[Federal Register: July 6, 2005 (Volume 70, Number 128)]
[Notices]
[Page 38944-38948]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy05-116]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a new System of Records (SOR).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system of records titled,
``Health Insurance Portability and Accountability Act (HIPAA)
Information Tracking System (HITS), System No. 09-70-0544.'' The Office
of E-Health Standards and Services (OESS) has been delegated the
responsibility to regulate and enforce compliance for violations of
Transactions and Code Sets, Security, and Unique Identifier provisions
of HIPAA. Enforcement of these provisions is a complaint driven
process; seeking voluntary compliance from all HIPAA covered entities.
OESS has procured the services of a contractor to provide a database
for complaint intake and management, to manage and maintain the overall
electronic complaint process. Due to investigatory activities, CMS is
exempting this system from the notification, access, correction and
amendment provisions of the Privacy Act of 1974.
The purpose of this system is to store the results of all OESS
regional investigations, to determine if there were violations as
charged in the original complaint, to investigate complaints that
appear to be in violation of the Transactions and Code Sets, Security,
and Unique Identifier provisions of HIPAA, to refer violations to law
enforcement activities as necessary, and to maintain and retrieve
records of the results of the complaint investigations. Information
retrieved from this SOR will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed within the
agency, HIPAA entities, or by a contractor or consultant; (2) assist
another Federal or state agency in the enforcement of HIPAA 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; (4) support litigation involving the
agency; and (5) combat fraud and abuse in certain health benefits
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 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 Government Reform and Oversight, the Chair of the
Senate Committee on Governmental Affairs, and the Administrator, Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB) on June 28, 2005. We will not disclose any information under a
routine use until 30 days after publication. We may defer
implementation of this SOR 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: Michael Phillips, Health Insurance
Specialist, OESS, CMS, 7500 Security Boulevard, Mail Stop S2-24-15,
Baltimore, Maryland 21244-1849, Telephone Number (410) 786-6713,
mphillips@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: HITS is used by OESS staff and consists of
an electronic repository of information and documents and supplementary
paper document files. The HITS system allows OESS to integrate all of
OESS' various business process including all of its investigation
activities to allow real time access and results reporting and other
varied information management needs. HITS provides (1) a single,
central, electronic repository of all OHS complaint documents and
information including investigative files, correspondence, and
administrative records; (2) easy, robust capability to search all of
the information in OESS' repository; (3) better quality control at the
front end with simplified data entry and stronger data validation; (4)
tools to help staff work on and manage their casework; and (5) includes
supplementary paper files. The system
[[Page 38945]]
has the capacity to generate reports concerning the status of current
and closed complaints, reviews and correspondence.
OESS investigative files maintained in HITS are either received as
electronic documents or paper records that are compiled for law
enforcement purposes. In the course of investigations, OESS often has a
need to obtain confidential information involving individuals other
than the complainant. In these cases, it is necessary for OHS to: (1)
Preserve the confidentiality of this information, (2) avoid unwarranted
invasions of personal privacy, and (3) assure recipients of Federal
financial assistance that such information provided to OESS will be
kept confidential. This assurance facilitates prompt and effective
completion of the investigations.
Unrestricted disclosure of confidential information in OESS files
can impede ongoing investigations, invade personal privacy of
individuals and organizations, reveal the identities of confidential
sources, or otherwise impair the ability of OESS to conduct
investigations. For these reasons, the CMS is exempting all
investigative files from the notification, access, correction and
amendment provisions under subsection (k)(2) of the Privacy Act.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
Authority for maintenance of this system is given under provisions
of the Health Insurance Portability and Accountability Act of 1996,
Public Law (Pub. L. 104-191), published at 68 FR 60694 (October 23,
2003). These regulations are codified at 45 Code of Federal Regulation,
parts 160, 162, and 164.
B. Collection and Maintenance of Data in the System
HITS will maintain a file of complaint allegations, 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 (HIC) 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 HITS 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 HITS. 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 store the results of
all OESS regional investigations, to determine if there were violations
as charged in the original complaint, to investigate complaints that
appear to be in violation of the HIPAA, to refer violations to law
enforcement activities as necessary, and to maintain and retrieve
records of the results of the complaint investigations.
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 or consultant 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 or records.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor or consultant whatever information is
necessary for the contractor or consultant to fulfill its duties. In
these situations, safeguards are provided in the contract prohibiting
the contractor or consultant from using or disclosing the information
for any purpose other than that described in the contract and requires
the contractor or consultant to return or destroy all information at
the completion of the contract.
2. To another Federal or state agency to:
a. Assist in the enforcement of HIPAA regulations for violations of
Transactions and Code Sets, Security, and Unique Identifiers 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 HITS information in order to
investigate complaint
[[Page 38946]]
allegations, evaluate information gathered during the complaint
investigation, review findings and results of the investigation
relating to the enforcement of HIPAA regulations for violations of
Transactions and Code Sets, Security, and Unique Identifiers.
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.
5. To a CMS contractor (including, but not necessarily limited to
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual relationship or
grant with a third party to assist in accomplishing CMS functions
relating to the purpose of combating fraud and abuse.
CMS occasionally contracts out certain of its functions and makes
grants when doing so would contribute to effective and efficient
operations. CMS must be able to give a contractor or grantee whatever
information is necessary for the contractor or grantee to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the contractor or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requiring the contractor or grantee to return or destroy all
information.
6. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
Other agencies may require HITS information for the purpose of
combating fraud and abuse in such Federally funded programs.
B. Additional Provisions Affecting Routine Use Disclosures. This
system contains Protected Health Information (PHI) as defined by HHS
regulation ``Standards for Privacy of Individually Identifiable Health
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (12-28-00),
Subparts A and E. Disclosures of PHI authorized by these routine uses
may only be made if, and as, permitted or required by the ``Standards
for Privacy of Individually Identifiable Health Information.''
In addition, our policy will be to prohibit release even of not
directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent NIST
publications; the DHHS Information Security 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 (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
[[Page 38947]]
individual privacy as a result of information relating to individuals.
John R. Dyer,
Chief Operating Officer.
SYSTEM NO. 09-70-0544
SYSTEM NAME:
``Health Insurance Portability and Accountability Act (HIPAA)
Information Tracking System (HITS), HHS/CMS/OESS''.
Security Classiffication:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
Atlantic Telephone & Telegraph Company, Ashburn, Virginia facility
under the control of the Center for Medicare & Medicaid Services.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals who have filed complaints alleging violations of the
Transactions and Code Sets, Security, and Unique Identifier provisions
under the Health Insurance Portability and Accountability Act of 1996,
Public Law 104-191, 68 FR 60694 (October 23, 2003). These regulations
are codified at 45 CFR, parts 160, 162 and 164.
CATEGORIES OF RECORDS IN THE SYSTEM:
HITS will maintain a file of complaint allegations, 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 (HIC) number, geographic location, as well as,
background information relating to Medicare or Medicaid issues.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of this system is given under provisions
of the Health Insurance Portability and Accountability Act of 1996,
(Pub. L. 104-191), published at 68 FR 60694 (October 23, 2003). These
regulations are codified at 45 Code of Federal Regulation, parts 160,
162, and 164.
PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to store the results of all OESS
regional investigations, to determine if there were violations as
charged in the original complaint, to investigate complaints that
appear to be in violation of the Transactions and Code Sets, Security,
and Unique Identifier provisions of HIPAA, to refer violations to law
enforcement activities as necessary, and to maintain and retrieve
records of the results of the complaint investigations. Information
retrieved from this SOR will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed within the
agency, HIPAA entities, or by a contractor or consultant; (2) assist
another Federal or state agency in the enforcement of HIPAA 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; (4) support litigation involving the
agency; and (5) combat fraud and abuse in certain health benefits
programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
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.'' We are proposing to establish the following routine use
disclosures of information maintained in the system. Information will
be disclosed:
1. To agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system 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 HIPAA regulations for violations of
Transactions and Code Sets, Security, and Unique Identifiers 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 hisor h4r official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to 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.
5. To a CMS contractor (including, but not necessarily limited to
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
6. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures This
system contains Protected Health Information as defines by HHS
regulation ``Standards for Privacy of Individually Identifiable Health
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (12-28-00),
Subparts A and E). Disclosures of Protected Health Information
authorized by these routine uses may only be made if, and as, permitted
or required by the ``Standards for Privacy of Individually Identifiable
Health Information.''
In addition, our policy will be to prohibit release even of not
directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the complaint
population is so small that individuals who are familiar with the
complainants could, because of
[[Page 38948]]
the small size, use this information to deduce the identity of the
complainant).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored electronically.
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 implements appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002; the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent NIST
publications; the DHHS Information Security 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, Office of E-Health Standards and Services, CMS, Room S2-
26-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
NOTIFICATION PROCEDURE:
Exempt. 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 ID number.
RECORD ACCESS PROCEDURE:
Same as notification procedures. Requestors should also specify the
record contents being sought.
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:
OESS investigative files maintained in HITS are either received as
electronic documents or paper records that are compiled for law
enforcement purposes. In the course of investigations, OESS 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 (law) enforcement in anticipation of a
criminal or administrative proceedings. (See Department Regulation (45
CFR 5b.11)).
[FR Doc. 05-13188 Filed 7-5-05; 8:45 am]
BILLING CODE 4120-03-P