Privacy Act of 1974; Report of a Modified or Altered System of Records, 67143-67148 [E6-19506]
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Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a
Modified or Altered System of Records
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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AGENCY:
SUMMARY: In accordance with the
Privacy Act of 1974, we are proposing
to modify or alter an existing SOR,
‘‘Inpatient Rehabilitation Facilities (IRF)
Patient Assessment Instrument (IRF–
PAI),’’ System No. 09–70–1518, last
published at 66 Federal Register 56681
(November 9, 2001). Information
maintained in this system will continue
to contain clinical assessment
information for all Medicare Part A feefor-service patients receiving the
services of a Medicare approved IRF.
This information will be useful in
developing core measures that provide
meaningful information on patient
characteristics and outcomes across
post-acute care settings and will be used
by CMS to fulfill its responsibility for
validating surveys conducted by
accrediting agencies. We propose to
assign a new CMS identification number
to this system to simplify the obsolete
and confusing numbering system
originally designed to identify the
Bureau, Office, or Center that
maintained information in the Health
Care Financing Administration systems
of records. The new assigned identifying
number for this system should read:
System No. 09–70–0521.
We propose to modify existing routine
use number 1 that permits disclosure to
agency contractors and consultants to
include disclosure to CMS grantees who
perform a task for the agency. CMS
grantees, charged with completing
projects or activities that require CMS
data to carry out that activity, are
classified separate from CMS
contractors and/or consultants. The
modified routine use will remain as
routine use number 1. We will modify
existing routine use number 2 that
permits disclosure to Peer Review
Organizations (PRO). Organizations
previously referred to as PROs will be
renamed to read: Quality Improvement
Organizations (QIO). Information will be
disclosed to QIOs relating to assessing
and improving IRF quality of care. The
modified routine use will be
renumbered as routine use number 4.
We will delete routine use number 5
authorizing disclosure to support
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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 7 and 8,
authorizing disclosures to combat fraud
and abuse in the Medicare and
Medicaid programs to include
combating ‘‘waste’’ which refers
increasingly more to specific beneficiary
or recipient practices that result in
unnecessary cost to federally-funded
health benefit programs.
CMS proposes to broaden the scope of
the disclosure requirement for routine
use number 5, authorizing disclosure to
national accrediting organizations that
have been approved by CMS for
deeming authority for Medicare
requirements for home health services.
Information will be released to these
organizations for only those facilities
that they accredit and that participate in
the Medicare program and if they meet
the following requirements: (1) Provide
identifying information for IRFs that
have an accreditation status with the
requesting accrediting organization that
has been granted deeming authority by
CMS, (2) submission of a finder file
identifying beneficiaries/patients
receiving IRF services, (3) safeguard the
confidentiality of the data and prevent
unauthorized access, and (4) upon
completion of a signed data exchange
agreement or a CMS data use agreement.
We are modifying the language in the
remaining routine uses to provide a
proper explanation as to the need for the
routine use and to provide clarity to
CMS’s intention to disclose individualspecific information contained in this
system. The routine uses will then be
prioritized and reordered according to
their usage. We will also take the
opportunity to update any sections of
the system that were affected by the
recent reorganization or because of the
impact of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (MMA) (Pub. L. 108–173)
provisions and to update language in
the administrative sections to
correspond with language used in other
CMS SORs.
The primary purpose of this modified
system is to support the IRF prospective
payment system (PPS) for payment of
the IRF Medicare Part A fee-for-services
furnished by the IRF to Medicare
beneficiaries. Information maintained in
this system will also be disclosed to: (1)
Support regulatory, reimbursement, and
policy functions performed within the
Agency or by a contractor, consultant, or
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67143
a CMS grantee; (2) assist another Federal
and/or state agency, agency of a state
government, an agency established by
state law, or its fiscal agent, for
evaluating and monitoring the quality of
IRF health care and contribute to the
accuracy of health insurance operations;
(3) support research, evaluation, or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment related projects; (4)
support the functions of Quality
Improvement Organizations; (5) assist
other insurers; (6) support the functions
of national accrediting organizations; (7)
support litigation involving the Agency;
and (8) combat fraud, waste, and abuse
in certain health care 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 modified or altered
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 system 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 November 14, 2006. To
ensure that all parties have adequate
time in which to comment, the modified
system, including routine uses, will
become effective 30 days from the
publication of the notice, or 40 days
from the date it was submitted to OMB
and 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,
Enterprise Architecture and Strategy
Group, Office of Information Services,
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 Time zone.
FOR FURTHER INFORMATION CONTACT:
Georgia Johnson, Division of Continuing
Care Providers, Survey and Certification
Group, Center for Medicaid and State
Operations, CMS, Mail Stop S2–12–25,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850. She can also be
reached by telephone at 410–786–6859,
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or via e-mail at
Georgia.Johnson@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 section 1886 (j)
(2) (D) of the Social Security Act
authorizing the secretary to collect the
data necessary to establish and
administer the payment system.
B. Collection and Maintenance of Data
in the System
The IRF–PAI will be completed on all
Medicare Part A fee-for-service patients
who receive services under Part A from
an IRF, it may also be completed on
Medicare Advantage enrollees. Records
in this system will include, but are not
limited to, name, address, date of birth,
gender, ethnicity, social security
number, health insurance claim
number, Medicaid number, patient
identification number, patient history,
diagnosis, and functional prognosis.
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II. Agency Policies, Procedures, and
Restrictions on Routine Uses
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 IRF–PAI
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 IRF–PAI. 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
support the IRF prospective payment
system (PPS) for payment of the IRF
Medicare Part A fee-for-services
furnished by the IRF to Medicare
beneficiaries.
2. Determines that:
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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. Proposed Routine Use Disclosures
of Data in The System
A. The Privacy Act allows us to
disclose information without an
indivdual’s consent if the information is
to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To support agency contractors,
consultants, or grantees who have been
engaged by the agency to assist in the
performance of a service related to this
collection 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 contractor or
consultant to fulfill its duties. In these
situations, safeguards are provided in
the contract prohibiting the contractor,
consultant or grantee from using or
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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 and/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. Improve the state survey process for
investigation of complaints related to
health and safety or quality of care and
to implement a more outcome oriented
survey and certification program.
Other Federal or state agencies in
their administration of a Federal health
program may require IRF–PAI
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper reimbursement for
services provided.
3. To an individual or organization for
research on the utilization of inpatient
rehabilitation services as well as
evaluation or epidemiological projects
related to the prevention of disease or
disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects.
The IRF–PAI data will provide for
research or in support of evaluation
projects, a broader, 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.
4. 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.
The QIO may use this data to support
quality improvement activities and
other QIO responsibilities as detailed in
Title XI §§ 1151–1164.
The QIO will work to implement
quality improvement programs, provide
consultation to CMS, its contractors,
and to state agencies. The QIO will
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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.
5. To assist 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
organization (HMO) or a competitive
medical plan (CMP)) with a Medicare
contract, or a Medicare-approved health
care payment plan (HCPP), 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 third
party administrator;
b. Utilize the information solely for
the purpose of processing the
individual’s insurance claims; and
c. Safeguard the confidentiality of the
data and prevent unauthorized access.
Other insurers, CMP, HMO and HCPP
may require IRF–PAI information in
order to support evaluations and
monitoring of Medicare claims
information of beneficiaries, including
proper payment for services provided.
6. To assist national accrediting
organization(s) whose accredited
facilities are presumed to meet certain
Medicare requirements for inpatient
hospital rehabilitation services (e.g., the
Joint Commission for the Accreditation
of Healthcare Organizations, the
American Osteopathic Association, or
the Commission on Accreditation of
Rehabilitation Facilities). Information
will be released to these organizations
for only those facilities that they
accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
IRFs that have an accreditation status
with the requesting deemed
organization;
b. Submission of a finder file
identifying beneficiaries/patients
receiving IRF services;
c. Safeguard the confidentiality of the
data and prevent unauthorized access;
and
d. Upon completion of a signed data
exchange agreement or a CMS data use
agreement.
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At this time, CMS anticipates
providing accrediting organizations
with IRF–PAI information to enable
them to target potential identified
problems during the organization’s
accreditation review process of the
facility.
7. To support the Department of
Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, and occasionally when
another party is involved in litigation
and CMS’ policies or operations could
be affected by the outcome of the
litigation, CMS would be able to
disclose information to the DOJ, court or
adjudicatory body involved.
8. To assist a CMS contractor
(including, but not necessarily limited
to fiscal intermediaries and carriers) that
assists in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste, or abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual relationship or grant
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud,
waste, and abuse.
CMS occasionally contracts out
certain of its functions and makes grants
when doing so would contribute to
effective and efficient operations. CMS
must be able to give a contractor or
grantee whatever information is
necessary for the contractor or grantee to
fulfill its duties. In these situations,
safeguards are provided in the contract
prohibiting the contractor or grantee
from using or disclosing the information
for any purpose other than that
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67145
described in the contract and requiring
the contractor or grantee to return or
destroy all information.
9. To assist 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 IRF–PAI
information for the purpose of
combating fraud, waste, and abuse in
such federally-funded programs.
B. Additional Provisions Affecting
Routine Use Disclosures
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164–512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
individuals could, because of the small
size, use this information to deduce the
identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against 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
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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 NIST
publications; the DHHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
V. Effects of the Modified 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.
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Dated: November 8, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO. 09–70–0521
SYSTEM NAME:
‘‘Inpatient Rehabilitation Facilities
Patient Assessment Instrument (IRF–
PAI),’’ HHS/CMS/CMSO.
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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 and at various contractor sites and
at CMS Regional Offices.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The IRF–PAI will be completed on all
Medicare Part A fee-for-service patients
who receive services under Part A from
an IRF, it may also be completed on
Medicare Advantage enrollees.
CATEGORIES OF RECORDS IN THE SYSTEM:
Records in this system will include,
but are not limited to, name, address,
date of birth, gender, ethnicity, social
security number (SSN), health insurance
claim number (HICN), Medicaid
number, patient identification number,
patient history, diagnosis, and
functional prognosis.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the
system is given under section
1886(j)(2)(D) of the Social Security Act
authorizing the secretary to collect the
data necessary to establish and
administer the payment system.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this modified
system is to support the IRF prospective
payment system (PPS) for payment of
the IRF Medicare Part A fee-for-services
furnished by the IRF to Medicare
beneficiaries. Information maintained in
this system 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
and/or state agency, agency of a state
government, an agency established by
state law, or its fiscal agent, for
evaluating and monitoring the quality of
IRF health care and contribute to the
accuracy of health insurance operations;
(3) support research, evaluation, or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment related projects; (4)
support the functions of Quality
Improvement Organizations (QIO); (5)
assist other insurers; (6) support the
functions of national accrediting
organizations; (7) support litigation
involving the Agency; (8) combat fraud,
waste, and abuse in certain health care
programs.
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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To support agency contractors,
consultants, or grantees who have been
engaged by the agency to assist in the
performance of a service related to this
collection and who need to have access
to the records in order to perform the
activity.
2. To assist another Federal and/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. Improve the state survey process for
investigation of complaints related to
health and safety or quality of care and
to implement a more outcome oriented
survey and certification program.
3. To an individual or organization for
research on the utilization of inpatient
rehabilitation services as well as
evaluation or epidemiological projects
related to the prevention of disease or
disability, the restoration or
maintenance of health, or for
understanding and improving payment
projects.
4. 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.
5. To assist 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
organization (HMO) or a competitive
medical plan (CMP)) with a Medicare
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contract, or a Medicare-approved health
care payment plan (HCPP), 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 third
party administrator;
b. Utilize the information solely for
the purpose of processing the
individual’s insurance claims; and
c. Safeguard the confidentiality of the
data and prevent unauthorized access.
6. To assist national accrediting
organization(s) whose accredited
facilities are presumed to meet certain
Medicare requirements for inpatient
hospital rehabilitation services (e.g., the
Joint Commission for the Accreditation
of Healthcare Organizations, the
American Osteopathic Association, or
the Commission on Accreditation of
Rehabilitation Facilities). Information
will be released to these organizations
for only those facilities that they
accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
IRFs that have an accreditation status
with the requesting deemed
organization;
b. Submission of a finder file
identifying beneficiaries/patients
receiving IRF services;
c. Safeguard the confidentiality of the
data and prevent unauthorized access;
and
d. Upon completion of a signed data
exchange agreement or a CMS data use
agreement.
7. To support the Department of
Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
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17:10 Nov 17, 2006
Jkt 211001
8. To assist a CMS contractor
(including, but not necessarily limited
to fiscal intermediaries and carriers) that
assists in the administration of a CMSadministered 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.
9. To assist 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 on magnetic
media.
RETRIEVABILITY:
The Medicare records are retrieved by
the HICN and SSN.
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67147
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 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 DHHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable IRF–PAI
data for a total period of 15 years. All
claims-related records are encompassed
by the document preservation order and
will be retained until notification is
received from DOJ.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Survey and Certification
Group, Center for Medicaid and State
Operations, CMS, Mail Stop C3–20–01,
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
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67148
Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices
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:
Information for this system is
collected from the Inpatient
Rehabilitation Facilities—Patient
Assessment Instrument.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E6–19506 Filed 11–17–06; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
sroberts on PROD1PC70 with NOTICES
Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator, Health
Resources and Services Administration
(HRSA), with authority to re-delegate,
the authority vested in the Secretary of
Health and Human Services under Title
III, Part B, Section 319F–4, titled
‘‘Covered Countermeasure Process,’’ of
the Public Health Service Act, as
amended, by the Public Readiness and
Emergency Preparedness Act of 2006
(Pub. L. 109–148), only insofar as it
pertains to the compensation program.
This delegation shall be exercised
under the Department’s existing
delegation of authority and policy on
regulations.
This delegation is effective upon
signature. In addition, I hereby affirmed
and ratified any actions taken by the
HRSA Administrator or other HRSA
officials which involved the exercise of
this authority prior to the effective date
of this delegation.
This delegation is effective upon date
of signature.
VerDate Aug<31>2005
17:10 Nov 17, 2006
Jkt 211001
Dated: November 8, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06–9264 Filed 11–17–06; 8:45 am]
BILLING CODE 4165–15–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute: Circulating Biomarkers of
Cardiovascular Risk in the NHLBI’s
Framingham Heart Study
National Heart, Lung, and
Blood Institute, NIH, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: National Heart, Lung, and
Blood Institute (NHLBI) seeks partners
in a biomarker consortium to promote
research on novel serum/plasma/urine
biomarkers of cardiovascular disease
(CVD) and related risk factors including
atherosclerosis, obesity, insulin
resistance, hypertension, and metabolic
syndrome. An immediate consequence
of this project will be the development
of new diagnostic tests to identify
individuals at high risk for CVD and its
risk factors at a time when intervention
is most feasible. A downstream result of
the identification of novel biomarkers of
CVD (and its risk factors) will be the
discovery of disease promoting
pathways, which may serve as new
therapeutic targets for treating and
preventing our nation’s leading cause of
death.
Background: Despite steady declines
in CVD mortality, CVD remains the
leading cause of death in the developed
world. The NHLBI’s Framingham Heart
Study (FHS) has been instrumental in
the identification and elucidation of key
modifiable risk factors for CVD, which
in turn have facilitated modern
approaches to the prevention and
treatment of CVD. Because of its
prospective study design, the NHLBI’s
FHS is ideally positioned to enable
identification of novel risk factors for
CVD. The availability of frozen serum/
plasma/urine samples from over 7000
FHS participants in the Offspring and
Third Generation cohorts, in concert
with new high-throughput quantitative
biomarker technology available from
commercial collaborators, provides a
unique opportunity to explore the
biochemical signatures of key CVD
phenotypes. In addition, by the end of
2007 genotyping of 550k SNPs will be
completed in nearly all the FHS
participants as part of the NHLBI’s
SHARe project and these data will
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Fmt 4703
Sfmt 4703
permit analysis of the associations of
gene variants with biomarker levels.
Scientific Scope: The proposed study
will measure 150 or more evolving and
novel biomarkers from the FHS in 7000
FHS subjects for whom subclinical and
clinical CVD and its risk factors have
been carefully characterized. Analyses
will be conducted for association of
biomarkers—individually and
collectively—with clinically relevant
phenotypes.
The aims of the project are to:
1. Identify the biochemical signature
of atherosclerosis as determined by: (a)
Aortic and coronary calcification on CT
(data available in 3500 people), (b)
aortic plaque burden by MRI (n=2000),
(c) carotid intimal-medial thickness by
ultrasound (n=3500), (d) clinical
atherosclerotic CVD (n=500), and (e) the
dynamic balance between arterial
calcification and bone demineralization
(n=3500).
2. Identify the biochemical signature
of metabolic syndrome components
including (a) systolic and diastolic
blood pressure (n=7000), (b) obesity
(n=7000) and visceral adiposity by CT
(n=3500), (c) dyslipidemia (n=7000),
and (d) impaired fasting glucose,
diabetes, and insulin resistance.
Biomarkers for this project will be
selected by expert consensus on the
basis of (a) a careful review of the
literature for biomarkers of
atherosclerosis and metabolic
syndrome, and (b) genes implicated in
atherosclerosis and metabolic syndrome
(and their constituent components and
pathways), or showing evidence of
association with the phenotypes of
interest.
Technology: As part of this project,
new quantitative tests will be developed
to measure circulating biomarker levels
using antibody sandwich assays and/or
proteomic approaches that are amenable
to high throughput application. Critical
to this project is the implementation of
methods to measure large numbers of
biomarkers with minimal sample
volume; proteomic, bead-linked
immunoassays, and nanotechnology
methods may be necessary to
accomplish this aim. Pathways to be
studied include but are not limited to:
Adhesion/chemoattraction, adipokines,
cytokines, growth factors, heat shock
proteins, inflammation, lipoproteins,
neurohormones, thrombosis/
fibrinolysis, and vascular calcification.
Demonstrated rigorous assay validation
using non-FHS samples will be
necessary before FHS biospecimens can
be used for this project.
Study Sample: The NHLBI’s FHS is
community-based[N1], which should
contribute to the generalizability of
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Agencies
[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Pages 67143-67148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19506]
[[Page 67143]]
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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).
-----------------------------------------------------------------------
SUMMARY: In accordance with the Privacy Act of 1974, we are proposing
to modify or alter an existing SOR, ``Inpatient Rehabilitation
Facilities (IRF) Patient Assessment Instrument (IRF-PAI),'' System No.
09-70-1518, last published at 66 Federal Register 56681 (November 9,
2001). Information maintained in this system will continue to contain
clinical assessment information for all Medicare Part A fee-for-service
patients receiving the services of a Medicare approved IRF. This
information will be useful in developing core measures that provide
meaningful information on patient characteristics and outcomes across
post-acute care settings and will be used by CMS to fulfill its
responsibility for validating surveys conducted by accrediting
agencies. We propose to assign a new CMS identification number to this
system to simplify the obsolete and confusing numbering system
originally designed to identify the Bureau, Office, or Center that
maintained information in the Health Care Financing Administration
systems of records. The new assigned identifying number for this system
should read: System No. 09-70-0521.
We propose to modify existing routine use number 1 that permits
disclosure to agency contractors and consultants to include disclosure
to CMS grantees who perform a task for the agency. CMS grantees,
charged with completing projects or activities that require CMS data to
carry out that activity, are classified separate from CMS contractors
and/or consultants. The modified routine use will remain as routine use
number 1. We will modify existing routine use number 2 that permits
disclosure to Peer Review Organizations (PRO). Organizations previously
referred to as PROs will be renamed to read: Quality Improvement
Organizations (QIO). Information will be disclosed to QIOs relating to
assessing and improving IRF quality of care. The modified routine use
will be renumbered as routine use number 4.
We will delete routine use number 5 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 7 and 8,
authorizing disclosures to combat fraud and abuse in the Medicare and
Medicaid programs to include combating ``waste'' which refers
increasingly more to specific beneficiary or recipient practices that
result in unnecessary cost to federally-funded health benefit programs.
CMS proposes to broaden the scope of the disclosure requirement for
routine use number 5, authorizing disclosure to national accrediting
organizations that have been approved by CMS for deeming authority for
Medicare requirements for home health services. Information will be
released to these organizations for only those facilities that they
accredit and that participate in the Medicare program and if they meet
the following requirements: (1) Provide identifying information for
IRFs that have an accreditation status with the requesting accrediting
organization that has been granted deeming authority by CMS, (2)
submission of a finder file identifying beneficiaries/patients
receiving IRF services, (3) safeguard the confidentiality of the data
and prevent unauthorized access, and (4) upon completion of a signed
data exchange agreement or a CMS data use agreement.
We are modifying the language in the remaining routine uses to
provide a proper explanation as to the need for the routine use and to
provide clarity to CMS's intention to disclose individual-specific
information contained in this system. The routine uses will then be
prioritized and reordered according to their usage. We will also take
the opportunity to update any sections of the system that were affected
by the recent reorganization or because of the impact of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173) provisions and to update language in the
administrative sections to correspond with language used in other CMS
SORs.
The primary purpose of this modified system is to support the IRF
prospective payment system (PPS) for payment of the IRF Medicare Part A
fee-for-services furnished by the IRF to Medicare beneficiaries.
Information maintained in this system 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 and/or state agency, agency of a state
government, an agency established by state law, or its fiscal agent,
for evaluating and monitoring the quality of IRF health care and
contribute to the accuracy of health insurance operations; (3) support
research, evaluation, or epidemiological projects related to the
prevention of disease or disability, or the restoration or maintenance
of health, and for payment related projects; (4) support the functions
of Quality Improvement Organizations; (5) assist other insurers; (6)
support the functions of national accrediting organizations; (7)
support litigation involving the Agency; and (8) combat fraud, waste,
and abuse in certain health care 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 modified or
altered 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 system 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 November
14, 2006. To ensure that all parties have adequate time in which to
comment, the modified system, including routine uses, will become
effective 30 days from the publication of the notice, or 40 days from
the date it was submitted to OMB and 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, Enterprise Architecture and Strategy
Group, Office of Information Services, 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 Time zone.
FOR FURTHER INFORMATION CONTACT: Georgia Johnson, Division of
Continuing Care Providers, Survey and Certification Group, Center for
Medicaid and State Operations, CMS, Mail Stop S2-12-25, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850. She can also be reached by
telephone at 410-786-6859,
[[Page 67144]]
or via e-mail at Georgia.Johnson@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 section 1886
(j) (2) (D) of the Social Security Act authorizing the secretary to
collect the data necessary to establish and administer the payment
system.
B. Collection and Maintenance of Data in the System
The IRF-PAI will be completed on all Medicare Part A fee-for-
service patients who receive services under Part A from an IRF, it may
also be completed on Medicare Advantage enrollees. Records in this
system will include, but are not limited to, name, address, date of
birth, gender, ethnicity, social security number, health insurance
claim number, Medicaid number, patient identification number, patient
history, diagnosis, and functional prognosis.
II. Agency Policies, Procedures, and Restrictions on Routine Uses
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 IRF-PAI 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 IRF-PAI. 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 support the IRF
prospective payment system (PPS) for payment of the IRF Medicare Part A
fee-for-services furnished by the IRF to Medicare beneficiaries.
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. Proposed Routine Use Disclosures of Data in The System
A. The Privacy Act allows us to disclose information without an
indivdual's consent if the information is to be used for a purpose that
is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To support agency contractors, consultants, or grantees who have
been engaged by the agency to assist in the performance of a service
related to this collection 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 contractor or consultant 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 and/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. Improve the state survey process for investigation of complaints
related to health and safety or quality of care and to implement a more
outcome oriented survey and certification program.
Other Federal or state agencies in their administration of a
Federal health program may require IRF-PAI information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To an individual or organization for research on the utilization
of inpatient rehabilitation services as well as evaluation or
epidemiological projects related to the prevention of disease or
disability, the restoration or maintenance of health, or for
understanding and improving payment projects.
The IRF-PAI data will provide for research or in support of
evaluation projects, a broader, 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.
4. 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.
The QIO may use this data to support quality improvement activities
and other QIO responsibilities as detailed in Title XI Sec. Sec. 1151-
1164.
The QIO will work to implement quality improvement programs,
provide consultation to CMS, its contractors, and to state agencies.
The QIO will
[[Page 67145]]
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.
5. To assist 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 organization (HMO)
or a competitive medical plan (CMP)) with a Medicare contract, or a
Medicare-approved health care payment plan (HCPP), 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 third party
administrator;
b. Utilize the information solely for the purpose of processing the
individual's insurance claims; and
c. Safeguard the confidentiality of the data and prevent
unauthorized access.
Other insurers, CMP, HMO and HCPP may require IRF-PAI information
in order to support evaluations and monitoring of Medicare claims
information of beneficiaries, including proper payment for services
provided.
6. To assist national accrediting organization(s) whose accredited
facilities are presumed to meet certain Medicare requirements for
inpatient hospital rehabilitation services (e.g., the Joint Commission
for the Accreditation of Healthcare Organizations, the American
Osteopathic Association, or the Commission on Accreditation of
Rehabilitation Facilities). Information will be released to these
organizations for only those facilities that they accredit and that
participate in the Medicare program and if they meet the following
requirements:
a. Provide identifying information for IRFs that have an
accreditation status with the requesting deemed organization;
b. Submission of a finder file identifying beneficiaries/patients
receiving IRF services;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Upon completion of a signed data exchange agreement or a CMS
data use agreement.
At this time, CMS anticipates providing accrediting organizations
with IRF-PAI information to enable them to target potential identified
problems during the organization's accreditation review process of the
facility.
7. To support the Department of Justice (DOJ), court or
adjudicatory body when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation and that
the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS' policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
8. To assist a CMS contractor (including, but not necessarily
limited to fiscal intermediaries and carriers) that assists in the
administration of a CMS-administered health benefits program, or to a
grantee of a CMS-administered grant program, when disclosure is deemed
reasonably necessary by CMS to prevent, deter, discover, detect,
investigate, examine, prosecute, sue with respect to, defend against,
correct, remedy, or otherwise combat fraud, waste, or abuse in such
program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual relationship or
grant with a third party to assist in accomplishing CMS functions
relating to the purpose of combating fraud, waste, and abuse.
CMS occasionally contracts out certain of its functions and makes
grants when doing so would contribute to effective and efficient
operations. CMS must be able to give a contractor or grantee whatever
information is necessary for the contractor or grantee to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the contractor or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requiring the contractor or grantee to return or destroy all
information.
9. To assist 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 IRF-PAI information for the purpose of
combating fraud, waste, and abuse in such federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164-
512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against 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
[[Page 67146]]
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 NIST
publications; the DHHS Information Systems Program Handbook and the CMS
Information Security Handbook.
V. Effects of the Modified 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 8, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0521
SYSTEM NAME:
``Inpatient Rehabilitation Facilities Patient Assessment Instrument
(IRF-PAI),'' HHS/CMS/CMSO.
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 and at various contractor sites and at CMS Regional
Offices.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The IRF-PAI will be completed on all Medicare Part A fee-for-
service patients who receive services under Part A from an IRF, it may
also be completed on Medicare Advantage enrollees.
CATEGORIES OF RECORDS IN THE SYSTEM:
Records in this system will include, but are not limited to, name,
address, date of birth, gender, ethnicity, social security number
(SSN), health insurance claim number (HICN), Medicaid number, patient
identification number, patient history, diagnosis, and functional
prognosis.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the system is given under section
1886(j)(2)(D) of the Social Security Act authorizing the secretary to
collect the data necessary to establish and administer the payment
system.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this modified system is to support the IRF
prospective payment system (PPS) for payment of the IRF Medicare Part A
fee-for-services furnished by the IRF to Medicare beneficiaries.
Information maintained in this system 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 and/or state agency, agency of a state
government, an agency established by state law, or its fiscal agent,
for evaluating and monitoring the quality of IRF health care and
contribute to the accuracy of health insurance operations; (3) support
research, evaluation, or epidemiological projects related to the
prevention of disease or disability, or the restoration or maintenance
of health, and for payment related projects; (4) support the functions
of Quality Improvement Organizations (QIO); (5) assist other insurers;
(6) support the functions of national accrediting organizations; (7)
support litigation involving the Agency; (8) combat fraud, waste, and
abuse in certain health care programs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To support agency contractors, consultants, or grantees who have
been engaged by the agency to assist in the performance of a service
related to this collection and who need to have access to the records
in order to perform the activity.
2. To assist another Federal and/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. Improve the state survey process for investigation of complaints
related to health and safety or quality of care and to implement a more
outcome oriented survey and certification program.
3. To an individual or organization for research on the utilization
of inpatient rehabilitation services as well as evaluation or
epidemiological projects related to the prevention of disease or
disability, the restoration or maintenance of health, or for
understanding and improving payment projects.
4. 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.
5. To assist 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 organization (HMO)
or a competitive medical plan (CMP)) with a Medicare
[[Page 67147]]
contract, or a Medicare-approved health care payment plan (HCPP),
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 third party
administrator;
b. Utilize the information solely for the purpose of processing the
individual's insurance claims; and
c. Safeguard the confidentiality of the data and prevent
unauthorized access.
6. To assist national accrediting organization(s) whose accredited
facilities are presumed to meet certain Medicare requirements for
inpatient hospital rehabilitation services (e.g., the Joint Commission
for the Accreditation of Healthcare Organizations, the American
Osteopathic Association, or the Commission on Accreditation of
Rehabilitation Facilities). Information will be released to these
organizations for only those facilities that they accredit and that
participate in the Medicare program and if they meet the following
requirements:
a. Provide identifying information for IRFs that have an
accreditation status with the requesting deemed organization;
b. Submission of a finder file identifying beneficiaries/patients
receiving IRF services;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Upon completion of a signed data exchange agreement or a CMS
data use agreement.
7. To support the Department of Justice (DOJ), court or
adjudicatory body when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation and that
the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
8. To assist 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.
9. To assist 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 on magnetic media.
RETRIEVABILITY:
The Medicare records are retrieved by the HICN and SSN.
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 DHHS
Information Systems Program Handbook and the CMS Information Security
Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable IRF-PAI data for a total period of 15
years. All claims-related records are encompassed by the document
preservation order and will be retained until notification is received
from DOJ.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Survey and Certification Group, Center for Medicaid and
State Operations, CMS, Mail Stop C3-20-01, 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
[[Page 67148]]
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:
Information for this system is collected from the Inpatient
Rehabilitation Facilities--Patient Assessment Instrument.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E6-19506 Filed 11-17-06; 8:45 am]
BILLING CODE 4120-03-P