Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Hospice Services, 65282-65291 [2010-26395]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Proposed Rules]
[Pages 65282-65291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 483

[CMS-3140-P]
RIN 0938-AP32


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

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would 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 are proposing these 
requirements to ensure that long-term care (LTC) facilities (that is, 
SNFs and NFs) that chose to arrange for the provision of hospice care 
through an agreement with one or more Medicare-certified hospice 
providers would have in place a written agreement with the hospice that 
specified the roles and responsibilities of each entity.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 21, 
2010.

ADDRESSES: In commenting, please refer to file code CMS-3140-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the instructions for 
``Comment or Submission'' and enter the file code to find the document 
accepting comments.
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address only:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3140-P, P.O. Box 8010, Baltimore, MD 
21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address only:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3140-P, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to either of the following addresses:
    a. For delivery in Washington, DC--
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue, SW., Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by following the 
instructions at the end of the ``Collection of Information 
Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:  Trish Brooks, (410) 786-4561. Marcia 
Newton, (410) 786-5265. Jeannie Miller, (410) 786-3164.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    According to CMS data, at any point in time, approximately 1.4 
million elderly and disabled nursing home residents are receiving care 
in nearly 16,000 Medicare- and Medicaid-certified Long-Term Care (LTC) 
facilities

[[Page 65283]]

in the United States. More than 20 percent of older Americans die in 
nursing homes. (Johnson, Sandra H., Hastings Center Report, Making Room 
for Dying: End of Life Care in Nursing Homes; November/December 2005, 
Special Report 35 (6), S37-S41.) Therefore, providing care at the end 
of life, particularly palliative care, is an important part of nursing 
home care.
    Palliative care means patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care in an LTC facility involves addressing 
physical, intellectual, emotional, social, and spiritual needs, as well 
as facilitating resident autonomy, access to information, and choice 
throughout the continuum of illness. Palliative care independent of the 
hospice benefit may also be provided by LTC facilities, which may 
eliminate the need for hospice services for their residents.
    Hospice care is provided for terminally ill individuals with a 
prognosis of 6 months or less if their terminal illness runs its normal 
course. These patients have elected to forgo curative care and wish to 
remain in their place of residence. A Medicare-certified hospice 
provides services in family homes, LTC facilities, and any other 
dwelling that individuals call ``home.'' Hospice care may also be 
provided while individuals are hospitalized. According to a March 2000 
Office of the Assistant Secretary for Planning and Evaluation's (ASPE) 
study, entitled ``Use of Medicare's Hospice Benefit by Nursing Facility 
Residents,'' nursing facilities served approximately 35 percent of all 
hospice beneficiaries in some markets. The study concluded, ``hospice 
in nursing homes is a very prevalent phenomenon,'' but added that 
``Guidelines are * * * needed to clarify the need for nursing 
facilities to provide palliative care and the roles and 
responsibilities of hospices and nursing facilities when treating a 
hospice patient. Minimal contract provisions affecting the two types of 
providers when treating residents enrolled in hospice are needed as 
well.'' (https://aspe.hhs.gov/daltcp/reports/2000/samhbes.htm.)
    Under current regulations, an LTC facility may choose to have a 
written agreement with one or more hospice providers to provide hospice 
care to a Medicare eligible resident who wishes to elect the hospice 
benefit. However, if the facility chooses not to contract with a 
Medicare-certified hospice to provide hospice services for the resident 
who wishes to elect the benefit, the LTC facility is responsible for 
assisting the resident in transferring to a facility that will arrange 
for the provision of such services, as requested by the resident. (See 
42 CFR 483.12(a)(2)(i), Transfer and discharge requirements.)
    Hospice care for residents who choose to live in various types of 
facilities has come under scrutiny as a result of a variety of 
findings, including Operation Restore Trust (ORT) activities, Office of 
Inspector General (OIG) reports from 1997, (U.S. D.H.H.S. OIG, 
``Hospice and Nursing Home Contractual Relationships,'' Nov. 1997, OEI-
05-95-00251, https://oig.hhs.gov/oei/reports/oei-05-95-00251.pdf) and 
1998 (OIG Special Fraud Alert, ``Fraud and Abuse, Nursing Home 
Arrangements with Hospices,'' Mar. 1998 https://oig.hhs.gov/fraud/docs/alertsandbulletins/hospice.pdf ), and a 2000 report from the 
Department's Assistant Secretary for Planning and Evaluation (ASPE) 
Office of Disability, Aging and Long-Term Care Policy and the Urban 
Institute; ``Synthesis and Analysis of Medicare Hospice Benefit 
Executive Summary and Recommendations.'' (Harvell, J.; Jackson, B.; 
Gage, B.; Miller, S.; and Mor, V., Mar. 2000, https://aspe.hhs.gov/daltcp/reports/2000/samhbes.htm). In addition, based on feedback to CMS 
from state surveyors, there is a lack of coordination between LTC 
facilities and Medicare-certified hospice providers.
    We believe there is a lack of clear regulatory direction regarding 
the responsibilities of providers in caring for LTC facility residents 
who receive hospice care from a Medicare-certified hospice provider, 
which could result in duplicative or missing services. We believe this 
problem would be remedied by a regulatory requirement for a written 
agreement between the two types of entities when they are both involved 
in the care of a Medicare beneficiary. A written agreement would help 
ensure that required services are provided to beneficiaries and protect 
beneficiary health and safety, which could be endangered by a lack of 
coordination between hospice and LTC providers. Such an agreement 
ensures that care is coordinated by specifying what services each 
provider will provide. For instance, an LTC facility is considered a 
resident's home. An agreement between the providers would specify that 
the LTC facility must furnish room and board and meet personal care and 
nursing needs, while the hospice must provide services that are 
necessary for the care of the resident's terminal illness, such as 
counseling and palliation of pain.

A. Statutory Authority

1. 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 or nursing facility 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. The original legislation (OBRA '86), adding the optional hospice 
benefit, specified, ``hospice care may be provided to an individual 
while such individual is a resident of a skilled nursing facility or 
intermediate care facility'' (Pub. L. 99-272, Sec. 9505(a)(2)).
    This proposed rule would set forth requirements consistent with 
requirements in the June 5, 2008 final rule (73 FR 32088) entitled 
``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. Section 418.112(e) specifies what must 
be included in a written agreement between a Medicare-certified hospice 
provider and an LTC facility. We propose making the requirements for 
LTC facilities consistent with the June 2008 final rule. To this end, 
the language in this proposed rule was crafted to mirror the hospice 
final rule as much as possible to ensure that both entities are held 
equally responsible for the written agreement.
    This proposed rule would also support 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.
2. Rationale for New Requirements
    A 2002 Secretary of the Department of Health and Human Services' 
(DHHS) Advisory Committee Report and a 2003 Hastings Center Report have 
identified a lack of coordination between LTC facilities and Medicare-
certified hospice providers. In 2002, the Secretary of DHHS' Advisory 
Committee on Regulatory Reform developed

[[Page 65284]]

recommendations to address key regulatory issues. One of the 
recommendations of the DHHS Secretary's Advisory Committee report was 
to clarify the relationship between nursing facilities and hospice 
providers. The DHHS Secretary's Advisory Committee report stated that 
there was a need to ``reconcile conflicts in regulations and/or 
guidance that prevent clear delineation as to which entity (LTC 
facility or the hospice) is required to have the lead in providing 
required end-of-life care to SNF residents once they elect their 
hospice benefit.'' The report recommended revising guidance and 
procedures to recognize hospice care in the context of the SNF survey 
protocol. The report further recommended that, if necessary, CMS revise 
the CoPs for Medicare-certified hospices, SNFs, and NFs to ensure 
beneficiaries' access to the full range of benefits to which they are 
statutorily entitled, and to ensure the appropriate entity is 
accountable for care that should be provided, which is based on a 
resident's unique needs (https://regreform.hhs.gov/finalreport.htm).
    An article in the March/April 2003 Hastings Center Report, ``Is 
discontinuity in palliative care a culpable act of omission?'' stated, 
``Hospice patients sign up to obtain palliative care, regardless of the 
care setting in which they reside. Part of honoring this obligation 
requires a hospice to attend to the needs of continuity when the site 
of care does change.'' The article further stated that, while most non-
hospice healthcare providers do not follow their terminally ill 
patients to other care sites, hospice staff are required by the 
Medicare CoPs at Sec.  418.56, as well as by industry and accreditation 
standards, to both provide and oversee palliative care as the patient 
moves across care sites with which the hospice has a contractual 
relationship. The article concludes that continuity of care is 
optimized by care management across care sites. (True Ryndes, Linda 
Emanuel, The Hastings Center Report, Hastings-on-Hudson: March/April 
2003, page S45). (https://findarticles.com/p/articles/mi_go2103/is_2_33/ai_n7517557/?tag=content;col1)
    This proposed rule, therefore, seeks to clarify the role of the LTC 
facility and the Medicare-certified hospice by requiring clear 
delineation of each provider's responsibility for maintaining 
continuity of care.
    The problems LTC facilities and hospices have with the coordination 
of care, as identified in both the Hastings Center Report and the HHS 
Secretary's Advisory Committee report, is a direct result of the lack 
of Medicare requirements specifically related to the provision of 
contracted hospice care in the current regulatory requirements for LTC 
facilities. The overall intent of this proposed rule is to promote 
consistency and continuity of care by requiring that a written 
agreement between the LTC facility and the Medicare-certified hospice 
provider clearly identify the responsibilities of each entity when 
arranging for the provision of hospice services to an LTC resident who 
elects the hospice benefit. This agreement would be required even if 
the Medicare-certified hospice and the LTC facility were under common 
control and/or ownership.
    Therefore, in light of the HHS Secretary's Advisory Committee 
report and Hastings Center Report, and to ensure quality hospice care 
is provided in a coordinated manner to LTC facility residents who have 
elected to receive hospice services, we are proposing a new standard at 
42 CFR 483.75(r), entitled ``Hospice services.'' At Sec.  483.75(r)(1), 
we propose that LTC facilities that choose to arrange for the provision 
of hospice services through an agreement with one or more Medicare-
certified hospices, must have a signed agreement with the hospice 
before any hospice care is provided to any resident. In addition, for 
those LTC facilities that decline to arrange for the provision of 
hospice services through an agreement with a Medicare-certified hospice 
provider, we propose that facilities would be required to assist a 
resident in transferring to a facility that would arrange for the 
provision of these services when the resident requested such a 
transfer.
    Requirements for discharge and transfer from LTC facilities are 
specified at Sec.  483.12. The current regulations do not specifically 
address a resident's request for transfer. Thus, an LTC facility may 
accept a written or verbal request for transfer. We propose that all 
transfers would have to be documented in the resident's medical record.
    Under this proposed rule, when hospice care is provided by a 
Medicare-certified hospice in an LTC facility through an agreement, the 
LTC facility would be required to meet additional requirements specific 
to written agreements between the two entities. The LTC facility would 
be required to ensure that the hospice services met professional 
standards and principles that apply to individuals providing services 
in the facility, and to ensure the timeliness of the services. The 
term, ``timeliness of services'' means that the LTC facility would be 
required to ensure that, from the time the resident elected the hospice 
benefit until the services were terminated, the Medicare-certified 
hospice would provide hospice services meeting the resident's needs in 
a timely manner, without any delay in the provision of services for the 
resident. We anticipate that LTC facilities would address timeliness of 
services in their agreements with hospices, based on resident needs.
    We propose requiring the signatures of both an authorized 
representative of the hospice and an authorized representative of the 
LTC facility for such agreements. These provisions would have to be met 
before any hospice care was furnished to an LTC facility resident who 
elected the hospice benefit.
    The purpose of the written agreement would be to ensure that the 
duties and responsibilities of the hospice and the LTC facility were 
clearly described. The signature requirement would prevent 
misunderstandings that could affect resident care because a responsible 
person representing each provider would be aware of the respective 
roles of each entity under the agreement. In addition, the written 
agreement would ensure that mechanisms were in place to ensure needs of 
the resident were identified and met, including the need for high 
quality hospice care.
    Under the agreement between the LTC facility and the hospice, the 
hospice would be responsible for making decisions related to a 
resident's care for the palliation and management of the terminal 
illness and related conditions, because Sec.  418.58 requires a hospice 
to establish and maintain a written plan of care for every individual 
admitted to its hospice program. The LTC facility would be responsible 
for making decisions that were not related to a resident's terminal 
illness, because Sec.  483.20(k) requires a LTC facility to develop a 
comprehensive care plan for each resident that meets the resident's 
medical, nursing, mental, and psychosocial needs. Under this proposed 
rule, the LTC facility would also be responsible for ensuring the 
hospice provider was informed about changes made to the resident's care 
plan.
    In general, a care plan is a document that provides a ``road map'' 
for everyone who is involved with a patient's care. The care planning 
process includes the interdisciplinary team that will be involved in 
the care of the patient. The ultimate purpose of a care plan is to 
guide all involved in the care of the patient in providing the 
appropriate treatment to ensure an optimal outcome for the patient. A 
healthcare worker should be able to find all the

[[Page 65285]]

information needed to care for an individual in that person's care 
plan.
    To encourage the completeness of patient information available to 
all staff responsible for the care of the patient, we are proposing to 
require that any written agreements would need to delineate: (1) Which 
services the Hospice would provide and which services the LTC facility 
would continue to provide, as delineated in the care plans; (2) how the 
LTC facility and hospice would communicate to ensure that needs of 
residents were being addressed and met; and (3) the conditions under 
which the LTC facility would need to contact the hospice immediately 
(specifically, this would include significant changes in the resident's 
physical, mental, social, or emotional status; clinical complications 
that suggested a need to alter the care plan; a need to transfer the 
resident from the LTC facility for any condition not related to the 
terminal condition; or resident death).
    As stated above, we are also specifically proposing at Sec.  
483.75(r) (2)(ii)(D) that the written agreement identify a specific 
method of communication between the LTC facility staff and the hospice 
staff to ensure the effectiveness and timeliness of care. In an 
emergency, staff could communicate orally, but we would expect 
facilities to use best practices and document the communication so 
there could be appropriate follow-up. Best practices are similar to the 
term ``professional standards of quality,'' which is defined in current 
guidelines for surveyors in the State Operations Manual (SOM) (https://www.cms.hhs.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf).
    The term ``best practices'' means that services are provided 
according to recognized standards of clinical practice. Standards may 
apply to care provided by a particular clinical discipline or in a 
specific clinical situation or setting. Standards regarding quality 
care practices may be established by professional organizations, 
licensing boards, accreditation bodies, and/or regulatory agencies.
    In addition to these requirements for the written agreement, we are 
proposing that the agreement include a provision stating that the 
hospice assumes responsibility for determining the appropriate course 
of hospice care, including changing the level of services provided, if 
necessary. Among the LTC facility's responsibilities under the written 
agreement, we are proposing that the agreement include a provision 
requiring the LTC facility 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 
appropriate based on the individual resident's needs.
    We are proposing that, under the written agreement, there also be a 
delineation of the hospice's responsibilities, which include, but are 
not limited to the following: Providing medical direction and 
management of the patient's hospice care; 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.
    For example, the written agreement might state that the hospice 
would be responsible for determining the correct medication for the 
terminal condition, but the LTC facility staff would be responsible for 
the medication's administration, because the LTC facility provides 24-
hour care for its residents. Delineating responsibility for these key 
services would ensure not only continuity of care, but would also 
guarantee appropriate care in a timely manner. For example, if a 
resident were in pain and needed medication, it would be vital to the 
care of the resident to have a clear delineation of each provider's 
specific responsibilities regarding pain control, including all steps 
from contacting the prescribing practitioner to obtaining medication, 
following the procedures set up by the hospice, administering the 
medication and monitoring its effectiveness.
    We propose at Sec.  483.75(r)(2)(ii)(I) that when the LTC facility 
personnel are responsible for the administration of prescribed 
therapies, including those therapies determined by the hospice and 
delineated in the hospice plan of care, the LTC facility personnel may 
be permitted to administer the therapies where permitted by State law 
and as specified by the LTC facility.
    We propose at Sec.  483.75(r)(2)(ii)(J) 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. This requirement would 
assure that the hospice is made aware of the alleged violation in a 
timely manner so that it can begin its own investigation and implement 
its own intervention(s). We note that under current regulations at 
Sec.  483.13(c)(3), an LTC facility must immediately provide protection 
for the resident continuing throughout the investigation. The hospice 
final rule includes a similar provision at Sec.  418.112(c)(8), which 
requires reporting of alleged violations involving mistreatment, 
neglect, or verbal, mental, sexual, and physical abuse, including 
injuries of unknown source, and misappropriation of patient property by 
LTC facility personnel to the facility administrator. Such provisions 
enhance LTC facility-hospice communication and cooperation.
    We propose at Sec.  483.75(r)(2)(ii)(K) that the agreement include 
a delineation of the responsibilities of the hospice to offer 
bereavement services to LTC facility staff. We propose at Sec.  
483.75(r)(3) that each LTC facility that arranges for the provision of 
hospice care through 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 
staff and the hospice staff. In addition, the designated 
interdisciplinary team member would 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 and related conditions, 
as well as 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 as needed to 
coordinate the hospice care of the hospice patient with the medical 
care provided by other physicians; (4) obtaining information from the 
hospice, including the most recent hospice plan of care specific to 
each patient, the hospice election form, any advance directives 
specific to each patient, and physician certification and 
recertification of the terminal illness specific to each patient, as 
well as 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

[[Page 65286]]

hospice physician and attending physician (if any) orders specific to 
each patient. In addition, we propose requiring that the LTC facility 
staff provide orientation to relevant hospice staff about the 
facility's policies and procedures, including patient rights, 
appropriate forms, and recordkeeping requirements.
    These proposed requirements would apply regardless of the financial 
and/or ownership relationship between the LTC facility and the hospice.
    Although we believe such orientation is critical for the protection 
of residents receiving hospice care, we understand that it may be 
difficult for an LTC facility to properly orient other hospice staff 
who, in unexpected circumstances, may occasionally provide coverage for 
a member of the identified hospice interdisciplinary group (IDG). 
Therefore, we welcome public comment on how LTC facilities can provide 
orientation for hospice staff that is quick and efficient but 
sufficient to protect residents who receive hospice care.
    Our intention is to ensure continuity of care by involving 
designated representatives from both the LTC facility and the hospice 
in the hospice care planning and hospice care implementation processes, 
as well as in LTC facility processes. The LTC facility would have the 
flexibility to assign one employee from the facility's 
interdisciplinary team as a coordinator for all hospice residents, or 
assign a separate coordinator for each hospice resident. The designated 
coordinator would ensure that the hospice plan of care and the LTC 
facility plan of care were implemented and updated as appropriate. 
``Interdisciplinary team'' refers to the professionals who work 
together to provide services to the resident, as defined at Sec.  
483.20(k)(2)(ii). Interdisciplinary team members may include 
physicians, nurses, therapists, social workers, dietitians, and other 
professionals, such as developmental disabilities specialists. 
Involvement of other disciplines is dependent upon resident needs.
    We propose at Sec.  483.75(r)(4) that each LTC facility that 
arranges for hospice care under a written agreement with a Medicare-
certified hospice 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). We expect that the LTC 
facility's designated coordinator would work with hospice 
representatives to meet this requirement.
    We believe that including the hospice plan of care (which addresses 
care for the terminal condition and related conditions) with the LTC 
facility care plan would improve care coordination and result in better 
implementation of the overall plan of care. We believe these proposed 
requirements would facilitate effective communication and coordination 
between the Medicare-certified hospice provider and the LTC facility, 
ensuring that quality care would be provided to residents receiving 
hospice services. We note that these proposed requirements would not 
limit the scope of the relationship between the Medicare-certified 
hospice and the facility. Each party could add provisions, subject to 
mutual agreement, as long as they met or exceeded the proposed 
requirements.
    We anticipate that these proposed requirements, aimed at improving 
the coordination of care between LTC facilities and Medicare-certified 
hospice care providers, would lead to improved consistency and quality 
of care for LTC facility residents who elect to receive hospice 
services.
    In addition, we are taking this opportunity to make a technical 
correction due to an incorrect citation at Sec.  483.10(n). The 
language states, ``An individual resident may self-administer drugs if 
the interdisciplinary team, as defined by Sec.  483.20(d)(2)(ii), has 
determined that this practice is safe.'' However, Sec.  
483.20(d)(2)(ii) does not exist. The correct citation is Sec.  
483.20(k)(2)(ii). In Sec.  483.10(n), we are proposing that the 
reference ``Sec.  483.20(d)(2)(ii)'' be revised to read ``Sec.  
483.20(k)(2)(ii).''
3. Relevance to Existing Hospice Requirements
    Our intent in proposing 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 proposed 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 would 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 
proposing different requirements because we believe they are in the 
best interests of the residents of LTC facilities. For instance, at 
proposed Sec.  483.75 (r)(2)(ii)(J), the LTC facility would be required 
to report all alleged violations by hospice personnel to the hospice 
administrator immediately when the LTC facility becomes aware of the 
alleged violation. However, the hospice is required at Sec.  
418.112(c)(8) to report these same violations within 24 hours of the 
hospice becoming aware of the alleged violation.
    The rationale for both these rules is to require a written 
agreement between the hospice and the LTC facility. (See Sec.  
418.112(c)(1) through (9) and proposed Sec.  483.75(r)(2)(ii)(A) 
through (K).) 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 proposed Sec.  483.75(r)(3)(i)(v) and Sec.  
418.112(e), to reflect the difference in the roles between the LTC 
facility and the hospice in providing resident care. Therefore, we are 
proposing requirements for communication and collaboration specific to 
the LTC facility that do not mirror the language in the hospice 
requirements. Rather, the proposed rule for LTC facilities would 
complement the hospice requirements, and our objective is that, 
together, these rules will allow for better coordination of care and 
quality of care for LTC facility residents.
    Notwithstanding our analysis that these rules are complimentary and 
substantively similar, and in view of the slight differences between 
these rules, we are requesting public comment on whether the 
differences found in the proposed rule would create a barrier to 
forming agreements between LTC facilities or interfere in coordination 
of residents' care between LTC facilities and hospices.

II. Provisions of the Proposed Regulations

    As stated above, we are proposing a new standard at 42 CFR 
483.75(r), entitled ``Hospice services.'' At Sec.  483.75(r)(1), we 
propose that LTC facilities may 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 will arrange for the 
provision of these services when the resident requests such a transfer.
    At Sec.  483.75(r)(2)(i) and (ii), we propose specific requirements 
for LTC facilities choosing to have hospice care provided by a 
Medicare-certified hospice in their facility. The LTC

[[Page 65287]]

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 propose 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.
    In addition, under this section, we are proposing that the written 
agreement would have to include, at the very least, the following 
provisions:
     Under Sec.  483.75(r)(2)(ii)(A), the services the hospice 
will provide;
     Under Sec.  483.75(r)(2)(ii)(B), the hospice's 
responsibilities for determining the appropriate hospice plan of care 
as specified in Sec.  418.112(d) of this chapter;
     Under Sec.  483.75(r)(2)(ii)(C), the services the LTC 
facility will continue to provide, based on each resident's care plan; 
and
     Under Sec.  483.75(r)(2)(ii)(D), 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 are addressed and met 24 hours per day.
    Additionally, under Sec.  483.75(r)(2)(ii), we are proposing 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 are proposing that the agreement contain 
a provision that the LTC facility must notify the hospice provider 
immediately regarding--
     A significant change in the resident's physical, mental, 
social, or emotional status;
     Any clinical complication(s) that would suggest 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.
    We propose at Sec.  483.75(r)(2)(ii)(F) that the hospice must 
assume responsibility for determining the appropriate course of hospice 
care, including the determination to change the level of services 
provided.
    We propose 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.
    At Sec.  483.75(r)(2)(ii)(H), we are proposing that the written 
agreement include a delineation of additional hospice responsibilities, 
which include, but are 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.
     All other hospice services that are necessary for the care 
of the resident's terminal illness and related conditions.
    We propose 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 are also specifically proposing, at Sec.  483.75(r)(2)(ii)(J), 
that the written agreement contain a provision 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. We propose at Sec.  
483.75(r)(2)(ii)(K) that the agreement must also include a delineation 
of the responsibilities of the hospice to offer bereavement services to 
LTC facility staff.
    At Sec.  483.75(r)(3)(i) through (v), we are proposing that the LTC 
facility that arranges for the provision of hospice care under a 
written agreement must 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 physicians;
    (4) Obtaining pertinent information from the hospice (that is, the 
most recent hospice plan of care specific to each patient; hospice 
election form and any advance directives specific to each patient; 
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 provide 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.
    At Sec.  483.75(r)(4), we are proposing that each LTC facility 
providing hospice care under a written agreement must 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).
    As stated in the previous section above, we are also taking this 
opportunity to make a technical correction due to an incorrect citation 
at Sec.  483.10(n). In Sec.  483.10(n), we are proposing that the 
reference ``Sec.  483.20(d)(2)(ii)'' be revised to read ``Sec.  
483.20(k)(2)(ii).''

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-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.

[[Page 65288]]

     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 are soliciting 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) states that if hospice care is 
provided in an LTC facility through an agreement with a Medicare-
certified hospice, the LTC facility must have a written agreement with 
the Medicare-certified hospice before care is furnished to any 
resident.
    An LTC facility would be required to have only one written 
agreement with each hospice that provides services in the facility. 
This proposed rule would 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 would 
require staff time; however, it would 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. 
The current requirements at Sec.  483.75(h) ``Use of Outside 
Resources,'' requires a written agreement when contracting for outside 
services. Therefore, we would expect that a facility would modify an 
existing agreement to make it specific to hospice services. Review and 
revision of an already existing agreement would be expected to take 
less time thereafter. We estimate that it would 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 sections 483.75(r)(2)(ii)(E)(1) through (4) state that the 
LTC must 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 would take the LTC facility to provide notification to the 
hospice. We estimate it would take approximately 5 minutes per 
notification. We anticipate that this would affect 16,139 LTC 
facilities. If each LTC facility makes 1 notification each month, the 
burden associated with this requirement is 16,139 annual burden hours 
and the cost would 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) states that under the agreement, 
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. The 
burden associated with this requirement is the time and effort it would 
take the LTC facility to report this information to the hospice 
administrator. We estimate it would take approximately 10 minutes per 
incident. We anticipate that this would affect 16,139 LTC facilities. 
If each LTC facility made one report per month, the burden associated 
with this requirement would be 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
                                                                             Burden per     Total      labor cost  Total labor     Total
       Regulation section(s)        OMB control   Respondents   Responses     response      annual         of        cost of      capital/    Total cost
                                        No.                                   (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.

    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Mail copies to the address specified in the ADDRESSES section of 
this proposed rule and to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
CMS-3140-P.
    Fax: (202) 395-6974; or
    E-mail: OIRA_submission@omb.eop.govIV.

Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

[[Page 65289]]

V. Regulatory Impact Analysis

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 19, 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 on 
Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
    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 
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 businesses, if a rule has a significant impact on a 
substantial number of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
government jurisdictions. 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 it affects, 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 significant. We 
estimate that these requirements would 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 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 603 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 would impact 
only long-term care facilities. Therefore, the Secretary has determined 
that this proposed rule would 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 2010, that 
threshold is approximately $135 million. This rule would 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.

B. 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 as proposed in this rule, 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 only LTC facilities and Medicare-certified hospice providers 
would be affected, as this proposed rule would 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.
3. Effects on the Medicare and Medicaid Programs
    An Office of the Inspector General (OIG) report released in 1997 
found that ``contractual arrangements between hospice providers and 
nursing homes present vulnerabilities for inappropriate use of 
excessive Medicare and Medicaid payments being made to hospice 
providers or to nursing homes'' (U.S. HHS OIG, Hospice and Nursing Home 
Contractual Relationships, 1997 Nov., OEI-05-95-00251). We anticipate 
that the proposed rule would decrease these vulnerabilities, as the 
services provided by both the LTC facility and the Medicare-certified 
hospice would be clearly defined.

C. 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 would result in 
improvement in the quality of care provided to LTC residents receiving 
hospice services.

D. Conclusion

    This proposed rule for a written agreement when arranging for the 
provision of hospice services in LTC facilities is intended to improve 
the continuity and quality of care provided to terminally ill LTC 
facility residents. It is consistent with the Administration's efforts 
toward broad-

[[Page 65290]]

based improvements in the quality of health care furnished by Medicare 
and Medicaid providers.
    This proposed rule identifies an LTC facility's choices if a 
resident elects to receive hospice care. This proposed 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.
    This proposed rule would 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 proposed requirements to the LTC regulations.
    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 proposes to amend 42 CFR Chapter IV as set forth 
below:

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

    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).

Subpart B--Requirements for Long Term Care Facilities


Sec.  483.10  [Amended]

    2. In Sec.  483.10(n), the reference ``Sec.  483.20(d)(2)(ii)'' is 
revised to read ``Sec.  483.20(k)(2)(ii).''
    3. Section 483.75 is amended by adding paragraph (r) to read as 
follows--


Sec.  483.75  Administration.

* * * * *
    (r) Hospice services. (1) A long-term care (LTC) facility may 
either--
    (i) Arrange for the provision of hospice services through an 
agreement with one or more Medicare-certified hospices; or
    (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 provided in an LTC facility through an 
agreement as specified in paragraph (r)(1)(i) of this section with a 
hospice, the LTC facility must:
    (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 care plan.
    (D) 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 are addressed and met 24 hours 
per day.
    (E) A provision that the LTC facility immediately notifies the 
hospice regarding--
    (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 that is not related to the terminal condition; or
    (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 appropriate based on the 
individual resident's needs.
    (H) A delineation of the hospice's responsibilities, which include, 
but are 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 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 violatio