[Federal Register: December 4, 2006 (Volume 71, Number 232)]
[Notices]
[Page 70396-70403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de06-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a Modified or Altered System of
Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a Modified or Altered System of Records (SOR).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to modify or alter an existing SOR, ``Medicare
Beneficiary Database (MBD),'' System No. 09-70-0536, established at 66
Federal Register (FR) 63392 (December 6, 2001), and modified at 71 FR
11420 (March 7, 2006). The Medicare Prescription Drug, Improvement, and
Modernization Act (MMA) authorizes Medicare payment to Part D sponsors
(including Medicare Advantage prescription drug plan sponsors) that
contract with CMS to provide qualified Part D prescription drug
coverage as described in 42 CFR Parts 417, 422 and 423. The MBD will
include data necessary to process certain activities associated with
the new Part D benefit including, but not limited to, the following
activities: (1) Determination of the status of Medicare beneficiaries
who are eligible for the Low Income Subsidy Program (LIS) and are
deemed to receive certain drug benefits; and (2) auto-assignment/auto-
enrollment of beneficiaries as required by the MMA, and regulation, to
include all LIS and deemed individuals who are not voluntarily enrolled
in a drug plan, will automatically be assigned to a Prescription Drug
Plan (PDP) or Medicare Advantage (MA) Prescription Drug Plan (MA-PD).
We propose to broaden the scope of the disclosure provisions of
this system by adding a new routine use to permit the release of Part D
enrollment data maintained in the MBD to support Patient Assistance
Programs (PAP) and other groups providing pharmaceutical assistance to
the Medicare beneficiary. The new routine use will be published as
routine use number 8. Specifically, the new routine use will facilitate
the sharing of information between PAPs and Part D plans to meet the
MMA provisions for drug utilization reviews, drug medication therapy
management, and quality of care that can only be addressed through the
cooperation between the PAP and the Part D Plan. Information may be
released to these organizations upon a specific request, and only if
the requester meets the following requirements. They must (1) Provide
an attestation or other qualifying information that they are providing
pharmaceutical assistance to Medicare beneficiaries; (2) submit a
finder file identifying Medicare beneficiaries receiving pharmaceutical
assistance and/or services; (3) safeguard the confidentiality of any
CMS data received and prevent unauthorized access; and, (4) complete a
written statement attesting to the information recipient's
understanding of and willingness to abide by CMS provisions regarding
Privacy protections and information security. Recipients of CMS data
must complete the Coordination of Benefits PAP Data Sharing Agreement
prior to the release of CMS data. The finder file submitted by the PAP
must provide the following data elements: (a) First initial of the
first name, (b) first 6 letters of the last name, (c) social security
number or health insurance claims number, (d) date of birth, and (e)
sex. Part D data maintained in the MBD that will be released to a PAP
or a group providing pharmaceutical assistance will consist of the
verification of Medicare status and the identification of the current
Part D Plan selected by the Medicare beneficiary.
We will delete published routine use number 8 authorizing
disclosure to support constituent requests made to a congressional
representative. If an authorization for the disclosure has been
obtained from the data subject, then no routine use is needed. The
Privacy Act allows for disclosures with the ``prior written consent''
of the data subject. We will broaden the scope of published routine
uses number 10 and 11 authorizing disclosures to combat fraud and abuse
in the Medicare and Medicaid programs to include combating ``waste''
which shall refer to specific beneficiary/recipient practices that
result in unnecessary cost to all federally-funded health benefit
programs.
The primary purpose of this modified system is to provide CMS with
a singular, authoritative, database of comprehensive enrollment data on
individuals in the Medicare program to support ongoing and expanded
program administration, service delivery modalities, and payment
coverage options. This collection will contain a complete ``beneficiary
insurance profile'' that reflects the individual's Medicare health
insurance coverage and Medicare health plan and demonstration
enrollment. 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
a 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 or her own affairs; (5) support Quality
Improvement Organizations (QIO); (6) assist other insurers for
processing individual insurance claims; (7) facilitate research on the
quality and effectiveness of care provided, as well as payment related
projects; (8) support Patient Assistance Programs and other groups
providing pharmaceutical assistance or services to Medicare
beneficiaries; (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 modified 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 Dates: CMS filed a modified or altered 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: CMS Privacy Officer,
Division of Privacy Compliance, Enterprise Architecture and Strategy
Group, Office of Information Services, CMS, Room N2-04-27, 7500
Security
[[Page 70397]]
Boulevard, Baltimore, Maryland 21244-1850. Comments received will be
available for review at this location, by appointment, during regular
business hours, Monday through Friday from 9 a.m.-3 p.m., Eastern Time
zone.
FOR FURTHER INFORMATION CONTACT: Danielle Moon, Director, Division of
Enrollment and Eligibility Policy, Medicare Enrollment and Appeals
Group, Center for Beneficiary Choices, CMS, Mail Stop S1-05-06, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Her telephone
number is 410-786-5724, and via e-mail at Danielle.Moon@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Description of the Modified or Altered System of Records
A. Statutory and Regulatory Basis for SOR
Authority for maintenance of the system is given under Sec. Sec.
226, 226A, 1811, 1818, 1818A, 1831, 1833(a)(1)(A), 1836, 1837, 1838,
1843, 1866, 1876, 1881, and 1902(a)(6) of the Act and Title 42 United
States Code (U.S.C.) 426, 426-1, 1395c, 1395cc, 1395i-2, 1395i-2a,
1395j, 13951, 1395mm, 1395o, 1395p, 1395q, 1395rr, 1395v, 1396a, and
Section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173) (Regulations at 42 CFR
Parts 403, 411, 417 and 423).
B. Collection and Maintenance of Data in the System
This system contains 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 that 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).
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.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The government will only release MBD information that can be associated
with an individual as provided for under ``Section III. Proposed
Routine Use Disclosures of Data in the System.'' Both identifiable and
non-identifiable data may be disclosed under a routine use.
We will only collect the minimum personal data necessary to achieve
the purpose of MBD. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from this system will be approved
only to the extent necessary to accomplish the purpose of the
disclosure and only after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., to provide CMS with a
singular, authoritative, database of comprehensive data on individuals
in the Medicare program to support ongoing and expanded program
administration, service delivery modalities, and payment coverage
options.
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if the record is provided in individually identifiable
form;
b. The purpose for which the disclosure is to be made is of
sufficient importance to warrant the effect and/or risk on the privacy
of the individual that additional exposure of the record might bring;
and
c. There is a strong probability that the proposed use of the data
would in fact accomplish the stated purpose(s).
3. Requires the information recipient to:
a. Establish administrative, technical, and physical safeguards to
prevent unauthorized use of disclosure of the record;
b. Remove or destroy at the earliest time all patient-identifiable
information; and
c. Agree to not use or disclose the information for any purpose
other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
III. Modified 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 modifying/altering the routine
use disclosures of information maintained in the system so that the
routine uses include the following:
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 function
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant or grantee whatever information
is necessary for the contractors, consultants or grantees to fulfill
its duties. In these situations, safeguards are provided in the
contract prohibiting the contractor, consultant or grantee from using
or disclosing the information for any purpose other than that described
in the contract and requires the contractor, consultant or grantee to
return or destroy all information at the completion of the contract.
2. To assist another Federal or State agency, agency of a State
government,
[[Page 70398]]
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 MBD 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 MBD data for the
application of tax penalties against employers and employee
organizations that contribute to Employer Group Health Plan or Large
Group Health Plans that are not in compliance with 42 U.S.C. 1395y(b).
In addition, other State agencies in their administration of a
Federal health program may require MBD 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 MBD 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 MBD 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 assist 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 MBD 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 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 and abuse, program integrity, quality appraisal, or
evaluation and measurement of activities.
Third parties contacts require MBD 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 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.
6. To 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
[[Page 70399]]
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
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:
c. 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);
d. To safeguard the confidentiality of the data and to prevent
unauthorized access to it; and,
e. 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
MBD 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.
7. 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 MBD 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.
8. To support Patient Assistance Programs and other groups
providing pharmaceutical assistance to a Medicare beneficiary. Medicare
Part D enrollment information may be released to these organizations
upon specific request, and then only if they meet the following
requirements, they must:
a. Provide an attestation or other qualifying information that they
are providing pharmaceutical assistance to Medicare beneficiaries;
b. Submit a finder file to CMS to identify Medicare beneficiaries
receiving pharmaceutical assistance and/or services consisting of the
following data elements:
(1) First initial of the first name,
(2) First 6 letters of the last name,
(3) Social security number or health insurance claims number,
(4) Date of birth, and
(5) Sex;
c. Safeguard the confidentiality of any data received and prevent
unauthorized access to the data; and,
d. Complete a written statement attesting to the information
recipient's understanding of and willingness to abide by CMS provisions
regarding Privacy protections and information security. Recipients of
CMS data must complete the PAP Data Sharing Agreement prior to the
release of CMS data.
Part D data maintained in the MBD that will be released to PAPs or
a group providing pharmaceutical assistance will consist of the
verification of Medicare status and the name of the current Part D Plan
selected by the Medicare beneficiary.
9. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
[[Page 70400]]
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 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 or 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 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 MBD information for the purpose of
combating fraud, waste or abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR Parts 160 and
164, Subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164.512 (a)
(1).)
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. Personnel having access to
the system have been trained in the Privacy Act and information
security requirements. Employees who maintain records in this system
are instructed not to release data until the intended recipient agrees
to implement appropriate management, operational and technical
safeguards sufficient to protect the confidentiality, integrity and
availability of the information and information systems and to prevent
unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the System of Records on Individual Rights
CMS proposes to modify 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. 09-70-0536
SYSTEM NAME:
``Medicare Beneficiary Database (MBD), HHS/CMS/CBC.''
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:
Individuals age 65 or over who have been, or currently are,
entitled to health insurance (Medicare) benefits under
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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 that 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).
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.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM
Authority for maintenance of the system is given under Sec. Sec.
226, 226A, 1811, 1818, 1818A, 1831, 1833(a)(1)(A), 1836, 1837, 1838,
1843, 1866, 1876, 1881, and 1902(a)(6) of the Act and Title 42 United
States Code (U.S.C.) 426, 426-1, 1395c, 1395cc, 1395i-2, 1395i-2a,
1395j, 13951, 1395mm, 1395o, 1395p, 1395q, 1395rr, 1395v, 1396a, and
Section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173) (Regulations at 42 CFR
Parts 403, 411, 417 and 423).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this modified system is to provide CMS with
a singular, authoritative, database of comprehensive enrollment data on
individuals in the Medicare program to support ongoing and expanded
program administration, service delivery modalities, and payment
coverage options. This collection will contain a complete ``beneficiary
insurance profile'' that reflects the individual's Medicare health
insurance coverage and Medicare health plan and demonstration
enrollment. 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
a 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 or her own affairs; (5) support Quality
Improvement Organizations (QIO); (6) assist other insurers for
processing individual insurance claims; (7) facilitate research on the
quality and effectiveness of care provided, as well as payment related
projects; (8) support Patient Assistance Programs and other groups
providing pharmaceutical assistance or services to Medicare
beneficiaries; (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 modifying/altering the routine
use disclosures of information maintained in the system so that the
routine uses include the following:
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 assist 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 and abuse, program integrity, quality appraisal, or
evaluation and measurement of activities.
5. 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.
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6. To 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. 1395 y(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. 1395 y(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
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;
c. 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);
d. To safeguard the confidentiality of the data and to prevent
unauthorized access to it; and
e. 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
7. 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.
8. To support Patient Assistance Programs and other groups
providing pharmaceutical assistance to a Medicare beneficiary. Medicare
Part D enrollment information may be released to these organizations
upon specific request, and then only if they meet the following
requirements, they must:
a. Provide an attestation or other qualifying information that they
are providing pharmaceutical assistance to Medicare beneficiaries;
b. Submit a finder file to CMS to identify Medicare beneficiaries
receiving pharmaceutical assistance and/or services consisting of the
following data elements:
(1) First initial of the first name,
(2) First 6 letters of the last name,
(3) Social security number or health insurance claims number,
(4) Date of birth,
(5) Sex;
c. Safeguard the confidentiality of any data received and prevent
unauthorized access to the data; and
d. Complete a written statement attesting to the information
recipient's understanding of and willingness to abide by CMS provisions
regarding Privacy protections and information security. Recipients of
CMS data must complete the PAP Data Sharing Agreement prior to the
release of CMS data.
9. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
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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 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 another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste or abuse in, a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164.512
(a)(1).)
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored electronically.
RETRIEVABILITY:
All Medicare records are accessible by HICN, and SSN search. This
system supports both on-line and batch access.
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.
RETENTION AND DISPOSAL:
Records are maintained in the active files for a period of 15
years. The records are then retired to archival files maintained at the
Health Care Data Center. All claims-related records are encompassed by
the document preservation order and will be retained until notification
is received from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Enrollment and Eligibility Policy, Medicare
Enrollment and Appeals Group, Center for Beneficiary Choices, CMS, Mail
Stop S1-05-06, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager who will require the system name, HICN, address, date of
birth, and gender, and for verification purposes, the subject
individual's name (woman's maiden name, if applicable), and SSN.
Furnishing the SSN is voluntary, but it may make searching for a record
easier and prevent delay.
RECORD ACCESS PROCEDURE:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also specify the
record contents being sought. (These procedures are in accordance with
department regulation 45 CFR 5b.5(a)(2).)
CONTESTING RECORDS PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the records and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These Procedures are in
accordance with Department regulation 45 CFR 5b.7.)
RECORDS SOURCE CATEGORIES:
The data contained in this system of records are extracted from
other CMS systems of records: Enrollment Database, Medicare Advantage
Prescription Drug System, and the Medicaid Statistical Information
System. 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. E6-20408 Filed 12-1-06; 8:45 am]
BILLING CODE 4120-03-P