Medicare and Medicaid Programs: Changes to the Hospital and Critical Access Hospital Conditions of Participation To Ensure Visitation Rights for All Patients, 70831-70844 [2010-29194]
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Federal Register / Vol. 75, No. 223 / Friday, November 19, 2010 / Rules and Regulations
§ 167.1332
In the Strait of Georgia.
In the Strait of Georgia, the following
are established:
(a) Precautionary area ‘‘GS,’’ which is
bounded by a line connecting the
following geographical positions:
Latitude
48°52.30′ N
48°54.81′ N
48°49.49′ N
48°47.93′ N
48°47.78′ N
48°48.19′ N
48°52.30′ N
Longitude
123°07.44′ W
123°03.66′ W
122°54.24′ W
122°57.12′ W
122°59.12′ W
123°00.84′ W
123°07.44′ W
N
N
N
N
Longitude
123°05.04′
123°10.08′
123°10.80′
123°05.70′
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
W
W
W
W
42 CFR Parts 482 and 485
[CMS–3228–F]
Longitude
123°03.66′ W
123°08.76′ W
Longitude
123°12.30′ W
123°07.44′ W
(e) Precautionary area ‘‘PR,’’ which is
bounded by a line connecting the
following geographical positions:
Latitude
48°55.34′
48°57.68′
49°02.20′
49°00.00′
N
N
N
N
Longitude
123°12.30′
123°08.76′
123°16.28′
123°19.69′
W
W
W
W
(f) A separation zone bounded by a
line connecting the following
geographical positions:
Latitude
49°01.39′
49°03.84′
49°03.24′
49°00.75′
N
N
N
N
Longitude
123°17.53′
123°21.30′
123°22.41′
123°18.52′
W
W
W
W
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(g) A traffic lane for north-westbound
traffic located between the separation
zone described in paragraph (f) of this
section and a line connecting the
following geographical positions:
Latitude
49°02.20′ N
49°04.52′ N
Longitude
123°16.28′ W
123°20.04′ W
(h) A traffic lane for south-eastbound
traffic between the separation zone
described in paragraph (f) of this section
and a line connecting the following
geographical positions:
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Medicare and Medicaid Programs:
Changes to the Hospital and Critical
Access Hospital Conditions of
Participation To Ensure Visitation
Rights for All Patients
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
(d) A traffic lane for south-eastbound
traffic between the separation zone
described in paragraph (b) of this
section and a line connecting the
following geographical positions:
Latitude
48°55.34′ N
48°52.30′ N
Dated: November 9, 2010.
Dana A. Goward,
U.S. Coast Guard, Director of Marine
Transportation Systems Management.
BILLING CODE 9110–04–P
(c) A traffic lane for north-westbound
traffic located between the separation
zone described in paragraph (b) of this
section and a line connecting the
following geographical positions:
Latitude
48°54.81′ N
48°57.68′ N
Longitude
123°23.76′ W
123°19.69′ W
[FR Doc. 2010–29165 Filed 11–18–10; 8:45 am]
(b) A separation zone bounded by a
line connecting the following
geographical positions:
Latitude
48°53.89′
48°56.82′
48°56.30′
48°53.39′
Latitude
49°02.51′ N
49°00.00′ N
This final rule will revise the
Medicare conditions of participation for
hospitals and critical access hospitals
(CAHs) to provide visitation rights to
Medicare and Medicaid patients.
Specifically, Medicare- and Medicaidparticipating hospitals and CAHs will
be required to have written policies and
procedures regarding the visitation
rights of patients, including those
setting forth any clinically necessary or
reasonable restriction or limitation that
the hospital or CAH may need to place
on such rights as well as the reasons for
the clinical restriction or limitation.
DATES: Effective Date: These regulations
are effective on January 18, 2011.
FOR FURTHER INFORMATION CONTACT:
Scott Cooper, (410) 786–9465. Danielle
Shearer, (410) 786–6617. Jeannie Miller,
(410) 786–3164.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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: https://www.whitehouse.gov/thepress-office/presidential/memorandum-/hospital-/visitation. As
part of the directives of the
memorandum, the Department, through
the Office of the Secretary, tasked CMS
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with developing proposed requirements
for hospitals (including Critical Access
Hospitals (CAHs)), that would address
the right of a patient to choose who may
and may not visit him or her. In the
memorandum, the President pointed out
the plight of individuals who are denied
the comfort of a loved one, whether a
family member or a close friend, at their
side during a time of pain or anxiety
after they are admitted to a hospital. The
memorandum indicated that these
individuals are often denied this most
basic of human needs simply because
the loved ones who provide them
comfort and support do not fit into a
traditional concept of ‘‘family.’’
Section 1861(e)(1) through (9) of the
Social Security Act—(1) Defines the
term’’hospital’’; (2) lists the statutory
requirements that a hospital must meet
to be eligible for Medicare participation;
and (3) specifies that a hospital must
also meet other requirements as the
Secretary finds necessary in the interest
of the health and safety of individuals
who are furnished services in the
facility. Under this authority, the
Secretary has established in the
regulations at 42 CFR part 482 the
requirements that a hospital must meet
in order to participate in the Medicare
program. This authority extends as well
to the separate requirements that a CAH
must also meet to participate in the
Medicare program, established in the
regulations at 42 CFR part 485.
Additionally, section 1820 of the Act
sets forth the conditions for designating
certain hospitals as CAHs. Section
1905(a) of the Act provides that
Medicaid payments may be applied to
hospital services. Regulations at 42 CFR
440.10(a)(3)(iii) require hospitals to
meet the Medicare CoPs to receive
payment under States’ Medicaid
programs.
While the existing hospital conditions
of participation (CoPs) in our
regulations at 42 CFR part 482 do not
address patient visitation rights
specifically, there is a specific CoP
regarding the overall rights of hospital
patients contained in § 482.13. We note
that the existing CoPs for CAHs in our
regulations do not address patient rights
in any form. The hospital CoP for
patient rights at § 482.13 specifically
requires hospitals to—(1) Inform each
patient or, when appropriate, the
patient’s representative (as allowed
under State law) of the patient’s rights;
(2) ensure the patient’s right to
participate in the development and
implementation of the plan of care; (3)
ensure the patient’s (or his or her
representative’s) right to make informed
decisions about care; (4) ensure the
patient’s right to formulate advance
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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:
https://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
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minimum, the requirement should
exclude a hospital or CAH from
requiring documentation when the
patient has the capacity to speak or
otherwise communicate for himself or
herself; where patient representation
automatically follows from a legal
relationship recognized under State law
(for example, a marriage, a civil union,
a domestic partnership, or a parentchild relationship); or where requiring
documentation would discriminate on
an impermissible basis.
In the April 15, 2010 Presidential
Memorandum, the President also
emphasized the consequences that
restricted or limited visitation has for
patients. Specifically, when a patient
does not have the right to designate who
may visit him or her simply because
there is not a legal relationship between
the patient and the visitor, physicians,
nurses, and other staff caring for the
patient often miss an opportunity to
gain valuable patient information from
those who may know the patient best
with respect to the patient’s medical
history, conditions, medications, and
allergies, particularly if the patient has
difficulties recalling or articulating, or is
totally unable to recall or articulate, this
vital personal information. Many times,
these individuals who may know the
patient best act as an intermediary for
the patient, helping to communicate the
patient’s needs to hospital staff. We
agree that restricted or limited hospital
and CAH visitation can effectively
eliminate these advocates for many
patients, potentially to the detriment of
the patient’s health and safety.
An article published in 2004 in the
Journal of the American Medical
Association (Berwick, D.M. and Kotagal,
M.: ‘‘Restricted visiting hours in ICUs:
time to change.’’ JAMA. 2004; Vol. 292,
pp. 736–737) discusses the health and
safety benefits of open visitation for
patients, families, and intensive care
unit (ICU) staff and debunks some of the
myths surrounding the issue
(physiologic stress for the patient;
barriers to provision of care; exhaustion
of family and friends) through a review
of the literature and through the
authors’ own experiences working with
hospitals that were attempting a
systematic approach to liberalizing ICU
visitation as part of a collaborative with
the Institute for Healthcare
Improvement. The authors of the article
ultimately concluded that ‘‘available
evidence indicates that hazards and
problems regarding open visitation are
generally overstated and manageable,’’
and that such visitation policies ‘‘do not
harm patients but rather may help them
by providing a support system and
shaping a more familiar environment’’ as
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they ‘‘engender trust in families, creating
a better working relationship between
hospital staff and family members.’’
II. Provisions of the Proposed Rule and
Response to Comments
We published a proposed rule in the
Federal Register on May 26, 2010 (75
FR 29479). In that rule, we proposed to
revise the Medicare hospital and CAH
CoPs to provide visitation rights to
Medicare and Medicaid patients.
We provided a 60-day public
comment period in which we received
approximately 7,600 timely comments
from individuals, advocacy
organizations, legal firms, and health
care facilities. Of the approximately
7,600 timely comments, more than
6,300 were versions of a form letter that
all expressed the same sentiment of
strong support for the proposed
regulation. The remaining comments,
with very few exceptions, also
expressed strong support for the concept
and overall goals of the proposed
regulation. Summaries of the public
comments are set forth below.
Hospital Visitation Rights
We proposed a visitation rights
requirement for hospitals as a new
standard within the patient rights CoP at
§ 482.13. In that provision, we specified
that hospitals would be required to have
written policies and procedures
regarding the visitation rights of
patients, including those setting forth
any clinically necessary or reasonable
restriction or limitation that the hospital
may need to place on such rights as well
as the reasons for the clinical restriction
or limitation. As part of these
requirements, the hospital must inform
each patient, or his or her representative
where appropriate, of the patient’s
visitation rights, including any clinical
restriction or limitation on those rights,
when the patient, or his or her
representative where appropriate, is
informed of the other rights specified in
§ 482.13. We also proposed that, as part
of his or her visitation rights, each
patient (or representative where
appropriate) must be informed of his or
her right, subject to his or her consent,
to receive the visitors whom he or she
designates, whether a spouse, a
domestic partner (including a same-sex
domestic partner), another family
member, or a friend, and of the right to
withdraw or deny such consent at any
time. We solicited public comment on
the style and form that patient notices
or disclosures would need to follow so
that patients would be best informed of
these rights.
We also proposed that hospitals
would not be permitted to restrict, limit,
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or otherwise deny visitation privileges
on the basis of race, color, national
origin, religion, sex, gender identity,
sexual orientation, or disability. In
addition, we proposed to require
hospitals to ensure that all visitors
designated by the patient (or
representative where appropriate) enjoy
visitation privileges that are no more
restrictive than those that immediate
family members would enjoy.
Visitation Rights With Respect to CAHs
We proposed to apply the same
visitation requirements to CAHs by
revising the CoPs for CAHs. Because the
CoPs for CAHs do not contain patient
rights provisions, we proposed to add a
new standard on patient visitation rights
at § 485.635(f) within the existing CoP
on provision of services.
Comment: The vast majority of
commenters expressed support for the
proposed regulation. Of those
commenters who submitted positive
comments, many also included a
rationale for their positive support.
Many commenters noted the harm in
keeping loved ones apart, and expressed
support for the rule based on the need
for compassionate treatment of all
patients and loved ones. One
commenter indicated it is shameful and
embarrassing to ask for ‘‘special’’
treatment to visit a sick loved one, when
it is not the hospital’s decision to make
in the first place. Another commenter
felt there was ‘‘no excuse’’ for hospitals
to make such visitation decisions. One
commenter stated that affording the
right of an individual to choose their
visitors or seek comfort is a crucial step
towards challenging discrimination and
improving health outcomes. A few
commenters supported the proposed
regulation based on the doctrine of the
separation of Church (in the form of the
personal religious beliefs of hospital
staff) and State (in the form of official
hospital policies and procedures). Other
commenters supported the proposed
regulation, citing the benefits that they
personally experienced when their
loved one was ill and they were granted
access, even without having an advance
directive naming them as the patient’s
representative. Still others described
scenarios where an individual was
permitted to visit a patient only because
the individual lied about his or her
relationship to the patient (such as
claiming to be a biological relation).
Many commenters supported the rule
because they believed that denying
access to hospitalized loved ones is
cruel and inhumane; some commenters
even described such a denial as a form
of punishment. The commenters
expressed the sentiment that visitation
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is a moral issue and a basic human
right, and that regardless of sexual
identity or recognized marital status,
one person being permitted to visit and
care for another should not require a
law.
Other commenters noted that some
current visitation policies in facilities
are discriminatory, unjust, and deny
basic equal rights to some patients.
Several commenters noted that facilities
should be focused on providing medical
treatment in keeping with the tenets of
the Hippocratic oath, rather than
dictating what constitutes an
appropriate visitor. Commenters agreed
that equal visitation rights are critical to
the safety, welfare and equal treatment
of persons who may unexpectedly find
themselves under the care of a hospital
or CAH.
Response: We thank the commenters
for their support, and agree that all
patients must be ensured the right to
choose their own visitors. We agree that
all Medicare- and Medicaidparticipating hospitals and CAHs must
have written policies and procedures
regarding the visitation rights of
patients, including those setting forth
any clinically necessary or reasonable
restriction or limitation that the hospital
or CAH may need to place on such
rights as well as the reasons for the
clinical restriction or limitation.
Comment: A few commenters
approved of the proposed regulation,
and suggested that fines, civil penalties,
and/or jail time should be imposed
upon hospitals and individuals that
deny loved ones access to patients on an
impermissible basis. Others suggested
that a list of non-compliant facilities
should be made available to the public.
Response: As a CoP for hospitals and
CAHs, noncompliance with this
provision could result in the provider’s
termination from the Medicare program.
Medicare is the single largest health care
payer in the country; therefore, being
terminated from participation in the
Medicare program, and therefore unable
to receive Medicare payments, is a very
serious consequence that all
participating hospitals endeavor to
avoid. Hospitals and CAHs that have
been terminated from Medicare
participation may also not receive
Medicaid payments. Therefore, we
believe that hospitals and CAHs already
have a very strong incentive, absent
fines and other consequences, to comply
with this requirement. In addition, CMS
does not have the legal authority to
impose other types of sanctions for noncompliant hospitals or CAHs outside of
the existing scheme. Because, at this
time, no quality measures have been
developed relating to compliance with
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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 (https://
www.hospitalcompare.hhs.gov/).
Comment: Many commenters were
confused by the use of the term
‘‘representative’’ in this section.
Commenters were unclear about
whether the patient’s representative for
visitation purposes needed to be the
patient’s legal representative for
decision-making purposes.
Response: We agree that using the
term ‘‘representative’’ in this rule is
confusing and may be misleading. For
purposes of exercising visitation rights,
we do not believe that the individual
exercising the patient’s visitation rights
needs to be the same individual who is
legally responsible for making medical
decisions on the patient’s behalf, though
it is certainly possible for both roles to
be filled by the same individual. To
avoid potential confusion, we have
replaced the word ‘‘representative’’ with
the term ‘‘support person.’’ The term
‘‘support person’’ will, we believe, allow
for a broader interpretation of the
requirement and increase flexibility for
patients and providers alike. A support
person could be a family member,
friend, or other individual who is there
to support the patient during the course
of the stay. This concept is currently
expressed in standard RI.01.01.01 of
The Joint Commission guidelines for
hospitals, and we believe that it
appropriately reflects our broad
interpretation of the individual who
may exercise a patient’s visitation rights
on his or her behalf.
Comment: Commenters were
uniformly supportive of the requirement
for hospitals and CAHs to have written
policies and procedures on visitation.
Commenters were also strongly
supportive of a clear, formalized,
written notice process for informing the
patient and, as appropriate, would-be
visitors and/or family and friends, of the
patient’s visitation rights. Some
commenters recommended specific
times as to when notice should be given,
such as upon admission, as early as
possible in the admissions process, and/
or whenever copies of the visitation
policy are requested. Other commenters
suggested that the notice of visitation
rights be limited to a single page.
Several other commenters requested
that the notice also be provided orally
and in an accessible manner in
accordance with Title VI of the 1964
Civil Rights Act, in order to ensure the
communication of the content in an
appropriate manner. Still other
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commenters suggested that the notice of
visitation rights should be posted in
public spaces and in the patient’s room.
Response: We thank the commenters
for their support of the need to notify
patients or their support person about
their rights. We agree that hospitals and
CAHs should be required to notify
patients or their support person, in
writing, of the patient’s rights, including
their right to receive visitors of their
choosing. In accordance with the
current requirements at § 482.13(a),
Notice of rights, hospitals must inform
patients or their support person, where
appropriate, of the patient’s rights in
that hospital before care is furnished to
a patient whenever possible. This
requirement for providing the notice of
patient rights, now including the right
to designate and receive visitors, before
care is initiated meets the concerns of
some commenters regarding the timing
of the notice. Therefore, we are retaining
the current requirements of § 482.13(a)
related to the timing of the notice of
rights, and are finalizing the
requirements of § 482.13(h)(1) and (2)
specifically related to the written notice
of visitation rights. Likewise, we are
modifying the requirement of proposed
§ 485.635(f)(1) to require CAHs to notify
patients of their visitation rights in
advance of furnishing patient care
whenever possible.
While we are finalizing the written
notice of visitation rights requirement
under the authority of sections
1861(e)(9) and 1820 of the Act, we agree
with commenters that there are other
legal requirements, most notably those
under Title VI of the Civil Rights Act of
1964, that are related to this provision.
Our requirement is compatible with
recent guidance on Title VI of the Civil
Rights Act of 1964. The Department of
Health and Human Services’ (HHS)
guidance related to Title VI of the Civil
Rights Act of 1964, ‘‘Guidance to Federal
Assistance Recipients Regarding Title VI
Prohibition Against National Origin
Discrimination Affecting Limited
English Proficient Persons’’ (August 8,
2003, 68 FR 47311) applies to those
entities that receive Federal financial
assistance from HHS, including
Medicare- and Medicaid-participating
hospitals and CAHs. This guidance may
assist hospitals and CAHs in ensuring
that patient rights information is
provided in a language and manner the
patient understands.
Providing each patient or support
person with the written notice of
visitation rights before the start of care
sufficiently achieves the goal of
informing patients; therefore, we are not
requiring such notice to be posted
within the facility. This rule does not
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prohibit hospitals and CAHs from
posting information about their
visitation policies of their own volition.
Furthermore, we are not requiring
facilities to provide the notice of rights
in any particular format or to
individuals other than the patient or
support person. Facilities are already
providing a notice of rights to patients
in accordance with the requirements of
the current rule and contemporary
standards of practice. In order to
facilitate prompt compliance and
minimize the burden upon facilities, it
is essential to allow them the flexibility
to adapt their current notice procedures
and documents to include this new
notice of visitation rights requirement
and to continue the strong focus on
patients, rather than the many visitors
who may pass through a facility in any
given day.
Comment: In addition to notifying
patients of their visitation rights, some
commenters suggested that the notice
should include information about any
restrictions on those visitation rights,
including common examples of
situations when visitation may be
restricted, and any specific restrictions
applicable to the patient. Additionally,
the following items were proposed as
elements of the disclosure notice:
Æ Recitation of the specific language
from the regulation (that ‘‘hospitals
cannot restrict, limit, or otherwise deny
visitation privileges on the basis of race,
color, national origin, religion, sex,
gender identity, sexual orientation, or
disability’’);
Æ Accompanying notice related to a
patient’s right to complete an advance
directive or other designation of a health
care agent to represent the patient;
Æ Accompanying notice about the
grievance process that a patient (or a
visitor) may follow to appeal a denial of
visitation; and
Æ Contact information for a dedicated
hospital staff person who can resolve
visitation conflicts.
Response: We agree that the notice of
visitation rights should include
information related to reasonable,
clinically necessary restrictions or
limitations on those rights. Therefore,
we are finalizing § 482.13(h)(1) and
§ 485.635(f)(1), which require hospitals
and CAHs to ‘‘inform each patient (or
support person, where appropriate) of
his or her visitation rights, including
any clinical restriction or limitation on
such rights.’’ In order to improve
compliance with this requirement and
minimize the burden on providers, it is
necessary to allow hospitals and CAHs
flexibility in meeting this requirement.
These facilities can consider the
usefulness of providing examples,
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developing medical condition-specific
notices tailored to the common needs of
different patient populations, and/or
reciting the text of this rule as they
develop their visitation rights notice.
We also agree that hospitals should
notify patients of their advance directive
rights and their right to access the
hospital’s grievance system, and
information on how to do so. This
information is currently required to be
provided to patients or their support
person in accordance with § 482.13(a)
and (b).
Comment: Several commenters
suggested that CMS identify (and create,
where necessary) best practices for
training staff and administrators on
cultural competency and the benefits of
open visitation policies. Several
commenters suggested that hospitals
should be required to train their staff in
discrimination prevention and cultural
competency, to better assure that the
rights of patients are promoted and
protected.
Response: We thank the commenters
for their suggestions. However, we
believe that it is outside the scope of
this rule for CMS to identify or create
best practices for training various
healthcare facility staff on cultural
competency and the benefits of open
visitation policies. We believe that the
establishment of these rules will lead
hospitals and CAHs to actively seek out
and implement best practices and other
recommendations for training staff on
these issues in order to fully comply
with the CoPs and continue
participation in the Medicare and
Medicaid programs. We encourage
hospitals to address issues of cultural
competencies specific to the needs of
their unique patient populations as part
of their quality assessment and
performance improvement programs. In
the future, CMS may use subregulatory
guidance and technical assistance
programs (such as Medicare Learning
Network at https://www.cms.gov/
MLNGenInfo/) to make known best
practice information that is developed
by other entities and organizations.
Comment: Several commenters
suggested that complaints regarding the
patient’s visitation rights should be
subject to a grievance process, and that
the right to file a grievance should be
readily available to the patient as well
as any would-be visitor.
Response: If a patient believes that his
or her visitation rights have been
violated, the patient or his or her
representative may file a grievance with
the hospital using the hospital’s internal
grievance resolution process. We note
that CAHs are not currently required to
have an internal complaint process;
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nonetheless, they may have such a
process in place for quality
improvement, State licensure,
accreditation, or other reasons. If the
patient believes that the quality of their
care was negatively impacted by a
violation of his or her rights, the patient
may also file a complaint with the State
survey agency responsible for oversight
of the facility, or the body responsible
for accrediting the facility (if
applicable). In the case of Medicare
beneficiaries, complaints may also be
filed with the QIO in that State. These
external complaint processes are
available to both hospital and CAH
patients. We believe that these current
complaint resolution mechanisms offer
the necessary protections for patients
who believe that their rights have been
violated. Likewise, if a visitor believes
that a hospital or CAH is not complying
with the requirements of this rule, the
visitor may file a complaint with the
State survey agency responsible for
oversight of the facility, as well as the
body responsible for accrediting the
facility (if applicable).
Comment: A few commenters
requested examples of how the new
regulation will be implemented in
facilities.
Response: This final rule requires
hospitals and CAHs to notify a patient
or support person of his or her visitation
rights, and sets forth the need for all
hospitals and CAHs to establish nondiscriminatory visitation policies that
treat all visitors equally, consistent with
the designations of patients or support
persons. This applies to all patients,
regardless of their payment source.
These are broad expectations and rights
that afford facilities the flexibility to
revise current practices and procedures
as necessary to meet these expectations.
As such, we are not in a position to
provide specific examples of how the
regulation will be implemented in any
facility because we do not know the
particular circumstances of each facility,
their current policies and practices,
their particular patient populations, etc.
Comment: Several commenters
suggested additional protected
categories that should be added so that
hospitals and CAHs are explicitly
prohibited in regulation from
discriminating against additional
specified populations. Commenters
stated that the protected categories in
the proposed rule should be expanded
to also include: marital status, family
composition, age, primary language and
immigration status. In addition,
commenters suggested that the proposed
rule make explicit that institutional or
individual conscience cannot be used to
deny a visitor access to the patient.
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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,
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all States continue to have the right to
determine the legal relationships that
will be recognized by State law and
practice, to the extent that they do so in
accordance with constitutional
principles. We do not have the authority
in this rule to compel one State to
recognize a legal relationship that is
established in another State. That said,
we remind hospitals and CAHs that this
rule does require full and equal
visitation for all visitors who are
designated by the patient or support
person, consistent with the patient’s
preferences. It is our understanding that,
even where one State does not recognize
a legal relationship recognized by
another State, the law of that State
generally does not prohibit a private
actor in that State—such as a hospital or
CAH—from recognizing that legal
relationship. Thus, there generally
appear to be no barriers to such a
hospital or CAH recognizing a legal
relationship recognized by another
State, even if its own State does not
recognize that legal relationship.
Comment: A few commenters
expressed concern that the validity of an
adoption in one State may not be
recognized by another State in cases
where a minor is the patient.
Commenters feared being required to
verify proof of parenthood at the height
of a medical emergency if located in a
different state than where adoption
occurred. Concern about the minor
patient’s representative having the right
to make decisions about medical care
‘‘as allowed under State law’’ was also
noted by few commenters. Commenters
felt that, as the language in the
regulation stands, it may allow hospitals
to deny the ability of adoptive parents
to act as a minor patient’s
representative, even though the
adoptive relationship is recognized
under the laws of a different State.
Other commenters expressed concern
about the ability of non-biological
parents to make decisions for their child
in the absence of a legal adoption.
Commenters expressed these same
concerns with respect to the ability to
visit a minor child.
Response: A legal adoption in one
State is generally recognized as a legal
parent-child relationship in another
State, along with all of the default
decision-making authorities that such a
legal relationship confers upon a legal
parent. This legal relationship continues
to exist even if that parent and minor
crosses State lines into another State in
which that parent would have been
prohibited from adopting that child. As
a legal parent and representative of the
minor child, the legal parent is, in
accordance with the requirements of
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this final rule, able to designate those
individuals who are permitted to visit
the child. Thus, this rule ensures the
representative’s ability to ensure
visitation access for other individuals.
Under this rule, issues of nonbiological and non-adoptive parents
acting as the minor child’s decision
maker are governed by State law. While
we do not have the authority in this
final rule to compel a State to generally
recognize such parents as legal parents,
we note that some States in fact
recognize ‘‘de facto’’ or ‘‘functional’’ or
‘‘equitable’’ parenthood, i.e., recognize
non-biological and non-adoptive parents
as legal parents. Nothing in this rule
prohibits a hospital or CAH from
recognizing non-biological and nonadoptive parents as legal parents for
purposes of the visitation policies set
forth in this rule.
Comment: Several commenters stated
that they supported the proposed
visitation regulation because it is critical
for patients to be able to choose their
own visitors, particularly for those
patients who belong to blended families.
Commenters described ‘‘families of
choice’’—strong relationships with
friends and other people who support
the patient and who can be contacted
during times of need. Accordingly,
commenters stated that, when a patient
is incapacitated, the patient’s
representative (which we now refer to as
a support person) should not be chosen
solely based on an individual’s legal
relationship with the patient.
Commenters noted the lack of
protection for ‘‘families of choice,’’
which do not necessarily fit a traditional
definition of a family, one based on
bloodlines, marriage, or adoption, make
it difficult for visitors to gain access to
sick loved ones. Commenters noted that
these representatives and sources of
support should enjoy full visitation
rights as any biological family member
of the patient would.
Response: We appreciate the support
of commenters, as it confirms our
understanding that this visitation rights
rule will help ensure that patients have
access to their chosen loved ones while
the patient is being cared for in a
hospital or CAH. We also agree that oral
designation of a support person,
regardless of a particular relationship’s
legal status, should be sufficient for
establishing the individual who may
exercise the patient’s visitation rights on
his or her behalf, should the patient be
unable to do so. In the absence of a
verbal support person designation,
hospitals and CAHs would look to their
established policies and procedures for
establishing a support person for the
purpose of exercising a patient’s
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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
https://www.regulations.gov. In the ‘‘key
word or I.D.’’ entry field, enter the
docket ID (CMS–2010–0207). Then,
select ‘‘public submissions’’ from the
drop-down menu under ‘‘select
document type’’). Numerous comments
reaffirmed our understanding of the
current practice in some medical
institutions that denies patients access
to their loved ones in times of need. The
commenters also confirmed our
understanding of the public’s deeplyheld desire to be with loved ones in
such medical institutions, which further
validates the need for this final rule. We
also appreciate the comments related to
advance directives, and encourage
individuals to establish written advance
directives that document the selection
of a designated patient representative,
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support person, and/or the patient’s
choices about specific medical
conditions and treatments. We believe
that such documentation will help
ensure that the patient’s wishes are
honored. We acknowledge that the Act
defers to State law to govern advance
directive issues, and that such deference
may be a source of concern to
commenters. However these advance
directive issues are beyond the purview
of this rule.
Comment: We received numerous
comments affirming our general
position that, when a patient can speak
for himself or herself, a hospital or CAH
does not need to require written
documentation of a patient
representative. That is, the commenters
supported our contention that oral
designation of ‘‘representative’’ status is
sufficient. Comments also suggested that
no proof should be required in cases
where the patient provides oral
confirmation that he or she would like
to receive any particular visitor.
Furthermore, the commenters advocated
against a formal documentation process,
whereby the hospital would be asked to
obtain a list of permitted and nonpermitted visitors from each patient.
They stated that, as a practical matter,
it would be simpler for the hospital to
recognize as welcome or not any
particular potential visitor, per the
patient’s wishes, when that patient
make his or her wishes known.
Response: We agree that an oral
designation of a support person
(formerly known as a ‘‘representative’’)
is sufficient for establishing the
individual who may exercise the
patient’s visitation rights on his or her
behalf, should the patient be unable to
do so. We also agree that the patient’s
or support person’s oral consent to
admit a visitor or to deny a visitor is
sufficient evidence of their wishes, and
that further proof of those wishes
should not be required. However,
hospitals and CAHs are permitted to
record such information in the patient’s
record for future reference, if they so
choose.
Comment: Some commenters
submitted comments related to the rare
cases in which hospitals may need to
require written documentation of
patient representation. Of these, some
commenters suggested that
documentation should be required only
in cases where more than one person
claims to be the patient’s spouse,
domestic partner or surrogate. Others
suggested that proof should be required
only if the patient is incapacitated.
Other commenters suggested dropping
‘‘proof’’ requirements altogether in an
emergency situation and/or if the
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patient is unconscious or otherwise
incapacitated. A few commenters stated
that the visitor should not have to leave
the bedside of the patient to obtain
proper documentation, while others
stated that proof should not be required
of same-sex couples where it is not
required of similarly-situated differentsex couples. Other comments to this
effect went further, suggesting that
hospitals requiring documentation from
a same-sex couple but not a differentsex couple in the same situation would
be engaging in discrimination on an
impermissible basis (i.e. on the basis of
sexual orientation).
Response: We agree with those
commenters who stated that a hospital
or CAH must apply its documentation
policy equally for all patients and
support persons. In accordance with the
comments submitted with respect to
this rule, we believe that documentation
to establish support person status for the
purpose of exercising a patient’s
visitation rights should be required only
in the event that the patient is
incapacitated and two or more
individuals claim to be the patient’s
support person. Since the visitation
rights provision is new, we do not
believe that States have established
separate laws and regulations that
would require documentation to
establish an individual as the support
person in other circumstances. While
we acknowledge the desire of the
individuals who claim to be the
patient’s support person to remain at the
patient’s bedside, we recognize that this
is not possible in every situation. In
these situations, such individuals may
need to leave the area in order to obtain
written documentation of the patient’s
wishes. Individuals may wish to
maintain such documentation on their
person and/or maintain such
documentation in an electronic
database, such as an advance directive
registry, that grants access to health care
facilities in order to avoid leaving the
patient’s bedside to obtain proof of
support person status.
Comment: A few comments spoke to
matters beyond a support person’s
ability to visit and designate other
visitors, suggesting that, where the
patient is unable to communicate and
decisions related to providing or
withdrawing medical care are necessary,
documentation should be required,
unless the patient designated the
representative for health care decision
making before being unable to
communicate.
Response: We agree that situations
related to medical decision making are
governed by State law, whether
established under legislative or judicial
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authority. We note that issues of
surrogate medical decision making fall
outside the scope of this rule on
visitation policies. Hospitals and CAHs
must always comply with their State
laws and regulations, and we remind
facilities that their policies and
procedures related to requiring
documentation of support person status
must be applied in a non-discriminatory
manner.
Comment: Comments were received
regarding what forms of proof might
suffice to establish the appropriateness
of a visitor where the patient is
incapacitated or otherwise unable to
designate visitors, and a representative
in accordance with State law or a
patient-designated support person is not
available to exercise the patient’s rights
on his or her behalf. Comments also
suggested that these forms of ‘‘proof’’
could also be used to help establish a
support person’s status as such.
The following forms of ‘‘proof’’ were
suggested:
• An advance directive naming the
individual as a support person,
approved visitor or designated decision
maker (regardless of the State in which
the directive is established);
• Shared residence;
• Shared ownership of a property or
business;
• Financial interdependence;
• Marital/Relationship status;
• Existence of a legal relationship
recognized in another jurisdiction, even
if not recognized in another jurisdiction,
including: Parent-child, civil union,
marriage, domestic partnership;
• Acknowledgment of a committed
relationship (e.g. an affidavit); and
• Written documentation of the
patient’s chosen individual(s) even if it
is not a legally recognized advance
directive.
Response: We agree that any of these
forms of proof could be sufficient for
hospitals and CAHs to establish the
appropriateness of a visitor when a
patient is incapacitated and no
representative or support person is
available to exercise a patient’s
visitation rights on his or her behalf. We
also agree that these forms of proof may
be helpful for establishing support
person status for the purpose of
exercising the patient’s visitation rights
when the patient is incapacitated. In
order to obtain this information,
hospitals and CAHs may choose to
examine licenses, State identification
cards, bank statements, deeds, lease
agreements, etc. These lists of proof and
documentation are not intended to be
exhaustive of all potential sources of
information regarding patient visitation
or support person preferences. Our
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overall expectation is that hospitals and
CAHs will use this information to guide
the establishment of flexible policies
and procedures that balance the dual
needs of ensuring patient safety and
ensuring patient access to loved ones.
Comment: A few commenters
suggested that the final rule should
ensure that patients have the right to
exclude certain visitors to assure their
well-being, and that the patient’s
support person should have the highest
level of authority to do so.
Response: We agree that the patient’s
right to choose visitors also includes the
right to deny visitors. We included this
concept at proposed § 482.13(h)(2) and
§ 485.635(f)(2), stating, ‘‘Inform each
patient (or representative, where
appropriate) of his or her visitation
rights * * * and his or her right to
withdraw or deny such consent at any
time.’’ We continue to believe that this
is an appropriate provision and are
finalizing it as such. Patients, or their
support person acting on their behalf,
have the right to deny visitors.
Comment: Some commenters
suggested that the regulation should
include an explicit requirement granting
the patient’s support person direct
access to the patient. One commenter
suggested that health care proxies or
powers of attorney that are legally
recognized in one State also be
recognized by hospitals and CAHs in
other States for the purpose of
establishing visitation rights.
Response: We agree that the patient’s
representative and/or support person, as
the individual responsible for exercising
the patient’s rights on the patient’s
behalf when the patient is incapacitated
or otherwise unable to do so directly,
should be granted direct access to the
patient. This basic concept is embodied
throughout the current hospital
regulations, including through the
requirement at § 482.13(a) and (b) that
the patient or patient’s representative
must be informed of the patient’s rights
and how to exercise those rights. We
also agree that using the information
provided in an advance directive or
other written document, whether it is or
is not legally recognized by the State,
may be useful for hospitals and CAHs
when trying to determine appropriate
visitors when a patient is unable to
communicate his or her own wishes and
a legal representative as established
consistent with State law or a support
person is not available to exercise the
patient’s visitation rights on his or her
behalf.
Comment: A number of commenters
expressed the concern that the
regulation’s reference to State law, as it
pertains to the hospital’s recognition of
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a patient’s representative, could be
interpreted as inappropriately limiting
the designation of a representative, and
suggested that we remove ‘‘as allowed
under State law’’ from the regulation.
Response: As previously discussed,
we agree that using the term
‘‘representative,’’ with its implicit links
to state law, is too narrow for this
regulation. Therefore, we have replaced
the term ‘‘representative’’ with the term
‘‘support person,’’ which is intended to
broadly describe the family member,
friend, or other individual who supports
the patient during his or her hospital or
CAH stay and may exercise the patient’s
visitation rights on his or her behalf.
Issues of legal representation and health
care decision making are beyond the
purview of this final rule. We remind all
hospitals and CAHs that these issues are
generally addressed in State law
(including case law). All Medicareparticipating providers, including
hospitals and CAHs, are required to
remain in full compliance with the laws
and regulations of their State, in
addition to these Federal requirements.
Comment: A few commenters noted
that they were denied access to visit a
loved one by the patient’s
representative, although they believed
that such a denial was not in the best
interest of the patient. The commenters
cited their ability to provide pertinent
medical information about the patient as
a primary reason for allowing them
access to the patient despite the
decision of the patient’s representative.
A few comments also noted the impact
of the well-recognized legal concept of
‘‘substituted judgment’’ as requiring
patients’ families and representatives to
make medical decisions based on the
patient’s values and interests and not
their own.
Response: As the individual
responsible for making decisions on the
patient’s behalf, the patient
representative has the authority to
exercise a patient’s right to designate
and deny visitors just as the patient
would if he or she were capable of doing
so. The designation of and exercise of
authority by the patient’s representative
is governed by State law, including
statutory and case law. Many State
courts have addressed the concept of
substituted judgment, whereby the
patient representative is expected to
make medical decisions based on the
patient’s values and interests, rather
than the representative’s own values
and interests. State courts have also
developed a body of closely related law
around the matter of a representative
acting in the patient’s best interest. Such
case law regarding substituted judgment
and best interest may be a resource for
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hospitals and CAHs as they establish
policies and procedures intended to
address these difficult situations.
Hospitals and CAHs may also choose to
utilize their own social work and
pastoral counseling resources to resolve
such conflicts to assure the patient’s
well-being.
Comment: Some commenters
suggested that we replace the term
‘‘immediate family,’’ as proposed at
§ 482.13(h)(4) and § 485.635(f)(4), with a
broader requirement that does not
distinguish among different types of
relationships. Some commenters
asserted that the regulation, as
proposed, would be difficult to define,
measure, and enforce. Furthermore,
some commenters stated that the
regulation, as proposed, created the
appearance of a hierarchy of family
relationship status that could put other
chosen family members and loved ones
at risk of unequal treatment.
Response: We agree that the proposed
language may have been difficult to
define, measure, and enforce, and that
amending the requirement would
further clarify our intent to assure equal
visitation privileges for all visitors in
accordance with the patient’s
preferences. Therefore, we have
amended the requirements at
§ 482.13(h)(4) and § 485.635(f)(4) to
state, ‘‘Ensure that all visitors enjoy full
and equal visitation privileges
consistent with patient preferences.’’
This revised requirement is patientcentered and will, we believe, ensure
that all visitors are treated in a fair and
equal manner by a hospital or CAH.
Comment: Many commenters
suggested that we broaden the context
in which the word ‘‘family’’ is used.
Commenters presented a variety of
options, citing sources such as the Joint
Commission, the Office of Personnel
Management for the United States
government, and current practices in
New York State. All of these
commenters suggested a broad concept
of family, including any individual who
plays a significant role in the patient‘s
life, such as spouses, domestic partners,
significant others (whether different-sex
or same-sex), and other individuals not
legally related to the patient.
Commenters also provided a list of
specific types of family relationships,
and described the challenges that can be
faced with respect to each.
Response: We believe that both the
preamble to the proposed rule and the
language of the proposed requirements
broaden the definition of ‘‘family’’ in the
context of hospital and CAH visitation
rights of patients. The language of the
proposed rule (see 75 FR 36612)
provides examples of visitors very
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similar to those given by the
commenters (‘‘a spouse, a domestic
partner (including a same-sex domestic
partner), another family member, or a
friend’’). Most importantly, the proposed
requirements go beyond these examples
by specifying that the patient has the
right to designate all visitors, regardless
of type of relationship, and, while
patient-designated visitors may
obviously include those mentioned, the
requirements do not place limits on who
may be designated as a visitor by the
patient. This final rule maintains the
policies articulated in the proposed rule
in this regard.
Comment: Commenters from the
provider community expressed broad
support for the rule’s recognition of the
need for clinically necessary or
reasonable restrictions or limitations on
visitation. In addition to supporting the
overall concept of ‘‘necessary
restrictions,’’ some commenters stated
that restrictions must be enforced
uniformly and restrictions must be
clearly communicated, along with their
medical basis, to would-be visitors
and/or the patient. These commenters
stressed that such additional measures
would reduce the opportunity for
discrimination and increase
understanding. These comments reflect
the concerns of some commenters that
an allowance for ‘‘reasonable’’
restrictions would be too broad. There
were concerns among some of the
commenters that a hospital or CAH
might apply this exception capriciously
and without adequate clinical
justification, and that such a broad
exception might also allow for
restrictions rooted in discriminatory
attitudes toward lesbian, gay, bisexual,
and transgender people or their families.
Several commenters asked for
clarification on the language in the
proposed regulation that would allow
for a hospital or CAH to place
limitations or restrictions on a patient’s
visitation rights when it determined that
it was clinically reasonable or necessary
to do so. A commenter requested that
one of the examples of a clinically
reasonable restriction on visitation,
which was used in the preamble (‘‘when
the patient is undergoing care
interventions’’), be stricken entirely from
this rule. This commenter was
concerned that a hospital or CAH might
apply this example too broadly when
restricting visitation for a patient, and
that the reasons for applying it might be
more logistical than clinical (e.g., it may
be used by overworked staff to justify a
restriction or limitation).
The commenters provided numerous
examples of legitimate reasons for
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restricting or limiting visitors,
including:
Æ Any court order limiting or
restraining contact;
Æ Behavior presenting a direct risk or
threat to the patient, hospital staff, or
others in the immediate environment;
Æ Behavior disruptive of the
functioning of the patient care unit;
Æ Reasonable limitations on the
number of visitors at any one time;
Æ Patient’s risk of infection by the
visitor;
Æ Visitor’s risk of infection by the
patient;
Æ Extraordinary protections because
of a pandemic or infectious disease
outbreak;
Æ Substance abuse treatment
protocols requiring restricted visitation;
Æ Patient’s need for privacy or rest;
Æ Need for privacy or rest by another
individual in the patient’s shared room.
Response: We appreciate the support
of commenters for this provision of the
proposed rule, and agree that this list,
though not exhaustive, is an appropriate
way to begin considering clinically
appropriate restrictions on visitation
privileges.
In his April 15, 2010 memorandum on
hospital visitation rights, the President
directed the Secretary to initiate
appropriate rulemaking that ‘‘should
take into account the need for hospitals
to restrict visitation in medically
appropriate circumstances as well as the
clinical decisions that medical
professionals make about a patient’s
care or treatment.’’ In crafting the
language of the requirements, we took
this Presidential directive into account,
and thoroughly weighed the rights of a
patient to receive visitors of his or her
choosing against the obligation and duty
of a hospital or CAH to provide the best
possible care to all of its patients. We
firmly believe that the requirements
must allow hospitals and CAHs some
flexibility regarding patient visitation so
that healthcare professionals may
exercise their best clinical judgment
when determining when visitation is,
and is not, appropriate. We believe that
the best clinical judgment takes into
account all aspects of patient health and
safety, including any negative impact
that patients, visitors, and staff may
have on other patients in the hospital or
CAH.
In the preamble to the proposed rule,
we provided three broad examples of
clinically reasonable areas where
hospitals and CAHs might impose
restrictions or limitations on visitors:
When the patient is undergoing care
interventions; when there may be
infection control issues; and when
visitation may interfere with the care of
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other patients. There are other, similarly
obvious areas where restriction or
limitation of visitation would also be
appropriate, and which commenters
also pointed out: Existing court orders
restricting contact of which the hospital
or CAH is aware; disruptive,
threatening, or violent behavior of any
kind; patient need for rest or privacy;
limitations on the number of visitors
during a specific period of time;
minimum age requirements for child
visitors; and inpatient substance abuse
treatment programs that have protocols
limiting visitation. While all of these
instances can be discussed individually,
it may be more useful to group all of
these examples, plus those examples
that we mentioned in the preamble,
under an even broader category of
clinically appropriate and reasonable
restriction or limitation on visitation:
When visitation would interfere with
the care of the patient and/or the care
of other patients. Whether the reason for
limiting or restricting visitation is
infection control, disruptive behavior of
visitors, or patient or roommate need for
rest or privacy, all of these reasons may
be considered as clinically reasonable
and necessary when viewed in light of
a hospital’s or CAH’s overarching goal
of advancing the care, safety, and wellbeing of all of its patients. As we
discussed in the preamble, we believe
that current clinical thinking, along
with some evidence in this area,
supports the role of visitation in
advancing the care, safety, and wellbeing of patients. However, we must
caution commenters that visitation is
but one aspect of patient care. Hospitals
and CAHs must balance all aspects of
care for all patients. Through the
hospital and CAH CoPs, CMS expects
all hospitals and CAHs to provide care
to patients in a safe manner that follows
nationally recognized guidelines and
standards. As part of this expectation,
CMS recognizes that hospitals and
CAHs must be allowed some degree of
flexibility when developing policies and
procedures for patient care and safety,
and in order to comply with the CoPs.
We remind hospitals and CAHs that,
when establishing and implementing
visitation policies and procedures, the
burden of proof is upon the hospital or
CAH to demonstrate that the visitation
restriction is necessary to provide safe
care.
As it is written, the requirement does
allow a hospital or CAH a degree of
flexibility when developing and
imposing policies that may limit or
restrict visitation. However, the rule
does require that a hospital or CAH
must contain these policies in written
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form, including the reasons for such
restrictions, and must inform a patient
(or his or her support person) of its
policies regarding clinical limitations or
restrictions on visitation rights.
However, while we agree that a
hospital or CAH must communicate its
policy on limited or restricted visitation
to patients when apprising them of their
rights (and the requirement is written as
such), we do not believe that a hospital
or CAH must delineate each of the
clinical reasons that may warrant
imposition of this policy because it may
be impossible to anticipate every
instance that may give rise to such a
situation. We do believe that hospitals
and CAHs should clearly communicate
how such policies are aimed at
protecting the health and safety of all
patients. Additionally, in situations
where it may be necessary for patient
visitation to be limited or restricted,
hospitals and CAHs have a duty to the
patient to clearly explain the reasons for
such restrictions or limitations.
Further, we disagree that the example
given in the preamble of a clinically
reasonable or necessary restriction or
limitation on visitation (‘‘when the
patient is undergoing care
interventions’’) should be stricken from
the rule entirely. This language was not
included in the proposed requirements
nor is it being finalized here; it was used
merely as an example. However, we are
aware that in some hospitals and CAHs
throughout the nation, there still exists
an unwritten policy of ‘‘clearing the
room’’ of all visitors when a patient is
undergoing an intervention. It should be
noted here that there are often valid
reasons for doing this. For instance,
many patients prefer privacy during this
time; many visitors are not prepared to
witness the physical aspects of some
patient care interventions and
procedures; the physical limitations of
the patient’s room can make the
intervention difficult to perform with
visitors in the room; and, when
performing interventions or procedures
that require aseptic technique,
additional persons or visitors in the
room may compromise the healthcare
professional’s ability to control for
infection. CMS believes that it is in the
patient’s best interest to allow those
healthcare professionals responsible for
the care of the patient to make these
clinical decisions regarding restricting
or limiting visitation when the patient is
undergoing a procedure or intervention.
However, we must emphasize here
that we strongly encourage hospitals
and CAHs to be aware of, and sensitive
to, the needs of any patient who may
request that at least one visitor be
allowed to stay in the room to provide
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support and comfort when undergoing a
procedure, and to make a best effort at
accommodating such requests if the
clinical situation allows for it. Despite
the hospital culture of ‘‘clearing the
room’’ for patient care interventions that
may still exist in some hospitals and
CAHs, we believe that many more
hospitals and CAHs are making a best
effort at recognizing and honoring the
need of many patients to have a loved
one close by while undergoing a
potentially frightening and painful
procedure. In this regard, we
respectfully disagree with the comment
stating that staff may justify such
restrictions or limitations for logistical,
rather than clinical, reasons. This
comment voices a concern that
‘‘overworked staff’’ would apply
restrictions or limitations for logistical
reasons and implies that logistical
reasons are more conveniences for the
staff than they are clinical reasons for
the patient. In the hospital setting, the
logistical and the clinical are often one
and the same, and the logistics of the
situation must sometimes be taken into
account by healthcare professionals in
order to ensure the best clinical
outcomes for patients. Of the examples
given above for restricting or limiting
visitation during a care intervention, it
can be argued that all are both clinical
and logistical in nature, with each
impacting the other. Again, CMS
believes that, in the interests of patient
safety, such decisions are best left to the
healthcare professionals responsible for
the care of the patient, and should not
be dictated through overly prescriptive
regulations.
Comment: Several commenters stated
that written documentation of patient
representation in the form of legally
valid advance directives, such as
durable powers of attorney and
healthcare proxies, (as opposed to oral
designation of the support person by the
patient) should be required only in the
very rarest of cases—such as when more
than one person claims to be a patient’s
spouse, domestic partner, or surrogate.
In all other cases, oral confirmation of
an individual acting as the support
person should suffice. Commenters
suggested that a hospital or CAH may
not require documentation in a
discriminatory manner.
Response: In the preamble, we
specifically asked for comments on how
to best identify those rare cases where
hospitals and CAHs should be permitted
to ask for written documentation to
establish the support person as such in
order to allow the support person the
right to designate visitors if the patient
is unable to do so. We appreciate the
comments offered on this issue. We
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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
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efforts to assure that the final regulation
is fair and balanced to protect patient
rights, as well as patient health and
safety.
Comment: Several commenters in
favor of the regulation proposed that all
hospitals, whether they are receiving
Federal funding from CMS or not,
respect this directive and its intention.
Response: While we agree that the
intent and spirit of this regulation
should be honored by all hospitals and
CAHs, even those that do not receive
Medicare or Medicaid funds, we do not
have the authority to enforce these
requirements upon non-Medicare or
Medicaid hospitals and CAHs. CMS’s
authority to enforce this and other CMS
regulations stems from the agreement
that hospitals and CAHs enter into with
CMS whereby those hospitals and CAHs
agree to abide by Medicare’s regulations
in exchange for their ability to
participate in the Medicare and
Medicaid programs, see and treat
Medicare and Medicaid patients, and be
paid by Medicare or Medicaid for the
care and services furnished to those
Medicare and Medicaid patients. Absent
that voluntary agreement, CMS lacks
authority to enforce its rules upon nonparticipating providers and suppliers.
Comment: Several commenters
suggested that the requirements of this
rule should apply to hospices, nursing
homes, ambulatory surgical centers
(ASCs), and intermediate care facilities
for the mentally disabled (ICF/MRs).
Commenters noted that the need for and
the benefits that flow from visitation are
just as important—and sometimes even
more so—for patients in hospices and
nursing homes than for those in
hospitals. Many commenters asserted
that the standards and rules for all
facilities should be consistent.
Response: While we agree that the
benefits of visitation go beyond hospital
and CAH patients, and we appreciate
the suggestions that this rule should
apply to other types of Medicare and
Medicaid providers, such revisions
would fall outside the scope of this rule.
We note that the current regulations for
hospices (§ 418.52, § 418.100, and
§ 418.110 in particular) and nursing
homes (§ 483.10(j)) already require
generous visitation privileges for all
patients, and that these generous
allowances minimize the need for new
regulations at this time. We also believe
that the short-term nature of ASC
services, which must be less than 24
hours in duration, and the fact surgery
centers generally require each patient to
be accompanied by a responsible adult
for discharge purposes, naturally
minimize the need for open visitation
regulations in ASCs. However, we will
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continue to consider modifying the
requirements for these provider types in
the future to ensure consistent
requirements and patient rights across
providers.
Each of these providers is required by
regulation to have an internal system to
handle patient grievances. If patients of
these providers believe that their rights
have been violated, they may file a
complaint using their provider’s
internal grievance system. All patients
may also file a complaint with the state
survey agency and/or the agency that
accredits the provider (if applicable).
Furthermore, Medicare beneficiaries
may file quality of care complaints with
the QIO in that state. We believe that
these robust complaint options help
assure that patient complaints are
documented, investigated, and resolved
in an appropriate manner.
Informed Decisions
The President’s Memorandum also
directed the Secretary to ensure that
patients’ representatives have the right
to make informed decisions regarding
patients’ care.
The hospital CoPs at 42 CFR
482.13(b)(2) state: ‘‘The patient or his or
her representative (as allowed under
State law) has the right to make
informed decisions regarding his or her
care. The patient’s rights include being
informed of his or her health status,
being involved in care planning and
treatment, and being able to request or
refuse treatment. This right must not be
construed as a mechanism to demand
the provision of treatment or services
deemed medically unnecessary or
inappropriate.’’
We believe that the ability of a patient
to designate a support person who can
act on behalf of the patient is critical to
the assurance of the patient’s health and
safety. Regardless of whether a patient
is incapacitated, the designation of a
support person, who is likely to be
especially familiar with the patient,
including his or her medical history,
conditions, medications, and allergies,
can serve as an invaluable asset to the
patient and caregivers during the
development and revision of the course
of treatment and associated decision
making.
In the proposed rule, we explained
that the requirement at § 482.13(b)(2)
was intended to ensure the patient’s
right to designate a representative for
health care decision-making purposes.
We solicited public comment on
whether, as a health and safety measure,
this requirement effectively addresses
any inappropriate barriers to a patient’s
ability to designate a representative for
visitation purposes, and consistently
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ensures the right to designate a
representative (for all purposes) for all
patients in all Medicare- and Medicaidparticipating hospitals.
Comment: Several commenters noted
suggestions to ensure that all patients
are able to designate a decision-maker,
have that designation respected, and
receive meaningful representation by
that individual regardless of whether
the State in which the patient is
hospitalized recognizes a formal legal
relationship between the two persons.
This would include hospitals’
obligations to provide patients with
designation forms. In urgent situations,
commenters suggested that patients
have the right to orally designate a
representative for decision-making
purposes. One commenter suggested
that CMS should create a model
advance directive rule that States could
use to revise their current legislation
and regulations related to advance
directives.
Response: We thank commenters for
their suggestions regarding the
designation of a representative by a
patient. With respect to designations in
advance directives, § 1866(f)(1) of the
Act defers to State law (whether
statutory or established by the courts) to
govern the establishment and
recognition of advance directives
(which can be used by the patient to
designate a representative). Thus, we do
not have the authority in this rule to
change this aspect of advance directives
policy. We believe, however, that an
advance directive remains a viable and
important option for those seeking to
document treatment preferences,
informed decision-making regarding
care, designation of a representative,
and designation of a support person
(who may be the representative). And
we encourage hospitals to consider
advance directives established in other
States as a viable source of information
about patient preferences, including
visitation preferences. It is not within
the scope of this regulation to draft
sample legislation that could guide State
laws and regulations on advance
directives.
Comment: Commenters expressed
various concerns related to the current
requirements for the establishment and
implementation of advance directives,
State requirements for designating a
patient’s representative for decisionmaking purposes, methods for
producing a copy of an existing advance
directive in a time of need (including
the hospital’s role in obtaining a copy),
and the practicalities involved with
establishing advance directives. These
commenters highlighted the
complexities of establishing, accessing,
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and implementing advance directives in
a variety of circumstances, and focused
particular attention on the role of
advance directives in establishing
patient ‘‘representative’’ status.
Response: We appreciate the
comments received in regard to advance
directive issues. We refer readers to the
statutory language at § 1866(f)(3) of the
Act, which defines an advance directive
as ‘‘a written instruction, such as a
living will or durable power of attorney
for health care, recognized under State
law (whether statutory or as recognized
by the courts of the State) and relating
to the provision of such care when the
individual is incapacitated.’’ All CMS
regulations related to advance
directives, including those advance
directives that designate a patient’s
representative for health care decision
making, are based on this statute which,
in turn, defers to State laws in all forms
to govern the establishment and
implementation of such documents. As
such, CMS does not have the legal
authority to broadly preempt, through
regulation or other administrative
action, those State laws that relate to
advance directives.
In regard to current CMS regulations
related to advance directives, we note
that the provider agreement regulations
at § 489.102, referenced by § 482.13,
specify very limited instances in which
services or procedures specified in a
State-recognized advance health care
directive may be refused. Section
489.102(c)(2) is limited to refusals to
provide services or procedures called
for in an advance health care directive,
as described in § 489.102(a)(1)(ii)(C),
which refers specifically to ‘‘the range of
medical conditions or procedures
affected by the conscience objection.’’
We believe that this narrow window
allowing for certain objections to the
content of an advance directive would
not allow a health care provider to
refuse to honor those portions of a Staterecognized advance directive that
designate an individual as the patient’s
representative, support person, or health
care decision-maker, since such
designation is not a medical condition
or procedure.
Comment: Some commenters noted a
variety of barriers that inhibit the
establishment of an advance directive.
Such barriers include the cost
associated with obtaining legal counsel
to help establish an advance directive
that is legal in the patient’s State, a lack
of knowledge about the need for and
benefits of an advance directive, an
overall cultural apathy towards advance
care planning as indicated by the low
percentage of the population that has an
advance directive, and the
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disadvantages faced by non-Englishproficient individuals.
Response: In the proposed rule, we
solicited comment on whether the
current requirement (at § 482.13(b)(2),
which is intended to ensure a patient’s
right to designate a representative to
make informed decisions about his or
her care) effectively addresses any
inappropriate barriers to a patient’s
ability to designate a representative, and
whether it consistently ensures the right
to designate a representative for all
patients in all Medicare- and Medicaidparticipating hospitals. We also stated
our intention to consider public
comments received in response to this
request as we consider any revision to
the current regulation that would
eliminate any inappropriate restriction
or limitation on a patient’s ability to
designate a representative that may be
permitted under the existing regulation.
In light of our direct solicitation of
comments on this issue, we greatly
appreciate the comments offered here
regarding various barriers that a patient
may experience when attempting to
designate a representative for health
care decision-making purposes. We will
give due consideration to these
comments when we contemplate future
rulemaking in this area of the CoPs.
Comment: Commenters observed that
in addition to establishing an advance
directive, patients, representatives, and
support persons must also be able to
produce the document in a time of
urgent need. These commenters also
observed that being able to do so may
be challenging and inconvenient for
people, given the nature of urgent
medical situations.
Response: Urgent situations are, by
nature, unplanned. As such, patients,
representatives, and support persons
may not have ready access to the
necessary medical documentation at the
time that the urgent situation occurs. In
addition to keeping such documentation
in a readily accessible physical location,
we are aware of the existence of advance
directive registries that store advance
directives and other legal documents in
an electronic format that can be
retrieved by individuals and health care
facilities alike. Such document storage
and access facilities may be an
appropriate source of the proper
documentation in urgent situations.
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We solicited public comment on each
of these issues for the following sections
of this document that contain
information collection requirements
(ICRs):
A. ICRs Regarding Condition of
Participation: Patient’s Rights (§ 482.13)
Section § 482.13(h) requires a hospital
to have written policies and procedures
regarding the visitation rights of
patients, including any clinically
necessary or reasonable restriction or
limitation that the hospital may need to
place on such rights and the reasons for
the clinical restriction or limitation.
Specifically, the written policies and
procedures must contain the
information listed in § 482.13(h)(1)
through (h)(4). The burden associated
with this requirement is the time and
effort necessary for a hospital to develop
written policies and procedures with
respect to visitation rights of patients
and to distribute that information to the
patients.
We believe that most hospitals
already have established policies and
procedures regarding visitation rights of
patients. Therefore, we are adding only
a minimal amount of additional burden
hours to comply with this requirement.
Additionally, we believe that most
hospitals include the visitation policies
and procedures as part of their standard
notice of patient rights. The burden
associated with the notice of patient
rights is currently approved under OMB
control number 0938–0328. We will be
submitting a revision of the currently
approved information collection request
to account for the following burden.
We estimate that 4,860 hospitals must
comply with the aforementioned
information collection requirements. We
further estimate that it will take each
hospital 0.25 hours to comply with the
requirement in proposed § 482.13(h).
The total estimated annual burden
associated with this requirement is
1,215 hours at a cost of $71,746.
B. ICRs Regarding Condition of
Participation: Provision of Services
(§ 485.635)
Section 485.635(f) requires a CAH to
have written policies and procedures
regarding the visitation rights of
patients, including any clinically
necessary or reasonable restriction or
limitation that the CAH may need to
place on such rights and the reasons for
the clinical restriction or limitation.
Specifically, the written policies and
procedures must contain the
information listed in § 485.635(f)(1)
through (f)(4). The burden associated
with this requirement is the time and
effort necessary for a CAH to develop
written policies and procedures with
respect to visitation rights of patients
and to distribute the information to the
patients.
We believe that most CAHs already
have established policies and
procedures regarding visitation rights of
patients. These policies and procedures
are most likely included as part of a
CAH’s patient care policies as required
for CAHs under § 485.635. Therefore,
we are adding a minimal amount of
additional burden hours to comply with
this requirement. We will be submitting
a revision of the ICR currently approved
under OMB control number 0938–1043
to account for the burden associated
with the requirements in § 485.635.
We estimate that 1,314 CAHs must
comply with the aforementioned
information collection requirements. We
further estimate that it will take each
CAH 0.25 hours to comply with the
requirement at § 482.13(h). The total
estimated annual burden associated
with this requirement is 329 hours at a
cost of $19,398.
TABLE 1—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS
Regulation section(s)
§ 482.13 ................................
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No.
Respondents
0938–0328
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Responses
Burden per
response
(hours)
4,860
Frm 00032
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Total annual
burden
(hours)
Hourly labor
cost of
reporting
($)
1,215
59.05
.25
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Total labor
cost of
reporting
($)
71,746
19NOR1
Total capital/
maintenance
costs ($)
0
Total cost
($)
71,746
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TABLE 1—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS—Continued
Burden per
response
(hours)
OMB control
No.
Respondents
0938–1034
1,314
1,314
Total .............................. ......................
6,174
§ 485.635 ..............................
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Total annual
burden
(hours)
Hourly labor
cost of
reporting
($)
329
58.96
6,174 ......................
Regulation section(s)
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 $100 million economic threshold
and therefore is not considered a major
rule under the Congressional Review
Act.
We believe that the benefits of this
rule will amply justify its relatively
minimal costs. Executive Order 12866
explicitly requires agencies to consider
non-quantifiable benefits, including
‘‘distributive impacts’’ and ‘‘equity,’’ and
the benefits of the final rule, in these
terms, will be significant. In the words
of Executive Order 12866, these benefits
are ‘‘difficult to quantify, but
nevertheless essential to consider.’’
More specifically, the benefits of this
rule include: (1) Ensuring the protection
of a patient’s ability to designate who
may and may not visit the patient;
(2) broadening patient participation in
the care received (a benefit that would
have, among other things, significant
emotional benefits for many patients);
and
(3) creating a more patient-designated
support system, with potentially large
improvements in hospital and CAH
experiences and health outcomes for
patients.
The cost of implementing these
changes will largely be limited to the
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.25
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19,398
Total capital/
maintenance
costs ($)
Total cost
($)
0
19,398
1,544 ...................... ...................... ......................
91,144
one-time cost related to the revisions of
hospital and CAH policies and
procedures as they relate to the
requirements for patient visitation
rights. There will also be the one-time
cost of producing a printed page
detailing the patient visitation rights
that will be provided to patients upon
admission. We have estimated the total
cost of revising the policies and
procedures related to patient visitation
rights as well as the total cost of
producing a printed page detailing these
rights that will be provided to hospital
and CAH patients upon admission. No
burden is being assessed on the
communication of these revisions to
hospital and CAH staff or on the
distribution of the visitation rights to
patients that will be required by this
rule, as these practices are usual and
customary business practices.
CMS data, as of March 31, 2010,
indicated that there were 4,860
hospitals and 1,314 CAHs (for a total of
6,174) in the United States. We prepared
the cost estimates for hospitals and
CAHs together since both types of
providers will be required to perform
the same functions. Regarding the costs
of revising hospital and CAH policies
and procedures as related to the
proposed patient visitation rights
requirements, this function will be
performed by the hospital or CAH
administrator at an hourly salary
(including a 35 percent benefits) of
$59.05 (based on wage estimates for a
Medical and Health Services Manager in
the May 2009 National, State,
Metropolitan, and Nonmetropolitan
Area Occupational Employment and
Wage Estimates report from the Bureau
of Labor Statistics) and that this
function will require approximately 15
minutes of an administrator’s time to
accomplish. Therefore, the total onetime cost for all hospitals and CAHs
would be $59.05 × .25 hours × 6,174
total hospitals/CAHs = $91,144.
The most recent CMS figures from
2008 also indicate that there were
37,529,270 total hospital (and CAH)
patient admissions in that year. Using
that as an estimate, we then calculated
the total cost for hospitals and CAHs to
produce a one-page printed disclosure
form detailing the patient visitation
PO 00000
Total labor
cost of
reporting
($)
rights that would be provided to all
patients upon admission. We estimated
the cost of production to be 2 cents per
page. Therefore, the total estimated cost
for all hospitals and CAHs to produce
this one-page printed patient visitation
rights disclosure form and provide it to
all patients upon admission (based on
the most recent hospital admission
figures) will be 37,529,270 total hospital
patient admissions × $0.02 = $750,585
for the first year. We will anticipate that
this form would be incorporated into
hospital and CAH admission materials
for subsequent years; therefore, we have
no way to estimate the future costs to
provide this form, but expect the costs
to be minimal once all hospitals and
CAHs have incorporated this disclosure
of patient visitation rights. In
conclusion, the total first-year cost for
all hospitals and CAHs to meet the
requirements of the patient visitation
rights will be $841,729. We believe that
the annual benefits of the rule, though
not susceptible to quantification, far
exceed that amount.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7.0 million to $34.5 million in any
1 year. Individuals and States are not
included in the definition of a small
entity. We are not preparing an analysis
for the RFA because the Secretary has
determined that this rule will not have
a significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area for
Medicare payment regulations and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
E:\FR\FM\19NOR1.SGM
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of the Act because the Secretary has
determined that this rule will not have
a significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2010, that threshold is approximately
$135 million. This rule will have no
consequential effect on State, local, or
tribal governments in the aggregate or
on the private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a rule
that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
Because this regulation will not impose
any substantial costs on State or local
governments, the requirements of
Executive Order 13132 are not
applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 482
Grant programs—Health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 485
Grant programs—Health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements.
■ For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
1. The authority citation for Part 482
continues to read as follows:
srobinson on DSKHWCL6B1PROD with RULES
■
VerDate Mar<15>2010
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Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395(hh)).
2. Section 482.13 is amended by
adding a new paragraph (h) to read as
follows:
■
§ 482.13 Condition of participation:
Patient’s rights.
*
*
*
*
*
(h) Standard: Patient visitation rights.
A hospital must have written policies
and procedures regarding the visitation
rights of patients, including those
setting forth any clinically necessary or
reasonable restriction or limitation that
the hospital may need to place on such
rights and the reasons for the clinical
restriction or limitation. A hospital must
meet the following requirements:
(1) Inform each patient (or support
person, where appropriate) of his or her
visitation rights, including any clinical
restriction or limitation on such rights,
when he or she is informed of his or her
other rights under this section.
(2) Inform each patient (or support
person, where appropriate) of the right,
subject to his or her consent, to receive
the visitors whom he or she designates,
including, but not limited to, a spouse,
a domestic partner (including a samesex domestic partner), another family
member, or a friend, and his or her right
to withdraw or deny such consent at
any time.
(3) Not restrict, limit, or otherwise
deny visitation privileges on the basis of
race, color, national origin, religion, sex,
gender identity, sexual orientation, or
disability.
(4) Ensure that all visitors enjoy full
and equal visitation privileges
consistent with patient preferences.
PART 485—CONDITIONS OF
PARTICIPATION: SPECIALIZED
PROVIDERS
3. The authority citation for Part 485
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395(hh)).
4. Section 485.635 is amended by
adding a new paragraph (f) to read as
follows:
■
PO 00000
Frm 00034
Fmt 4700
Sfmt 9990
§ 485.635 Condition of participation:
Provision of services.
*
*
*
*
*
(f) Standard: Patient visitation rights.
A CAH must have written policies and
procedures regarding the visitation
rights of patients, including those
setting forth any clinically necessary or
reasonable restriction or limitation that
the CAH may need to place on such
rights and the reasons for the clinical
restriction or limitation. A CAH must
meet the following requirements:
(1) Inform each patient (or support
person, where appropriate) of his or her
visitation rights, including any clinical
restriction or limitation on such rights,
in advance of furnishing patient care
whenever possible.
(2) Inform each patient (or support
person, where appropriate) of the right,
subject to his or her consent, to receive
the visitors whom he or she designates,
including, but not limited to, a spouse,
a domestic partner (including a samesex domestic partner), another family
member, or a friend, and his or her right
to withdraw or deny such consent at
any time.
(3) Not restrict, limit, or otherwise
deny visitation privileges on the basis of
race, color, national origin, religion, sex,
gender identity, sexual orientation, or
disability.
(4) Ensure that all visitors enjoy full
and equal visitation privileges
consistent with patient preferences.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program). (Catalog of Federal
Domestic Assistance Program No. 93.778,
Medical Assistance Program).
Dated: October 21, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: November 15, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–29194 Filed 11–17–10; 11:15 am]
BILLING CODE 4120–01–P
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Agencies
[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Rules and Regulations]
[Pages 70831-70844]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: https://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: https://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 (https://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
https://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 https://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:
An advance directive naming the individual as a support
person, approved visitor or designated decision maker (regardless of
the State in which the directive is established);
Shared residence;
Shared ownership of a property or business;
Financial interdependence;
Marital/Relationship status;
Existence of a legal relationship recognized in another
jurisdiction, even if not recognized in another jurisdiction,
including: Parent-child, civil union, marriage, domestic partnership;
Acknowledgment of a committed relationship (e.g. an
affidavit); and
Written documentation of the patient's chosen
individual(s) even if it is not a legally recognized advance directive.
Response: We agree that any of these forms of proof could be
sufficient for hospitals and CAHs to establish the appropriateness of a
visitor when a patient is incapacitated and no representative or
support person is available to exercise a patient's visitation rights
on his or her behalf. We also agree that these forms of proof may be
helpful for establishing support person status for the purpose of
exercising the patient's visitation rights when the patient is
incapacitated. In order to obtain this information, hospitals and CAHs
may choose to examine licenses, State identification cards, bank
statements, deeds, lease agreements, etc. These lists of proof and
documentation are not intended to be exhaustive of all potential
sources of information regarding patient visitation or support person
preferences. Our overall expectation is that hospitals and CAHs will
use this information to guide the establishment of flexible policies
and procedures that balance the dual needs of ensuring patient safety
and ensuring patient access to loved ones.
Comment: A few commenters suggested that the final rule should
ensure that patients have the right to exclude certain visitors to
assure their well-being, and that the patient's support person should
have the highest level of authority to do so.
Response: We agree that the patient's right to choose visitors also
includes the right to deny visitors. We included this concept at
proposed 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 clea