[Federal Register Volume 64, Number 141 (Friday, July 23, 1999)]
[Rules and Regulations]
[Pages 39934-39938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 431 and 498
[HCFA-2054-IFC]
RIN 0938-AJ59
Medicare and Medicaid Program; Appeal of the Loss of Nurse Aide
Training Programs
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule revises current Medicare and Medicaid
regulations to provide participating nursing facilities, skilled
nursing facilities, and dually participating nursing facilities an
opportunity for an evidentiary hearing before an administrative law
judge to challenge a facility's loss of its approved nurse aide
training program. This rule also amends Medicaid regulations to permit
States to provide evidentiary hearings for facilities that participate
only in the Medicaid program and that face a loss of their nurse aide
training programs. Previous regulations have provided only for an
informal hearing when facilities lose training programs and do not
otherwise face enforcement remedies under the Medicare and Medicaid
programs.
DATES: Effective date: These regulations are effective July 23, 1999.
Comment date: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on
September 21, 1999.
ADDRESSES: Mail an original and 3 copies of written comments to the
following address:
Health Care Financing Administration, Department of Health and Human
Services, Attention: HCFA-2054-IFC, P.O. Box 9010, Baltimore, MD 21244-
9010
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-16-03, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Comments may be submitted electronically to the following e-mail
address: (filecode 2054ifc)@hcfa.gov. For e-mail procedures and
information on ordering copies of the Federal Register containing this
document and electronic access, see the beginning of
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jeffrey Golland, (202) 619-3377.
SUPPLEMENTARY INFORMATION:
E-Mail, Comments, Procedures, Availability of Copies, and
Electronic Access
E-mail comments must include the full name and address of the
sender, and must be submitted to the referenced address to be
considered. All comments must be incorporated in the e-mail message
because we may not be able to access attachments. Electronically
submitted comments will be available for public inspection at the
Independence Avenue address, below. Because of staffing and resource
limitations, we cannot accept comments by facsimile (FAX) transmission.
In commenting, please refer to file code HCFA-2054-IFC. Comments
received timely will be available for public inspection as they are
received, generally beginning approximately 3 weeks after publication
of a document, in Room 443-G of the Department's offices at 200
Independence Avenue, SW., Washington, DC, on Monday through Friday of
each week from 8:30 a.m. to 5 p.m. (phone: (202) 690-7890).
I. Background
To participate in the Medicare and Medicaid programs, facilities
furnishing nursing services must satisfy certain requirements as a
prerequisite to their receiving a provider agreement. Specifically,
they must comply with the requirements set forth at section 1819(b),
(c), and (d) of the Social Security Act (the Act) for the Medicare
program, and section 1919(b), (c), and (d) of the Act for the Medicaid
program. Implementing regulations further clarifying these statutory
requirements are set forth at 42 CFR Part 483 (Requirements for States
and Long Term Care Facilities). Facilities wishing to
[[Page 39935]]
participate in these programs may do so only after they have been
surveyed, or inspected, by a survey team and found to be in substantial
compliance with program requirements. While we administer these
programs at the Federal level, typically these surveys are performed by
State agencies acting under an agreement with us pursuant to section
1864 of the Act. States conduct routine surveys on the average of once
annually for each facility. When States perform these surveys, they
make recommendations to us if Medicare determinations are involved,
whereas determinations for facilities wishing to participate only in
the Medicaid program are made predominately by the States. Facilities
found to be furnishing services in substantial compliance with Federal
requirements are issued a provider agreement and are thereby entitled
to furnish reimbursable nursing services to Medicare beneficiaries and
Medicaid recipients.
Among the requirements that nursing facilities must meet is an
obligation to employ only those nurse aides who are qualified to fill
those positions. Sections 1819(b)(5)(A) and 1919(b)(5)(A) of the Act
specifically prohibit nursing facilities from employing individuals as
nurse aides for more than 4 months unless these individuals have
completed a training and competency evaluation program and are
competent to furnish nursing or nursing related services. These
requirements are reflected in the regulations at Sec. 483.75(g) (Staff
qualifications). According to sections 1819(f)(2)(B) and 1919(f)(2)(B)
of the Act, States approve these training programs and have discretion
to approve nurse aide training programs that are offered by or in
facilities.
Under sections 1819(g)(2)(B) and 1919(g)(2)(B) of the Act, if a
facility is found to have furnished substandard quality of care during
a standard survey, it is subject to an extended survey that is designed
to probe in more depth the facility's policies and procedures that
produced substandard quality of care. If a facility is subjected to an
extended survey and has been operating an approved nurse aide training
program, it loses its ability to provide the program for 2 years as
required by sections 1819(f)(2)(B)(iii)(I) and 1919(f)(2)(B)(iii)(I) of
the Act.
When we published the nursing home survey and enforcement
regulations in the November 10, 1994 final rule (59 FR 56116), we
addressed issues raised by a facility's loss of its nurse aide training
program. In that final rule (59 FR 56228), we concluded that facilities
facing this loss should have access to the informal dispute resolution
process offered under Sec. 488.331, but that they should not have an
opportunity for an administrative law judge (ALJ) hearing since we
perceived a facility's loss in this context as not rising to the level
of deprivation marked by sanctions described elsewhere in the statute
such as facility agreement terminations or civil money penalties. It is
only if a facility suffers an adverse and direct legal consequence
under the Medicare program that it is entitled to administrative and
judicial review. Accordingly, the regulations at Sec. 498.3(d)(10)(iii)
(Scope and applicability), precluded the opportunity for an ALJ hearing
when a facility loses its approval to train nurse aides. Similarly,
Medicaid regulations, at Sec. 431.153(f)(2) (Evidentiary hearing), also
precluded the opportunity for Medicaid-only certified facilities to
receive a full evidentiary hearing for losses of their approved nurse
aide training programs. Facilities have had the ability to challenge
the loss of their nurse aide training programs only if they also were
challenging the imposition of a remedy that was appealable.
II. Provisions of the Interim Final Rule
We are amending the Medicare and Medicaid regulations to permit a
facility an opportunity for an evidentiary hearing if it loses its
approved nurse aide training program. In the context of the appeals
system available to long term care facilities that are either Medicare
or Medicaid certified or dually certified for both the Medicare and
Medicaid programs, this means the opportunity for a hearing before an
ALJ of the Departmental Appeals Board and to request review by the
Board of an ALJ decision. As has always been the case, the nurse aide
training program ceases to operate pending an appeal. While we are
deleting the Medicaid regulation that foreclosed the possibility of an
evidentiary hearing in these cases, we are leaving to States the
details of whether or how they may provide hearings to those facilities
participating only in the Medicaid program. However, nurse aid training
programs provided by Medicaid-only facilities in States that elect to
provide these hearings must cease to operate pending an appeal just has
been the case for Medicare certified facilities.
When we published the survey and enforcement final rule in November
1994, we did not have the benefit of the experience we have had since
that time. We could continue to advance the same arguments we made in
the preamble to the November 1994 final rule as to the relative merits
of losing a nurse aide training program compared with the impact of one
or more of the remedies set out in the statute. We believe, however,
that we should acknowledge the arguments that have been advanced by
individual facilities on the magnitude of the loss to them when they
are unable to train nurse aides themselves. Facilities have alerted us
to the difficulty they sometimes have in finding qualified nurse aides
once they are unable to train their own. Those employed as nurse aides
are not highly paid and are not always available in abundance to
facilities whenever they need to hire additional staff or replace those
who leave. Turnover in these positions is high, thereby placing
increased pressures on facilities to maintain the staff they need to
furnish essential services to facility residents. Thus, the loss of an
ability to train nurse aides can have significant consequences for a
facility.
Although the waiver provision in the statute, at sections
1819(f)(2)(C) and 1919(f)(2)(C) of the Act, provides relief to some
facilities in these situations, it is not universal in scope and,
therefore, may not reach all facilities that have difficulty employing
qualified individuals as nurse aides. The waiver provision authorizes a
State to permit a facility that has lost its approval to train its
nurse aides to continue that training in the facility (although not
under the direction of the facility) if it determines that there is no
other training program within a reasonable distance of the facility and
the State can assure that there is an adequate environment to operate
the program in the facility.
Because the reason for the loss of nurse aide training is a fact-
driven conclusion that the facility has provided substandard quality of
care, we recognize the desirability of furnishing a facility the
opportunity to challenge these factual findings in a forum that is
designed to hear identical disputes that arise when remedies are
imposed on noncompliant facilities. Thus, there is sufficient reason to
have a regulation that furnishes the same appeal process that has been
available for the imposition of remedies on a facility.
We view the provision of administrative hearings in cases involving
the loss of nurse aide training, along with those that have been
furnished up to now for most of the remedies imposed under Sec. 488.406
(Available remedies), as being derived from sections 1866(b)(2) and
1866(h) of the Act. These sections provide for the review of certain
determinations we have made such as those in which we conclude that a
facility is not complying substantially with the requirements of
[[Page 39936]]
the Act. We believe these sections of the statute are triggered when
affected facilities sustain genuinely adverse legal consequences under
the Medicare program as a result of action we have taken. As a matter
governed by sections 1866(b)(2) and 1866(h) of the Act, these hearings
are funneled through the administrative process described in section
205(b) of the Act and to judicial review of our final decision
according to section 205(g) of the Act. Both sections 205(b) and 205(h)
are incorporated in the Medicare statute at section 1866(h) of the Act.
Therefore, we are revising the Medicare and the Medicaid sections
of the regulations. We are revising the Medicaid hearing regulations by
deleting the reference at Sec. 431.153(b)(3) (Limit on grounds for
appeal) that preclude States from granting evidentiary hearings to
Medicaid facilities losing their nurse aide training programs. We are
not affirmatively requiring States to provide a hearing in these cases
because that is a decision we believe States should determine in light
of circumstances that are apt to differ among the States.
We are revising the Medicare hearing regulations that have
precluded facilities from challenging the level of noncompliance we
have found since findings of substandard quality of care are uniquely
sensitive to specific findings of noncompliance. Specifically, a
finding of substandard quality of care is premised upon a determination
that there are discrete levels of noncompliance found under three
regulations (Secs. 483.13 (Resident behavior and facility practices),
483.15 (Quality of life), and 483.25 (Quality of care)). Thus, to
adequately challenge a finding of substandard quality of care, a
facility may need to be in a position to challenge the specific levels
of noncompliance that gave rise to the finding. Accordingly, we are
revising Sec. 498.3(b)(13) to permit this kind of challenge.
We are also revising Sec. 498.3(b) (Initial determinations by HCFA)
by adding a new paragraph (15) that will make a finding of substandard
quality of care that results in the loss of the approval of a
facility's nurse aide training program an initial determination for
purposes of receiving an evidentiary hearing.
Additionally, we are revising the regulations at
Sec. 498.3(d)(10)(iii) (Administrative actions that are not initial
determinations) by deleting the reference to the loss of nurse aide
training as an administrative action that is not an initial
determination. These revisions will affect the hearing rights of
facilities that are participating in the Medicare or Medicaid program
or are dually participating in the Medicare and Medicaid programs.
We intend that these changes to the regulations be effective upon
publication. Thus, we will apply the new rules to determinations made
after the effective date of this interim final rule in which we or the
States find substandard quality of care (communicated to the facility
in a statement of deficiencies on HCFA Form 2567) that leads to the
facility's loss of its ability to train nurse aides.
III. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, 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.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
We believe that engaging in proposed rulemaking in the context of
this rule is unnecessary. We are not making substantive changes in the
standards that nursing facilities must meet to participate in the
Medicare and Medicaid programs. Facilities will continue to be
obligated to meet the requirements of 42 C.F.R. Part 483 to retain
program certification including the requirement that only trained nurse
aides be employed by the facility. Nor are we changing in any way the
basis for the imposition of remedies on long term care facilities when
they are found to be out of compliance with Federal certification
requirements. Facilities will still face the imposition of remedies, as
they have before, when they fail to comply. They will continue to be
subject to the consequences of a finding of substandard quality of care
including the loss of nurse aide training programs and the required
notifications to attending physicians and a State's Administrator
Licensing Board. Thus, these rule changes will not affect the well
being of residents by releasing facilities from any obligation they
already owe under these programs. Indeed, under this rule, facilities
that have lost their ability to train nurse aides will face that
consequence unless our determination that the facility has provided
substandard quality of care is reversed by an ALJ or by the
Departmental Appeals Board upon its review of the hearing decision.
This final rule only affects the type of review that nursing facilities
may receive when they face the loss of their training programs.
In addition, we do not believe that this rule will adversely impact
States. While those States that choose to provide hearings in nurse
aide training cases may experience some added burdens, we believe they
will be minimal. Specifically, we expect that there will be very few
cases involving the loss of nurse aide training in facilities certified
only in the Medicaid program.
Moreover, we are providing facilities with appeal rights that were
not previously granted. In doing so, we are recognizing the industries'
interest in having additional appeal rights.
For the same reasons, we believe that we have good cause to
dispense with the usual 30 day delay in the effective date of a rule,
and believe that this rule should become effective immediately upon
publication. Because we are not revising either a substantive standard
that governs nursing home conduct or the consequences facilities may
face because of their failure to comply with these requirements, we
are, therefore, not affecting any provision that governs the manner in
which nursing facilities must furnish safe and healthful conditions for
the delivery of nursing services they furnish to their residents.
Nursing home residents will continue to have all the protections they
have always had under the nursing home requirements of participation
and the survey and enforcement rules. Accordingly, we believe that we
have good cause to make this procedural change effective immediately.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue this final rule on an interim basis. We are
providing a 60-day comment period for public comment.
[[Page 39937]]
V. Information Collection Requirements
Ordinarily, we would be required to estimate the public reporting
burden for information collection requirements for these regulations in
accordance with Chapter 35 of Title 44 of the United State Code.
However, sections 4204(b) and 4214(d) of the Omnibus Budget
Reconciliation Act of 1987 provide for a waiver of Paperwork Reduction
Act requirements for these regulations.
VI. Regulatory Impact Statement
We have examined the impacts of this interim final rule as required
by Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub.
L. 96-354). Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects, distributive impacts, and equity). 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. Most hospitals and most
other providers and suppliers are small entities, either by non-profit
status or by having revenues of $5 million or less annually. For
purposes of the RFA, all participating nursing facilities, skilled
nursing facilities, and dually participating nursing facilities are
considered to be small entities. Individuals and States are not
included in the definition of a small entity.
Section 1102(b) of the Social Security Act, (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. Such an analysis must conform to the provisions of
section 604 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 50 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4 also requires that agencies assess anticipated costs and benefits
before issuing any rule that may result in an annual expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million. We believe that this interim final
rule is not an economically significant rule as described in the
Executive order, nor a significant action as defined in the Unfunded
Mandates Reform Act. Aggregate impacts of the rule, and aggregate
expenditures caused by the rule, would not approach $100 million for
either the public or the private sector. Also, we believe that nursing
facilities will not object to any additional costs they might incur in
pursuing challenges to a loss of their nurse aide training programs
because they have been advocating this type of hearing since we
published our nursing facility enforcement final rule in November 1994.
In addition, national provider organizations, as well as individual
providers, have requested that we permit an appeal through our
administrative process. Furthermore, this interim final rule would not
affect a facility's decision to continue to serve beneficiaries.
According to our survey estimates, approximately 400 of the 17,000
long term care facilities participating in Medicare and Medicaid
programs would be affected by this interim final rule. The facilities
affected are those that have had an extended survey conducted as a
result of an inspection finding substandard quality of care, with no
remedies imposed. Whenever substandard quality of care is found, the
facility may not conduct nurse aide training in its facility.
Although there would be no economic impact on Medicare contractors
or beneficiaries, some providers would incur the cost of preparing an
appeal when an inspection triggers an extended survey (and subsequent
loss of the ability to provide nurse aide training). This would be in
addition to appealing the finding through the already available
informal dispute resolution process. Also, States may incur additional
costs if their surveyors need to testify in cases that previously would
not have been permitted to be heard by an ALJ and would incur
additional costs if they choose to provide hearings themselves for
Medicaid-only facilities. These costs, however, would be minimal since
we anticipate very few of these cases to arise in any State.
As stated earlier, we believe that this interim final rule will not
have a significant economic impact on providers, Medicare contractors,
or beneficiaries. In addition, long term care facilities that lose the
ability to conduct nurse aide training with no other remedies involved,
will be supportive of their ability to appeal the findings that gave
rise to the loss of their training programs since they have been
seeking just this solution since the publication of the final nursing
home enforcement rule in 1994.
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined, and we
certify, that this rule will not have a significant economic impact on
a substantial number of small entities or a significant impact on the
operations of a substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 431
Grant programs-health, Health facilities, Medicaid, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 42 CFR Chapter IV is
amended as set forth below:
PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION
A. Part 431 is amended as set forth below.
1. The authority citation for part 431 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
Sec. 431.153 [Amdended]
2. In Sec. 431.153, paragraph (b)(3) is removed and reserved.
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFs/MR AND CERTAIN NFs IN THE MEDICAID
PROGRAM
B. Part 498 is amended as set forth below:
1. The authority citation for part 498 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social security Act (42
U.S.C. 1302 and 1395hh).
2. In Sec. 498.3, paragraph (b)(13) is revised, a new paragraph
(b)(15) is added, and paragraph (d)(10)(iii) is revised to read as
follows:
Sec. 498.3 Scope and applicability.
* * * * *
(b) Initial determinations by HCFA. * * *
(13) The level of noncompliance found by HCFA in a SNF or NF but
only
[[Page 39938]]
if a successful challenge on this issue would affect--
(i) The range of civil money penalty amounts that HCFA could
collect (The scope of review during a hearing on imposition of a civil
money penalty is set forth in Sec. 488.438(e) of this chapter); or
(ii) A finding of substandard quality of care that results in the
loss of approval for a SNF or NF of its nurse aide training program.
* * * * *
(15) The finding of substandard quality of care that leads to the
loss by a SNF or NF of the approval of its nurse aide training program.
* * * * *
(d) Administrative actions that are not initial determinations. * *
*
(10) * * *
(iii) The imposition of State monitoring.
* * * * *
(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: July 14, 1999.
Michael M. Hash,
Deputy Administrator, Health Care Financing Administration.
Approved: July 16, 1999.
Donna E. Shalala,
Secretary.
[FR Doc. 99-18802 Filed 7-20-99; 12:04 pm]
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