[Federal Register: October 28, 2005 (Volume 70, Number 208)]
[Rules and Regulations]
[Page 62065-62073]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc05-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 483
[CMS-3121-F]
RIN 0938-AM55
Medicare and Medicaid Programs; Requirements for Long Term Care
Facilities; Nursing Services; Posting of Nurse Staffing Information
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: In this rule, we finalize provisions specified in the
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act
of 2000 (BIPA) that establish new data collection, posting, and
recordkeeping requirements for skilled nursing facilities (SNFs) and
nursing facilities (NFs). It requires that on a daily basis for each
shift, SNFs and NFs must post nurse staffing data for the licensed and
unlicensed staff directly responsible for resident care in the
facility. Facility census information must also be posted. This final
rule is also part of a broader communication outreach initiative by CMS
to provide beneficiaries, their families, and the public with access to
updated data and other information that can assist them in making
healthcare decisions.
DATES: The provisions of this final rule are effective on December 27,
2005.
FOR FURTHER INFORMATION CONTACT: Anita Panicker, (410) 786-5646, or
Jeannie Miller, (410) 786-3164.
SUPPLEMENTARY INFORMATION:
I. Statutory and Regulatory Background
Medicare and Medicaid-participating nursing homes are regulated by
sections 1819 and 1919 of the Social Security Act (the Act), added by
Title IV, subtitle C of the Omnibus Budget Reconciliation Act of 1987
(OBRA '87) (Pub. L. 100-203, December 22, 1987).
On February 27, 2004 we published a proposed rule in the Federal
Register entitled ``Medicare and Medicaid Programs; Requirements for
Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing
Information'' (69 FR 9282). In the proposed rule, we presented our
proposal to implement section 941 of the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA) by establishing
a new data collection and recordkeeping requirement for SNFs and NFs.
Section 941 of BIPA, which was effective January 1, 2003, requires SNFs
and NFs to post daily, for each shift, the number of licensed and
unlicensed nursing staff directly responsible for resident care in the
facility, and it requires the information to be displayed clearly in a
visible place. Additionally, section 941 of BIPA requires the Secretary
of Health and Human Services (the Secretary) to specify a ``uniform
manner'' for display of this information.
In the February 27, 2004 proposed rule, we proposed that SNFs and
NFs be required to: (1) On a daily basis, use a CMS-specified form at
the end of each shift to indicate the number of full-time equivalents
(FTEs) of registered nurses, licensed practical nurses, licensed
vocational nurses, and certified nurse aides (CNAs) directly
responsible for resident care; (2) verify or determine the resident
census on a daily basis, (3) post the completed form in a prominent
place readily accessible to residents and visitors; (4) make the form
available to the public upon request; and (5) maintain the forms for a
minimum of 3 years or as required by State law, whichever is greater.
The requirements in this final rule were revised based on the comments
we received on the proposed rule.
To date, we have also taken the following actions to educate
providers and clarify the requirements to implement section 941 of
BIPA:
An October 10, 2002 letter to State Agency Directors,
which can be found at http://www.cms.hhs.gov/medicaid/survey-cert/SC0303.pdf
.
Presentation of information at a national nursing home
conference.
Publication of a notice on an electronic bulletin board
used by nursing homes.
A December 24, 2002 letter to nursing homes, which can be
found at http://www.cms.hhs.gov/medicaid/bipa/bipanh.asp.
II. Ongoing Research on Nursing Home Quality Improvement
In November 2001, the Secretary announced an initiative to focus on
efforts to address quality of care improvement for nursing homes. The
Nursing Home Quality Initiative, implemented nationwide in November
2002, represents a broad-based program that includes our continuing
regulatory and enforcement systems, new and improved consumer
information, community-based nursing home quality improvement programs
and partnerships, and collaborative efforts to promote quality
awareness and improvement.
Working with quality measurement experts, the National Quality
Forum and a diverse group of nursing home industry stakeholders, we
adopted a set of nursing home quality measures. The Nursing Home
Quality Initiative combines new information for consumers about the
quality of care provided in individual nursing homes with current
resources available to nursing homes to improve the quality of care in
their facilities data for comparison, deficiency survey results and
staffing information about the nation's Medicare and Medicaid-certified
nursing homes through the Nursing Home Compare Web site, which is
updated quarterly.
The main components of the initiative are nursing home quality
measures derived from resident assessment data. This information is
routinely collected by nursing homes at specified intervals during a
resident's stay (using the Minimum Data Set or MDS). These measures
provide additional information to help consumers make informed
decisions about nursing home care options. Publication of the measures
is intended to motivate nursing homes to improve care delivery and
encourage discussions about quality between consumers and clinicians.
Additional CMS-sponsored quality improvement information may be
found in the ``Nursing Home Compare'' section of our Web site at http://www.medicare.gov.
The primary purpose of Nursing Home Compare is to
provide detailed information about the past performance of every
Medicare- and Medicaid-certified nursing home in the country. Nursing
Home Compare contains the following sections of detailed information:
About the Nursing Home: including the number of beds and
type of ownership.
Quality Measures: including the percentage of residents
with pressure (bed) sores, percentage of residents with physical
restraints, and more.
Inspection Result Information: including health and safety
deficiencies found during the most recent State nursing home survey and
from recent complaint investigations.
Nursing Home Staff Information: including the average
number of hours worked by registered nurses, licensed practical or
vocational nurses, and certified nurse aides per resident per day.
Each nursing home is required to report nursing staff totals to its
State survey agency during the annual survey. We receive this
information from the State survey agencies and convert the nursing
staff hours reported into the
[[Page 62066]]
number of staff hours per resident per day. We report the total nursing
staff hours per resident per day, as well as the total nursing staff
hours per resident per day for registered nurses, licensed practical
nurses, and licensed vocational nurses. (Facility staffing measures
reflected in Nursing Home Compare may be updated or revised in the
future.)
NFs are required to have adequate staff to give appropriate care to
all residents. SNFs and NFs must have at least one registered nurse for
at least 8 consecutive hours per day, 7 days per week, and either a
registered nurse, licensed practical nurse or licensed vocational
nurse, and other nursing personnel on duty 24 hours per day, unless a
waiver has been granted in accordance with Sec. 483.30(c) or Sec.
483.30(d). Certain States may have more stringent nurse staffing
specifications than the Federal requirements.
Section 4801(e)(17)(B) of the Omnibus Budget Reconciliation Act of
1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990) required the
Secretary to report the results of a study to the Congress on the
appropriateness of establishing minimum caregiver-to-resident and
supervisor-to-nurse ratios for Medicare- and Medicaid-certified nursing
homes. The purpose of the study was to examine the analytic
justification for establishing minimum nurse staffing ratios for
nursing homes. The study, entitled ``Appropriateness of Minimum Nurse
Staffing Ratios in Nursing Homes,'' (Report to Congress, July 2000) was
conducted in two phases. Phase I of the study http://www.cms.hhs.gov/Medicaid/reports/rp700hmp.asp
) examined whether an association exists
between staffing levels in nursing homes and quality of care. Phase II
of the study (http://www.cms.hhs.gov/medicaid/reports/rp1201home.asp)
examined the cost and benefits associated with establishing staffing
minimums and expanding the data used in the multivariate analysis from
three States to a more representative national sample. It included an
exploration of more refined case mix classification methods and case
studies to validate Phase I findings, while examining related issues
affecting certified nurse aide recruitment and retention. In both Phase
I and Phase II studies, the phrase ``nurse staffing'' referenced all
three categories of nurses and nurse aides: registered nurses, licensed
practical nurses, and nurse aides. Based upon these studies, we do not
believe sufficient evidence exists to warrant minimum nurse staffing
ratio requirements. Abt Associates and CMS staff have completed a draft
report with options for: (1) Collecting more accurate staffing data;
(2) auditing the data collected; (3) transmitting the data; and (4)
configuring the data so that they can be informative to the public when
placed on our website.
Consistent with our November 2002 initiative to disseminate
reliable information on nursing home quality for Medicare and Medicaid
beneficiaries, our objective in finalizing the February 27, 2004,
proposed rule is to make staffing information available to the public
to assist them in making informed decisions when choosing health care
providers. This regulation provides consumers with staffing information
on a day-to-day basis.
III. Provisions of the February 27, 2004 Proposed Rule
On February 27, 2004, we published a proposed rule in the Federal
Register entitled ``Medicare and Medicaid Programs; Requirements for
Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing
Information'' (69 FR 9282). Below we summarize and discuss the proposed
changes to the general conditions and requirements in Sec. 483.30,
Nursing services.
We proposed to revise Sec. 483.30 by adding a new paragraph (e)
that would require nursing homes to post nurse-staffing information in
accordance with section 941 of BIPA, specified as sections 1819(b)(8)
and 1919(b)(8) of the Act. We proposed daily collection requirements
for staffing information, identified categories of staff for which the
provision would apply, and established record keeping specifications,
that is, a specific form SNFs and NFs would use to display staffing
information by shift. We also proposed requiring SNFs and NFs to make
this information available to the public upon request and maintain the
forms for 3 years or as required by State law, whichever is greater.
In the February 27, 2004 proposed rule, we also noted that neither
section 1819(b)(8) nor section 1919(b)(8) of the Act specifies what
constitutes ``licensed and unlicensed nursing staff.'' In the proposed
rule, we interpreted ``licensed and unlicensed nursing staff'' to mean
registered nurses, licensed practical nurses or licensed vocational
nurses (as the term(s) are defined under State law), and certified
nurse aides.
We also proposed to revise Sec. 483.30 by adding a requirement
that SNFs and NFs collect and display the resident census for each day.
While collection of resident census information is not specifically
required under section 941 of BIPA, we believe that collection of this
information is authorized under our general statutory authority as
defined in sections 1819(f)(1) and 1919(f)(1) of the Act. These
sections require the Secretary to ``assure that requirements which
govern the provision of care [in both SNFs and NFs] * * * and the
enforcement of those requirements, are adequate to protect the health,
safety, welfare, and rights of residents and to promote the effective
and efficient use of public moneys.'' We believe the addition of census
information makes the nurse staffing data more meaningful and useful to
the public and is in line with our rulemaking authority. Providing
resident census data along with nurse staffing data gives consumers a
context and information they can use to interpret the data and reach
conclusions regarding the nurse staffing levels in relation to the
resident population.
We proposed to add a new Sec. 483.30(e)(1) that would specify the
contents and format of the information in accordance with the statutory
authority provided by BIPA, which mandates that the information must be
``displayed in a uniform manner.'' Proposed Sec. 483.30(e)(1) through
Sec. 483.30(e)(3) would require that the nurse staffing and census
information:
Include current nurse staffing numbers calculated as full
time equivalents (FTEs) for each shift;
Include the daily resident census;
Be posted on the CMS Daily Nurse Staffing Form; and
Be displayed in a prominent place readily accessible to
residents and visitors.
IV. Analysis of and Responses to Public Comments Received on the
February 27, 2004 Proposed Rule
We received a total of 82 timely items of correspondence from
individuals, providers, national and regional health care professional
associations and advocacy groups, State and local health organizations,
labor unions, health care law firms, and others. Summaries of the
public comments received and our responses to those comments are set
forth below under the appropriate subject headings. The first section,
``Information Requirements,'' includes comments and responses that
primarily relate to the proposed requirements in Sec. 483.30(e)(1),
that is, the proposed requirement to calculate full time equivalents
(FTEs) for nursing staff and the proposed requirement to determine or
verify resident census. The second section, ``Form Use and Posting
Requirements,'' contains comments and responses regarding the
requirements in Sec. 483.30(e)(2), that is, the proposed
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CMS-specified form and the proposed requirements for displaying the
form. The third section, ``Public Access and Data Retention
Requirements,'' includes comments and responses regarding the proposed
requirements in Sec. 483.30(e)(3) for maintaining data and making them
publicly available. The fourth section, ``General Comments'' includes
comments about the preamble discussion and other issues that fall
outside the specified requirements of the February 27, 2004, proposed
rule.
A. Information Requirements, Proposed Sec. 483.30(e)(1)
In Sec. 483.30(e)(1), we proposed requiring that SNFs and NFs on a
daily basis, at the end of each shift, calculate the number of full
time equivalents (FTEs) for the following licensed and unlicensed
nursing staff directly responsible for resident care: (A) Registered
nurses (RN); (B) Licensed practical nurses (LPN) or licensed vocational
nurses(LVN) (as defined under State law); and (C) Certified nurse
aides. In addition we proposed requiring SNFs and NFs to determine or
verify the resident census on a daily basis.
1. Using Full Time Equivalents (FTEs)
Comment: A number of commenters voiced their disagreement with the
proposal to require facilities to post staffing data according to FTEs.
Commenters stated that the requirement ``goes beyond the law'' and
pointed out that section 941 of BIPA requires only that nursing
facilities post the number of licensed and unlicensed staff for each
shift every day. In addition, commenters pointed out that in our
December 24, 2002 memorandum sent to nursing facilities, we gave
facilities discretion with respect to how the nurse staffing and census
data are to be displayed, provided that the required information is
displayed in a uniform manner in a clearly visible place.
Commenters further indicated that the use of FTEs may make it
difficult for families and the public to understand, and staff time
will be wasted explaining FTEs to visitors.
Response: We agree with the commenters that displaying nurse
staffing totals using FTEs could be confusing and may not accurately
represent the number of staff providing care during a given time
period. For example, 1 LPN FTE during an 8-hour (3 p.m. to 11 p.m.)
shift could mean that 1 LPN worked the entire 8-hour shift. However, it
could also mean that 2 LPNs worked 4 hours each from 3 p.m. to 7 p.m.
and that no LPNs worked in the unit from 7 p.m. to 11 p.m. Clearly,
displaying FTEs does not provide sufficient information to determine
the number of staff present at a given point in time, which is
important for families and visitors to know.
Therefore, instead of requiring facilities to post FTEs, in this
final rule we are requiring facilities to post the number of nursing
staff by category (RN, LPN or LVN, and CNA) providing direct care to
residents during each shift and the actual hours worked by the staff
during each shift (for example 7 p.m. to 11 p.m.). More specific
information about the required data and the method for displaying the
data are presented later in this preamble.
2. Suggestions for Additional Data
Comment: A few commenters stated that staffing level data would not
be helpful to the public unless information about resident acuity was
included. One commenter indicated that without consideration of the
acuity of the residents the posting of staffing will be meaningless.
Response: We agree that it would be valuable to have the acuity
information posted along with the staffing data. However, there are
wide variations in the types of populations served in SNFs and NFs. In
addition, there are no accepted standardized measures of resident
acuity that can be applied across all facilities. Therefore, in this
final rule, we are not requiring facilities to post resident acuity
level data.
Comment: One commenter stated that instead of posting the number of
staff, the facility should post the number of hours of training and the
type of training the staff receives.
Response: We appreciate the comment, but requiring the posting of
information about staff training is not within the scope of this
regulation, which is to develop requirements for implementation and
codification of the requirements of section 941 of BIPA, which requires
the posting of specific nurse staffing information. We would point out
that requiring facilities to identify the number of each category of
nursing staff (that is RN, LPN, LVN and CNA) provides the public with
some degree of knowledge about their education and training.
Comment: Many commenters stated that nurse staffing data are not
sufficient to inform families and the public about the quality of care
in a facility.
Response: While we are in agreement with commenters who noted that
the provision of nurse staffing data alone is insufficient to evaluate
quality of care within a facility, we are currently conducting a wide
range of regulatory and research activities focused on nursing home
quality assessment and improvement. For example, at our Nursing Home
Compare website, we present quality measures, deficiency information,
and other basic information about facility performance. We also
encourage consumers to visit facilities.
Nurse staffing information is critical data to help consumers make
informed decisions when selecting a facility. Census information
provides a basis for consumers to understand the relative number of
nursing staff providing direct care to all of the residents during each
shift. We believe that implementing the nurse staffing requirements in
section 941 of BIPA, as well as establishing a requirement for
collecting and posting census data offers the public access to updated
data and other information that can assist them in making healthcare
decisions.
Comment: Some commenters stated they would like the nurse staffing
form to include all the staff working on a particular shift, including
medical records reviewers, MDS coordinators, directors of nursing,
persons conducting interdisciplinary team meetings, and others who work
with residents at some level.
Response: Activities such as data collecting, conducting and
coordinating meetings, and reviewing records are outside the scope of
BIPA requirements. However, facilities may choose to provide that
information separately as part of the same documentation that is used
to display nurse-staffing data. Therefore, in this final rule,
facilities have been given discretion with respect to the manner in
which the nurse staffing and census data are displayed, provided that
the required information is displayed in a uniform manner in a clearly
visible place.
Comment: One commenter suggested that we require staff-to-resident
ratios on the form.
Response: As we stated in the preamble of the February 27, 2004
proposed rule, we do not believe sufficient evidence exists to warrant
minimum nurse staffing ratio requirements. In addition, the level of
care needed and the resident acuity level varies from facility to
facility, which limits the utility of those data. However, a facility
is not prevented from posting that information should they choose to do
so. Therefore, in this final rule facilities have been given discretion
with respect to the manner in which the nurse staffing and census data
are displayed, provided that the required information is displayed in a
uniform manner in a clearly visible place.
[[Page 62068]]
Comment: Some commenters stated the forms should include the names
of each staff member at work during the shift.
Response: We appreciate the comment but do not believe that
facilities should be required to post names of staff. Such a
requirement would increase the paperwork and recordkeeeping burden on
SNFs and NFs without serving the purpose of making staff level
information available. We believe collecting and updating staff data
would be more time consuming. In this final rule, facilities have been
given discretion to create their own document that may include more
information than the mandated data.
Comment: Some commenters stated that the nurse staffing form should
include the name and signature of the person who completes it, so that
the public knows to whom questions should be directed.
Response: Facilities may wish to include contact information for
someone who can answer questions. (This is likely to be the nursing
supervisor on each shift, not necessarily the person who completed the
information that is posted.) Facilities certainly may post information
that is not required under this final rule. However, in this final
rule, to minimize the burden of these requirements, we are not
specifically requiring that facilities include that information.
3. Impact of the Requirements on Facilities
Comment: Many commenters expressed their concern that the process
of collecting and posting of data will take nursing staff away from
resident care.
Response: We appreciate the commenters' concerns. However, this
final rule does not require that nursing staff complete and update this
information, and we do not expect that preparing and posting the
information will take much time. Clerical staff should be able to
prepare and post the data quickly. Therefore, we are not requiring
specific personnel to collect, verify, or post the data that have to be
displayed daily.
4. Clarification of Terms
Comment: Some commenters were not sure how to determine which
nursing staff should be included under section 941 of BIPA. They asked
for clarification of the meaning of ``directly responsible for resident
care.''
Response: In this final rule, we clarify the term ``directly
responsible for resident care'' to mean that an individual is providing
direct care to residents or is directly responsible for care provided
to residents. Providing direct care means that an individual has
responsibility for the residents' total care or some aspect of the
residents' care. Resident contact is an intrinsic part of direct care.
``Directly responsible for resident care'' includes, but is not limited
to, such activities as assisting with activities of daily living
(ADLs), performing gastro-intestinal feeds, giving medications,
supervising the care given by CNAs, and performing nursing assessments
to admit residents or notify physicians about a change in condition.
For example, when an RN is assigned to submit MDS data to a State
agency for the day, that RN would not be regarded as providing direct
care. However, if the same RN is assigned to the unit for providing
resident care, then the hours worked by the RN in the unit would be
included in the posted data. Therefore, in this final rule, we require
only the data related to the number of direct care staff on each shift
be posted.
5. Survey Issues
Comment: Many commenters stated that this data collection is a
redundant process as the facilities already collect and report those
data to surveyors.
Response: We are aware that facilities are required to provide
information, including the actual number of direct care staff and
direct care hours worked to us. Therefore, this final rule codifies
section 941 of BIPA, which specifically requires the posting of nurse
staffing information. The purpose of this final regulation is to make
the data available to the public on a daily basis. Facilities should be
able to reduce the burden by providing surveyors with the staffing
level data they collect and post every day for families and the public.
This would eliminate the need to collect the data twice.
Comment: Many commenters stated that CMS needs an enforcement
mechanism to ensure accuracy of the data. Some commenters suggested
that the data be transmitted to CMS for validation and others stated
that surveyors must validate it. Other commenters stated that the
validation is much more reliable when family members or others who are
in the facility visiting at a particular time check the validity of the
posted data, as they can verify the number of staff working at a given
time.
Response: As we discussed in the preamble of the February 27, 2004
proposed rule, we would expect facilities to retain this information in
order to be able to produce it if requested by a State Agency, the
public, or CMS. While surveyors are aware of the nurse staff posting
requirements and can check for compliance at any time and report their
findings to us, we do not currently require them to do so. (We are
currently working to update nursing home survey requirements and revise
the State Operations Manual (SOM) to provide additional guidance for
surveyors and facilities.) Sending the information to us would not
serve the purpose of validating the accuracy of the displayed
information. Family members, ombudsmen, and others visiting the
facilities will be able to verify the accuracy of the data posted, as
they can check the number of nursing staff in realtime.
6. Resident Census Data
We proposed at Sec. 483.30(e)(1)(ii) that SNFs and NFs determine
or verify the resident census on a daily basis. Forty percent of the
comments we received included a comment about posting of census data.
Comment: Many commenters supported the presentation of the census
data on the staffing form.
Response: We appreciate your comments and agree that providing
resident census data gives families and residents a frame of reference
by which they can view the nurse-staffing level data. The number of
nursing staff alone, without the census data, may not be meaningful.
Census information provides a basis for inferring the number of nursing
hours available to residents. In this final rule, we require that
census data be posted daily.
Comment: Some commenters did not support the posting of census data
and stated that it is of little value if staffing ratio or acuity of
the resident population is not captured.
Response: Although we do not require that resident acuity level be
posted, we believe it is important for consumers to have information
about the number of residents in the facility to provide a context for
understanding of the nurse-staffing data. Facilities that have been
posting nurse staffing information since BIPA was implemented report
that posting staff data has helped them, as it has addressed families'
questions regarding the number of staff working at a given time. Acuity
levels across facilities vary tremendously, and currently there are no
generally accepted standard measures. Additionally, requiring the
posting of this information is beyond this scope of the statute.
Therefore, in this final rule, we require census data to be posted
daily.
[[Page 62069]]
B. Form Use and Posting Requirements, Proposed Sec. 483.30(e)(2)
We proposed at Sec. 483.30(e)(2)(i) to require SNFs and NFs to use
a CMS-specified form (Daily Nurse Staffing Form) to enter the
information specified in paragraph (e)(1) of this section, and we
proposed at Sec. 483.30(e)(2)(ii) to require that the completed Daily
Nurse Staffing Form be posted in a prominent place readily accessible
to residents and visitors.
Approximately 90 percent of commenters had comments concerning the
proposed requirement for use of the CMS-specified form; about 30
percent of commenters had comments about where the form should be
posted.
1. CMS-Specified Form
Comment: Many commenters expressed concerns that the CMS-specified
form does not meet their facility's staffing patterns, and that the
calculations would be very burdensome if a facility does not use
standard 8-hour shifts or has overlapping shifts. Commenters stated
that the nursing shortage has caused them to use 2-hour shifts and 4-
hour shifts to help meet the needs of their residents. Others stated
that nurses may work 12 hours just on a weekend to cover the shortage
in a facility. Commenters stated that alternate staffing patterns
cannot be captured on the proposed CMS-specified form. Some commenters
also stated that requiring the use of a CMS-specified form does not
conform to the information in the December 24, 2003 CMS State agency
directors' letter.
Response: After reviewing the comments on the proposed mandatory
form, we reviewed the issues raised by the commenters and found that
many facilities have non-standard or overlapping shifts. For example 1
unit within a facility may have 1 RN working 7 a.m. to 7 p.m., 1 LPN
working 7 a.m. to 3 p.m., 1 LPN working 8 a.m. to 4 p.m., 2 CNAs
working 6 a.m. to 2 p.m., 4 CNAs working 7 a.m. to 3 p.m., and 2 CNAs
working 7 a.m. through 7 p.m. Overlapping shifts ensure that a unit has
sufficient staffing available during the busiest times of the day, for
example, giving medications, preparing end stage renal disease (ESRD)
patients to be transported for dialysis, or assisting residents at
mealtimes. To address these varied staffing patterns, many facilities
have developed their own forms to display nurse staffing data and have
found their own forms to be useful and informative.
Therefore, we have concluded that facilities should have the
flexibility to develop their own documents for displaying the required
information. Note that in the context of this final rule, we are using
the term ``document'' to refer to the medium a facility may use to
display nurse staffing information. The ``document'' may be a form or a
spreadsheet, as long as all the required information is displayed in a
clearly visible place. Further, the information on the document should
be displayed in a uniform manner and presented in a clear and readable
format. If requested, hard copies of the document must be made
available to families and the public, as specified in Sec.
483.30(e)(3)(i) of the proposed rule and Sec. 483.30(e)(3) of this
final rule.
The following is an example of one method for displaying nurse
staffing information, using the information for one shift in a 24-hour
period.
Name of the Facility:
Sample Nursing Home
Date: January 24, 2005
Resident Census at the Start of the Shift: 88
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Shift Category of staff Actual hours Staffing total
worked
---------------------------------
7 a.m.-3 p.m.................... Licensed.......... RN................ 1 RN 7 a.m.-3 p.m. 2.5 RNs.
2 RN 7 a.m.-11
a.m..
1 RN 11 a.m.-3
p.m..
LPN/LVN........... 2 LPN 7 a.m.-3 2 LPNs.
p.m..
Non-Licensed...... CNA............... 5 CNA 7 a.m.-3 5 CNAs.
p.m..
3 p.m.-11 p.m.
----------------------------------------------------------------------------------------------------------------
2. Time Frame for Posting Information
Comment: Several commenters strongly opposed the proposal to delay
calculating and posting nurse staffing data until the end of the shift.
Commenters stated that data posted at the end of a shift are not of any
use to resident families since it is after the fact. Some commenters
pointed out that CMS agreed to the form being posted closer to the
beginning of the shift in the December 24, 2003 State Agency Directors'
letter.
Response: We agree that it is preferable for families and visitors
to have the opportunity to view nurse-staffing data that reflects the
staffing level at the time they are visiting the facility. Therefore,
in this final rule, we are requiring facilities to post the information
at the beginning of the shift. If any changes to the information posted
are needed, they must be made as soon as possible.
Comment: Some commenters stated that the staffing sheet should show
the staffing levels for the entire day, not just for one shift at a
time.
Response: We agree families may be interested in knowing the
staffing levels for the entire 24-period, rather than staffing levels
for a single shift. However, it is also important to have accurate and
updated information posted each shift. If families are interested in
staffing levels for other shifts, they can ask to see data from those
shifts.
Comment: One commenter expressed concern regarding identifying the
first shift of the day. The commenter pointed out that a day starts
after midnight; therefore, the night shift would be the first shift.
Response: Standard practice in most facilities is to consider the
start of the day as the morning shift. However, there are variations in
shifts among facilities. Some have night shifts starting at 10 p.m.;
some at 11 p.m.; and some at 12 midnight. Additionally, the length of
shifts vary among facilities. Some have 12-hour shifts and others 8-
hour or even 4-hour shifts. While we are requiring uniformity in the
displaying of the nurse-staffing level data for each shift, we are
providing facilities with the flexibility to identify the shift
breakdowns so the 24-hour staffing coverage can be determined in an
accurate manner.
Comment: Many commenters stated that we should require that the
staffing form be posted within 1 hour of the start of the shift; others
suggested 2 hours.
Response: Although we are requiring that facilities post nurse
staffing data at the beginning of the facility-specified shift, we do
not believe it is necessary to dictate a particular time frame.
Staffing levels may change unexpectedly, and we believe facilities
should have the flexibility to ensure the
[[Page 62070]]
accuracy of the information before posting it.
Comment: Some commenters asked, ``which census should be recorded,
the census at midnight or the average census for the day?''
Response: The facility must post the census at the beginning of
each shift. For example, the 7am to 3pm shift would post the census at
7am and so forth. In most facilities, the census data can be obtained
from the shift report that nursing supervisors give to the next shift.
3. Clarification of Terms
Comment: Some commenters stated that the term ``uniform manner''
needs to be clarified, referring to the requirement that the
information must be displayed in a uniform manner.
Response: ``Uniform manner'' means that certain required
information must be displayed on or in a document of the facility's
choosing in a format that assures the information can be read and
clearly understood by the reader. The required information includes:
(1) The name of the facility; (2) the date, (3) the resident census;
(4) each facility shift for a 24 hour period; and (5) the specific
hours worked, per shift, aggregated by category (registered nurses,
licensed practical nurses or licensed vocational nurses (as the term(s)
are defined under State law), and certified nurse aides).
For example: Three RNs worked for 4 hours each during an 8-hour
shift, which started at 7 a.m. and ended at 3 p.m. Two of the RNs
worked from 7 a.m. to 11 p.m., and one RN worked from 11 a.m. to 3 p.m.
The facility's posting would show the shift (7 a.m. to 3 p.m.), the
specific work hours (2 RNs from 7 a.m. through 11 p.m., and 1 RN from
11 a.m. through 3 p.m.), and the total number of RNs on duty during the
shift (1.5). Note that although 3 RNs worked for some part of the
shift, the total number displayed would be 1.5 because each RN worked
for only half the 8-hour shift. The total number of RNs would be 3 only
if all 3 RNs worked for the entire 8-hour shift.
The data should be updated at the beginning of every shift to
reflect actual hours worked by registered nurses, licensed practical
nurses, and nurse aides during the facility-identified shift in
question and the total hours worked. The document on which the
information is displayed should be clear and readable to residents and
visitors.
The facilities have discretion with respect to displaying the nurse
staffing and census data provided the information is in a clearly
visible place and contains the required data elements.
4. Location of Form
Comment: Some commenters stated that the daily nurse staffing form
should be posted on each unit.
Response: The facilities can choose to post information on each
unit. We require that the nurse staffing information be posted in a
visible and easily accessible area that is common to visitors and
residents. If a facility posts the information on each unit, for just
that unit, we would still expect all nurse staffing information to be
posted in a visible and easily accessible common area.
Comment: Many commenters voiced their support for the requirement
that the information is to be posted in a prominent place readily
accessible to residents and visitors.
Response: We appreciate the support and agree that it is important
for visitors and residents to be able to locate the information.
Therefore, in this final rule, we require that the data be displayed in
a clear and readable manner and be posted in a prominent place that is
readily accessible to residents and visitors.
5. Format and Instructions
Comment: Some commenters stated that CMS needs to mandate the size
of the paper or the size of the font to ensure that the form is
readable.
Response: We are requiring facilities to display the information in
a clear and readable manner. Facilities are free to use the paper and
font they choose, as long as the information is displayed in a manner
that meets these requirements. We believe facilities should have the
flexibility to determine how best to display the information so that it
is clear and readable. Therefore, in this final rule, we require that
the data be displayed in a clear and readable manner.
Comment: Some commenters wanted more precise instructions for
completing the required nurse staffing data.
Response: As discussed earlier, after reviewing the comments on the
feasibility of using a standardized form regarding variations in shifts
and staffing patterns, we have concluded that facilities must have the
flexibility to capture daily nurse staffing data. This final rule does
not prevent facilities from providing additional data.
C. Public Access and Data Retention Requirements, Proposed Sec.
483.30(e)(3)
We proposed public access and data retention requirements at Sec.
483.30(e)(3). Forty percent of the commenters had a comment about the
proposed access requirements at Sec. 483.30(e)(3)(i) that would
require SNFs and NFs to make the Daily Nurse Staffing Form(s) available
to the public upon request. Sixty percent of the comments received
included a comment about the proposed data retention requirements.
Comment: A few commenters agreed with the proposed requirement and
suggested that facilities keep the forms in a notebook at the front
desk so the public would have easy access to them. The commenters
further stated that both oral and written requests to see the forms
should be honored; records should be provided within 24 hours of the
request; and records should be copied at costs not to exceed community
photocopying standards and the actual cost of clerical time to copy the
documents.
Response: Facilities have the flexibility to decide how to make the
documents accessible to the public. In this final rule, we require that
upon oral or written request, facilities must make the nurse staffing
data available to the public for review. Furthermore, we require that
facilities must provide, as requested, photocopies of the documents at
a cost not to exceed the community standard.
This requirement is similar to the current requirements at 42 CFR
483.10(b)(2) that the resident or his or her legal representative has
the right--(i) Upon an oral or written request, to access all records
pertaining to himself or herself including current clinical records
within 24 hours (excluding weekends and holidays); and (ii) After
receipt of his or her records for inspection, to purchase at a cost not
to exceed the community standards, photocopies of their records or any
portion of them upon request after a 2 working days advance notice to
the facility.
We proposed that the Daily Nurse Staffing Form(s) be maintained for
a minimum of 3 years, or as required by State law, whichever is
greater. It is our expectation that a SNF or NF will retain this
information in keeping with standard business practices and be able to
produce it if requested by the State Agency or the public.
Comment: A few commenters agreed with the proposed requirement that
the forms should be retained for 3 years or as required by State law,
whichever is greater. However, many other commenters stated that a
requirement to maintain records for 3 years would be burdensome,
unnecessary, and costly in terms of wasted time, paper, storage space,
and personnel. One commenter suggested reducing the requirement to 1
year or deleting it altogether. Another commenter suggested retaining
the
[[Page 62071]]
records only until the next certification survey.
Response: We understand the commenters' concerns and have concluded
that it is not beneficial for facilities to retain the nurse staffing
records for 3 years. Therefore in this final rule, we are requiring
facilities to retain nurse staffing data for only 18 months. Since
nursing home surveys generally are conducted every 9 to 15 months,
retaining the data for 18 months ensures their availability to
surveyors. It also ensures that records are available for a reasonable
period of time if residents or the public want to see them.
Comment: Some commenters stated that maintaining the nurse staffing
data are redundant, since staffing schedules, pay roll, and other data
typically maintained by facilities would provide the same information.
Response: We understand that facilities keep certain records that
would contain the same information. However, this information is not
maintained in a format that would enable families and the public to
determine staffing levels across the facility on a given day or days.
The data, as displayed, are different from the data acquired from
payroll records, as payroll records contain only the hours each staff
person worked in a given pay period, not whether the staff person
provided direct care to residents or performed some other duty, such as
coordinating MDS data. Furthermore, section 941 of BIPA mandates that
facilities post nurse staffing information daily and make the posted
information available to the public. Therefore, in this final rule, we
require the facilities to post daily nurse staffing data for specified
direct care nursing staff.
Comment: A commenter stated that the retention of records is not
necessary since the information will not be submitted to an agency.
Response: The commenter is correct that we are not requiring data
to be submitted to an agency; however, the statute requires the
information be available to the public. Therefore, in this final rule,
we require that nurse staffing data to be maintained for a minimum of
18 months which will also cover the annual survey period.
V. General Comments on the Proposed Rule
A number of commenters included discussions on topics related to
nurse staffing, but not specifically proposed in the February 27, 2004
rule. The comments that follow were considered out of scope and as such
were not part of our consideration in this final rule.
Comment: Several commenters stated that the BIPA requirements are
helpful, although some commenters expressed concerns related to
specific implementation requirements. One commenter reported that
posting of the nurse staffing form in their facility for the past year
has posed no problem at all. The commenter stated that it has even
helped the facility resolve certain issues with family members.
Response: We appreciate the support; it is encouraging to know that
facilities have been able to comply with our requirements and have
found the display of the information to be helpful.
Comment: A few commenters wanted to know if these requirements
apply to swing beds and hospitals.
Response: The requirements in this proposed rule apply only to
nursing facilities, that is, SNFs and NFs.
Comment: One commenter stated that ``a better way would be to
require a resident's family member or guardian to visit the resident a
minimum of once per week to observe the care of the resident and report
any concerns to the facility management or, if unresolved, to a liaison
to the government.''
Response: Family members of residents are free to visit and observe
the care given to the resident and report concerns to the facility, the
State survey agency or the ombudsman. Requiring a resident's family
member or guardian to visit the resident a minimum of once per week is
beyond the scope of this final rule.
Comment: One commenter interpreted the preamble language that
discusses the Nursing Home Quality Initiative as being a part of the
proposed requirement. The commenter stated that the background
information contradicts itself. The referenced section states,
``Although staffing is not an explicit part of this initiative * * *''
and ``Based upon these studies, at this time, we do not believe
sufficient evidence exists to warrant minimum nurse staffing ratio
requirements.''
Response: We would like to clarify that the ``initiative'' that is
being discussed is the Nursing Home Quality Initiative and is not part
of this final regulation. The preamble to the February 27, 2004
proposed rule states that we do not believe sufficient evidence exists
to warrant minimum nurse staffing ratio requirements based on the study
discussed. In our discussion of the value of the data required by this
regulation, for example we noted, ``Consistent with our November 2002
initiative to disseminate and publish reliable information on nursing
home quality for Medicare and Medicaid beneficiaries, our objective is
to make staffing information available to the public to assist them in
making informed decisions when choosing health care providers.''
Comment: One commenter stated that requiring a nursing home to post
the FTE and census data does not ensure nurse staffing levels will
increase due to the market demand created by an informed public.
Response: We agree with the comment. Clearly, providing information
to consumers about nurse staffing levels will not be sufficient to
increase staffing levels. However, the intent of the requirements in
this rule is to make staffing information available to residents and
visitors at any given time.
1. Staffing Ratios
Comment: A few commenters stated that they were not in agreement
with the contention that the Minimum Staffing Ratios in Nursing Home
Phase I and Phase II fail to provide sufficient evidence to warrant
minimum staffing ratio requirements.
Response: We appreciate the comments. However, we do not believe
sufficient evidence exists to warrant minimum nurse staffing ratio
requirements. There exists a great variation in the population served
in nursing facilities, not just in the acuity level but also in the
experience and credentials of staff. Additionally, requiring a specific
nurse-to-resident ratio is beyond the scope of this final rule.
Comment: Some commenters urged CMS to release Abt Associates'
recommendations to the public as soon as they are made so that the
facilities can implement them in a timely manner.
Response: We appreciate the comments and will share them with our
staff overseeing the Abt Associate study. The study is mentioned in the
preamble of this final rule as it is related to staffing, but it is not
directly related to these requirements as this rule codifies the BIPA
941 requirements.
Comment: Some commenters suggested that it would be a good idea to
use the data in the Online Survey Certification and Reporting (OSCAR),
which is derived from the 671 Form that the State survey agency uses
when conducting facility surveys.
Response: We agree that the data can be used on the 671 Form. The
facilities have the flexibility to use the data to reduce the burden of
collection when the same data are to be used in other documents or
reports. However, this rule is focused on codifying the BIPA 941
requirements.
[[Page 62072]]
VI. Provisions of the Final Rule
Section 483.30(e)(1) Information Requirements
This final rule requires SNFs and NFs to post, for each shift, on a
daily basis the actual hours of and total number of hours worked by,
licensed and unlicensed nursing staff who are directly responsible for
resident care on each shift in the facility. In the February 27, 2004
proposed rule, we noted that neither section 1819(b)(8) of the Act nor
section 1919(b)(8) of the Act specifies what constitutes licensed and
unlicensed nursing staff. In this final rule, we interpret the term
``licensed nursing staff'' to mean registered nurses (RNs); licensed
practical nurses (LPNs) or licensed vocational nurses (LVNs), and
``unlicensed nursing staff'' to mean certified nurse aides (CNAs), as
defined under State law.
As discussed in section IV of the preamble of this final rule, we
use the term ``directly responsible for resident care'' to mean that an
individual is providing direct care to residents or is supervising
those who provide direct care to residents and has the responsibility
for residents' total care or some aspect of residents' care. Resident
contact is the intrinsic part of direct care. ``Directly responsible
for resident care'' includes, but is not limited to, those activities
as assisting with activities of daily living (ADLs), performing gastro-
intestinal feeds, giving medications, supervising the care given by
CNAs, and performing nursing assessments to admit residents or
notifying physicians about a change in condition.
Therefore, in this final rule, we require only nursing staff
assigned and responsible for direct resident care under the categories
of RN, LPN/LVN and CNA to be captured in the daily nurse staffing data.
This final rule does not require data collection on other staff,
volunteers, or feeding assistants. This final rule provides the
flexibility to facilities to post more data if they choose to do so to
fit the individual facility needs.
In addition, SNFs and NFs must post the resident facility census
and update the data as needed.
Section 483.30(e)(1) Required Data Elements
On a daily basis, at the beginning of the shift, NFs and SNFs must
post the following data:
1. Facility Name
2. Current Date
3. Resident Census
4. Facility-specific shifts for the 24-hour period, (for example 7
a.m. through 3 p.m., 3 p.m. through 11 p.m., and 11 p.m. to 7 a.m.).
5. Categories of nursing staff employed or contracted by the
facility, per shift.
6. Actual time worked for the specified categories of nursing
staff, including split shifts.
7. Number of nursing staff working per shift
Section 483.30(e)(2) Posting Requirements
In the February 27, 2004 proposed rule, we proposed that SNFs and
NFs post, on a CMS-specified form, information on a daily basis that
includes the date, the name of the facility, the total number of
licensed and unlicensed nursing staff who are directly responsible for
resident care and the specific hours they work. However, in this final
rule, we deleted the required use of a CMS-specific form. Nurse
staffing data must be displayed in a clear and readable format and be
posted in a prominent place readily accessible to residents and
visitors. However, we are not mandating a specific form be used, and we
are providing facilities the flexibility to use the form or format
which best meets their needs.
We proposed requiring facilities to post a CMS-specified form at
the end of the shift. However, this final rule requires facilities to
post nurse staffing information at the beginning of the shift. In
addition, we do not require facilities to post the number of FTEs on
the form because we determined, based on public comments received on
the February 27, 2004 proposed rule, that the process of calculating
FTEs would be burdensome for facilities and the data collected might
not be comprehensible to residents and visitors.
Section 483.30(e)(3) Public Access and Data Retention Requirements
SNFs and NFs must make their daily nurse staffing records available
to the public for review at a cost not to exceed the community
standard.
Section 483.30(e)(4) Facility Data Retention Requirements
SNFs and NFs must maintain nurse staffing records for 18 months or
as required by State law, whichever is greater. This covers the annual
survey period and gives the surveyors the opportunity to verify the
records if they choose to do so.
VII. 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 before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the 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.
Below is a summary of the information collection requirements in
this regulation:
Section 483.30 Nursing Services
In summary, section 483.30(e)(2) requires that long-term care
facilities use the CMS-specified form (Daily Nurse Staffing Form) to
enter the information specified in paragraph (e)(1) of this section;
and to post the completed Daily Nurse Staffing Form in a prominent
place readily accessible to residents and visitors.
The burden associated with this requirement is the time and effort
it will take for the facility to complete the form and post it.
Currently, there are 16,473 participating nursing homes. We estimate a
total of 5 minutes to fill in the information per day. We further
estimate that it will require facilities 30.42 hours each on an annual
basis to meet these collection requirements.
Section 483.30(e)(3) requires the facility to make the information
required in Sec. 483.30(e)(1)-(2) available to the public and to
maintain documentation.
The burden associated with this requirement will be the time it
will take for the facility to retrieve the documented information being
requested. We believe this requirement to be usual and customary
business practice; therefore, the burden for this collection
requirement is exempt under 5 CFR 1320.3(b)(2) and 5 CFR 1320.3(b)(3).
VIII. Regulatory Impact
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354),
section 1102(b) of
[[Page 62073]]
the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and
Executive Order 13132. Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any one
year). This rule does 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 entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
According to the Small Business Administration (SBA) approximately 53
percent of all SNFs and NFs generate revenues of $11.5 million or less
in a one year period, and are considered small entities. Individuals
and States are not included in the definition of small entities. The
only burden associated with this rule is the information collection
burden associated with collecting and posting nurse staffing data. We
are not preparing an analysis for the RFA because we have determined
that this 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. This
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 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this final rule will not have a significant impact on the operations of
a substantial number of small rural hospitals because it applies only
to SNFs and NFs.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. The only burden associated with this
rule is the information collection burden associated with collecting
and posting nurse staffing data. This final rule will have no
consequential effect on the governments mentioned or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation will not impose any costs on State
or local governments, the requirements of Executive Order 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 homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR part 483 as follows:
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 483.30 is amended by adding paragraph (e) to read as
follows:
Sec. 483.30 Nursing services.
* * * * *
(e) Nurse staffing information--(1) Data requirements. The facility
must post the following information on a daily basis:
(i) Facility name.
(ii) The current date.
(iii) The total number and the actual hours worked by the following
categories of licensed and unlicensed nursing staff directly
responsible for resident care per shift:
(A) Registered nurses.
(B) Licensed practical nurses or licensed vocational nurses (as
defined under State law).
(C) Certified nurse aides.
(iv) Resident census.
(2) Posting requirements. (i) The facility must post the nurse
staffing data specified in paragraph (e)(1) of this section on a daily
basis at the beginning of each shift.
(ii) Data must be posted as follows:
(A) Clear and readable format.
(B) In a prominent place readily accessible to residents and
visitors.
(3) Public access to posted nurse staffing data. The facility must,
upon oral or written request, make nurse staffing data available to the
public for review at a cost not to exceed the community standard.
(4) Facility data retention requirements. The facility must
maintain the posted daily nurse staffing data for a minimum of 18
months, or as required by State law, whichever is greater.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
Dated: April 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 16, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-21278 Filed 10-27-05; 8:45 am]
BILLING CODE 4120-01-P