Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 53667 

which the Secretary may contract with 

eligible entities to conduct a variety of 

program safeguard activities, including 

fraud review employing equipment and 

software technologies that surpass the 

existing capabilities of FIs and carriers 

(42 U.S.C. 1395ddd)). The contracting 

entities are called Program Safeguards 

Contractors. 

Pursuant to § 409.902, Florida 

Statutes (F.S.), AHCA is charged with 

the administration of the Medicaid 

program in Florida, and is the single 

state agency for such purpose. AHCA is 

required to operate a program to oversee 

the activities of Florida Medicaid 

recipients and providers to ensure that 

fraudulent and abusive behavior occurs 

to the minimum extent possible 

(§ 409.913, F.S.). 

AHCA’s disclosure of the Medicaid 

data pursuant to this agreement is for 

purposes directly connected with the 

administration of the Medicaid program, 

in compliance with 42 CFR 431.300 

through 431.307. Those purposes are the 

detection, prosecution and deterrence of 

fraud and abuse (F&A) in the Medicaid 

program. 

PURPOSE(S) OF THE MATCHING PROGRAM: 

The purpose of this agreement is to 

establish the conditions, safeguards, and 

procedures under which CMS will 

conduct a computer matching program 

with AHCA to study claims, billing, and 

eligibility information to detect 

suspected instances of Medicare and 

Medicaid F&A in the State of Florida. 

CMS and AHCA will provide EDS, a 

CMS contractor (hereinafter referred to 

as the ‘‘Custodian’’) with Medicare and 

Medicaid records pertaining to 

eligibility, claims, and billing which the 

Custodian will match in order to merge 

the information into a single database. 

Utilizing fraud detection software, the 

information will then be used to 

identify patterns of aberrant practices 

requiring further investigation. The 

following are examples of the type of 

aberrant practices that may constitute 

F&A by practitioners, providers, and 

suppliers in the State of Florida 

expected to be identified in this 

matching program: (1) Billing for 

provisions of more than 24 hours of 

services in one day, (2) providing 

treatment and services in ways more 

statistically significant than similar 

practitioner groups, and (3) up-coding 

and billing for services more expensive 

than those actually performed. 

CATEGORIES OF RECORDS AND INDIVIDUALS

COVERED BY THE MATCH: 

This CMP will enhance the ability of 

CMS and AHCA to detect F&A by 

matching claims data, eligibility, and 

practitioner, provider, and supplier 

enrollment records of Medicare 

beneficiaries, practitioners, providers, 

and suppliers in the State of Florida 

against records of Florida Medicaid 

beneficiaries, practitioners, providers, 

and suppliers in the State of Florida. 

DESCRIPTION OF RECORDS TO BE USED IN THE

MATCHING PROGRAM: 

The data for CMS are maintained in 

the following Systems of Records: 

National Claims History (NCH), System 

No. 09–70–0005 was most recently 

published in the Federal Register, at 67 

FR 57015 (September 6, 2002.) NCH 

contains records needed to facilitate 

obtaining Medicare utilization review 

data that can be used to study the 

operation and effectiveness of the 

Medicare program. Matched data will be 

released to AHCA pursuant to the 

routine use as set forth in the system 

notice. 

Carrier Medicare Claims Record, 

System No. 09–70–0501 was published 

in the Federal Register at 67 FR 54428 

(August 22, 2002). Matched data will be 

released to AHCA pursuant to the 

routine use as set forth in the system 

notice. 

Enrollment Database, System No. 09–

70–0502 was published in the Federal 

Register at 67 FR 3203 (January 23, 

2002). Matched data will be released to 

AHCA pursuant to the routine use set 

forth in the system notice. 

Intermediary Medicare Claims 

Record, System No. 09–70–0503 was 

published in the Federal Register at 67 

FR 65982 (October 29, 2002). Matched 

data will be released to AHCA pursuant 

to the routine use as set forth in the 

system notice. 

Unique Physician/Provider 

Identification Number, System No. 09–

70–0525, was most recently published 

in the Federal Register at 69 FR 75316 

(December 16, 2004). Matched data will 

be released to AHCA pursuant to the 

routine use as set forth in the system 

notice. 

Medicare Supplier Identification File, 

System No. 09–70–0530 was most 

recently published in the Federal 

Register, at 67 FR 48184 (July 23, 2002). 

Matched data will be released to AHCA 

pursuant to the routine use as set forth 

in the system notice. 

Medicare Beneficiary Database, 

System No. 09–70–0536 was published 

in the Federal Register at 67 FR 63392 

(December 6, 2001). Matched data will 

be released to AHCA pursuant to the 

routine use as set forth in the system 

notice. 

The data for AHCA are maintained in 

the following data files: Claims File 

Layouts HIPAA Version, Download File 

Record File-Claims, Recipient File 

Layout, Provider File Layout. 

INCLUSIVE DATES OF THE MATCH: 

The CMP shall become effective no 

sooner than 40 days after the report of 

the Matching Program is sent to OMB 

and Congress, or 30 days after 

publication in the Federal Register, 

which ever is later. The matching 

program will continue for 18 months 

from the effective date and may be 

extended for an additional 12 months 

thereafter, if certain conditions are met. 

[FR Doc. 05–17846 Filed 9–8–05; 8:45 am] 

BILLING CODE 4120–03–P 

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 create a new SOR 

titled, ‘‘Data Collection Secondary to 

Coverage Decision (DCSCD) System, 

HHS/CMS/OCSQ, System No. 09–70–

0547.’’ National Coverage 

Determinations (NCDs) are 

determinations by the Secretary with 

respect to whether or not a particular 

item or service is covered nationally 

under title XVIII of the Social Security 

Act (the Act) § 1869(f)(1)(B). In order to 

be covered by Medicare, an item or 

service must fall within one or more 

benefit categories contained within Part 

A or Part B, and must not be otherwise 

excluded from coverage. Moreover, with 

limited exceptions, the expenses 

incurred for items or services must be 

‘‘reasonable and necessary for the 

diagnosis or treatment of illness or 

injury or to improve the functioning of 

a malformed body member,’’

§ 1862(a)(1)(A). CMS has determined 

that the evidence is adequate to 

conclude that certain identified 

diagnoses are reasonable and necessary 

in several patient groups where certain 

criteria for these patients have been met. 

The reasonable and necessary 

determination requires that patients 

meet the criteria and are consistent with 

the trials discussed. Collection of these 

data elements allows that determination 

to be made. We are particularly 

53668 Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 

interested in seeing evidence that would 

permit us to make a coverage or noncoverage decision, i.e., to move a 

diagnostic indication from coverage 

under a clinical trial or study to 

coverage or non-coverage based on 

definitive evidence of benefit, no 

benefit, or harm. If adequate new 

evidence is available, the decision may 

be changed to either ‘‘coverage based on 

evidence of benefit,’’ ‘‘limited coverage’’

or ‘‘non-coverage based on evidence of 

harm or no benefit.’’

The purpose of this system is to 

collect and maintain data on patients to 

review determinations of ‘‘reasonable 

and necessary’’ with respect to whether 

or not a particular item or service is 

covered nationally under title XVIII of 

the Act § 1869(f)(1)(B). Information 

retrieved from this system will also 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) 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) 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 

all portions of this notice. See EFFECTIVE

DATES section for comment period. 

EFFECTIVE DATES: CMS 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 09/01/2005. We will not 

disclose any information under a 

routine use until 30 days after 

publication. We may defer 

implementation of this SOR or one or 

more of the routine use statements listed 

below if we receive comments that 

persuade us to defer implementation. 

ADDRESSES: 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, 

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 

rhakim@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the case 

of ‘‘limited coverage’’, in NCDs for 

which additional evidence is required, 

CMS has determined that the evidence 

is adequate to conclude that the item or 

service improves net health outcomes 

only under specific circumstances. One 

of these circumstances is that the 

service is delivered in the context of 

specific data being collected. Coverage 

may be limited to providers who 

participate in and beneficiaries who are 

enrolled in a defined prospective data 

collection activity, when this data 

collection activity constitutes part of the 

evidence required to ensure that the 

item or service provided to that patient 

is reasonable and necessary. 

CMS is committed to ensuring that 

advances in medical technology are 

available for its Medicare beneficiaries 

while ensuring the care they receive is 

reasonable and necessary, which is a 

necessary condition for payment. The 

coverage with evidence development 

initiative is intended to enable Medicare 

to provide payment for items and 

services under conditions that help 

assure significant net benefits of the 

treatment for beneficiaries, and to give 

rise to additional information. This 

evidence will also assist doctors and 

patients in better understanding the 

risks, benefits and costs of alternative 

diagnostic and treatment options. 

Consequently, the linkage of coverage to 

data collection will also help to ensure 

that individual patients are receiving 

care that is reasonable and necessary 

given their specific clinical situation; 

systematic, protocol-driven data has the 

potential to increase the likelihood of 

improved health outcomes. Care 

provided under these protocols may 

lead to greater attention to appropriate 

patient evaluation and selection, as well 

as the appropriate application of the 

technology. These additional data may 

alter the course of patient treatment 

based on the best available evidence, 

and may lead a physician to reconsider 

the use of the item or service or 

otherwise alter a patient’s management 

plan, potentially improving health 

outcomes. In addition, these additional 

data will be made available in some 

form to providers and practitioners to 

inform their decisions, monitor 

performance quality, benchmark and 

identify best practices. Collection of 

these data elements allows that 

determination to be made. We will also 

ensure that any future data collection 

system is consistent with the Standards 

for Privacy of Individually Identifiable 

Health Information and that all issues 

related to patient confidentiality, 

privacy, and compliance with other 

Federal laws will be resolved prior to 

the collection of any data. 

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 

Information will be collected on 

individuals where CMS has determined 

that the evidence is adequate to 

conclude that certain identified 

diagnoses are reasonable and necessary 

in several patient groups where certain 

criteria for these patients have been met 

and the criteria are consistent with the 

trials reviewed. The collected 

information will contain, but is not 

limited to, name, address, telephone 

number, health insurance claim (HIC) 

number, geographic location, race/ 

ethnicity, gender, and date of birth, as 

well as, background information relating 

to Medicare or Medicaid issues. 

Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 53669 

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 DCSCD 

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 DCSCD. 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 

provide reimbursement for NCDs and 

assist in the collection of data on 

patients receiving an NCD for primary 

prevention to a data collection process 

to assure patient safety and protection 

and to determine that the NCD is 

reasonable and necessary. 

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 of 

records 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 of records. 

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. Assist in the review determinations 

of ‘‘reasonable and necessary’’ with 

respect to whether or not a particular 

item or service is covered nationally 

under title XVIII of the Act 

§ 1869(f)(1)(B). 

b. Contribute to the accuracy of CMS’s 

proper payment of Medicare benefits, 

and/or 

c. 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. 

Other Federal or state agencies in 

their administration of a Federal health 

program may require DCSCD 

information in order to assist in the 

review determinations of ‘‘reasonable 

and necessary’’ with respect to whether 

or not a particular item or service is 

covered nationally under title XVIII of 

the Act § 1869(f)(1)(B). 

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. 

The DCSCD 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 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 

53670 Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 

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 DCSCD 

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 of 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 

Prescription Drug Improvement, and 

Modernization Act (MMA) 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 System 

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 

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. 

John R. Dyer, 

Chief Operating Officer, Centers for Medicare 

& Medicaid Services. 

SYSTEM NO. 09–70–0547 

SYSTEM NAME: 

‘‘Data Collection Secondary to 

Coverage Decision (DCSCD) System, 

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: 

Individuals where CMS has 

determined that the evidence is 

adequate to conclude that certain 

identified diagnoses are reasonable and 

necessary in several patient groups 

where certain criteria for these patients 

have been met and the criteria are 

consistent with the trials reviewed. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The data collection should include 

baseline patient characteristics. The 

collected information will contain, but 

is not limited to, name, address, 

telephone number, health insurance 

claim (HIC) 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 

(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 

Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 53671 

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. 

PURPOSE(S) OF THE SYSTEM: 

The purpose of this system is to 

collect and maintain data on patients to 

review determinations of ‘‘reasonable 

and necessary’’ with respect to whether 

or not a particular item or service is 

covered nationally under title XVIII of 

the Act § 1869(f)(1)(B). Information 

retrieved from this system will also 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) 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) 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: 

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.’’ We 

are proposing to establish the following 

routine use disclosures of information 

maintained in the system. Information 

will be disclosed: 

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 of 

records and who need to have access to 

the records in order to perform the 

activity. 

2. To another Federal or state agency 

to: 

a. Assist in the review determinations 

of ‘‘reasonable and necessary’’ with 

respect to whether or not a particular 

item or service is covered nationally 

under title XVIII of the Act 

§ 1869(f)(1)(B). 

b. Contribute to the accuracy of CMS’s 

proper payment of Medicare benefits, 

and/or 

c. 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. 

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 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, 

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. 

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 

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 of 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 complaint population is so 

small that individuals who are familiar 

with the complainants could, because of 

the small size, use this information to 

deduce the identity of the complainant). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored electronically. 

RETRIEVABILITY: 

The data is retrieved by an individual 

identifier i.e., name of beneficiary. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against excessive or 

unauthorized use. Personnel having 

access to the system have been trained 

in the Privacy Act and information 

security requirements. Employees who 

maintain records in this system are 

instructed not to release data until the 

intended recipient agrees to implements 

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 

53672 Federal Register / Vol. 70, No. 174 / Friday, September 9, 2005 / Notices 

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 

Prescription Drug Improvement, 

Modernization Act (MMA) 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 is received 

from the Department of Justice. 

SYSTEM MANAGER AND ADDRESS: 

Director, Office of Clinical Standards 

and Quality, CMS, Room S2–26–17, 

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 

reasonable 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. 05–17845 Filed 9–8–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Availability of the Biennial 

Report to Congress on the Status of 

Children in Head Start Programs 

AGENCY: Administration on Children, 

Youth and Families (ACYF) 

Administration for Children and 

Families (ACF), Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: The Administration for 

Children and Families announces 

publication of the Biennial Report to 

Congress on the Status of Children in 

Head Start Programs, Fiscal Year (FY) 

2003. The report is mandated under 

Section 650 of the Head Start Act, as 

amended, which requires the Secretary 

of Health and Human Services to submit 

a report to Congress at least once during 

every two-year period on the status of 

children in Head Start programs. During 

FY 2003 more than 909,000 children 

were enrolled in Head Start programs 

including 62,000 children in Early Head 

Start programs serving children between 

birth and three years of age. 

EFFECTIVE DATE: September 9, 2005. 

ADDRESSES: Persons wishing to receive 

a copy of the Biennial Report to 

Congress on the Status of Children in 

Head Start Programs, FY 2003 may 

contact the Head Start Publication 

Center on 866–763–6481. Copies of the 

report may also be obtained by 

accessing the Head Start Web site at 

http://www.acf.hhs.gov/programs/hsb/ 

research/index.htm. 

FOR FURTHER INFORMATION CONTACT: 

Frank Fuentes, Acting Associate 

Commissioner, Head Start Bureau, 

Administration on Children, Youth and 

Families, 330 C Street, SW., 

Washington, DC 20447. 

SUPPLEMENTARY INFORMATION: The Head 

Start and Early Head Start programs are 

authorized under the Head Start Act (42 

U.S.C. 9801 et seq.) It is a national 

program providing comprehensive 

developmental services to low-income 

preschool children, primarily age three 

to age of compulsory school attendance, 

and their families. To help enrolled 

children achieve their full potential, 

Head Start programs provide 

comprehensive health, nutritional, 

educational, social and other services. 

Section 650 of the Head Start Act 

requires that the Secretary publish a 

Biennial Report of the Status of 

Children in Head Start Programs. The 

FY 2003 Biennial Report provides 

information about children enrolled in 

the program and the services they 

receive. During FY 2003 more than 

909,000 children were enrolled in Head 

Start programs. Head Start operated 

47,000 classrooms in more than 19,000 

Head Start centers at an average annual 

cost per child of $7,092. Over 1,428,000 

volunteers contributed their services to 

Head Start programs. 

Dated: August 30, 2005. 

Joan E. Ohl, 

Commissioner, Administration on Children, 

Youth and Families. 

[FR Doc. 05–17920 Filed 9–8–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

National Native American Emergency 

Medical Services Association 

AGENCY: Indian Health Service, IHS. 

ACTION: Notice of Single Source 

Cooperative Agreement with the 

National Native American Emergency 

Medical Services Association. 

SUMMARY: The Indian Health Service 

(IHS) announces the award of a 

cooperative agreement that will be 

funded on a competitive continuing 

basis to the National Native American 

Emergency Medical Services 

Association (NNAEMSA) for a 

demonstration project to improve 

emergency medical services for Native 

American people by improving 

communications between the IHS and 

the Native American Emergency 

Medical Services (EMS) providers; by 

improving communications and 

information among other federal 

agencies, professional organizations and 

Native American EMS providers; and by 

supporting an Annual Educational 

Conference. 

Project Period: The cooperative 

agreement is for a five-year project 

period effective on or about September 

15, 2005 to September 14, 2010. 

Amount of Award(s): Total funding 

for the project is $450,000. Funding in 

the amount of $90,000.00 is available in