[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Proposed Rules]
[Pages 65692-65697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22629]


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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.

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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

[[Page 65693]]

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 Sec.  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 State-approved 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 
Sec.  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 Sec.  
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

[[Page 65694]]

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, Sec.  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, Sec.  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, Sec.  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, Sec.  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.

[[Page 65695]]

    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 case-by-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 Sec.  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.

[[Page 65696]]

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 Sec.  483.151 (c), (d), and (e) as Sec.  483.151 (d), (e), and 
(f), respectively.
    We propose to add a new paragraph (c)(1) in Sec.  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 Sec.  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 
Sec.  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 Sec.  483.156(d) as Sec.  
483.156(e). We propose to add a new paragraph (d)(1) in Sec.  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 Sec.  
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), [email protected]. 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.

[[Page 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).


Sec.  483.150  [Amended]

    2. Section 483.150(a) is revised to read as follows:


Sec.  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.
* * * * *


Sec.  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:


Sec.  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.
* * * * *


Sec.  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:


Sec.  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