Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73095 

We encourage the participation of 

appropriate organizations with expertise 

in the use of ESAs for treatment of 

anemia in adults with CKD including 

patients on dialysis and patients not on 

dialysis. 

II. Meeting Format 

This meeting is open to the public. 

The Committee will hear oral 

presentations from the public for 

approximately 45 minutes. The 

Committee may limit the number and 

duration of oral presentations to the 

time available. Your comments should 

focus on issues specific to the list of 

topics that we have proposed to the 

Committee. The list of research topics to 

be discussed at the meeting will be 

available on the following Web site 

prior to the meeting: http:// 

www.cms.hhs.gov/mcd/index_list.asp?

list_type=mcac. We require that you 

declare at the meeting whether you have 

any financial involvement with 

manufacturers (or their competitors) of 

any items or services being discussed. 

The Committee will deliberate openly 

on the topics under consideration. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15-minute unscheduled open 

public session for any attendee to 

address issues specific to the topics 

under consideration. At the conclusion 

of the day, the members will vote and 

the Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating the meetings registration 

process. While there is no registration 

fee, individuals must register to attend. 

You may register online at http:// 

www.cms.gov/apps/events/ 

upcomingevents.asp?

strOrderBy=1&type=3 or by phone by 

contacting the person listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by the deadline listed in the 

DATES section of this notice. Please 

provide your full name (as it appears on 

your government—issued photographic 

identification), address, organization, 

telephone, fax number(s), and e-mail 

address. You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex or you will 

be notified the seating capacity has been 

reached. 

You must register for the Webinar 

portion of the meeting at https:// 

webinar.cms.hhs.gov/esamedcac119/ 

event/registration.html by the deadline 

listed in the DATES section of this notice. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants 

arrive reasonably early, but no earlier 

than 45 minutes prior to the start of the 

meeting, to allow additional time to 

clear security. Security measures 

include the following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means of all persons 

brought entering the building. We note 

that all items brought into CMS, 

whether personal or for the purpose of 

presentation or to support a 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

presentation or to support a 

presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. All visitors must 

be escorted in areas other than the lower and 

first floor levels in the Central Building. 

Authority: 5 U.S.C. App. 2, section 10(a). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 16, 2010. 

Barry M. Straube, 

CMS Chief Medical Officer and Director, 

Office of Clinical Standards and Quality, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2010–29964 Filed 11–26–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of New 

System of Records 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice of a New System of 

Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

CMS is establishing a new system of 

records (SOR) titled, ‘‘Medicare and 

Medicaid Electronic Health Record 

(EHR) Incentive Program National Level 

Repository’’ System No. 09–70–0587. 

The final rule for the Medicare and 

Medicaid EHR Incentive Program 

implements the provisions of the 

American Recovery and Reinvestment 

Act of 2009 (the Recovery Act) (Pub. L. 

111–5). Specifically, Title IV of Division 

B of the Recovery Act amends Titles 

XVIII and XIX of the Social Security Act 

(the Act) by establishing incentive 

payments to eligible professionals (EPs), 

eligible hospitals and critical access 

hospitals (CAHs) and Medicare 

Advantage (MA) Organizations 

participating in Medicare and Medicaid 

programs that adopt and successfully 

demonstrate meaningful use of certified 

electronic health record (EHR) 

technology. These Recovery Act 

provisions, together with Title XIII of 

Division A of the Recovery Act, may be 

cited as the ‘‘Health Information 

Technology for Economic and Clinical 

Health Act,’’ or the ‘‘HITECH Act.’’ 

The final rule specified the initial 

criteria EPs, eligible hospitals and 

CAHs, and MA Organizations must meet 

in order to qualify for an incentive 

payment; calculation of the incentive 

payment amounts; payment adjustments 

under Medicare for covered professional 

services and inpatient hospital services 

provided by EPs, eligible hospitals and 

CAHs failing to demonstrate meaningful 

use of certified EHR technology 

beginning in 2015; and other program 

participation requirements. Also, the 

Office of the National Coordinator for 

Health Information Technology (ONC) 

issued a closely related final rule that 

specified the initial set of standards, 

implementation specifications, and 

certification criteria for certified EHR 

technology. ONC has also issued a 

separate final rule on the establishment 

of certification programs for health 

information technology (HIT). 

To register for the Medicare and 

Medicaid EHR Incentive Program, EPs, 

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73096 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

eligible hospitals and CAHs, and MA 

Organizations will be required to 

provide the following information: 

Name, National Provider Identifier 

(NPI), business address and business 

phone for each EP, eligible hospital or 

CAH; Taxpayer Identification Number 

(TIN) to which the EP, eligible hospital 

or CAH wants the incentive payment to 

be made; For EPs, whether they choose 

to participate in the Medicare EHR 

Incentive Program or the Medicaid EHR 

Incentive Program; For eligible hospitals 

and CAHs, their CMS Certification 

Number (CCN); and other information as 

specified by CMS. EPs, eligible hospitals 

and CAHs will also have the option to 

provide their e-mail address at the time 

of registration. MA Organizations will 

be required to provide their contract 

number on behalf of their MA-affiliated 

EPs and hospitals. At this time, 

participation in the Medicare and 

Medicaid EHR Incentive Programs is 

voluntary for EPs, eligible hospitals and 

CAHs. 

Per section 1886(n)(4)(B) of the Act, as 

added by section 4102(c) of the HITECH 

Act, the Secretary will post on the 

Internet Web site of the Centers for 

Medicare & Medicaid Services, in an 

easily understandable format, a list of 

the names, business addresses, and 

business phone numbers of the 

Medicare EPs, eligible hospitals and 

CAHs who are meaningful EHR users in 

the Medicare EHR Incentive Program. 

Sections 1853(m)(5) and 1853(l)(7) of 

the Act, as added by sections 4101(c) 

and 4102(c) of the HITECH Recovery 

Act, require the Secretary to post the 

same information for EPs and eligible 

hospitals participating in the MA 

program as would be required if they 

were in the Medicare FFS program. 

Additionally, the Secretary must post 

the names of the qualifying MA 

Organizations receiving the incentive 

payment or payments. The routine uses 

established with this system contain a 

proper explanation as to the need for the 

disclosure provisions and provide 

clarity to CMS’ intention to disclose 

provider-specific information contained 

in this system. 

The primary purpose of this system, 

called the National Level Repository or 

NLR, is to collect, maintain, and process 

information that is required for the 

Medicare and Medicaid EHR Incentive 

Program. Information in this system will 

also be disclosed to: (1) Support 

regulatory, incentive payments and 

policy functions such as evaluation and 

reporting, whether performed by the 

Agency or by an Agency contractor or 

consultant; (2) assist another Federal 

and/or state agency, agency of a state 

government, or an agency established by 

state law; (3) assist in making the 

individual physician-level participation 

data available through an Agency 

website and by various other means of 

data dissemination; (4) assist the 

Department’s Office of the National 

Coordinator of Health Information 

Technology’s (ONC’s) grantees for the 

purpose of supporting ‘‘eligible 

professional’’ (EP) adoption and 

meaningful use of certified EHR 

technology; (5) support litigation 

involving the Agency; (6) combat fraud, 

waste, and abuse in certain health 

benefits programs, and (7) assist in a 

response to a suspected or confirmed 

breach of the security or confidentiality 

of information. We have provided 

background information about this 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 information about the 

comment period. 

DATES: Effective Dates: CMS filed a new 

system report with the Chair of the 

House Committee on Government 

Reform and Oversight, the Chair of the 

Senate Committee on Homeland 

Security & Governmental Affairs, and 

the Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 

November 29, 2010. To ensure that all 

parties have adequate time in which to 

comment, the new system, including 

routine uses, will become effective 30 

days from the publication of the notice, 

or 40 days from the date it was 

submitted to OMB and Congress, 

whichever is later, unless CMS receives 

comments that require alterations to this 

notice. 

ADDRESSES: The public should address 

comments to: CMS Privacy Officer, 

Division of Information Security and 

Privacy Management, Enterprise 

Architecture and Strategy Group, Office 

of Information Services, CMS, Room 

N1–24–08, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9 a.m.—3 p.m., 

eastern time zone. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Maisler, Health Insurance 

Specialist, Office of E–Health Standards 

and Services, CMS, 7500 Security 

Boulevard, Mail-stop: S2–26–17, 

Baltimore, MD 21244–1850. Office: 410– 

786–5754, Facsimile: 410–786–1347, Email address: rachel.maisler@cms.gov. 

SUPPLEMENTARY INFORMATION: Sections 

4101(a), 4102(a) and 4102(a)(2) of the 

HITECH Act respectively add sections 

1848(o), 1886(n) and 1814(l)(A)(3) to the 

Act to limit incentive payments in the 

Medicare Fee-for-service (FSS) EHR 

incentive program to an EP, eligible 

hospital or CAH that is a ‘‘meaningful 

EHR user.’’ Sections 4101(c) and 4102(c) 

of the HITECH Act respectively adds 

sections 1853(l) and 1853(m) which 

outline the application of incentive 

payments for certain MA-affiliated EPs 

and MA-affiliated hospitals. Section 

4201(a)(2) of the HITECH Act added 

section 1903(t) to the Act to limit 

incentive payments in the Medicaid 

context to EPs, as defined at section 

1903(t)(2)(A), who meet the 

requirements of 1903(t). As described in 

our final rule discussed below, these 

eligible professionals can receive an 

incentive payment for adoption or 

utilization of, or upgrade to, certified 

EHR technology in 2011, and can 

receive incentive payments in certain 

subsequent years if they demonstrate 

meaningful use of certified EHR 

technology. 

In sections 1848(o)(2)(A) and 

1886(n)(3) of the Act, the Congress 

specified three types of requirements for 

meaningful use in the Medicare context: 

(1) Use of certified EHR technology in 

a meaningful manner; (2) that the 

certified EHR technology is connected 

in a manner that provides for the 

electronic exchange of health 

information to improve the quality of 

care; and (3) that, in using certified EHR 

technology, the provider submits to the 

Secretary information on clinical quality 

measures and such other measures 

selected by the Secretary. 

In our final rule on the EHR incentive 

program, we stated that we are not 

limited to collecting only information 

pertaining to Medicare and Medicaid 

beneficiaries. Therefore, in our final 

rule, we require that, in order to 

demonstrate meaningful use, an EP, 

eligible hospital or CAH, or MA 

Organization must report aggregate 

information on clinical quality measures 

for all patients to whom clinical quality 

measures apply. As explained in the 

final rule for EHR incentive payments, 

for the 2011 payment year, we use an 

attestation methodology for the 

submission of summary information on 

clinical quality measures as a condition 

of demonstrating meaningful use of 

certified EHR technology. 

For the Medicaid incentive program, 

as stated in our final rule, for their first 

year of payment, providers are not 

required to demonstrate meaningful use, 

and may receive an incentive payment 

by demonstrating adoption, 

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implementation, or upgrade to certified 

EHR technology. We expect that, for 

2011, the majority of Medicaid 

providers will receive an incentive 

payment through this pathway. In their 

second, third, fourth, fifth and sixth 

payment year, Medicaid EPs and 

hospitals will be required to 

demonstrate meaningful use of certified 

EHR technology to qualify for an 

incentive payment. 

As stated in our final rule, we will use 

a phased approach for meaningful use 

criteria, based on currently available 

technology capabilities and provider 

practice experience. We refer to the 

initial meaningful use criteria as ‘‘Stage 

1.’’ In the final rule, we require that EPs, 

eligible hospitals and CAHs, including 

MA-affiliated EPs and hospitals, 

demonstrate that they satisfy all the 

required meaningful use objectives and 

associated measures of the Stage 1 

criteria during the reporting period for 

2011 through attestation in order to 

receive incentive payments. In addition, 

we require that EPs, eligible hospitals 

and CAHs, and MA Organizations attest 

to the accuracy and completeness of the 

numerators and denominators for each 

of the applicable measures, and that the 

information submitted includes 

information on all patients to whom the 

measure applies. 

To qualify as a meaningful EHR user 

for 2011, we require that EPs, eligible 

hospitals, or CAHs demonstrate that 

they meet all of the required meaningful 

use objectives and the associated 

measures using certified EHR 

technology. In order to receive an 

incentive payment, all EPs, eligible 

hospitals and CAHs must register for the 

program in the NLR and then attest that 

they have successfully demonstrated 

meaningful use of certified EHR 

technology after the completion of their 

EHR reporting period, which is defined 

at 75 FR 44566. 

Section 1848(o)(3)(D) of the Act 

requires the Secretary to list, in an 

easily understandable format, the 

names, business addresses, and business 

phone numbers of the Medicare EPs for 

being meaningful EHR users under the 

Medicare FFS program on the Internet 

web site of CMS. Section 1886(n)(4)(B) 

of the Act requires the Secretary to list, 

in an easily understandable format, the 

names and other relevant data as 

determined appropriate, of eligible 

hospitals and CAHs who are meaningful 

EHR users under the Medicare FFS 

program, on the CMS Internet web site. 

Sections 1853(m)(5) and 1853(I)(7) of 

the Act require the Secretary to post the 

same information for EPs and eligible 

hospitals in the MA program as would 

be required if they were in the Medicare 

FFS program. Therefore, we collect the 

information necessary to post the name, 

business address and business phone 

numbers of all EPs, eligible hospitals 

and CAHs participating in the Medicare 

FFS and MA EHR Incentive Program,, 

and post this information on our 

Internet web site. The routine uses 

established with this system contain a 

proper explanation as to the need for the 

disclosure provisions and provide 

clarity to CMS’ intention to disclose 

provider-specific information contained 

in this system. 

I. Description of the Proposed System of 

Records 

A. Statutory and Regulatory Basis for 

System 

Authority for the collection, 

maintenance, and disclosures from this 

system is provided under §§ 1848(o), 

1886(m), 1848(l), and 1853(m) of the 

Social Security Act which were added 

by the HITECH Act, respectively 

authorize incentive payments for EPs, 

eligible hospitals, CAHs and MA 

Organizations that successfully 

demonstrate meaningful use of certified 

EHR technology. Sections 1903(a)(3) 

and 1903(t) of the Social Security Act 

provides authority for the Medicaid 

EHR Incentive Program. These 

provisions are implemented by 75 FR 

44314 and 42 CFR parts 412, 413, 422, 

collectively known as the Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program; Final Rule. 

B. Collection and Maintenance of Data 

in the System 

The National Level Repository (NLR) 

contains information on eligible 

professionals who receive Medicare 

incentives as meaningful users of 

certified EHR technology. Information 

in the NLR will be populated from other 

CMS systems, including the Provider 

Enrollment, Chain, and Ownership 

System (PECOS) and the National Plan 

& Provider Enumeration System 

(NPPES). The NLR will contain provider 

name, National Provider Identifier 

(NPI), business address and phone 

number, Taxpayer Identification 

Number (TIN) to which the EP, eligible 

hospital or CAH, or MA Organization 

wants the incentive payment to be 

made, and, for EPs, whether they choose 

to participate in the Medicare EHR 

Incentive Program or the Medicaid EHR 

Incentive Program. For eligible hospitals 

and CAHs, their CCN will also be 

included. For MA Organizations, their 

CMS contract number will be included. 

For providers participating in the 

Medicaid EHR Incentive Program, it will 

include the State in which they choose 

to participate. Additionally, EPs, 

eligible hospitals and CAHs will have 

the option to provide an e-mail address 

for inclusion in the system. At this time, 

participation in the Medicare and 

Medicaid EHR Incentive Program is 

voluntary for EPs, eligible hospitals and 

CAHs. 

II. Agency Policies, Procedures, and 

Restrictions On Routine Uses 

A. 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 information collected in the 

NLR that can be associated with an 

individual EP as provided for under 

‘‘Section III. Proposed Routine Use 

Disclosures of Data in the System.’’ 

Identifiable data may be disclosed under 

a routine use. 

We will only disclose the minimum 

provider-level data necessary to achieve 

the purpose of the Medicare and 

Medicaid EHR Incentive Program. CMS 

has the following policies and 

procedures concerning disclosures of 

information that will be maintained in 

the system. These policies do not apply 

to Routine Use No. 3 for this system. In 

general, disclosure of information from 

the system will be approved only for the 

minimum information 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, maintain, and process 

information promoting the nationwide 

health information technology 

infrastructure that allows for the 

electronic use and exchange of 

information. 

2. Determines that: 

a. The purpose of the disclosure can 

only be accomplished if the record is 

provided in an 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 

provider 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; 

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b. Remove or destroy at the earliest 

time all individually-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. Entities Who May Receive 

Disclosures under Routine Use 

These routine uses specify 

circumstances, in addition to those 

provided by statute in the Privacy Act 

of 1974, under which CMS may release 

information from the Medicare and 

Medicaid EHR Incentive Program 

without the consent of the individual to 

whom such information pertains. Each 

proposed disclosure of information 

under these routine uses will be 

evaluated to ensure that the disclosure 

is legally permissible, including but not 

limited to ensuring that the purpose of 

the disclosure is compatible with the 

purpose for which the information was 

collected. We propose to establish the 

following routine use disclosures of 

information maintained in the system: 

1. To support Agency contractors or 

consultants who have been engaged by 

the Agency to assist in accomplishment 

of a CMS function relating to the 

purposes for this SOR and who need to 

have access to the records in order to 

assist CMS. 

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 a CMS function relating 

to purposes for this SOR. 

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 assist another Federal or state 

agency, agency of a state government, or 

an agency established by state law 

pursuant to agreements with CMS to: 

a. Contribute to the accuracy of CMS’s 

proper incentive payment to Medicare 

and Medicaid EHR Incentive Program 

participants, and 

b. Assist Federal/state Medicaid 

programs which may require Medicare 

and Medicaid EHR Incentive Program 

information for purposes related to this 

system. 

c. Assist other Federal agencies that 

have the authority to perform collection 

of debts owed to the Federal 

government. 

Other Federal or state agencies in 

their administration of a Federal health 

program may require EHR Incentive 

Program information in order to support 

evaluations and monitoring of various 

aspects of the Medicare and Medicaid 

EHR Incentive payments. 

2. To assist in making the information 

for EPs, eligible hospitals and CAHs, 

and MA Organizations that receive 

Medicare EHR incentive payments 

through the new payment contractor, 

available through a public web site. If 

local websites are used by a local or 

regional collaborative, CMS would have 

links to these Web sites on its main Web 

site. 

This information would be posted for 

the purpose of, and in a manner that 

would promote the use of EHRs by EPs, 

eligible hospitals and CAHs, and MA 

Organizations to Medicare and 

Medicaid beneficiaries. 

3. To assist the Department’s Office of 

the National Coordinator of Health 

Information Technology’s (ONC’s) 

grantees for the purpose of supporting 

‘‘eligible professional’’ (EP) adoption and 

meaningful use of certified EHR 

technology. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may be 

asked to provide necessary information 

to ONC grantees, also referred to as 

Health Information Technology 

Regional Extension Centers (RECs) to 

assist in accomplishing an ONC 

function relating to support for ‘‘eligible 

professional’’ (EP) adoption of, 

meaningful use of certified EHR 

technology, and provider support. 

4. To support the Department of 

Justice (DOJ), court, or adjudicatory 

body when: 

a. The Agency or any component 

thereof, or 

b. Any employee of the Agency in his 

or her official capacity, or 

c. Any employee of the Agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

d. The United States Government, is 

a party to litigation or has an interest in 

such litigation, and by careful review, 

CMS determines that the records are 

both relevant and necessary to the 

litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

Whenever CMS is involved in 

litigation, or occasionally when another 

party is involved in litigation and CMS’s 

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. 

5. To assist a CMS contractor 

(including, but not 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, 

waste or abuse in such program. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may enter 

into a contract or grant with a third 

party to assist in accomplishing CMS 

functions relating to the purpose of 

combating fraud, waste or abuse. 

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 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 or grant and requiring the 

contractor or grantee to return or destroy 

all information. 

6. To assist another Federal agency or 

to an instrumentality of any 

governmental jurisdiction within or 

under the control of the United States 

(including any state or local 

governmental agency), that administers, 

or that has the authority to investigate 

potential fraud, waste or abuse in a 

health benefits program funded in 

whole or in part by Federal funds, when 

disclosure is deemed reasonably 

necessary by CMS to prevent, deter, 

discover, detect, investigate, examine, 

prosecute, sue with respect to, defend 

against, correct, remedy, or otherwise 

combat fraud, waste or abuse in such 

programs. 

Other agencies may require Medicare 

and Medicaid EHR Incentive Program 

information for the purpose of 

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combating fraud, waste or abuse in such 

Federally-funded programs. 

7. To assist appropriate Federal 

agencies and Department contractors 

that have a need to know the 

information for the purpose of assisting 

the Department’s efforts to respond to a 

suspected or confirmed breach of the 

security or confidentiality of 

information maintained in this system 

of records, and the information 

disclosed is relevant and unnecessary 

for the assistance. 

Other Federal agencies and 

contractors may require EHR Incentive 

Program information for the purpose of 

assisting in a respond to a suspected or 

confirmed breach of the security or 

confidentiality of information. 

IV. Safeguards 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

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 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; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

V. Effects of the New System On the 

Rights of Individuals 

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. 

We will only disclose the minimum 

personal data necessary to achieve the 

purpose of the data collection and the 

routine uses contained in this notice. 

Disclosure of information from the 

system will be approved only to the 

extent necessary to accomplish the 

purpose of the disclosure. CMS has 

assigned a higher level of security 

clearance for the information 

maintained in this system in an effort to 

provide added security and protection 

of data in this system. 

CMS will take precautionary 

measures to minimize the risks of 

unauthorized access to the records and 

the potential harm to individual privacy 

or other personal or property rights. 

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 the 

disclosure of information relating to 

individuals. 

Dated: November 16, 2010. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

SYSTEM No. 09–70–0587 

SYSTEM NAME: 

‘‘Medicare and Medicaid Electronic 

Health Record (EHR) Incentive Program 

National Level Repository’’ HHS/CMS/ 

OESS. 

SECURITY CLASSIFICATION: 

Level Three Privacy Act Sensitive. 

SYSTEM LOCATION: 

CMS Data Center, 7500 Security 

Boulevard, North Building, First Floor, 

Baltimore, Maryland 21244–1850 and at 

various contractor sites. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

The National Level Repository (NLR) 

contains information on eligible 

professionals who receive Medicare 

incentives as meaningful users of 

certified EHR technology. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The NLR will contain provider name, 

National Provider Identifier (NPI), 

business address and phone number, 

Taxpayer Identification Number (TIN) to 

which the EP, eligible hospital or CAH, 

or MA Organization wants the incentive 

payment to be made, and, for EPs, 

whether they choose to participate in 

the Medicare EHR Incentive Program or 

the Medicaid EHR Incentive Program. 

For eligible hospitals and CAHs, their 

CCN will also be included. For MA 

Organizations, their CMS contract 

number will be included. For providers 

participating in the Medicaid EHR 

Incentive Program, it will include the 

State in which they choose to 

participate. Additionally, EPs, eligible 

hospitals and CAHs will have the option 

to provide an e-mail address for 

inclusion in the system. At this time, 

participation in the Medicare and 

Medicaid EHR Incentive Program is 

voluntary for EPs, eligible hospitals and 

CAHs. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Authority for the collection, 

maintenance, and disclosures from this 

system is provided under §§ 1848(o), 

1886(m), 1848(l), and 1853(m) of the 

Social Security Act which were added 

by the HITECH Act, respectively 

authorize incentive payments for EPs, 

eligible hospitals, CAHs and MA 

Organizations that successfully 

demonstrate meaningful use of certified 

EHR technology. Sections 1903(a)(3) 

and 1903(t) of the Social Security Act 

provides authority for the Medicaid 

EHR Incentive Program. These 

provisions are implemented by 75 FR 

44314 and 42 CFR parts 412, 413, 422, 

collectively known as the Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program; Final Rule. 

PURPOSE(S) OF THE SYSTEM: 

The primary purpose of this system, 

called the National Level Repository or 

NLR, is to collect, maintain, and process 

information that is required for the 

Medicare and Medicaid EHR Incentive 

Program. Information in this system will 

also be disclosed to: (1) Support 

regulatory, incentive payments and 

policy functions such as evaluation and 

reporting, whether performed by the 

Agency or by an Agency contractor or 

consultant; (2) assist another Federal 

and/or state agency, agency of a state 

government, or an agency established by 

state law; (3) assist in making the 

individual physician-level participation 

data available through an Agency 

website and by various other means of 

data dissemination; (4) assist the 

Department’s Office of the National 

Coordinator of Health Information 

Technology’s (ONC’s) grantees for the 

purpose of supporting ‘‘eligible 

professional’’ (EP) adoption and 

meaningful use of certified EHR 

technology; (5) support litigation 

involving the Agency; (6) combat fraud, 

waste, and abuse in certain health 

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73100 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

benefits programs, and (7) assist in a 

response to a suspected or confirmed 

breach of the security or confidentiality 

of information. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OR USERS AND

THE PURPOSES OF SUCH USES: 

A. ENTITIES WHO MAY RECEIVE DISCLOSURES

UNDER ROUTINE USE

These routine uses specify 

circumstances, in addition to those 

provided by statute in the Privacy Act 

of 1974, under which CMS may release 

information from the EHRI without the 

consent of the individual to whom such 

information pertains. Each proposed 

disclosure of information under these 

routine uses will be evaluated to ensure 

that the disclosure is legally 

permissible, including but not limited to 

ensuring that the purpose of the 

disclosure is compatible with the 

purpose for which the information was 

collected. We propose to establish the 

following routine use disclosures of 

information maintained in the system: 

1. To support Agency contractors, 

consultants, or CMS grantees who have 

been engaged by the Agency to assist in 

accomplishment of a CMS function 

relating to the purposes for this SOR 

and who need to have access to the 

records in order to assist CMS. 

2. To assist another Federal or state 

agency, agency of a state government, or 

an agency established by state law 

pursuant to agreements with CMS to: 

a. Contribute to the accuracy of CMS’s 

proper incentive payment to Medicare 

and Medicaid EHR Incentive Program 

participants, and 

b. Assist Federal/state Medicaid 

programs which may require Medicare 

and Medicaid EHR Incentive Program 

information for purposes related to this 

system. 

c. Assist other Federal agencies that 

have the authority to perform collection 

of debts owed to the Federal 

government. 

3. To assist in making the information 

for EPs, eligible hospitals and critical 

access hospitals (CAHs), who receive 

EHR incentive payments through the 

new payment contractor, available 

through a public website. If local Web 

sites are used by a local or regional 

collaborative, CMS would have links to 

these websites on its main website. 

4. To assist the Department’s Office of 

the National Coordinator of Health 

Information Technology’s (ONC’s) 

grantees for the purpose of supporting 

‘‘eligible professional’’ (EP) adoption and 

meaningful use of certified EHR 

technology. 

5. To support the Department of 

Justice (DOJ), court, or adjudicatory 

body when: 

a. The Agency or any component 

thereof, or 

b. Any employee of the Agency in his 

or her official capacity, or 

c. Any employee of the Agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

d. The United States Government, is 

a party to litigation or has an interest in 

such litigation, and by careful review, 

CMS determines that the records are 

both relevant and necessary to the 

litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

6. To assist a CMS contractor 

(including, but not limited to fiscal 

intermediaries and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste or abuse in such program. 

7. To assist another Federal agency or 

to an instrumentality of any 

governmental jurisdiction within or 

under the control of the United States 

(including any state or local 

governmental agency), that administers, 

or that has the authority to investigate 

potential fraud, waste or abuse in a 

health benefits program funded in 

whole or in part by Federal funds, when 

disclosure is deemed reasonably 

necessary by CMS to prevent, deter, 

discover, detect, investigate, examine, 

prosecute, sue with respect to, defend 

against, correct, remedy, or otherwise 

combat fraud, waste or abuse in such 

programs. 

8. To assist appropriate Federal 

agencies and Department contractors 

that have a need to know the 

information for the purpose of assisting 

the Department’s efforts to respond to a 

suspected or confirmed breach of the 

security or confidentiality of 

information maintained in this system 

of records, and the information 

disclosed is relevant and necessary for 

the assistance. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Records are stored on both tape 

cartridges (magnetic storage media) and 

in a DB2 relational database 

management environment (DASD data 

storage media). 

RETRIEVABILITY: 

Information is most frequently 

retrieved by provider number (facility, 

physician, IDs), service dates, and 

prescriber identification number. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations 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 

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; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions after they 

are entered into the system for a period 

of 10 years. Records are housed in both 

active and archival files. All claimsrelated 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 E–Health Standards 

and Services, Centers for Medicare & 

Medicaid Services, 7500 Security Blvd, 

Mail-stop: S2–26–17, Baltimore, MD 

21244–1850. 

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Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73101 

NOTIFICATION PROCEDURE: 

For purpose of notification, the 

subject individual should write to the 

system manager who will require the 

system name, and the retrieval selection 

criteria (e.g., Provider number, SSN, 

etc.). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined 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(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record 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: 

Information in the National Level 

Repository will be populated from other 

CMS systems of records, including the 

Provider Enrollment, Chain, and 

Ownership System (PECOS) and the 

National Plan & Provider Enumeration 

System (NPPES). 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 2010–29952 Filed 11–26–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Evaluation of Pregnancy 

Prevention Approaches and Teen 

Pregnancy Prevention Evaluation. 

OMB No.: 0970–0360. 

Description: The Administration for 

Children and Families (ACF), the Office 

of the Assistant Secretary for Planning 

and Evaluation (ASPE), and the Office 

of the Assistant Secretary for Health 

(ASH), 13.5. Department of Health and 

Human Services (HHS), are proposing a 

data collection activity to be undettaken 

by two related studies—the Evaluation 

of Pregnancy Prevention Approaches 

study and the Teen Pregnancy 

Prevention Evaluation. Both studies are 

sponsored by ASH and will use the 

same data collection instruments; ACF 

is facilitating the Evaluation of 

Pregnancy Prevention Approaches, 

while ASPE is facilitating the Teen 

Pregnancy Prevention Evaluation. 

These two studies will assess the 

effectiveness of a range of programs 

designed to prevent or reduce sexual 

risk behavior and pregnancy among 

older adolescents. Knowing what types 

of programs are effective will enhance 

programmatic decisions by 

policymakers and practitioners. 

The proposed activity involves the 

collection of information from 

observations of program activities and 

interviews with a range of experts and 

persons involved with programs about 

various aspects of existing prevention 

programs and topics the experts view as 

important to address through 

evaluation. These data will be used to 

help enhance decisions about the types 

of programs to be evaluated in the 

studies. 

Respondents: Researchers and policy 

experts, program directors, program 

staff, or school administrators. 

ANNUAL BURDEN ESTIMATES 

Instrument 

Annual number of respondents Number of responses per 

respondent 

Average burden hours per 

response 

Estimated annual burden 

hours 

Discussion Guide for Use with Researchers and Policy Experts ................... 30 1 1 30 

Discussion Guide for Use with Program Directors .......................................... 30 2 2 120 

Discussion Guide for Use with Program Staff ................................................. 60 1 2 120 

Focus Group Discussion Guide for Use with Program Participants ............... 300 1 1 .5 450 

Discussion Guide for Use with School Administrators .................................... 200 1 1 200 

Estimated Total Annual Burden 

Hours: 920. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. E-mail address: 

OPREinfocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: November 22, 2010. 

Steven Hanmer, 

OPRE Reports Clearance Officer. 

[FR Doc. 2010–29917 Filed 11–26–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0601] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Medicated Feeds 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

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