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[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Rules and Regulations]
[Pages 38594-38606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15313]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 483

[CMS-3140-F]
RIN 0938-AP32

Medicare and Medicaid Programs; Requirements for Long Term Care 
Facilities; Hospice Services

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

ACTION: Final rule.

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SUMMARY: This final rule will revise the requirements that an 
institution will have to meet in order to qualify to participate as a 
skilled nursing facility (SNF) in the Medicare program, or as a nursing 
facility (NF) in the Medicaid program. These requirements will ensure 
that long-term care (LTC) facilities (that is, SNFs and NFs) that 
choose to arrange for the provision of hospice care through an 
agreement with one or more Medicare-certified hospice providers will 
have in place a written agreement with the hospice that specifies the 
roles and responsibilities of each entity. This final rule reflects the 
Centers for Medicare and Medicaid Services' (CMS') commitment to the 
principles of the President's Executive Order 13563, released on 
January 18, 2011, titled ``Improving Regulation and Regulatory 
Review.'' It will improve quality and consistency of care between 
hospices and LTC facilities in the provision of hospice care to LTC 
residents.

[[Page 38595]]

DATES: These regulations are effective on August 26, 2013.

FOR FURTHER INFORMATION CONTACT: Lisa Parker, (410) 786-4665.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Overview

    Sections 1819(b)(4)(A)(i) and 1919(b)(4)(A)(i) of the Social 
Security Act (the Act) state that, to the extent needed to fulfill all 
plans of care described in sections 1819(b)(2) and 1919(b)(2) of the 
Act, a skilled nursing facility (SNF) or nursing facility (NF) must 
provide, or arrange for the provision of, nursing and related services 
and specialized rehabilitative services to attain or maintain the 
highest practicable physical, mental, and psychosocial well-being of 
each resident. The Omnibus Budget Reconciliation Act (OBRA) of 1986 
permitted States to add a hospice benefit to their State Medicaid 
plans, and specified that such care could be provided to an individual 
while such individual was a resident of a SNF or intermediate care 
facility (Pub. L. 99-272 (1986), section 9505(a)(2)). Additionally, 
eligible residents of long-term care (LTC) facilities may elect to 
receive services under the Medicare hospice benefit.
    Medicare does not have a separate payment rate for routine hospice 
services provided in a nursing home. Because hospice services are 
typically provided to patients in their homes, the routine home care 
hospice rate does not include any payment for room or board. For 
routine home care services provided to patients in LTC facilities, 
hospices receive the Medicare routine home care rate, which is a fixed 
amount per day for the services provided by the hospice, regardless of 
the volume or intensity of the services provided. Accordingly, when the 
hospice patient resides in an LTC facility, the patient generally 
remains responsible for payment of the LTC facility's room and board 
charges. If, however, a patient receiving Medicare hospice benefits in 
an LTC facility is also eligible for Medicaid, Medicaid will pay the 
hospice at least 95 percent of the State's daily LTC facility rate, and 
the hospice is then responsible for paying the LTC facility for the 
beneficiary's room and board. The specific services included in the 
daily rate payment are determined by the State's Medicaid program and 
may vary from State to State. In addition to the room and board 
payment, a hospice may contract with the nursing home for the nursing 
home to provide non-core hospice services (that is, those services 
which the hospice is not required by law to provide itself) to its 
hospice patients.
    LTC facilities and hospices are required to provide many of the 
same services to residents who have elected to receive the hospice 
benefit. The LTC facility regulations clearly specify what services the 
facility is required to provide to residents. Those services include 
nursing services (including aide services), dietary services, physician 
services, dental services, pharmacy services, specialized 
rehabilitative services if appropriate, laboratory services, and social 
services. Similarly, if a resident chooses to elect the hospice 
benefit, hospice providers are required to provide many of the same 
services as the LTC facility. As required at 42 CFR 418.100(c), a 
hospice must provide certain specified care and services and must do so 
in a manner that is consistent with accepted standards of practice. 
Those services include nursing services (including aide services), 
medical social services, physician services, counseling services 
(spiritual, dietary, and bereavement), volunteer services, therapy 
services as appropriate, short-term inpatient care, and medical 
supplies.
    Due to so many of the same services being provided by both LTC 
facilities and hospice providers, there is a clear potential for 
residents to receive duplicative and/or conflicting services. The 
Department of Health and Human Services' Office of Inspector General 
(OIG) has recently raised a number of concerns about Medicare hospice 
care for nursing facility residents. OIG found that 31 percent of 
Medicare hospice beneficiaries resided in nursing facilities in 2006 
and that 82 percent of hospice claims for these beneficiaries did not 
meet Medicare coverage requirements. (OIG, Medicare Hospice Care: 
Services Provided to Beneficiaries Residing in Nursing Facilities, OEI-
02-06-00223, September 2009). Additionally, OIG reported that, unlike 
private homes, nursing facilities are staffed with professional 
caregivers and are often paid by third-party payers, such as Medicaid. 
These facilities are required to provide personal care services, which 
are similar to hospice aide services that are paid for under the 
hospice benefit. (OIG, Medicare Hospices that Focus on Nursing Facility 
Residents, OEI-02-10-00070, July 2011). To address this issue, we are 
establishing a requirement that will ensure LTC facilities that choose 
to arrange for the provision of hospice care through an agreement with 
one or more Medicare-certified hospice providers will have in place a 
written agreement with the hospice that will specify the roles and 
responsibilities of each entity. These clarifications will increase 
coordination of care for patients as well as help foster a stronger 
channel of communication between the two providers assisting patients 
and their families. We believe that a clear division of 
responsibilities and increased communication required by this rule will 
help eliminate duplication of and/or missing services.
    This final rule sets forth requirements consistent with 
requirements in the June 5, 2008 final rule (73 FR 32088) titled 
``Medicare and Medicaid Program: Hospice Conditions of Participation.'' 
The hospice care final rule set forth new requirements that a Medicare-
certified hospice provider must meet when it provides services, 
including the provision of hospice care to residents of an LTC facility 
who elect the hospice benefit. In regulations at 42 CFR 418.112(c), we 
specify what must be included in a written agreement between a 
Medicare-certified hospice provider and an LTC facility. In this final 
rule, we have made the requirements for LTC facilities consistent with 
the June 2008 final rule.
    This final rule also supports current LTC requirements that protect 
a resident's right to a dignified existence, self-determination, and 
communication with, and access to, persons and services inside and 
outside the facility.

B. Relevance to Existing Hospice Requirements

    Our intent in finalizing these requirements for LTC facilities is 
to ensure they are in accord with our existing requirements at Sec.  
418.112 for hospices that provide services to residents of LTC 
facilities. Our requirements for LTC facilities to have agreements with 
hospices and to collaborate and communicate with hospices to provide 
care for LTC facility residents largely parallels the language and 
intent of the hospice requirements. There are, however, instances where 
employing the same language will not reflect the distinct roles of each 
entity or where we believe it is important to provide clarity and 
detail without disturbing the substance or the proper interpretation of 
the requirements. In some instances, we are finalizing different 
requirements because we believe they are in the best interests of the 
residents of LTC facilities. For instance, we are requiring at Sec.  
483.75(t)(2)(ii)(E)(3) that the LTC facility notify the hospice about a 
need to transfer the resident from the facility for any condition. As a 
slight variation, the hospice is currently required at

[[Page 38596]]

Sec.  418.112(c)(2)(iii) to provide in an agreement with a SNF/NF or 
ICF/IID that the SNF/NF or ICF/IID will notify the hospice of a need to 
transfer a patient from the SNF/NF or ICF/IID, and the hospice makes 
arrangements for, and remains responsible for necessary continuous care 
or inpatient care related to the terminal illness and related 
conditions. While these provisions are similar, the hospice regulations 
also highlight the hospice's continued responsibility for care related 
to the terminal illness. We believe that these provisions, which are 
tailored to the unique needs and circumstances of each provider type, 
will promote higher quality of care and safety for the resident.
    The rationale for both of these rules is to require a written 
agreement between the hospice and the LTC facility, which will help 
ensure safe and quality care if provided to the residents. (See Sec.  
418.112 (c)(1) through (9) for hospice and Sec.  483.75(t)(2)(ii) (A) 
through (K) finalized in this rule for LTC facilities.) While the rules 
have slight differences in language, substantively, the requirements 
are the same. We believe it is appropriate for the remainder of the 
rule, including the coordination of care requirements at Sec.  
483.75(t)(3)(i) through (v) for LTC facilities and Sec.  418.112(e) for 
hospice, to reflect the difference in the roles between these two 
providers in delivering resident care. Therefore, we are finalizing 
requirements for communication and collaboration specific to the LTC 
facility that do not entirely mirror the language in the hospice 
requirements. Rather, the final rule for LTC facilities will complement 
the hospice requirements, and together, these rules will allow for 
better coordination of care and quality of care for LTC facility 
residents who elect to receive the hospice benefit.
    This final rule reflects the Centers for Medicare and Medicaid 
Services' (CMS') commitment to the principles of the President's 
Executive Order 13563, released on January 18, 2011, titled ``Improving 
Regulation and Regulatory Review.'' It will improve quality and 
consistency of care between hospices and LTC facilities in the 
provision of hospice care to LTC residents.

II. Provisions of the Proposed Rule and Response to Comments

    We published a proposed rule in the Federal Register on October 22, 
2010 (75 FR 65282). In that rule, we proposed to revise the 
requirements that an institution would have to meet in order to qualify 
to participate as a skilled nursing facility (SNF) in the Medicare 
program, or as a nursing facility (NF) in the Medicaid program.
    We provided a 60-day public comment period, during which we 
received approximately 30 timely comments from individuals, advocacy 
organizations, and industry associations. Summaries of the proposed 
provisions, as well as the public comments and our responses, are set 
forth below. We originally proposed the standard regarding LTC 
facility/Hospice cooperation at Sec.  483.75(r); however, during the 
process of finalizing this rule, CMS published a separate interim final 
rule, titled ``Requirements for Long-Term Care (LTC) Facilities; Notice 
of Facility Closure'' (76 FR 9503). The interim final rule added 
separate standards at Sec. Sec.  483.75(r) and (s). Since the 
designations (r) and (s) are now in use, we are finalizing this 
standard at Sec.  483.75(t). However, in this discussion, we will 
continue to refer to the proposed regulations text at Sec.  483.75(r).

Comments Regarding Possible Barrier Creation

    Notwithstanding our analysis that this rule and 2008 final hospice 
rule are complimentary and substantively similar, and in view of the 
slight differences between these rules, we requested public comment on 
whether the differences found in the proposed rule would create a 
barrier to forming agreements between LTC facilities and hospices, or 
interfere in coordination of residents' care between LTC facilities and 
hospices. We received a few comments regarding the differences between 
the two rules. Those comments and our response are set forth below.
    Comment: Several commenters had concerns that the proposed rule, as 
written, has the potential of creating a barrier to agreements between 
LTC facilities and hospice providers. Commenters noted that this 
requirement imposes responsibility and liability on the LTC facilities 
to make decisions regarding whether or not a hospice provider is 
meeting professional standards and principles. Those duties and 
responsibilities are the province of the State licensing agency and 
CMS, and should not be placed on LTC facilities.
    Response: The requirements in the final rule will ensure that LTC 
facilities that chose to arrange for the provision of hospice care 
through an agreement with one or more Medicare-certified hospice 
providers will have in place a written agreement with the hospice that 
specified the roles and responsibilities of each entity. If an LTC 
facility is establishing an agreement for the provision of services, 
the LTC facility should be monitoring the delivery of the services to a 
resident in order to assure that professional standards and principles 
are followed in the provision of the services within their facility. 
The LTC facility is responsible for assuring that services and care 
provided meet the assessed needs of each resident.

General Comments

    Comment: The majority of commenters support the rule. Several 
commenters stated that having a mandated set of written expectations 
between LTC facilities and hospice providers would help clarify 
specific responsibilities of each entity. The commenters also stated 
that clarifications will increase coordination of care for patients as 
well as help foster a stronger channel of communication between the two 
providers assisting patients and their families. With a clear division 
of responsibilities and increased communication, this rule will help 
eliminate duplication of and/or missing services.
    Response: We appreciate the support from the commenters on this 
proposal. We believe that having a consistent set of regulatory 
requirements that establish the expectations for both hospices (Sec.  
418.112(e)) and LTC facilities (Sec.  483.75(t)) will help both 
entities clarify their specific patient/resident-care roles and 
responsibilities. The regulatory clarity will also help to eliminate 
duplication of and/or missing services.
    Comment: One commenter suggested extending the deadline for the 
implementation of the rule to allow hospices and LTC facilities more 
time to develop agreements to be reached, reviewed, and signed along 
with training of LTC and hospice staff to be conducted.
    Response: The rule will be effective on August 26, 2013. We believe 
this is an adequate timeframe since hospices already have to meet this 
requirement.
    Comment: Several commenters suggested the final rule should include 
the creation of a liaison position. Commenters suggested the on-staff, 
clinically trained professional should serve as a point of contact and 
mediator collaborating directly with hospice and LTC facility staff 
members to coordinate effective patient care. Some commenters suggested 
that the point of contact person be on the LTC facility's staff, while 
other commenters suggested the position be filled by a member of the 
hospice staff. Commenters suggested that the liaison position should 
help to eliminate division of services and ensure that all appropriate 
medical care

[[Page 38597]]

safety precautions were being observed and provided.
    Response: We believe the requirement that we are finalizing, which 
designates a member of the LTC facility's interdisciplinary team as a 
point of contact who will directly collaborate with hospice to 
coordinate effective patient care sufficiently, addresses the 
commenter's suggestion. Likewise, current hospice regulations (Sec.  
418.112(e)(1)) require the designation of a person who is responsible 
for coordinating the care of the resident provided by the LTC facility 
and hospice staff.
    Comment: One commenter stated that SNFs and NFs should provide 
hospice services to residents in their facilities and there should be 
reimbursement for the care.
    Response: The current regulations do not prohibit an LTC facility 
from providing palliative care to its residents with its own staff. 
However, we do not have the statutory authority to modify LTC facility 
payments to include the full range of hospice services. In addition, in 
order to receive Medicare payment for hospice services, the hospice 
provider must meet Medicare hospice requirements, including the 
statutory requirement that a hospice be primarily engaged in providing 
the hospice care and services set out at section 1861(dd)(1) of the 
Act. Therefore, under the above statutory requirements an LTC facility 
could not receive Medicare hospice benefit payments because it is not 
primarily engaged in providing hospice services and does not meet the 
definition of a hospice. If a provider does not meet the definition of 
a ``hospice'' it cannot be Medicare-certified and therefore, cannot 
receive payment under the Medicare hospice benefit.
    Comment: One commenter mentioned that they disagreed with the 
increased responsibility that the proposed rule placed on LTC 
facilities. Another commenter suggested that the focus of the proposed 
rule was incorrect. Rather than the expense and additional regulation 
that the proposed rule would generate, the commenter would like each 
State to provide the guidance for facilities desiring to provide 
hospice services.
    Response: We do not believe that the written agreement and resident 
care requirements increase an LTC facility's responsibilities. An LTC 
facility's responsibilities for the care of its residents already exist 
in regulation at Sec.  483.25, which states that ``each resident must 
receive and the facility must provide the necessary care and services 
to attain or maintain the highest practicable physical, mental, and 
psychosocial well-being, in accordance with the comprehensive 
assessment and plan of care.'' The requirements of this final rule 
simply clarify the roles and responsibilities of LTC facilities when 
they choose to contract with hospices to serve their residents. For 
more than a decade, States have regulated the overlapping relationship 
between LTC facilities and hospice providers. As we explained in the 
proposed rule, there is clear and consistent evidence of a lack of care 
coordination and persistent ambiguities in care responsibilities when 
LTC residents are also hospice patients. Both a 2002 Department of 
Health and Human Services' (DHHS) Advisory Committee Report (http://regreform.hhs.gov/finalreport.htm) and a 2003 Hastings Center Report 
(True Ryndes, Linda Emanuel, The Hastings Center Report, Hastings-on-
Hudson: March/April 2003, page S45) addressed the need for more care 
coordination. We believe it is in the best interest of the patients to 
regulate this overlapping relationship in order to improve the safety 
and quality of care provided to LTC residents who receive hospice 
services. Information gathered from surveys in both LTC facilities and 
hospice providers has informed our policy making for this rule. 
Furthermore, as this regulation is a companion rule to the current 
hospice CoPs, the industry has voiced support for this rule because it 
clarifies the responsibilities of both providers.
    Comment: One commenter questioned how this rule affects hospice 
provision in other types of facilities in which an individual may 
reside (for example, Intermediate Care Facilities for Individuals with 
Intellectual Disabilities (ICFs/IID), formerly referred to as ICFs/MR). 
The commenter asked if the exclusion of other facilities, for example 
ICFs/IID, implies that a State could not provide the hospice benefit, 
or does it imply that a State has the option to provide hospice?
    Response: This regulation specifically clarifies the 
responsibilities of LTC facilities and hospice providers that choose to 
have in place a written agreement for hospice services. Therefore, the 
requirements in this rule will only apply to LTC facilities. However, 
we believe the commenters concerns regarding hospice services in ICFs/
IID are addressed in the current hospice regulations. Section 
418.112(c) ``Written agreement,'' sets forth the requirements for a 
written agreement between hospice and ICFs/IID. Since this regulation 
only affects LTC facilities we did not intend to imply anything 
regarding the State's ability to provide hospice services.

Notice of Availability of Hospice Services

    We proposed a new standard at Sec.  483.75(r), titled ``Hospice 
services.'' At Sec.  483.75(r)(1), we proposed that LTC facilities 
could either arrange for the provision of hospice services through an 
agreement with one or more Medicare-certified hospice providers or not 
arrange for such services and assist a resident in transferring to a 
facility that would arrange for the provision of these services when 
the resident requested such a transfer.
    Comment: Some commenters believed LTC facilities should be required 
to provide notice to residents upon admission as to whether hospice 
care will be available at the facility along with the names of the 
Medicare-certified hospice providers with which the facility has 
agreements. Additionally, commenters suggested that LTC facilities 
should also be required to give notice to their residents should 
substantial changes occur regarding their agreements with Medicare-
certified hospice programs. If the facility has no agreement for the 
provision of hospice care, commenters suggested that the admission 
notice should explain to the resident that hospice care is not 
available at the facility and include information regarding the 
facility's responsibility to assist with transfer should the resident 
become terminally ill and wish to elect the hospice benefit.
    Response: We agree with the commenters that notifying residents of 
services that an LTC facility provides is important. However, we 
believe that the current requirements at Sec.  483.10(b)(6) 
sufficiently address this issue. Section 483.10(b)(6) currently 
requires an LTC facility to inform each resident before, or at the time 
of admission, and periodically during the resident's stay, of all 
services available in the facility. From past experience with LTC 
facilities, we would assume that information regarding available 
hospice services would be discussed at the time in which the resident 
wishes to utilize the hospice benefit.
    Additionally, while it is uncommon for residents to enter an LTC 
facility and have need of hospice services right away, it can sometimes 
occur. A resident transferring into an LTC facility with the intention 
of using his or her hospice benefit right away is more than likely 
either being discharged from a hospital, or already receiving hospice 
care at home and in need of care in an LTC facility because the 
caregiver can no longer meet the individual's

[[Page 38598]]

custodial care needs. In the event that the resident is being 
discharged from a hospital and entering an LTC facility opting to use 
their hospice benefit, the hospital would be responsible for developing 
an appropriate discharge care plan to an LTC facility that provides 
hospice services. If the resident is already receiving hospice services 
at home and chooses to move to an LTC facility, the hospice, through 
its medical social services, would assist the individual and family in 
selecting an appropriate LTC facility with a hospice agreement.

Timeliness of Service

    At Sec.  483.75(r)(2)(i) and (ii), we proposed specific 
requirements for LTC facilities choosing to have hospice care provided 
by a Medicare-certified hospice in their facility. The LTC facility 
would be required to ensure that the hospice services met professional 
standards and principles that would apply to individuals providing 
services in the facility, and the timeliness of the services. We also 
proposed requiring that, before any hospice care was provided to a 
facility resident, a written agreement would have to be signed by both 
an individual authorized by the hospice administration and an 
individual authorized by the LTC facility administration.
    Comment: Seven commenters recommended that we clarify the meaning 
of ``timeliness of services.'' Commenters also suggested that the 
interdisciplinary team be responsible for ensuring that the hospice 
provider is meeting the requirements. Another commenter suggested that 
the proposed requirement was duplicative of existing conditions of 
participation (CoPs) for LTC facilities and should be deleted from the 
final rule.
    Response: The term, ``timeliness of services'' means that the LTC 
facility will be required to ensure that the Medicare-certified hospice 
will provide services to the resident in a way that meets their needs 
in a timely manner, for example, by increasing the resident's pain 
medication to ensure an optimal comfort level. We anticipate that LTC 
facilities will address timeliness of services in their agreements with 
hospices, based on resident needs. Although the existing LTC facility 
standard at Sec.  483.75(h)(2)(ii) requires the facility to assure the 
timeliness of the current services that an LTC facility provides, this 
provision does not specifically apply to the content of written 
agreements for hospice services. Therefore, the requirement at Sec.  
483.75(t)(2)(i) is not duplicative. We are finalizing the language as 
proposed.

Services and Responsibilities of Hospice Plan of Care

    We proposed under Sec.  483.75(r)(2)(ii)(A) through Sec.  
483.75(r)(2)(ii)(D) that the written agreement include, at least, 
descriptions of the services the hospice will provide; the hospice's 
responsibilities for determining the appropriate hospice plan of care 
as specified in Sec.  418.112(d); the services the LTC facility would 
continue to provide, based on each resident's care plan; and a 
communication process, including how the communication will be 
documented between the LTC facility and the hospice provider, to ensure 
that the needs of the resident were addressed and met 24 hours per day.
    Comment: One commenter suggested that it would be helpful if there 
was a standardized communication form that hospice providers and LTC 
facilities could use to inform each other of new orders and changes, 
and if it indicated whether or not the primary physician and family 
member had been notified. Another commenter suggested that the facility 
document family engagement, consent, acknowledgement of an agreement 
with the patient's care plan, and any changes requested by the patient 
or their family in the patient's medical record. This would assist the 
family and the caregivers in identifying when there was a deviation 
from the plan of care.
    Response: The written agreements between the hospice and the LTC 
facilities require communication between the two entities regarding the 
provision of care to the resident receiving hospice services. The LTC 
facility and hospice must collaborate on how they will communicate 
information regarding the resident's care and staff must be aware of 
the system and/or form for communication that will be used. The 
development of a system and/or form for communication is the 
responsibility of the hospice and LTC facility. Additionally, we 
believe that the commenter's suggestion regarding documentation in the 
resident's medical record is sufficiently addressed at Sec.  
483.75(l)(5). That requirement sets forth the information LTC facility 
clinical records must contain.
    Comment: One commenter suggested that CMS update the instructions 
used by the State Agencies responsible for LTC facility survey and 
certification to ensure that sufficient emphasis is placed on surveyor 
review of a facility's clinical and administrative documentation. The 
commenter stated that this update would assure proper communication 
between all caregivers, regardless of their employer, and that issues 
of concern expressed in that documentation would be appropriately 
addressed by the LTC facility and other providers serving the 
facility's residents.
    Response: We appreciate the commenter's suggestion regarding 
updates for surveyors. We expect shortly after the publication of the 
rule that updates to the State Operations Manual (SOM), which among 
other things provides interpretive guidelines for our surveyors, will 
be made regarding the new requirements. The instructions to surveyors 
for reviewing the care of a resident receiving hospice services are 
found in the interpretive guidelines for Sec.  483.25, ``Quality of 
Care.'' (TAG F309 in Appendix PP of the SOM). This guidance 
provides instruction for the surveyor for the review and observation of 
the delivery of care, and for the review of the collaboration of the 
services between the hospice and the nursing home, including the 
coordination of care, the plan of care and the communication between 
the two entities.

Notifying Hospice of Change in Patient Status

    Under Sec.  483.75(r)(2)(ii), we proposed the inclusion of other 
duties and responsibilities that must be delineated by the LTC facility 
and the hospice in their written agreement. Under Sec.  
483.75(r)(2)(ii)(E), we proposed that the agreement contain a provision 
that the LTC facility notify the hospice provider immediately regarding 
a significant change in the resident's physical, mental, social, or 
emotional status, any clinical complication(s) that suggests a need to 
alter the plan of care, a condition unrelated to the terminal condition 
that might require transfer of the resident from the facility, or the 
resident's death.
    Comment: A few commenters stated that hospice providers should be 
notified of any transfer of a resident receiving hospice services, 
regardless of whether it was related to the terminal illness or not. 
Therefore, commenters suggested amending the rule to read, ``a need to 
transfer the resident from the facility for any condition.''
    Response: We agree with the commenters and have revised the 
regulation at Sec.  483.75(t)(2)(ii)(E)(3) to remove the phrase ``that 
is not related to the terminal condition'' in order to clarify that the 
LTC facility immediately notifies the hospice regarding a need to 
transfer the resident from the facility for any condition.

[[Page 38599]]

Appropriate Level of Hospice Services

    We proposed at Sec.  483.75(r)(2)(ii)(F) that the hospice assume 
responsibility for determining the appropriate course of hospice care, 
including the determination to change the level of services provided.
    Comment: One commenter stated that there was often disagreement 
between hospice staff and LTC facility staff due to hospice providers 
changing orders unrelated to the terminal diagnosis and/or palliative 
care. In addition, the commenter stated that hospice providers did not 
always provide rationale for changed orders. Another commenter 
expressed difficulty receiving information from local hospice providers 
in a timely manner; therefore, the commenter thought that this 
requirement would be difficult to fulfill.
    Response: In accordance with the hospice regulations at Sec.  
418.112(c)(3), the hospice is responsible for establishing and updating 
the hospice plan of care, which encompasses all issues related to the 
terminal illness and all related conditions. We encourage LTC 
facilities and hospices to establish procedures for communicating 
patient care between both providers, more specifically to determine 
which provider is responsible for the care planning. For example, both 
hospice staff and LTC facility staff need to be aware of conditions 
related to the resident's terminal illness, which are handled under the 
hospice's care planning. Additionally, they need to be aware of 
conditions not related to the resident's terminal illness, which are 
handled under the LTC facility's care planning. Effective communication 
among both LTC facilities and hospices is, we believe, the most 
appropriate way for both providers to address this issue. The 
regulations for the written agreements for the hospice regulations at 
Sec.  418.112(c)(1) and the LTC facility regulations at Sec.  
483.75(t)(2)(ii)(D) require both entities to establish, in writing, the 
manner in which they are to communicate with one another, and the 
method(s) that will be used to document such communications.

Continuation of Appropriate Resident's Needs

    We proposed at Sec.  483.75(r)(2)(ii)(G) that the LTC facility must 
continue to provide 24-hour room and board care, meet the resident's 
personal care and nursing needs in coordination with the hospice 
representative, and ensure that the level of care provided is 
appropriate based on the individual resident's needs.
    Comment: A commenter stated that most hospice care, whether in the 
home or in an LTC facility, is provided at the routine level of care. 
If an LTC resident elects the Medicare hospice benefit and is receiving 
a routine level of care, Medicare does not pay for the resident's room 
and board. This billing caveat frequently creates a great deal of 
confusion for Medicare beneficiaries and their families. One commenter 
suggested that before the start of hospice care in the LTC facility and 
the consequent financial liability of the Medicare beneficiary for the 
cost of the room and board, the LTC facility should be required by 
regulation to provide notice to the beneficiary clearly explaining the 
liability for room and board and the estimated cost of that liability.
    Response: At Sec.  418.52(c)(7) of the hospice CoPs, hospice 
providers are required to ensure that residents receive information 
about the services covered under the hospice benefit. Likewise, Sec.  
483.10(b)(6) of the LTC facility regulations, require LTC facilities to 
inform each resident before, or at the time of admission, and 
periodically during the resident's stay, of services available in the 
facility and of charges for those services, including any charges for 
services not covered under Medicare or by the facility's per diem rate. 
Therefore, we believe that the current LTC and hospice regulations 
address the concerns of the comments.

Additional Hospice Responsibilities

    At Sec.  483.75(r)(2)(ii)(H), we proposed that the written 
agreement include a delineation of additional hospice responsibilities, 
which would include, but not be limited to, providing medical direction 
and management of the patient; nursing; counseling (including 
spiritual, dietary, and bereavement); social work; and the provision of 
medical supplies, durable medical equipment, and drugs necessary for 
the palliation of pain and symptoms associated with the terminal 
illness and related conditions. In addition, the written agreement 
would delineate all other hospice services that would be necessary for 
the care of the resident's terminal illness and related conditions.
    Comment: Several commenters had concerns with the lack of clarity 
as to whether the LTC facility or the hospice provider would take the 
lead as the primary decision maker. Two commenters suggested that the 
attending physician maintain oversight of care of the resident and 
ensure that the care providers are in compliance with the documented 
plan in the patient's medical record. One commenter also stated that 
the hospice medical director should serve as a consultant and advisor 
to correct problems with the delivery of hospice services by LTC 
facility personnel. Another commenter suggested that only one physician 
should approve or disapprove all documented orders for patient care and 
that doctor must be credentialed in the LTC facility.
    Response: There is no Federal regulation precluding the LTC staff 
from taking orders for care from the hospice physician regarding a 
resident's terminal illness and related condition. The written 
agreement should identify how the LTC staff communicate and receive 
orders from the hospice physician in relation to the terminal care.
    The hospice regulations at Sec.  418.112(c)(3) through Sec.  
418.112(c)(7) describe the role of the hospice in caring for an LTC 
resident. The hospice is responsible for all decisions related to the 
care provided for the terminal illness and related conditions. The LTC 
facility maintains responsibility for all other care decisions. In 
accordance with the requirements at Sec.  418.56(c)(2), hospices are 
responsible for communicating with the patient/resident, family 
members, and attending physician at all points during the decision-
making process to develop and update the content of the hospice plan of 
care. The hospice medical director, as the individual responsible for 
the medical component of the hospice's patient care program, is 
available to provide expertise in all necessary cases.
    In addition, hospices are required to provide physician services 
(Sec.  418.64(a)) in conjunction with the patient's attending physician 
to manage the patient's hospice care and to provide additional non-
hospice physician services when the patient's attending physician is 
not available. Therefore, we believe care coordination is explicit in 
the regulation.
    Comment: One commenter suggested that the reference to ``all other 
hospice services that are necessary . . .'' in Sec.  
483.75(r)(2)(ii)(H) of the proposed rule should be elaborated to 
include `home health aide/nursing assistant services and therapy.' The 
commenter noted that these services have posed the biggest challenges 
regarding determination of responsibility. For example when the hospice 
plan of care has included placement of a home health aide/nursing 
assistant in the facility, the entities have been confused regarding 
their obligations for personal care.
    Response: We understand the commenter's concern with the 
abbreviated list not including all

[[Page 38600]]

possible services that the hospice would provide. We do not view those 
services not listed as less important, however, the list of services 
provided is an abbreviated list; we did not intend it to be all-
inclusive. Hospice is responsible for providing all hospice services 
including the provision of hospice aide services, if these services are 
determined necessary by the Interdisciplinary Group (IDG) to supplement 
the nurse aide services provided by the facility. In entering into a 
written agreement with each other, each provider clearly delineates 
responsibilities for the quality and appropriateness of the care it 
provides in accordance with their respective laws and regulations. Both 
providers must comply with their applicable conditions or requirements 
for participation in the Medicare and/or Medicaid programs. The 
facility's services must be consistent with the plan of care developed 
in coordination with the hospice, and the facility must offer the same 
services to its residents who have elected the hospice benefit as it 
furnishes to its residents who have not elected the hospice benefit. 
Therefore, the hospice patient residing in a facility should not 
experience any lack of services or personal care because of his or her 
status as a hospice patient.

Administration of Prescribed Therapies

    We proposed at Sec.  483.75(r)(2)(ii)(I) that the agreement include 
a provision that the hospice may use LTC facility personnel, where 
permitted by State law and as specified by the LTC facility, to assist 
in the administration of prescribed therapies included in the hospice 
plan of care. We did not receive any comments on this proposal. 
Therefore, we are adopting it in this final rule without change.

Abuse

    We proposed at Sec.  483.75(r)(2)(ii)(J) that the written agreement 
contain a provision that the LTC facility report all alleged violations 
involving mistreatment, neglect, or verbal, mental, sexual, and 
physical abuse, including injuries of unknown source, and 
misappropriation of patient property by hospice personnel, to the 
hospice administrator immediately when the LTC facility becomes aware 
of the alleged violation.
    Comment: One commenter believed that the proposed rule lacked 
direction in reporting alleged abuse and what the LTC facility's 
liability would be if the situation was not corrected and documented 
within the patient's records. The commenter suggested that the final 
rule require that a resolution process be documented in the patient's 
care plan, enabling those who are accountable for the care of the 
patient to be aware of their roles and responsibilities as well as 
increasing patient safety and improving quality of care.
    Response: The written agreement specifies that the LTC facility 
must report alleged violations by hospice personnel to the hospice 
administrator immediately when the LTC facility becomes aware of the 
alleged violation. This is to assure that the hospice administrator is 
not only aware of the alleged violation, but also begins an 
investigation as required in the hospice CoPs at Sec.  418.52(b)(4). We 
disagree with the commenter's suggestion regarding reporting alleged 
abuse in the resident's plan of care. The plan of care is a treatment 
plan that is developed according to the needs of the residents upon 
admission. Changes to the plan of care are made according to changes in 
the resident's condition and treatment needs. Moreover, the LTC 
facility must follow our regulations at Sec.  483.13(c), ``Staff 
Treatment of Residents,'' which require the facility to protect its 
residents from abuse; to identify, investigate, and report any alleged 
violations; and to take appropriate corrective action. Additionally, 
Sec.  483.13(c) currently includes requirements for abuse 
documentation; therefore it would be duplicative to include an 
additional requirement in this final rule.

Bereavement Services

    We proposed at Sec.  483.75(r)(2)(ii)(K) that the agreement also 
include a delineation of the responsibilities of the hospice and the 
LTC facility to provide bereavement services to LTC facility staff.
    Comment: Several commenters had concerns with this requirement in 
the proposed rule. One commenter suggested that the requirement should 
be removed, stating that the hospice agency should not be held 
responsible for providing bereavement counseling for LTC facility 
staff. It was suggested instead that LTC facilities should be held 
responsible for providing bereavement counseling for their own staff 
members. A few commenters requested additional information to be added 
regarding the duration and location of the services and whether one-on-
one or group services would be acceptable. Additionally, commenters 
requested information clarifying which hospice would be responsible for 
providing the services in an LTC facility in the event that the 
facility contracts with more than one hospice for services.
    Response: We understand the concerns expressed by the commenter 
regarding the removal of the bereavement requirement for hospices. 
However, this requirement is consistent with hospice requirements at 
Sec.  418.112(c)(9) and changes to the hospice regulations are beyond 
the scope of this regulation. The agreement between the hospice and the 
LTC facility should detail how the services will be coordinated and 
provided by the hospice provider for the LTC staff. The bereavement 
services are based upon the relationship between the care provider and 
the hospice resident. The hospice and the LTC facility should 
collaborate and communicate in order to determine which LTC staff will 
benefit from the bereavement services. In the cases of several hospices 
offering services in a facility, the individual hospice and the 
facility, as noted above, should review and identify those LTC staff 
who will benefit from the bereavement services. This should be 
individualized based on the resident involved and the staff involvement 
in their care. The agreement will identify how this service will be 
implemented by the certified hospice. Since the proposed language 
reflects the requirement already in hospice CoPs, we are not making any 
changes to the current language. Rather, we believe it should stay 
consistent with the current hospice regulation at Sec.  418.112(c)(9).

Interdisciplinary Team Member

    At Sec.  483.75(r)(3)(i) through (v), we proposed that the LTC 
facility that arranges for the provision of hospice care under a 
written agreement designate a member of the facility's 
interdisciplinary team to be responsible for working with hospice 
representatives to coordinate care provided by the LTC facility and 
hospice staff to the resident. This individual must be responsible 
for--(1) Collaborating with hospice representatives and coordinating 
LTC facility staff participation in the hospice care planning process 
for those residents receiving these services; (2) communicating with 
hospice representatives and other healthcare providers participating in 
the provision of care for the terminal illness, related conditions, and 
other conditions to ensure quality of care for the patient and family; 
(3) ensuring that the LTC facility communicates with the hospice 
medical director, the patient's attending physician, and other 
physicians participating in the provision of care to the patient as 
needed to coordinate the hospice care of the hospice patient with the 
medical care provided by other

[[Page 38601]]

physicians; (4) obtaining pertinent information from the hospice 
including the most recent hospice plan of care specific to each 
patient; hospice election form; physician certification and 
recertification of the terminal illness specific to each patient; names 
and contact information for hospice personnel involved in hospice care 
of each patient; instructions on how to access the hospice's 24-hour 
on-call system; hospice medication information specific to each 
patient; and hospice physician and attending physician (if any) orders 
specific to each patient); and (5) ensuring that the LTC facility staff 
provides orientation in the policies and procedures of the facility, 
including patient rights, appropriate forms, and record keeping 
requirements, to hospice staff furnishing care to LTC residents.
    Comment: The majority of the commenters supported the requirement 
designating a member of the LTC facility's interdisciplinary team to be 
responsible for working with hospice representatives to facilitate the 
coordination of care. A few commenters however, were unsure if the 
designation of the facility's interdisciplinary team member required a 
specific person by name or designation of a specified staff position 
and/or discipline. One commenter suggested the final rule specify the 
LTC representative be someone with a clinical background, possibly a 
registered nurse (RN), as well as credentialed in the nursing facility.
    Response: We agree with commenters that the LTC representative 
should be an employee of the facility with a clinical background. 
However, we do not want to limit LTC facilities' clinical personnel 
options solely to a professional registered nurse. The responsibilities 
of the interdisciplinary team member could be fulfilled by other 
clinicians participating in the care of the resident. We believe that 
by limiting the interdisciplinary team member to only a registered 
nurse, staffing issues may arise in addition to the possibility of 
increasing burden on the facility. In light of the complex clinical 
needs of a resident who is in the terminal stages of life, we believe 
it would be beneficial for the interdisciplinary team member to have 
the ability to assess the resident or have access to someone that has 
the ability to assess the resident. We are not requiring the person 
assessing the resident to be on the LTC facility staff: for example, it 
could be the hospice RN that is required to be available 24 hours. 
Therefore, we have revised the regulation at Sec.  483.75(t)(3) to 
clarify that the LTC representative must have a clinical background, 
function within their State scope of practice act, and have the ability 
to assess the resident or have access to someone that has the skills 
and capabilities to assess the resident.
    Comment: One commenter requested additional information regarding 
how a hospice program can best incorporate the LTC interdisciplinary 
member into the IDG. This commenter also wanted to know if this 
requirement would mandate that the interdisciplinary member directly 
participate in the hospice IDG meetings.
    Response: In accordance with Sec.  418.56(d), the hospice 
interdisciplinary group is required to update the hospice plan of care 
no less frequently than every 15 calendar days. The hospice 
interdisciplinary group must include specified core members; however, 
it is not limited to those core members. Rather, it is our expectation 
that all licensed professionals who participate in a patient's care 
will give input to the interdisciplinary group (Sec.  418.62(b)). 
Furthermore, the hospice is required to have a system of communication 
that ensures the ongoing sharing of information with non-hospice 
providers that are caring for a patient (Sec.  418.56(e)(5)). Finally, 
the hospice is specifically required to designate an individual from 
each interdisciplinary group that is responsible for a patient that 
resides in an LTC facility to act as a communicator and coordinator 
with the LTC representatives. In addition, the LTC facility is 
specifically required to designate an individual to coordinate with the 
hospice representatives. The regulation doesn't stipulate that the 
facility staff coordinator directly participate in the hospice care 
planning meeting, but it does not preclude them from attending. The LTC 
facility and hospice must work out the arrangements on how needed 
information for care planning and the delivery of care and services 
will be coordinated and provided based upon the needs of the resident.
    Comment: One commenter has expressed concern with the requirement 
of the LTC facility interdisciplinary team member obtaining hospice 
medication information specific to each patient. An LTC pharmacy may 
experience difficulty with billing hospice medications to the correct 
payer without the appropriate notification by either the hospice 
provider or the LTC facility. This includes information as to whether 
the medication is ``related to'' the terminal illness, and the 
patient's insurance information. Because payment for medications not 
related to the terminal illness is the responsibility of the hospice 
patient or secondary payer, it is critical for the LTC pharmacy to have 
correct information. Generally, when an LTC facility resident elects 
hospice care, the LTC facility will typically have more information on 
the patient's secondary insurance coverage. Because the hospice 
provider may not know the pharmacy contact information for each 
resident, it is only logical that notification by the LTC facility to 
the pharmacy seems most appropriate. Having specific regulatory 
language that would make the LTC facility aware of this requirement is 
needed to avoid the potential for inappropriate billing. The commenter 
recommends that the LTC facility be responsible for obtaining 
medication information from the hospice, and that the notification be 
communicated among the hospice provider, the LTC facility, and the 
pharmacy within 1 business day of any admission, discharge or any 
change in the patient's medications or payer status.
    Response: We agree with the commenter that it is the responsibility 
of the LTC facility to obtain medication information from the hospice 
provider, and we believe that this concern has already been addressed 
in the regulations (see Sec.  483.75(t)(3)(iv)(F)). Further, Sec.  
483.75(t)(3)(iv) clarifies what information the designated member of 
the LTC facility's interdisciplinary team is responsible for obtaining 
from the hospice provider, including, medication information as set out 
at Sec.  483.75(t)(3)(iv)(F)). Also, we expect that the LTC facility's 
designated member of the interdisciplinary team would appropriately 
communicate medication information and would identify the payer source 
for a resident before a change in their medical condition.
    After carefully considering how resident information is 
communicated between the hospice and the LTC providers, we are making a 
change in the regulations text at Sec.  483.75(t)(3)(iii) regarding who 
is responsible for communicating with the hospice about, among other 
things, the resident's medication orders. We are replacing the phrase, 
``other physicians'' with ``other practitioners'' to encompass all 
other non-physician personnel such as an advanced practice registered 
nurse (APRN), licensed therapist, or pharmacist, in accordance with 
State law and scope of practice participating in the provision of care 
to the patient. We believe that this will address the commenter's 
concerns.
    Comment: The majority of commenters agreed with the requirement 
that the LTC facility provide a written overview for

[[Page 38602]]

orientation on the policies and procedures of the facility to hospice 
staff furnishing care to LTC residents. One commenter suggested that 
the information be standardized and readily available in electronic 
format throughout all facilities in order for hospice staff to have 
access to quick and concise training. Another commenter suggested the 
overview address high priority regulatory and care related issues 
including facility layout with a tour of the facility, abuse and/or 
neglect prohibition and reporting policies and procedures, fire safety, 
infection control, falls prevention, and internal communications 
processes. Another commenter suggested that the facility-based 
orientation overview should be reviewed and signed by hospice staff 
before provision of care and services to residents electing the hospice 
benefit. A commenter also suggested that a list of the services the 
facility would anticipate from the hospice would also help in focusing 
the orientation.
    Response: We appreciate the suggestion offered by the commenter 
regarding a standardized electronic format to facilitate training of 
hospice staff. This regulation does not preclude LTC facilities from 
using a standardized electronic format for their hospice orientation. 
Therefore, we believe that the proposed language at Sec.  
483.75(t)(3)(v) provides enough flexibility to LTC facilities that 
provide orientation to hospice providers on their policies and 
procedures. Although, we have not required all of the specific elements 
of an orientation, we expect that both the LTC facility and the hospice 
provider will ensure appropriate orientation, including an outline of 
services that the hospice will provide, before the provision of care.
    Comment: One commenter stated that cross orientation would increase 
the quality of patient care, therefore, it was suggested that language 
from the hospice regulation at Sec.  418.112 be added to the proposed 
rule to ensure that LTC staff furnishing care to hospice patients will 
also be oriented to the hospice procedures and policies.
    Response: The regulations for the written agreements between the 
LTC facility and a hospice provide for orientation from the perspective 
of each entity. The SNF/NF orientation is meant to address the overall 
facility environment including policies, rights, record keeping and 
forms requirements. The hospice regulations at Sec.  418.112(f) require 
hospices to assure that LTC facility staff are educated about the 
hospice philosophy, hospice policies and procedures, principles of 
death and dying, individual responses to death, hospice patient rights, 
and paperwork requirements. The orientation requirements, while 
separate regulations for both the LTC facility and Medicare Certified 
Hospice, should be a collaborative effort between the hospice and the 
LTC facility, to assure that the hospice employees provide services and 
care effectively in the LTC facility and that the hospice ensures that 
the LTC facility staff understands the basic philosophy and principles 
of hospice care. We believe that the requirement at Sec.  
483.75(t)(4)(v) is sufficient; therefore, we are finalizing this 
requirement as proposed.

Plan of Care

    At Sec.  483.75(r)(4), we proposed that each LTC facility providing 
hospice care under a written agreement ensure that each resident's 
written plan of care includes both the hospice plan of care and a 
description of the services furnished by the LTC facility to attain or 
maintain the resident's highest practicable physical, mental, and 
psychosocial well-being, as required at Sec.  483.20(k).
    Comment: Some commenters suggested that the regulation be changed 
to mirror the State Operations Manual (SOM) which states, ``Highest 
practicable physical, mental, and psychosocial well-being is defined as 
the highest possible level of functioning and well-being, limited by 
the individual's recognized pathology and normal aging process.''
    Response: We do not agree that this regulation should include the 
language that mirrors the definition in the SOM. The interpretive 
guidelines in the SOM are subject to more frequent informal changes 
based on the regulatory text of a final rule. Therefore, we will not 
change the language in the regulation.
    Comment: One commenter suggested deleting the requirement for LTC 
facilities to have the most recent hospice care plan in its possession. 
LTC facilities would not know when the hospice revised its care plan 
and would rely on hospice staff to provide the updated care plan. The 
LTC facility should not be held responsible for not having it in place. 
It should be the obligation and compliance requirement for hospice. 
Therefore, if hospice staff failed to provide the most current plan of 
care, the LTC facility would not be held responsible.
    Response: At Sec.  418.112(e)(3)(i) of the hospice regulations, 
hospices are required to provide the LTC facility with the most recent 
hospice plan of care for each patient. To ensure that all care 
providers are performing their duties in accordance with the most 
recent plan, it is appropriate to require the LTC facility to include 
the most recent plan of care in its files. If an LTC facility has 
reason to believe that the plan of care in its possession is out of 
date, it is incumbent upon the LTC facility to seek out the most recent 
information. The intent of this regulation is to ensure coordination of 
care between the hospice and LTC facility. We would expect, through 
this coordination that the LTC facility would always have the most 
current hospice plan of care.
    Comment: While the majority of the commenters supported the written 
agreement, some commenters had concerns about the lack of clear 
regulatory direction regarding the responsibilities of the LTC facility 
and the hospice provider and requested clarification regarding the 
requirement for two plans of care. There was concern that medical 
errors that could result from a requirement for two plans of care for 
patients electing to use the hospice benefit along with the subsequent 
increase in possible transitions and transfer. Commenters believed that 
dividing medical care duties and services between two facilities will 
open the door for medical malpractice and further the chances for 
neglect of health care and safety and continue to exacerbate the lack 
of coordination between hospice and LTC providers.
    Response: Having a written agreement that clearly delineates roles, 
responsibilities, expectations, and communication strategies should 
enhance, rather than impede, the coordination of care. This rule, when 
paired with the hospice regulatory requirements for written agreements, 
required services, and designated hospice representatives, will provide 
the overall structure for LTC-hospice relationships and written 
agreements. The hospice and LTC facility must collaborate to develop a 
coordinated plan of care for each patient that guides both providers. 
When a hospice patient is a resident of a facility, that patient's 
hospice plan of care must be established and maintained in consultation 
with representatives of the facility and the patient and/or family (to 
the extent possible). The hospice portion of the plan of care governs 
the actions of the hospice and describes the services that are needed 
to care for the patient. In addition, the coordinated plan of care must 
identify which provider (hospice or facility) is responsible for 
performing a specific service. The coordinated plan of care may be 
divided into two portions, one of which is maintained by the facility 
and the other by the hospice. The facility is required to update its

[[Page 38603]]

plan of care in accordance with any Federal, State or local laws and 
regulations governing the particular facility, just as hospices need to 
update their plans of care according to Sec.  418.56(d) of the CoPs. 
The hospice plan of care must specifically identify or delineate the 
provider responsible for each function, service, and intervention 
included in the plan of care. The providers must have a procedure that 
clearly outlines the chain of communication between the hospice and 
facility in the event a crisis or emergency develops, a change of 
condition occurs, and/or changes to the hospice portion of the plan of 
care are indicated.

III. Provisions of This Final Rule

    We are adopting the provisions of this final rule as proposed, with 
the following changes:
     We originally proposed the standard regarding LTC 
facility/Hospice cooperation at Sec.  483.75(r); however, during the 
process of finalizing this rule, CMS published a separate interim final 
rule, Requirements for Long-Term Care (LTC) Facilities; Notice of 
Facility Closure (76 FR 9503). The interim final rule added standards 
Sec.  483.75(r) and (s). Since the standards at Sec.  483.75(r) and (s) 
are now in use, we are finalizing this standard at Sec.  483.75(t).
     In consideration of public comments, we are making three 
substantive changes in this final rule. We have made a revision at 
483.75(t)(3) to clarify that the LTC representative must have a 
clinical background, function within their State scope of practice act, 
and have the ability to assess the resident or have access to someone 
that has the skills and capabilities to assess the resident. We have 
also made a revision to the requirement at Sec.  483.75(t)(3)(iii) 
removing the phrase ``other physicians'' and replacing it with ``other 
practitioners.'' Lastly, we have made a revision to the requirement at 
Sec.  483.75(t)(2)(ii)(E)(3) by removing the phrase ``that is not 
related to the terminal condition.''

Technical Correction

     We are finalizing the proposed technical correction which 
would fix an incorrect citation at Sec.  483.10(n). In Sec.  483.10(n), 
we are revising the reference ``Sec.  483.20(d)(2)(ii)'' to read 
``Sec.  483.20(k)(2)(ii).''
     We are also finalizing the proposed technical correction 
which would fix an incorrect citation at proposed Sec.  483.75(r)(4). 
In Sec.  483.75(t)(4), we are revising the reference ``483.20(k)'' to 
read ``483.25.''

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment 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.
    We solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    Proposed Sec.  483.75(r)(2)(ii) stated that if hospice care were to 
be provided in an LTC facility through an agreement with a Medicare-
certified hospice, the LTC facility would have to have a written 
agreement with the Medicare-certified hospice before care was furnished 
to any resident.
    An LTC facility will be required to have only one written agreement 
with each hospice that provides services in the facility. This final 
rule will not require an LTC facility to have an individual agreement 
with a hospice for each resident receiving hospice services. Therefore, 
the burden associated with this requirement is the time and effort 
necessary for an LTC facility to develop and finalize one written 
agreement. Initially, the development of an agreement will require 
staff time; however, it will also require additional staff time to 
coordinate the care between the hospice and the LTC facility.
    We estimate the number of hours to develop and finalize a written 
agreement to be approximately 5 hours the first year. The estimated 
burden associated with the first year is 80,695 hours or $5,512,275 for 
the 16,139 LTC facilities that would be affected by this rule. The 
current requirements at Sec.  483.75(h) ``Use of Outside Resources,'' 
requires a written agreement when contracting for outside services. 
Therefore, we expect that a facility will modify an existing agreement 
to make it specific to hospice services. Review and revision of an 
already existing agreement will be expected to take less time 
thereafter. We estimate that it will take 2 hours to review and revise 
the agreement annually. The estimated annual burden associated with 
each successive year after the first is 32,278 hours or $2,204,910. We 
have based our projections of the hourly cost on the rate for a staff 
lawyer at $68.31 an hour, which includes fringe benefits (estimated to 
be 25 percent of the salary). (Source: Bureau of Labor Statistics, 
Occupational Employment Statistics Survey.)
    Proposed Sec.  483.75(r)(2)(ii)(E)(1) through (4) stated that the 
LTC would have to notify the hospice immediately about--
     A significant change in the resident's physical, mental, 
social, or emotional status;
     Clinical complications that suggest a need to alter the 
plan of care;
     A need to transfer the resident from the facility for any 
condition that is not related to the terminal condition; or
     The resident's death.
    The burden associated with these requirements is the time and 
effort it will take the LTC facility to provide notification to the 
hospice. We estimate it will take approximately 5 minutes per 
notification. We anticipate that this will affect 16,139 LTC 
facilities. If each LTC facility makes one notification each month, the 
burden associated with this requirement is 16,139 annual burden hours 
and the cost will be $504,344 annually, based on an hourly rate of 
$31.25 for a blended salary of a registered nurse and licensed 
practical nurse that includes fringe benefits, since either 
practitioner could notify the hospice of stated changes. (Source: 
Bureau of Labor Statistics, Occupational Employment Statistics Survey).
    Proposed Sec.  483.75(r)(2)(ii)(J) stated that under the agreement, 
the LTC facility would be required to report all alleged violations 
involving mistreatment, neglect, or verbal, mental, sexual, and 
physical abuse, including injuries of unknown source, and 
misappropriation of patient property by hospice personnel to the 
hospice administrator immediately when the LTC facility becomes aware 
of the alleged violation. The burden associated with this requirement 
is the time and effort it will take the LTC facility to report this 
information to the hospice administrator. We estimate it will take 
approximately 10 minutes per incident. We anticipate that this will 
affect 16,139 LTC facilities. If each LTC facility made one report per 
month, the burden associated with this requirement will be

[[Page 38604]]

32,278 annual burden hours and the cost would be $1,032,895 annually 
based on an hourly rate of $32 for a registered nurse that includes 
fringe benefits. (Source: Bureau of Labor Statistics, Occupational 
Employment Statistics Survey.)

                                                   Estimated Annual Reporting and Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           Hourly       Total
                                                                                 Burden per     Total    labor cost  labor cost     Total
      Regulation section(s)         OMB control No.     Respondents   Responses   response     annual        of          of        capital/   Total cost
                                                                                   (hours)     burden     reporting   reporting  maintenance      ($)
                                                                                               (hours)       ($)         ($)      costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   483.75(r)(2)(ii).........  0938--New..........        16,139      16,139           5    * 80,695       68.31   5,512,275            0   5,512,275
                                                             16,139      16,139           2   ** 32,278       68.31   2,204,910            0   2,204,910
Sec.   483.75(r)(2)(ii)(E)(1-4).  0938--New..........        16,139     193,668      .08333      16,139       31.25     504,344            0     504,344
Sec.   483.75(r)(2)(ii)(J)......  0938--New..........        16,139     193,668      .16666      32,278       32.00   1,032,895            0   1,032,895
                                 -----------------------------------------------------------------------------------------------------------------------
    Total.......................  ...................        16,139     209,807  ..........     161,390  ..........  ..........  ...........   9,254,424
--------------------------------------------------------------------------------------------------------------------------------------------------------
* One time burden estimate for initial development of written agreement.
** Annual burden estimate associated with updating existing written agreements.

    The comments we received on this proposal and our responses are set 
forth below.
    Comment: A few commenters expressed concern about this rule 
creating additional administrative burden. One commenter was concerned 
that if the contracting process became too burdensome it could reduce 
beneficiary access to the critical services being requested.
    Response: The burden associated with this requirement is the time 
and effort necessary to develop, draft, sign, and maintain the written 
agreement. The hospice regulations at Sec.  418.112 require hospices 
that provide services to LTC residents to have written agreements with 
LTC facilities. Furthermore, the regulations at Sec.  418.112 require 
those written agreements to include specific provisions that are 
equivalent to the specific provisions that were proposed for LTC 
facilities. This requirement has been in place for hospices since 
December, 2008. Therefore, LTC facilities that currently have 
relationships with hospice providers should already have these written 
agreements in place. In addition, we believe the use of this type of 
written agreement is a usual and customary business practice, and 
therefore will not create additional burden on the facility.
    Comment: Other commenters stated that the rule would save money by 
preventing double billing of services provided to the patients.
    Response: We appreciate the support from commenters who recognized 
that this rule may save money by preventing double billing of services 
to the patients.
    If you have comments on the reporting, recordkeeping or third-party 
disclosure requirements contained in this final rule, please submit 
your comments to the Office of Information and Regulatory Affairs, 
Office of Management and Budget,
    Attention: CMS Desk Officer, [CMS-3140-F]
    Fax: (202) 395-6974; or
    Email: OIRA_submission@omb.eop.gov.

V. Regulatory Impact Analysis

A. Statement of Need

    This final rule will revise the requirements that an institution 
will have to meet in order to qualify to participate as a SNF in the 
Medicare program, or as an NF in the Medicaid program. These 
requirements will ensure that LTC facilities that choose to arrange for 
the provision of hospice care through an agreement with one or more 
Medicare-certified hospice providers will have in place a written 
agreement with the hospice that specified the roles and 
responsibilities of each entity.
    Additionally, this rule will ensure that the duties and 
responsibilities of a hospice are clearly articulated if the hospice 
provides care in an LTC facility. Therefore, in order to ensure that 
quality hospice care is provided to LTC residents, we believe it is 
essential to add these requirements to the LTC regulations.

B. Overall Impact

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2).
    Executive Orders 12866 and 13563 direct 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 does not qualify as a major rule as the estimated economic 
impact is $7,049,515 the first year and $3,742,150, thereafter.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that the 
great majority of hospitals and most other health care providers and 
suppliers are small entities, either by being nonprofit organizations 
or by meeting the SBA definition of a small business (having revenues 
of less than $7.0 million to $34.5 million in any 1 year). For purposes 
of the RFA, the majority of hospitals, LTC facilities and hospices are 
considered to be small entities. Individuals and States are not 
included in the definition of a small entity. A rule has a significant 
economic impact on the small entities if it significantly affects their 
total costs or revenues. Under statute, we are required to assess the 
compliance burden the regulation will impose on small entities. 
Generally, we analyze the burden in terms of the impact it will have on 
entities' costs if these are identifiable or revenues. As a matter of 
sound analytic methodology, to the extent that data are available, we 
attempt to stratify entities by major operating characteristics such as 
size and geographic location. If the average annual impact on small 
entities is 3 to 5 percent or more, it is to be considered

[[Page 38605]]

significant. We estimate that these requirements will cost $437 
($7,049,515/16,139 facilities) per facility initially and $232 
($3,742,150/16,139 facilities) thereafter. This clearly is much below 1 
percent; therefore, we do not anticipate it to have a significant 
impact. We do not have any data related to the number of LTC facilities 
contracting hospice care through an outside hospice provider; however, 
we are aware through annual surveys that not all LTC facilities arrange 
for the provision of hospice care.
    In addition, section 1102(b) of the Social Security 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 the 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 
rule will impact only LTC facilities. Therefore, the Secretary has 
determined that this proposed rule will not have any impact on the 
operations of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2011, that 
threshold is approximately $136 million. This rule will not have a 
significant impact on the governments mentioned or on private sector 
costs. The estimated economic effect of this rule is $7,049,515 the 
first year and $3,742,150 thereafter. These estimates are derived from 
our analysis of burden associated with these requirements in section 
III, ``Collection of Information Requirements.''
    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. This rule will not have any effect on State or local 
governments.

C. Anticipated Effects

1. Effects on LTC Facilities
    The purpose of this rule is to ensure the coordination of care for 
LTC facility residents who elect hospice services. The coordination of 
care is anticipated to result in better outcomes related to quality of 
care and quality of life for residents. With appropriate coordination 
of care, we anticipate improved outcomes through more efficient 
coordination of care between the LTC facility staff and hospice staff, 
a decrease in duplication of services provided, and improved resident 
care.
2. Effects on Other Providers
    We expect improved consistency in the provision of services to 
residents receiving hospice care in an LTC facility. We anticipate that 
primarily LTC facilities and Medicare-certified hospice providers will 
be affected, as this rule will be expected to improve coordination of 
care between LTC facilities and Medicare-certified hospice providers. 
In instances where a patient is transferred to the hospital for care 
unrelated to their terminal illness, the hospital should be notified 
that the patient has elected hospice care.

D. Alternatives Considered

    We considered the effects of not addressing specific requirements 
for the provision of hospice care in LTC facilities. However, we 
believe that to improve quality and ensure consistency in the provision 
of hospice services in LTC facilities, it is important to delineate 
clear responsibilities for Medicare-certified hospice providers and LTC 
facilities. We expect that these requirements will result in 
improvement in the quality of care provided to LTC residents receiving 
hospice services.

E. Conclusion

    This rule sets out an LTC facility's responsibilities for 
developing a written agreement with a hospice if a resident elects to 
receive hospice care. This rule also clarifies the responsibility of 
the facility that chooses not to arrange for the provision of hospice 
services at the facility through an agreement with a Medicare-certified 
hospice. These facilities must assist the resident in transferring to a 
facility that will arrange for the provision of hospice services when a 
resident requests a transfer.
    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.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR part 483 as set forth below:

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

0
1. The authority citation for part 483 continues to read as follows:

    Authority:  Secs. 1102, 11281, and 1871 of the Social Security 
Act (42 U.S.C. 1302 and 1395hh).

Subpart B--Requirements for Long Term Care Facilities

Sec.  483.10  [Amended]

0
2. In Sec.  483.10(n), the reference ``Sec.  483.20(d)(2)(ii)'' is 
revised to read ``Sec.  483.20(k)(2)(ii)''.

0
3. Section 483.75 is amended by adding paragraph (t) to read as 
follows:

Sec.  483.75  Administration.

* * * * *
    (t) Hospice services. (1) A long-term care (LTC) facility may do 
either of the following:
    (i) Arrange for the provision of hospice services through an 
agreement with one or more Medicare-certified hospices.
    (ii) Not arrange for the provision of hospice services at the 
facility through an agreement with a Medicare-certified hospice and 
assist the resident in transferring to a facility that will arrange for 
the provision of hospice services when a resident requests a transfer.
    (2) If hospice care is furnished in an LTC facility through an 
agreement as specified in paragraph (t)(1)(i) of this section with a 
hospice, the LTC facility must meet the following requirements:
    (i) Ensure that the hospice services meet professional standards 
and principles that apply to individuals providing services in the 
facility, and to the timeliness of the services.
    (ii) Have a written agreement with the hospice that is signed by an 
authorized representative of the hospice and an authorized 
representative of the LTC facility before hospice care is furnished to 
any resident. The written agreement must set out at least the 
following:
    (A) The services the hospice will provide.
    (B) The hospice's responsibilities for determining the appropriate 
hospice plan of care as specified in Sec.  418.112 (d) of this chapter.
    (C) The services the LTC facility will continue to provide, based 
on each resident's plan of care.
    (D) A communication process, including how the communication will 
be documented between the LTC facility and the hospice provider, to 
ensure that

[[Page 38606]]

the needs of the resident are addressed and met 24 hours per day.
    (E) A provision that the LTC facility immediately notifies the 
hospice about the following:
    (1) A significant change in the resident's physical, mental, 
social, or emotional status.
    (2) Clinical complications that suggest a need to alter the plan of 
care.
    (3) A need to transfer the resident from the facility for any 
condition.
    (4) The resident's death.
    (F) A provision stating that the hospice assumes responsibility for 
determining the appropriate course of hospice care, including the 
determination to change the level of services provided.
    (G) An agreement that it is the LTC facility's responsibility to 
furnish 24-hour room and board care, meet the resident's personal care 
and nursing needs in coordination with the hospice representative, and 
ensure that the level of care provided is appropriately based on the 
individual resident's needs.
    (H) A delineation of the hospice's responsibilities, including but 
not limited to, providing medical direction and management of the 
patient; nursing; counseling (including spiritual, dietary, and 
bereavement); social work; providing medical supplies, durable medical 
equipment, and drugs necessary for the palliation of pain and symptoms 
associated with the terminal illness and related conditions; and all 
other hospice services that are necessary for the care of the 
resident's terminal illness and related conditions.
    (I) A provision that when the LTC facility personnel are 
responsible for the administration of prescribed therapies, including 
those therapies determined appropriate by the hospice and delineated in 
the hospice plan of care, the LTC facility personnel may administer the 
therapies where permitted by State law and as specified by the LTC 
facility.
    (J) A provision stating that the LTC facility must report all 
alleged violations involving mistreatment, neglect, or verbal, mental, 
sexual, and physical abuse, including injuries of unknown source, and 
misappropriation of patient property by hospice personnel, to the 
hospice administrator immediately when the LTC facility becomes aware 
of the alleged violation.
    (K) A delineation of the responsibilities of the hospice and the 
LTC facility to provide bereavement services to LTC facility staff.
    (3) Each LTC facility arranging for the provision of hospice care 
under a written agreement must designate a member of the facility's 
interdisciplinary team who is responsible for working with hospice 
representatives to coordinate care to the resident provided by the LTC 
facility staff and hospice staff. The interdisciplinary team member 
must have a clinical background, function within their State scope of 
practice act, and have the ability to assess the resident or have 
access to someone that has the skills and capabilities to assess the 
resident. The designated interdisciplinary team member is responsible 
for the following:
    (i) Collaborating with hospice representatives and coordinating LTC 
facility staff participation in the hospice care planning process for 
those residents receiving these services.
    (ii) Communicating with hospice representatives and other 
healthcare providers participating in the provision of care for the 
terminal illness, related conditions, and other conditions, to ensure 
quality of care for the patient and family.
    (iii) Ensuring that the LTC facility communicates with the hospice 
medical director, the patient's attending physician, and other 
practitioners participating in the provision of care to the patient as 
needed to coordinate the hospice care with the medical care provided by 
other physicians.
    (iv) Obtaining the following information from the hospice:
    (A) The most recent hospice plan of care specific to each patient.
    (B) Hospice election form.
    (C) Physician certification and recertification of the terminal 
illness specific to each patient.
    (D) Names and contact information for hospice personnel involved in 
hospice care of each patient.
    (E) Instructions on how to access the hospice's 24-hour on-call 
system.
    (F) Hospice medication information specific to each patient.
    (G) Hospice physician and attending physician (if any) orders 
specific to each patient.
    (v) Ensuring that the LTC facility staff provides orientation in 
the policies and procedures of the facility, including patient rights, 
appropriate forms, and record keeping requirements, to hospice staff 
furnishing care to LTC residents.
    (4) Each LTC facility providing hospice care under a written 
agreement must ensure that each resident's written plan of care 
includes both the most recent hospice plan of care and a description of 
the services furnished by the LTC facility to attain or maintain the 
resident's highest practicable physical, mental, and psychosocial well-
being, as required at Sec.  483.25.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

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

    Dated: December 7, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: June 14, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-15313 Filed 6-26-13; 8:45 am]
BILLING CODE 4120-01-P
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