Security Classification: Unclassified. System Location: Division of Select Agents and Toxins (DSAT), Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), Bldg. 20, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Atlanta, GA 30333 and Federal Records Center, 4712 Southpark Blvd., Ellenwood, GA 30294. Categories of Individuals Covered By the System: The Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals requesting access to select agents under the provisions of Part 73, of Title 42 of the Code of Federal Regulations (42 CFR part 73), Part 121 of Title 9 of the Code of Federal Regulations (9 CFR Part 121), and Part 331 of Title 7 of the Code of Federal Regulations (7 CFR part 331). Categories of Records in the System: The DSAT maintains records which include the names of the Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals who have access, or who have applied to have access to select agents (defined as a virus, bacteria, fungus or toxin that could pose a severe threat to public health and safety, to animal or plant health; or animal or plant products), and the list of select agents to which they have access. The Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals requesting access to select agents are required to provide their name, address, date of birth, and job title and the name of the institution that would be housing the select agent(s). Authority For Maintenance of the System: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and The Agricultural Bioterrorism Protection Act of 2002 (Pub. L. 107-188). Purpose(s): Records maintained in the National Select Agent Registry (NSAR)—a joint DSAT and U.S. Department of Agriculture/Animal and Plant Health Inspection Service (APHIS) information management system—are accessed by DSAT through the Select Agent Transfer and Entity Registration Information System (SATERIS) which is an user interface for data entry, data query, and routine reporting activities. The purpose of this system of records is to limit access to those select agents listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331 to those individuals who have a legitimate need to handle or use such select agents, and who are not identified as a restricted person by the U.S. Attorney General. The NSAR is also used to track the possession, use, and transfer of select agents and is a single Web-based system shared by DSAT and APHIS. DSAT conducts regulatory oversight of individuals and entities that possess, use, or transfer select agents. This includes the review of registration applications, conducting inspections of registered facilities or facilities requesting registration, processing requests to import select agents, processing all reports and requests received from individuals or entities regarding a select agent, and maintaining this information pertaining to individuals and entities that possess, use, and/or transfer select agents. Routine Uses of Records Maintained In the System, Including Categories of Users and the Purposes of Such Uses 1. Records may be disclosed to contractors to handle program work overflow duties, performing many of the same functions (listed in the Purpose section above) as DSAT employees. Contractors are required to maintain Privacy Act safeguards with respect to such records. 2. Records may be disclosed to health departments and other public health or cooperating medical authorities to deal more effectively with outbreaks and conditions of public health significance. 3. Personal information from this system may be disclosed as a routine use to assist the recipient Federal agency in making a determination concerning an individual's trustworthiness to access select agents; to any Federal or State agency where the purpose in making the disclosure is to prevent access to select agents for use in domestic or international terrorism or for any criminal purpose; or to any Federal or State agency to protect the public health and safety with regard to the possession, use, or transfer of select agents. 4. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual. 5. In the event of litigation where the defendant is:
(a)The Department, any component of the Department, or any employee of the Department in his or her official capacity;
(b)the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or
(c)any Department employee in his or her individual capacity where the Justice Department has agreed to represent such employee, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected. Policies and Practices For Storing, Retrieving, Accessing, Retaining, and Disposing of Records In the System Storage: File folders, computer tapes and disks, CD-ROMs. Retrievability: By name or DOJ identifier number. Safeguards: The following special safeguards are provided to protect the records from inadvertent disclosure: 1. Authorized Users: A database security package is implemented on CDC computers to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Individuals who have routine access to these records are limited to Select Agent Program staff (DSAT FTEs and contractors) who have responsibility for conducting regulatory oversight of individuals and entities that possess, use, or transfer select agents. 2. Physical Safeguards: Paper records are maintained in locked cabinets in locked rooms in a restricted access location that is controlled by a cardkey system, and security guard service provides personnel screening of visitors. Electronic data files are password protected and stored in a restricted access location. The computer room is protected by an automatic sprinkler system, numerous automatic sensors (e.g., water, heat, smoke, etc.) are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. The system is backed up on a nightly basis with copies of the files stored off site in a secure location. Computer workstations, lockable personal computers, and automated records are located in secured areas. 3. Procedural Safeguards: Protection for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system; mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily backup procedures and secure off-site storage is available for backup files. Knowledge of individual tape passwords is required to access tapes, and access to the system is limited to users obtaining prior supervisory approval. To avoid inadvertent data disclosure, a special additional procedure is performed to ensure that all Privacy Act data are removed from computer tapes and/or other magnetic media. When possible, a backup copy of data is stored at an offsite location and a log kept of all changes to each file and all persons reviewing the file. Additional safeguards may also be built into the program by the system analyst as warranted by the sensitivity of the data set. The DSAT and contractor employees who maintain records are instructed in specific procedures to protect the security of records, and are to check with the system manager prior to making disclosure of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Appropriate Privacy Act provisions are included in contracts and the CDC Project Director, contract officers, and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract. The USDA/APHIS maintains similarly stringent safeguards that are discussed within that agency's Select Agent system of records notice. 4. Implementation Guidelines: The safeguards outlined above are in accordance with the HHS Information Security Program Policy and FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems.” Data maintained on CDC's Mainframe and the COTPER LAN are in compliance with OMB Circular A-130, Appendix III. Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications. Retention and Disposal: The DSAT records and associated information are retained and dispositioned in accordance with DSAT records retention schedule, N1-442-06-1, pending approval by the National Archives and Records Administration. The DSAT records will be retained for 10 years in compliance with the records retention schedule requirements or until such time as no longer needed for litigation or other records purposes. Records will be transferred to a Federal Records Center for storage when no longer in active use. Final disposition of records stored offsite at the Federal Records Center will be accomplished by a controlled process requesting final disposition approval from the record owner prior to any destruction to ensure records are not needed for litigation or other records purposes. Hard copy records and Sensitive But Unclassified
(SBU)information designated for local disposition will be placed in a locked container or designated secure storage area while awaiting destruction. All SBU data will be destroyed in a manner that precludes its reconstruction, such as shredding. Electronic information will be deleted or overwritten using overwriting software that wipes the entire physical disk and not just the virtual disk. Overwriting is required for the destruction of all electronic SBU information. System manager(s) and Address: Director, Division of Select Agents and Toxins, Coordinating Office for Terrorism Preparedness and Emergency Response, Bldg. 20, Rm. 4100, MS A46, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333. Notification Procedure: An individual may learn if a record exists about himself or herself by contacting the system manager at the above address. Requesters in person must provide driver's license or other positive identification. Individuals who do not appear in person must submit a notarized request on institutional letterhead to verify their identity. The knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Privacy Act subject to a $5,000 fine and/or imprisonment. Record Access Procedures: Same as notification procedures. Requestors should also reasonably specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may also be requested. Contesting Record Procedures: Contact the system manager at the address specified above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. Record Source Categories: Applicants registering for possession, use, and transfer of select agents and the U.S. Attorney General. [FR Doc. E7-12682 Filed 6-29-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Medicare Master Death Records File (MMDRF), System No. 09-70-0597.” Under the provisions of Sections 1106 (42 U.S.C. 1306 and 205(r) (42 U.S.C. 405(r) of the Social Security Act (the Act), the Social Security Administration
(SSA)will provide to CMS the SSA Death Master File including unrestricted State death data. CMS will use this death data to:
(1)Ensure that no future payments are made to any physician or individually enrolled practitioner and other individuals for whom CMS has a record of death, and
(2)investigate and initiate an appropriate response where a deceased physician's billing number has been found to have been used as the basis for a request for payment for services allegedly rendered after the physician's date of death. Upon independent verification of the facts with respect to specific individuals, the results will be used to update CMS databases and may also be used to support payment recovery operations and or the work of law enforcement. We have provided additional background information about the new system in the “Supplementary Information” section below. The primary purpose of this system is to collect and maintain Social Security Administration death records for physicians, non-physician practitioners and individuals associated with organizational providers and suppliers to ensure payments are not made for services rendered after confirmed date of death and to prevent and/or detect any fraud, waste and abuse. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, CMS grantee;
(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support litigation involving the agency; and
(4)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. EFFECTIVE DATES: CMS filed a new system report with the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on *June 25, 2007.* To ensure that all parties have adequate time in which to comment, the new SOR, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless CMS receives comments that require alterations to this notice. 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. 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: Allen Gillespie, Technical Advisor, Division of Provider/Supplier Enrollment, Program Integrity Group, Office of Financial Management, Mail Stop C3-24-01, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. He can be reached by telephone at 410-786-5996, or via e-mail at *allen.gillespie@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: CMS staff will develop a program to compare data on the monthly MMDRF with individuals in the Provider Enrollment Chain Ownership System (PECOS). A report of potential matches from the MMDRF and PECOS will be distributed monthly to the Parts A and B MACs and affiliated contractors. CMS will issue manual instructions with procedures contractors should follow to determine if the individual name on the monthly report is a match to the individual in the PECOS database. When contractors verify there is a match there will be additional procedures for updating PECOS and, in turn, the corresponding claims systems. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for maintenance of this system is given under the provisions of Sections 1106 (42 U.S.C. 1306) and 205(r) (42 U.S.C. 405(r)) of the Social Security Act (the Act). B. Collection and Maintenance of Data in the System Information is collected on all providers with a Social Security number
(SSN)whose death has been reported to the Social Security Administration or to CMS, and the death has not been verified. The system will comprise death records about providers who participate in the Medicare program. Examples include, but are not limited to: name, SSN, demographic information, unique provider identification number, National Provider Identifier (NPI), etc. II. Agency Policies, Procedures, and Restrictions on Routine Uses 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 MMDRF information that can be associated with an individual as prt will only release MMDRF 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 MMDRF. 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 Social Security Administration death records for physicians, non-physician practitioners and individuals associated with organizational providers and suppliers to ensure payments are not made for services rendered after confirmed date of death and to prevent and/or detect any fraud, waste and abuse. 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. Routine Uses of Data A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or State agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the State. Other Federal or State agencies, in their administration of a Federal health program, may require MMDRF information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. 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. 4. To a CMS contractor 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, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 5. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require MMDRF information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. IV. Protections CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002; the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: June 20, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0597 SYSTEM NAME: “Medicare Master Death Records File (MMDRF),” HHS/CMS/OFM. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Information is collected on all providers with a Social Security number
(SSN)whose death has been reported to the Social Security Administration or to CMS, and the death has not been verified. The system will comprise death records about providers who participate in the Medicare program. CATEGORIES OF RECORDS IN THE SYSTEM: The collected information will include, but is not limited to: name, SSN, demographic information, unique provider identification number, National Provider Identifier (NPI), etc. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for maintenance of this system is given under the provisions of Sections 1106 (42 U.S.C. 1306) and 205(r) (42 U.S.C. 405(r)) of the Social Security Act (the Act). PURPOSE(S) OF THE SYSTEM: The primary purpose of this system is to collect and maintain Social Security Administration death records for physicians, non-physician practitioners and individuals associated with organizational providers and suppliers to ensure payments are not made for services rendered after confirmed date of death and to prevent and/or detect any fraud, waste and abuse. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, CMS grantee;
(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support litigation involving the agency; and
(4)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and 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 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. 4. To a CMS contractor 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. 5. 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. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on electronic media. RETRIEVABILITY: The collected data are retrieved by the name or other identifying information of the physician/practitioner, health care provider. PROTECTIONS: CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain identifiable information maintained in the MMDRF system of records for a period of 6 years 3 months. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER AND ADDRESS: Director, Division of Provider/Supplier Enrollment, Program Integrity Group, Office of Financial Management, Mail Stop C3-24-01, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), NPI, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES Data will be collected from beneficiary enrollment records, provider enrollment records, and the Death Master File including unrestricted State death data provided by the Social Security Administration. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT None. [FR Doc. E7-12677 Filed 6-29-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a 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, “Supplemental Medical Insurance
(SMI)and Hospital Insurance
(HI)Premium Accounting Collection and Enrollment (SPACE) System,” System No. 09-70-0505, last published at 67 **Federal Register** 40933 (June 14, 2002). The third party premium collection system bills and collects Part A and/or Part B Medicare premiums paid by third party payers on behalf of beneficiaries represented by that entity. In September, 2003, the third party premium collection system known as “SPACE” was replaced by a redesigned system referred to as the “Third Party System (TPS).” The new system was designed to:
(1)Integrate beneficiary third party data onto the EDB with Direct Billing and Enrollment/Entitlement data;
(2)eliminate redundant and discrepant data;
(3)reduce the number of exception cases requiring processing;
(4)provide daily update of third party data at CMS and Social Security Administration;
(5)implement several legislative provisions affecting premium collection; and
(6)provide integrated online access to Medicare enrollment data. To more accurately reflect the changes proposed for this system, we will modify the name of this system to read: “Third Party System (TPS).” TPS will retain its current system identification number: CMS No. 09-70-0505. We propose to modify existing routine use number 3 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 be renumbered as routine use number 1. 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 to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. 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)(Public Law 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 process beneficiary premium billing accretions and deletions to third party premium payer accounts (state Medicaid agencies, Office of Personnel Management (OPM), and formal third party groups and surcharge only group payers (latter as defined in 42 Code of Federal Regulations
(CFR)408.80 through 408.92 and 408.200 through 408.210)) for the payment of Part B
(SMI)and/or Part A
(HI)premiums on behalf of Medicare beneficiaries, the payment of the surcharge portion of the Part B premium on behalf of Medicare beneficiaries by a State or local government entity, and for enrolling individuals for Part A or Part B coverage under state buy-in agreements. The information retrieved from this system of records 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 or State agency, agency of a State government, an agency established by State law, or its fiscal agent;
(3)support formal third party groups and surcharge only group payers pursuant to an agreement with CMS;
(4)assist an individual or research organization to support research evaluation of epidemiological projects;
(5)support litigation involving the agency; and
(6)combat fraud, waste, and abuse in certain Federally-funded 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 *June 25, 2007.* 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. FOR FURTHER INFORMATION CONTACT: Frances Ferrante, Division of Premium Billing and Collections, Accounting Management Group, Office of Financial Management, CMS, Mail Stop N3-21-06, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. She can also be reached by telephone at 410-786-6193, or via e-mail at *Frances.Ferrante@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 §§ 1818, 1818A, (42 United States Code (U.S.C.) 1395i-2 and 2a), §§ 1818(e) and
(g)(42 U.S.C. 1395i-2(e) and (g)), 1839(e) (42 U.S.C. 1395r), 1840(d) and
(e)(42 U.S.C. 1395s(d) and (e)), and 1843 (42 U.S.C. 1395v) of Title XVIII of the Social Security Act (the Act). B. Collection and Maintenance of Data in the System The system contains information on Medicare beneficiaries whose Part A benefit and/or Part B Medicare premiums are paid by a state Medicaid agency, OPM, a formal third party group, or a surcharge only group payer. Information collected includes, but is not limited to, name, social security number, health insurance claims number, date of birth, gender, amount of premium liability, date agency first became liable for Part A or Part B premiums or Part B surcharges, last month of agency premium liability, agency identification number, and an OPM annuity number. II. Agency Policies, Procedures, and Restrictions on the Routine Use 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 TPS 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 TPS. 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 process beneficiary premium billing accretions and deletions to third party premium payer accounts (state Medicaid agencies, Office of Personnel Management (OPM), and formal third party groups and surcharge only group payers (latter as defined in 42 Code of Federal Regulations
(CFR)408.80 through 408.92 and 408.200 through 408.210)) for the payment of Part B
(SMI)and/or Part A
(HI)premiums on behalf of Medicare beneficiaries, the payment of the surcharge portion of the Part B premium on behalf of Medicare beneficiaries by a State or local government entity, and for enrolling individuals for Part A or Part B coverage under state buy-in agreements. 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 is valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To 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 functions 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: 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. Assist Federal/state Medicaid programs within the State. Other Federal or State agencies in their administration of a Federal health program may require TPS information in order to support evaluations and monitoring of Medicare premium billing information. In addition, state Medicaid agencies may require TPS data, pursuant to agreements with HHS, for enrollment of dually eligible beneficiaries for medical insurance under § 1843 of the Act. The Social Security Administration
(SSA)requires TPS data to enable them to assist in the implementation and maintenance of the Medicare program. The Railroad Retirement Board
(RRB)requires TPS information to enable them to assist in the implementation and maintenance of the Medicare program. OPM requires TPS information in order to perform monthly premium billing functions to identify annuitants for whom premium collections must be initiated, and to periodically reconcile third-party master records. 3. To support formal third party groups and surcharge only group payers pursuant to agreements with CMS to pay the Medicare premiums or surcharge only portion of the Part B premium on behalf of their members 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 has entered into a contractual or similar agreement with a formal third-party group; *e.g.* , private groups, retirement funds, religious orders, local government agency, etc., or surcharge only group payer; *e.g.* , State or local government entity, that can pay Medicare Part A &/or Part B premiums or the surcharge only portion of the Part B premium or as necessary to assist in a CMS function relating to the payment on behalf of their members. 4. To assist an individual or organization for research, evaluation, or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. TPS data will provide for the research, evaluation, and epidemiological 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. 5. 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. 6. To assist a CMS contractor (including, but not limited to fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS has entered into a contract 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 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. 7. 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, and 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, and abuse in such programs. Other agencies may require TPS 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 information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the 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 (see item IV above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in 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: June 20, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0505 SYSTEM NAME: “Third Party System (TPS),” HHS/CMS/OFM. 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 system contains information on Medicare beneficiaries whose Part A benefit and/or Part B Medicare premiums are paid by a state Medicaid agency, OPM, a formal third party group, or a surcharge only group payer. CATEGORIES OF RECORDS IN THE SYSTEM: Information collected includes, but is not limited to, name, social security number, health insurance claims number, date of birth, gender, amount of premium liability, date agency first became liable for Part A or Part B premiums or Part B surcharges, last month of agency premium liability, agency identification number, and an OPM annuity number. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for maintenance of the system is given under §§ 1818, 1818A, (42 United States Code (U.S.C.) 1395i-2 and 2a), 1818(e) and
(g)(42 U.S.C. 1395i-2(e) and (g)), 1839(e) (42 U.S.C. 1395r), 1840
(d)and
(e)(42 U.S.C. 1395s
(d)and (e)), and 1843 (42 U.S.C. 1395v) of Title XVIII of the Social Security Act (the Act). PURPOSE(S) OF THE SYSTEM: The primary purpose of this modified system is to process beneficiary premium billing accretions and deletions to third party premium payer accounts (state Medicaid agencies, Office of Personnel Management (OPM), and formal third party groups and surcharge only group payers (latter as defined in 42 Code of Federal Regulations
(CFR)408.80 through 408.92 and 408.200 through 408.210)) for the payment of Part B
(SMI)and/or Part A
(HI)premiums on behalf of Medicare beneficiaries, the payment of the surcharge portion of the Part B premium on behalf of Medicare beneficiaries by a State or local government entity, and for enrolling individuals for Part A or Part B coverage under state buy-in agreements. The information retrieved from this system of records 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 or State agency, agency of a State government, an agency established by State law, or its fiscal agent;
(3)support formal third party groups and surcharge only group payers pursuant to an agreement with CMS;
(4)assist an individual or research organization to support research, evaluation of epidemiological projects;
(5)support litigation involving the agency; and
(6)combat fraud, waste, and abuse in certain Federally-funded 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: 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. Assist Federal/state Medicaid programs within the State. 3. To support formal third party groups and surcharge only group payers pursuant to agreements with CMS to pay the Medicare premiums or surcharge only portion of the Part B premium on behalf of their members and who need to have access to the records in order to perform the activity. 4. To assist an individual or organization for research, evaluation, or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 5. 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. 6. To assist a CMS contractor (including, but not limited to fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. 7. 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, and 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, and 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 direct access storage devices and other electronically retrievable media. RETRIEVABILITY: Information can be retrieved by name, HICN, and assigned agency identification number. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records are maintained in a secure storage area with identifiers for 6 years 3 months after final action of the case is completed. 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, Division of Premium Billing and Collections, Accounting Management Group, Office of Financial Management, CMS, Mail Stop N3-21-06, 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 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 contained in this system is obtained from third party agencies, Social Security Administration's Master Beneficiary Record, and CMS' Enrollment Database. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-12679 Filed 6-29-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “State Health Insurance Assistance Program
(SHIP)National Performance Report (SHIP-NPR),” System No. 09-70-0510. The demands, expectations and funding for the State Health Insurance Assistance Program
(SHIP)increased under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Under this increase CMS is now required to implement an improved performance measurement system to manage the program effectively. This includes increased access to personalized counseling services by beneficiaries and enrollment assistance provided to beneficiaries in the MMA. The purpose of this system is to collect and maintain information on how beneficiaries use SHIP services, which includes individually identifiable information on Medicare and Medicaid beneficiaries who have contacted SHIP representatives. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support litigation involving the agency; and
(4)combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Oversight and Government Reform, 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 June 25, 2007. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should send 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: Patricia Gongloff, Division of State Health Insurance Program Relations, Strategic Research & Campaign Management Group, Office of External Affairs, Mail Stop S1-13-05, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-7610, or via e-mail at *Patricia.Gongloff@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: The demands, expectations and funding for the State Health Insurance Assistance Program
(SHIP)increased under the MMA. Under this increase CMS is now required to implement an improved performance measurement system to manage the program effectively. This includes increased access to personalized counseling services by beneficiaries and enrollment assistance provided to beneficiaries in the MMA. The SHIP-NPR will provide maintenance support and evaluate data, and implement performance targets established by CMS. Further efforts will include strategies to eliminate the duplication in reporting of NPR data by SHIPs to CMS and other agencies providing services to beneficiaries, reduce the under-reporting of data on services provided by SHIPs, and development of a system to validate data prior to entry into the NPR database for the purpose of quality improvement of the SHIP Network. The SHIP-NPR is part of an overall effort by CMS to monitor and assess customer service information efforts, and develop outcome measures to assess CMS' progress in improving overall communications with beneficiaries and other partners over time. As part of the tasks associated with this effort, a contractor provided assistance to CMS staff who were developing program-monitoring systems of their customer service and information projects with the objective to achieve continuous quality improvement. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for maintenance of this system is given under § 4360 of Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), the outreach and education requirements of the Balanced Budget Act of 1997, and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. B. Collection and Maintenance of Data in the System The system will collect and maintain individually identifiable information on Medicare and Medicaid beneficiaries who have contacted SHIP representatives, as well as the SHIP counselors. Information collected includes, but is not limited to: Name, counseling zip code, beneficiary zip code, telephone number, data of birth, gender, race/ethnicity and date of contact. 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 SHIP-NPR 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 SHIP-NPR. 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 information on how beneficiaries use SHIP services, which includes individually identifiable information on Medicare and Medicaid beneficiaries who have contacted SHIP representatives. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS functions relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require SHIP-NPR information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. 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. 4. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 5. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs. Other agencies may require SHIP-NPR 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 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a) (1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that an individual could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Proposed System of Records on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: June 21, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0510 SYSTEM NAME: “State Health Insurance Assistance Program
(SHIP)National Performance Report (SHIP-NPR),” HHS/CMS/OEA. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: The system will collect and maintain individually identifiable information on Medicare and Medicaid beneficiaries who have contacted SHIP representatives, as well as the SHIP counselors. CATEGORIES OF RECORDS IN THE SYSTEM: Information collected includes, but is not limited to: Name, counseling zip code, beneficiary zip code, telephone number, data of birth, gender, race/ethnicity and date of contact. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for maintenance of this system is given under § 4360 of Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), the outreach and education requirements of the Balanced Budget Act of 1997, and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. PURPOSE(S) OF THE SYSTEM: The purpose of this system is to collect and maintain information on how beneficiaries use SHIP services, which includes individually identifiable information on Medicare and Medicaid beneficiaries who have contacted SHIP representatives. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support litigation involving the agency; and
(4)combat fraud, waste and abuse in certain Federally-funded health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and 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 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. 4. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such program. 5. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a) (1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that an individual could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on electronic media. RETRIEVABILITY: The collected data are retrieved by the name or other identifying information of the participating provider or beneficiary, and may also be retrieved by a distinct identifier such as the Health Insurance Claim Number (HICN), at the individual beneficiary level. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records will be retained for a period of 6 years and 3 months. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER AND ADDRESS: Division of State Health Insurance Program Relations, Strategic Research & Campaign Management Group, Office of External Affairs, Mail Stop S1-13-05, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or Social Security Number
(SSN)(furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicare and SHIP administrative records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-12680 Filed 6-29-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities Under Emergency Review for the Office of Management and Budget
(OMB)The Health Resources and Services Administration
(HRSA)has submitted the following request (see below) for emergency OMB review under the Paperwork Reduction Act (44 U.S.C. Chapter 35). OMB approval has been requested within 20 days of publication of this notice. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on
(301)443-1129. Written comments and recommendations should be sent within 14 days of publication of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence “to the attention of the desk officer for HRSA.” Proposed Project: Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
(NEW)Title XXVI of the Public Health Service
(PHS)Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year
(FY)2007. In order for grantees under Parts A, B, and C to be exempted from the 75 percent core medical services requirement, they must request and receive a waiver from HRSA, as required in the Act. HRSA has developed a process for waiver request submission, review, and notification. The core medical services waiver uniform standard and waiver request process will apply to Ryan White HIV/AIDS Program grant awards under Parts A, B, and C of Title XXVI of the PHS Act beginning FY 2008. Core medical services waivers will be effective for a one-year period consistent with the grant award period. Grantees must submit a waiver request with the annual grant application containing the following certifications and documentations which will be utilized by HRSA in making determinations regarding waiver requests. The waiver must include: 1. Certification from the Part B state grantee that there are no current or anticipated ADAP services waiting lists in the state for the year in which such waiver request is made. This certification must also specify that there are no waiting lists for a particular core class of antiretroviral therapeutics established by the Secretary, e.g., fusion inhibitors; 2. Certification that all core medical services listed in the statute (Part A section 2604(c)(3), Part B section 2612(b)(3), and Part C section 2651(c)(3)), regardless of whether such services are funded by the Ryan White HIV/AIDS Program, are available within 30 days for all identified and eligible individuals with HIV/AIDS in the service area; 3. Evidence that a public process was conducted to seek public input on availability of core medical services; 4. Evidence that receipt of the core medical services waiver is consistent with the grantee's Ryan White HIV/AIDS Program application (e.g., “Description of Priority Setting and Resource Allocation Processes” and “Unmet Need Estimate and Assessment” sections of the application for Parts A, “Needs Assessment and Unmet Need” section of the application under Part B, and “Description of the Local HIV Service Delivery System,” and “Current and Projected Sources of Funding” sections of the application under Part C). *The estimated annual burden is as follows:* Application Number of respondents Responses per respondent Total responses Hours per response Total burden hours Waiver Request 20 1 20 6.5 130 Total 20 20 130 Dated: June 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. 07-3219 Filed 6-27-07; 3:32 pm]
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U.S. Code
- Disclosure of information in possession of Social Security Administration or Department of Health and Human Services§ 1306
- Evidence, procedure, and certification for payments§ 405
- Hospital insurance benefits for uninsured elderly individuals not otherwise eligible§ 1395i–2
- Amount of premiums for individuals enrolled under this part§ 1395r
- Payment of premiums§ 1395s
- Agreements with States§ 1395v
10 references not yet in our index
- 42 CFR 73
- 9 CFR 121
- 7 CFR 331
- Pub. L. 107-188
- 45 CFR 5
- Pub. L. 108-173
- 45 CFR 164.512(a)(1)
- Pub. L. 101-508
- 65 FR 82462
- 45 CFR 164.512(a)
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Notices
Notice of a New System of Records
Cite42 CFR 73
Cite9 CFR 121
Cite7 CFR 331
Pub. L.Pub. L. 107-188
Cite45 CFR 5
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