[Federal Register Volume 70, Number 197 (Thursday, October 13, 2005)]
[Notices]
[Pages 59754-59759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20370]


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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 
[email protected].

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