[Federal Register: November 16, 2005 (Volume 70, Number 220)]
[Notices]
[Page 69569-69574]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no05-81]
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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), 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 propose to create a new system of records titled, ``Medicare
True Out-of-Pocket (TrOOP) Expenditures System,'' HHS/CMS/OIS, System
No. 09-70-0557. The TrOOP facilitation process is mandated by the
Medicare Prescription Drug Benefit Program enacted into law December 8,
2003 under provisions of Section 101 of Title 1 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173). MMA amends Title XVIII, Section 1860D of the Social
Security Act (the Act). Section 1860D-2 of the Act requires the
tracking of beneficiaries' TrOOP expenditures. TrOOP costs are treated
as ``incurred'' only if they were paid by the individual (or by another
person, such as a family member, on behalf of the individual), paid on
behalf of a low-income subsidy-eligible individual under the Sec.
1860D-14 provisions, or paid under a State Pharmaceutical Assistance
Program (SPAP) as defined in Sec. 1860D-23. Section 1860D-
2(b)(4)(D)(i) of the MMA authorizes CMS to establish procedures for
determining whether costs for Part D enrollees are being reimbursed by
excluded payers and alerting Part D plans about the existence of such
payers.
The purpose of this system is to collect and maintain a master file
to establish a ``TrOOP'' facilitation process, maintain information on
individuals and entities that make payments on covered drugs under the
Medicare Part D Program, and coordinate TrOOP relevant data from State
Pharmaceutical Programs (SPAPs) and other health insurers. Information
retrieved from this system may be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor, grantee, consultant or other legal agent; (2) support
Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through a CMS contractor for
the administration of Title XVIII of the Act; (3) assist another
Federal or state agency with information to enable such agency to
administer a Federal health benefits program, or to enable such agency
to fulfill a requirement of Federal statute or regulation that
implements a health benefits program funded in whole or in part with
Federal funds; (4) assist Quality Improvement Organization (QIO) in
connection with review of claims; (5) assist insurance companies and
other groups providing protection against medical expenses of their
enrollees; (6) assist an individual or organization engaged in the
performance activities of the demonstration or in a research project or
in support of an evaluation project related to the prevention of
disease or disability, the restoration or maintenance of health, or
payment related projects; (7) support constituent requests made to a
congressional representative; (8) support litigation involving the
agency; and (9) combat fraud and abuse in certain health benefits
programs. We have provided background information about the new system
in the SUPPLEMENTARY INFORMATION section below. Although the Privacy
Act requires only that CMS provide an opportunity for interested
persons to comment on the proposed routine uses, CMS invites comments
on all portions of this notice. See EFFECTIVE DATE section for comment
period.
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 11/07/2005. In any event, we will not disclose any information
under a routine use until 40 days after publication. 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, Room N2-04-27, 7500 Security Boulevard, Baltimore, Maryland
21244-1850. Comments received will be available for review at this
location by appointment during regular business hours, Monday through
Friday from 9 a.m.-3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT: Henry Chao, Manager, Immediate Office
of the Director, Office of Information Services, CMS, Room N3-19-23,
7500 Security Boulevard, Baltimore, Maryland 21244-1849, telephone
number (410) 786-7811, e-mail Henry.Chao@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: In order to calculate TrOOP, Medicare Part D
plans will have to determine if other entities have made payments on
covered drugs, and whether such payments fall under the legal
definition of incurred costs. If the payments by alternate payers, such
as retiree prescription drug coverage, do not count toward the TrOOP
threshold, then Part D plans must reduce the out-of-pocket amounts
accumulated in their claims processing systems. Alternatively, if the
payments by alternate payers, such as SPAPs, do count toward the TrOOP
threshold, then the Part D plan will maintain the level of beneficiary
out-of-pocket spending in their systems.
All Part D Plans will have to correctly calculate the TrOOP amount
in order to properly adjudicate beneficiary claims, as well as to
communicate to beneficiaries where they are in their benefits.
Beneficiaries will expect that pharmacies will have all the information
they need to determine their eligibility and to bill the appropriate
payers and that plans will
[[Page 69570]]
have accurate real-time TrOOP calculations on demand.
The process, along with coordination of benefits (COB) is
logistically complex because there may be multiple payers (e.g., SPAPs
or employer or union retiree plans, etc.). True COB, in which the order
of payment among multiple payers with responsibility for paying
prescription drug claims on behalf of an individual is established and
programmed into the systems of the alternate payers, does not take
place in pharmacy benefit management today. In the absence of
significant change, this would mean that Part D plans would have to
separately set up procedures to coordinate benefits with every other
payer with responsibility for drug coverage for one of their Part D
enrollees.
Importantly, this process will enable Part D Plans to track and
calculate a beneficiary's TrOOP expenditures in as near to real time as
possible, so that when a beneficiary calls, they can retrieve accurate
TrOOP information. In addition, the TrOOP level will be available on-
line to correctly process the beneficiary's next claim. This will mean
that beneficiaries will know when they have reached certain coverage
limits or when they can expect even greater financial relief in the
case of catastrophic coverage, and will have their claims processed
correctly without the need for bringing in receipts or submitting other
documentation from other coverage.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under Part D of
Title XVIII of the Social Security Act, as amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003.
B. Collection and Maintenance of Data in the System
This system will maintain individually identifiable information on
individuals and entities that make payments on covered drugs under the
Medicare Part D Program. The collected information will contain name,
address, health insurance claim number (HICN), gender type, and date of
birth.
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 TrOOP 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 TrOOP.
CMS has the following policies and procedures concerning
disclosures of information that will be maintained in the system.
Disclosure of information from the system will be approved only to the
extent necessary to accomplish the purpose of the disclosure and only
after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected; e.g., to collect and maintain
a master file to establish a ``TrOOP'' facilitation process, maintain
information on individuals and entities that make payments on covered
drugs under the Medicare Part D Program, and coordinate TrOOP relevant
data from SPAPs and other health insurers.
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. Entities Who May Receive Disclosures Under Routine Use
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the TrOOP facilitator without the consent of
the individual to whom such information pertains. Each proposed
disclosure of information under these routine uses will be evaluated to
ensure that the disclosure is legally permissible, including but not
limited to ensuring that the purpose of the disclosure is compatible
with the purpose for which the information was collected. We propose to
establish or modify the following routine use disclosures of
information maintained in the system:
1. To Agency contractors or consultants who have been contracted by
the Agency to assist in accomplishment of a CMS function relating to
the purposes for this SOR and who need to have access to the records in
order to assist CMS.
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 a CMS function
relating to purposes for this SOR.
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 Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through a CMS contractor for
the administration of Title XVIII of the Act.
PDPs and MAPDs require TrOOP information in order to establish the
validity of evidence or to verify the accuracy of information presented
by the individual, as it concerns the individual's entitlement to Part
D benefits under the Medicare Prescription Drug Benefit Program.
3. To another Federal or state agency, agency of a state
government, an agency
[[Page 69571]]
established by state law, or its fiscal agent pursuant to agreements
with CMS to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies in their administration of a
Federal health program may require TrOOP information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
The Internal Revenue Service may require TrOOP data for the
application of tax penalties against employers and employee
organizations that contribute to Employer Group Health Plan or Large
Group Health Plans that are not in compliance with 42 U.S.C. 1395y(b).
In addition, state agencies in their administration of a Federal
health program may require TrOOP information for the purposes of
determining, evaluating and/or assessing cost, effectiveness, and/or
the quality of health care services provided in the state.
Disclosure under this routine use shall be used by state Medicaid
agencies pursuant to agreements with the HHS for determining Medicaid
and Medicare eligibility, for quality control studies, for determining
eligibility of recipients of assistance under Titles IV, XVIII, and XIX
of the Act, and for the administration of the Medicaid program. Data
will be released to the state only on those individuals who are
patients under the services of a Medicaid program within the state or
who are residents of that state.
We also contemplate disclosing information under this routine use
in situations in which state auditing agencies require TrOOP
information for auditing state Medicaid eligibility considerations. CMS
may enter into an agreement with state auditing agencies to assist in
accomplishing functions relating to purposes for this SOR.
4. To Quality Improvement Organization (QIO) in connection with
review of claims, or in connection with studies or other review
activities conducted pursuant to Part D of Title XVIII of the Act and
in performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
Prescription Drug Program benefits or other drug plan benefits.
QIOs will work to implement quality improvement programs, provide
consultation to CMS, its contractors, and to state agencies. QIOs will
assist the state agencies in related monitoring and enforcement
efforts, assist CMS and intermediaries in program integrity assessment,
and prepare summary information for release to CMS.
5. To insurance companies, underwriters, third party administrators
(TPA), employers, self-insurers, group health plans, health maintenance
organizations (HMO), health and welfare benefit funds, managed care
organizations, other supplemental insurers, non-coordinating insurers,
multiple employer trusts, other groups providing protection against
medical expenses of their enrollees without the beneficiary's
authorization, and any entity having knowledge of the occurrence of any
event affecting: (a) An individual's right to any such benefit or
payment, or (b) the initial right to any such benefit or payment, for
the purpose of coordination of benefits with the Medicare program and
implementation of the Medicare Secondary Payer (MSP) provision at 42
U.S.C. 1395y(b). Information to be disclosed shall be limited to
Medicare utilization data necessary to perform that specific function.
In order to receive the information, they must agree to:
a. Certify that the individual about whom the information is being
provided is one of its insured or employees, or is insured and/or
employed by another entity for whom they serve as a TPA;
b. Utilize the information solely for the purpose of processing the
individual's insurance claims; and
c. Safeguard the confidentiality of the data and prevent
unauthorized access.
Other insurers may require TrOOP information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
6. To an individual or organization for research, evaluation, or
epidemiological projects related to the prevention of disease or
disability, and the restoration or maintenance of health, or payment
related projects.
TrOOP data will provide for research, evaluations and
epidemiological projects, a broader, longitudinal, national perspective
of the status of Medicare beneficiaries. CMS anticipates that many
researchers will have legitimate requests to use these data in projects
that could ultimately improve the care provided to Medicare
beneficiaries and the policy that governs the care.
7. To a Member of Congress or 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 often 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.
8. 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, or occasionally when
another party is involved in litigation and CMS's 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.
9. To a CMS contractor (including, but not limited to fiscal
intermediaries and carriers) that assists in the administration of a
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contract 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 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.
[[Page 69572]]
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.
10. 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 TrOOP information for the purpose of
combating fraud and abuse in such Federally-funded programs.
B. Additional Circumstances Affecting Routine Use Disclosures
This system contains Protected Health Information 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 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 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
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 National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effect of the Proposed System 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. We will only
disclose the minimum personal data necessary to achieve the purpose of
TrOOP. Disclosure of information from the system will be approved only
to the extent necessary to accomplish the purpose of the disclosure.
CMS has assigned a higher level of security clearance for the
information maintained in this system in an effort to provide added
security and protection of data in this system.
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. CMS will collect only
that information necessary to perform the system's functions. In
addition, CMS will make disclosure from the proposed system only with
consent of the subject individual, or his/her legal representative, or
in accordance with an applicable exception provision of the Privacy
Act.
CMS, therefore, does not anticipate an unfavorable effect on
individual privacy as a result of the disclosure of information
relating to individuals.
Dated: October 27, 2005.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0557
System Name:
``True Out-of-Pocket (TrOOP) Expenditures System,'' HHS/CMS/OIS.
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850 and at various co-locations of
CMS contractors.
Categories of Individuals Covered by the System:
This system will maintain individually identifiable information on
individuals and entities that make payments on covered drugs under the
Medicare Part D Program.
Categories of Records in the System:
The collected information will contain name, address, telephone
number, health insurance claim number (HICN), gender type, and date of
birth.
Authority for Maintenance of the System:
The statutory authority for this system is given under Part D of
Title XVIII of the Social Security Act, as amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003.
Purpose(s) of the System:
The purpose of this system is to collect and maintain a master file
to establish a ``TrOOP'' facilitation process, maintain information on
individuals and entities that make payments on covered drugs under the
Medicare Part D Program, and coordinate TrOOP relevant data from State
Pharmaceutical Programs (SPAPs) and other health insurers. Information
retrieved from this system may be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor, grantee, consultant or other legal agent; (2) support
Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through a CMS contractor for
the administration of Title XVIII of the Act; (3) assist another
Federal or state agency with information to enable such agency to
administer a Federal health benefits program, or to enable such agency
to fulfill a requirement of Federal statute or regulation that
implements a health
[[Page 69573]]
benefits program funded in whole or in part with Federal funds; (4)
assist Quality Improvement Organization (QIO) in connection with review
of claims; (5) assist insurance companies and other groups providing
protection against medical expenses of their enrollees; (6) assist an
individual or organization engaged in the performance activities of the
demonstration or in a research project or in support of an evaluation
project related to the prevention of disease or disability, the
restoration or maintenance of health, or payment related projects; (7)
support constituent requests made to a congressional representative;
(8) support litigation involving the agency; and (9) 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:
C. Entities Who May Receive Disclosures Under Routine Use
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the TrOOP facilitator without the consent of
the individual to whom such information pertains. Each proposed
disclosure of information under these routine uses will be evaluated to
ensure that the disclosure is legally permissible, including but not
limited to ensuring that the purpose of the disclosure is compatible
with the purpose for which the information was collected. We propose to
establish or modify the following routine use disclosures of
information maintained in the system:
To Agency contractors or consultants who have been contracted by
the Agency to assist in accomplishment of a CMS function relating to
the purposes for this SOR and who need to have access to the records in
order to assist CMS.
1. To Medicare Prescription Drug Plans (PDP) and Medicare Advantage
Prescription Drug Plans (MAPD) directly or through the Enterprise
Business Services, a CMS intermediary for the administration of Title
XVIII of the Act.
2. To another Federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent
pursuant to agreements with CMS to:
d. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
e. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds; and/or
f. Assist Federal/state Medicaid programs within the state.
3. To Quality Improvement Organization (QIO) in connection with
review of claims, or in connection with studies or other review
activities conducted pursuant to Part D of Title XVIII of the Act and
in performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
Prescription Drug Program benefits or other drug plan benefits.
4. To insurance companies, underwriters, third party administrators
(TPA), employers, self-insurers, group health plans, health maintenance
organizations (HMO), health and welfare benefit funds, managed care
organizations, other supplemental insurers, non-coordinating insurers,
multiple employer trusts, other groups providing protection against
medical expenses of their enrollees without the beneficiary's
authorization, and any entity having knowledge of the occurrence of any
event affecting: (a) An individual's right to any such benefit or
payment, or (b) the initial right to any such benefit or payment, for
the purpose of coordination of benefits with the Medicare program and
implementation of the Medicare Secondary Payer (MSP) provision at 42
U.S.C. 1395y (b). Information to be disclosed shall be limited to
Medicare utilization data necessary to perform that specific function.
In order to receive the information, they must agree to:
b. Certify that the individual about whom the information is being
provided is one of its insured or employees, or is insured and/or
employed by another entity for whom they serve as a TPA;
c. Utilize the information solely for the purpose of processing the
individual's insurance claims; and
d. Safeguard the confidentiality of the data and prevent
unauthorized access.
5. To an individual or organization for research, evaluation, or
epidemiological projects related to the prevention of disease or
disability, and the restoration or maintenance of health, or payment
related projects.
6. To a Member of Congress or 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.
7. To the Department of Justice (DOJ), court, or adjudicatory body
when:
d. The Agency or any component thereof, or
e. Any employee of the Agency in his or her official capacity, or
f. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
g. 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.
8. To a CMS contractor (including, but not limited to fiscal
intermediaries and carriers) that assists in the administration of a
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
9. 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.
D. Additional Circumstances Affecting Routine Use Disclosures
This system contains Protected Health Information 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 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 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
[[Page 69574]]
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
All records are stored electronically. Some input may be generated
in hardcopy, such as eligibility, enrollment, or other health insurance
information before transcription to electronic media.
Retrievability:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HIC number.
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 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 information for a total period not to exceed 25
years. Data residing with the TrOOP facilitation contractor site agent
shall be returned to CMS at the end of the contract period, with all
data then being the responsibility of CMS for adequate storage and
security.
System Manager and Address:
Henry Chao, Manager, Immediate Office of the Director, Office of
Information Services, CMS, Room N3-19-23, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
Notification Procedure:
For the purpose of access, the subject individual should write to
the system manager who will require the system name, address, age,
gender type, and, for verification purposes, the subject individual's
name (woman's maiden name, if applicable).
Record Access Procedure:
For the 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, parts 160, 162, and 164.)
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).
Systems Exempted From Certain Provisions of the Act:
None.
[FR Doc. 05-22657 Filed 11-15-05; 8:45 am]
BILLING CODE 4120-03-P