[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Notices]
[Pages 69569-69574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22657]


-----------------------------------------------------------------------

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).

-----------------------------------------------------------------------

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 [email protected].

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