Privacy Act of 1974; Report of Modified or Altered System, 60530-60535 [05-20909]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of Modified
or Altered System
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of Modified or Altered
System of Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to modify or alter a
SOR titled, ‘‘Medicare Managed Care
System (MMCS), No. 09–70–4001.’’
MMCS processes beneficiary enrollment
and creates beneficiary level payments
for the Managed Care Organizations
(MCO). We propose to broaden the
scope of this system by adding the
Medicare Part D Program under Title
XVIII. The Medicare+Choices Program
has been changed to the Medicare
Advantage (MA) Program. The MA was
mandated by the Balance Budget Act
(BBA) of 1997 (Public Law (Pub. L.)
105–33). To more accurately reflect the
changes proposed for this system, we
will modify the name to read:
‘‘Medicare Advantage Prescription Drug
(MARx) System.’’ The enhanced system
will continue to perform all current
MMCS processing requirements. In
addition, MARx will be a stand alone
system that will include the processing
of all enrollment/disenrollment
transactions associated with the Part D
Program. MARx will include the
following: Health Maintenance
Organizations (HMO), Health Care
Prepayment Plan (HCPP), Medicare
Advantage Organizations (MAO),
Medicare Advantage Prescription Drug
(MAPD) Plans and Prescription Drug
Plans (PDP).
On December 8, 2003, Congress
passed the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173). MMA
amends the Social Security Act (the Act)
by adding the Medicare Part D Program
under Title XVIII and mandate that CMS
establish a voluntary Medicare
prescription drug benefit program
effective January 1, 2006. Under the new
Medicare Part D benefit, the Act allows
Medicare payment to MA plans that
contract with CMS to provide qualified
Part D prescription drug coverage as
described in 42 Code of Federal
Regulations (CFR) 417 and 422.
We are modifying the language in
some of the routine uses to provide
clarity to CMS’s intention to disclose
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individual-specific information
contained in this system. The routine
uses will remain prioritized according
to their proposed usage. Information
previously retrieved from the
Enrollment Database (System No. 09–
70–0502) will now be retrieved by the
Medicare Beneficiary Database (MBD)
(System No. 09–70–0536). We will also
take the opportunity to update any
sections of the system that were affected
by the recent reorganization and to
update language in the administrative
sections to correspond with language
used in other CMS SORs.
The primary purpose of the SOR is to
maintain a master file of MA and MAPD
plan members for accounting and
payment control; expedite the exchange
of data with MA and MAPD; control the
posting of pro-rata amounts to the Part
B deductible of currently enrolled MA
members; and track participation of the
prescription drug benefits provided
under private prescription drug plans
and Medicare employer plans.
Information in this system will also be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed by a contractor or consultant
contracted by the Agency; (2) support
another Federal or State agency, agency
of a state government, an agency
established by state law, or its fiscal
agent; (3) assist provider and suppliers
of service directly or dealing through
contractors, fiscal intermediaries (FI) or
carriers for the administration of Title
XVIII; (4) assist third party contacts 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; (5)
assist insurance companies, third party
administrators, employers, self-insurers,
managed care organizations, and other
supplemental insurers; (6) facilitate
research on the quality and effectiveness
of care provided, as well as paymentrelated projects; (7) support constituent
requests made to a congressional
representative; (8) support litigation
involving the Agency, and (9) combat
fraud and abuse in certain health
benefits programs. We have provided
background information about the
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 proposed
routine uses, CMS invites comments on
all portions of this notice. See EFFECTIVE
DATES section for comment period.
EFFECTIVE DATES: CMS filed a modified
or altered system report with the Chair
of the House Committee on Government
Reform and Oversight, the Chair of the
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Senate Committee on Governmental
Affairs, and the Administrator, Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB) on October 14, 2005. To ensure
that all parties have adequate time in
which to comment, the modified or
altered SOR, including routine uses,
will become effective 40 days from the
publication of the notice, or from the
date it was submitted to OMB and the
Congress, whichever is later, unless
CMS receives comments that require
alterations to this notice.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Privacy Compliance Data
Development (DPCDD), CMS, Room N2–
04–27, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Comments received will be available for
review at this location, by appointment,
during regular business hours, Monday
through Friday from 9 a.m.–3 p.m.,
Eastern daylight time.
FOR FURTHER INFORMATION CONTACT:
Mary Sincavage, Division Director,
Division of Medicare Advantage
Appeals and Payment Systems,
Information Services Modernization
Group, Office of Information Services,
CMS, Room N3–16–24, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. The telephone number is 410–
786–1163.
SUPPLEMENTARY INFORMATION: The
Medicare Managed Care System
(MMCS) is the redesign of the legacy
system Group Health Plan (GHP)
system. MMCS processes beneficiary
enrollment and creates beneficiary level
payments for the Managed Care
Organizations (MCO). The beneficiary
level payments are aggregated to the
MCO level and sent to the Automated
Plan Payment System (APPS) for
additional organization level
adjustments before payments are sent to
the MCOs. An independent technical
evaluation of CMS’ managed care
system found that without major
enhancements, MA provisions could not
be supported by existing Medicare
systems. Also, the comprehensive
review of existing systems was
necessary in order to proceed with a
development effort that would ensure
those future customer service and
program management objectives were
met.
The CMS has long realized that the
Medicare program is in the middle of
rapidly changing health insurance
industry characterized by an expansion
of service delivery models and payment
options. The MA provisions of the BBA
of 1997 (Pub. L. 105–33) has made the
challenge of managing beneficiary
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health choices one of the most critical
challenges facing CMS and the health
industry at large. To be of maximum
use, the data must be organized and
categorized into a comprehensive
system. CMS sought to identify key
sources, including both organizations
and systems that could provide valid
and reliable information. Medicare will
no longer exist within an environment
characterized by limited health
insurance options and standard delivery
models.
MARx will recalculate payments due
to Part D risk adjustment factor
reconciliation. MARx will receive low
income subsidy status information from
the MBD, including notification of any
changes. MARx will calculate
adjustments due to any retroactive
changes to low income subsidy status.
MARx is not responsible for sending
Social Security Administration (SSA)
the Part D plan data. It is assumed that
this will come from the Health Plan
Management System (HPMS) (System
No. 09–70–4004). Fallback plans will
not be paid by MARx. MARx
enrollments may be rejected if a
beneficiary is currently enrolled in a
plan that is part of the retiree drug
subsidy (RDS). MARx will notify the
RDS of any rejected enrollments due to
this situation. Plans will be notified on
a weekly basis, if MARx has adjusted
the premium or if SSA/Railroad
Retirement Board/Office of Personnel
Management cannot deduct the
premium. Additionally, MARx is a
stand alone system that will be
processing all enrollment/disenrollment
transactions associated with the Part D
program.
I. Description of the Modified System of
Records
A. Statutory and Regulatory Basis for
the System. Authority for maintenance
of the system is given under Section 101
of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173) amended
the Title XVIII of the Social Security
Act. Authority for maintenance of the
system is also given under the
provisions of §§ 1833(a)(1)(A), 1860,
1866, and 1876 of Title XVIII of the Act
(42 CFR 417 and 422).
B. Collection and Maintenance of Data
in the System. The system will include
information on recipients of Medicare
hospital insurance (Part A) and
Medicare medical insurance (Part B)
and recipients of the Prescription Drug
Benefits Program (Part D) enrolled in the
MA Program. The system will also
include information about a
beneficiary’s entitlement to Medicare
benefits and enrollment in Medicare
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Programs, prescription drug coverage
and supplementary medical claims
information. The system will contact
identifying information such as
beneficiary name, health insurance
claim number, social security number,
and other demographic information.
II. Agency Policies, Procedures, and
Restrictions on Routine Uses
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 MARx information that can
be associated with an individual as
provided for under ‘‘Section III.
Modified 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 MARx. CMS has the
following policies and procedures
concerning disclosures of information
that will be maintained in the system.
Disclosure of information from the SOR
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
data is being collected; e.g., to maintain
a master file of MA and MAPD plan
members for accounting and payment
control; expedite the exchange of data
with MA and MAPD; control the posting
of pro-rata amounts to the Part B
deductible of currently enrolled MA
members; and track participation of the
prescription drug benefits provided
under private prescription drug plans
and Medicare employer plans.
2. Determines that the purpose for
which the disclosure is to be made can
only be accomplished if the record is
provided in individually identifiable
form;
a. 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
b. 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;
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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. Entities Who May Receive
Disclosures Under Routine Use. These
routine uses specify circumstances, in
addition to those provided by statute in
the Privacy Act of 1974, under which
CMS may release information from the
MARx without the consent of the
individual to whom such information
pertains. Each proposed disclosure of
information under these routine uses
will be evaluated to ensure that the
disclosure is legally permissible,
including but not limited to ensuring
that the purpose of the disclosure is
compatible with the purpose for which
the information was collected. We are
proposing to establish or modify the
following routine use disclosures of
information maintained in the system:
1. To Agency contractors, or
consultants who have been contracted
by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this system
and who need to have access to the
records in order to assist CMS.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual or similar agreement
with a third party to assist in
accomplishing a CMS function relating
to purposes for this 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 or consultant
whatever information is necessary for
the contractor or consultant to fulfill its
duties. In these situations, safeguards
are provided in the contract prohibiting
the contractor or consultant from using
or disclosing the information for any
purpose other than that described in the
contract and requires the contractor or
consultant to return or destroy all
information at the completion of the
contract.
2. To 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’s
proper payment of Medicare benefits,
b. Enable such agency to administer a
Federal health benefits program, or as
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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 MARx information
in order to support evaluations and
monitoring of Medicare claims
information of beneficiaries, including
proper reimbursement for services
provided.
Disclosure under this routine use
shall be used by state Medicaid agencies
pursuant to agreements with the HHS
for determining Medicaid and Medicare
eligibility, for quality control studies,
for determining eligibility of recipients
of assistance under Titles IV, XVIII, and
XIX of the Act, and for the
administration of the Medicaid program.
Data will be released to the state only on
those individuals who are patients
under the services of a Medicaid
program within the state or who are
residents of that state.
We also contemplate disclosing
information under this routine use in
situations in which state auditing
agencies require MARx information for
auditing state Medicaid eligibility
considerations. CMS may enter into an
agreement with state auditing agencies
to assist in accomplishing functions
relating to purposes for this system to
providers and suppliers of services
directly or through fiscal intermediaries
or carriers for the administration of Title
XVIII of the Act.
3. To providers and suppliers of
services directly or dealing through
fiscal intermediaries or carriers for the
administration of Title XVIII of the Act.
Providers and suppliers of services
require MARx 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 third party contacts 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
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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 and abuse,
program integrity, quality appraisal, or
evaluation and measurement of
activities.
Third party contacts require MARx
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 insurance companies, third
party administrators (TPA), employers,
self-insurers, managed care
organizations, other supplemental
insurers, non-coordinating insurers,
multiple employer trusts, group health
plans (i.e., health maintenance
organizations or a competitive medical
plan with a Medicare contract, or a
Medicare-approved health care
prepayment plan), directly or through a
contractor, and other groups providing
protection for their enrollees.
Information to be disclosed shall be
limited to Medicare entitlement data. In
order to receive the information, they
must agree to:
a. Certify that the individual about
whom the information is being provided
is one of its insured or employees, or is
insured and/or employed by another
entity for whom they serve as a TPA;
b. Utilize the information solely for
the purpose of processing the identified
individual’s insurance claims; and
c. Safeguard the confidentiality of the
data and prevent unauthorized access.
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Other insurers, TPAs, HMOs, and
HCPPs may require MARx information
in order to support evaluations and
monitoring of Medicare claims
information of beneficiaries, including
proper reimbursement for services
provided.
6. To an individual or organization for
a research, evaluation, or
epidemiological project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment-related projects.
MARx data will provide for research,
evaluation, and epidemiological
projects, a broader, longitudinal,
national perspective of the status of
Medicare beneficiaries. CMS anticipates
that many researchers will have
legitimate requests to use these data in
projects that could ultimately improve
the care provided to Medicare
beneficiaries and the policy that governs
the care.
7. To a Member of Congress or a
congressional staff member in response
to an inquiry of the congressional office
made at the written request of the
constituent about whom the record is
maintained.
Beneficiaries often request the help of
a Member of Congress in resolving some
issue relating to a matter before CMS.
The Member of Congress then writes
CMS, and CMS must be able to give
sufficient information tin response to
the inquiry.
8. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The Agency or any component
thereof, or
b. Any employee of the Agency in his
or her official capacity, or
c. Any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government, is
a party to litigation or has an interest in
such litigation, and, by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, or occasionally when another
party is involved in litigation and CMS’s
policies or operations could be affected
by the outcome of the litigation, CMS
would be able to disclose information to
the DOJ, court, or adjudicatory body
involved.
9. To a CMS contractor (including, but
not limited to FIs and carriers) that
assists in the administration of a CMSadministered health benefits program,
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or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such programs.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contract or grant with a third
party to assist in accomplishing CMS
functions relating to the purpose of
combating fraud and abuse.
CMS occasionally contracts out
certain of its functions when doing so
would contribute to effective and
efficient operations. CMS must be able
to give a contractor or grantee whatever
information is necessary for the
contractor or grantee to fulfill its duties.
In these situations, safeguards are
provided in the contract prohibiting the
contractor or grantee from using or
disclosing the information for any
purpose other than that described in the
contract and requiring the contractor or
grantee to return or destroy all
information.
10. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any State
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
Other agencies may require MARx
information for the purpose of
combating fraud and abuse in such
Federally-funded programs.
B. Additional Circumstances
Affecting Routine Use Disclosures. This
system contains Protected Health
Information as defined by HHS
regulation ‘‘Standards for Privacy of
Individually Identifiable Health
Information’’ (45 CFR Parts 160 and 164,
65 FR 82462 (12–28–00), Subparts A
and E. The protected health information
is collected from the Plan during the
enrollment process and passed onto the
Medicare Beneficiary Database. These
elements include the Beneficiary Name,
Sex, Date of Birth, and Health Insurance
Claim Number. Disclosures of Protected
Health Information authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’
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In addition, our policy will be to
prohibit release even of data not directly
identifiable information, except
pursuant to one of the routine uses or
if required by law, if we determine there
is a possibility that an individual can be
identified through implicit deduction
based on small cell sizes (instances
where the patient population is so small
that individuals who are familiar with
the enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: The Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen 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 Modified System on
Individual Rights
CMS proposes to establish this system
in accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
We will only disclose the minimum
personal data necessary to achieve the
purpose of MARx. Disclosure of
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information from the system will be
approved only to the extent necessary to
accomplish the purpose of the
disclosure. CMS has assigned a higher
level of security clearance for the
information maintained in this system
in an effort to provide added security
and protection of data in this system.
CMS will take precautionary
measures to minimize the risks of
unauthorized access to the records and
the potential harm to individual privacy
or other personal or property rights.
CMS will collect only that information
necessary to perform the system’s
functions. In addition, CMS will make
disclosure from the proposed system
only with consent of the subject
individual, or his/her legal
representative, or in accordance with an
applicable exception provision of the
Privacy Act.
CMS, therefore, does not anticipate an
unfavorable effect on individual privacy
as a result of the disclosure of
information relating to individuals.
Dated: October 12, 2005.
Lori Davis,
Acting Chief Operating Officer, Centers for
Medicare & Medicaid Services.
SYSTEM NO. 09–70–4001.
SYSTEM NAME:
‘‘Medicare Advantage Prescription
Drug (MARx)’’ System HHS/CMS/OIS.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive.
SYSTEM LOCATION:
CMS Data Center, 7500 Security
Boulevard, North Building, First Floor,
Baltimore, Maryland 21244–1850.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The system will include information
on recipients of Medicare hospital
insurance (Part A) and Medicare
medical insurance (Part B) and
recipients of the Prescription Drug
Benefits Program (Part D) enrolled in the
Medicare Advantage (MA) Program.
CATEGORIES OF RECORDS IN THE SYSTEM:
The system will also include
information about a beneficiary’s
entitlement to Medicare benefits and
enrollment in Medicare Programs,
prescription drug coverage and
supplementary medical claims
information. The system will contain
identifying information such as
beneficiary name, health insurance
claim number, social security number,
and other demographic information.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the
system is given under Section 101 of the
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Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173) amended
the Title XVIII of the Social Security
Act. Authority for maintenance of the
system is also given under the
provisions of §§ 1833(a)(1)(A), 1860,
1866, and 1876 of Title XVIII of the Act
(42 CFR 417 and 422).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the SOR is to
maintain a master file of MA and MAPD
plan members for accounting and
payment control; expedite the exchange
of data with MA and MAPD; control the
posting of pro-rata amounts to the Part
B deductible of currently enrolled MA
members; and track participation of the
prescription drug benefits provided
under private prescription drug plans
and Medicare employer plans.
Information in this system will also be
disclosed to: (1) Support regulatory,
reimbursement, and policy functions
performed by a contractor or consultant
contracted by the Agency; (2) support
another Federal or State agency, agency
of a state government, an agency
established by state law, or its fiscal
agent; (3) assist provider and suppliers
of service directly or dealing through
contractors, fiscal intermediaries (FI) or
carriers for the administration of Title
XVIII; (4) assist third party contacts 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; (5)
assist insurance companies, third party
administrators, employers, self-insurers,
managed care organizations, and other
supplemental insurers; (6) facilitate
research on the quality and effectiveness
of care provided, as well as paymentrelated projects; (7) support constituent
requests made to a congressional
representative; (8) support litigation
involving the Agency, and (9) combat
fraud and abuse in certain health
benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
A. Entities Who May Receive
Disclosures Under Routine Use. These
routine uses specify circumstances, in
addition to those provided by statute in
the Privacy Act of 1974, under which
CMS may release information from the
MARx without the consent of the
individual to whom such information
pertains. Each proposed disclosure of
information under these routine uses
will be evaluated to ensure that the
disclosure is legally permissible,
including but not limited to ensuring
that the purpose of the disclosure is
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17:22 Oct 17, 2005
Jkt 208001
compatible with the purpose for which
the information was collected. We are
proposing to establish or modify the
following routine use disclosures of
information maintained in the system:
1. To Agency contractors, or
consultants who have been contracted
by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this system
and who need to have access to the
records in order to assist CMS.
2. To another Federal or state agency,
agency of a state government, an agency
established by state law, or its fiscal
agent to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
b. Enable such agency to administer a
Federal health benefits program, or as
necessary to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds, and/or
c. Assist Federal/state Medicaid
programs within the state.
3. To providers and suppliers of
services directly or through fiscal
intermediaries or carriers for the
administration of Title XVIII of the Act.
4. To third party contacts 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 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
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Fmt 4703
Sfmt 4703
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 insurance companies, third
party administrators (TPA), employers,
self-insurers, managed care
organizations, other supplemental
insurers, non-coordinating insurers,
multiple employer trusts, group health
plans (i.e., health maintenance
organizations or a competitive medical
plan with a Medicare contract, or a
Medicare-approved health care
prepayment plan), directly or through a
contractor, and other groups providing
protection for their enrollees.
Information to be disclosed shall be
limited to Medicare entitlement data. In
order to receive the information, they
must agree to:
a. Certify that the individual about
whom the information is being provided
is one of its insured or employees, or is
insured and/or employed by another
entity for whom they serve as a TPA;
b. Utilize the information solely for
the purpose of processing the identified
individual’s insurance claims; and
c. Safeguard the confidentiality of the
data and prevent unauthorized access.
6. To an individual or organization for
a research, evaluation, or
epidemiological project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment-related projects.
7. To a Member of Congress or a
congressional staff member in response
to an inquiry of the congressional office
made at the written request of the
constituent about whom the record is
maintained.
8. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The Agency or any component
thereof, or
b. Any employee of the Agency in his
or her official capacity, or
c. Any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government, is
a party to litigation or has an interest in
such litigation, and, by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
9. To a CMS contractor (including, but
not limited to FIs and carriers) that
assists in the administration of a CMSadministered health benefits program,
E:\FR\FM\18OCN1.SGM
18OCN1
Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such programs.
10. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any state
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
B. Additional Circumstances
Affecting Routine Use Disclosures. This
system contains Protected Health
Information as defined by the
Department of Health and Human
Services (HHS) regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR Parts 160
and 164, 65 Fed. Reg. 82462 (12–28–00),
Subparts A and E. Disclosures of
Protected Health Information authorized
by these routine uses may only be made
if, and as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’
In addition, our policy will be to
prohibit release even of data not directly
identifiable information, except
pursuant to one of the routine uses or
if required by law, if we determine there
is a possibility that an individual can be
identified through implicit deduction
based on small cell sizes (instances
where the patient population is so small
that individuals who are familiar with
the enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
Computer diskette and on magnetic
storage media.
RETRIEVABILITY:
Information can be retrieved by name
and health insurance claim number of
the beneficiary.
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
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17:22 Oct 17, 2005
Jkt 208001
RETENTION AND DISPOSAL:
Records are maintained with
identifiers for all transactions after they
are entered into the system for a period
of 6 years and 3 months. Records are
housed in both active and archival files.
All claims-related records are
encompassed by the document
preservation order and will be retained
until notification is received from the
Department of Justice.
SYSTEM MANAGER AND ADDRESS:
STORAGE:
SAFEGUARDS:
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. Office of Management and
Budget 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.
Director, Division of Medicare
Advantage Appeals and Payment
Systems, Information Services
Modernization Group, Office of
Information Services, CMS, Room N3–
16–24, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject
individual should write to the systems
manager who will require the system
name, SSN, address, date of birth, sex,
and for verification purposes, the
subject individual’s name (woman’s
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Frm 00051
Fmt 4703
Sfmt 4703
60535
maiden name, if applicable). 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 reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5
(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record 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).
RECORD SOURCE CATEGORIES:
Data for this system is collected from
MAs and MAPDs (which obtained the
data from the individuals concerned),
Social Security Administration, and the
Medicare Beneficiary Database system
of records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 05–20909 Filed 10–17–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Planning, Research and
Evaluation; Notice of Secretary’s
Advisory Committee Meeting
OPRE, ACF, HHS.
Notice of Meeting—Advisory
Committee on Head Start Accountability
and Educational Performance Measures.
AGENCY:
ACTION:
SUMMARY: The Secretary of Health and
Human Services, by authority of 42
U.S.C. 9836A, Section 641A(b) of the
Head Start Act, as amended (5 U.S.C.
Appendix 2), has formed the Advisory
Committee on Head Start Accountability
and Educational Performance Measures
(the Committee). The Committee is
governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
Appendix 2).
The function of the Committee is to
help assess the progress of HHS in
developing and implementing
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[Federal Register Volume 70, Number 200 (Tuesday, October 18, 2005)]
[Notices]
[Pages 60530-60535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20909]
[[Page 60530]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of Modified or Altered System
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of Modified or Altered System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to modify or alter a SOR titled, ``Medicare
Managed Care System (MMCS), No. 09-70-4001.'' MMCS processes
beneficiary enrollment and creates beneficiary level payments for the
Managed Care Organizations (MCO). We propose to broaden the scope of
this system by adding the Medicare Part D Program under Title XVIII.
The Medicare+Choices Program has been changed to the Medicare Advantage
(MA) Program. The MA was mandated by the Balance Budget Act (BBA) of
1997 (Public Law (Pub. L.) 105-33). To more accurately reflect the
changes proposed for this system, we will modify the name to read:
``Medicare Advantage Prescription Drug (MARx) System.'' The enhanced
system will continue to perform all current MMCS processing
requirements. In addition, MARx will be a stand alone system that will
include the processing of all enrollment/disenrollment transactions
associated with the Part D Program. MARx will include the following:
Health Maintenance Organizations (HMO), Health Care Prepayment Plan
(HCPP), Medicare Advantage Organizations (MAO), Medicare Advantage
Prescription Drug (MAPD) Plans and Prescription Drug Plans (PDP).
On December 8, 2003, Congress passed the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-
173). MMA amends the Social Security Act (the Act) by adding the
Medicare Part D Program under Title XVIII and mandate that CMS
establish a voluntary Medicare prescription drug benefit program
effective January 1, 2006. Under the new Medicare Part D benefit, the
Act allows Medicare payment to MA plans that contract with CMS to
provide qualified Part D prescription drug coverage as described in 42
Code of Federal Regulations (CFR) 417 and 422.
We are modifying the language in some of the routine uses to
provide clarity to CMS's intention to disclose individual-specific
information contained in this system. The routine uses will remain
prioritized according to their proposed usage. Information previously
retrieved from the Enrollment Database (System No. 09-70-0502) will now
be retrieved by the Medicare Beneficiary Database (MBD) (System No. 09-
70-0536). We will also take the opportunity to update any sections of
the system that were affected by the recent reorganization and to
update language in the administrative sections to correspond with
language used in other CMS SORs.
The primary purpose of the SOR is to maintain a master file of MA
and MAPD plan members for accounting and payment control; expedite the
exchange of data with MA and MAPD; control the posting of pro-rata
amounts to the Part B deductible of currently enrolled MA members; and
track participation of the prescription drug benefits provided under
private prescription drug plans and Medicare employer plans.
Information in this system will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed by a
contractor or consultant contracted by the Agency; (2) support another
Federal or State agency, agency of a state government, an agency
established by state law, or its fiscal agent; (3) assist provider and
suppliers of service directly or dealing through contractors, fiscal
intermediaries (FI) or carriers for the administration of Title XVIII;
(4) assist third party contacts 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; (5) assist
insurance companies, third party administrators, employers, self-
insurers, managed care organizations, and other supplemental insurers;
(6) facilitate research on the quality and effectiveness of care
provided, as well as payment-related projects; (7) support constituent
requests made to a congressional representative; (8) support litigation
involving the Agency, and (9) combat fraud and abuse in certain health
benefits programs. We have provided background information about the
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 proposed routine uses, CMS
invites comments on all portions of this notice. See Effective Dates
section for comment period.
EFFECTIVE DATES: CMS filed a modified or altered system report with the
Chair of the House Committee on Government Reform and Oversight, the
Chair of the Senate Committee on Governmental Affairs, and the
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB) on October 14, 2005. To ensure that all
parties have adequate time in which to comment, the modified or altered
SOR, including routine uses, will become effective 40 days from the
publication of the notice, or from the date it was submitted to OMB and
the Congress, whichever is later, unless CMS receives comments that
require alterations to this notice.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Privacy Compliance Data Development (DPCDD), CMS, Room N2-
04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Comments received will be available for review at this location, by
appointment, during regular business hours, Monday through Friday from
9 a.m.-3 p.m., Eastern daylight time.
FOR FURTHER INFORMATION CONTACT: Mary Sincavage, Division Director,
Division of Medicare Advantage Appeals and Payment Systems, Information
Services Modernization Group, Office of Information Services, CMS, Room
N3-16-24, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The
telephone number is 410-786-1163.
SUPPLEMENTARY INFORMATION: The Medicare Managed Care System (MMCS) is
the redesign of the legacy system Group Health Plan (GHP) system. MMCS
processes beneficiary enrollment and creates beneficiary level payments
for the Managed Care Organizations (MCO). The beneficiary level
payments are aggregated to the MCO level and sent to the Automated Plan
Payment System (APPS) for additional organization level adjustments
before payments are sent to the MCOs. An independent technical
evaluation of CMS' managed care system found that without major
enhancements, MA provisions could not be supported by existing Medicare
systems. Also, the comprehensive review of existing systems was
necessary in order to proceed with a development effort that would
ensure those future customer service and program management objectives
were met.
The CMS has long realized that the Medicare program is in the
middle of rapidly changing health insurance industry characterized by
an expansion of service delivery models and payment options. The MA
provisions of the BBA of 1997 (Pub. L. 105-33) has made the challenge
of managing beneficiary
[[Page 60531]]
health choices one of the most critical challenges facing CMS and the
health industry at large. To be of maximum use, the data must be
organized and categorized into a comprehensive system. CMS sought to
identify key sources, including both organizations and systems that
could provide valid and reliable information. Medicare will no longer
exist within an environment characterized by limited health insurance
options and standard delivery models.
MARx will recalculate payments due to Part D risk adjustment factor
reconciliation. MARx will receive low income subsidy status information
from the MBD, including notification of any changes. MARx will
calculate adjustments due to any retroactive changes to low income
subsidy status. MARx is not responsible for sending Social Security
Administration (SSA) the Part D plan data. It is assumed that this will
come from the Health Plan Management System (HPMS) (System No. 09-70-
4004). Fallback plans will not be paid by MARx. MARx enrollments may be
rejected if a beneficiary is currently enrolled in a plan that is part
of the retiree drug subsidy (RDS). MARx will notify the RDS of any
rejected enrollments due to this situation. Plans will be notified on a
weekly basis, if MARx has adjusted the premium or if SSA/Railroad
Retirement Board/Office of Personnel Management cannot deduct the
premium. Additionally, MARx is a stand alone system that will be
processing all enrollment/disenrollment transactions associated with
the Part D program.
I. Description of the Modified System of Records
A. Statutory and Regulatory Basis for the System. Authority for
maintenance of the system is given under Section 101 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173) amended the Title XVIII of the Social Security Act.
Authority for maintenance of the system is also given under the
provisions of Sec. Sec. 1833(a)(1)(A), 1860, 1866, and 1876 of Title
XVIII of the Act (42 CFR 417 and 422).
B. Collection and Maintenance of Data in the System. The system
will include information on recipients of Medicare hospital insurance
(Part A) and Medicare medical insurance (Part B) and recipients of the
Prescription Drug Benefits Program (Part D) enrolled in the MA Program.
The system will also include information about a beneficiary's
entitlement to Medicare benefits and enrollment in Medicare Programs,
prescription drug coverage and supplementary medical claims
information. The system will contact identifying information such as
beneficiary name, health insurance claim number, social security
number, and other demographic information.
II. Agency Policies, Procedures, and Restrictions on Routine Uses
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 MARx information that can be
associated with an individual as provided for under ``Section III.
Modified 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 MARx. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from the SOR 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 data is being collected; e.g., to maintain a master file of MA
and MAPD plan members for accounting and payment control; expedite the
exchange of data with MA and MAPD; control the posting of pro-rata
amounts to the Part B deductible of currently enrolled MA members; and
track participation of the prescription drug benefits provided under
private prescription drug plans and Medicare employer plans.
2. Determines that the purpose for which the disclosure is to be
made can only be accomplished if the record is provided in individually
identifiable form;
a. 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
b. 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. Entities Who May Receive Disclosures Under Routine Use. These
routine uses specify circumstances, in addition to those provided by
statute in the Privacy Act of 1974, under which CMS may release
information from the MARx without the consent of the individual to whom
such information pertains. Each proposed disclosure of information
under these routine uses will be evaluated to ensure that the
disclosure is legally permissible, including but not limited to
ensuring that the purpose of the disclosure is compatible with the
purpose for which the information was collected. We are proposing to
establish or modify the following routine use disclosures of
information maintained in the system:
1. To Agency contractors, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this system and who need to have access to the records
in order to assist CMS.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing a CMS function
relating to purposes for this 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 or consultant whatever information is
necessary for the contractor or consultant to fulfill its duties. In
these situations, safeguards are provided in the contract prohibiting
the contractor or consultant from using or disclosing the information
for any purpose other than that described in the contract and requires
the contractor or consultant to return or destroy all information at
the completion of the contract.
2. To 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's proper payment of Medicare
benefits,
b. Enable such agency to administer a Federal health benefits
program, or as
[[Page 60532]]
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 MARx information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
Disclosure under this routine use shall be used by state Medicaid
agencies pursuant to agreements with the HHS for determining Medicaid
and Medicare eligibility, for quality control studies, for determining
eligibility of recipients of assistance under Titles IV, XVIII, and XIX
of the Act, and for the administration of the Medicaid program. Data
will be released to the state only on those individuals who are
patients under the services of a Medicaid program within the state or
who are residents of that state.
We also contemplate disclosing information under this routine use
in situations in which state auditing agencies require MARx information
for auditing state Medicaid eligibility considerations. CMS may enter
into an agreement with state auditing agencies to assist in
accomplishing functions relating to purposes for this system to
providers and suppliers of services directly or through fiscal
intermediaries or carriers for the administration of Title XVIII of the
Act.
3. To providers and suppliers of services directly or dealing
through fiscal intermediaries or carriers for the administration of
Title XVIII of the Act.
Providers and suppliers of services require MARx 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 third party contacts 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 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 and abuse, program integrity, quality appraisal, or
evaluation and measurement of activities.
Third party contacts require MARx 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 insurance companies, third party administrators (TPA),
employers, self-insurers, managed care organizations, other
supplemental insurers, non-coordinating insurers, multiple employer
trusts, group health plans (i.e., health maintenance organizations or a
competitive medical plan with a Medicare contract, or a Medicare-
approved health care prepayment plan), directly or through a
contractor, and other groups providing protection for their enrollees.
Information to be disclosed shall be limited to Medicare entitlement
data. In order to receive the information, they must agree to:
a. Certify that the individual about whom the information is being
provided is one of its insured or employees, or is insured and/or
employed by another entity for whom they serve as a TPA;
b. Utilize the information solely for the purpose of processing the
identified individual's insurance claims; and
c. Safeguard the confidentiality of the data and prevent
unauthorized access.
Other insurers, TPAs, HMOs, and HCPPs may require MARx information
in order to support evaluations and monitoring of Medicare claims
information of beneficiaries, including proper reimbursement for
services provided.
6. To an individual or organization for a research, evaluation, or
epidemiological project related to the prevention of disease or
disability, the restoration or maintenance of health, or payment-
related projects.
MARx data will provide for research, evaluation, and
epidemiological projects, a broader, longitudinal, national perspective
of the status of Medicare beneficiaries. CMS anticipates that many
researchers will have legitimate requests to use these data in projects
that could ultimately improve the care provided to Medicare
beneficiaries and the policy that governs the care.
7. To a Member of Congress or a congressional staff member in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
Beneficiaries often request the help of a Member of Congress in
resolving some issue relating to a matter before CMS. The Member of
Congress then writes CMS, and CMS must be able to give sufficient
information tin response to the inquiry.
8. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The Agency or any component thereof, or
b. Any employee of the Agency in his or her official capacity, or
c. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
Whenever CMS is involved in litigation, or occasionally when
another party is involved in litigation and CMS's policies or
operations could be affected by the outcome of the litigation, CMS
would be able to disclose information to the DOJ, court, or
adjudicatory body involved.
9. To a CMS contractor (including, but not limited to FIs and
carriers) that assists in the administration of a CMS-administered
health benefits program,
[[Page 60533]]
or to a grantee of a CMS-administered grant program, when disclosure is
deemed reasonably necessary by CMS to prevent, deter, discover, detect,
investigate, examine, prosecute, sue with respect to, defend against,
correct, remedy, or otherwise combat fraud or abuse in such programs.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contract or grant with a
third party to assist in accomplishing CMS functions relating to the
purpose of combating fraud and abuse.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor or grantee whatever information is necessary
for the contractor or grantee to fulfill its duties. In these
situations, safeguards are provided in the contract prohibiting the
contractor or grantee from using or disclosing the information for any
purpose other than that described in the contract and requiring the
contractor or grantee to return or destroy all information.
10. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs. Other agencies may require MARx
information for the purpose of combating fraud and abuse in such
Federally-funded programs.
B. Additional Circumstances Affecting Routine Use Disclosures. This
system contains Protected Health Information as defined by HHS
regulation ``Standards for Privacy of Individually Identifiable Health
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (12-28-00),
Subparts A and E. The protected health information is collected from
the Plan during the enrollment process and passed onto the Medicare
Beneficiary Database. These elements include the Beneficiary Name, Sex,
Date of Birth, and Health Insurance Claim Number. Disclosures of
Protected Health Information authorized by these routine uses may only
be made if, and as, permitted or required by the ``Standards for
Privacy of Individually Identifiable Health Information.''
In addition, our policy will be to prohibit release even of data
not directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: The Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the Modified System on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. We will only
disclose the minimum personal data necessary to achieve the purpose of
MARx. Disclosure of information from the system will be approved only
to the extent necessary to accomplish the purpose of the disclosure.
CMS has assigned a higher level of security clearance for the
information maintained in this system in an effort to provide added
security and protection of data in this system.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights. CMS will collect only
that information necessary to perform the system's functions. In
addition, CMS will make disclosure from the proposed system only with
consent of the subject individual, or his/her legal representative, or
in accordance with an applicable exception provision of the Privacy
Act.
CMS, therefore, does not anticipate an unfavorable effect on
individual privacy as a result of the disclosure of information
relating to individuals.
Dated: October 12, 2005.
Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-4001.
SYSTEM NAME:
``Medicare Advantage Prescription Drug (MARx)'' System HHS/CMS/OIS.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive.
SYSTEM LOCATION:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The system will include information on recipients of Medicare
hospital insurance (Part A) and Medicare medical insurance (Part B) and
recipients of the Prescription Drug Benefits Program (Part D) enrolled
in the Medicare Advantage (MA) Program.
CATEGORIES OF RECORDS IN THE SYSTEM:
The system will also include information about a beneficiary's
entitlement to Medicare benefits and enrollment in Medicare Programs,
prescription drug coverage and supplementary medical claims
information. The system will contain identifying information such as
beneficiary name, health insurance claim number, social security
number, and other demographic information.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the system is given under Section 101
of the
[[Page 60534]]
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) (Pub. L. 108-173) amended the Title XVIII of the Social Security
Act. Authority for maintenance of the system is also given under the
provisions of Sec. Sec. 1833(a)(1)(A), 1860, 1866, and 1876 of Title
XVIII of the Act (42 CFR 417 and 422).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the SOR is to maintain a master file of MA
and MAPD plan members for accounting and payment control; expedite the
exchange of data with MA and MAPD; control the posting of pro-rata
amounts to the Part B deductible of currently enrolled MA members; and
track participation of the prescription drug benefits provided under
private prescription drug plans and Medicare employer plans.
Information in this system will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed by a
contractor or consultant contracted by the Agency; (2) support another
Federal or State agency, agency of a state government, an agency
established by state law, or its fiscal agent; (3) assist provider and
suppliers of service directly or dealing through contractors, fiscal
intermediaries (FI) or carriers for the administration of Title XVIII;
(4) assist third party contacts 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; (5) assist
insurance companies, third party administrators, employers, self-
insurers, managed care organizations, and other supplemental insurers;
(6) facilitate research on the quality and effectiveness of care
provided, as well as payment-related projects; (7) support constituent
requests made to a congressional representative; (8) support litigation
involving the Agency, and (9) combat fraud and abuse in certain health
benefits programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
A. Entities Who May Receive Disclosures Under Routine Use. These
routine uses specify circumstances, in addition to those provided by
statute in the Privacy Act of 1974, under which CMS may release
information from the MARx without the consent of the individual to whom
such information pertains. Each proposed disclosure of information
under these routine uses will be evaluated to ensure that the
disclosure is legally permissible, including but not limited to
ensuring that the purpose of the disclosure is compatible with the
purpose for which the information was collected. We are proposing to
establish or modify the following routine use disclosures of
information maintained in the system:
1. To Agency contractors, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this system and who need to have access to the records
in order to assist CMS.
2. To another Federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
b. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds, and/or
c. Assist Federal/state Medicaid programs within the state.
3. To providers and suppliers of services directly or through
fiscal intermediaries or carriers for the administration of Title XVIII
of the Act.
4. To third party contacts 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 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 and abuse, program integrity, quality appraisal, or
evaluation and measurement of activities.
5. To insurance companies, third party administrators (TPA),
employers, self-insurers, managed care organizations, other
supplemental insurers, non-coordinating insurers, multiple employer
trusts, group health plans (i.e., health maintenance organizations or a
competitive medical plan with a Medicare contract, or a Medicare-
approved health care prepayment plan), directly or through a
contractor, and other groups providing protection for their enrollees.
Information to be disclosed shall be limited to Medicare entitlement
data. In order to receive the information, they must agree to:
a. Certify that the individual about whom the information is being
provided is one of its insured or employees, or is insured and/or
employed by another entity for whom they serve as a TPA;
b. Utilize the information solely for the purpose of processing the
identified individual's insurance claims; and
c. Safeguard the confidentiality of the data and prevent
unauthorized access.
6. To an individual or organization for a research, evaluation, or
epidemiological project related to the prevention of disease or
disability, the restoration or maintenance of health, or payment-
related projects.
7. To a Member of Congress or a congressional staff member in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
8. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The Agency or any component thereof, or
b. Any employee of the Agency in his or her official capacity, or
c. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation, and, by careful review, CMS determines
that the records are both relevant and necessary to the litigation and
that the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
9. To a CMS contractor (including, but not limited to FIs and
carriers) that assists in the administration of a CMS-administered
health benefits program,
[[Page 60535]]
or to a grantee of a CMS-administered grant program, when disclosure is
deemed reasonably necessary by CMS to prevent, deter, discover, detect,
investigate, examine, prosecute, sue with respect to, defend against,
correct, remedy, or otherwise combat fraud or abuse in such programs.
10. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Circumstances Affecting Routine Use Disclosures. This
system contains Protected Health Information as defined by the
Department of Health and Human Services (HHS) regulation ``Standards
for Privacy of Individually Identifiable Health Information'' (45 CFR
Parts 160 and 164, 65 Fed. Reg. 82462 (12-28-00), Subparts A and E.
Disclosures of Protected Health Information authorized by these routine
uses may only be made if, and as, permitted or required by the
``Standards for Privacy of Individually Identifiable Health
Information.''
In addition, our policy will be to prohibit release even of data
not directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Computer diskette and on magnetic storage media.
RETRIEVABILITY:
Information can be retrieved by name and health insurance claim
number of the beneficiary.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. Office of Management and Budget
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 with identifiers for all transactions after
they are entered into the system for a period of 6 years and 3 months.
Records are housed in both active and archival files. All claims-
related records are encompassed by the document preservation order and
will be retained until notification is received from the Department of
Justice.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Medicare Advantage Appeals and Payment
Systems, Information Services Modernization Group, Office of
Information Services, CMS, Room N3-16-24, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
systems manager who will require the system name, SSN, address, date of
birth, sex, and for verification purposes, the subject individual's
name (woman's maiden name, if applicable). 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 reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5 (a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the record 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).
RECORD SOURCE CATEGORIES:
Data for this system is collected from MAs and MAPDs (which
obtained the data from the individuals concerned), Social Security
Administration, and the Medicare Beneficiary Database system of
records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-20909 Filed 10-17-05; 8:45 am]
BILLING CODE 4120-03-P