[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74915-74923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21123]


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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 ``Medicare Integrated Data Repository (IDR),'' System No. 09-70-
0571. In December 2003, Congress passed the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), 
that amends Title XVIII of the Social Security Act (the Act) by adding 
Part D, the voluntary prescription drug benefit program.
    The IDR 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 IDR will 
integrate and load data from various CMS systems consisting of Medicare 
Parts A, B, C, and D entitlement, enrollment and utilization data. It 
is proposed that the IDR 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 
data with other data (e.g., historic data, Part A and Part B data) that 
the IDR will have value for quality improvement, research on outcomes 
and effectiveness of drugs, post-market surveillance, and other 
analytic efforts.
    The primary purpose of this system is to establish an enterprise 
resource that will provide one integrated view of all CMS data to 
administer the Medicare and Medicaid programs. 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 CMS 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 
providers and suppliers of services for administration of Title XVIII; 
(4) assist third parties where the contact is expected to have 
information relating to the individual's capacity to manage his

[[Page 74916]]

or her own affairs; (5) assist Medicare Advantage Plans and Part D 
Prescription Drug Plans; (6) support Quality Improvement Organizations 
(QIO); (7) assist other insurers for processing individual insurance 
claims; (8) facilitate research on the quality and effectiveness of 
care provided, as well as payment related projects; (9) support 
litigation involving the agency; and (10) 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 
Dates section for comment period.

DATES: Effective Date: CMS filed a new SOR report with the Chair of the 
House Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Homeland Security & Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on 11/28/2006. 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, CMS, Mailstop 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:
    Robyn Thomas, Director, Division of Business Analysis & Operations, 
Enterprise Databases Group, Office of Information Services, CMS, Room 
N1-14-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The 
telephone number is 410-786-6063 or contact [email protected].

SUPPLEMENTARY INFORMATION:
    In December 2003, Congress passed the Medicare Prescription Drug, 
Improvement, and Modernization Act, amending the Act by adding Part D 
under Title XVIII. Under the new Medicare benefit, prescription drug 
coverage is available to everyone with Medicare, regardless of income 
or health status. 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. Implementation of provisions of the MMA requires that 
CMS develop and maintain databases and systems to manage the enrollment 
of individuals in the drug benefit or subsidy assistance programs, pay 
prescription drug plans, evaluate the quality of the new prescription 
drug benefit, support drug research, provide better access to data, and 
provide opportunities for other government and research organizations 
to improve healthcare for the public.
    In order to more efficiently and effectively carry out the 
requirements of CMS's various program areas, data must be available to 
meet regulatory requirements and support research. Better access to 
data from all CMS healthcare programs will provide opportunities for 
other government and research organizations to use this same source 
data in their efforts to improve healthcare for the public. 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 IDR will be an enterprise resource that 
will provide one 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. Additionally, the IDR will contain 
protections that will maintain the privacy of beneficiaries and 
providers. Data will most frequently be retrieved by health insurance 
claim account number, provider or physician identification number, 
State of residence, or date of service. Such protections will consist 
of, but are not limited to, identity management, authentication, 
encrypted identifiers, governance roles, and personally identifiable 
and non-personally identifiable data stores.
    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 (71 FR 11425 (March 7, 2006)); Medicare 
Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 
(October 18, 2005)); Medicaid Statistical Information System, System 
No. 09-70-0541 (71 FR 65527 (November 8, 2006)); Retiree Drug Subsidy 
Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common 
Working File, System No. 09-70-0526 (71 FR 64955 (November 6, 2006)); 
National Claims History, System No. 09-70-0005 (67 FR 57015 (September 
6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 
(January 23, 2002)); Multi-Carrier Claims System (formerly known as the 
Carrier Medicare Claims Record), System No. 09-70-0501 (71 FR 64968 
(November 6, 2006)); Fiscal Intermediary Shared System (formerly known 
as the Intermediary Medicare Claims Record), System No. 09-70-0503 (71 
FR 64961 (November 6, 2006)); 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 (71 FR 
65527 (November 8, 2006).

I. Description of the Proposed System of Records

 A. Statutory and Regulatory Basis for System

    Authority for the collection of data maintained in this system is 
given under section 226, 226A, 1811, 1818, 1818A, 1831, 1833(a)(1)(A), 
1836, 1837, 1838, 1843, 1866, 1874a, 1875, 1876, 1881, and 1902(a)(6) 
of the Social Security Act (the Act). The following are the 
corresponding sections from Title 42 of the United States Code 
(U.S.C.): 426, 426-1, 1395c, 1395i-2, 1395i-2a, 1395j, 1395l(a)(1)(A), 
1395o, 1395p, 1395q, 1395v, 1395cc, 1395kk-l, 1395ll, 1395mm, 1395rr, 
1396a(a)(6), and section 101 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), 
which established the Medicare Part D program.

 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 and entitlement information, 
MSP data necessary for appropriate Medicare claim payment, hospice 
election, MA plan elections and enrollment, End Stage Renal Disease

[[Page 74917]]

(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 IDR 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 IDR. 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 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 assist in a variety 
of health care initiatives with other entities related to the 
evaluation and study of the operation and effectiveness of the Medicare 
program.
    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 support 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 functions 
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 assist 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 
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 IDR 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 IDR data for the 
application of tax penalties against employers and employee 
organizations that contribute to Employer Group Health Plans or Large 
Group Health Plans that are not in compliance with 42 U.S.C. 1395y(b).
    In addition, other state agencies in their administration of a 
Federal health program may require IDR information for the purpose of 
determining, evaluating and/or assessing cost effectiveness, and/or the 
quality of health care services provided in the state.
    The Railroad Retirement Board requires IDR information to 
administer provisions of the Railroad Retirement Act and Social 
Security Act relating to railroad employment and/or the administration 
of the Medicare program.
    The Social Security Administration requires IDR data to enable them 
to assist in the implementation and maintenance of the Medicare 
program.
    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 support providers and suppliers of services directly or 
through fiscal intermediaries or carriers for the administration of 
Title XVIII of the Act.
    Providers and suppliers of services require IDR 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 benefits under the Medicare program, 
including proper reimbursement for services provided.
    4. To assist third party contact in situations where the party to 
be contacted has, or is expected to have information relating to the 
individual's capacity to manage his or her affairs or to his or her 
eligibility for, or an entitlement to, benefits under the Medicare 
program and;
    a. The individual is unable to provide the information being sought 
(an individual is considered to be unable to provide certain types of 
information when any of the following conditions exists: The individual 
is confined to a

[[Page 74918]]

mental institution, a court of competent jurisdiction has appointed a 
guardian to manage the affairs of that individual, a court of competent 
jurisdiction has declared the individual to be mentally incompetent, or 
the individual's attending physician has certified that the individual 
is not sufficiently mentally competent to manage his or her own affairs 
or to provide the information being sought, the individual cannot read 
or write, cannot afford the cost of obtaining the information, a 
language barrier exist, or the custodian of the information will not, 
as a matter of policy, provide it to the individual), or
    b. The data are needed to establish the validity of evidence or to 
verify the accuracy of information presented by the individual, and it 
concerns one or more of the following: The individual's entitlement to 
benefits under the Medicare program, the amount of reimbursement, and 
in cases in which the evidence is being reviewed as a result of 
suspected fraud, waste, and abuse, program integrity, quality 
appraisal, or evaluation and measurement of activities.
    Third parties contacts require IDR information in order to provide 
support for the individual's entitlement to benefits under the Medicare 
program; to establish the validity of evidence or to verify the 
accuracy of information presented by the individual, and assist in the 
monitoring of Medicare claims information of beneficiaries, including 
proper reimbursement of services provided.
    5. To assist Medicare Advantage Plans, Part D Prescription Drug 
Plans and their Prescription Drug Event submitters, providing 
protection against medical expenses of their enrollees without the 
beneficiary's authorization, and 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 provision at 42 U.S.C. 
1395y (b).
    Information to be disclosed shall be limited to Medicare 
entitlement, enrollment and 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 Third Party 
Administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's enrollment or insurance claim; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    Other insurers may require IDR information in order to support 
evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper reimbursement for services provided.
    6. To support 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.
    7. To assist other insurers, underwriters, third party 
administrators (TPAs), self-insurers, group health plans, employers, 
health maintenance organizations, health and welfare benefit funds, 
Federal agencies, a state or local government or political subdivision 
of either (when the organization has assumed the role of an insurer, 
underwriter, or third party administrator, or in the case of a state 
that assumes the liabilities of an insolvent insurers pool or fund), 
multiple-employers trusts, no-fault medical, automobile insurers, 
workers' compensation carriers plans, liability insurers, and other 
groups providing protection against medical expenses who are primary 
payers to Medicare in accordance with 42 U.S.C. 1395y(b), or 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 or continued right to any such benefit or payment 
(for example, a State Medicaid Agency, State Workers' Compensation 
Board, or Department of Motor Vehicles) for the purpose of coordination 
of benefits with the Medicare program and implementation of the MSP 
provisions at 42 U.S.C. 1395y(b). The information CMS may disclose will 
be:
     Beneficiary Name
     Beneficiary Address
     Beneficiary Health Insurance Claim Number
     Beneficiary Social Security Number
     Beneficiary Gender
     Beneficiary Date of Birth
     Amount of Medicare Conditional Payment
     Provider Name and Number
     Physician Name and Number
     Supplier Name and Number
     Dates of Service
     Nature of Service
     Diagnosis
    To administer the MSP provision at 42 U.S.C. 1395y(b)(2), (3), and 
(4) more effectively, CMS would receive (to the extent that it is 
available) and may disclose the following types of information from 
insurers, underwriters, third party administrator, self-insurers, etc.:
     Subscriber Name and Address
     Subscriber Date of Birth
     Subscriber Social Security number
     Dependent Name
     Dependent Date of Birth
     Dependent Social Security Number
     Dependent Relationship to Subscriber
     Insurer/Underwriter/TPA Name and Address
     Insurer/Underwriter/TPA Group Number
     Insurer/Underwriter/Group Name
     Prescription Drug Coverage
     Policy Number
     Effective Date of Coverage
     Employer Name, Employer Identification Number (EIN) and 
Address
     Employment Status
     Amounts of Payment
    To administer the MSP provision at 42 U.S.C. 1395y(b)(1) more 
effectively for entities such as Workers' Compensation carriers or 
boards, liability insurers, no-fault and automobile medical policies or 
plans, CMS would receive (to the extent that it is available) and may 
disclose the following information:
     Beneficiary's Name and Address
     Beneficiary's Date of Birth
     Beneficiary's Social Security number
     Name of Insured
     Insurer Name and Address

[[Page 74919]]

     Type of coverage; automobile medical, no-fault, liability 
payment, or workers' compensation settlement
     Insured's Policy Number
     Effective Date of Coverage
     Date of accident, injury or illness
     Amount of payment under liability, no-fault, or automobile 
medical policies, plans, and workers' compensation settlements
     Employer Name and Address (Workers' Compensation Only)
     Name of insured could be the driver of the car, a 
business, the beneficiary (i.e., the name of the individual or entity 
which carries the insurance policy or plan)
    In order to receive this information the entity must agree to the 
following conditions;
    a. To utilize the information solely for the purpose of 
coordination of benefits with the Medicare program and other third 
party payer in accordance with Title 42 U.S.C. 1395y(b);
    b. To safeguard the confidentiality of the data and to prevent 
unauthorized access to it; and,
    c. To prohibit the use of beneficiary-specific data for the 
purposes other than for the coordination of benefits among third party 
payers and the Medicare program. This agreement would allow the 
entities to use the information to determine cases where they or other 
third party payers have primary responsibility for payment. Examples of 
prohibited uses would include but are not limited to: Creation of a 
mailing list, sale or transfer of data.
    To administer the MSP provisions more effectively, CMS may receive 
or disclose the following types of information from or to entities 
including insurers, underwriters, TPAs, and self-insured plans, 
concerning potentially affected individuals:
     Subscriber HICN
     Dependent Name
     Funding arrangements of employer group health plans, for 
example, contributory or non-contributory plan, self-insured, re-
insured, HMO, TPA insurance
     Claims payment information, for example, the amount paid, 
the date of payment, the name of the insurers or payer
     Dates of employment including termination date, if 
appropriate
     Number of full and/or part-time employees in the current 
and preceding calendar years
     Employment status of subscriber, for example, full or part 
time or self-employed
    Other insurers, HMO, and Health Care Prepayment Plans may require 
IDR information in order to support evaluations and monitoring of 
Medicare claims information of beneficiaries, including proper 
reimbursement for services provided.
    1860D-23 and 1860D-24 of the Act require that the Secretary 
establish requirements for prescription drug plans (Part D plans) to 
ensure the effective coordination between a Part D plan and a State 
Pharmaceutical Assistance Program (SPAP), as well as other payers of 
prescription drug benefits, including enrollment file sharing. 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 Part D enrollment data. The data shared is mainly 
enrollment information (date of enrollment into Part D, what Part D 
plan they are enrolled with). SPAPs, but not other payers, will also 
receive data indicating whether the beneficiary qualifies for a low-
income subsidy to pay for drug costs.
    8. To assist 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 IDR data will provide for research or in support of evaluation 
projects, a broader, longitudinal, national perspective of the status 
of Medicare 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 beneficiaries and the 
policy that governs the care.
    9. To support 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.
    10. To support 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.
    11. To support 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 IDR 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

[[Page 74920]]

(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).

III. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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.

IV. 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 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: November 24, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0571

SYSTEM NAME:
    ``Medicare Integrated Data Repository (IDR), HHS/CMS/OIS''

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 maintains information on individuals age 65 or over who 
have been, or currently are, entitled to health insurance (Medicare) 
benefits under Title XVIII of the Social Security Act (the Act) or 
under provisions of the Railroad Retirement Act; individuals under age 
65 who have been, or currently are, entitled to such benefits on the 
basis of having been entitled for not less than 24 months to disability 
benefits under Title II of the Act or under the Railroad Retirement 
Act; individuals who have been, or currently are, entitled to such 
benefits because they have End-Stage Renal Disease (ESRD); individuals 
age 64 and 8 months or over who are likely to become entitled to health 
insurance (Medicare) benefits upon attaining age 65, and individuals 
under age 65 who have at least 21 months of disability benefits who are 
likely to become entitled to Medicare upon the 25th month or 
entitlement to such benefits and those populations that are dually 
eligible for both Medicare and Medicaid (Title XIX of the Act). 
Additionally, 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 and entitlement 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. 
Additionally, this system will maintain identifying information on 
physicians, providers, employer plans, Medicaid recipients and Medicare 
secondary payers.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for the collection of data maintained in this system is 
given under Sec. Sec.  226, 226A, 1811, 1818, 1818A, 1831, 
1833(a)(1)(A), 1836, 1837, 1838, 1843, 1866, 1874a, 1875, 1876, 1881, 
and 1902(a)(6) of the Social Security Act (the Act). The following are 
the corresponding sections from Title 42 of the United States Code 
(U.S.C.): 426, 426-1, 1395c, 1395i-2, 1395i-2a, 1395j, 1395l(a)(1)(A), 
1395o, 1395p, 1395q, 1395v, 1395cc, 1395kk-l, 1395ll, 1395mm, 1395rr, 
1396a(a)(6), and Sec.  101 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), 
which established the Medicare Part D program.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this system is to establish an enterprise 
resource that will provide one integrated view of all CMS data to 
administer the Medicare and Medicaid programs. 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 CMS 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

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providers and suppliers of services for administration of Title XVIII; 
(4) assist third parties where the contact is expected to have 
information relating to the individual's capacity to manage his or her 
own affairs; (5) assist Medicare Advantage Plans and Part D 
Prescription Drug Plans; (6) support Quality Improvement Organizations 
(QIO); (7) assist other insurers for processing individual insurance 
claims; (8) facilitate research on the quality and effectiveness of 
care provided, as well as payment related projects; (9) support 
litigation involving the agency; and (10) 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 support 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 assist 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 
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 support providers and suppliers of services directly or 
through fiscal intermediaries or carriers for the administration of 
Title XVIII of the Act.
    4. To assist third party contact in situations where the party to 
be contacted has, or is expected to have information relating to the 
individual's capacity to manage his or her affairs or to his or her 
eligibility for, or an entitlement to, benefits under the Medicare 
program; and
    a. The individual is unable to provide the information being sought 
(an individual is considered to be unable to provide certain types of 
information when any of the following conditions exists: The individual 
is confined to a mental institution, a court of competent jurisdiction 
has appointed a guardian to manage the affairs of that individual, a 
court of competent jurisdiction has declared the individual to be 
mentally incompetent, or the individual's attending physician has 
certified that the individual is not sufficiently mentally competent to 
manage his or her own affairs or to provide the information being 
sought, the individual cannot read or write, cannot afford the cost of 
obtaining the information, a language barrier exists, or the custodian 
of the information will not, as a matter of policy, provide it to the 
individual), or
    b. The data are needed to establish the validity of evidence or to 
verify the accuracy of information presented by the individual, and it 
concerns one or more of the following: the individual's entitlement to 
benefits under the Medicare program, the amount of reimbursement, and 
in cases in which the evidence is being reviewed as a result of 
suspected fraud, waste, and abuse, program integrity, quality 
appraisal, or evaluation and measurement of activities.
    5. To assist Medicare Advantage Plans, Part D Prescription Drug 
Plans and their Prescription Drug Event submitters, providing 
protection against medical expenses of their enrollees without the 
beneficiary's authorization, and 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 provision at 42 U.S.C. 
1395y(b).
    Information to be disclosed shall be limited to Medicare 
entitlement, enrollment and 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 Third Party 
Administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's enrollment or insurance claim; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    6. To support 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.
    7. To assist other insurers, underwriters, third party 
administrators (TPAs), self-insurers, group health plans, employers, 
health maintenance organizations, health and welfare benefit funds, 
Federal agencies, a state or local government or political subdivision 
of either (when the organization has assumed the role of an insurer, 
underwriter, or third party administrator, or in the case of a state 
that assumes the liabilities of an insolvent insurers pool or fund), 
multiple-employers trusts, no-fault medical, automobile insurers, 
workers' compensation carriers plans, liability insurers, and other 
groups providing protection against medical expenses who are primary 
payers to Medicare in accordance with 42 U.S.C. 1395y(b), or 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 or continued right to any such benefit or payment 
(for example, a State Medicaid Agency, State Workers' Compensation 
Board, or Department of Motor Vehicles) for the purpose of coordination 
of benefits with the Medicare program and implementation of the MSP 
provisions at 42 U.S.C. 1395y(b). The information CMS may disclose will 
be:
     Beneficiary Name
     Beneficiary Address
     Beneficiary Health Insurance Claim Number
     Beneficiary Social Security Number
     Beneficiary Gender
     Beneficiary Date of Birth
     Amount of Medicare Conditional Payment
     Provider Name and Number
     Physician Name and Number
     Supplier Name and Number
     Dates of Service
     Nature of Service
     Diagnosis
    To administer the MSP provision at 42 U.S.C. 1395y(b)(2), (3), and 
(4) more effectively, CMS would receive (to the extent that it is 
available) and may disclose the following types of information from 
insurers, underwriters,

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third party administrator, self-insurers, etc.:
     Subscriber Name and Address
     Subscriber Date of Birth
     Subscriber Social Security number
     Dependent Name
     Dependent Date of Birth
     Dependent Social Security Number
     Dependent Relationship to Subscriber
     Insurer/Underwriter/TPA Name and Address
     Insurer/Underwriter/TPA Group Number
     Insurer/Underwriter/Group Name
     Prescription Drug Coverage
     Policy Number
     Effective Date of Coverage
     Employer Name, Employer Identification Number (EIN) and 
Address
     Employment Status
     Amounts of Payment
    To administer the MSP provision at 42 U.S.C. 1395y(b)(1) more 
effectively for entities such as Workers' Compensation carriers or 
boards, liability insurers, no-fault and automobile medical policies or 
plans, CMS would receive (to the extent that it is available) and may 
disclose the following information:
     Beneficiary's Name and Address
     Beneficiary's Date of Birth
     Beneficiary's Social Security number
     Name of Insured
     Insurer Name and Address
     Type of coverage; automobile medical, no-fault, liability 
payment, or workers' compensation settlement
     Insured's Policy Number
     Effective Date of Coverage
     Date of accident, injury or illness
     Amount of payment under liability, no-fault, or automobile 
medical policies, plans, and workers' compensation settlements
     Employer Name and Address (Workers' Compensation Only)
     Name of insured could be the driver of the car, a 
business, the beneficiary (i.e., the name of the individual or entity 
which carries the insurance policy or plan).
    In order to receive this information the entity must agree to the 
following conditions;
    a. To utilize the information solely for the purpose of 
coordination of benefits with the Medicare program and other third 
party payer in accordance with Title 42 U.S.C. 1395y(b);
    b. To safeguard the confidentiality of the data and to prevent 
unauthorized access to it; and,
    c. To prohibit the use of beneficiary-specific data for the 
purposes other than for the coordination of benefits among third party 
payers and the Medicare program. This agreement would allow the 
entities to use the information to determine cases where they or other 
third party payers have primary responsibility for payment. Examples of 
prohibited uses would include but are not limited to; creation of a 
mailing list, sale or transfer of data.
    To administer the MSP provisions more effectively, CMS may receive 
or disclose the following types of information from or to entities 
including insurers, underwriters, TPAs, and self-insured plans, 
concerning potentially affected individuals:
     Subscriber HICN
     Dependent Name
     Funding arrangements of employer group health plans, for 
example, contributory or non-contributory plan, self-insured, re-
insured, HMO, TPA insurance.
     Claims payment information, for example, the amount paid, 
the date of payment, the name of the insurers or payer
     Dates of employment including termination date, if 
appropriate
     Number of full and/or part-time employees in the current 
and preceding calendar years
     Employment status of subscriber, for example, full or part 
time or self-employed
    8. To assist 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.
    9. To support 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.
    10. To support 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.
    11. To support 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, 
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 Medicare 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 unauthorized use. Personnel having access to 
the system have been trained in the Privacy

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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 are maintained for a period of 6 years and 3 months. All 
claims-related records are encompassed by the document preservation 
order and will be retained until notification is received from DOJ.

SYSTEM MANAGER AND ADDRESSES:
    Director, Division of Business Analysis & Analysis, Enterprise 
Databases Group, Office of Information Services, CMS, Room N1-14-08, 
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 collected and maintained in this system are retrieved from 
the following databases: Medicare Drug Data Processing System, System 
No. 09-70-0553 (70 Federal Register (FR) 58436 (October 6, 2005)); 
Medicare Beneficiary Database, System No. 09-70-0536 (71 FR 11425 
(March 7, 2006)); Medicare Advantage Prescription Drug System, System 
No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical 
Information System, System No. 09-70-0541 (71 FR 65527 (November 8, 
2006)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 
41035 (July 15, 2005)); Common Working File, System No. 09-70-0526 (71 
FR 64955 (November 6, 2006)); National Claims History, System No. 09-
70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System 
No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Multi-Carrier Claims 
System (formerly known as the Carrier Medicare Claims Record), System 
No. 09-70-0501 (71 FR 64968 (November 6, 2006)); Fiscal Intermediary 
Shared System (formerly known as the Intermediary Medicare Claims 
Record), System No. 09-70-0503 (71 FR 64961 (November 6, 2006)); 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 (71 FR 65527 (November 8, 2006). Information will 
also be provided from the application submitted by the individual 
through state Medicaid agencies, the Social Security Administration and 
through other entities assisting beneficiaries.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. E6-21123 Filed 12-12-06; 8:45 am]
BILLING CODE 4120-03-P