[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]
[Page 74915-74923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-53]
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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 robyn.thomas@cms.hhs.gov.
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
[[Page 74921]]
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,
[[Page 74922]]
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
[[Page 74923]]
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