[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]               
[Page 55528-55539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-21]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 483 and 488

[CMS-2131-F]
RIN 0938-AL04

 
Medicare and Medicaid Programs; Requirements for Paid Feeding 
Assistants in Long Term Care Facilities

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule permits a long term care facility to use paid 
feeding assistants to supplement the services of certified nurse aides 
under certain conditions. States must approve training programs for 
feeding assistants using Federal requirements as minimum standards. 
Feeding assistants must successfully complete a State-approved training 
program and work under the supervision of a registered nurse or 
licensed practical nurse. The intent is to provide more residents with 
help in eating and drinking and reduce the incidence of unplanned 
weight loss and dehydration.

EFFECTIVE DATE: These regulations are effective on October 27, 2003.

FOR FURTHER INFORMATION CONTACT: Nola Petrovich, (410) 786-4671.

SUPPLEMENTARY INFORMATION: Copies: This Federal Register document is 
also available from the Federal Register online database through GPO 
access, a service of the U.S. Government Printing Office. The Web site 
address is http://www.access.gpo.gov/nara/index.html.

I. Background

Legislation

    Sections 1819(a) through (e) and 1919(a) through (e) of the Social 
Security Act (the Act) set forth the requirements that long term care 
facilities must meet to participate in the Medicare and Medicaid 
programs, respectively. Sections 1819(f)(2) and 1919(f)(2) of the Act 
contain requirements for nurse aide training and competency evaluation 
programs (NATCEP). Sections 1819(g) and 1919(g) of the Act contain the 
criteria that we use to assess a facility's compliance with the 
requirements. These statutory provisions were mandated by the Omnibus 
Budget Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100-203, enacted 
December 22, 1987). The requirements for long term care facilities are 
codified at 42 CFR part 483, subpart B; the nurse aide training and 
competency evaluation program requirements are codified at 42 CFR part 
483, subpart D; and the survey, certification and enforcement 
procedures are codified at 42 CFR part 488, subparts E and F.
    Sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act and regulations 
at Sec.  483.75(e) define a nurse aide as any individual furnishing 
nursing or nursing-related services to residents in a facility, who is 
not a licensed health professional, a registered dietitian, or someone 
who volunteers to provide services without pay. Sections 1819(f)(2) and 
1919(f)(2) of the Act set forth the requirements for approval of a 
nurse aide training and competency evaluation program, but do not 
define ``nursing'' or ``nursing related'' skills. Section 483.152 of 
the regulations specifies nurse aide training requirements. These 
include, for example, basic nursing skills, personal care skills, 
communication and interpersonal skills, infection control, safety and 
emergency procedures, mental health and social service needs, 
residents' rights, care of cognitively impaired residents, and basic 
restorative services.
    On March 29, 2002, we published in the Federal Register a proposed 
rule, ``Requirements for Paid Feeding Assistants in Long Term Care 
Facilities'' (67 FR 15149), that offered long-term care facilities the 
option to use paid feeding assistants, if consistent with State law.
Current Program Experience
    Currently, there is no provision in the regulations for the use of 
single-task workers, such as paid feeding assistants, in nursing homes. 
To ensure the safety

[[Page 55529]]

of facility residents, we require that qualified nursing staff provide 
assistance with eating and drinking, although there is some question 
whether or not all residents need medical supervision. This group of 
personnel includes registered nurses, licensed practical nurses, and 
certified nurse aides who have completed 75 hours of training. However, 
volunteers, who are usually family members, may also feed residents, 
because the law and regulations exclude volunteers from the definition 
of certified nurse aide.
    Nursing homes in many States report a continuing shortage of 
certified nurse aides.\1\, \2\, \3\. Nursing homes are finding it 
increasingly difficult to train and retain sufficient numbers of 
qualified nursing staff, especially certified nurse aides. Certified 
nurse aides perform the majority of resident care tasks. Other 
employers often pay similar wages for less physically and emotionally 
demanding jobs. This makes it harder for nursing homes to employ enough 
nursing staff to perform routine nursing care and to feed residents who 
need minimal help or just encouragement at mealtimes. Feeding residents 
is often a slow process and competes with more complex tasks, such as 
bathing, toileting, and dressing changes, as well as urgent medical 
care.
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    \1\ Stone, R.I. (2001) Frontline workers in long-term care: 
Research challenges and opportunities. Generations, 25(1), 49-57.
    \2\ Stone, R.I., with Weiner, J. A. (2001). Who will care for 
us? Addressing the long-term care workforce crisis. Washington, D.C: 
Robert Wood Johnson Foundation.
    \3\ United States General Accounting Office. Nursing Workforce: 
Recruitment and Retention of Nurses and Nurses Aides Is a Growing 
Problem. (Washington, DC., May 2001)
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    For many elderly nursing home residents, physical and psychological 
changes often interfere with eating ability and meal consumption. 
Residents may need assistance with feeding if they have, for example, 
cognitive impairment, impaired swallowing due to muscular weakness or 
paralysis, a tendency to aspirate or choke, poor teeth, ill-fitting 
dentures or partial plates, or poor muscular or neurological control of 
their arms or hands, as with Parkinson's disease.

Current Trends

    Nursing homes are caring for an aging population that has more 
acute clinical conditions than in the past. The result is a higher 
percentage of nursing home residents who need higher levels of care, 
which takes more staff time and leaves less time for routine tasks, 
such as ensuring that residents eat their meals and drink enough 
fluids.
    In addition, evidence suggests that there has been a recent 
increase in assisted living facilities that house many individuals with 
minimal medical needs who previously would have been cared for in 
nursing homes. Both of these trends have resulted in a frailer nursing 
home population than previously, with residents who are more dependent 
on nursing staff for basic needs, such as feeding and personal care. A 
critical shortage of certified nurse aides in many parts of the country 
has resulted in a need for staff who are specially trained to help 
residents eat at mealtimes, to supplement, not replace certified nurse 
aides.
    Some residents only need encouragement or minimal assistance, which 
does not require nursing training. Properly trained non-nursing 
personnel could provide this type of assistance. Nurse aides and other 
nursing staff receive training so that they are able to feed residents 
with all kinds of feeding problems. A higher level of training is 
required of nurse aides because nurse aides need to be able to deal 
with complicated feeding problems. However, when there is a nurse aide 
shortage, it is often the case that residents without complicated 
feeding problems receive little or no assistance at mealtimes with 
eating or drinking, while the nursing staff focuses on feeding 
residents with complicated problems. We believe there is a place in 
nursing homes for the use of feeding assistants who, after proper basic 
training in feeding techniques and working with the elderly, are able 
to feed residents who do not have complicated feeding problems. It is 
reasonable to require that feeding assistants receive a lower level of 
training than a nurse aide because feeding assistants would not handle 
complicated feeding cases. This would allow facilities, if they choose, 
to train other facility employees as feeding assistants so that 
available staff can feed residents at mealtimes.
Facility Staff Shortages
    Because of the shortage of certified nurse aides and the 
increasingly complex medical needs of residents, facilities in some 
States have used paid feeding assistants to supplement certified nurse 
aides to ensure that residents take in adequate food and fluids. 
Generally, feeding assistants used by these facilities are part-time 
workers, often retired individuals, or homemakers who are available for 
a few hours a day. They may also be older students who come into the 
facility between 1 and 2 hours either at the noon or evening meal. In 
other facilities, staff shortages are so acute that all nonmedical 
employees, including the administrator of the facility, are required to 
complete training and help feed residents at mealtimes. Training 
facility personnel for functions other than their primary position is 
known as cross-training. There is anecdotal evidence that cross-
training of personnel in nursing homes increases coordination and 
continuity of care.\1\ It also contributes to increased morale and 
lower staff turnover.
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    \1\ Stone, R.I., Reinhard, S.C., Bowers, B., Zimmerman, D., 
Phillips, C.D., Hawes, C., Fielding, J.A., and Jacobson, N. 
(2002).Evaluation of the Wellspring Model for Improving Nursing Home 
Quality.
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    There is no provision in Federal regulations for the employment of 
nursing home workers who perform only a single task without completing 
75 hours of nurse aide training. Currently, residents must be fed by a 
registered nurse, licensed practical nurse, or a nurse aide who has 
completed 75 hours of training and who has been certified as competent 
to perform all nurse aide tasks. Volunteers may also feed residents. 
The reason for this existing policy is to ensure that residents who 
cannot, or do not, feed themselves are fed by trained nursing staff. 
This is intended to protect residents from unskilled workers who might 
injure a resident by not recognizing serious medical complications 
associated with eating.
    Wisconsin and North Dakota are two States in which nursing homes 
have had serious difficulty hiring enough certified nurse aides and 
have used feeding assistants as a supplement to certified nurse aides. 
Other States have expressed interest in using paid feeding assistants, 
including Ohio, Minnesota, Florida, California, and Illinois. Florida 
and Illinois have both passed laws that permit the use of single task 
workers in their States, but they have not yet implemented the 
provisions.
    Wisconsin nursing homes have been using single-task feeding 
assistants for more than 7 years. Wisconsin uses a structured, formal 
program that requires a facility wanting to implement a feeding 
assistant program to submit an application for approval by the State. 
The classes are taught by a registered nurse, with a registered 
dietitian teaching the dietary elements of the program. A facility's 
approved program must include the following core areas: Interpersonal 
communication and social interaction; Basic nursing skills (including 
infection control); Personal care skills (assisting with eating, 
hydration); Basic restorative services (assistive devices for eating); 
Resident

[[Page 55530]]

rights; and special problems associated with Dementia (specialized 
feeding and intake problems). Participants who complete the training 
must demonstrate skills and pass a written test with a score of 80 
percent or better. Feeding assistants are used solely for feeding 
residents who have no feeding complications. They are permitted to feed 
residents only in the dining room and operate under the direction of a 
registered nurse or licensed practical nurse. Feeding assistants serve 
to supplement care delivered by certified nurse aides, which frees up 
more extensively trained aides to perform more complex resident care 
tasks.
    North Dakota has used paid feeding assistants for a number of years 
and has a slightly less formal program than that of Wisconsin. The 
residents to be fed are selected by the dietary and nursing staff. If a 
facility has a nurse aide training program, the training coordinator 
and dietitian work together to train new feeding assistants 
individually. After training and orientation, a new feeding assistant 
is assigned to one resident who needs minimal assistance. As the 
assistant gains skill and confidence, he or she is assigned to more 
residents at a meal or to a resident who requires a higher level of 
skill to feed. Typically, feeding assistants work only about 1\1/2\ 
hours per day, providing assistance at either the noon or evening meal.

Conclusion

    We are committed to ensuring that long term care residents receive 
the best possible care. We recognize that a shortage of certified nurse 
aides may adversely affect resident care and prevent many residents 
from receiving adequate help with eating and drinking. Further, we are 
persuaded by the experience of States that have used paid feeding 
assistants, that proper training and medical direction of these feeding 
assistants minimizes the risk to residents, while providing substantial 
benefits to residents. After thoroughly considering this issue, we 
believe that the benefits to residents outweigh the potential risks. We 
believe that a policy change to allow the use of feeding assistants can 
be accommodated under existing statute. There is nothing in the statute 
governing requirements for long term care facilities (sections 1819 and 
1919 of the Act) that would preclude the use of these workers and we 
believe that there is no conflict with other statutory requirements.

II. Provisions of the Proposed Regulations

    We proposed that feeding assistants must complete successfully a 
State-approved training course that meets minimum Federal requirements 
specified in proposed Sec.  483.160. These course requirements would 
consist of relevant items from the nurse aide training curriculum and 
would include feeding techniques; assistance with feeding and 
hydration; communication and interpersonal skills; appropriate 
responses to resident behavior; safety and emergency procedures, 
including the Heimlich Maneuver; infection control; resident rights; 
and recognizing changes in residents that are inconsistent with their 
normal behavior, and the importance of reporting those changes to the 
supervisory nurse. Facilities or States may want to add items to these 
minimum requirements.
    We proposed that each facility that uses feeding assistants 
maintain a record of the individuals who have successfully completed 
the feeding assistance training. Facilities would be required to report 
to the State any incidents in which a feeding assistant has been found 
to neglect or abuse a resident, or misappropriate a resident's 
property. The State must then maintain a record of all reported 
incidents.
    We proposed that a facility may use a paid feeding assistant to 
feed residents who do not have a clinical condition that would require 
the training of a nurse or nurse aide. Selection of residents to be fed 
would be made by the professional nursing staff, using the 
comprehensive assessment. Nurses or nurse aides would continue to feed 
residents who require the assistance of staff with more specialized 
training, such as those residents with recurrent lung aspirations, 
difficulty swallowing, or those residents on feeding tubes or 
parenteral/IV feedings. Feeding assistants would work under the direct 
supervision of registered nurses (RN) or licensed practical nurses 
(LPN), who are in the unit or on the floor where the feeding assistance 
is furnished. In proposed Sec.  483.75(e), we revised the definition of 
``nurse aide'' to clarify that paid feeding assistants are not 
performing nursing or nursing-related tasks.
    Feeding assistants could be paid by the facility or paid under an 
arrangement with another agency or organization (Sec.  488.301). 
Facilities would be able to use staff who are not health care personnel 
as feeding assistants if they successfully complete the training 
program. This might include the administrator, activity staff, 
clerical, laundry, housekeeping staff, or others who see residents on a 
daily basis. However, feeding assistants are intended to supplement 
certified nurse aides, not substitute for certified or licensed nursing 
staff.
    We proposed that these requirements would not apply to volunteers 
and family members.

III. Analysis of and Responses to Public Comments

    We received over 6,000 public comments on the proposed rule. About 
99 percent of commenters were overwhelmingly supportive of the 
proposal, but raised a large number of issues and offered many 
suggestions for clarifications and revisions to the final regulation. 
Commenters supporting the proposal included for-profit and not-for-
profit nursing homes, national and State nursing home associations, 
national and State health care associations, State health and human 
services agencies, United States Congresspersons, and private citizens. 
Many beneficiary advocates and employee unions opposed giving 
facilities the option to use paid feeding assistants. A summary of the 
major issues and our responses follow.

Facility Option To Use Feeding Assistants

    Comment: One commenter recommended that we conduct a pilot study or 
do further research before finalizing the proposal because there is a 
lack of data that would support the proposal. Another commenter 
suggested that we implement the proposal, but reevaluate the policy in 
3 years to see if the objective is being met.
    Response: We believe that the experience of Wisconsin and North 
Dakota has provided a demonstration of the merits of the use of paid 
feeding assistants. Both States have reported that in facilities that 
use feeding assistants, the benefits to residents include fewer cases 
of unexplained weight loss and dehydration than in facilities that do 
not use feeding assistants, with no reported ill effects.
    Comment: Some commenters believed that the proposal is illegal, 
that is, there is no basis in the law to support the use of paid 
feeding assistants.
    Response: Our review of the law indicates that there is nothing 
that would prohibit the use of feeding assistants and we believe that 
we have the authority and discretion under the law to implement this 
practice. Although commenters have focused on the language of the 
statute, at sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act that 
requires persons engaged in nursing or nursing related care to be 
trained either as a nurse or nurse aide, we do not consider the kinds 
of tasks facilities may ask feeding assistants to

[[Page 55531]]

provide as either nursing or nursing related. While feeding has been 
part of the nurse aide training curriculum, that requirement was 
predicated on the nurse aide having to tend to persons with pronounced 
eating complications (such as swallowing disorders) for which 
specialized training is essential. What facilities would be free to do 
as a result of this rule, however, is to use persons who have had a 
lesser level of training to assist residents who have no feeding issues 
that require any specialized attention. Thus, we do not consider 
feeding assistants who may be used by facilities under this rule to be 
engaged in nursing or nursing related activities.
    Comment: Several commenters cited the lack of Federal oversight 
built into the proposal.
    Response: The survey process will provide the Federal oversight of 
facilities' use of feeding assistants, as it does for other 
participation requirements. During surveys of nursing homes, surveyors 
will observe the meal or snack service to note if any of the residents 
receiving feeding assistance are having trouble, such as coughing or 
choking. If this is observed, surveyors will investigate to determine 
if this is an unusual occurrence or a chronic problem and whether 
feeding assistants have successfully completed the 8-hour training 
course. Surveyors will also determine if the resident receiving the 
feeding assistance is one who has no complicated feeding problems. This 
will be done by a review of medical charts and discussion with the 
professional nursing staff. Similarly, surveyors will note concerns 
about supervision of paid feeding assistants and investigate how the 
facility provides supervision by interviewing staff during meal or 
snack times and drawing their own conclusions from observations. 
Deficiencies will be cited by surveyors when they identify problems. By 
retaining training and employment records of feeding assistants, a 
facility will help document its compliance with Federal requirements, 
and have a record that surveyors may review when they survey the 
facility.
    Comment: Some commenters were convinced that the use of feeding 
assistants will not improve the quality of care and may, in fact, lower 
it. One commenter contended that Wisconsin's use of feeding assistants 
did not lead to a documented improvement in quality of care. Others 
commented that use of feeding assistants would disrupt the continuity 
of care and reduce quality by creating an assembly line atmosphere.
    Response: We are not aware of any data that would suggest that 
there is an improvement in the quality of care when residents are 
helped to eat by feeding assistants, nor are we aware of any data that 
would suggest a decline in quality of care. We are relying on support 
for the use of paid feeding assistants that has been provided by the 
Wisconsin and North Dakota survey agencies. Neither agency has 
indicated that use of feeding assistants has resulted in diminished 
quality of care.
    Comment: A few commenters recommended that we prohibit a facility 
from training feeding assistants when it has certain deficiencies, in 
the same way we currently prohibit a facility from training nurse 
aides. For example, commenters suggested that we prohibit facilities 
from training feeding assistants if the facility has (1) any deficiency 
at level F or above; (2) a deficiency at any level in the area of 
nutrition, staffing, and residents' rights; (3) imposed against it a 
per instance civil money penalty (CMP) of $5,000 or more, a per day CMP 
of $5,000 or more cumulatively, a State monitor, or temporary manager; 
(4) an approved nurse-staffing waiver.
    Several consumer advocacy groups recommended that we limit the 
authority for a facility to use feeding assistants to facilities that 
are authorized to conduct nurse aide training programs. In other words, 
if a facility loses the right to train nurse aides, it should also lose 
the right to train feeding assistants. Many providers took the opposite 
position, that a facility that loses nurse aide training rights should 
retain the right to train feeding assistants.
    Response: The prohibition to which commenters refer is a statutory 
requirement that causes a facility to lose the right to train nurse 
aides when the facility has certain deficiencies specified in the law. 
We disagree with commenters and believe that each State needs the 
flexibility to respond to specific situations and make its own decision 
whether or not to permit a facility to train and use feeding 
assistants.
    Facilities that have an approved nurse-staffing waiver, which 
waives requirements in Sec.  483.30 to have a RN on staff 8 hours per 
day, 7 days per week, are still required to have adequate numbers of 
LPNs on staff at all times. Thus, even if RNs are unavailable, the 
supervision requirement for feeding assistants would be met by having 
LPNs on duty.
    Comment: Many commenters said that they did not want us to limit 
hours worked by feeding assistants to mealtimes and advocated 
permitting feeding assistants to work whenever needed by a facility. 
Some facilities thought that feeding assistants could be used full time 
to provide snacks and liquids to residents, particularly those who 
cannot leave their room. These commenters believed that this would be a 
good way to reduce the potential for dehydration since assistants would 
have time to deliver liquids, provide social stimulation, and encourage 
bedfast residents to drink more fluids.
    Response: The text of the regulations does not limit working hours 
to mealtimes. According to Sec.  483.35(h), facilities may use feeding 
assistants at any time that the supervision requirements are met.
    Comment: Many providers and individuals expressed strong support 
for the use of existing staff as feeding assistants, after proper 
training. A large number of providers reported that they favor this 
because existing staff, such as clerical, dietary, and housekeeping 
staff, are already trained in facility policies, are usually well 
acquainted with residents, and have time available to devote to feeding 
residents.
    A number of other commenters were opposed to using existing staff 
as feeding assistants, citing their full-time responsibilities and 
concern about added burden.
    Response: The text of the proposed regulations permits any 
individual to act as a feeding assistant if he or she meets the 
training and supervision requirements (Sec.  483.35(h)). Each 
facility's administrator is responsible for allocating available staff 
to necessary tasks and we believe that it is reasonable to leave the 
decision to the administrator whether to use as feeding assistants 
staff who are not health care personnel.
    Comment: Some commenters suggested requiring that facilities assign 
feeding assistants to certain residents to ensure continuity of care.
    Response: We believe that this decision is best left to each 
facility and the supervisory nurses.
    Comment: Consumer advocates were concerned that insufficiently 
trained feeding assistants would endanger residents. Other commenters 
were concerned that feeding assistants might make clinical judgments 
and take actions that are beyond their scope of training or be unable 
to handle emergency situations.
    Response: The purpose of the training is to ensure that feeding 
assistants are properly prepared to feed residents and recognize 
emergency situations that need the immediate help of a supervisory 
nurse. We believe that a training program that meets the requirements 
listed in Sec.  483.160 will

[[Page 55532]]

ensure that a feeding assistant receives proper training.
    Comment: One commenter suggested that we consider expanding the 
role and training of feeding assistants so that they can eventually 
assist in feeding residents with complex feeding problems.
    Response: Individuals who have complex feeding problems, such as 
the need for IV or parenteral feedings, swallowing problems, and those 
with recurrent lung aspirations, need the assistance of professional 
nurses or certified nurses aides who have been trained to work with 
residents who have these needs. We do not believe that it is 
appropriate for feeding assistants to feed any residents other than 
those who are low risk and whose eating problems are uncomplicated.
    Comment: Two senators and one congressman wrote in support of the 
proposal, noting the success of one state that used feeding assistants 
and experienced reduced weight loss and dehydration among nursing home 
residents. These commenters also reported that the Board of Nursing of 
one state had defined feeding as a nursing task and was concerned that 
this might prevent the state from using feeding assistants. (In the 
proposal, we indicated that feeding assistants would not be performing 
nursing or nursing-related tasks.) Another commenter believed that 
feeding is a nursing-related service and should not be performed by an 
individual with minimal training.
    Response: The definition of the term, ``nursing and nursing-related 
tasks,'' is frequently prescribed by State law and, therefore, we are 
declining to impose a Federal definition of this term on all States. We 
believe the matter should be left with the State in those situations in 
which State law or standards-setting organizations have established a 
definition that is more restrictive than the Federal definition 
permitting the use of feeding assistants. We suggest that the State 
investigate whether a revision to State law would resolve this issue.

Staffing Issues

    Comment: One consumer advocacy group suggested that we require 
state survey agencies to use the investigative protocol for staffing 
from the State Operations Manual in all facilities that request to use 
or use feeding assistants. This protocol, used to identify problems 
that may be associated with insufficient nursing staff, would ensure 
that a facility has an appropriate number of RNs and LPNs to supervise 
feeding assistants.
    Response: We believe that facilities that request to use or use 
feeding assistants should be surveyed in the same way as any other 
facility. Surveyors should use the investigative protocol for staffing 
only when systemic problems relate to insufficient nursing staff.
    Comment: A consumer advocate asked that we require facilities to 
post information about the numbers of feeding assistants, in addition 
to the current requirement to post the number of licensed and 
unlicensed staff employed per shift. The commenter also suggested that 
we require that feeding assistants wear badges or name tags so that 
they will be clearly recognized by other staff.
    Response: A provision in the Medicare, Medicaid & State Child 
Health Insurance Program (SCHIP) Benefits Improvement & Protection Act 
of 2000 (BIPA) requires facilities to post daily for each shift the 
current number of licensed and unlicensed nursing staff directly 
responsible for resident care in the facility. This provision is 
effective January 1, 2003. Because paid feeding assistants do not 
qualify as licensed or unlicensed nursing staff, facilities do not need 
to post the numbers of feeding assistants used by the facility. 
However, we will consider at a later date whether this might be useful 
and what additional burden it may impose on facilities.
    With regard to name tags, we believe it is probably a good idea, 
but leave that decision to each facility and do not see the need for us 
to make this a requirement.

Use of Volunteers

    Comment: Several commenters suggested that we require volunteers to 
complete the training requirements for feeding residents, pointing out 
that it is inconsistent not to do so.
    Response: While we believe that it is a good idea for family 
members and volunteers to take the training, and we encourage it, we 
are not making this a requirement. Many volunteers in facilities are 
family members who are only there to feed a relative. Often, family 
members have been feeding the ailing resident for years, both at home 
and in the facility. We are leaving it to each facility to determine 
whether or not to require volunteers and family members to complete 
feeding assistance training. Ultimately, facilities are responsible for 
the care and safety of residents, even if the resident is fed by a 
relative or friend.

Payment Issues

    Comment: Some providers were concerned about how they would be paid 
for the training and services of feeding assistants. A few commenters 
recommended that we allocate payment for feeding assistants to the 
nursing cost center.
    Response: Skilled nursing facilities will not receive additional 
Medicare payment for the costs of using feeding assistants. Medicare 
payment for residents in skilled nursing facilities is made through a 
prospective payment system, which covers all costs (routine, ancillary, 
and capital) of covered skilled nursing facility services furnished to 
beneficiaries under Part A of the Medicare program. For Medicare 
payment, the term and concept, ``nursing cost center,'' is outdated, 
but still may be used in some State Medicaid programs. The Medicare SNF 
PPS per diem payment rate is based, in part, on levels of care and 
resources required and received by residents, established by the 
resident assessment instrument specified in Sec.  483.20. The system 
does not require that tasks performed by a staff person fit within a 
direct care or indirect care category (such as a nursing cost center).
    Medicaid payments for nursing facilities are established by each 
State. Therefore, it would be up to individual States to determine 
whether they would need to change their payment rates for those 
facilities that use feeding assistants and how the rates would be 
changed. However, because feeding assistants will likely be paid at a 
minimum wage, which is less than the wage paid to certified nurse 
aides, facilities participating in Medicare and Medicaid may incur less 
cost than if they had hired additional certified nurse aides to perform 
feeding and hydration duties.
    Comment: One provider reported using workers who pass out trays, 
provide beverages and condiments, talk to and encourage residents, 
record food intake, and perform routine dining room tasks. The 
commenter asked if the facility would be able to continue to use these 
workers.
    Response: A facility may continue to use workers who perform the 
dietary service functions described by the commenter. They need not be 
trained as feeding assistants if they do not feed residents. Facilities 
are required to employ sufficient support personnel to carry out the 
functions of the dietary service. If these workers successfully 
complete the feeding assistant training course, the facility may also 
use them to feed residents. However, as we indicated in the last 
response, the Medicare program pays skilled nursing facilities a 
prospectively determined per diem rate, which does not require that

[[Page 55533]]

tasks performed by personnel fit into a direct or indirect care 
category. For Medicaid payment, payment is determined by each Medicaid 
state agency.

Determining Which Residents Can Be Fed by Feeding Assistants

    Comment: One state commented that it is cumbersome to rely on the 
comprehensive assessment to determine which residents may be safely fed 
by a feeding assistant. Instead, the decision should be left entirely 
up to the professional judgment of the licensed nurse. A consumer 
advocacy group also indicated that the comprehensive assessment/annual 
evaluation is not an effective tool for the assessment of residents to 
be fed because the information may not be current. Several 
organizations suggested that we emphasize the importance of the RN or 
LPN's professional judgment along with input from the interdisciplinary 
team, as reflected in the comprehensive assessment, when selecting 
residents for feeding assistance.
    Response: We agree with commenters and are revising Sec.  
483.35(h)(1)(ii) to say that the decision about whether a resident is 
to be fed by a feeding assistant is based on the charge nurse's 
assessment and the resident's latest assessment and plan of care. We 
note that facilities that choose to use paid feeding assistants remain 
responsible for any adverse actions resulting from the use of these 
assistants, as with any other employee.
    Comment: An organization representing licensed professionals 
suggested that the RN or LPN should consult with a speech-language 
pathologist when a resident is suspected to have, or is at risk for, 
swallowing difficulties.
    Response: We have no objection to this and facilities may use this 
approach if they choose.
    Comment: Several commenters indicated that the criteria for 
selecting residents to be fed is inadequate and suggested that we 
define the clinical conditions that would require feeding by an RN or 
LPN or nurse aide. Another commenter suggested that we prohibit feeding 
assistants from feeding residents with swallowing problems.
    Response: We believe that the clinical decisions as to which 
residents may be fed by feeding assistants are best left to the 
professional judgment and experience of RNs and LPNs who work in the 
facility and have personal knowledge of a resident's day-to-day 
condition. If we were to define clinical conditions, we would only be 
substituting the judgment of professional nurses employed by the 
Federal government for the judgment of nurses working in facilities. We 
believe that professional nurses conclude that certain clinical 
conditions relating to eating and drinking would require the skills and 
knowledge of an RN or LPN. These conditions include, but are not 
limited to, recurrent lung aspirations, difficulty swallowing, and tube 
or parenteral/IV feedings.
    Comment: One commenter suggested a number of more stringent 
requirements for facilities, including (1) obtaining informed consent 
from the resident or resident's representative that the resident agrees 
to be fed by a feeding assistant and accepts the risks and benefits; 
(2) an individualized feeding plan; and (3) a certification by a 
licensed nurse in a resident's medical record that the resident can be 
safely fed by a feeding assistant prior to each instance of feeding.
    Response: We understand that the commenter intends the proposed 
provisions to be in the best interest of residents, but we believe 
that, for the most part, they are unduly burdensome for facilities to 
implement. To require consent before a resident can receive help from a 
feeding assistant implies that this is a high risk procedure, which we 
believe it is not. We believe that the Wisconsin and North Dakota 
experience indicates that it is safe to use well-trained feeding 
assistants who are properly supervised. It would be inconsistent to 
require residents to give informed consent for feeding assistance when 
they need not do so for any other services provided by a facility. 
Further, a feeding plan would very likely duplicate part of the care 
planning process. Consequently, we are not revising the rule to 
accommodate the commenter's suggestions.

Supervision

    Comment: Commenters, concerned about lack of supervision, pointed 
out that the proposed requirement, in Sec.  483.35(h)(2)(ii), that a 
nurse is in the unit or on the floor, exceeds the licensed nursing 
requirements in most states. Other commenters worried that the shortage 
and high turnover rates of licensed and unlicensed nursing staff could 
mean that fewer staff are familiar with residents and could result in 
inadequate monitoring.
    Response: Facilities are required by Sec.  483.30, Nursing 
services, to have sufficient qualified nursing staff available on a 
daily basis to meet residents' needs for nursing care. The requirement 
in Sec.  483.30, Nursing services, is that, unless waived, a facility 
must have a RN on duty 8 consecutive hours per day, 7 days a week. A 
facility must also have a sufficient number of licensed nurses and 
other nursing personnel on a 24-hour basis to provide nursing and 
related services to residents. The proposed requirement that a feeding 
assistant work under the direct supervision of a RN or LPN builds on 
the requirement that sufficient licensed nursing staff are on duty 24 
hours a day. We believe that, if a facility chooses to use feeding 
assistants, it is the facility's responsibility, and in its best 
interest, to ensure that adequate supervisory nursing staff is 
available.
    However, we recognize that the supervision requirement is unclear 
and subject to a variety of interpretations. Therefore, we are revising 
Sec.  483.35(h)(2) by removing the word, ``direct'' from the phrase, 
``direct supervision,'' because it may unintentionally imply visual 
contact between a feeding assistant and a supervisory nurse. This is 
not possible in most facilities, especially if assistants are feeding 
residents in their rooms. Next, we are removing the requirement that a 
nurse be in the unit or on the floor where the feeding assistance is 
furnished and immediately available to give help. As commenters noted, 
this sentence is unclear. While we are not prescribing the precise 
means by which facility RNs or LPNs assert their supervisory 
responsibilities, we will expect that facilities do so in a way that 
avoids negative outcomes for their residents. Additionally, we are 
requiring that a feeding assistant call a supervisory nurse on the 
resident call system when there is an emergency or a need for help. All 
facilities are currently required to have a resident call system.
    Comment: Consumer advocates expressed concern about a potential 
lack of supervision and suggested that all residents who are fed by 
feeding assistants be fed in the dining room or other congregate area 
to ensure that a licensed nurse is physically present. Other commenters 
supported allowing feeding assistants to feed residents in their rooms, 
citing the fact that many of the most frail residents do not go to the 
dining room and are least likely to get adequate assistance with 
eating. Numerous commenters cited examples of bedfast residents, unable 
to feed themselves or reach the food, receiving no help at mealtime, 
after which the tray is removed, untouched by the resident.
    Response: We share commenters' concerns about adequate supervision 
of feeding assistants to ensure the safety of residents. We are equally 
concerned, however, that those residents who are

[[Page 55534]]

unable or unwilling to go to a congregate dining area receive needed 
feeding assistance in their rooms. We are confident that the nurse in 
charge, using his or her professional judgment in assessing residents 
who are appropriate for feeding assistance, will be able to select 
residents who can safely be fed in their own rooms.
    Comment: An organization representing nursing home employees noted 
that nursing staff is already overworked and supervising feeding 
assistants would only add to the burden. Another commenter indicated 
that the proposed supervision requirement would further burden RNs and 
LPNs because they would have to stay in the dining room during 
mealtimes and this would limit their availability elsewhere in the 
facility.
    Response: Adequate supervisory staff is just one factor that a 
facility needs to consider when deciding whether or not to use feeding 
assistants. If a facility chooses to use paid feeding assistants, it 
would be the facility's responsibility to ensure that it has sufficient 
RNs and LPNs available to adequately supervise feeding assistants 
without adding undue burden on the staff. When using feeding 
assistants, there will be a need for a facility to balance the increase 
in staff available to meet resident needs with the increased need to 
supervise these assistants.

Training

State-Approved Training Course
    Comment: Several providers asked whether facilities would be able 
to hire paid feeding assistants if the State does not approve a 
training program for feeding assistants. Many providers supported 
giving facilities maximum flexibility to implement the proposal without 
lengthy state approval requirements. One commenter suggested that we 
require all states to mandate feeding assistant programs in all 
facilities.
    Other commenters believed that, before facilities may opt to use 
feeding assistants, States should be able to decide whether 
implementing feeding assistant programs is in the best interest of the 
State or consistent with State law.
    Several providers, provider organizations, and States asked that we 
remove the requirement that a training course for feeding assistants be 
State approved, citing potential burden on States, cost, and delays in 
implementing feeding programs. One State with a large number of 
facilities and a shortage of resources was concerned about the 
potential burden of approving a large number of feeding programs. 
Commenters, instead, suggested that we require that an individual 
complete a training course that meets the requirements of Sec.  
483.160. In this case, the facility would maintain documentation of 
compliance with the requirements and surveyors would review the 
training records at annual surveys.
    Many states and providers asked for clarification on our 
expectations in terms of state approval. They wondered whether other 
entities, such as community colleges, would be permitted to offer the 
training. One commenter noted that travel to community colleges and 
cost would discourage individuals from taking the training. There was 
also a question about the frequency with which a state would need to 
review or reapprove a feeding assistant program. Another commenter 
suggested that we offer more specific guidance to states to assist them 
in establishing criteria for training programs and others suggested 
using established models from Wisconsin and North Dakota.
    Response: We have chosen to retain the requirement that States 
approve training programs for feeding assistants. We believe that this 
will give States the necessary control and flexibility to structure 
approval processes for training programs to fit the needs of each 
State. States that have large numbers of facilities and resources that 
are stretched to the limit may want to minimize any burden associated 
with State approval of training programs, while States with fewer 
facilities may structure approval in a very different way.
    However, States also have the flexibility not to implement a 
program for approval of feeding assistant training programs. If a State 
does not implement an approval program, the result is that facilities 
in that State will not be able to hire any paid feeding assistants.
Training Content
    Comment: We received a variety of comments on training, including 
requests for additional requirements, removal of requirements, and 
clarifying changes. Many commenters asked that we provide more 
specificity on training requirements and establish a minimum number of 
hours of training. Suggestions for hours of training ranged from 5 to 
75.
    Response: We believe that being overly prescriptive on the content 
of training is unnecessary, would reduce flexibility to offer these 
training programs, and would unnecessarily limit the ability of States 
and providers to develop these programs within the scope of their 
considerable knowledge. However, to ensure that training is not 
conducted in a superficial manner, we are revising Sec.  483.160(a) to 
require that a training course for feeding assistants include, at a 
minimum, 8 hours of training.
    Comment: A few commenters suggested that we specify in the text of 
the regulation that a feeding assistant must ``successfully'' complete 
the entire training course before he or she is qualified to work with 
residents in the facility.
    Response: We agree with the commenters that successful completion 
of the training course is essential and are revising Sec.  
483.35(h)(2)(i) by adding the word ``successful.'' We believe that it 
is reasonable to expect that a feeding assistant will successfully 
complete the training course before working directly with residents. 
This is a basic safety precaution to ensure that residents are 
protected. After completion of training, a facility may want to slowly 
ease a feeding assistant into the work by feeding a resident who needs 
minimal assistance, as North Dakota does.
    Comment: Many commenters advocated requiring a competency test 
before feeding assistants are permitted to work with residents.
    Response: We are not including a requirement for a competency test 
in the final rule. We believe that the instructor or supervisory nurse 
will be able to assess the competency of trained feeding assistants.
    Comment: Several commenters objected to the inclusion of the 
Heimlich Maneuver in the training course and its use by feeding 
assistants. They were concerned that its use by a robust feeding 
assistant on a frail resident might result in rib fractures or other 
injuries. Commenters emphasized that only nursing staff should 
determine the need for, and administer, the Heimlich Maneuver. Instead, 
they suggested that the training course emphasize the need for feeding 
assistants to recognize symptoms that should be immediately reported to 
licensed supervisory staff for further action.
    Response: The Heimlich Maneuver is an emergency procedure that is 
taught to the public, as well as medical personnel. It seems reasonable 
to retain this training requirement in view of the fact that nurse 
aides are trained to use this procedure and they may also be strong 
individuals. Proper training is essential and feeding assistants will 
receive the same training on the Heimlich Maneuver as nurse aides. 
Also, experienced RNs tell us that training in handling emergencies 
will

[[Page 55535]]

emphasize the need for a feeding assistant to call for help 
immediately, and then, if necessary, begin a procedure like the 
Heimlich.
    Comment: One commenter suggested that, if a facility uses a feeding 
assistant under an arrangement with another organization, the facility 
must verify that the feeding assistant has successfully completed the 
training.
    Response: Section 483.35(h)(2) already provides for this. It says 
that, if a facility uses a paid feeding assistant, the facility must 
ensure that the individual has completed a State-approved training 
course. The burden of proof is on the facility to ensure that any 
feeding assistant it uses is properly trained.
    Comment: Commenters suggested a number of additions to the general 
training requirements. One suggestion was to require that training 
programs explicitly include feeding problems of the cognitively 
impaired, since 60-70 percent of nursing home residents are cognitively 
impaired. Other suggestions included training in dementia, food and 
drug interactions, diet consistencies, how much and how to feed, 
resident preferences, difficulty swallowing, and emphasis on performing 
only feeding tasks for which training has been provided. A consistent 
concern of commenters was a need for a training emphasis on recognition 
and prevention of emergency situations associated with feeding, such as 
dysfunctional swallowing, tracheal aspiration, esophageal obstruction, 
and other potentially severe emergency situations.
    Response: It is important to note that the training course 
requirements proposed in Sec.  483.160 are minimum requirements. States 
and facilities are free to add to those requirements. However, many of 
the training additions suggested by commenters appear to be more useful 
in the training of nurse aides than feeding assistants, who will feed 
residents without any significant eating problems.
    Comment: Several commenters suggested that we address payment for 
training in the same way that we do in the regulations for nurse aides. 
One commenter asked that we prohibit facilities from charging potential 
feeding assistants for training. Another asked if a facility may 
require that a trained feeding assistant repay the facility for 
training if he or she leaves? A commenter asked if a facility can 
require that a trained feeding assistant work for a set period of time.
    Response: Judging from provider comments received, there will be a 
strong demand for feeding assistants and it is unlikely that facilities 
will want to charge for training. Generally, these positions will be 
part time and will not require extensive training that would be costly 
for the facility. We think it is unnecessary to amend the regulations 
to provide for payment provisions similar to those for nurse aides. 
With regard to a facility entering into a contract with a feeding 
assistant that would require that individual to work for a certain 
period of time, there is nothing in our regulations that would prohibit 
this practice. This is strictly between the facility and the feeding 
assistant.
Qualifications of Instructors
    Comment: Many individual commenters and professional organizations 
asked that we establish standards or qualifications for instructors of 
the training program. Commenters suggested numerous licensed or 
certified health care professionals who could conduct the training, 
including RNs, registered dietitians, licensed physical therapists, 
licensed speech therapists, and occupational therapists. Dietitians 
argued that they have the expertise in food and nutrition issues in 
long-term care settings, are trained to teach self-help feeding 
devices, and basic restorative feeding services, citing established 
manuals and materials that would support this practice. Occupational 
therapists argued that they are trained to match an analysis of 
disabilities with effective interventions, resources and adaptations.
    Several commenters strongly recommended that we prohibit feeding 
assistants from teaching each other on-the-job.
    Response: It is apparent that a number of options are available in 
terms of the variety of licensed or certified health care professionals 
that may be qualified to conduct training for feeding assistants. Some, 
RNs and LPNs, are employed full time in facilities and would be 
available without additional cost to conduct the training. Dietitians 
may be employed by a facility full time, part time, or on a consultant 
basis. Other health care professionals may be available at additional 
cost; however we believe that it would be inappropriate to permit a 
feeding assistant to train another. Consistent with the flexibility for 
States to develop a State-approved training program, we are deferring 
to States the decision as to which individuals would be qualified to 
teach the feeding assistant training.
Maintenance of Records
    Comment: Several commenters pointed out that there is no 
requirement for states to maintain a formal registry of feeding 
assistants or to check with other states for background information. 
One commenter suggested that states report information on feeding 
assistants to the nurse aide registry and provide this information to 
facilities for hiring purposes. Others suggested that we require 
facilities to check with the nurse aide registry before employing 
individuals as feeding assistants in case the individual had worked as 
a nurse aide previously.
    Response: We have decided to include only nurse aides in the nurse 
aide registry, largely because the law is so specific about the 
requirements. Also, we believe it is not necessary to further burden 
States by requiring them to establish and maintain a separate registry 
for feeding assistants. As we explain later in the preamble, states are 
already required by Sec.  488.335 to review and investigate all 
allegations of abuse, neglect, and misappropriation of resident 
property. This information can be accessed by any hiring facility. 
Facilities need to screen feeding assistants, as any other employee, to 
try to ensure that individuals have no history that would preclude 
their interaction with frail elderly residents.
    Comment: Several commenters reported that there is no provision for 
feeding assistants trained in one facility, city, or state to carry 
that training forward so that it does not have to be repeated. There is 
no requirement for a facility to request a copy of an individual's 
training record before he or she is hired as a feeding assistant. A 
commenter suggested that we establish a requirement for states to have 
reciprocity agreements within each state or between states.
    Response: It is not our intent that individuals repeat training 
when moving to another facility. However, we believe that it is 
unnecessary to establish extensive regulatory provisions for requesting 
records or for state reciprocity agreements in this case. As with any 
other job applicant, a feeding assistant should indicate where he or 
she was last employed and a hiring facility may contact the former 
employer to verify employment and training. States are currently 
required to review allegations of abuse, neglect, or misappropriation 
of resident property. A hiring facility should be able to contact the 
state for that information.

Reporting Abuse, Neglect, and Misappropriation of Residents' Property

    Comment: Commenters had a number of suggestions concerning proposed 
Sec.  483.160(c), which requires a facility to report to the state all 
incidents of a paid

[[Page 55536]]

feeding assistant who has been found to neglect or abuse a resident, or 
misappropriate a resident's property. That section also requires a 
state to maintain a record of all reported incidents. One state 
reported that it already has a requirement for criminal background 
checks and a law requiring that facilities report allegations of abuse 
and neglect. Other commenters suggested language changes to the text. 
One commenter noted that Sec.  483.160(c) is inconsistent with Sec.  
488.335, which requires a state to review all allegations of resident 
neglect, abuse, and misappropriation of property, and follow procedures 
in Sec.  488.332. Section 488.332 requires a state to establish 
procedures to investigate complaints of participation requirements.
    Response: We agree with the commenter regarding requirements in 
proposed Sec.  483.160(c). Paragraph (c) is unnecessary because it 
repeats certain provisions of existing Sec.  488.335. Since Sec.  
488.335 already establishes state requirements for review of 
allegations of neglect, abuse, misappropriation of property, and 
procedures for investigation of complaints and hearings, we are 
removing proposed paragraph (c) in Sec.  483.160.

Definition of Paid Feeding Assistant

    Comment: Many commenters objected to the term, feeding assistant, 
saying that it has a pejorative connotation and it lacks sensitivity to 
the elderly. Others thought that the term failed to include the 
importance of fluid intake. Commenters suggested a variety of 
alternatives, including the following: meal assistant; food and 
hydration aide or assistant; nourishment aide, nutrition assistant, 
nutritional aide, nutrition-hydration assistant; dining assistant; and 
resident assistant.
    Response: The commenters make a good point, which we had not 
recognized when drafting the proposal. However, the term, feeding 
assistant, was widely used by states and organizations before our 
proposal. Rather than change the term in the regulations, we suggest 
that facilities and states use whatever term they prefer.

IV. Provisions of the Final Regulations

    For the most part, this final rule incorporates the provisions of 
the proposed rule. The following provisions of this final rule differ 
from the proposed rule:
    [sbull] We are reorganizing and revising Sec.  483.35(h) so that 
paragraph (h)(1) applies to State approval of training courses for 
feeding assistants. We are adding the requirement that a feeding 
assistant must successfully complete a State-approved training course, 
and do so before feeding residents.
    [sbull] Also, in revised Sec.  483.35(h)(1), we are clarifying that 
a facility may use a paid feeding assistant if it is consistent with 
State law.
    [sbull] In revised Sec.  483.35(h)(2), we are revising the 
supervision requirement to remove the word, ``direct,'' from the 
phrase, ``direct supervision.''
    [sbull] Also, in revised Sec.  483.35(h)(2), we are removing the 
requirement that a supervisory nurse be in the unit or on the floor 
where the feeding assistance is furnished and is immediately available 
to give help, if necessary. In place of that sentence, we are adding 
the requirement that a feeding assistant call a supervisory nurse for 
help during an emergency on the resident call system.
    [sbull] In revised Sec.  483.35(h), we are adding a new paragraph 
(3) concerning resident selection criteria to replace proposed Sec.  
483.35(h)(1)(ii). In new paragraph (3), we are replacing the term, 
``clinical condition'' with the phrase, ``complicated feeding 
problem.''
    [sbull] In Sec.  483.35, we also specify that a complicated feeding 
problem includes, but is not limited to, difficulty swallowing, 
recurrent lung aspirations, and tube or parenteral/IV feedings.
    [sbull] Also, in Sec.  483.35, we provide that a facility must base 
resident selection on the charge nurse's assessment and the resident's 
latest assessment and plan of care.
    [sbull] In Sec.  483.160(a), we are adding a requirement that the 
State-approved training course include a minimum of 8 hours of training 
covering the topics listed in Sec.  483.160(a).
    [sbull] In Sec.  483.160(c), we are removing the requirement that a 
facility report to the State all incidents of a paid feeding assistant 
who has been found to neglect or abuse a resident, or misappropriate a 
resident's property, and that a State must maintain a record of all 
reported incidents. This paragraph unnecessarily duplicates existing 
requirements in Sec.  488.335, Action on complaints of resident neglect 
and abuse, and misappropriation of resident property.

V. 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 OMB should approve an information 
collection, section 3506(c)(A) of the Paperwork Reduction Act of 1995 
requires that we solicit comment on the following issues:
    [sbull] The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    [sbull] The accuracy of our estimate of the information collection 
burden.
    [sbull] The quality, utility, and clarity of the information to be 
collected.
    [sbull] Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Nursing homes in two States currently use feeding assistants and 
eight other States have expressed an interest in implementing this 
policy. While public comments from nursing homes and provider 
organizations indicated strong support for the use of feeding 
assistants, only 13 States responded to the proposal. Some States 
indicated interest and others had concerns about the cost of 
implementation and other issues, so we do not now have a better idea of 
how many States will choose to approve the use of feeding assistants in 
nursing homes. In addition, it remains a facility option, so we still 
do not know how many facilities in which States will choose this 
option, nor do we know how many feeding assistants would be used by 
each facility. There are approximately 17,000 nursing homes in the 
nation, and they are not evenly distributed within States. Wisconsin 
reported that about 25 percent of nursing homes in the State used 
feeding assistants. On a nationwide basis, we believe that it is 
reasonable to project that 20 percent of facilities will use feeding 
assistants. We are soliciting public comment on each of these issues 
for the following sections of this document that contain information 
collection requirements:
    Section 483.160(b)
1. Requirement
    A facility must maintain a record of all individuals, used by the 
facility as feeding assistants, who have successfully completed the 
training course for paid feeding assistants.
2. Burden
    We estimate that 20 percent of nursing homes may implement this 
policy (20 percent of 17,000 = 3,400 facilities/respondents). If we 
assume that each facility will hire two feeding assistants, this 
results in a total of 6,800 feeding assistants. Depending on the method 
chosen by a facility to collect this information, we believe that each 
facility (respondent) would spend no more than 30 minutes per month (6 
hours per year) entering feeding assistant information into its record-

[[Page 55537]]

keeping system. Some months, facilities may have no information to add. 
With 3,400 facilities at 6 hours/year, the total would be 20,400 hours 
for facilities. Using a clerical wage cost of $10 per hour, the total 
facility burden is estimated to be $204,000.
    We are submitting a copy of regulation Sec.  483.160 to OMB for its 
review of the information collection requirements. The revision is not 
effective until OMB has approved it.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following addresses:

Centers for Medicare & Medicaid Services, Office of Information 
Services, Information Technology Investment Management Group, Attn.: 
Julie Brown, Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 
21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Brenda Aguilar, CMS Desk Officer.

    Comments submitted to OMB may also be emailed to the following address: email: baguilar@omb.eop.gov; or faxed to OMB at (202) 395-
6974.

VI. Regulatory Impact Statement

A. Overall Impact

    We have examined the impacts 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 the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This rule is 
not a major rule. The costs of using feeding assistants will be covered 
by existing Medicare payment and, most likely Medicaid payment, 
depending on how a State establishes payment rates. Skilled nursing 
facilities receive an all-inclusive per diem Medicare payment rate for 
each resident's care. This includes all costs (routine, ancillary, and 
capital) of covered skilled nursing facility services furnished to 
beneficiaries under Part A of the Medicare program. Skilled nursing 
facilities will not receive additional Medicare payment for the costs 
of using feeding assistants.
    Medicaid payments for nursing facilities are established by each 
State. Therefore, it would be up to individual States to determine 
whether they would need to change their payment rates for those 
facilities that use feeding assistants and how the rates would be 
changed. However, because feeding assistants will likely be paid at a 
minimum wage, which is less than the wage paid to certified nurse 
aides, facilities participating in Medicare and Medicaid that use 
feeding assistants may incur less cost than if they had hired 
additional certified nurse aides to perform feeding and hydration 
duties.
    State costs associated with feeding assistant training programs are 
considered administrative expenses and are funded under Medicaid with 
matching funds at 50 percent Federal financial participation. Any 
information we have on potential State costs of implementing feeding 
assistant programs comes from States that have used such programs in 
the past. One State, Wisconsin, has a well-structured program and has 
experienced relatively minimal costs. One registered nurse spends 
approximately 10 percent of her time reviewing and approving facility 
feeding assistant training programs. This represents 10 percent of a 
full-time equivalent position (FTE), which is reported by Wisconsin to 
be a cost of about $7,000 per year. At a time when the use of feeding 
assistants was highest, a quarter of Wisconsin's 420 nursing homes, or 
100 to 110 facilities, used feeding assistants. The number of feeding 
assistants used by each facility varies according to the size of the 
home, with the maximum number estimated to be 5 for a large, 200- to 
250-bed home. Feeding assistants are typically paid at the same minimum 
wage. The number of hours each feeding assistant works at a facility is 
also variable and different for each worker and facility. Further, some 
facilities use only existing staff as trained feeding assistants. 
Because of the number of hours worked by each feeding assistant is 
variable, we do not have an exact estimate of the total cost to 
Wisconsin for using feeding assistants. However, this summary of 
Wisconsin's program may be helpful to other States, which are 
interested in establishing feeding assistant programs.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small government 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$6 to $29 million in any 1 year. For purposes of the RFA, all long-term 
care facilities are considered to be small entities. Individuals and 
States are not included in the definition of a small entity. The Small 
Business Administration considers 62 percent of long term care 
facilities to meet their definition of small entity (those facilities 
with total revenues of $11.5 million or less in any 1 year. We have 
determined that this rule will affect these entities, but, in general, 
we expect any cost to be covered by Medicare and Medicaid program 
payments.
    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. This final rule does not 
affect small rural hospitals.
    For these reasons, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act because we have determined 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.
    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 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. This final rule will not have a cost greater 
than $110 million on the governments mentioned or on the private 
sector. In general, we believe that existing Medicare and Medicaid 
payments will cover the facility costs of using feeding assistants. 
Costs associated with surveys of long term care facilities are 
Federally funded, as are costs of State approval of training programs.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has Federalism implications. We 
believe that this rule contributes to State flexibility by giving 
States the option to allow the use of feeding

[[Page 55538]]

assistants, control over how to structure the process of the approval 
of facility feeding assistant programs, and over elements of training, 
including instructor qualifications. In this way, States can establish 
policies that fit their unique circumstances. We believe that this rule 
will not have a substantial effect on State or local governments.

B. Anticipated Effects

    These provisions will affect long term care facilities. We expect 
the provisions to be a substantial benefit both to facilities that are 
short-staffed and to residents who need help with eating and drinking. 
By using feeding assistants to help residents with eating and drinking, 
facilities can use trained, certified nurse aides to perform other, 
more complex resident care tasks.
    Based on the large number of comments we received from nursing 
homes in a variety of States, we now believe that there is widespread 
support for the proposal and widespread intent to implement the 
provisions. However, because this is an optional provision, and some 
States may have legal barriers to implementation, we do not know how 
many States or facilities may implement these provisions, or how many 
feeding assistants will be used by facilities. Based on public 
comments, we anticipate that some facilities may hire no additional 
staff as feeding assistants, opting instead to use existing staff whose 
primary function is not direct care of residents, such as 
administrative or activities staff. We believe that feeding assistant 
training most likely will be conducted by existing facility staff and 
that there will be some nominal training costs to the facility since 
training requires time away from other duties that other staff may have 
to perform.
State-Approved Training Programs
    We require that a feeding assistant successfully complete an 8-hour 
State-approved training course, which meets the Federal requirements in 
Sec.  483.160(a). We have established no requirements on how States are 
to approve these programs, thereby giving each State the flexibility to 
decide what method makes the most sense in terms of use of its 
resources. There are several ways in which States may approach approval 
of training programs. States might choose to develop a model training 
program that complies with Federal requirements and require that any 
facility that trains and uses feeding assistants use that specific 
program. One model might be based on an existing training program 
already established, such as those conducted in Wisconsin or North 
Dakota. A State might choose to do a paper review of each facility's 
training program, or the State might insist on a site visit to review a 
facility's program. Lastly, a State might initially deem each 
facility's training program approved and then review the program when 
the facility is next surveyed. For some of these options, a State may 
need additional staff hours to review and approve training programs. 
However, States already review and approve training programs for nurse 
aides, so there is an existing administrative structure in place. There 
is the potential for increased State costs associated with review and 
approval of facility feeding assistant programs. However, any cost will 
depend on the approval method that is chosen by each State.
    1. Effects on the Medicare and Medicaid programs.
    There are approximately 17,000 facilities nationally. Long term 
care facilities that participate in the Medicare and Medicaid programs 
must provide the necessary care and services to residents so that they 
attain or maintain the highest practicable physical, mental, and 
psychosocial well being. To do this, facilities must employ sufficient 
staff on a 24-hour basis, including nursing staff, administrative, 
medically-related social services, dietary, housekeeping, and 
maintenance staff.
    The Medicare program pays for skilled nursing facility services to 
eligible beneficiaries through a prospective payment system that covers 
all costs of covered services furnished to residents on a per diem 
basis. This Medicare SNF PPS per diem payment rate is based, in part, 
on levels of care and resources required and received by residents. The 
payment rate covers all care required and received by a resident and 
does not require that tasks performed by a staff person fit within a 
direct or indirect care category. Therefore, the Medicare program would 
not pay a skilled nursing facility any additional funds if the facility 
chooses to use feeding assistants.
    Medicaid payments for nursing facilities are established by each 
State. Therefore, it would be up to individual States to determine 
whether they would need to change their payment rates for those 
facilities that use feeding assistants and how the rates would be 
changed.

C. Alternatives Considered

    There has been a continuing shortage of certified nurse aides in 
recent years, along with a shortage of RNs and LPNs willing to work in 
nursing homes. Certified nurse aides perform the majority of resident 
care in a long term care facility and are the lowest paid workers, 
while RNs and LPNs receive higher wages commensurate with their 
advanced training, experience, and supervisory responsibilities.
    One alterative to the use of paid feeding assistants is to broaden 
the hours during which meals are served so that everyone is not fed at 
the same time within a one-hour mealtime. Expanded meal service, 
covering perhaps a 3-hour mealtime, or a restaurant model, where meals 
are available most of the time, would allow existing staff more time to 
help feed residents. However, this option already exists in 
regulations, and other than a few innovative facilities, nursing homes 
have chosen not to use this method. The current preference of most 
nursing homes is for an institutional approach in which meals are 
served to all residents early morning, noon, and evening at fixed 
hours. As a result, the nursing home industry prefers the use of 
feeding assistants rather than an expanded meal service. The other 
alternative is not to publish a regulation on the use of feeding 
assistants and, instead, make greater use of volunteers to assist with 
feeding. The use of volunteers to assist with feeding assistance is 
permitted in the current regulations. However, it is questionable 
whether facilities could find sufficient numbers of volunteers to meet 
their needs.

D. Conclusion

    We believe that both residents and providers will benefit from 
these provisions. Residents will receive more assistance with eating 
and drinking, both at meals and at snack time. Facilities will be able 
to use existing staff to assist at mealtimes and hire additional staff 
to meet the needs of residents, freeing certified nurse aides to 
perform more complex tasks that require their training.
    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 483

    Grant programs-health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 488

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

[[Page 55539]]


0
For the reasons set forth in the preamble, CMS is amending 42 CFR 
chapter IV as set forth below:
0
A. Part 483 is amended as follows:

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

Subpart B--Requirements for 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. In Sec.  483.35, the introductory text is republished, paragraph (h) 
is redesignated as paragraph (i), and a new paragraph (h) is added to 
read as follows:


Sec.  483.35  Dietary services.

    The facility must provide each resident with a nourishing, 
palatable, well-balanced diet that meets the daily nutritional and 
special dietary needs of each resident.
* * * * *
    (h) Paid feeding assistants--(1) State-approved training course. A 
facility may use a paid feeding assistant, as defined in Sec.  488.301 
of this chapter, if--
    (i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec.  483.160 
before feeding residents; and
    (ii) The use of feeding assistants is consistent with State law.
    (2) Supervision. (i) A feeding assistant must work under the 
supervision of a registered nurse (RN) or licensed practical nurse 
(LPN).
    (ii) In an emergency, a feeding assistant must call a supervisory 
nurse for help on the resident call system.
    (3) Resident selection criteria.
    (i) A facility must ensure that a feeding assistant feeds only 
residents who have no complicated feeding problems.
    (ii) Complicated feeding problems include, but are not limited to, 
difficulty swallowing, recurrent lung aspirations, and tube or 
parenteral/IV feedings.
    (iii) The facility must base resident selection on the charge 
nurse's assessment and the resident's latest assessment and plan of 
care.
* * * * *


Sec.  483.7  [Amended]

0
3. Section 483.7 is amended as follows:
0
a. In paragraph (e)(1), the definition of ``Nurse aide'' is amended by 
adding a sentence to the end of the definition;
0
b. A new paragraph (q) is added.
    The additions read as follows:


Sec.  483.75  Administration.

* * * * *
    (e) * * * (1) * * *
    (1) * * * Nurse aides do not include those individuals who furnish 
services to residents only as paid feeding assistants as defined in 
Sec.  488.301 of this chapter.
* * * * *
    (q) Required training of feeding assistants. A facility must not 
use any individual working in the facility as a paid feeding assistant 
unless that individual has successfully completed a State-approved 
training program for feeding assistants, as specified in Sec.  483.160 
of this part.

Subpart D--Requirements That Must Be Met by States and State 
Agencies: Nurse Aide Training and Competency Evaluation; and Paid 
Feeding Assistants

0
4. The heading of subpart D is revised to read as set forth above.

0
5. A new Sec.  483.160 is added to read as follows:


Sec.  483.160  Requirements for training of paid feeding assistants.

    (a) Minimum training course contents. A State-approved training 
course for paid feeding assistants must include, at a minimum, 8 hours 
of training in the following:
    (1) Feeding techniques.
    (2) Assistance with feeding and hydration.
    (3) Communication and interpersonal skills.
    (4) Appropriate responses to resident behavior.
    (5) Safety and emergency procedures, including the Heimlich 
maneuver.
    (6) Infection control.
    (7) Resident rights.
    (8) Recognizing changes in residents that are inconsistent with 
their normal behavior and the importance of reporting those changes to 
the supervisory nurse.
    (b) Maintenance of records. A facility must maintain a record of 
all individuals, used by the facility as feeding assistants, who have 
successfully completed the training course for paid feeding assistants.

0
B. Part 488, subpart E is amended as follows:

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

Subpart E--Survey and Certification of Long Term Care Facilities

0
1. The authority citation for part 488 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1895hh).

0
2. Section 488.301 is amended by adding a new definition of ``Paid 
feeding assistant'' in alphabetical order to read as follows:


Sec.  488.301  Definitions.

    As used in this subpart--
* * * * *
    Paid feeding assistant means an individual who meets the 
requirements specified in Sec.  483.35(h)(2) of this chapter and who is 
paid to feed residents by a facility, or who is used under an 
arrangement with another agency or organization.
* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: May 22, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: June 24, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-24362 Filed 9-25-03; 8:45 am]

BILLING CODE 4120-03-U