[Federal Register: October 13, 2005 (Volume 70, Number 197)]
[Notices]
[Page 59754-59759]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13oc05-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of Records (SOR).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new SOR titled, ``Fluoro-Deoxy
Glucose (FDG) Positron Emission Tomography (PET) for Dementia and
Neurodegenerative Diseases (DND) (PET DND), HHS/CMS/OCSQ, System No.
09-70-0561.'' National Coverage Determinations are determinations by
the Secretary (HHS) with respect to whether or not a particular item or
service is covered nationally under Title XVIII of the Social Security
Act (the Act) section 1869(f)(1)(B). In order to be covered by
Medicare, an item or service must fall within one or more benefit
categories contained in Part A or Part B, and must not be otherwise
excluded from coverage.
In our review of DND indications, we found sufficient evidence to
determine that PET scans are no longer experimental. However, the
evidence was insufficient to reach a conclusion that FDG PET is
reasonable and necessary in all instances. A sufficient inference of
benefit, however, can be drawn to support limited coverage if certain
safeguards for patients are provided. This inference is based on both
the physiological basis for FDG PET usefulness in a differential
diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease
(AD), as well as, evidence of a positive benefit of PET for patients
with several other dementing neurodegenerative diseases for which there
is evidence of sufficient quality to warrant coverage.
The purpose of this system is to collect and maintain information
on Medicare beneficiaries receiving FDG PET scans for indications for
DND when there is not sufficient evidence to reach a firm conclusion
that the scan is reasonable and necessary unless they are enrolled in
an approved study. Information retrieved from this system will be
disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the agency or by a contractor or consultant;
(2) assist another Federal or state agency with information to enable
such agency to administer a Federal health benefits program, or to
enable such agency to fulfill a requirement of Federal statute or
regulation that implements a health benefits program funded in whole or
in part with Federal funds; (3) support an individual or organization
for a research project or in support of an evaluation project related
to the prevention of disease or disability, the restoration or
maintenance of health, or payment related projects; (4) support
constituent requests made to a Congressional representative; (5)
support litigation involving the agency; and (6) combat fraud and abuse
in certain health benefits programs. We have provided background
information about the new system in the Supplementary Information
section below. Although the Privacy Act requires only that CMS provide
an opportunity for interested persons to comment on the proposed
routine uses, CMS invites comments on
[[Page 59755]]
all portions of this notice. See Effective Date section for comment
period.
EFFECTIVE DATE: CMS has filed a new SOR 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 5, 2005. We will not disclose any information under a
routine use until 30 days after publication. We may defer
implementation of this system or one or more of the routine use
statements listed below if we receive comments that persuade us to
defer implementation.
ADDRESS: The public should address comments to the CMS Privacy Officer,
Mail Stop 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: Rosemarie Hakim, Epidemiologist,
Division of Operations and Committee Management, Coverage and Analysis
Group, Office of Clinical Standards and Quality, CMS, Mail Stop C1-09-
06, 7500 Security Boulevard, Baltimore, Maryland 21244-1849. Her
telephone number is (410) 786-3934, or she can be reached via e-mail at
Rosemarie.Hakim@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Medicare covers FDG-PET scans for either the
differential diagnosis of FTD and AD under specific requirements; or,
its use in a CMS approved practical clinical trial focused on the
utility of FDG-PET in the diagnosis or treatment of dementing
neurodegenerative diseases. Specific requirements for each indication
are clarified as follows: an FDG-PET scan is considered reasonable and
necessary in patients with a recent diagnosis of dementia and
documented cognitive decline of at least 6 months, who meet diagnostic
criteria for both AD and FTD. These patients have been evaluated for
specific alternate neurodegenerative diseases or other causative
factors, but the cause of the clinical symptoms remains uncertain.
The following additional conditions must be met before an FDG-PET
scan will be covered: (1) The patient's onset, clinical presentation,
or course of cognitive impairment is such that FTD is suspected as an
alternative neurodegenerative cause of the cognitive decline.
Specifically, symptoms such as social disinhibition, awkwardness,
difficulties with language, or loss of executive function are more
prominent early in the course of FTD than the memory loss typical of
AD;
(2) The patient has had a comprehensive clinical evaluation (as
defined by the American Academy of Neurology) encompassing a medical
history from the patient and a well-acquainted informant (including
assessment of activities of daily living), physical and mental status
examination (including formal documentation of cognitive decline
occurring over at least 6 months) aided by cognitive scales or
neuropsychological testing, laboratory tests, and structural imaging
such as magnetic resonance imaging (MRI) or computed tomography (CT);
(3) The evaluation of the patient has been conducted by a physician
experienced in the diagnosis and assessment of dementia;
(4) The evaluation of the patient did not clearly determine a
specific neurodegenerative disease or other cause for the clinical
symptoms, and information available through FDG-PET is reasonably
expected to help clarify the diagnosis between FTD and AD and help
guide future treatment;
(5) The FDG-PET scan is performed in a facility that has all the
accreditation necessary to operate nuclear medicine equipment. The
reading of the scan should be done by an expert in nuclear medicine,
radiology, neurology, or psychiatry, with experience interpreting such
scans in the presence of dementia and;
(6) A brain single photon emission computed tomography (SPECT) or
FDG-PET scan has not been obtained for the same indication. (The
indication can be considered to be different in patients who exhibit
important changes in scope or severity of cognitive decline, and meet
all other qualifying criteria listed above and below (including the
judgment that the likely diagnosis remains uncertain.) The results of a
prior SPECT or FDG-PET scan must have been inconclusive or, in the case
of SPECT, difficult to interpret due to immature or inadequate
technology. In these instances, an FDG-PET scan may be covered after
one year has passed from the time the first SPECT or FDG-PET scan was
performed.)
The referring and billing provider(s) have documented the
appropriate evaluation of the Medicare beneficiary. Providers should
establish the medical necessity of an FDG-PET scan by ensuring that the
following information has been collected and is maintained in the
beneficiary medical record: Date of onset of symptoms; diagnosis of
clinical syndrome (normal aging; mild cognitive impairment; mild,
moderate or severe dementia); mini mental status exam or similar test
score; presumptive cause (possible, probable, uncertain AD); any
neuropsychological testing performed; results of any structural imaging
(MRI or CT) performed; relevant laboratory tests (B12, thyroid
hormone); and, number and name of prescribed medications.
The billing provider must furnish a copy of the FDG-PET scan result
for use by CMS and its contractors upon request. These verification
requirements are consistent with Federal requirements set forth in 42
Code of Federal Regulations (CFR) Section 410.32 generally for
diagnostic x-ray tests, diagnostic laboratory tests, and other tests.
In summary, section 410.32 requires the billing physician and the
referring physician to maintain information in the medical record of
each patient to demonstrate medical necessity [410.32(d)(2)] and submit
the information demonstrating medical necessity to CMS and/or its
agents upon request [410.32(d)(3)(I)] (OMB number 0938-0685).
A FDG-PET scan is considered reasonable and necessary in patients
with mild cognitive impairment or only in the context of an approved
clinical trial that contains patient safeguards and protections to
ensure proper administration, use and evaluation of the FDG-PET scan.
The clinical trial must compare patients who do and do not receive
an FDG-PET scan and have as its goal to monitor, evaluate, and improve
clinical outcomes. In addition, it must meet the following basic
criteria: written protocol on file; Institutional Review Board review
and approval; scientific review and approval by two or more qualified
individuals who are not part of the research team; and, certification
that investigators have not been disqualified.
All other uses of FDG-PET for patients with a presumptive diagnosis
of dementia-causing neurodegenerative disease (e.g., possible or
probable AD, clinically typical FTD, dementia of Lewy bodies, or
Creutzfeld-Jacob disease) for which CMS has not specifically indicated
coverage continue to be noncovered.
CMS will consider prospective data collection systems to be
qualified if they provide assurance that the specific hypotheses are
addressed and they collect appropriate data elements. The data
collection shall include baseline patient characteristics: Indications
for the PET scan; PET scan type and characteristics; FDG PET results;
results of all other imaging studies; facility and provider
characteristics; differential diagnosis; and stage; long term patient
[[Page 59756]]
outcomes; disease management changes; and treatment received. The
clinical data collection must ensure that specific hypotheses are
identified prospectively; hospitals and providers are qualified to
provide FDG PET and interpret the results; and participating hospitals
and providers collect prospective data at the time of payment on all
enrolled patients undergoing FDG PETs for DND indications. Data
elements will be transmitted to CMS for evaluation of the short and
long term benefits of the FDG PET for its beneficiaries and inform
future clinical decision making. CMS shall be assured that all
applicable patient confidentiality, privacy, and other Federal laws are
complied with, including the Standards for Privacy of Individually
Identifiable Health Information.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for linking coverage decisions to the
collection of additional data is derived from Sec. 1862(a)(1)(A) of the
Act, which states that Medicare may not provide payment for items and
services unless they are ``reasonable and necessary'' for the treatment
of illness or injury. In some cases, CMS will determine that an item or
service is only reasonable and necessary when specific data collections
accompany the provision of the service. In these cases, the collection
of data is required to ensure that the care provided to individual
patients will improve health outcomes.
B. Collection and Maintenance of Data in the System
The data collection shall include baseline patient characteristics:
Indications for the PET scan; PET scan type and characteristics; FDG
PET results; results of all other imaging studies; facility and
provider characteristics; differential diagnosis; long term patient
outcomes; disease management changes; and DND treatment received. The
collected information will contain name, address, telephone number,
Health Insurance Claim Number (HICN), geographic location, race/
ethnicity, gender, and date of birth, as well as, background
information relating to Medicare or Medicaid issues.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The government will only release PET DND 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 PET DND. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from the 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 collect and maintain
information on Medicare beneficiaries receiving FDG PET scans for
indications for which there is not sufficient evidence to reach a firm
conclusion that the scan is reasonable and necessary unless they are
enrolled in an approved study.
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
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 agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system and who need to have access to the records in order to perform
the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS function
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor 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 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.
Other Federal or state agencies in their administration of a
Federal health program may require PET DND information in order to
collect information on Medicare beneficiaries receiving FDG PET scans
for sufficient evidence to reach a firm conclusion that the scan is
reasonable and necessary.
3. To an individual or organization for a research project or in
support of an evaluation project related to the
[[Page 59757]]
prevention of disease or disability, the restoration or maintenance of
health, or payment related projects.
The PET DND data will provide for research or in support of
evaluation projects, a broader, longitudinal, national perspective of
the status of Medicare beneficiaries. CMS anticipates that many
researchers will have legitimate requests to use this data in projects
that could ultimately improve the care provided to Medicare
beneficiaries and the policy that governs the care.
4. To a member of Congress or to 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 sometimes request the help of a member of Congress in
resolving an issue relating to a matter before CMS. The member of
Congress then writes CMS, and CMS must be able to give sufficient
information to be responsive to the inquiry.
5. 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, 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.
6. To a CMS contractor (including, but not necessarily limited to
Medicare administrative contractors, 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 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 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.
7. 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 PET DND information for the purpose of
combating fraud and abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures. 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, 65 FR 82462 (12-28-00),
Subparts A and E. Disclosures of PHI 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 if 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; HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the Proposed System of Records on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will take precautionary measures (see item IV above) 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
[[Page 59758]]
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: October 3, 2005.
Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0561.
System Name
Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for
Dementia and Neurodegenerative Diseases (DND) (PET DND) HHS/CMS/OCSQ.''
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850; and at various co-locations of CMS contractors.
Categories of Individuals Covered by the System:
Providers participating in and patients enrolled in one of the
following types of prospective clinical studies: a clinical trial of
FDG PET that meets the Food and Drug Administration category B
investigational device exemption or an FDG PET clinical study that is
designed to prospectively collect information at the time of the scan
to assist in patient management.
Categories of Records in the System:
The data collection should include baseline patient
characteristics: Indications for the PET scan; PET scan type and
characteristics; FDG PET results; results of all other imaging studies;
facility and provider characteristics; differential diagnosis; long
term patient outcomes; disease management changes; and DND treatment
received. The collected information will contain name, address,
telephone number, Health Insurance Claim Number (HICN) number,
geographic location, race/ethnicity, gender, and date of birth, as well
as, background information relating to Medicare or Medicaid issues.
Authority for Maintenance of the System:
The statutory authority for linking coverage decisions to the
collection of additional data is derived from Sec. 1862(a)(1)(A) of the
Social Security Act, which states that Medicare may not provide payment
for items and services unless they are ``reasonable and necessary'' for
the treatment of illness or injury. In some cases, CMS will determine
that an item or service is only reasonable and necessary when specific
data collections accompany the provisions of the service. In these
cases, the collection of data is required to ensure that the care
provided to individual patients will improve health outcomes.
Purpose(s) of the System:
The purpose of this system is to collect and maintain information
on Medicare beneficiaries receiving FDG PET scans for indications for
DND when there is not sufficient evidence to reach a firm conclusion
that the scan is reasonable and necessary unless they are enrolled in
an approved study. Information retrieved from this system will be
disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the agency or by a contractor or consultant;
(2) assist another Federal or state agency with information to enable
such agency to administer a Federal health benefits program, or to
enable such agency to fulfill a requirement of Federal statute or
regulation that implements a health benefits program funded in whole or
in part with Federal funds; (3) support an individual or organization
for a research project or in support of an evaluation project related
to the prevention of disease or disability, the restoration or
maintenance of health, or payment related projects; (4) support
constituent requests made to a Congressional representative; (5)
support litigation involving the agency; and (6) 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. 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 agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system and who need to have access to the records in order to perform
the activity.
2. To another Federal or state agency 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 an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
4. To a member of Congress or to 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.
5. 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.
6. To a CMS contractor (including, but not necessarily limited to
Medicare administrative contractors, 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 or abuse in such program.
7. 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,
[[Page 59759]]
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 Provisions Affecting Routine Use Disclosures. This
system contains Protected Health Information (PHI) as defined by
Department of Health and Human Services (HHS) regulation ``Standards
for Privacy of Individually Identifiable Health Information'' (45 Code
of Federal Regulations (CFR) Parts 160 and 164, 65 Fed. Reg. 82462 (12-
28-00), Subparts A and E. Disclosures of PHI 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 if 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:
All records are stored electronically.
RETRIEVABILITY:
The data are retrieved by an individual identifier i.e., name of
beneficiary or provider.
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; HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain information for a total period of 10 years. All
claims-related records are encompassed by the document preservation
order and will be retained until notification from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Coverage and Analysis Group, Office of Clinical Standards
and Quality, CMS, Mail Stop C1-09-06, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
NOTIFICATION PROCEDURE:
For the purpose of access, the subject individual should write to
the system manager who will require the system name, address, age,
gender, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable).
RECORD ACCESS PROCEDURE:
For the purpose of access, use the same procedures outlines 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.)
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.)
RECORD SOURCE CATEGORIES:
Records maintained in this system are derived from Carrier and
Fiscal Intermediary Systems of Records, Common Working File System of
Records, clinics, institutions, hospitals and group practices
performing the procedures, and outside registries and professional
interest groups.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-20370 Filed 10-12-05; 8:45 am]
BILLING CODE 4120-03-P