[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Rules and Regulations]
[Pages 70831-70844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29194]


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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.

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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 Medicaid-participating 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/
the-press-office/presidential-[sol]memorandum-[sol]hospital-
[sol]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 Sec.  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 Sec.  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

[[Page 70832]]

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 parent-child 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 Sec.  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 Sec.  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,

[[Page 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 Sec.  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 Medicaid-participating 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 non-compliant 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

[[Page 70834]]

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 Sec.  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 Sec.  482.13(a) related to the timing of the 
notice of rights, and are finalizing the requirements of Sec.  
482.13(h)(1) and (2) specifically related to the written notice of 
visitation rights. Likewise, we are modifying the requirement of 
proposed Sec.  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:
    [cir] 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'');
    [cir] 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;
    [cir] Accompanying notice about the grievance process that a 
patient (or a visitor) may follow to appeal a denial of visitation; and
    [cir] 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 Sec.  482.13(h)(1) and Sec.  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 Sec.  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;

[[Page 70835]]

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 non-
discriminatory 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

[[Page 70836]]

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 non-biological 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 non-adoptive 
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 deeply-held 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 non-permitted 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

[[Page 70837]]

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 different-sex couples. Other comments to this effect 
went further, suggesting that hospitals requiring documentation from a 
same-sex couple but not a different-sex 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:
    <bullet> 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);
    <bullet> Shared residence;
    <bullet> Shared ownership of a property or business;
    <bullet> Financial interdependence;
    <bullet> Marital/Relationship status;
    <bullet> Existence of a legal relationship recognized in another 
jurisdiction, even if not recognized in another jurisdiction, 
including: Parent-child, civil union, marriage, domestic partnership;
    <bullet> Acknowledgment of a committed relationship (e.g. an 
affidavit); and
    <bullet> 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 Sec.  482.13(h)(2) and Sec.  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 Sec.  
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

[[Page 70838]]

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 
Medicare-participating 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 Sec.  482.13(h)(4) and Sec.  
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 Sec.  
482.13(h)(4) and Sec.  485.635(f)(4) to state, ``Ensure that all 
visitors enjoy full and equal visitation privileges consistent with 
patient preferences.'' This revised requirement is patient-centered 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

[[Page 70839]]

restricting or limiting visitors, including:
    [cir] Any court order limiting or restraining contact;
    [cir] Behavior presenting a direct risk or threat to the patient, 
hospital staff, or others in the immediate environment;
    [cir] Behavior disruptive of the functioning of the patient care 
unit;
    [cir] Reasonable limitations on the number of visitors at any one 
time;
    [cir] Patient's risk of infection by the visitor;
    [cir] Visitor's risk of infection by the patient;
    [cir] Extraordinary protections because of a pandemic or infectious 
disease outbreak;
    [cir] Substance abuse treatment protocols requiring restricted 
visitation;
    [cir] Patient's need for privacy or rest;
    [cir] 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 well-being 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 well-being 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

[[Page 70840]]

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 non-
participating 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 (Sec.  418.52, Sec.  418.100, and 
Sec.  418.110 in particular) and nursing homes (Sec.  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

[[Page 70841]]

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 Sec.  
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 
Medicaid-participating 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, Sec.  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 decision-making 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 Sec.  
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 Sec.  489.102, 
referenced by Sec.  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 Sec.  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 State-recognized 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

[[Page 70842]]

disadvantages faced by non-English-proficient individuals.
    Response: In the proposed rule, we solicited comment on whether the 
current requirement (at Sec.  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 
Medicaid-participating 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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> 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 (Sec.  
482.13)

    Section Sec.  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 
Sec.  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 Sec.  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 
(Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Hourly labor   Total labor      Total
                                                                     OMB control                               Burden per   Total annual     cost of       cost of      capital/     Total cost
                       Regulation section(s)                             No.       Respondents    Responses     response       burden       reporting     reporting    maintenance       ($)
                                                                                                                 (hours)       (hours)         ($)           ($)        costs ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   482.13.....................................................     0938-0328         4,860         4,860           .25         1,215         59.05        71,746             0        71,746

[[Page 70843]]

 
Sec.   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 one-time cost for all hospitals and 
CAHs would be $59.05 x .25 hours x 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 x $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)

[[Page 70844]]

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.

0
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

0
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)).


0
2. Section 482.13 is amended by adding a new paragraph (h) to read as 
follows:


Sec.  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 same-sex 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

0
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)).


0
4. Section 485.635 is amended by adding a new paragraph (f) to read as 
follows:


Sec.  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 same-sex 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