[Federal Register: May 22, 2006 (Volume 71, Number 98)]
[Notices]
[Page 29336-29340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my06-57]
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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 Michele.Walton@cms.hhs.gov.
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