65282 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 

remote access capabilities where 

interested parties may listen in and 

review the presentations over the 

internet simultaneously. Parties 

remotely accessing the meeting will 

have the opportunity to ask questions 

during the open comment period. To 

register to use this capability, please 

contact the NPPTL, Policy and 

Standards Development Branch, P.O. 

Box 18070, 626 Cochrans Mill Road, 

Pittsburgh, PA 15236, telephone 412– 

386–5200, fax 412–386–4089. This 

option will be available to participants 

on a first come, first served basis and is 

limited to the first 50 participants. 

Background: NIOSH, National 

Personal Protective Technology 

Laboratory (NPPTL), will present 

information to attendees concerning the 

development of the concepts being 

considered for performance criteria of 

various classes of respirators. 

Participants will be given an 

opportunity to ask questions and to 

present individual comments that they 

may wish to have considered. 

Reference: Information regarding 

documents that will be discussed at the 

meeting may be obtained from the 

NIOSH Web site using this link: 

http://www.cdc.gov/niosh/review/ 

public/ using the docket numbers listed 

in this notice. 

Authority: 29 U.S.C. 651–675, 677; 30 

U.S.C. 3, 5, 7, 811, 842(h), 844. 

Dated: October 12, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–26129 Filed 10–21–10; 8:45 am] 

BILLING CODE 4163–19–P 

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. 

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 http://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: http:// 

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 Medicaidcertified Long-Term Care (LTC) facilities 


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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 Medicarecertified 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.’’ (http:// 

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, http://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 http://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, http://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 


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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 Medicarecertified 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 

(http://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 § 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). (http://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 Medicarecertified 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 

§ 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 Medicarecertified 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 § 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 Medicarecertified 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 § 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 

§ 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 


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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 § 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) (http:// 

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 § 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 § 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 

§ 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 

§ 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 § 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 

§ 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 oncall system; hospice medication 

information specific to each patient; and 


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65286 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 

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 § 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 § 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 

§ 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 Medicarecertified 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 

§ 483.10(n). The language states, ‘‘An 

individual resident may self-administer 

drugs if the interdisciplinary team, as 

defined by § 483.20(d)(2)(ii), has 

determined that this practice is safe.’’ 

However, § 483.20(d)(2)(ii) does not 

exist. The correct citation is 

§ 483.20(k)(2)(ii). In § 483.10(n), we are 

proposing that the reference 

‘‘§ 483.20(d)(2)(ii)’’ be revised to read 

‘‘§ 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 § 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 § 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 § 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 

§ 418.112(c)(1) through (9) and proposed 

§ 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 

§ 483.75(r)(3)(i)(v) and § 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 

§ 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 Medicarecertified 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 § 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 


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Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 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 § 483.75(r)(2)(ii)(A), the 

services the hospice will provide; 

• Under § 483.75(r)(2)(ii)(B), the 

hospice’s responsibilities for 

determining the appropriate hospice 

plan of care as specified in § 418.112(d) 

of this chapter; 

• Under § 483.75(r)(2)(ii)(C), the 

services the LTC facility will continue 

to provide, based on each resident’s care 

plan; and 

• Under § 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 § 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 § 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 § 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 § 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 § 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 § 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 

§ 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 § 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 § 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 § 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 

§ 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 

§ 483.10(n). In § 483.10(n), we are 

proposing that the reference 

‘‘§ 483.20(d)(2)(ii)’’ be revised to read 

‘‘§ 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. 


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65288 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 

• 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 § 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 § 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 § 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

Regulation section(s) OMB control 

No. Respondents Responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

($) 

Total 

labor 

cost of 

reporting 

($) 

Total capital/maintenance costs 

($) 

Total cost 

($) 

§ 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 

§ 483.75(r)(2)(ii)(E)(1–4) .......... 0938—New 16,139 193,668 .08333 16,139 31.25 504,344 0 504,344 

§ 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. 


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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 longterm 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 Medicarecertified 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 broadVerDate Mar<15>2010 17:19 Oct 21, 2010 Jkt 223001 PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 E:\FR\FM\22OCP1.SGM 22OCP1

emcdonald on DSK2BSOYB1PROD with PROPOSALS
65290 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 

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 

§ 483.10 [Amended] 

2. In § 483.10(n), the reference 

‘‘§ 483.20(d)(2)(ii)’’ is revised to read 

‘‘§ 483.20(k)(2)(ii).’’ 

3. Section 483.75 is amended by 

adding paragraph (r) to read as 

follows— 

§ 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 § 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 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 to be responsible 

for working with hospice 

representatives to coordinate care to the 

resident provided by the LTC facility 

staff and hospice staff. The designated 

interdisciplinary team member is 

responsible for: 

(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 physicians 

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; 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Proposed Rules 65291 

(B) Hospice election form and any 

advance directives specific to each 

patient; 

(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; and 

(G) Hospice physician and attending 

physician (if any) orders specific to each 

patient. 

(v) 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. 

(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 § 483.20(k). 

(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: May 27, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 1, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–26395 Filed 10–21–10; 8:45 am] 

BILLING CODE 4120–01–P 


emcdonald on DSK2BSOYB1PROD with PROPOSALS