Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases, 21175-21179 [2010-8902]
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Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 483
[CMS–2266–F]
RIN 0938–AO82
Medicare and Medicaid Programs;
Waiver of Disapproval of Nurse Aide
Training Program in Certain Cases
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
SUMMARY: This final rule will permit a
waiver of a 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).
DATES: Effective Date: These regulations
are effective on May 24, 2010.
FOR FURTHER INFORMATION CONTACT: Pat
Miller, (410) 786–6780.
SUPPLEMENTARY INFORMATION:
I. Background
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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
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
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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. Therefore,
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 facilitybased 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
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21175
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)(C) and 1919(f)(2)(C) 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 $5,000 and that is not related to
quality of care provided to residents in
the facility.
II. Summary of the Proposed Provisions
and Response to Comments
In the November 23, 2007 Federal
Register 72 FR 65692, we published the
proposed rule entitled, ‘‘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’’ and provided for a 30 day
comment period.
A. Waiver of Disapproval of Nurse Aide
Training Program in Certain Cases
The statutory provisions set forth in
the published proposed rule pertain
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
establish 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.
We received a total of 23 comments
from various States, health care
associations and consumer advocacy
organizations. The comments for this
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proposal ranged from general support or
general opposition of the proposal to
more specific comments regarding the
new training program disapproval
waiver.
B. Nurse Aide Petition for Removal of
Information for Single Finding of
Neglect
We received nine comments on the
proposed rule provision requiring 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 as found at sections
1819(g)(1)(D) and 1919(g)(1)(D) of the
Social Security Act (section 4755 of the
Balanced Budget Act of 1997—Pub. L.
105–33, enacted on August 5, 1997).
The thoughtful comments received on
these provisions of the proposed rule
necessitate that CMS take additional
time to further explore the issues put
forth in the comments and analyze the
statute to reconsider whether regulatory
action is necessary and the available
options before proceeding. In the event
that the Secretary determines that
regulatory action is required for this
issue, we will publish a new notice of
proposed rulemaking. Therefore, we are
not finalizing these provisions in this
final rule and are removing them from
this final rule at this time.
General Comments
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Waiver of Disapproval of Nurse Aide
Training Program in Certain Cases
Comment: One commenter suggested
that CMS propose a legislative change
that would remove the loss of nurse aide
training as an automatic consequence to
the three specified events discussed
earlier in this preamble, and, instead,
establish the training program
disapproval as another available
enforcement remedy. This commenter
believes it would be more rational to
create the training program disapproval
as another enforcement option to be
considered when deficiencies bear a
relationship to the care and services that
a nurse aide provides. The loss of the
training program in this case would be
appropriate because the facility’s
deficiencies demonstrate that it is not
providing a positive training model for
its nurse aides.
Another commenter believes that the
2-year program disapproval period is
excessive and that it impedes a facility’s
ability to recruit and retain staff. This
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commenter is particularly concerned
about the 2-year program disapproval
based on a facility having a nurse
staffing waiver because the ‘‘lock out’’
contradicts the staffing waiver criteria
and it does not permit a facility to begin
a training program once it has acquired
the needed staff.
Response: This comment falls outside
the purview of this regulation. This rule
specifically pertains to permitting a
waiver of a facility’s nurse aide training
program disapproval when the facility is
assessed a civil money penalty of at
least $5,000 for noncompliance that is
not related to quality of care.
Regarding the length of the
disapproval period, we note that the 2year disapproval period is a statutory
provision. Such a legislative change
falls outside the purview of this
regulation.
Comment: One commenter suggested
that the variability in the use of civil
money penalties among States could
create inequities in the waiver
application process.
Response: Some variations may exist
given the fact that these penalties are a
discretionary remedy and are, therefore,
not imposed with identical frequency
and amount from State to State. We
have expended great efforts to ensure all
determinations are made as consistently
as possible, particularly with civil
money penalty determinations.
Comment: One commenter suggested
that the word ‘‘assessed’’ not be used as
it relates to the $5,000 civil money
penalty threshold amount that enables a
facility to request a training program
disapproval waiver. Since ‘‘assessed’’
has been defined in CMS’s State
Operations Manual to mean the final
amount determined to be owed after a
hearing, waiver of right to a hearing, or
settlement, this commenter believes that
it allows a facility to delay the
imposition of the nurse aide training
prohibition for too long. Instead, the
commenter proposed that CMS redefine
‘‘assessed’’ to mean the final decision of
CMS to impose a civil money penalty.
Response: We do not have the
authority to hasten or otherwise change
the timeframe in which determinations
are made about nurse aide training
disapproval based on imposition of civil
money penalties of at least $5,000 or
more. The statute is explicit that a nurse
aide training program must be
prohibited when a facility is ‘‘assessed’’
a civil money penalty of at least $5,000.
Additionally, a facility has a right to
appeal a certification of noncompliance
that leads to an enforcement remedy,
such as a civil money penalty, and/or to
waive its right to a hearing which
reduces the assessed penalty amount
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under 42 CFR 488.436(b) before the final
penalty amount owed by the facility is
determined. Indeed, under 42 CFR
498.3(b)(14) and (d)(10)(i), a facility may
only challenge the scope and severity
level of noncompliance found by CMS
if a successful challenge would affect
the range of the civil money penalty that
could be collected by CMS or impact
upon the facility’s nurse aide training
program. Since various events could
result in a different amount of civil
money penalty ‘‘assessed’’ than the
original amount, decisions about
training program disapproval prior to
knowing the final assessed penalty
amount would be contrary to the intent
of the statute. Nurse aide training
program disapproval takes effect after a
final civil money penalty amount is
assessed if the amount exceeds at least
$5,000.
Comment: One commenter wanted to
know if a facility would still lose its
nurse aide training program if it had
other disapproval-causing events, even
though it had a civil money penalty that
qualified for a training program
disapproval waiver. In other words,
does each separate event, that requires
nurse aide training disapproval, stand
alone?
Response: Yes. This waiver does not
eliminate the loss of nurse aide training
based on other occurring events that
also require training disapproval, such
as if, within the previous 2 years, a
facility is subjected to an extended (or
partial extended) survey under sections
1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) or
when a facility has been subject to a
remedy described in sections
1819(h)(2)(B)(i), or (iii), 1819(h)(4),
1919(h)(1)(B)(i) or 1919(h)(2)(A)(i), (iii)
or (iv) of the Act.
Comment: One commenter wondered
whether the waiver request should be
submitted to the State or to CMS. This
commenter also asked whether the
training program disapproval waiver
applies only to facilities that operate
their own training program or if it also
applies to facilities that serve as a
training site for another program, for
example, a technical college.
Response: Waivers should be
submitted to the State. Waiver
determinations will be made by CMS on
a case-by-case basis after considering
the recommendation and facts of that
case as provided by the State. This point
was made in the November 23, 2007
proposed rule on page 65694 in the
preamble to the proposed rule and will
be included in manual guidance that
will be developed in collaboration with
interested stakeholders.
Regarding the waiver’s applicability,
the new training program disapproval
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waiver provision cross-references to
sections 1819(f)(2)(B)(iii)(I) and
1919(f)(2)(B)(iii)(I) of the Act, which
specifically apply only to training
programs ‘‘offered by or in’’ a facility.
Therefore, the training program
disapproval waivers would also apply to
a facility that serves as a training site for
another program because it is being
offered within the facility.
Comment: One commenter believes
that CMS should make waiver
determinations, as well as the rationale
for the determinations, available to the
public in order to ensure transparency
in the process.
Response: While this comment is
outside the scope of this final rule, we
appreciate the recommendation and will
consider expanding current disclosure
policies in a separate regulatory
document.
Comment: Some commenters believe
that broader and more specific direction
needs to be provided about what factors
will be considered in making waiver
request determinations. One commenter
stressed the need for specific timeframes
and procedures relative to submitting
and approving these requests. Other
commenters disagreed with the
examples and rationale provided in the
preamble to the proposed rule to
demonstrate the general expectation of
the rule’s applicability. These
commenters urged that different and
expanded examples and decision
making criteria be provided, and some
offered criteria. A few of these
commenters believe that such additional
direction should be provided in this
final rule rather than issued as manual
guidance in CMS’s State Operations
Manual in order to ensure appropriate
public awareness and comment. Other
commenters requested that stakeholders
be included in developing the manual
guidance.
Response: While we do not intend to
include instructions in this final rule on
these operational issues, we will work
with all interested stakeholders to
develop the guidance necessary to
implement the regulatory provisions set
forth in this final rule. Participation of
all interested parties will ensure that the
various perspectives are represented
and considered.
Comment: One commenter expressed
concern about the distinction that the
proposed rule made between per
instance civil money penalties and per
day civil money penalties relative to
determining how discrete and aggregate
noncompliance should be evaluated in
applying the waiver provision. This
commenter contends that no such
flexibility exists in the supporting
legislation because it does not
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specifically differentiate between civil
money penalties that are based on
single, or multiple, instances of
noncompliance. CMS is urged to remove
the flexibility and instead require that
any noncompliance with quality of care
should, regardless of whether singularly
or in combination with other nonquality of care noncompliance, prevent
a training disapproval waiver.
Response: We do not agree with this
comment. The statute refers to civil
money penalties generally so it does not
specifically acknowledge the two civil
money penalty types, that is, the per day
and per instance, nor does it preclude
differentiating between them. Since
civil money penalties can be assessed
for specific instances of noncompliance
(per instance) as well as for aggregate
noncompliance (per day), we needed a
method of determining how discrete
and aggregate noncompliance should be
evaluated for waiver approval purposes.
As stated in the preamble to the
proposed rule, 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
because the penalty amount is not
directly attributable to any one
deficiency but, instead, is for the total
noncompliance of the facility.
Additionally, aggregate noncompliance
may be comprised of a combination of
quality of care and non quality of care
deficiencies as well as various levels of
severity and scope. When this is the
case, all of the 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 residents. A single care-giving
deficiency, among other non care-giving
deficiencies (none of which meet other
criteria for nurse aide training
disapproval), may result in a conclusion
that the facility, overall, is providing
quality care to its residents and
therefore, is providing a positive
training model for its nurse aides.
However, it is also possible that the
seriousness of that single facility failure,
among other non care-giving
deficiencies, may result in a conclusion
that the facility, overall, is not providing
quality care to its residents and
therefore, is not providing a positive
training model for its nurse aides. The
ability to make these determinations is
critical to ensure that rational and
defensible conclusions can be made
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relative to the facility’s ability to
provide quality care to its residents as
well as whether the loss of its nurse aide
training program is appropriate or
eligible for a waiver.
Part 483—Requirements for States and
Long Term Care Facilities
Section 483.151 State Review and
Approval of Nurse Aide Training and
Competency Evaluation Programs
We proposed to redesignate the
current § 483.151(c), (d), and (e) as
§ 483.151(d), (e), and (f), respectively.
We also proposed 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 proposed 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 proposed 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.
Comment: Several commenters
believe that the proposed definition of
‘‘quality of care’’, as direct hands-on care
and treatment that a health care
professional or direct care staff provides
to a resident, is too limited and should
be expanded to include other aspects of
care and services that the facility
provides to residents. These
commenters contend that issues related
to, for example, resident’s rights,
cleanliness, and safety can impact a
resident’s quality of care as significantly
as those that constitute direct hands-on
care and they should also preclude a
training program disapproval waiver.
Response: While we do not disagree
that all care and services provided by a
nursing home are important,
Congressional intent about what
constitutes ‘‘quality of care’’ is made
clear 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), which states
that, ‘‘* * * Quality of care in such
instances refers to direct, hands on care
furnished to residents of a facility.’’ In
order to address this reference, it was
necessary to identify care-giving
requirements, that is, care and treatment
that a health care professional or direct
care staff provides to a resident. That
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determination will lead to conclusions
about the impact the noncompliance
may have on the facility’s ability to
provide a positive training model to its
nurse aides. Additionally, it is
important to note as we did in the
preamble to the proposed rule, that
noncompliance need not be in a caregiving requirement in order to be
assessed a civil money penalty of at
least $5,000 nor to disapprove a nurse
aide training program. Noncompliance
with any requirement, whether caregiving or non-care-giving, may result in
the imposition of a civil money penalty
or other remedy. Once a $5,000 or
greater civil money penalty remedy or
other triggering remedies are imposed, a
facility’s ability to provide nurse aide
training is prohibited for 2 years unless
a waiver is approved and no other
training-disapproval event has occurred.
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IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment when 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 Paperwork
Reduction Act 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
comment on each of these issues for the
following information collection
requirements discussed below.
Section 483.151 State Review and
Approval of Nurse Aide Training and
Competency Evaluation Programs
Section 483.151(c)(1) states that a
facility may request that CMS waive
disapproval of its nurse aide training
program when a 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
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as well as the time and effort for States
to make determinations on each waiver
request. We estimate it would take one
facility 1 hour to submit a waiver and
one State 1 hour to make a
determination on the request. We
believe that 462 facilities may
potentially request a waiver annually;
therefore, the total annual burden
associated with this requirement is 462
hours for facilities and 462 hours for
States.
As required by section 3504(h) of the
Paperwork Reduction Act of 1995, we
have submitted a copy of this final
regulation to OMB for its review of these
information collection requirements
described above.
If you comment on 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, Division of
Regulations Development, Attn.:
Melissa Musotto, CMS–2266–F, Room
C5–14–03, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Room 10235, New Executive
Office Building, Washington, DC 20503,
Attn.: Katherine T. Astrich, CMS Desk
Officer, CMS–2266–F,
Katherine_T._Astrich@omb.eop.gov. Fax
(202) 395–6974.
V. Regulatory Impact Statement
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993, as further
amended), the Regulatory Flexibility
Act (RFA) (September 19, 1980, Pub. L.
96–354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4), and Executive Order
13132 on Federalism (August 4, 1999),
and the Congressional Review Act (5
U.S.C. 804 (2)).
Executive Order 12866 (as amended
by Executive Order 13258, 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). This regulatory
requirement will not reach the
economic threshold and thus is not
considered a major rule.
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The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
non-profit organizations and
government agencies. For purposes of
the RFA, most nursing homes are
considered to be small entities. We are
not preparing an analysis for the RFA
for this regulatory proposal because we
have determined that this rule will not
have a significant economic impact on
a substantial number of small
businesses or other small entities.
Therefore, the Secretary has determined
that this final rule will not 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. We are not preparing an
analysis for section 1102(b) of the Act
for this regulatory proposal because we
have determined, and the Secretary has
determined, that this rule will not have
a significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
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. In 2008 that
threshold was approximately $125
million. This regulatory proposal will
have no consequential effect on State,
local, or Tribal governments in the
aggregate or by the private sector, of
$127 million.
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 this regulation will not impose a
substantial direct cost on State or local
governments, preempt States, or
otherwise have a Federalism
implication, 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 42 CFR Part 483
Grant programs—health, Health
facilities, Health professions, Health
Records, Medicaid, Medicare, Nursing
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homes, Nutrition, Reporting and
recordkeeping requirements, Safety.
■ For the reasons set forth in the
preamble, the Centers for Medicare and
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 483—REQUIREMENTS FOR
STATES AND LONG TERM CARE
FACILITIES
Medicare—Supplementary Medical
Insurance Program)
Dated: January 14, 2010.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: April 12, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–8902 Filed 4–22–10; 8:45 am]
■
1. The authority citation for part 483
continues to read as follows:
BILLING CODE 4120–01–P
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
DEPARTMENT OF THE INTERIOR
*
*
*
*
*
2. Section 483.150(a) is revised to read
as follows:
Fish and Wildlife Service
§ 483.150 Statutory basis: Deemed
meeting or waiver of requirements.
[Docket No. FWS–R1–ES–2009–0005;
92220–1113–0000–C6]
(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.
*
*
*
*
*
■ 3. Section 483.151 is amended by—
■ A. Revising the section heading.
■ B. Redesignating paragraphs (c), (d),
and (e) as paragraphs (d), (e), and (f)
respectively.
■ C. Adding new paragraph (c).
The revision and addition reads as
follows:
RIN 1018–AW42
■
§ 483.151 State review and approval of
nurse aide training and competency
evaluation programs.
mstockstill on DSKH9S0YB1PROD with RULES
*
*
*
*
*
(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.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
VerDate Nov<24>2008
15:47 Apr 22, 2010
Jkt 220001
50 CFR Part 17
Endangered and Threatened Wildlife
and Plants; Reclassification of the
Oregon Chub From Endangered to
Threatened
AGENCY: Fish and Wildlife Service,
Interior.
ACTION: Final rule.
SUMMARY: We, the U.S. Fish and
Wildlife Service (Service), are
reclassifying the federally endangered
Oregon chub (Oregonichthys crameri) to
threatened status under the authority of
the Endangered Species Act of 1973, as
amended (Act). This decision is based
on a thorough review of the best
available scientific and commercial
data, which indicate that the species’
status has improved to the point that the
Oregon chub is not currently in danger
of extinction throughout all or a
significant portion of its range.
DATES: This final rule is effective on
May 24, 2010.
ADDRESSES: Comments and materials
received, as well as supporting
documentation used in the preparation
of this final rule, are available for
inspection, by appointment, during
normal business hours, at the U.S. Fish
and Wildlife Service, Oregon Fish and
Wildlife Office, 2600 SE 98th Avenue,
Suite 100, Portland, OR 97266;
(telephone 503/231–6179).
FOR FURTHER INFORMATION CONTACT:
State Supervisor, U.S. Fish and Wildlife
Service, Oregon Fish and Wildlife Office
(see ADDRESSES). Persons who use a
telecommunications device for the deaf
(TDD) may call the Federal Information
Relay Service (FIRS) at 800/877–8339,
24 hours a day, 7 days a week.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
21179
Background
The purposes of the Act (16 U.S.C.
1531 et seq.) are to provide a means
whereby the ecosystems upon which
endangered and threatened species
depend may be conserved and to
provide a program for the conservation
of those species. A species can be listed
as endangered or threatened because of
any of the following factors: (1) The
present or threatened destruction,
modification, or curtailment of its
habitat or range; (2) overutilization for
commercial, recreational, scientific, or
educational purposes; (3) disease or
predation; (4) the inadequacy of existing
regulatory mechanisms; or (5) other
natural or manmade factors affecting its
continued existence. When we
determine that protection of a species
under the Act is no longer warranted,
we take steps to remove (delist) the
species from the Federal list. If a species
is listed as endangered, we may
reclassify it to threatened status as an
intermediate step before delisting;
however, reclassification to threatened
status is not required in order to delist.
Section 3 of the Act defines terms that
are relevant to this final rule. An
endangered species is any species that
is in danger of extinction throughout all
or a significant portion of its range. A
threatened species is any species that is
likely to become an endangered species
within the foreseeable future throughout
all or a significant portion of its range.
A species includes any subspecies of
fish or wildlife or plants, and any
distinct population segment of any
species of vertebrate fish or wildlife that
interbreeds when mature.
Previous Federal Actions
In our December 30, 1982, Review of
Vertebrate Wildlife for Listing as
Endangered or Threatened Species, we
listed the Oregon chub as a Category 2
candidate species (47 FR 58454).
Category 2 candidates, a designation no
longer used by the Service, were species
for which information contained in
Service files indicated that proposing to
list was possibly appropriate but
additional data were needed to support
a listing proposal. The Oregon chub
maintained its Category 2 status in both
the September 18, 1985 (50 FR 37958)
and January 6, 1989 (54 FR 554) Notices
of Review.
On April 10, 1990, the Service
received a petition to list the Oregon
chub as an endangered species and to
designate critical habitat. The petition
and supporting documentation were
submitted by Dr. Douglas F. Markle and
Mr. Todd N. Pearsons, both affiliated
with Oregon State University. The
E:\FR\FM\23APR1.SGM
23APR1
Agencies
[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Rules and Regulations]
[Pages 21175-21179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8902]
[[Page 21175]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 483
[CMS-2266-F]
RIN 0938-AO82
Medicare and Medicaid Programs; Waiver of Disapproval of Nurse
Aide Training Program in Certain Cases
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule will permit a waiver of a 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).
DATES: Effective Date: These regulations are effective on May 24, 2010.
FOR FURTHER INFORMATION CONTACT: Pat Miller, (410) 786-6780.
SUPPLEMENTARY INFORMATION:
I. Background
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 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.
Therefore, 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)(C) and 1919(f)(2)(C) 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 $5,000 and that is not
related to quality of care provided to residents in the facility.
II. Summary of the Proposed Provisions and Response to Comments
In the November 23, 2007 Federal Register 72 FR 65692, we published
the proposed rule entitled, ``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'' and provided for a 30 day comment period.
A. Waiver of Disapproval of Nurse Aide Training Program in Certain
Cases
The statutory provisions set forth in the published proposed rule
pertain 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 establish 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.
We received a total of 23 comments from various States, health care
associations and consumer advocacy organizations. The comments for this
[[Page 21176]]
proposal ranged from general support or general opposition of the
proposal to more specific comments regarding the new training program
disapproval waiver.
B. Nurse Aide Petition for Removal of Information for Single Finding of
Neglect
We received nine comments on the proposed rule provision requiring
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 as found at sections 1819(g)(1)(D) and
1919(g)(1)(D) of the Social Security Act (section 4755 of the Balanced
Budget Act of 1997--Pub. L. 105-33, enacted on August 5, 1997). The
thoughtful comments received on these provisions of the proposed rule
necessitate that CMS take additional time to further explore the issues
put forth in the comments and analyze the statute to reconsider whether
regulatory action is necessary and the available options before
proceeding. In the event that the Secretary determines that regulatory
action is required for this issue, we will publish a new notice of
proposed rulemaking. Therefore, we are not finalizing these provisions
in this final rule and are removing them from this final rule at this
time.
General Comments
Waiver of Disapproval of Nurse Aide Training Program in Certain Cases
Comment: One commenter suggested that CMS propose a legislative
change that would remove the loss of nurse aide training as an
automatic consequence to the three specified events discussed earlier
in this preamble, and, instead, establish the training program
disapproval as another available enforcement remedy. This commenter
believes it would be more rational to create the training program
disapproval as another enforcement option to be considered when
deficiencies bear a relationship to the care and services that a nurse
aide provides. The loss of the training program in this case would be
appropriate because the facility's deficiencies demonstrate that it is
not providing a positive training model for its nurse aides.
Another commenter believes that the 2-year program disapproval
period is excessive and that it impedes a facility's ability to recruit
and retain staff. This commenter is particularly concerned about the 2-
year program disapproval based on a facility having a nurse staffing
waiver because the ``lock out'' contradicts the staffing waiver
criteria and it does not permit a facility to begin a training program
once it has acquired the needed staff.
Response: This comment falls outside the purview of this
regulation. This rule specifically pertains to permitting a waiver of a
facility's nurse aide training program disapproval when the facility is
assessed a civil money penalty of at least $5,000 for noncompliance
that is not related to quality of care.
Regarding the length of the disapproval period, we note that the 2-
year disapproval period is a statutory provision. Such a legislative
change falls outside the purview of this regulation.
Comment: One commenter suggested that the variability in the use of
civil money penalties among States could create inequities in the
waiver application process.
Response: Some variations may exist given the fact that these
penalties are a discretionary remedy and are, therefore, not imposed
with identical frequency and amount from State to State. We have
expended great efforts to ensure all determinations are made as
consistently as possible, particularly with civil money penalty
determinations.
Comment: One commenter suggested that the word ``assessed'' not be
used as it relates to the $5,000 civil money penalty threshold amount
that enables a facility to request a training program disapproval
waiver. Since ``assessed'' has been defined in CMS's State Operations
Manual to mean the final amount determined to be owed after a hearing,
waiver of right to a hearing, or settlement, this commenter believes
that it allows a facility to delay the imposition of the nurse aide
training prohibition for too long. Instead, the commenter proposed that
CMS redefine ``assessed'' to mean the final decision of CMS to impose a
civil money penalty.
Response: We do not have the authority to hasten or otherwise
change the timeframe in which determinations are made about nurse aide
training disapproval based on imposition of civil money penalties of at
least $5,000 or more. The statute is explicit that a nurse aide
training program must be prohibited when a facility is ``assessed'' a
civil money penalty of at least $5,000. Additionally, a facility has a
right to appeal a certification of noncompliance that leads to an
enforcement remedy, such as a civil money penalty, and/or to waive its
right to a hearing which reduces the assessed penalty amount under 42
CFR 488.436(b) before the final penalty amount owed by the facility is
determined. Indeed, under 42 CFR 498.3(b)(14) and (d)(10)(i), a
facility may only challenge the scope and severity level of
noncompliance found by CMS if a successful challenge would affect the
range of the civil money penalty that could be collected by CMS or
impact upon the facility's nurse aide training program. Since various
events could result in a different amount of civil money penalty
``assessed'' than the original amount, decisions about training program
disapproval prior to knowing the final assessed penalty amount would be
contrary to the intent of the statute. Nurse aide training program
disapproval takes effect after a final civil money penalty amount is
assessed if the amount exceeds at least $5,000.
Comment: One commenter wanted to know if a facility would still
lose its nurse aide training program if it had other disapproval-
causing events, even though it had a civil money penalty that qualified
for a training program disapproval waiver. In other words, does each
separate event, that requires nurse aide training disapproval, stand
alone?
Response: Yes. This waiver does not eliminate the loss of nurse
aide training based on other occurring events that also require
training disapproval, such as if, within the previous 2 years, a
facility is subjected to an extended (or partial extended) survey under
sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) or when a facility has
been subject to a remedy described in sections 1819(h)(2)(B)(i), or
(iii), 1819(h)(4), 1919(h)(1)(B)(i) or 1919(h)(2)(A)(i), (iii) or (iv)
of the Act.
Comment: One commenter wondered whether the waiver request should
be submitted to the State or to CMS. This commenter also asked whether
the training program disapproval waiver applies only to facilities that
operate their own training program or if it also applies to facilities
that serve as a training site for another program, for example, a
technical college.
Response: Waivers should be submitted to the State. Waiver
determinations will be made by CMS on a case-by-case basis after
considering the recommendation and facts of that case as provided by
the State. This point was made in the November 23, 2007 proposed rule
on page 65694 in the preamble to the proposed rule and will be included
in manual guidance that will be developed in collaboration with
interested stakeholders.
Regarding the waiver's applicability, the new training program
disapproval
[[Page 21177]]
waiver provision cross-references to sections 1819(f)(2)(B)(iii)(I) and
1919(f)(2)(B)(iii)(I) of the Act, which specifically apply only to
training programs ``offered by or in'' a facility. Therefore, the
training program disapproval waivers would also apply to a facility
that serves as a training site for another program because it is being
offered within the facility.
Comment: One commenter believes that CMS should make waiver
determinations, as well as the rationale for the determinations,
available to the public in order to ensure transparency in the process.
Response: While this comment is outside the scope of this final
rule, we appreciate the recommendation and will consider expanding
current disclosure policies in a separate regulatory document.
Comment: Some commenters believe that broader and more specific
direction needs to be provided about what factors will be considered in
making waiver request determinations. One commenter stressed the need
for specific timeframes and procedures relative to submitting and
approving these requests. Other commenters disagreed with the examples
and rationale provided in the preamble to the proposed rule to
demonstrate the general expectation of the rule's applicability. These
commenters urged that different and expanded examples and decision
making criteria be provided, and some offered criteria. A few of these
commenters believe that such additional direction should be provided in
this final rule rather than issued as manual guidance in CMS's State
Operations Manual in order to ensure appropriate public awareness and
comment. Other commenters requested that stakeholders be included in
developing the manual guidance.
Response: While we do not intend to include instructions in this
final rule on these operational issues, we will work with all
interested stakeholders to develop the guidance necessary to implement
the regulatory provisions set forth in this final rule. Participation
of all interested parties will ensure that the various perspectives are
represented and considered.
Comment: One commenter expressed concern about the distinction that
the proposed rule made between per instance civil money penalties and
per day civil money penalties relative to determining how discrete and
aggregate noncompliance should be evaluated in applying the waiver
provision. This commenter contends that no such flexibility exists in
the supporting legislation because it does not specifically
differentiate between civil money penalties that are based on single,
or multiple, instances of noncompliance. CMS is urged to remove the
flexibility and instead require that any noncompliance with quality of
care should, regardless of whether singularly or in combination with
other non-quality of care noncompliance, prevent a training disapproval
waiver.
Response: We do not agree with this comment. The statute refers to
civil money penalties generally so it does not specifically acknowledge
the two civil money penalty types, that is, the per day and per
instance, nor does it preclude differentiating between them. Since
civil money penalties can be assessed for specific instances of
noncompliance (per instance) as well as for aggregate noncompliance
(per day), we needed a method of determining how discrete and aggregate
noncompliance should be evaluated for waiver approval purposes. As
stated in the preamble to the proposed rule, 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 because the penalty amount is not directly
attributable to any one deficiency but, instead, is for the total
noncompliance of the facility. Additionally, aggregate noncompliance
may be comprised of a combination of quality of care and non quality of
care deficiencies as well as various levels of severity and scope. When
this is the case, all of the 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
residents. A single care-giving deficiency, among other non care-giving
deficiencies (none of which meet other criteria for nurse aide training
disapproval), may result in a conclusion that the facility, overall, is
providing quality care to its residents and therefore, is providing a
positive training model for its nurse aides. However, it is also
possible that the seriousness of that single facility failure, among
other non care-giving deficiencies, may result in a conclusion that the
facility, overall, is not providing quality care to its residents and
therefore, is not providing a positive training model for its nurse
aides. The ability to make these determinations is critical to ensure
that rational and defensible conclusions can be made relative to the
facility's ability to provide quality care to its residents as well as
whether the loss of its nurse aide training program is appropriate or
eligible for a waiver.
Part 483--Requirements for States and Long Term Care Facilities
Section 483.151 State Review and Approval of Nurse Aide Training and
Competency Evaluation Programs
We proposed to redesignate the current Sec. 483.151(c), (d), and
(e) as Sec. 483.151(d), (e), and (f), respectively. We also proposed
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 proposed 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 proposed 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.
Comment: Several commenters believe that the proposed definition of
``quality of care'', as direct hands-on care and treatment that a
health care professional or direct care staff provides to a resident,
is too limited and should be expanded to include other aspects of care
and services that the facility provides to residents. These commenters
contend that issues related to, for example, resident's rights,
cleanliness, and safety can impact a resident's quality of care as
significantly as those that constitute direct hands-on care and they
should also preclude a training program disapproval waiver.
Response: While we do not disagree that all care and services
provided by a nursing home are important, Congressional intent about
what constitutes ``quality of care'' is made clear 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), which states that, ``* * * Quality of
care in such instances refers to direct, hands on care furnished to
residents of a facility.'' In order to address this reference, it was
necessary to identify care-giving requirements, that is, care and
treatment that a health care professional or direct care staff provides
to a resident. That
[[Page 21178]]
determination will lead to conclusions about the impact the
noncompliance may have on the facility's ability to provide a positive
training model to its nurse aides. Additionally, it is important to
note as we did in the preamble to the proposed rule, that noncompliance
need not be in a care-giving requirement in order to be assessed a
civil money penalty of at least $5,000 nor to disapprove a nurse aide
training program. Noncompliance with any requirement, whether care-
giving or non-care-giving, may result in the imposition of a civil
money penalty or other remedy. Once a $5,000 or greater civil money
penalty remedy or other triggering remedies are imposed, a facility's
ability to provide nurse aide training is prohibited for 2 years unless
a waiver is approved and no other training-disapproval event has
occurred.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment when 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 Paperwork Reduction Act
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 comment on each of these issues
for the following information collection requirements discussed below.
Section 483.151 State Review and Approval of Nurse Aide Training and
Competency Evaluation Programs
Section 483.151(c)(1) states that a facility may request that CMS
waive disapproval of its nurse aide training program when a 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 as well as the time and
effort for States to make determinations on each waiver request. We
estimate it would take one facility 1 hour to submit a waiver and one
State 1 hour to make a determination on the request. We believe that
462 facilities may potentially request a waiver annually; therefore,
the total annual burden associated with this requirement is 462 hours
for facilities and 462 hours for States.
As required by section 3504(h) of the Paperwork Reduction Act of
1995, we have submitted a copy of this final regulation to OMB for its
review of these information collection requirements described above.
If you comment on 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, Division of Regulations Development,
Attn.: Melissa Musotto, CMS-2266-F, Room C5-14-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
Office of Information and Regulatory Affairs, Office of Management
and Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn.: Katherine T. Astrich, CMS Desk Officer, CMS-2266-F,
Katherine_T._Astrich@omb.eop.gov. Fax (202) 395-6974.
V. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993, as
further amended), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), and Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 804 (2)).
Executive Order 12866 (as amended by Executive Order 13258, 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). This regulatory requirement will not reach the economic
threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, non-profit organizations and government agencies. For
purposes of the RFA, most nursing homes are considered to be small
entities. We are not preparing an analysis for the RFA for this
regulatory proposal because we have determined that this rule will not
have a significant economic impact on a substantial number of small
businesses or other small entities. Therefore, the Secretary has
determined that this final rule will not 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. We are
not preparing an analysis for section 1102(b) of the Act for this
regulatory proposal because we have determined, and the Secretary has
determined, that this rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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. In 2008 that
threshold was approximately $125 million. This regulatory proposal will
have no consequential effect on State, local, or Tribal governments in
the aggregate or by the private sector, of $127 million.
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 this regulation will not impose a substantial
direct cost on State or local governments, preempt States, or otherwise
have a Federalism implication, 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 42 CFR Part 483
Grant programs--health, Health facilities, Health professions,
Health Records, Medicaid, Medicare, Nursing
[[Page 21179]]
homes, Nutrition, Reporting and recordkeeping requirements, Safety.
0
For the reasons set forth in the preamble, the Centers for Medicare and
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
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).
* * * * *
0
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.
* * * * *
0
3. Section 483.151 is amended by--
0
A. Revising the section heading.
0
B. Redesignating paragraphs (c), (d), and (e) as paragraphs (d), (e),
and (f) respectively.
0
C. Adding new paragraph (c).
The revision and addition reads as follows:
Sec. 483.151 State review and approval of nurse aide training 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.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: January 14, 2010.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: April 12, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-8902 Filed 4-22-10; 8:45 am]
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