Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 70831 

§ 167.1332 In the Strait of Georgia. 

In the Strait of Georgia, the following 

are established: 

(a) Precautionary area ‘‘GS,’’ which is 

bounded by a line connecting the 

following geographical positions: 

Latitude Longitude 

48°52.30′ N 123°07.44′ W 

48°54.81′ N 123°03.66′ W 

48°49.49′ N 122°54.24′ W 

48°47.93′ N 122°57.12′ W 

48°47.78′ N 122°59.12′ W 

48°48.19′ N 123°00.84′ W 

48°52.30′ N 123°07.44′ W 

(b) A separation zone bounded by a 

line connecting the following 

geographical positions: 

Latitude Longitude 

48°53.89′ N 123°05.04′ W 

48°56.82′ N 123°10.08′ W 

48°56.30′ N 123°10.80′ W 

48°53.39′ N 123°05.70′ W 

(c) A traffic lane for north-westbound 

traffic located between the separation 

zone described in paragraph (b) of this 

section and a line connecting the 

following geographical positions: 

Latitude Longitude 

48°54.81′ N 123°03.66′ W 

48°57.68′ N 123°08.76′ W 

(d) A traffic lane for south-eastbound 

traffic between the separation zone 

described in paragraph (b) of this 

section and a line connecting the 

following geographical positions: 

Latitude Longitude 

48°55.34′ N 123°12.30′ W 

48°52.30′ N 123°07.44′ W 

(e) Precautionary area ‘‘PR,’’ which is 

bounded by a line connecting the 

following geographical positions: 

Latitude Longitude 

48°55.34′ N 123°12.30′ W 

48°57.68′ N 123°08.76′ W 

49°02.20′ N 123°16.28′ W 

49°00.00′ N 123°19.69′ W 

(f) A separation zone bounded by a 

line connecting the following 

geographical positions: 

Latitude Longitude 

49°01.39′ N 123°17.53′ W 

49°03.84′ N 123°21.30′ W 

49°03.24′ N 123°22.41′ W 

49°00.75′ N 123°18.52′ W 

(g) A traffic lane for north-westbound 

traffic located between the separation 

zone described in paragraph (f) of this 

section and a line connecting the 

following geographical positions: 

Latitude Longitude 

49°02.20′ N 123°16.28′ W 

49°04.52′ N 123°20.04′ W 

(h) A traffic lane for south-eastbound 

traffic between the separation zone 

described in paragraph (f) of this section 

and a line connecting the following 

geographical positions: 

Latitude Longitude 

49°02.51′ N 123°23.76′ W 

49°00.00′ N 123°19.69′ W 

Dated: November 9, 2010. 

Dana A. Goward, 

U.S. Coast Guard, Director of Marine 

Transportation Systems Management. 

[FR Doc. 2010–29165 Filed 11–18–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482 and 485 

[CMS–3228–F] 

RIN 0938–AQ06 

Medicare and Medicaid Programs: 

Changes to the Hospital and Critical 

Access Hospital Conditions of 

Participation To Ensure Visitation 

Rights for All Patients 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule will revise the 

Medicare conditions of participation for 

hospitals and critical access hospitals 

(CAHs) to provide visitation rights to 

Medicare and Medicaid patients. 

Specifically, Medicare- and Medicaidparticipating hospitals and CAHs will 

be required to have written policies and 

procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the hospital or CAH may need to place 

on such rights as well as the reasons for 

the clinical restriction or limitation. 

DATES: Effective Date: These regulations 

are effective on January 18, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Scott Cooper, (410) 786–9465. Danielle 

Shearer, (410) 786–6617. Jeannie Miller, 

(410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 15, 2010, the President 

issued a Presidential Memorandum on 

Hospital Visitation to the Secretary of 

Health and Human Services. The 

memorandum may be viewed on the 

Web at: http://www.whitehouse.gov/thepress-office/presidential- 

/memorandum-/hospital-/visitation. As 

part of the directives of the 

memorandum, the Department, through 

the Office of the Secretary, tasked CMS 

with developing proposed requirements 

for hospitals (including Critical Access 

Hospitals (CAHs)), that would address 

the right of a patient to choose who may 

and may not visit him or her. In the 

memorandum, the President pointed out 

the plight of individuals who are denied 

the comfort of a loved one, whether a 

family member or a close friend, at their 

side during a time of pain or anxiety 

after they are admitted to a hospital. The 

memorandum indicated that these 

individuals are often denied this most 

basic of human needs simply because 

the loved ones who provide them 

comfort and support do not fit into a 

traditional concept of ‘‘family.’’ 

Section 1861(e)(1) through (9) of the 

Social Security Act—(1) Defines the 

term’’hospital’’; (2) lists the statutory 

requirements that a hospital must meet 

to be eligible for Medicare participation; 

and (3) specifies that a hospital must 

also meet other requirements as the 

Secretary finds necessary in the interest 

of the health and safety of individuals 

who are furnished services in the 

facility. Under this authority, the 

Secretary has established in the 

regulations at 42 CFR part 482 the 

requirements that a hospital must meet 

in order to participate in the Medicare 

program. This authority extends as well 

to the separate requirements that a CAH 

must also meet to participate in the 

Medicare program, established in the 

regulations at 42 CFR part 485. 

Additionally, section 1820 of the Act 

sets forth the conditions for designating 

certain hospitals as CAHs. Section 

1905(a) of the Act provides that 

Medicaid payments may be applied to 

hospital services. Regulations at 42 CFR 

440.10(a)(3)(iii) require hospitals to 

meet the Medicare CoPs to receive 

payment under States’ Medicaid 

programs. 

While the existing hospital conditions 

of participation (CoPs) in our 

regulations at 42 CFR part 482 do not 

address patient visitation rights 

specifically, there is a specific CoP 

regarding the overall rights of hospital 

patients contained in § 482.13. We note 

that the existing CoPs for CAHs in our 

regulations do not address patient rights 

in any form. The hospital CoP for 

patient rights at § 482.13 specifically 

requires hospitals to—(1) Inform each 

patient or, when appropriate, the 

patient’s representative (as allowed 

under State law) of the patient’s rights; 

(2) ensure the patient’s right to 

participate in the development and 

implementation of the plan of care; (3) 

ensure the patient’s (or his or her 

representative’s) right to make informed 

decisions about care; (4) ensure the 

patient’s right to formulate advance 


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70832 Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 

directives and have hospital staff 

comply with these directives (in 

accordance with the provisions at 42 

CFR 489.102); (5) ensure the patient’s 

right to have a family member or 

representative of his or her choice and 

his or her own physician notified 

promptly of admission to the hospital; 

(6) inform each patient whom to contact 

at the hospital to file a grievance; and 

(7) ensure that the hospital’s grievance 

process has a mechanism for timely 

referral of patient concerns regarding 

quality of care or premature discharge to 

the appropriate Utilization and Quality 

Control Quality Improvement 

Organization (QIO). (Additional 

information regarding the Medicare 

beneficiary patient’s right to file a 

grievance or a complaint with a QIO 

may be found at the HHS Centers for 

Medicare & Medicaid Services Web site: 

http://www.cms.gov/ 

QualityImprovementOrgs/.) The 

hospital patient rights CoP also 

guarantees a patient’s right to privacy; 

care in a safe setting; freedom from all 

forms of harassment and abuse; and 

confidentiality of patient records. In 

addition, this CoP contains detailed 

standards on the use of restraint and 

seclusion in the hospital, including 

provisions regarding the training of staff 

on appropriate restraint and seclusion of 

patients as well as a requirement for the 

hospital to report any and all deaths 

associated with the use of restraint or 

seclusion. 

As the President noted in his 

memorandum to the Secretary, many 

States have already taken steps to 

ensure that a patient has the right to 

determine who may and may not visit 

him or her, regardless of whether the 

visitor is legally related to the patient. 

In addressing the President’s request to 

ensure patient visitation rights, we 

focused on developing requirements to 

ensure that hospitals and CAHs protect 

and promote patient visitation rights in 

a manner consistent with that in which 

hospitals are currently required to 

protect and promote all patient rights 

under the current CoPs. Therefore, we 

proposed a visitation rights requirement 

for hospitals and CAHs as a CoP in the 

Medicare and Medicaid programs. In 

addition to addressing the President’s 

directives regarding patient rights, we 

are also ensuring that all hospitals and 

CAHs fully inform patients (or their 

representatives) of this right, and that all 

patients are guaranteed full 

participation in designating who may 

and who may not visit them. Therefore, 

we solicited public comment on how to 

best implement this requirement. In the 

proposed rule we noted that, at a 

minimum, the requirement should 

exclude a hospital or CAH from 

requiring documentation when the 

patient has the capacity to speak or 

otherwise communicate for himself or 

herself; where patient representation 

automatically follows from a legal 

relationship recognized under State law 

(for example, a marriage, a civil union, 

a domestic partnership, or a parentchild relationship); or where requiring 

documentation would discriminate on 

an impermissible basis. 

In the April 15, 2010 Presidential 

Memorandum, the President also 

emphasized the consequences that 

restricted or limited visitation has for 

patients. Specifically, when a patient 

does not have the right to designate who 

may visit him or her simply because 

there is not a legal relationship between 

the patient and the visitor, physicians, 

nurses, and other staff caring for the 

patient often miss an opportunity to 

gain valuable patient information from 

those who may know the patient best 

with respect to the patient’s medical 

history, conditions, medications, and 

allergies, particularly if the patient has 

difficulties recalling or articulating, or is 

totally unable to recall or articulate, this 

vital personal information. Many times, 

these individuals who may know the 

patient best act as an intermediary for 

the patient, helping to communicate the 

patient’s needs to hospital staff. We 

agree that restricted or limited hospital 

and CAH visitation can effectively 

eliminate these advocates for many 

patients, potentially to the detriment of 

the patient’s health and safety. 

An article published in 2004 in the 

Journal of the American Medical 

Association (Berwick, D.M. and Kotagal, 

M.: ‘‘Restricted visiting hours in ICUs: 

time to change.’’ JAMA. 2004; Vol. 292, 

pp. 736–737) discusses the health and 

safety benefits of open visitation for 

patients, families, and intensive care 

unit (ICU) staff and debunks some of the 

myths surrounding the issue 

(physiologic stress for the patient; 

barriers to provision of care; exhaustion 

of family and friends) through a review 

of the literature and through the 

authors’ own experiences working with 

hospitals that were attempting a 

systematic approach to liberalizing ICU 

visitation as part of a collaborative with 

the Institute for Healthcare 

Improvement. The authors of the article 

ultimately concluded that ‘‘available 

evidence indicates that hazards and 

problems regarding open visitation are 

generally overstated and manageable,’’ 

and that such visitation policies ‘‘do not 

harm patients but rather may help them 

by providing a support system and 

shaping a more familiar environment’’ as 

they ‘‘engender trust in families, creating 

a better working relationship between 

hospital staff and family members.’’ 

II. Provisions of the Proposed Rule and 

Response to Comments 

We published a proposed rule in the 

Federal Register on May 26, 2010 (75 

FR 29479). In that rule, we proposed to 

revise the Medicare hospital and CAH 

CoPs to provide visitation rights to 

Medicare and Medicaid patients. 

We provided a 60-day public 

comment period in which we received 

approximately 7,600 timely comments 

from individuals, advocacy 

organizations, legal firms, and health 

care facilities. Of the approximately 

7,600 timely comments, more than 

6,300 were versions of a form letter that 

all expressed the same sentiment of 

strong support for the proposed 

regulation. The remaining comments, 

with very few exceptions, also 

expressed strong support for the concept 

and overall goals of the proposed 

regulation. Summaries of the public 

comments are set forth below. 

Hospital Visitation Rights 

We proposed a visitation rights 

requirement for hospitals as a new 

standard within the patient rights CoP at 

§ 482.13. In that provision, we specified 

that hospitals would be required to have 

written policies and procedures 

regarding the visitation rights of 

patients, including those setting forth 

any clinically necessary or reasonable 

restriction or limitation that the hospital 

may need to place on such rights as well 

as the reasons for the clinical restriction 

or limitation. As part of these 

requirements, the hospital must inform 

each patient, or his or her representative 

where appropriate, of the patient’s 

visitation rights, including any clinical 

restriction or limitation on those rights, 

when the patient, or his or her 

representative where appropriate, is 

informed of the other rights specified in 

§ 482.13. We also proposed that, as part 

of his or her visitation rights, each 

patient (or representative where 

appropriate) must be informed of his or 

her right, subject to his or her consent, 

to receive the visitors whom he or she 

designates, whether a spouse, a 

domestic partner (including a same-sex 

domestic partner), another family 

member, or a friend, and of the right to 

withdraw or deny such consent at any 

time. We solicited public comment on 

the style and form that patient notices 

or disclosures would need to follow so 

that patients would be best informed of 

these rights. 

We also proposed that hospitals 

would not be permitted to restrict, limit, 


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Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 70833 

or otherwise deny visitation privileges 

on the basis of race, color, national 

origin, religion, sex, gender identity, 

sexual orientation, or disability. In 

addition, we proposed to require 

hospitals to ensure that all visitors 

designated by the patient (or 

representative where appropriate) enjoy 

visitation privileges that are no more 

restrictive than those that immediate 

family members would enjoy. 

Visitation Rights With Respect to CAHs 

We proposed to apply the same 

visitation requirements to CAHs by 

revising the CoPs for CAHs. Because the 

CoPs for CAHs do not contain patient 

rights provisions, we proposed to add a 

new standard on patient visitation rights 

at § 485.635(f) within the existing CoP 

on provision of services. 

Comment: The vast majority of 

commenters expressed support for the 

proposed regulation. Of those 

commenters who submitted positive 

comments, many also included a 

rationale for their positive support. 

Many commenters noted the harm in 

keeping loved ones apart, and expressed 

support for the rule based on the need 

for compassionate treatment of all 

patients and loved ones. One 

commenter indicated it is shameful and 

embarrassing to ask for ‘‘special’’ 

treatment to visit a sick loved one, when 

it is not the hospital’s decision to make 

in the first place. Another commenter 

felt there was ‘‘no excuse’’ for hospitals 

to make such visitation decisions. One 

commenter stated that affording the 

right of an individual to choose their 

visitors or seek comfort is a crucial step 

towards challenging discrimination and 

improving health outcomes. A few 

commenters supported the proposed 

regulation based on the doctrine of the 

separation of Church (in the form of the 

personal religious beliefs of hospital 

staff) and State (in the form of official 

hospital policies and procedures). Other 

commenters supported the proposed 

regulation, citing the benefits that they 

personally experienced when their 

loved one was ill and they were granted 

access, even without having an advance 

directive naming them as the patient’s 

representative. Still others described 

scenarios where an individual was 

permitted to visit a patient only because 

the individual lied about his or her 

relationship to the patient (such as 

claiming to be a biological relation). 

Many commenters supported the rule 

because they believed that denying 

access to hospitalized loved ones is 

cruel and inhumane; some commenters 

even described such a denial as a form 

of punishment. The commenters 

expressed the sentiment that visitation 

is a moral issue and a basic human 

right, and that regardless of sexual 

identity or recognized marital status, 

one person being permitted to visit and 

care for another should not require a 

law. 

Other commenters noted that some 

current visitation policies in facilities 

are discriminatory, unjust, and deny 

basic equal rights to some patients. 

Several commenters noted that facilities 

should be focused on providing medical 

treatment in keeping with the tenets of 

the Hippocratic oath, rather than 

dictating what constitutes an 

appropriate visitor. Commenters agreed 

that equal visitation rights are critical to 

the safety, welfare and equal treatment 

of persons who may unexpectedly find 

themselves under the care of a hospital 

or CAH. 

Response: We thank the commenters 

for their support, and agree that all 

patients must be ensured the right to 

choose their own visitors. We agree that 

all Medicare- and Medicaidparticipating hospitals and CAHs must 

have written policies and procedures 

regarding the visitation rights of 

patients, including those setting forth 

any clinically necessary or reasonable 

restriction or limitation that the hospital 

or CAH may need to place on such 

rights as well as the reasons for the 

clinical restriction or limitation. 

Comment: A few commenters 

approved of the proposed regulation, 

and suggested that fines, civil penalties, 

and/or jail time should be imposed 

upon hospitals and individuals that 

deny loved ones access to patients on an 

impermissible basis. Others suggested 

that a list of non-compliant facilities 

should be made available to the public. 

Response: As a CoP for hospitals and 

CAHs, noncompliance with this 

provision could result in the provider’s 

termination from the Medicare program. 

Medicare is the single largest health care 

payer in the country; therefore, being 

terminated from participation in the 

Medicare program, and therefore unable 

to receive Medicare payments, is a very 

serious consequence that all 

participating hospitals endeavor to 

avoid. Hospitals and CAHs that have 

been terminated from Medicare 

participation may also not receive 

Medicaid payments. Therefore, we 

believe that hospitals and CAHs already 

have a very strong incentive, absent 

fines and other consequences, to comply 

with this requirement. In addition, CMS 

does not have the legal authority to 

impose other types of sanctions for noncompliant hospitals or CAHs outside of 

the existing scheme. Because, at this 

time, no quality measures have been 

developed relating to compliance with 

this requirement, CMS is not in a 

position to publicly report this data. 

However, should a quality measure be 

developed in the future, this 

information could be included on the 

Hospital Compare Web site (http:// 

www.hospitalcompare.hhs.gov/). 

Comment: Many commenters were 

confused by the use of the term 

‘‘representative’’ in this section. 

Commenters were unclear about 

whether the patient’s representative for 

visitation purposes needed to be the 

patient’s legal representative for 

decision-making purposes. 

Response: We agree that using the 

term ‘‘representative’’ in this rule is 

confusing and may be misleading. For 

purposes of exercising visitation rights, 

we do not believe that the individual 

exercising the patient’s visitation rights 

needs to be the same individual who is 

legally responsible for making medical 

decisions on the patient’s behalf, though 

it is certainly possible for both roles to 

be filled by the same individual. To 

avoid potential confusion, we have 

replaced the word ‘‘representative’’ with 

the term ‘‘support person.’’ The term 

‘‘support person’’ will, we believe, allow 

for a broader interpretation of the 

requirement and increase flexibility for 

patients and providers alike. A support 

person could be a family member, 

friend, or other individual who is there 

to support the patient during the course 

of the stay. This concept is currently 

expressed in standard RI.01.01.01 of 

The Joint Commission guidelines for 

hospitals, and we believe that it 

appropriately reflects our broad 

interpretation of the individual who 

may exercise a patient’s visitation rights 

on his or her behalf. 

Comment: Commenters were 

uniformly supportive of the requirement 

for hospitals and CAHs to have written 

policies and procedures on visitation. 

Commenters were also strongly 

supportive of a clear, formalized, 

written notice process for informing the 

patient and, as appropriate, would-be 

visitors and/or family and friends, of the 

patient’s visitation rights. Some 

commenters recommended specific 

times as to when notice should be given, 

such as upon admission, as early as 

possible in the admissions process, and/ 

or whenever copies of the visitation 

policy are requested. Other commenters 

suggested that the notice of visitation 

rights be limited to a single page. 

Several other commenters requested 

that the notice also be provided orally 

and in an accessible manner in 

accordance with Title VI of the 1964 

Civil Rights Act, in order to ensure the 

communication of the content in an 

appropriate manner. Still other 


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70834 Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 

commenters suggested that the notice of 

visitation rights should be posted in 

public spaces and in the patient’s room. 

Response: We thank the commenters 

for their support of the need to notify 

patients or their support person about 

their rights. We agree that hospitals and 

CAHs should be required to notify 

patients or their support person, in 

writing, of the patient’s rights, including 

their right to receive visitors of their 

choosing. In accordance with the 

current requirements at § 482.13(a), 

Notice of rights, hospitals must inform 

patients or their support person, where 

appropriate, of the patient’s rights in 

that hospital before care is furnished to 

a patient whenever possible. This 

requirement for providing the notice of 

patient rights, now including the right 

to designate and receive visitors, before 

care is initiated meets the concerns of 

some commenters regarding the timing 

of the notice. Therefore, we are retaining 

the current requirements of § 482.13(a) 

related to the timing of the notice of 

rights, and are finalizing the 

requirements of § 482.13(h)(1) and (2) 

specifically related to the written notice 

of visitation rights. Likewise, we are 

modifying the requirement of proposed 

§ 485.635(f)(1) to require CAHs to notify 

patients of their visitation rights in 

advance of furnishing patient care 

whenever possible. 

While we are finalizing the written 

notice of visitation rights requirement 

under the authority of sections 

1861(e)(9) and 1820 of the Act, we agree 

with commenters that there are other 

legal requirements, most notably those 

under Title VI of the Civil Rights Act of 

1964, that are related to this provision. 

Our requirement is compatible with 

recent guidance on Title VI of the Civil 

Rights Act of 1964. The Department of 

Health and Human Services’ (HHS) 

guidance related to Title VI of the Civil 

Rights Act of 1964, ‘‘Guidance to Federal 

Assistance Recipients Regarding Title VI 

Prohibition Against National Origin 

Discrimination Affecting Limited 

English Proficient Persons’’ (August 8, 

2003, 68 FR 47311) applies to those 

entities that receive Federal financial 

assistance from HHS, including 

Medicare- and Medicaid-participating 

hospitals and CAHs. This guidance may 

assist hospitals and CAHs in ensuring 

that patient rights information is 

provided in a language and manner the 

patient understands. 

Providing each patient or support 

person with the written notice of 

visitation rights before the start of care 

sufficiently achieves the goal of 

informing patients; therefore, we are not 

requiring such notice to be posted 

within the facility. This rule does not 

prohibit hospitals and CAHs from 

posting information about their 

visitation policies of their own volition. 

Furthermore, we are not requiring 

facilities to provide the notice of rights 

in any particular format or to 

individuals other than the patient or 

support person. Facilities are already 

providing a notice of rights to patients 

in accordance with the requirements of 

the current rule and contemporary 

standards of practice. In order to 

facilitate prompt compliance and 

minimize the burden upon facilities, it 

is essential to allow them the flexibility 

to adapt their current notice procedures 

and documents to include this new 

notice of visitation rights requirement 

and to continue the strong focus on 

patients, rather than the many visitors 

who may pass through a facility in any 

given day. 

Comment: In addition to notifying 

patients of their visitation rights, some 

commenters suggested that the notice 

should include information about any 

restrictions on those visitation rights, 

including common examples of 

situations when visitation may be 

restricted, and any specific restrictions 

applicable to the patient. Additionally, 

the following items were proposed as 

elements of the disclosure notice: 

Æ Recitation of the specific language 

from the regulation (that ‘‘hospitals 

cannot restrict, limit, or otherwise deny 

visitation privileges on the basis of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, or 

disability’’); 

Æ Accompanying notice related to a 

patient’s right to complete an advance 

directive or other designation of a health 

care agent to represent the patient; 

Æ Accompanying notice about the 

grievance process that a patient (or a 

visitor) may follow to appeal a denial of 

visitation; and 

Æ Contact information for a dedicated 

hospital staff person who can resolve 

visitation conflicts. 

Response: We agree that the notice of 

visitation rights should include 

information related to reasonable, 

clinically necessary restrictions or 

limitations on those rights. Therefore, 

we are finalizing § 482.13(h)(1) and 

§ 485.635(f)(1), which require hospitals 

and CAHs to ‘‘inform each patient (or 

support person, where appropriate) of 

his or her visitation rights, including 

any clinical restriction or limitation on 

such rights.’’ In order to improve 

compliance with this requirement and 

minimize the burden on providers, it is 

necessary to allow hospitals and CAHs 

flexibility in meeting this requirement. 

These facilities can consider the 

usefulness of providing examples, 

developing medical condition-specific 

notices tailored to the common needs of 

different patient populations, and/or 

reciting the text of this rule as they 

develop their visitation rights notice. 

We also agree that hospitals should 

notify patients of their advance directive 

rights and their right to access the 

hospital’s grievance system, and 

information on how to do so. This 

information is currently required to be 

provided to patients or their support 

person in accordance with § 482.13(a) 

and (b). 

Comment: Several commenters 

suggested that CMS identify (and create, 

where necessary) best practices for 

training staff and administrators on 

cultural competency and the benefits of 

open visitation policies. Several 

commenters suggested that hospitals 

should be required to train their staff in 

discrimination prevention and cultural 

competency, to better assure that the 

rights of patients are promoted and 

protected. 

Response: We thank the commenters 

for their suggestions. However, we 

believe that it is outside the scope of 

this rule for CMS to identify or create 

best practices for training various 

healthcare facility staff on cultural 

competency and the benefits of open 

visitation policies. We believe that the 

establishment of these rules will lead 

hospitals and CAHs to actively seek out 

and implement best practices and other 

recommendations for training staff on 

these issues in order to fully comply 

with the CoPs and continue 

participation in the Medicare and 

Medicaid programs. We encourage 

hospitals to address issues of cultural 

competencies specific to the needs of 

their unique patient populations as part 

of their quality assessment and 

performance improvement programs. In 

the future, CMS may use subregulatory 

guidance and technical assistance 

programs (such as Medicare Learning 

Network at http://www.cms.gov/ 

MLNGenInfo/) to make known best 

practice information that is developed 

by other entities and organizations. 

Comment: Several commenters 

suggested that complaints regarding the 

patient’s visitation rights should be 

subject to a grievance process, and that 

the right to file a grievance should be 

readily available to the patient as well 

as any would-be visitor. 

Response: If a patient believes that his 

or her visitation rights have been 

violated, the patient or his or her 

representative may file a grievance with 

the hospital using the hospital’s internal 

grievance resolution process. We note 

that CAHs are not currently required to 

have an internal complaint process; 


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nonetheless, they may have such a 

process in place for quality 

improvement, State licensure, 

accreditation, or other reasons. If the 

patient believes that the quality of their 

care was negatively impacted by a 

violation of his or her rights, the patient 

may also file a complaint with the State 

survey agency responsible for oversight 

of the facility, or the body responsible 

for accrediting the facility (if 

applicable). In the case of Medicare 

beneficiaries, complaints may also be 

filed with the QIO in that State. These 

external complaint processes are 

available to both hospital and CAH 

patients. We believe that these current 

complaint resolution mechanisms offer 

the necessary protections for patients 

who believe that their rights have been 

violated. Likewise, if a visitor believes 

that a hospital or CAH is not complying 

with the requirements of this rule, the 

visitor may file a complaint with the 

State survey agency responsible for 

oversight of the facility, as well as the 

body responsible for accrediting the 

facility (if applicable). 

Comment: A few commenters 

requested examples of how the new 

regulation will be implemented in 

facilities. 

Response: This final rule requires 

hospitals and CAHs to notify a patient 

or support person of his or her visitation 

rights, and sets forth the need for all 

hospitals and CAHs to establish nondiscriminatory visitation policies that 

treat all visitors equally, consistent with 

the designations of patients or support 

persons. This applies to all patients, 

regardless of their payment source. 

These are broad expectations and rights 

that afford facilities the flexibility to 

revise current practices and procedures 

as necessary to meet these expectations. 

As such, we are not in a position to 

provide specific examples of how the 

regulation will be implemented in any 

facility because we do not know the 

particular circumstances of each facility, 

their current policies and practices, 

their particular patient populations, etc. 

Comment: Several commenters 

suggested additional protected 

categories that should be added so that 

hospitals and CAHs are explicitly 

prohibited in regulation from 

discriminating against additional 

specified populations. Commenters 

stated that the protected categories in 

the proposed rule should be expanded 

to also include: marital status, family 

composition, age, primary language and 

immigration status. In addition, 

commenters suggested that the proposed 

rule make explicit that institutional or 

individual conscience cannot be used to 

deny a visitor access to the patient. 

Response: As revised, we believe that 

this rule makes clear that hospitals must 

establish and implement visitation 

policies that grant full and equal 

visitation access to all individuals 

designated by the patient or support 

person, consistent with patient 

preferences. Patients (or their support 

persons) may designate anyone as an 

approved visitor, and a hospital or CAH 

may not discriminate against any 

approved visitors(and may impose only 

reasonable, clinically necessary 

restrictions or limitations on visitation). 

We believe that this regulatory policy is 

responsive to the concerns of 

commenters while still adhering to the 

specific instructions of the President’s 

April 15, 2010 memorandum to the 

Secretary. Therefore, we are not 

expanding the list of explicitly 

protected classes at this time. 

Comment: Several commenters stated 

that they feared crossing state lines 

because not all States recognize the legal 

status of relationships in the same way. 

Without such consistent recognition of 

legal status, an individual may be 

recognized as the default decision 

making authority by one State, but may 

not be recognized as such by another 

State. A few commenters also stated 

that, while traveling, it could be 

difficult to obtain the documentation 

required to verify the legal status of a 

relationship, particularly in emergency 

situations. Commenters noted that, even 

if documentation of a legal relationship 

as recognized in a certain State was 

available while traveling and medical 

attention was needed, people may not 

seek treatment because they fear that 

their legal relationship documentation 

may not be recognized by the State in 

which they are traveling. 

Response: We understand the 

concerns of commenters in this area. 

These concerns highlight the need for 

individuals to establish an advance 

directive as described in 42 CFR Part 

489. As a legal document expressing the 

patient’s preferences in one or more 

areas related to medical treatment, an 

advance directive can designate the 

individual who is permitted to represent 

the patient, should the patient become 

incapacitated. Although section 

1866(f)(1) of the Act defers to State law 

(whether statutory or established by the 

courts) to govern the establishment and 

recognition of advance directives, we 

believe that this type of document 

continues to be a generally viable option 

for patients seeking to document, in 

writing, their representative and/or 

support person designation and 

treatment preferences. Consistent with 

provisions concerning the establishment 

and recognition of advance directives, 

all States continue to have the right to 

determine the legal relationships that 

will be recognized by State law and 

practice, to the extent that they do so in 

accordance with constitutional 

principles. We do not have the authority 

in this rule to compel one State to 

recognize a legal relationship that is 

established in another State. That said, 

we remind hospitals and CAHs that this 

rule does require full and equal 

visitation for all visitors who are 

designated by the patient or support 

person, consistent with the patient’s 

preferences. It is our understanding that, 

even where one State does not recognize 

a legal relationship recognized by 

another State, the law of that State 

generally does not prohibit a private 

actor in that State—such as a hospital or 

CAH—from recognizing that legal 

relationship. Thus, there generally 

appear to be no barriers to such a 

hospital or CAH recognizing a legal 

relationship recognized by another 

State, even if its own State does not 

recognize that legal relationship. 

Comment: A few commenters 

expressed concern that the validity of an 

adoption in one State may not be 

recognized by another State in cases 

where a minor is the patient. 

Commenters feared being required to 

verify proof of parenthood at the height 

of a medical emergency if located in a 

different state than where adoption 

occurred. Concern about the minor 

patient’s representative having the right 

to make decisions about medical care 

‘‘as allowed under State law’’ was also 

noted by few commenters. Commenters 

felt that, as the language in the 

regulation stands, it may allow hospitals 

to deny the ability of adoptive parents 

to act as a minor patient’s 

representative, even though the 

adoptive relationship is recognized 

under the laws of a different State. 

Other commenters expressed concern 

about the ability of non-biological 

parents to make decisions for their child 

in the absence of a legal adoption. 

Commenters expressed these same 

concerns with respect to the ability to 

visit a minor child. 

Response: A legal adoption in one 

State is generally recognized as a legal 

parent-child relationship in another 

State, along with all of the default 

decision-making authorities that such a 

legal relationship confers upon a legal 

parent. This legal relationship continues 

to exist even if that parent and minor 

crosses State lines into another State in 

which that parent would have been 

prohibited from adopting that child. As 

a legal parent and representative of the 

minor child, the legal parent is, in 

accordance with the requirements of 


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this final rule, able to designate those 

individuals who are permitted to visit 

the child. Thus, this rule ensures the 

representative’s ability to ensure 

visitation access for other individuals. 

Under this rule, issues of nonbiological and non-adoptive parents 

acting as the minor child’s decision 

maker are governed by State law. While 

we do not have the authority in this 

final rule to compel a State to generally 

recognize such parents as legal parents, 

we note that some States in fact 

recognize ‘‘de facto’’ or ‘‘functional’’ or 

‘‘equitable’’ parenthood, i.e., recognize 

non-biological and non-adoptive parents 

as legal parents. Nothing in this rule 

prohibits a hospital or CAH from 

recognizing non-biological and nonadoptive parents as legal parents for 

purposes of the visitation policies set 

forth in this rule. 

Comment: Several commenters stated 

that they supported the proposed 

visitation regulation because it is critical 

for patients to be able to choose their 

own visitors, particularly for those 

patients who belong to blended families. 

Commenters described ‘‘families of 

choice’’—strong relationships with 

friends and other people who support 

the patient and who can be contacted 

during times of need. Accordingly, 

commenters stated that, when a patient 

is incapacitated, the patient’s 

representative (which we now refer to as 

a support person) should not be chosen 

solely based on an individual’s legal 

relationship with the patient. 

Commenters noted the lack of 

protection for ‘‘families of choice,’’ 

which do not necessarily fit a traditional 

definition of a family, one based on 

bloodlines, marriage, or adoption, make 

it difficult for visitors to gain access to 

sick loved ones. Commenters noted that 

these representatives and sources of 

support should enjoy full visitation 

rights as any biological family member 

of the patient would. 

Response: We appreciate the support 

of commenters, as it confirms our 

understanding that this visitation rights 

rule will help ensure that patients have 

access to their chosen loved ones while 

the patient is being cared for in a 

hospital or CAH. We also agree that oral 

designation of a support person, 

regardless of a particular relationship’s 

legal status, should be sufficient for 

establishing the individual who may 

exercise the patient’s visitation rights on 

his or her behalf, should the patient be 

unable to do so. In the absence of a 

verbal support person designation, 

hospitals and CAHs would look to their 

established policies and procedures for 

establishing a support person for the 

purpose of exercising a patient’s 

visitation rights. As discussed later in 

this section, there are numerous sources 

of information and documentation that 

may be appropriate to establish the 

appropriateness of an individual to 

exercise an incapacitated patient’s 

visitation rights on his or her behalf. We 

note that this section does not apply to 

designation of an individual as the 

patient’s representative for purposes of 

medical decision making, as this 

designation may be governed by State 

law and regulation. 

Comment: Many commenters 

submitted personal anecdotes related to 

their hospital and CAH visitation 

experiences. Some stated that they were 

denied information about or access to a 

sick loved one while in the hospital. In 

contrast, some commenters requested 

examples of situations where patient 

visitation rights have been violated. 

Other commenters noted that if they 

were to be hospitalized in the future, 

they would like for their spouse or 

domestic partner to be able to make 

medical decisions on their behalf. 

Several commenters stated that they had 

prepared advance directive 

documentation in the event something 

should warrant a hospital visit for 

themselves and/or a spouse or domestic 

partner, while others expressed concern 

about advance directives, stating that 

they cannot rely on those directives 

being honored in all health care settings, 

institutions, or States uniformly, based 

on their marital/relationship status. Still 

other commenters appeared to believe 

that this final rule removes the need for 

advance directives to designate 

healthcare decision makers. 

Response: We appreciate all of the 

experiences and concerns shared by the 

commenters, and we encourage those 

commenters who sought examples of 

patient visitation rights being denied to 

refer to the many detailed personal 

examples that were submitted to us (see 

http://www.regulations.gov. In the ‘‘key 

word or I.D.’’ entry field, enter the 

docket ID (CMS–2010–0207). Then, 

select ‘‘public submissions’’ from the 

drop-down menu under ‘‘select 

document type’’). Numerous comments 

reaffirmed our understanding of the 

current practice in some medical 

institutions that denies patients access 

to their loved ones in times of need. The 

commenters also confirmed our 

understanding of the public’s deeplyheld desire to be with loved ones in 

such medical institutions, which further 

validates the need for this final rule. We 

also appreciate the comments related to 

advance directives, and encourage 

individuals to establish written advance 

directives that document the selection 

of a designated patient representative, 

support person, and/or the patient’s 

choices about specific medical 

conditions and treatments. We believe 

that such documentation will help 

ensure that the patient’s wishes are 

honored. We acknowledge that the Act 

defers to State law to govern advance 

directive issues, and that such deference 

may be a source of concern to 

commenters. However these advance 

directive issues are beyond the purview 

of this rule. 

Comment: We received numerous 

comments affirming our general 

position that, when a patient can speak 

for himself or herself, a hospital or CAH 

does not need to require written 

documentation of a patient 

representative. That is, the commenters 

supported our contention that oral 

designation of ‘‘representative’’ status is 

sufficient. Comments also suggested that 

no proof should be required in cases 

where the patient provides oral 

confirmation that he or she would like 

to receive any particular visitor. 

Furthermore, the commenters advocated 

against a formal documentation process, 

whereby the hospital would be asked to 

obtain a list of permitted and nonpermitted visitors from each patient. 

They stated that, as a practical matter, 

it would be simpler for the hospital to 

recognize as welcome or not any 

particular potential visitor, per the 

patient’s wishes, when that patient 

make his or her wishes known. 

Response: We agree that an oral 

designation of a support person 

(formerly known as a ‘‘representative’’) 

is sufficient for establishing the 

individual who may exercise the 

patient’s visitation rights on his or her 

behalf, should the patient be unable to 

do so. We also agree that the patient’s 

or support person’s oral consent to 

admit a visitor or to deny a visitor is 

sufficient evidence of their wishes, and 

that further proof of those wishes 

should not be required. However, 

hospitals and CAHs are permitted to 

record such information in the patient’s 

record for future reference, if they so 

choose. 

Comment: Some commenters 

submitted comments related to the rare 

cases in which hospitals may need to 

require written documentation of 

patient representation. Of these, some 

commenters suggested that 

documentation should be required only 

in cases where more than one person 

claims to be the patient’s spouse, 

domestic partner or surrogate. Others 

suggested that proof should be required 

only if the patient is incapacitated. 

Other commenters suggested dropping 

‘‘proof’’ requirements altogether in an 

emergency situation and/or if the 


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patient is unconscious or otherwise 

incapacitated. A few commenters stated 

that the visitor should not have to leave 

the bedside of the patient to obtain 

proper documentation, while others 

stated that proof should not be required 

of same-sex couples where it is not 

required of similarly-situated differentsex couples. Other comments to this 

effect went further, suggesting that 

hospitals requiring documentation from 

a same-sex couple but not a differentsex couple in the same situation would 

be engaging in discrimination on an 

impermissible basis (i.e. on the basis of 

sexual orientation). 

Response: We agree with those 

commenters who stated that a hospital 

or CAH must apply its documentation 

policy equally for all patients and 

support persons. In accordance with the 

comments submitted with respect to 

this rule, we believe that documentation 

to establish support person status for the 

purpose of exercising a patient’s 

visitation rights should be required only 

in the event that the patient is 

incapacitated and two or more 

individuals claim to be the patient’s 

support person. Since the visitation 

rights provision is new, we do not 

believe that States have established 

separate laws and regulations that 

would require documentation to 

establish an individual as the support 

person in other circumstances. While 

we acknowledge the desire of the 

individuals who claim to be the 

patient’s support person to remain at the 

patient’s bedside, we recognize that this 

is not possible in every situation. In 

these situations, such individuals may 

need to leave the area in order to obtain 

written documentation of the patient’s 

wishes. Individuals may wish to 

maintain such documentation on their 

person and/or maintain such 

documentation in an electronic 

database, such as an advance directive 

registry, that grants access to health care 

facilities in order to avoid leaving the 

patient’s bedside to obtain proof of 

support person status. 

Comment: A few comments spoke to 

matters beyond a support person’s 

ability to visit and designate other 

visitors, suggesting that, where the 

patient is unable to communicate and 

decisions related to providing or 

withdrawing medical care are necessary, 

documentation should be required, 

unless the patient designated the 

representative for health care decision 

making before being unable to 

communicate. 

Response: We agree that situations 

related to medical decision making are 

governed by State law, whether 

established under legislative or judicial 

authority. We note that issues of 

surrogate medical decision making fall 

outside the scope of this rule on 

visitation policies. Hospitals and CAHs 

must always comply with their State 

laws and regulations, and we remind 

facilities that their policies and 

procedures related to requiring 

documentation of support person status 

must be applied in a non-discriminatory 

manner. 

Comment: Comments were received 

regarding what forms of proof might 

suffice to establish the appropriateness 

of a visitor where the patient is 

incapacitated or otherwise unable to 

designate visitors, and a representative 

in accordance with State law or a 

patient-designated support person is not 

available to exercise the patient’s rights 

on his or her behalf. Comments also 

suggested that these forms of ‘‘proof’’ 

could also be used to help establish a 

support person’s status as such. 

The following forms of ‘‘proof’’ were 

suggested: 

• An advance directive naming the 

individual as a support person, 

approved visitor or designated decision 

maker (regardless of the State in which 

the directive is established); 

• Shared residence; 

• Shared ownership of a property or 

business; 

• Financial interdependence; 

• Marital/Relationship status; 

• Existence of a legal relationship 

recognized in another jurisdiction, even 

if not recognized in another jurisdiction, 

including: Parent-child, civil union, 

marriage, domestic partnership; 

• Acknowledgment of a committed 

relationship (e.g. an affidavit); and 

• Written documentation of the 

patient’s chosen individual(s) even if it 

is not a legally recognized advance 

directive. 

Response: We agree that any of these 

forms of proof could be sufficient for 

hospitals and CAHs to establish the 

appropriateness of a visitor when a 

patient is incapacitated and no 

representative or support person is 

available to exercise a patient’s 

visitation rights on his or her behalf. We 

also agree that these forms of proof may 

be helpful for establishing support 

person status for the purpose of 

exercising the patient’s visitation rights 

when the patient is incapacitated. In 

order to obtain this information, 

hospitals and CAHs may choose to 

examine licenses, State identification 

cards, bank statements, deeds, lease 

agreements, etc. These lists of proof and 

documentation are not intended to be 

exhaustive of all potential sources of 

information regarding patient visitation 

or support person preferences. Our 

overall expectation is that hospitals and 

CAHs will use this information to guide 

the establishment of flexible policies 

and procedures that balance the dual 

needs of ensuring patient safety and 

ensuring patient access to loved ones. 

Comment: A few commenters 

suggested that the final rule should 

ensure that patients have the right to 

exclude certain visitors to assure their 

well-being, and that the patient’s 

support person should have the highest 

level of authority to do so. 

Response: We agree that the patient’s 

right to choose visitors also includes the 

right to deny visitors. We included this 

concept at proposed § 482.13(h)(2) and 

§ 485.635(f)(2), stating, ‘‘Inform each 

patient (or representative, where 

appropriate) of his or her visitation 

rights * * * and his or her right to 

withdraw or deny such consent at any 

time.’’ We continue to believe that this 

is an appropriate provision and are 

finalizing it as such. Patients, or their 

support person acting on their behalf, 

have the right to deny visitors. 

Comment: Some commenters 

suggested that the regulation should 

include an explicit requirement granting 

the patient’s support person direct 

access to the patient. One commenter 

suggested that health care proxies or 

powers of attorney that are legally 

recognized in one State also be 

recognized by hospitals and CAHs in 

other States for the purpose of 

establishing visitation rights. 

Response: We agree that the patient’s 

representative and/or support person, as 

the individual responsible for exercising 

the patient’s rights on the patient’s 

behalf when the patient is incapacitated 

or otherwise unable to do so directly, 

should be granted direct access to the 

patient. This basic concept is embodied 

throughout the current hospital 

regulations, including through the 

requirement at § 482.13(a) and (b) that 

the patient or patient’s representative 

must be informed of the patient’s rights 

and how to exercise those rights. We 

also agree that using the information 

provided in an advance directive or 

other written document, whether it is or 

is not legally recognized by the State, 

may be useful for hospitals and CAHs 

when trying to determine appropriate 

visitors when a patient is unable to 

communicate his or her own wishes and 

a legal representative as established 

consistent with State law or a support 

person is not available to exercise the 

patient’s visitation rights on his or her 

behalf. 

Comment: A number of commenters 

expressed the concern that the 

regulation’s reference to State law, as it 

pertains to the hospital’s recognition of 


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a patient’s representative, could be 

interpreted as inappropriately limiting 

the designation of a representative, and 

suggested that we remove ‘‘as allowed 

under State law’’ from the regulation. 

Response: As previously discussed, 

we agree that using the term 

‘‘representative,’’ with its implicit links 

to state law, is too narrow for this 

regulation. Therefore, we have replaced 

the term ‘‘representative’’ with the term 

‘‘support person,’’ which is intended to 

broadly describe the family member, 

friend, or other individual who supports 

the patient during his or her hospital or 

CAH stay and may exercise the patient’s 

visitation rights on his or her behalf. 

Issues of legal representation and health 

care decision making are beyond the 

purview of this final rule. We remind all 

hospitals and CAHs that these issues are 

generally addressed in State law 

(including case law). All Medicareparticipating providers, including 

hospitals and CAHs, are required to 

remain in full compliance with the laws 

and regulations of their State, in 

addition to these Federal requirements. 

Comment: A few commenters noted 

that they were denied access to visit a 

loved one by the patient’s 

representative, although they believed 

that such a denial was not in the best 

interest of the patient. The commenters 

cited their ability to provide pertinent 

medical information about the patient as 

a primary reason for allowing them 

access to the patient despite the 

decision of the patient’s representative. 

A few comments also noted the impact 

of the well-recognized legal concept of 

‘‘substituted judgment’’ as requiring 

patients’ families and representatives to 

make medical decisions based on the 

patient’s values and interests and not 

their own. 

Response: As the individual 

responsible for making decisions on the 

patient’s behalf, the patient 

representative has the authority to 

exercise a patient’s right to designate 

and deny visitors just as the patient 

would if he or she were capable of doing 

so. The designation of and exercise of 

authority by the patient’s representative 

is governed by State law, including 

statutory and case law. Many State 

courts have addressed the concept of 

substituted judgment, whereby the 

patient representative is expected to 

make medical decisions based on the 

patient’s values and interests, rather 

than the representative’s own values 

and interests. State courts have also 

developed a body of closely related law 

around the matter of a representative 

acting in the patient’s best interest. Such 

case law regarding substituted judgment 

and best interest may be a resource for 

hospitals and CAHs as they establish 

policies and procedures intended to 

address these difficult situations. 

Hospitals and CAHs may also choose to 

utilize their own social work and 

pastoral counseling resources to resolve 

such conflicts to assure the patient’s 

well-being. 

Comment: Some commenters 

suggested that we replace the term 

‘‘immediate family,’’ as proposed at 

§ 482.13(h)(4) and § 485.635(f)(4), with a 

broader requirement that does not 

distinguish among different types of 

relationships. Some commenters 

asserted that the regulation, as 

proposed, would be difficult to define, 

measure, and enforce. Furthermore, 

some commenters stated that the 

regulation, as proposed, created the 

appearance of a hierarchy of family 

relationship status that could put other 

chosen family members and loved ones 

at risk of unequal treatment. 

Response: We agree that the proposed 

language may have been difficult to 

define, measure, and enforce, and that 

amending the requirement would 

further clarify our intent to assure equal 

visitation privileges for all visitors in 

accordance with the patient’s 

preferences. Therefore, we have 

amended the requirements at 

§ 482.13(h)(4) and § 485.635(f)(4) to 

state, ‘‘Ensure that all visitors enjoy full 

and equal visitation privileges 

consistent with patient preferences.’’ 

This revised requirement is patientcentered and will, we believe, ensure 

that all visitors are treated in a fair and 

equal manner by a hospital or CAH. 

Comment: Many commenters 

suggested that we broaden the context 

in which the word ‘‘family’’ is used. 

Commenters presented a variety of 

options, citing sources such as the Joint 

Commission, the Office of Personnel 

Management for the United States 

government, and current practices in 

New York State. All of these 

commenters suggested a broad concept 

of family, including any individual who 

plays a significant role in the patient‘s 

life, such as spouses, domestic partners, 

significant others (whether different-sex 

or same-sex), and other individuals not 

legally related to the patient. 

Commenters also provided a list of 

specific types of family relationships, 

and described the challenges that can be 

faced with respect to each. 

Response: We believe that both the 

preamble to the proposed rule and the 

language of the proposed requirements 

broaden the definition of ‘‘family’’ in the 

context of hospital and CAH visitation 

rights of patients. The language of the 

proposed rule (see 75 FR 36612) 

provides examples of visitors very 

similar to those given by the 

commenters (‘‘a spouse, a domestic 

partner (including a same-sex domestic 

partner), another family member, or a 

friend’’). Most importantly, the proposed 

requirements go beyond these examples 

by specifying that the patient has the 

right to designate all visitors, regardless 

of type of relationship, and, while 

patient-designated visitors may 

obviously include those mentioned, the 

requirements do not place limits on who 

may be designated as a visitor by the 

patient. This final rule maintains the 

policies articulated in the proposed rule 

in this regard. 

Comment: Commenters from the 

provider community expressed broad 

support for the rule’s recognition of the 

need for clinically necessary or 

reasonable restrictions or limitations on 

visitation. In addition to supporting the 

overall concept of ‘‘necessary 

restrictions,’’ some commenters stated 

that restrictions must be enforced 

uniformly and restrictions must be 

clearly communicated, along with their 

medical basis, to would-be visitors 

and/or the patient. These commenters 

stressed that such additional measures 

would reduce the opportunity for 

discrimination and increase 

understanding. These comments reflect 

the concerns of some commenters that 

an allowance for ‘‘reasonable’’ 

restrictions would be too broad. There 

were concerns among some of the 

commenters that a hospital or CAH 

might apply this exception capriciously 

and without adequate clinical 

justification, and that such a broad 

exception might also allow for 

restrictions rooted in discriminatory 

attitudes toward lesbian, gay, bisexual, 

and transgender people or their families. 

Several commenters asked for 

clarification on the language in the 

proposed regulation that would allow 

for a hospital or CAH to place 

limitations or restrictions on a patient’s 

visitation rights when it determined that 

it was clinically reasonable or necessary 

to do so. A commenter requested that 

one of the examples of a clinically 

reasonable restriction on visitation, 

which was used in the preamble (‘‘when 

the patient is undergoing care 

interventions’’), be stricken entirely from 

this rule. This commenter was 

concerned that a hospital or CAH might 

apply this example too broadly when 

restricting visitation for a patient, and 

that the reasons for applying it might be 

more logistical than clinical (e.g., it may 

be used by overworked staff to justify a 

restriction or limitation). 

The commenters provided numerous 

examples of legitimate reasons for 


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restricting or limiting visitors, 

including: 

Æ Any court order limiting or 

restraining contact; 

Æ Behavior presenting a direct risk or 

threat to the patient, hospital staff, or 

others in the immediate environment; 

Æ Behavior disruptive of the 

functioning of the patient care unit; 

Æ Reasonable limitations on the 

number of visitors at any one time; 

Æ Patient’s risk of infection by the 

visitor; 

Æ Visitor’s risk of infection by the 

patient; 

Æ Extraordinary protections because 

of a pandemic or infectious disease 

outbreak; 

Æ Substance abuse treatment 

protocols requiring restricted visitation; 

Æ Patient’s need for privacy or rest; 

Æ Need for privacy or rest by another 

individual in the patient’s shared room. 

Response: We appreciate the support 

of commenters for this provision of the 

proposed rule, and agree that this list, 

though not exhaustive, is an appropriate 

way to begin considering clinically 

appropriate restrictions on visitation 

privileges. 

In his April 15, 2010 memorandum on 

hospital visitation rights, the President 

directed the Secretary to initiate 

appropriate rulemaking that ‘‘should 

take into account the need for hospitals 

to restrict visitation in medically 

appropriate circumstances as well as the 

clinical decisions that medical 

professionals make about a patient’s 

care or treatment.’’ In crafting the 

language of the requirements, we took 

this Presidential directive into account, 

and thoroughly weighed the rights of a 

patient to receive visitors of his or her 

choosing against the obligation and duty 

of a hospital or CAH to provide the best 

possible care to all of its patients. We 

firmly believe that the requirements 

must allow hospitals and CAHs some 

flexibility regarding patient visitation so 

that healthcare professionals may 

exercise their best clinical judgment 

when determining when visitation is, 

and is not, appropriate. We believe that 

the best clinical judgment takes into 

account all aspects of patient health and 

safety, including any negative impact 

that patients, visitors, and staff may 

have on other patients in the hospital or 

CAH. 

In the preamble to the proposed rule, 

we provided three broad examples of 

clinically reasonable areas where 

hospitals and CAHs might impose 

restrictions or limitations on visitors: 

When the patient is undergoing care 

interventions; when there may be 

infection control issues; and when 

visitation may interfere with the care of 

other patients. There are other, similarly 

obvious areas where restriction or 

limitation of visitation would also be 

appropriate, and which commenters 

also pointed out: Existing court orders 

restricting contact of which the hospital 

or CAH is aware; disruptive, 

threatening, or violent behavior of any 

kind; patient need for rest or privacy; 

limitations on the number of visitors 

during a specific period of time; 

minimum age requirements for child 

visitors; and inpatient substance abuse 

treatment programs that have protocols 

limiting visitation. While all of these 

instances can be discussed individually, 

it may be more useful to group all of 

these examples, plus those examples 

that we mentioned in the preamble, 

under an even broader category of 

clinically appropriate and reasonable 

restriction or limitation on visitation: 

When visitation would interfere with 

the care of the patient and/or the care 

of other patients. Whether the reason for 

limiting or restricting visitation is 

infection control, disruptive behavior of 

visitors, or patient or roommate need for 

rest or privacy, all of these reasons may 

be considered as clinically reasonable 

and necessary when viewed in light of 

a hospital’s or CAH’s overarching goal 

of advancing the care, safety, and wellbeing of all of its patients. As we 

discussed in the preamble, we believe 

that current clinical thinking, along 

with some evidence in this area, 

supports the role of visitation in 

advancing the care, safety, and wellbeing of patients. However, we must 

caution commenters that visitation is 

but one aspect of patient care. Hospitals 

and CAHs must balance all aspects of 

care for all patients. Through the 

hospital and CAH CoPs, CMS expects 

all hospitals and CAHs to provide care 

to patients in a safe manner that follows 

nationally recognized guidelines and 

standards. As part of this expectation, 

CMS recognizes that hospitals and 

CAHs must be allowed some degree of 

flexibility when developing policies and 

procedures for patient care and safety, 

and in order to comply with the CoPs. 

We remind hospitals and CAHs that, 

when establishing and implementing 

visitation policies and procedures, the 

burden of proof is upon the hospital or 

CAH to demonstrate that the visitation 

restriction is necessary to provide safe 

care. 

As it is written, the requirement does 

allow a hospital or CAH a degree of 

flexibility when developing and 

imposing policies that may limit or 

restrict visitation. However, the rule 

does require that a hospital or CAH 

must contain these policies in written 

form, including the reasons for such 

restrictions, and must inform a patient 

(or his or her support person) of its 

policies regarding clinical limitations or 

restrictions on visitation rights. 

However, while we agree that a 

hospital or CAH must communicate its 

policy on limited or restricted visitation 

to patients when apprising them of their 

rights (and the requirement is written as 

such), we do not believe that a hospital 

or CAH must delineate each of the 

clinical reasons that may warrant 

imposition of this policy because it may 

be impossible to anticipate every 

instance that may give rise to such a 

situation. We do believe that hospitals 

and CAHs should clearly communicate 

how such policies are aimed at 

protecting the health and safety of all 

patients. Additionally, in situations 

where it may be necessary for patient 

visitation to be limited or restricted, 

hospitals and CAHs have a duty to the 

patient to clearly explain the reasons for 

such restrictions or limitations. 

Further, we disagree that the example 

given in the preamble of a clinically 

reasonable or necessary restriction or 

limitation on visitation (‘‘when the 

patient is undergoing care 

interventions’’) should be stricken from 

the rule entirely. This language was not 

included in the proposed requirements 

nor is it being finalized here; it was used 

merely as an example. However, we are 

aware that in some hospitals and CAHs 

throughout the nation, there still exists 

an unwritten policy of ‘‘clearing the 

room’’ of all visitors when a patient is 

undergoing an intervention. It should be 

noted here that there are often valid 

reasons for doing this. For instance, 

many patients prefer privacy during this 

time; many visitors are not prepared to 

witness the physical aspects of some 

patient care interventions and 

procedures; the physical limitations of 

the patient’s room can make the 

intervention difficult to perform with 

visitors in the room; and, when 

performing interventions or procedures 

that require aseptic technique, 

additional persons or visitors in the 

room may compromise the healthcare 

professional’s ability to control for 

infection. CMS believes that it is in the 

patient’s best interest to allow those 

healthcare professionals responsible for 

the care of the patient to make these 

clinical decisions regarding restricting 

or limiting visitation when the patient is 

undergoing a procedure or intervention. 

However, we must emphasize here 

that we strongly encourage hospitals 

and CAHs to be aware of, and sensitive 

to, the needs of any patient who may 

request that at least one visitor be 

allowed to stay in the room to provide 


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support and comfort when undergoing a 

procedure, and to make a best effort at 

accommodating such requests if the 

clinical situation allows for it. Despite 

the hospital culture of ‘‘clearing the 

room’’ for patient care interventions that 

may still exist in some hospitals and 

CAHs, we believe that many more 

hospitals and CAHs are making a best 

effort at recognizing and honoring the 

need of many patients to have a loved 

one close by while undergoing a 

potentially frightening and painful 

procedure. In this regard, we 

respectfully disagree with the comment 

stating that staff may justify such 

restrictions or limitations for logistical, 

rather than clinical, reasons. This 

comment voices a concern that 

‘‘overworked staff’’ would apply 

restrictions or limitations for logistical 

reasons and implies that logistical 

reasons are more conveniences for the 

staff than they are clinical reasons for 

the patient. In the hospital setting, the 

logistical and the clinical are often one 

and the same, and the logistics of the 

situation must sometimes be taken into 

account by healthcare professionals in 

order to ensure the best clinical 

outcomes for patients. Of the examples 

given above for restricting or limiting 

visitation during a care intervention, it 

can be argued that all are both clinical 

and logistical in nature, with each 

impacting the other. Again, CMS 

believes that, in the interests of patient 

safety, such decisions are best left to the 

healthcare professionals responsible for 

the care of the patient, and should not 

be dictated through overly prescriptive 

regulations. 

Comment: Several commenters stated 

that written documentation of patient 

representation in the form of legally 

valid advance directives, such as 

durable powers of attorney and 

healthcare proxies, (as opposed to oral 

designation of the support person by the 

patient) should be required only in the 

very rarest of cases—such as when more 

than one person claims to be a patient’s 

spouse, domestic partner, or surrogate. 

In all other cases, oral confirmation of 

an individual acting as the support 

person should suffice. Commenters 

suggested that a hospital or CAH may 

not require documentation in a 

discriminatory manner. 

Response: In the preamble, we 

specifically asked for comments on how 

to best identify those rare cases where 

hospitals and CAHs should be permitted 

to ask for written documentation to 

establish the support person as such in 

order to allow the support person the 

right to designate visitors if the patient 

is unable to do so. We appreciate the 

comments offered on this issue. We 

agree that this practice would most 

clearly be justified in those rare cases 

where the hospital or CAH faces a 

dispute among two or more persons 

claiming to be the patient’s support 

person, and the patient is incapacitated. 

Comment: One provider urged CMS to 

be cautious about fashioning ‘‘overly 

prescriptive’’ policies in the interpretive 

guidelines. 

Response: We appreciate the 

commenter’s warning, and agree that 

being overly prescriptive may stifle the 

flexibility that we intend hospitals and 

CAHs to exercise when establishing and 

implementing full and equal visitation 

for all visitors in accordance with 

patient preferences. We note that the 

Interpretive Guidelines for the CoPs, 

which will be updated to reflect these 

new requirements, fall outside of the 

scope of this rulemaking process and are 

not addressed here. 

Comment: A very small number of 

commenters suggested that CMS should 

not adopt this proposed rule, believing 

that there does not exist a pressing need 

for it to exist, and that adding the 

additional patient rights information to 

the existing notice of patient rights 

disclosure would serve only to increase 

hospital costs, lengthen the admission 

process, and further overwhelm 

patients. 

Response: While we recognize the 

commenters’ concern regarding the large 

amount of information that is provided 

to patients and the time that it takes to 

do so, we continue to believe that it is 

better to apprise patients and their 

support person of the patient’s rights, 

and to ensure this practice through the 

requirements of the conditions of 

participation. We also continue to 

believe that this regulation will address 

a very real problem that negatively 

impacts patient outcomes and that runs 

contrary to our goal of safe and effective 

care for every patient, every time. 

Furthermore, we continue to believe 

that the flexible structure of these 

requirements minimizes the cost impact 

of this final rule. 

Comment: Several commenters made 

ambiguous statements that did not 

speak to either support for or 

disagreement with the proposed rule. 

Response: While we believe that 

statements such as ‘‘Please come into the 

new millennium’’ may be in support of 

the proposed regulation, encouraging 

CMS to adopt regulations that address 

changing social norms and 

contemporary situations, we were 

unable to classify these comments as 

such due to their ambiguous nature. 

Nonetheless, we thank the commenters 

for expressing their thoughts on this 

proposed regulation and will make all 

efforts to assure that the final regulation 

is fair and balanced to protect patient 

rights, as well as patient health and 

safety. 

Comment: Several commenters in 

favor of the regulation proposed that all 

hospitals, whether they are receiving 

Federal funding from CMS or not, 

respect this directive and its intention. 

Response: While we agree that the 

intent and spirit of this regulation 

should be honored by all hospitals and 

CAHs, even those that do not receive 

Medicare or Medicaid funds, we do not 

have the authority to enforce these 

requirements upon non-Medicare or 

Medicaid hospitals and CAHs. CMS’s 

authority to enforce this and other CMS 

regulations stems from the agreement 

that hospitals and CAHs enter into with 

CMS whereby those hospitals and CAHs 

agree to abide by Medicare’s regulations 

in exchange for their ability to 

participate in the Medicare and 

Medicaid programs, see and treat 

Medicare and Medicaid patients, and be 

paid by Medicare or Medicaid for the 

care and services furnished to those 

Medicare and Medicaid patients. Absent 

that voluntary agreement, CMS lacks 

authority to enforce its rules upon nonparticipating providers and suppliers. 

Comment: Several commenters 

suggested that the requirements of this 

rule should apply to hospices, nursing 

homes, ambulatory surgical centers 

(ASCs), and intermediate care facilities 

for the mentally disabled (ICF/MRs). 

Commenters noted that the need for and 

the benefits that flow from visitation are 

just as important—and sometimes even 

more so—for patients in hospices and 

nursing homes than for those in 

hospitals. Many commenters asserted 

that the standards and rules for all 

facilities should be consistent. 

Response: While we agree that the 

benefits of visitation go beyond hospital 

and CAH patients, and we appreciate 

the suggestions that this rule should 

apply to other types of Medicare and 

Medicaid providers, such revisions 

would fall outside the scope of this rule. 

We note that the current regulations for 

hospices (§ 418.52, § 418.100, and 

§ 418.110 in particular) and nursing 

homes (§ 483.10(j)) already require 

generous visitation privileges for all 

patients, and that these generous 

allowances minimize the need for new 

regulations at this time. We also believe 

that the short-term nature of ASC 

services, which must be less than 24 

hours in duration, and the fact surgery 

centers generally require each patient to 

be accompanied by a responsible adult 

for discharge purposes, naturally 

minimize the need for open visitation 

regulations in ASCs. However, we will 


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continue to consider modifying the 

requirements for these provider types in 

the future to ensure consistent 

requirements and patient rights across 

providers. 

Each of these providers is required by 

regulation to have an internal system to 

handle patient grievances. If patients of 

these providers believe that their rights 

have been violated, they may file a 

complaint using their provider’s 

internal grievance system. All patients 

may also file a complaint with the state 

survey agency and/or the agency that 

accredits the provider (if applicable). 

Furthermore, Medicare beneficiaries 

may file quality of care complaints with 

the QIO in that state. We believe that 

these robust complaint options help 

assure that patient complaints are 

documented, investigated, and resolved 

in an appropriate manner. 

Informed Decisions 

The President’s Memorandum also 

directed the Secretary to ensure that 

patients’ representatives have the right 

to make informed decisions regarding 

patients’ care. 

The hospital CoPs at 42 CFR 

482.13(b)(2) state: ‘‘The patient or his or 

her representative (as allowed under 

State law) has the right to make 

informed decisions regarding his or her 

care. The patient’s rights include being 

informed of his or her health status, 

being involved in care planning and 

treatment, and being able to request or 

refuse treatment. This right must not be 

construed as a mechanism to demand 

the provision of treatment or services 

deemed medically unnecessary or 

inappropriate.’’ 

We believe that the ability of a patient 

to designate a support person who can 

act on behalf of the patient is critical to 

the assurance of the patient’s health and 

safety. Regardless of whether a patient 

is incapacitated, the designation of a 

support person, who is likely to be 

especially familiar with the patient, 

including his or her medical history, 

conditions, medications, and allergies, 

can serve as an invaluable asset to the 

patient and caregivers during the 

development and revision of the course 

of treatment and associated decision 

making. 

In the proposed rule, we explained 

that the requirement at § 482.13(b)(2) 

was intended to ensure the patient’s 

right to designate a representative for 

health care decision-making purposes. 

We solicited public comment on 

whether, as a health and safety measure, 

this requirement effectively addresses 

any inappropriate barriers to a patient’s 

ability to designate a representative for 

visitation purposes, and consistently 

ensures the right to designate a 

representative (for all purposes) for all 

patients in all Medicare- and Medicaidparticipating hospitals. 

Comment: Several commenters noted 

suggestions to ensure that all patients 

are able to designate a decision-maker, 

have that designation respected, and 

receive meaningful representation by 

that individual regardless of whether 

the State in which the patient is 

hospitalized recognizes a formal legal 

relationship between the two persons. 

This would include hospitals’ 

obligations to provide patients with 

designation forms. In urgent situations, 

commenters suggested that patients 

have the right to orally designate a 

representative for decision-making 

purposes. One commenter suggested 

that CMS should create a model 

advance directive rule that States could 

use to revise their current legislation 

and regulations related to advance 

directives. 

Response: We thank commenters for 

their suggestions regarding the 

designation of a representative by a 

patient. With respect to designations in 

advance directives, § 1866(f)(1) of the 

Act defers to State law (whether 

statutory or established by the courts) to 

govern the establishment and 

recognition of advance directives 

(which can be used by the patient to 

designate a representative). Thus, we do 

not have the authority in this rule to 

change this aspect of advance directives 

policy. We believe, however, that an 

advance directive remains a viable and 

important option for those seeking to 

document treatment preferences, 

informed decision-making regarding 

care, designation of a representative, 

and designation of a support person 

(who may be the representative). And 

we encourage hospitals to consider 

advance directives established in other 

States as a viable source of information 

about patient preferences, including 

visitation preferences. It is not within 

the scope of this regulation to draft 

sample legislation that could guide State 

laws and regulations on advance 

directives. 

Comment: Commenters expressed 

various concerns related to the current 

requirements for the establishment and 

implementation of advance directives, 

State requirements for designating a 

patient’s representative for decisionmaking purposes, methods for 

producing a copy of an existing advance 

directive in a time of need (including 

the hospital’s role in obtaining a copy), 

and the practicalities involved with 

establishing advance directives. These 

commenters highlighted the 

complexities of establishing, accessing, 

and implementing advance directives in 

a variety of circumstances, and focused 

particular attention on the role of 

advance directives in establishing 

patient ‘‘representative’’ status. 

Response: We appreciate the 

comments received in regard to advance 

directive issues. We refer readers to the 

statutory language at § 1866(f)(3) of the 

Act, which defines an advance directive 

as ‘‘a written instruction, such as a 

living will or durable power of attorney 

for health care, recognized under State 

law (whether statutory or as recognized 

by the courts of the State) and relating 

to the provision of such care when the 

individual is incapacitated.’’ All CMS 

regulations related to advance 

directives, including those advance 

directives that designate a patient’s 

representative for health care decision 

making, are based on this statute which, 

in turn, defers to State laws in all forms 

to govern the establishment and 

implementation of such documents. As 

such, CMS does not have the legal 

authority to broadly preempt, through 

regulation or other administrative 

action, those State laws that relate to 

advance directives. 

In regard to current CMS regulations 

related to advance directives, we note 

that the provider agreement regulations 

at § 489.102, referenced by § 482.13, 

specify very limited instances in which 

services or procedures specified in a 

State-recognized advance health care 

directive may be refused. Section 

489.102(c)(2) is limited to refusals to 

provide services or procedures called 

for in an advance health care directive, 

as described in § 489.102(a)(1)(ii)(C), 

which refers specifically to ‘‘the range of 

medical conditions or procedures 

affected by the conscience objection.’’ 

We believe that this narrow window 

allowing for certain objections to the 

content of an advance directive would 

not allow a health care provider to 

refuse to honor those portions of a Staterecognized advance directive that 

designate an individual as the patient’s 

representative, support person, or health 

care decision-maker, since such 

designation is not a medical condition 

or procedure. 

Comment: Some commenters noted a 

variety of barriers that inhibit the 

establishment of an advance directive. 

Such barriers include the cost 

associated with obtaining legal counsel 

to help establish an advance directive 

that is legal in the patient’s State, a lack 

of knowledge about the need for and 

benefits of an advance directive, an 

overall cultural apathy towards advance 

care planning as indicated by the low 

percentage of the population that has an 

advance directive, and the 


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disadvantages faced by non-Englishproficient individuals. 

Response: In the proposed rule, we 

solicited comment on whether the 

current requirement (at § 482.13(b)(2), 

which is intended to ensure a patient’s 

right to designate a representative to 

make informed decisions about his or 

her care) effectively addresses any 

inappropriate barriers to a patient’s 

ability to designate a representative, and 

whether it consistently ensures the right 

to designate a representative for all 

patients in all Medicare- and Medicaidparticipating hospitals. We also stated 

our intention to consider public 

comments received in response to this 

request as we consider any revision to 

the current regulation that would 

eliminate any inappropriate restriction 

or limitation on a patient’s ability to 

designate a representative that may be 

permitted under the existing regulation. 

In light of our direct solicitation of 

comments on this issue, we greatly 

appreciate the comments offered here 

regarding various barriers that a patient 

may experience when attempting to 

designate a representative for health 

care decision-making purposes. We will 

give due consideration to these 

comments when we contemplate future 

rulemaking in this area of the CoPs. 

Comment: Commenters observed that 

in addition to establishing an advance 

directive, patients, representatives, and 

support persons must also be able to 

produce the document in a time of 

urgent need. These commenters also 

observed that being able to do so may 

be challenging and inconvenient for 

people, given the nature of urgent 

medical situations. 

Response: Urgent situations are, by 

nature, unplanned. As such, patients, 

representatives, and support persons 

may not have ready access to the 

necessary medical documentation at the 

time that the urgent situation occurs. In 

addition to keeping such documentation 

in a readily accessible physical location, 

we are aware of the existence of advance 

directive registries that store advance 

directives and other legal documents in 

an electronic format that can be 

retrieved by individuals and health care 

facilities alike. Such document storage 

and access facilities may be an 

appropriate source of the proper 

documentation in urgent situations. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We solicited public comment on each 

of these issues for the following sections 

of this document that contain 

information collection requirements 

(ICRs): 

A. ICRs Regarding Condition of 

Participation: Patient’s Rights (§ 482.13) 

Section § 482.13(h) requires a hospital 

to have written policies and procedures 

regarding the visitation rights of 

patients, including any clinically 

necessary or reasonable restriction or 

limitation that the hospital may need to 

place on such rights and the reasons for 

the clinical restriction or limitation. 

Specifically, the written policies and 

procedures must contain the 

information listed in § 482.13(h)(1) 

through (h)(4). The burden associated 

with this requirement is the time and 

effort necessary for a hospital to develop 

written policies and procedures with 

respect to visitation rights of patients 

and to distribute that information to the 

patients. 

We believe that most hospitals 

already have established policies and 

procedures regarding visitation rights of 

patients. Therefore, we are adding only 

a minimal amount of additional burden 

hours to comply with this requirement. 

Additionally, we believe that most 

hospitals include the visitation policies 

and procedures as part of their standard 

notice of patient rights. The burden 

associated with the notice of patient 

rights is currently approved under OMB 

control number 0938–0328. We will be 

submitting a revision of the currently 

approved information collection request 

to account for the following burden. 

We estimate that 4,860 hospitals must 

comply with the aforementioned 

information collection requirements. We 

further estimate that it will take each 

hospital 0.25 hours to comply with the 

requirement in proposed § 482.13(h). 

The total estimated annual burden 

associated with this requirement is 

1,215 hours at a cost of $71,746. 

B. ICRs Regarding Condition of 

Participation: Provision of Services 

(§ 485.635) 

Section 485.635(f) requires a CAH to 

have written policies and procedures 

regarding the visitation rights of 

patients, including any clinically 

necessary or reasonable restriction or 

limitation that the CAH may need to 

place on such rights and the reasons for 

the clinical restriction or limitation. 

Specifically, the written policies and 

procedures must contain the 

information listed in § 485.635(f)(1) 

through (f)(4). The burden associated 

with this requirement is the time and 

effort necessary for a CAH to develop 

written policies and procedures with 

respect to visitation rights of patients 

and to distribute the information to the 

patients. 

We believe that most CAHs already 

have established policies and 

procedures regarding visitation rights of 

patients. These policies and procedures 

are most likely included as part of a 

CAH’s patient care policies as required 

for CAHs under § 485.635. Therefore, 

we are adding a minimal amount of 

additional burden hours to comply with 

this requirement. We will be submitting 

a revision of the ICR currently approved 

under OMB control number 0938–1043 

to account for the burden associated 

with the requirements in § 485.635. 

We estimate that 1,314 CAHs must 

comply with the aforementioned 

information collection requirements. We 

further estimate that it will take each 

CAH 0.25 hours to comply with the 

requirement at § 482.13(h). The total 

estimated annual burden associated 

with this requirement is 329 hours at a 

cost of $19,398. 

TABLE 1—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

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 

($) 

§ 482.13 ................................ 0938–0328 4,860 4,860 .25 1,215 59.05 71,746 0 71,746 


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Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 70843 

TABLE 1—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS—Continued 

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 

($) 

§ 485.635 .............................. 0938–1034 1,314 1,314 .25 329 58.96 19,398 0 19,398 

Total .............................. ...................... 6,174 6,174 ...................... 1,544 ...................... ...................... ...................... 91,144 

IV. Regulatory Impact Statement 

We have examined the impact of this 

proposed rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, section 202 of the Unfunded 

Mandates Reform Act of 1995 (March 

22, 1995; Pub. L. 104–4), Executive 

Order 13132 on Federalism (August 4, 

1999) and the Congressional Review Act 

(5 U.S.C. 804(2)). 

Executive 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 reach 

the $100 million economic threshold 

and therefore is not considered a major 

rule under the Congressional Review 

Act. 

We believe that the benefits of this 

rule will amply justify its relatively 

minimal costs. Executive Order 12866 

explicitly requires agencies to consider 

non-quantifiable benefits, including 

‘‘distributive impacts’’ and ‘‘equity,’’ and 

the benefits of the final rule, in these 

terms, will be significant. In the words 

of Executive Order 12866, these benefits 

are ‘‘difficult to quantify, but 

nevertheless essential to consider.’’ 

More specifically, the benefits of this 

rule include: (1) Ensuring the protection 

of a patient’s ability to designate who 

may and may not visit the patient; 

(2) broadening patient participation in 

the care received (a benefit that would 

have, among other things, significant 

emotional benefits for many patients); 

and 

(3) creating a more patient-designated 

support system, with potentially large 

improvements in hospital and CAH 

experiences and health outcomes for 

patients. 

The cost of implementing these 

changes will largely be limited to the 

one-time cost related to the revisions of 

hospital and CAH policies and 

procedures as they relate to the 

requirements for patient visitation 

rights. There will also be the one-time 

cost of producing a printed page 

detailing the patient visitation rights 

that will be provided to patients upon 

admission. We have estimated the total 

cost of revising the policies and 

procedures related to patient visitation 

rights as well as the total cost of 

producing a printed page detailing these 

rights that will be provided to hospital 

and CAH patients upon admission. No 

burden is being assessed on the 

communication of these revisions to 

hospital and CAH staff or on the 

distribution of the visitation rights to 

patients that will be required by this 

rule, as these practices are usual and 

customary business practices. 

CMS data, as of March 31, 2010, 

indicated that there were 4,860 

hospitals and 1,314 CAHs (for a total of 

6,174) in the United States. We prepared 

the cost estimates for hospitals and 

CAHs together since both types of 

providers will be required to perform 

the same functions. Regarding the costs 

of revising hospital and CAH policies 

and procedures as related to the 

proposed patient visitation rights 

requirements, this function will be 

performed by the hospital or CAH 

administrator at an hourly salary 

(including a 35 percent benefits) of 

$59.05 (based on wage estimates for a 

Medical and Health Services Manager in 

the May 2009 National, State, 

Metropolitan, and Nonmetropolitan 

Area Occupational Employment and 

Wage Estimates report from the Bureau 

of Labor Statistics) and that this 

function will require approximately 15 

minutes of an administrator’s time to 

accomplish. Therefore, the total onetime cost for all hospitals and CAHs 

would be $59.05 × .25 hours × 6,174 

total hospitals/CAHs = $91,144. 

The most recent CMS figures from 

2008 also indicate that there were 

37,529,270 total hospital (and CAH) 

patient admissions in that year. Using 

that as an estimate, we then calculated 

the total cost for hospitals and CAHs to 

produce a one-page printed disclosure 

form detailing the patient visitation 

rights that would be provided to all 

patients upon admission. We estimated 

the cost of production to be 2 cents per 

page. Therefore, the total estimated cost 

for all hospitals and CAHs to produce 

this one-page printed patient visitation 

rights disclosure form and provide it to 

all patients upon admission (based on 

the most recent hospital admission 

figures) will be 37,529,270 total hospital 

patient admissions × $0.02 = $750,585 

for the first year. We will anticipate that 

this form would be incorporated into 

hospital and CAH admission materials 

for subsequent years; therefore, we have 

no way to estimate the future costs to 

provide this form, but expect the costs 

to be minimal once all hospitals and 

CAHs have incorporated this disclosure 

of patient visitation rights. In 

conclusion, the total first-year cost for 

all hospitals and CAHs to meet the 

requirements of the patient visitation 

rights will be $841,729. We believe that 

the annual benefits of the rule, though 

not susceptible to quantification, far 

exceed that amount. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $7.0 million to $34.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA because the Secretary has 

determined that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area for 

Medicare payment regulations and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 


srobinson on DSKHWCL6B1PROD with RULES
70844 Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations 

of the Act because the Secretary has 

determined that this rule will not have 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule 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 will have no 

consequential effect on State, local, or 

tribal governments in the aggregate or 

on the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Because this regulation will not impose 

any substantial costs on State or local 

governments, the requirements of 

Executive Order 13132 are not 

applicable. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 482 

Grant programs—Health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements. 

42 CFR Part 485 

Grant programs—Health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 1. The authority citation for Part 482 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

■ 2. Section 482.13 is amended by 

adding a new paragraph (h) to read as 

follows: 

§ 482.13 Condition of participation: 

Patient’s rights. 

* * * * * 

(h) Standard: Patient visitation rights. 

A hospital must have written policies 

and procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the hospital may need to place on such 

rights and the reasons for the clinical 

restriction or limitation. A hospital must 

meet the following requirements: 

(1) Inform each patient (or support 

person, where appropriate) of his or her 

visitation rights, including any clinical 

restriction or limitation on such rights, 

when he or she is informed of his or her 

other rights under this section. 

(2) Inform each patient (or support 

person, where appropriate) of the right, 

subject to his or her consent, to receive 

the visitors whom he or she designates, 

including, but not limited to, a spouse, 

a domestic partner (including a samesex domestic partner), another family 

member, or a friend, and his or her right 

to withdraw or deny such consent at 

any time. 

(3) Not restrict, limit, or otherwise 

deny visitation privileges on the basis of 

race, color, national origin, religion, sex, 

gender identity, sexual orientation, or 

disability. 

(4) Ensure that all visitors enjoy full 

and equal visitation privileges 

consistent with patient preferences. 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

■ 3. The authority citation for Part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

■ 4. Section 485.635 is amended by 

adding a new paragraph (f) to read as 

follows: 

§ 485.635 Condition of participation: 

Provision of services. 

* * * * * 

(f) Standard: Patient visitation rights. 

A CAH must have written policies and 

procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the CAH may need to place on such 

rights and the reasons for the clinical 

restriction or limitation. A CAH must 

meet the following requirements: 

(1) Inform each patient (or support 

person, where appropriate) of his or her 

visitation rights, including any clinical 

restriction or limitation on such rights, 

in advance of furnishing patient care 

whenever possible. 

(2) Inform each patient (or support 

person, where appropriate) of the right, 

subject to his or her consent, to receive 

the visitors whom he or she designates, 

including, but not limited to, a spouse, 

a domestic partner (including a samesex domestic partner), another family 

member, or a friend, and his or her right 

to withdraw or deny such consent at 

any time. 

(3) Not restrict, limit, or otherwise 

deny visitation privileges on the basis of 

race, color, national origin, religion, sex, 

gender identity, sexual orientation, or 

disability. 

(4) Ensure that all visitors enjoy full 

and equal visitation privileges 

consistent with patient preferences. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). (Catalog of Federal 

Domestic Assistance Program No. 93.778, 

Medical Assistance Program). 

Dated: October 21, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: November 15, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–29194 Filed 11–17–10; 11:15 am] 

BILLING CODE 4120–01–P 


srobinson on DSKHWCL6B1PROD with RULES