65692 Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Proposed Rules 

(5) It is in the best interest of the 

government to contract with the offeror 

or contractor even though the conflict of 

interest exists and a request for waiver 

is approved in accordance with 48 CFR 

9.503. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

Dated: June 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: August 20, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E7–22773 Filed 11–21–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 483 

[CMS–2266–P] 

RIN 0938–AO82 

Medicare and Medicaid Programs; 

Waiver of Disapproval of Nurse Aide 

Training Program in Certain Cases and 

Nurse Aide Petition for Removal of 

Information for Single Finding of 

Neglect 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

permit a waiver of nurse aide training 

disapproval as it applies to skilled 

nursing facilities, in the Medicare 

program, and nursing facilities, in the 

Medicaid program, that are assessed a 

civil money penalty of at least $5,000 

for noncompliance that is not related to 

quality of care. This is a statutory 

provision enacted by section 932 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173, enacted 

December 8, 2003.) 

In addition, this proposed rule would 

codify an additional statutory provision 

enacted by section 4755 of the Balanced 

Budget Act of 1997 (BBA) (Pub. L. 105–

33, enacted on August 5, 1997) that 

requires the State to establish a 

procedure to permit a nurse aide to 

petition the State to have a single 

finding of neglect removed from the 

nurse aide registry if the State 

determines that the employment and 

personal history of the nurse aide does 

not reflect a pattern of abusive behavior 

or neglect and the neglect involved in 

the original finding was a single 

occurrence. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on December 24, 2007. 

ADDRESSES: In commenting, please refer 

to file code CMS–2266–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–2266–

P, P.O. Box 8017, Baltimore, MD 21244–

8017. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–2266–P, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

7195 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: Pat 

Miller, (410) 786–6780. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–2266–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://www.cms.hhs.gov/ 

eRulemaking. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. Waiver of Disapproval of Nurse Aide 

Training Program in Certain Cases 

To participate in the Medicare and or 

Medicaid programs, long-term care 

facilities must be certified as meeting 

Federal participation requirements. 

Long-term care facilities include skilled 

nursing facilities (SNFs) for Medicare 

and nursing facilities (NFs) for 

Medicaid. The Federal participation 


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requirements for these facilities are 

specified in regulations at 42 CFR part 

483, subpart B. 

Section 1864(a) of the Social Security 

Act (the Act) authorizes the Secretary to 

enter into agreements with State survey 

agencies to determine whether SNFs 

meet the Federal participation 

requirements for Medicare. Section 

1902(a)(33)(B) of the Act provides for 

State survey agencies to perform the 

same survey tasks for facilities 

participating or seeking to participate in 

the Medicaid program. The results of 

Medicare and Medicaid related surveys 

are used by the Centers for Medicare & 

Medicaid Services and the State 

Medicaid agency, respectively, as the 

basis for a decision to enter into or deny 

a provider agreement, recertify facility 

participation in one or both programs, 

or impose remedies on a noncompliant 

facility. 

To assess compliance with Federal 

participation requirements, surveyors 

conduct onsite inspections (surveys) of 

facilities. In the survey process, 

surveyors directly observe the actual 

provision of care and services to 

residents and the effect or possible 

effects of that care to evaluate whether 

the care furnished meets the assessed 

needs of individual residents. 

Sections 1819(b)(5) and 1919(b)(5) of 

the Act and implementing regulations at 

§ 483.75(e) require that all individuals 

employed by a facility as nurse aides 

must have successfully completed a 

nurse aide training program. 

Sections 1819(f)(2) and 1919(f)(2) of 

the Act provide that facility-based nurse 

aide training could be offered either by 

the facility or in the facility by another 

entity approved by the State. In other 

words, a facility in good standing (that 

is, one that is not subject to an event 

that results in disapproval of a nurse 

aide training program) may offer a 

facility-based program in one of two 

ways: It can either conduct its own 

facility-based State-approved nurse aide 

training and have the State or a Stateapproved entity administer the nurse 

aide competency evaluation program, or 

it can offer the entire nurse aide training 

and competency evaluation program 

through an outside entity which has 

been approved by the State to conduct 

both components. 

Further, these sections prohibit States 

from approving a nurse aide training 

and competency evaluation program or 

a nurse aide competency evaluation 

program offered by or in a SNF or NF 

when any of the following specified 

events have occurred in that facility—

• The facility has operated under a 

nurse staffing waiver; 

• The facility has been subject to an 

extended or partial extended survey 

unless the survey shows the facility is 

in compliance with the participation 

requirements; or 

• The facility has been assessed a 

civil money penalty of not less than 

$5,000, or has been subject to a denial 

of payment, the appointment of a 

temporary manager, termination, or in 

the case of an emergency, been closed 

and had its residents transferred. 

Program disapproval is a required, 

rather than a discretionary, response 

whenever any of these events occur. 

Since facilities are required to employ 

nurse aides who have successfully 

completed a training program, when a 

facility loses its ability to conduct 

facility-based training, it must, for the 

duration of the 2 year program 

disapproval, provide the required 

training through either the State or 

another State-approved outside 

organization as provided by 

§ 483.151(a). However, sections 

1819(f)(2)(D) and 1919(f)(2)(D) of the 

Act permit a waiver for program 

disapproval of programs offered in (but 

not by) a facility if the State—

• Determines that there is no other 

such program offered within a 

reasonable distance of the facility; 

• Assures that an adequate 

environment exists for operating the 

program in the facility; and 

• Notifies the State Long Term Care 

Ombudsman of this determination and 

these assurances. 

Section 932(c)(2)(B) of the MMA added 

sections 1819(f)(2)(D) and 1919(f)(2)(D) 

of the Act which allows the Secretary to 

waive a facility’s disapproval of its 

nurse aide training program upon 

application of a facility if the 

disapproval resulted from the 

imposition of a civil money penalty of 

at least $5000 and that is not related to 

quality of care provided to residents in 

the facility. 

The statutory provision being 

implemented in this proposed rule 

pertains specifically and only to the 

civil money penalty disapproval trigger 

under sections 1819(f)(2)(B)(iii)(I)(c) and 

1919(f)(2)(B)(iii)(I)(c) of the Act and 

establishes authority for CMS to 

approve a facility’s request to waive 

disapproval of its nurse aide training 

program when that facility has been 

assessed a civil money penalty of at 

least $5,000 for deficiencies that are not 

related to quality of care. 

B. Nurse Aide Petition for Removal of 

Information for Single Finding of 

Neglect 

The nurse aide registry is one of the 

tools to ensure that nursing homes are 

employing qualified nurse aides who 

are properly trained, appropriately 

tested, and have no adverse findings 

against them of abuse, neglect, or 

misappropriation of property. Sections 

1819(e)(2) and 1919(e)(2) of the Act and 

the implementing regulations at 

§ 483.156 require each State to establish 

and maintain a registry of nurse aides 

who have successfully completed a 

nurse aide training and competency 

evaluation program and have been 

found by the State to be competent. The 

nurse aide registry also includes 

information for any nurse aides who 

have had an adverse finding of abuse, 

neglect, or misappropriation of resident 

property substantiated by the State 

survey agency. This information must 

be included in the registry within 10 

working days of the finding and remain 

in the registry permanently unless the 

finding was made in error, the 

individual was found not guilty by a 

court of law, or the State is notified of 

the individual’s death. Nursing homes 

are required to verify with State nurse 

aide registries (in the State where the 

facility is located and in other States 

that may have information on the 

individual) that prospective nurse aide 

employees have not abused, neglected, 

or mistreated residents nor 

misappropriated their property. A 

nursing home must not employ 

individuals who have been found guilty 

of abusing, neglecting, or mistreating 

residents by a court of law or who have 

had a finding entered into the State 

nurse aide registry concerning abuse, 

neglect, mistreatment of residents or 

misappropriation of their property. 

Section 483.13 of the regulations 

provides that if there has been a finding 

of abuse, neglect, mistreatment of 

residents or misappropriation of their 

property entered into the nurse aide 

registry against a nurse aide, the nurse 

aide is permanently prohibited from 

working in a nursing home. The 

additional purpose of this proposed rule 

is to implement a legislative provision 

enacted as part of the BBA and included 

in the statutory language at sections 

1819(g)(1)(D) and 1919(g)(1)(D) of the 

Act which reads in part, ‘‘Removal of 

name from nurse aide registry.’’

However, since the nurse aide registry 

must also include information about 

nurse aides who have successfully 

completed a nurse aide training and 

competency evaluation program and 

have been found by the State to be 

competent, the name of the nurse aide 

would not be removed completely from 

the registry. Rather, it is technically the 

removal of the single adverse finding 

itself against a nurse aide from the nurse 


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aide registry in limited circumstances 

under specific conditions that is 

contemplated. 

II. Discussion of the Issues 

A. Waiver of Disapproval of Nurse Aide 

Training Program in Certain Cases 

Some participation requirements for 

nursing homes, if unmet and which 

result in the assessment of a civil money 

penalty of at least $5,000, results in the 

loss of the facility’s nurse aide training 

program for 2 years. For example, 

§ 483.13, Resident behavior and facility 

practices, requires in paragraph (a) that 

the resident has the right to be free from 

any physical or chemical restraints 

imposed for purposes of discipline or 

convenience, and not required to treat 

the resident’s medical symptoms. 

Another example, § 483.25, Quality of 

care, requires in paragraph (c) that the 

facility must ensure that residents who 

enter the facility without pressure sores 

do not develop them unless they are 

unavoidable and that residents having 

pressure sores receive necessary 

treatment and services to promote 

healing, prevent infection, and prevent 

new sores from developing. These are 

facility failures of direct care-giving 

requirements that could compromise the 

facility’s ability to provide quality 

health care services directly to residents 

and could lead us to conclude that the 

facility is not providing positive role 

models for the training of its nurse 

aides. 

On the other hand, there are other 

participation requirements that are not 

directly related to the provision of 

hands-on health care services or to the 

training of nurse aides. Thus, even if 

unmet, these facility failures would 

have no direct negative impact on care 

furnished to residents or the facility’s 

ability to provide a positive role model 

for the training of its aides regarding 

appropriate care for residents. For 

example, § 483.10, Resident rights, 

requires in paragraph (b)(2) that a 

resident or his or her legal 

representative, has the right, after 

inspecting all of his or her records, to 

purchase, at a cost not to exceed the 

community standard, photocopies of the 

records or any portions of them upon 

request, with 2 working days advance 

notice to the facility. Another example, 

§ 483.12, Admission, transfer and 

discharge rights, requires in paragraph 

(a)(5) that a facility must provide notice 

of transfer or discharge to a resident at 

least 30 days before the transfer or 

discharge occurs. While failure to meet 

these requirements may subject the 

facility to a civil money penalty of 

$5,000 or more, these facility failures 

concern administrative and procedural 

requirements which are not directly 

related to the provision of hands-on 

health care services to residents, and, 

therefore, would not be indicative of a 

poor facility model for its nurse aide 

training program. 

There is currently no regulatory 

distinction between care-giving and non 

care-giving participation requirements 

for purposes of the nurse aide training 

program disapproval. Rather, the 

disapproval automatically results when 

there is any noncompliance for which a 

civil money penalty of $5,000 or more 

is assessed. 

Currently, facilities assessed a civil 

money penalty of at least $5,000 for 

noncompliance with any Federal 

participation requirement are prohibited 

from offering such a training program 

for a period of 2 years. The purpose of 

this proposed rule is to implement the 

legislative waiver provision enacted on 

December 8, 2003 as part of the MMA 

and which amended the Act. This 

revision would improve the 

applicability of the training disapproval 

requirement as it applies to assessed 

civil money penalty sanctions of at least 

$5,000, by distinguishing between 

facility noncompliance that warrants the 

training program disapproval and 

noncompliance that does not. 

As a result of these issues, the 

Congress concluded that the compliance 

assessment and response system for 

nursing homes needed to be improved 

to distinguish between what does and 

does not relate to the quality of care 

furnished to residents for purposes of 

determining whether disapproval of a 

facility’s nurse aide training program 

should result when assessment of a civil 

money penalty of at least $5,000 is the 

only basis for disapproving the program. 

This proposed rule would implement 

section 932 of the MMA such that the 

additional consequence of program 

disapproval need not necessarily result 

if we determine that the noncompliance 

is not related to direct hands-on resident 

care, and as such, would not likely 

compromise the facility’s ability to 

provide successful role modeling for its 

training program. However, we wish to 

emphasize that our authority to approve 

a facility’s request for such a waiver 

does not assure that a waiver would be 

granted. These waiver determinations 

would be made by CMS upon 

application of a nursing facility on a 

case-by-case basis after considering the 

recommendation and facts of that case 

as provided by the State. We do not 

foresee this process of noncompliance—

fact gathering, analysis, and subsequent 

recommendation for action to CMS for 

purposes of determining program 

disapproval waivers—as an additional 

workload burden for States. States 

currently perform these functions under 

their agreements with CMS when they 

perform survey functions. They 

currently evaluate facility 

noncompliance scope, severity, nature, 

and impact on residents whenever they 

make a determination about the 

seriousness of a facility’s 

noncompliance as well as when they 

make enforcement remedy 

recommendations to CMS. This 

proposed rule simply acknowledges that 

these State activities currently occur 

and that they would now also be used 

by CMS in making nurse aide training 

program disapproval waiver 

determinations. 

The plain language of the statute 

permits waiver of training program 

disapproval based on the imposition of 

at least a $5,000 CMP that was not 

related to the quality of care furnished 

to residents. However, it does not 

provide guidance for what this means. 

On page 776 of the Conference Report 

to the MMA (H.R. Rep. No. 108–391 

(2003), reprinted in 2004 U.S.C.C.A.N. 

1808, 2130), it states that, ‘‘* * * 

Quality of care in such instances refers 

to direct, hands on care furnished to 

residents of a facility.’’ We believe that 

this proposed rule proposes an 

appropriate and rational way to 

implement the legislative intent of 

evaluating noncompliance with ‘‘quality 

of care furnished to residents’’ in order 

to determine what impact it may have 

on the facility’s ability to provide a 

positive training model to its nurse 

aides. In order to assess the ‘‘quality of 

care being furnished to residents,’’ we 

needed to find a way to differentiate 

between care-giving and non-care-giving 

requirements. So, for purposes of 

implementing this new legislative 

provision, we are proposing to define 

‘‘quality of care furnished to residents’’

as direct care and treatment that a 

health care professional or direct care 

staff provides to a resident. 

We also emphasize that a finding of 

noncompliance with a direct care giving 

requirement is not necessary in order to 

assess a civil money penalty of at least 

$5,000 or to disapprove a facility’s nurse 

aide training program. Regardless of 

whether or not the noncompliance is 

with a direct care giving requirement, 

the existence of the noncompliance, 

itself, may result in the imposition of a 

civil money penalty or another remedy 

from the menu of available sanctions. 

Once a remedy or remedies are 

imposed, a facility’s ability to provide 

nurse aide training is prohibited for 2 

years unless a waiver is approved. 


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In response to a facility’s request for 

a waiver of its nurse aide training 

program disapproval when a civil 

money penalty of at least $5,000 has 

been assessed, the nature of the facility’s 

deficiencies would be evaluated to 

determine if they are central to 

furnishing direct hands-on care to 

residents. 

‘‘Assessed’’ is defined in our State 

Operations Manual, (Pub. 100–07), 

section 7536 A as, ‘‘* * * the final 

amount determined to be owed after a 

hearing, waiver of right to hearing, or 

settlement.’’

Civil money penalties can be assessed 

for specific instances of noncompliance 

(per instance) as well as for aggregate 

facility noncompliance (per day), we 

needed a method of determining how 

discrete and aggregate noncompliance 

should be evaluated for purposes of 

applying this waiver provision. 

When a per instance civil money 

penalty of at least $5,000 is assessed for 

noncompliance with a specific 

participation requirement, the 

evaluation of that specific deficiency’s 

direct impact on residents is clear-cut. 

However, when the civil money penalty 

of at least $5,000 is per day, the 

evaluation becomes more difficult. In 

the latter case, all of the facility’s 

deficiencies would need to be reviewed 

to determine if individually or, in total, 

they are indicative of an overall facility 

failure or inability to directly provide 

quality care to its residents. The 

resulting determination would allow us 

to conclude whether the facility is still 

likely to provide a positive nurse aide 

training model. 

Although a single care-giving 

deficiency, among other non care-giving 

deficiencies, may result in a conclusion 

that the facility, overall, is providing 

quality care to its residents, it is also 

possible that the seriousness of that 

single facility failure could cause us to 

conclude otherwise. While we do not 

intend to provide specific detail in this 

rule about how to operationalize this 

decision making process, we will 

provide guidance and examples in the 

CMS State Operations Manual. 

We wish to reiterate that this proposal 

would not automatically mandate a 

waiver of a nurse aide training program 

disapproval in cases when a civil money 

penalty of $5,000 or more is assessed for 

non care-giving noncompliance. Rather, 

it implements the legislative flexibility 

to evaluate the noncompliance in 

context with other factors in order for 

CMS to make better decisions, on a caseby-case basis, about whether or not to 

waive the training program disapproval. 

While we do not intend to include 

instructions in this rule about which 

participation requirements would be 

considered to be related to the direct 

care and hands-on treatment that a 

health care professional or direct care 

staff provides to the resident, we have 

included examples of our intent earlier 

in this preamble and will provide 

operational guidance in our State 

Operations Manual. The examples we 

have furnished simply illustrate the 

distinctions we believe exist between 

noncompliance that realistically 

constitutes direct hands-on care and 

noncompliance that does not. We 

encourage public comment regarding 

examples or issues that should be 

addressed in CMS operational guidance. 

In consideration of the issues 

described, we believe that the regulation 

change we propose below to implement 

the new legislative provision strikes a 

fair balance between characteristics of 

care that a reasonable person would 

expect to be indicative of quality health 

care services. This determination would 

then lead us to conclude whether the 

facility, despite its deficiencies, is still 

likely to provide a positive role model 

for its nurse aides. 

B. Nurse Aide Petition for Removal of 

Information for Single Finding of 

Neglect 

A nurse aide is defined in § 483.75 of 

the regulations as any individual 

providing nursing or nursing-related 

services to residents in a facility who is 

not a licensed health professional, a 

registered dietician, or someone who 

volunteers to provide these services 

without pay. Although the efforts of all 

nursing home staff are required to 

provide care to residents, the role of the 

nurse aide is vital. Nurse aides provide 

much of the direct hands-on care that 

residents receive and are actively 

involved in their daily lives. Competent 

and caring nurse aides are essential to 

providing quality care to nursing home 

residents. Federal regulations at 42 CFR 

part 483, subpart D establish standards 

for training nurse aides and for 

evaluating their competency to assure 

that they have the education, practical 

knowledge, and skills needed to care for 

nursing home residents. Section 483.13 

of the regulations prohibits nursing 

homes from employing individuals who 

have been found guilty of abusing, 

neglecting, or mistreating residents by a 

court of law or have had a finding 

entered into the State nurse aide registry 

concerning resident abuse, neglect, or 

misappropriation of resident property. 

This information must be included in 

the registry within 10 working days of 

the finding and must remain in the 

registry permanently unless the finding 

was made in error, the individual was 

found not guilty by a court of law, or the 

State is notified of the individual’s 

death. Nursing homes are required to 

verify with State nurse aide registries (in 

the State where the facility is located 

and in other States that may have 

information on the individual) that 

nurse aides they are considering for 

employment have not abused, 

neglected, or mistreated residents nor 

misappropriated their property. 

Initially, a specific incident in one 

State raised a concern regarding the 

severe effects of an adverse finding on 

the nurse aide registry. This led to an 

examination of the current regulations 

and subsequently to an addition to the 

Act addressing one specific aspect of the 

existing regulations. This incident 

involved a nurse aide with a long and 

exemplary work record. While assisting 

a resident, the nurse aide was distracted 

by another work demand, and the 

resident fell and suffered an injury. This 

nurse aide was found guilty of neglect 

and, per the current regulations, would 

be barred for life from ever working in 

a nursing home for this isolated 

incident. We believe permanently 

barring a nurse aide from working in a 

nursing home in this type of 

circumstance is inappropriate, limited, 

and not the kind of abuse that the 

original legislation was intended to 

prevent. This proposed regulation 

incorporates statutory language at 

sections 1819(g)(1)(D) and 1919(g)(1)(D) 

(Removal of name from nurse aide 

registry) of the Act and requires every 

State to establish a procedure to permit 

a nurse aide to petition for removal of 

a finding of neglect from the registry if 

the State determines that the 

employment and personal history of the 

nurse aide does not reflect a pattern of 

abusive behavior or neglect and the 

neglect involved in the original finding 

was a single occurrence. 

The determination on a petition for 

removal of the finding of neglect can not 

be made before the expiration of the 1- 

year period beginning on the date on 

which the name of the nurse aide who 

is petitioning for removal was added to 

the nurse aide registry as a result of an 

investigation. As long as the State’s 

process addresses the elements 

specified in the regulation, States may 

use a variety of methods to assure 

compliance with this requirement. For 

example, some States may choose a 

formal process through their State 

legislature while other States may 

choose an informal process, such as 

sending a letter to notify the nurse aide 

of this opportunity to petition. 


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III. Provisions of the Proposed 

Regulation 

A. Waiver of Disapproval of Nurse Aide 

Training Program in Certain Cases 

For the reasons discussed above, we 

propose to redesignate the current 

§ 483.151 (c), (d), and (e) as § 483.151 

(d), (e), and (f), respectively. 

We propose to add a new paragraph 

(c)(1) in § 483.151 where a facility may 

request that we waive the disapproval of 

its nurse aide training program when 

the facility has been assessed a civil 

money penalty of not less than $5,000 

if the civil money penalty was not 

related to the quality of care furnished 

to residents in the facility. We propose 

to add a new paragraph (c)(2) in 

§ 483.151 to define the term quality of 

care furnished to residents, as the direct 

hands-on care and treatment that a 

health care professional or direct care 

staff provides to a resident. We propose 

to add a new paragraph (c)(3) in 

§ 483.151 to specify that any waiver of 

disapproval of a nurse aide training 

program does not waive any civil money 

penalty imposition. 

B. Nurse Aide Petition for Removal of 

Information for Single Finding of 

Neglect 

We propose to redesignate the current 

§ 483.156(d) as § 483.156(e). We propose 

to add a new paragraph (d)(1) in 

§ 483.156 to require the States to 

establish a procedure for permitting a 

nurse aide to petition for removal of a 

finding of neglect from the nurse aide 

registry if the State determines that the 

employment and personal history of the 

nurse aide does not reflect a pattern of 

abusive behavior or neglect and the 

neglect involved in the original finding 

was a single finding. We propose to add 

a new paragraph (d)(2) in § 483.156 to 

require that the petition for removal can 

not be made before the expiration of the 

1-year period beginning on the date on 

which the name of the petitioner was 

added to the nurse aide registry as a 

result of an investigation. An individual 

may petition a State for review of any 

finding made by a State under sections 

1819(g)(1)(c) or 1919(g)(1)(C) of the Act 

after January 1, 1995. 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

(PRA) of 1995, we are required to 

provide 60-day notice in the Federal 

Register and solicit public comment 

before a collection of information 

requirement is submitted to the Office of 

Management and Budget (OMB) for 

review and approval. In order to fairly 

evaluate whether an information 

collection should be approved by OMB, 

section 3506(c)(2)(A) of the PRA of 1995 

requires that we solicit comment on the 

following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

Therefore, we are soliciting public 

comments on each of these issues for 

the information collection requirements 

discussed below. 

Section 483.151 State review and 

approval of nurse aide training and 

competency evaluation programs and 

competency evaluation programs. 

Section 483.151(c)(1) states that a 

facility may request that CMS waive the 

disapproval of its nurse aid training 

program when the facility has been 

assessed a civil money penalty of not 

less than $5,000 if the civil money 

penalty was not related to the quality of 

care furnished to residents in the 

facility. 

The burden associated with this 

requirement is the time and effort put 

forth by the facility to request a waiver. 

While this requirement is subject to the 

PRA, we believe it meets the exemption 

requirements for the PRA found at 5 

CFR 1320.4(a)(2). 

If you comment on any of these 

information collection and record 

keeping requirements, please mail 

copies directly to the following: 

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development Group, 

Attn.: Melissa Musotto, CMS–2266–P 

Room C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–

1850; and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, 

Attn: Carolyn Lovett, CMS Desk Officer, 

(CMS–2266–P), 

carolyn_lovett@omb.eop.gov. Fax (202) 

395–6974. 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

VI. Regulatory Impact Statement 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). These two regulatory 

proposals would not reach the economic 

threshold and thus are not considered 

major rules. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

business. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6.5 million to $31.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA for either of these regulatory 

proposals because we have determined, 

and the Secretary certifies, that neither 

rule would have a significant economic 

impact on a substantial number of small 

entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act for either of these regulatory 

proposals because we have determined, 

and the Secretary certifies, that neither 

rule would have a significant impact on 

the operations of a substantial number 

of small rural hospitals. 


ebenthall on PROD1PC69 with PROPOSALS
Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Proposed Rules 65697 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $120 million. These 

regulatory proposals would have no 

consequential effect on State, local, or 

tribal governments or on the private 

sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Since these regulations would not 

impose costs on State or local 

governments, the requirements of E.O. 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in Part 483 

Grant programs—health, Health 

facilities, Health professions, Health 

Records, Medicaid, Medicare, Nursing 

homes, Nutrition, Reporting and 

recordkeeping requirements, Safety. 

For the reasons set forth in the 

preamble, the Centers for Medicare and 

Medicaid Services would amend 42 CFR 

chapter IV as set forth below: 

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

1. The authority citation for part 483 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

§ 483.150 [Amended] 

2. Section 483.150(a) is revised to 

read as follows: 

§ 483.150 Statutory basis: deemed 

meeting or waiver of requirements. 

(a) Statutory basis. This subpart is 

based on sections 1819(b)(5), 1819(f)(2), 

1919(b)(5), and 1919(f)(2) of the Act, 

which establish standards for training 

nurse-aides and for evaluating their 

competency. 

* * * * * 

§ 483.151 [Amended] 

3. Section 483.151 is amended by—

A. Redesignating paragraphs (c), (d), 

and (e) as paragraphs (d), (e), and (f), 

respectively. 

B. Adding new paragraph (c). 

The addition reads as follows: 

§ 483.151 State review and approval of 

nurse aide training and competency 

evaluation programs and competency 

evaluation programs. 

* * * * * 

(c) Waiver of disapproval of nurse 

aide training programs. 

(1) A facility may request that CMS 

waive the disapproval of its nurse aide 

training program when the facility has 

been assessed a civil money penalty of 

not less than $5,000 if the civil money 

penalty was not related to the quality of 

care furnished to residents in the 

facility. 

(2) For purposes of this provision, 

‘‘quality of care furnished to residents’’

means the direct hands-on care and 

treatment that a health care professional 

or direct care staff furnished to a 

resident. 

(3) Any waiver of disapproval of a 

nurse aide training program does not 

waive any requirement upon the facility 

to pay any civil money penalty. 

* * * * * 

§ 483.156 [Amended] 

4. Section 483.156 is amended by—

A. Redesignating paragraph (d) as 

paragraph (e). 

B. Adding new paragraph (d). 

The addition reads as follows: 

§ 483.156 Registry of nurse aides. 

* * * * * 

(d) Nurse aide petition for removal of 

information for a single finding of 

neglect. (1) The State must establish a 

procedure to permit a nurse aide to 

petition for removal of a finding of 

neglect from the nurse aide registry if 

the State determines that both of the 

following conditions exist: 

(i) The employment and personal 

history of the nurse aide does not reflect 

a pattern of abusive behavior or neglect. 

(ii) The neglect involved in the 

original finding was a single occurrence. 

(2) The determination on a petition 

for removal cannot be made before the 

expiration of the 1-year period 

beginning on the date on which the 

name of the petitioner was added to the 

nurse aide registry as a result of an 

investigation. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

Dated: May 16, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: July 31, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E7–22629 Filed 11–21–07; 8:45 am] 

BILLING CODE 4120–01–P 


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