[Federal Register Volume 71, Number 98 (Monday, May 22, 2006)]
[Notices]
[Pages 29336-29340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

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

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

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new SOR titled, ``Organ 
Procurement Organizations System (OPOS), System No. 09-70-0575.'' The 
Organ Procurement Organization (OPO) Certification Act of 2000 (Sec.  
701 of Pub. L. 106-505) directs the Secretary of HHS to establish 
regulations that provide the statutory qualifications and requirements 
that an OPO must meet in order for organ procurement costs to be 
reimbursed under the Medicare and Medicaid programs. As part of the 
efficient administration of this program, CMS is charged with the 
responsibility to conduct investigations, analysis, and reporting of 
adverse events that are described as an untoward, undesirable, and 
unanticipated event that causes death or serious injury. At this time, 
individually-identifiable data is only requested from OPOs under two 
circumstances: (1) Due to the suspicion that an infectious disease has 
been transmitted to a recipient; and (2) when there has been a 
complaint alleged against an OPO. CMS regional office survey and 
certification staff would request individually-identifiable data to 
complete the investigation. Due to certain investigatory activities 
related to this system, CMS proposes to exempt this system from the 
notification, access, correction and amendment provisions of the 
Privacy Act of 1974.
    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. 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 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

[[Page 29337]]

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 May 15, 2006. 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 address comment to the CMS Privacy 
Officer, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850. Comments received will be available for review at 
this location, by appointment, during regular business hours, Monday 
through Friday from 9 a.m.-3 p.m., eastern daylight time.

FOR FURTHER INFORMATION CONTACT: Michele Walton, 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. She can be reached by telephone at 
(410) 786-3353, or via e-mail at [email protected].

SUPPLEMENTARY INFORMATION: OPOs play a crucial role in ensuring that an 
immensely valuable, but scarce resource--transplantable human organs--
become available to seriously ill patients who are on a waiting list 
for an organ transplant. OPOs are responsible for identifying potential 
organ donors and for obtaining as many organs as possible from those 
donors. They are also responsible for ensuring that the organs they 
obtain are properly preserved and quickly delivered to a suitable 
recipient awaiting transplantation. Therefore, OPO performance is a 
critical element of the organ transplant system in the United States. 
An OPO that is efficient in procuring organs and delivering them to 
recipients will, quite literally, save more lives than an ineffective 
OPO.
    CMS believes that OPOs will continue to improve their performance. 
CMS has four Regional OPO Coordinators, who work directly with the OPOs 
to increase organ donation rates by assisting them in developing and 
implementing quality assessment and performance improvement programs. 
In addition, they also make periodic quality visits to identify areas 
in which an OPO needs to improve. The CMS Regional OPO Coordinators 
collaborate with the Health Resources and Services Administration, the 
OPOs, and the hospitals to ensure the continuous implementation of best 
practices identified through the Organ Donation Breakthrough 
Collaborative (the Collaborative). However, the Collaborative is a 
voluntary initiative and, as such, has no enforcement mechanism.
    Pursuant to the Health Insurance Portability and Accountability Act 
(HIPAA), individually-identifiable data is protected from disclosure to 
third parties, unless an individual has given his or her permission for 
the information to be disclosed, or the disclosure falls under an 
exception or permissible use. At this time, individually-identifiable 
data is only requested from OPOs under two circumstances. This data 
would be requested whenever there is an investigation due to the 
suspicion that an infectious disease has been transmitted to a 
recipient. The request for this data falls under the public health 
exception in HIPAA. The second is when there has been a complaint 
alleged against an OPO. CMS is required to investigate complaints made 
against OPOs. The regional office survey and certification staff would 
request individually-identifiable data to complete the investigation. 
The request for this data would be covered under the oversight 
exception in HIPAA.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for SOR

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

B. Collection and Maintenance of Data in 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. The collected information will contain name, address, 
telephone number, health insurance claim number, geographic location, 
as well as, background information relating to Medicare or Medicaid 
issues of the complainant.

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 OPOS 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 OPOS. CMS 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 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 
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.
    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).

[[Page 29338]]

    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 system of records 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 contractors, consultants or grantees whatever information 
is necessary for the contractors, consultants or grantees to fulfill 
its duties. In these situations, safeguards are provided in the 
contract prohibiting the contractors, consultants or grantees from 
using or disclosing the information for any purpose other than that 
described in the contract and requires the contractors, consultants or 
grantees to return or destroy all information at the completion of the 
contract.
    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.
    Other Federal or state agencies in their administration of a 
Federal health program may require OPOS information in order to 
investigate complaint allegations, evaluate information gathered during 
the complaint investigation, review findings and results of the 
investigation relating to the enforcement of OPO regional office 
investigations.
    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.
    Beneficiaries sometimes request the help of a member of Congress in 
resolving an issue relating to a matter before CMS. The member of 
Congress then writes CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    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.
    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.
    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 who are familiar with the enrollees could, because of the 
small size, use this information to deduce the identity of the 
individual).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations 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.

[[Page 29339]]

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 the system. CMS will collect only that information 
necessary to perform the system's purpose. In addition, CMS 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. CMS, therefore, does 
not anticipate an unfavorable effect on individual privacy as a result 
of information relating to individuals.

    Dated: May 15, 2006.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
SYSTEM NO. 09-70-0575

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

Security Classification:
    Level Three Privacy Act Sensitive Data.

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

Purpose(s) of the System:
    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 
or Users and the Purposes of Such Uses:
    C. 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

[[Page 29340]]

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 and Address:
    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 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 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:
    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.

Systems Exempted from Certain Provisions of the Act:
    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)).

[FR Doc. E6-7690 Filed 5-19-06; 8:45 am]
BILLING CODE 4120-03-P