59754 Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 

Research and Acquired 

Immunodeficiency Syndrome 

James Strachan, Director, Office of 

Resource Management 

George Strader Jr., Deputy Assistant 

Secretary for Finance 

Stewart Streimer, Director, Provider 

Billing Group 

Richard Suzman, Director of Behavioral 

and Social Research Program 

Edgar Swindell, Associate General 

Counsel 

Sheila Taube, Associate Director, Cancer 

Diagnosis Program 

Deborah Taylor, Deputy Director, Office 

of Financial Management 

John Teeter, Information Technology 

Enterprise Architect 

Dianne Thomas, Deputy Director, Office 

of Human Resources 

Joyce Thomas, Regional Hub Director 

Nancy Thompson, Director, Medicare 

Hearings and Appeals Transition 

John Tibbs, Financial Manager 

James Toya, Director, Albuquerque Area 

Brenda Tranchida, Deputy Director 

Employer Policy and Operations 

Group 

Anthony Trenkle, Director, Office of EHealth Standards and Services 

Alexander Trujillo, Denver Regional 

Administrator 

Richard Turman, Deputy Assistant 

Secretary for Budget 

Timothy Ulatowski, Director, Office of 

Compliance 

Mary Lou Valdez, Deputy Director for 

Policy, Office of Global Health Affairs 

Ronald Valdiserri, Deputy Director 

Peter Van Dyck, Associate 

Administrator for Maternal and Child 

Health Bureau 

Joseph Vanlandingham, Deputy 

Assistant Secretary for Program 

Support 

Martha Vaughan, Chief Metabolic 

Regulation Section 

Terrell Vermillion, Director Office 

Criminal Investigations 

Francis Vocci Jr., Director, Medication 

Development 

Linda Vogel, Senior Public Health 

Advisor 

Sheila Walcoff, Associate Commissioner 

for External Relations 

Edwin Walker, Deputy Assistant 

Secretary for Policy and Programs 

Frederick Walker, Associate Director for 

Management 

Sondra Wallace, Associate General 

Counsel 

Gerald Walters, Director, Financial 

Services Group 

Kenneth Warren, Director, Office of 

Scientific Affairs 

Rueben Warren, Associate 

Administration for Urban Affairs 

Richard Waterman, Chief Counsel 

Mark Weber, Associate Administration 

for Communications 

Kerry Weems, Deputy Chief of Staff 

Michael Weinrich, Director, National 

Center for Medical Rehabilitation 

Research 

Donna Weinstein, Chief Counsel 

Marc Weisman, Director, Office of 

Acquisition Management 

Jacquelyn White, Director, Office of 

Strategic Operations and Regulatory 

Affairs 

Donalda Wilder, Director Portland Area 

Carlis Williams, Regional Hub Director 

Dennis Williams, Deputy Administrator, 

Health Resources and Services 

Administration 

Paula Williams, Director, Tribal SelfGovernance 

Harry Wilson, Associate Commissioner, 

Family and Youth Services Bureau 

Laurence Wilson, Director, Chronic Care 

Policy Group 

Helen Winkle, Director, Office of 

Pharmaceutical Science 

Ann Wion, Deputy Chief Counsel, 

Program Review 

Edwin Woo, Associate General Counsel 

Charlotte Yeh, Boston Regional 

Administrator 

David Young, Deputy Director for 

Management Operations 

Donald Young, Principal Deputy 

Assistant Secretary 

Samir Zakhari, Director, Division of 

Basic Research 

Howard Zucker, Deputy Assistant 

Secretary for Health (Science, 

Technology, and Medicine) 

Phyllis Zucker, Director, Policy 

Coordination, Executive Secretariat 

and Departmental Liaison 

[FR Doc. 05–20475 Filed 10–12–05; 8:45 am] 

BILLING CODE 5150–04–M 

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). 

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 

Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 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 wellacquainted 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 

59756 Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 

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 

Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 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 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 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 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; 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 

59758 Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 

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 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 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, 

Federal Register / Vol. 70, No. 197 / Thursday, October 13, 2005 / Notices 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 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; 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Administration on Children, Youth and 

Families; Award Announcement 

AGENCY: Administration on Children, 

Youth and Families, ACF, HHS. 

ACTION: Award announcement. 

SUMMARY: The Administration on 

Children, Youth and Families, Family 

and Youth Services Bureau (FYSB), 

herein announces the awarding of 

twenty-eight urgent grant awards in 

order to enable seventeen Mentoring 

Children of Prisoner Programs and 

eleven Training and Technical 

Assistance providers to respond 

immediately to hurricane disaster 

evacuee needs in their States and local 

communities. The effects of Hurricane 

Katrina have disrupted the ability of the 

children whose parents are incarcerated 

to receive mentoring services due to 

their forced relocation throughout the 

nation. As a result, FYSB’s network of 

mentoring grantees and training and 

technical assistance providers are 

uniquely positioned to respond to the 

increase in the numbers of children of 

incarcerated parents arriving in their 

new communities. The following 

agencies are receiving grant funds for a 

twelve month project period: Big 

Brothers Big Sisters of Heart, Macon, 

Georgia, in the amount of $95,000; State 

of Alabama Child Abuse and Neglect 

Prevention Board, Montgomery, 

Alabama, in the amount of $50,000; 

YMCA of Greater Louisville, Louisville, 

Kentucky, in the amount of $50,000; Big 

Brothers Big Sisters of Mississippi, 

Jackson, Mississippi, in the amount of 

$95,000; Family and Children’s Agency, 

Inc., Norwalk, Connecticut, in the 

amount of $21,350; America on Track of 

Santa Ana, California in the amount of 

$95,000; Volunteers in Prevention, 

Probation and Prisons, Detroit,