SORN 09-70-0575

System Name: "Organ Procurement Organizations System (OPOS)" HHS/CMS/OCSQ.

Security Classification: Level Three Privacy Act Sensitive Data.

System Location(s): Centers for Medicare & Medicaid Services (CMS) Central Office and Regional Offices, and at various contractor locations.

Categories of Individuals Covered by the System: OPOS will maintain a file of complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the investigation.

Categories of Records in the System: The collected information will contain name, address, telephone number, health insurance claim number (HICN), geographic location, as well as, background information relating to Medicare or Medicaid issues of the complainant.

Authority for Maintenance of the System: Authority for this system is given under the Organ Procurement Organization Certification Act of 2000 (§ 701 of Pub. L. 106 -505) and § 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L. 106-554) containing identical provisions that amended § 371(b)(1) of the Public Health Service (PHS) Act (42 U.S.C. 273(b)(1)). Authority is also given under §§ 1102 and 1138 of the Social Security Act (the Act) (42 U.S.C. 1302, and 42 U.S.C. 1320b-8), § 1138(b) of the Act also specifies that an OPO must operate under a grant made under § 371(a) of the PHS Act.

Purpose(s): The purpose of this system is to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee; (2) assist another Federal or state agency in the enforcement of OPO regulations where sharing the information is necessary to complete the processing of a complaint, contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or enable such agency to administer a Federal health benefits program; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the agency.

Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:


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 system of records and who need to have access to the records in order to perform the activity.

2. To another Federal or state agency to:

a. Assist in the enforcement of Organ Procurement Organizations regulations for violations of Conditions for Coverage for Organ Procurement Organizations where sharing the information is necessary to complete the processing of a complaint,

b. Contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or

c. 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.

3. To a member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.

4. 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.

D. 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 who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the individual).

Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—

Storage: All records are stored electronically and in hard copy.

Retrievability: The complaint data are retrieved by an individual identifier i.e., name of complainant.

Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.

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

Retention and Disposal: CMS will retain complaint information for a total period not to exceed 25 years.

System Manager(s) and Address(es):

Director, Division of Continuing Care Providers, Survey and Certification Group, Center for Medicaid and State Operations, CMS, 7500 Security Boulevard, Mail Stop S2-01-16, Baltimore, Maryland 21244-1849.

Notification Procedure: This system is exempt under the provisions of 5 U.S.C. 552a(k)(2) of the Privacy Act. However, portions of this system notice are non- exempt and consideration will be given to requests addressed to the system manager for those portions. For general inquiries, it would be helpful if the request included the system name, address, age, sex, and for verification purposes, the subject individual's name (woman's maiden name, if applicable) and complaint tracking identification number.

Record Access Procedures: 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 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).

Record Source Categories: CMS investigative files maintained in OPOS are either received as electronic documents or paper records that are compiled for administrative, civil, and law enforcement purposes. In the course of investigations, CMS often has a need to obtain confidential information involving individuals other than the complainant.

Exemptions Claimed for the System: HHS claims exemption of certain records (case files on active fraud investigations) in the system from notification and access procedures under 5 U.S.C. 552a(k)(2) inasmuch as these records are investigatory materials compiled for program, administrative, and law enforcement in anticipation of a criminal or administrative proceedings. (See Department Regulation (45 CFR 5b.11)).

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