[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Notices]
[Pages 64530-64535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of 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.

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, CMS is proposing to establish a new system of records (SOR) 
titled ``One Program Integrity Data Repository (ODR),'' System No. 09-
70-0568. Section 1893 of the Social Security Act (the Act) established 
the ``Medicare Integrity Program'' that requires CMS to contract with 
eligible entities to ``review activities of providers of services or 
other individuals and entities furnishing items and services for which 
payment may be made under this title'' by utilizing equipment and 
software technologies. Likewise, section 1893 of the Act requires CMS 
to establish the Medicare Medicaid Data Match Program (Medi-Medi) in 
which data from both the Medicare and Medicaid programs are analyzed 
together to better detect fraud, waste, and abuse existent in these 
programs. In order to comply with these requirements and enhance our 
ability to detect fraud, waste, and abuse in Medicare and Medicaid, CMS 
is proposing to construct the ODR.
    CMS maintains numerous systems housing Medicare beneficiary Parts 
A, B, C, and D entitlement, enrollment, and utilization information. 
Additionally, CMS maintains data on physicians, providers, employer 
plans, Medicaid recipients and Medicare secondary payers. There are a 
large number of data sources, extraction tools, and access mechanisms. 
Users of the data often experience inconsistent, untimely, or 
duplicated information. The ODR will be an enterprise resource that 
will provide an integrated view of the data to all of CMS and its 
partners providing a single authoritative source of information and 
providing quality and timely data.
    The ODR will provide an organized structure for reaching the data 
through a consistent application of access policies, processes and 
procedures, common services, governance, and framework. The ODR will 
integrate and load data from various CMS systems consisting of Medicare 
Parts A, B, C, and D, Medicaid and Retiree Drug Subsidy entitlement, 
enrollment and utilization data. The ODR will also contain demographic 
information on Medicaid beneficiaries, Medicare providers and 
physicians, and employer plans that are receiving a subsidy from CMS 
for providing creditable drug coverage to their retirees. It is through 
the integration of this Medicare data with other data; e.g., historic 
data, Part A and Part B data, and Medicaid data sets provided by state 
agencies that CMS fraud, waste, and abuse, quality improvement, 
research, and other analytic activities are maximized.
    The data collected and maintained in this system are retrieved from 
the following databases: Medicare Drug Data Processing System, System 
No. 09-70-0553 (70 FR 58436 (October 6, 2005)); Medicare Beneficiary 
Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); 
Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 
FR 60530 (October 18, 2005)); Medicaid Statistical Information System, 
System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug 
Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); 
Common Working File, System No. 09-70-0526 (67 FR 3210 (January 23, 
2002)); National Claims History,

[[Page 64531]]

System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment 
Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); 
Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 
(August 22, 2002)); Intermediary Medicare Claims Record, System No. 09-
70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider 
Identification Number, System No. 09-70-0525, (69 FR 75316 (December 
16, 2004)); Medicare Supplier Identification File, System No. 09-70-
0530 (67 FR 48184 (July 23, 2002)); and the Medicaid data sets provided 
by participating state agencies.
    The primary purpose of this system is to establish an enterprise 
resource that will provide a single source of information for all CMS 
fraud, waste, and abuse activities. Information retrieved from this 
system of records will also be disclosed to: (1) Support regulatory, 
reimbursement, and policy functions performed within the agency or by a 
contractor, consultant or grantee; (2) assist another Federal or State 
agency, agency of a state government, an agency established by state 
law, or its fiscal agent; (3) support Quality Improvement Organizations 
(QIO); (4) assist other insurers for processing individual insurance 
claims; (5) facilitate research on the quality and effectiveness of 
care provided, as well as payment related projects; (6) support 
litigation involving the agency; and (7) combat fraud, waste, 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 routine uses, 
CMS invites comments on all portions of this notice. See Effective Date 
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 Homeland Security & Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on October 27, 2006. To ensure that all 
parties have adequate time in which to comment, the new system will 
become effective 30 days from the publication of the notice, or 40 days 
from the date it was submitted to OMB and the congress, whichever is 
later. We may defer implementation of this system or one or more of the 
routine use statements listed below if we receive comments that 
persuade us to defer implementation.

ADDRESSES: The public should address comments to the CMS Privacy 
Officer, Division of Privacy Compliance, Enterprise Architecture and 
Strategy Group, Office of Information Services, 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: Christa Robertson, Division of 
Analysis and Evaluation, Program Integrity Group, Office of Financial 
Management, CMS, Room N3-07-04, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850. She can be reached by telephone at 410-786-6965 or 
via e-mail at [email protected].

SUPPLEMENTARY INFORMATION: The ODR will work in conjunction with the 
Integrated Data Repository system of records to support the One Program 
Integrity (PI) Group. While the IDR will initially focus on fee-for-
service and some prescription drug data, the ODR will initially focus 
on supplementary data to support the new Medicare Prescription Drug 
program along with Medicaid data to support the Medi-Medi contractors. 
CMS has contracted with Medicare Drug Integrity Contractors (MEDICs). 
The MEDICs are required to perform a myriad of functions including: 
fraud, waste, and abuse detection; coordination with law enforcement; 
data analysis to identify fraud, waste, and abuse; fraud, waste, and 
abuse audits; other audits as required; anti-fraud Part D education and 
outreach; and the development of a Part D error rate. Due to the 
complexity of Part D data, to perform the above-mentioned functions, it 
is imperative that MEDICs have access to a wide variety of CMS data, 
including Parts A, B, C, D and Medicaid data.
    The Office of Financial Management, Program Integrity Group serves 
as the point of contact for program integrity issues related to 
Medicare benefits. Major Program Integrity Group program initiatives 
include the Program Safeguard Contractor Program, Medical Review, 
Provider and Supplier Enrollment, MMA Integrity, and cross cutting 
issues between Medicare and Medicaid including the `Medi-Medi' program. 
As part of its program integrity work, the Program Integrity Group 
works closely with law enforcement (e.g., Federal Bureau of 
Investigation, Department of Justice, Office of Inspector General). For 
example, the Program Integrity Group, and its contractors, refer 
potential fraud cases and fulfill law enforcement's requests for data. 
All of these functions can be better served through a comprehensive set 
of common data structures and modern tools that encourage collaboration 
and innovation.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for System

    Authority for maintenance of this system is given under section 
1893 of the Social Security Act.

B. Collection and Maintenance of Data in the System

    This system will maintain information on Medicare beneficiaries 
Parts A, B, C, and D and physicians, providers, employer plans, 
Medicaid recipients and Medicare secondary payers.
    Information maintained in the system include, but are not limited 
to: standard data for identification such as health insurance claim 
number, social security number, gender, race/ethnicity, date of birth, 
geographic location, Medicare enrollment, entitlement, and utilization 
information, Medicaid enrollment, entitlement, and utilization 
information, MSP data necessary for appropriate Medicare claim payment, 
hospice election, MA plan elections and enrollment, End Stage Renal 
Disease (ESRD) entitlement, historic and current listing of residences, 
and Medicare eligibility and Managed Care institutional status.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

    A. 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 ODR 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 disclose the minimum personal data necessary to 
achieve the purpose of ODR. CMS has the following policies and 
procedures concerning disclosures of information that will be 
maintained in the system. In general, disclosure of information from 
the

[[Page 64532]]

system will be approved only for the minimum information 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 establish an 
enterprise resource that will provide a single source of information 
for all CMS fraud, waste, and abuse activities.
    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 individually-
identifiable information; and
    c. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees who have been 
engaged by the agency to assist in the performance of a service related 
to this system and who need to have access to the records in order to 
perform the activity.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing CMS function 
relating to purposes for this system. CMS occasionally contracts out 
certain of its functions when doing so would contribute to effective 
and efficient operations. CMS must be able to give a contractor, 
consultant or grantee whatever information is necessary for the 
contractors, consultants or grantees to fulfill its duties. In these 
situations, safeguards are provided in the contract prohibiting the 
contractor, consultant or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requires the contractor, consultant or grantee to return or destroy 
all information at the completion of the contract.
    2. To another Federal or State agency, agency of a State 
government, an agency established by State law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' proper payment of Medicare 
and Medicaid 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 ODR information in order to support 
evaluations and monitoring of Medicare and Medicaid claims information 
of beneficiaries, including proper reimbursement for services provided. 
In addition, other state agencies in their administration of a Federal 
health program may require ODR information for the purpose 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 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 who 
are residents of that State.
    3. To Quality Improvement Organizations (QIO) in connection with 
review of claims, or in connection with studies or other review 
activities conducted pursuant to Part B of Title XI of the Act, and in 
performing affirmative outreach activities to individuals for the 
purpose of establishing and maintaining their entitlement to Medicare 
benefits or health insurance plans.
    As established by the Part D Program, QIOs will conduct reviews of 
prescription drug events data, or in connection with studies or other 
review activities conducted pursuant to Part D of Title XVIII of the 
Act.
    QIOs will work to implement quality improvement programs, provide 
consultation to CMS, MA-PD, PDPs, and state agencies, to assist CMS in 
prescription drug event assessments, and prepare summary information 
for release to CMS.
    QIOs will work to implement quality improvement programs, provide 
consultation to CMS, its contractors, and to State agencies. QIOs will 
assist State agencies in related monitoring and enforcement efforts, 
assist CMS and intermediaries in program integrity assessment, and 
prepare summary information for release to CMS.
    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:
    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, HMO, and Health Care Prepayment Plans may require 
ODR information in order to support evaluations and monitoring of 
Medicare claims information of beneficiaries, including proper 
reimbursement for services provided.

[[Page 64533]]

    CMS, using its coordination of benefits contractor, allows this to 
happen by having payers that will be secondary to part D submit their 
enrollment data in exchange for enrollment data. The data shared is 
mainly enrollment information (date of enrollment).
    5. To an individual or organization for 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.
    The ODR data will provide for research or in support of evaluation 
projects, a broader, longitudinal, national perspective of the status 
of Medicare and Medicaid beneficiaries. CMS anticipates that many 
researchers will have legitimate requests to use this data in projects 
that could ultimately improve the care provided to Medicare and 
Medicaid beneficiaries and the policy that governs the care.
    6. 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.
    7. 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, waste, 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, waste, 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.
    8. 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, 
waste, 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, waste, or abuse in such programs.
    Other agencies may require ODR information for the purpose of 
combating fraud, waste, and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise authorized by these routine uses may only be made 
if, and as, permitted or required by the ``Standards for Privacy of 
Individually Identifiable Health Information.'' (See 45 CFR 164-
512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals 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 may apply but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

V. Effects of the System of Records on Individual Rights

    CMS proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will take precautionary measures to minimize the risks of 
unauthorized access to the records and the potential harm to individual 
privacy or other personal or property rights of patients whose data are 
maintained in the system. CMS will collect only that information 
necessary to perform the system's functions. In addition, CMS will make 
disclosure from the proposed system only with consent of the subject 
individual, or his/her legal

[[Page 64534]]

representative, or in accordance with an applicable exception provision 
of the Privacy Act. CMS, therefore, does not anticipate an unfavorable 
effect on individual privacy as a result of information relating to 
individuals.

    Dated: October 24, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
System No. 09-70-0568

SYSTEM NAME:
    ``One Program Integrity Data Repository (ODR), HHS/CMS/OFM''.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    The Centers for Medicare & Medicaid Services (CMS) Data Center, 
7500 Security Boulevard, North Building, First Floor, Baltimore, 
Maryland 21244-1850.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    This system will maintain information on Medicare beneficiaries 
Parts A, B, C, and D and physicians, providers, employer plans, 
Medicaid recipients and Medicare secondary payers.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Information maintained in the system include, but are not limited 
to: Standard data for identification such as health insurance claim 
number, social security number, gender, race/ethnicity, date of birth, 
geographic location, Medicare enrollment, entitlement, and utilization 
information, Medicaid enrollment, entitlement, and utilization 
information, MSP data necessary for appropriate Medicare claim payment, 
hospice election, MA plan elections and enrollment, End Stage Renal 
Disease (ESRD) entitlement, historic and current listing of residences, 
and Medicare eligibility and Managed Care institutional status.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of this system is given under section 
1893 of the Social Security Act.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this system is to establish an enterprise 
resource that will provide a single source of information for all CMS 
fraud and abuse activities. Information retrieved from this system of 
records will also be disclosed to: (1) Support regulatory, 
reimbursement, and policy functions performed within the agency or by a 
contractor, consultant or grantee; (2) assist another Federal or State 
agency, agency of a State government, an agency established by State 
law, or its fiscal agent; (3) support Quality Improvement Organizations 
(QIO); (4) assist other insurers for processing individual insurance 
claims; (5) facilitate research on the quality and effectiveness of 
care provided, as well as payment related projects; (6) support 
litigation involving the agency; and (7) combat fraud, waste, 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:
    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees who have been 
engaged by the agency to assist in the performance of a service related 
to this system and who need to have access to the records in order to 
perform the activity.
    2. To another Federal or State agency, agency of a State 
government, an agency established by State law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' proper payment of Medicare 
and Medicaid 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.
    3. To Quality Improvement Organizations (QIO) in connection with 
review of claims, or in connection with studies or other review 
activities conducted pursuant to Part B of Title XI of the Act, and in 
performing affirmative outreach activities to individuals for the 
purpose of establishing and maintaining their entitlement to Medicare 
benefits or health insurance plans.
    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:
    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.
    5. To an individual or organization for 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.
    6. 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.
    7. 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,

[[Page 64535]]

remedy, or otherwise combat fraud, waste, or abuse in such program.
    8. 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, 
waste, 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, waste, or abuse in such programs.
    B. Additional Provisions Affecting Routine Use Disclosures
    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI 
that are otherwise authorized by these routine uses may only be made 
if, and as, permitted or required by the ``Standards for Privacy of 
Individually Identifiable Health Information.'' (See 45 CFR 164-
512(a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals 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.

RETRIEVABILITY:
    All records are accessible by HICN, SSN, and unique provider 
identification 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 may apply but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    Records will be retained until an approved disposition authority is 
obtained from the National Archives and Records Administration. All 
claims-related records are encompassed by the document preservation 
order and will be retained until notification is received from DOJ.

SYSTEM MANAGER AND ADDRESS:
    Director, Division of MMA Integrity, Program Integrity Group, 
Office of Financial Management, CMS, Mailstop: C3-02-16, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual should write to the 
system manager who will require the system name, HICN, address, date of 
birth, and gender, and for verification purposes, the subject 
individual's name (woman's maiden name, if applicable), and SSN. 
Furnishing the SSN is voluntary, but it may make searching for a record 
easier and prevent delay.

RECORD ACCESS PROCEDURE:
    For purpose of access, use the same procedures outlined in 
Notification Procedures above. Requestors should also specify the 
record contents being sought. (These procedures are in accordance with 
department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above, and reasonably identify the records and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These Procedures are in 
accordance with Department regulation 45 CFR 5b.7).

RECORDS SOURCE CATEGORIES:
    The data contained in this system of records are extracted from 
other CMS systems of records: Medicare Drug Data Processing System; 
Medicare Beneficiary Database; Medicare Advantage Prescription Drug 
System; State Medicaid Records; Medicaid Statistical Information 
System; Retiree Drug Subsidy Program; Common Working File; National 
Claims History; Enrollment Database; Carrier Medicare Claims Record; 
Intermediary Medicare Claims Record; Unique Physician/Provider 
Identification Number; Provider Enrollment Chain & Ownership System 
(PECOS); and Medicare Supplier Identification File. Information will 
also be provided from the participating state Medicaid agencies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

 [FR Doc. E6-18454 Filed 11-1-06; 8:45 am]
BILLING CODE 4120-03-P