[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Proposed Rules]
[Pages 36610-36615]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482 and 485

[CMS-3228-P]
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: Proposed rule.

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SUMMARY: This proposed rule would revise the Medicare conditions of 
participation for hospitals and critical access hospitals (CAHs) to 
ensure the visitation rights of all patients. Medicare- and Medicaid-
participating hospitals and CAHs 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 or CAH may need to place on 
such rights as well as the reasons for the clinical restriction or 
limitation.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 27, 2010.

ADDRESSES: In commenting, please refer to file code CMS-3228-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
proposed regulation to http://www.regulations.gov. Follow the 
instructions under the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address only: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3228-P, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address only: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3228-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments before the close of the comment period 
to either of the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: CDR Scott Cooper, USPHS, (410) 786-
9465. Marcia Newton, (410) 786-5265. Jeannie Miller, (410) 786-3164.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid

[[Page 36611]]

Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday 
through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an 
appointment to view public comments, phone 1-800-743-3951.

I. Background

    On April 15, 2010, the President issued a Presidential Memorandum 
on Hospital Visitation to the Secretary of Health and Human Services. 
(The memorandum may be viewed on the Web at: http://www.whitehouse.gov/the-press-office/presidential-memorandum-hospital-visitation.) As part 
of the directives of the memorandum, the Department, through the Office 
of the Secretary, tasked CMS with developing proposed requirements for 
hospitals (including Critical Access Hospitals (CAHs)), that would 
address the right of a patient to choose who may and may not visit him 
or her. In the memorandum, the President pointed out the plight of 
individuals who are denied the comfort of a loved one 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 and close friends who provide them comfort and support do not fit 
into a traditional concept of ``family.''
    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 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 Web site: http://www.cms.gov/QualityImprovementOrgs/). The hospital patient rights CoP also 
guarantees a patient's right to: privacy; care in a safe setting; 
freedom from all forms of harassment and abuse; and confidentiality of 
patient records. In addition, this CoP contains detailed standards on 
the use of restraint and seclusion in the hospital, including 
provisions regarding the training of staff on appropriate restraint and 
seclusion of patients as well as a requirement for the hospital to 
report any and all deaths associated with the use of restraint or 
seclusion.
    As the President noted in his memorandum to the Secretary, many 
States have already taken steps to ensure that a patient has the right 
to determine who may and may not visit him or her, regardless of 
whether the visitor is legally related to the patient. In addressing 
the President's request to propose patient visitation rights in 
regulations, we have focused on developing proposed requirements that 
would 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. Accordingly, the proposed visitation rights 
requirement, which would require hospital and CAH compliance as a 
condition of participation in the Medicare and Medicaid programs (see 
Section II below for further discussion of the regulatory requirements 
of participation in the Medicaid program), not only addresses the 
President's directives regarding this important proposed patient right, 
but also would ensure that all hospitals and CAHs fully inform patients 
(or their designated representatives) of this right and that all 
patients are guaranteed full participation in designating who may and 
who may not visit them.
    We believe that such a requirement would need to be broad in scope 
(that is, would need to apply to all patients and all visitors as 
designated by the patient (or the patient's representative)). In 
addition, we believe that the requirement would need to be flexible 
enough in its application to permit the hospital or CAH to require 
written documentation of patient representation by legally valid 
advance directives, such as durable powers of attorney and healthcare 
proxies (as opposed to verbal designation of the representative by the 
patient), but only in rare cases. In such cases, the patient's 
documented representative could specify which visitors are and are not 
allowed to see the patient. We seek comment on how best to identify 
these rare cases. We believe that, at a minimum, a hospital or CAH may 
not require documentation where 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. 
We recognize that many States, such as Delaware, Minnesota, Nebraska, 
and North Carolina (as mentioned in the Presidential Memorandum), have 
already taken the lead in this area and adopted laws that directly 
address these types of issues. Finally, we believe that a patient 
visitation rights requirement also would need to accommodate medically 
appropriate visitation policies generally recognized by the Nation's 
hospitals and CAHs, i.e., those that set forth any clinically necessary 
or reasonable restrictions or limitations on visitors (for example, 
when the patient is undergoing care interventions, when there may be 
infection control issues, or when visitation may interfere with the 
care of other patients).
    In the April 15, 2010 Presidential Memorandum, the President also 
emphasized the consequences that restricted or limited visitation has 
for patients. 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 
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

[[Page 36612]]

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.''
    While the Presidential Memorandum specifically called for patient 
visitation rights in hospitals (and, by natural extension, CAHs since 
they are also hospitals, but with separate and distinct CoPs under the 
Medicare and Medicaid programs), there are other Medicare and Medicaid 
providers with respect to which the issue of patient visitation rights 
also may factor into the degree to which patients receive appropriate 
and compassionate care. Both the existing hospice CoPs and the nursing 
home requirements in the Medicare and Medicaid programs contain 
provisions that address visitors directly. The existing inpatient 
hospice CoP at 42 CFR 418.100(e) provides that ``[p]atients must be 
permitted to receive visitors at any hour, including small children,'' 
and contains another provision that requires hospices to provide 
privacy for patients and their family members when they are residing in 
the inpatient setting. The existing resident rights provision within 
the nursing home requirements under 42 CFR 483.10(j) contains even more 
extensive provisions concerning the rights of residents to receive 
visitors, including the right at any time to withdraw or deny consent 
to immediate family members, other relatives, or other individuals who 
are visiting the resident. While neither the hospice CoPs nor the 
nursing home requirements contains regulatory language that expressly 
prohibits the denial of visitation privileges based on race, color, 
national origin, religion, sex, sexual orientation, gender identity, or 
disability, as contemplated by the April 15, 2010 Presidential 
Memorandum with respect to hospitals, we believe that these existing 
acknowledgements of the visitation rights of hospice patients and 
nursing home residents can operate to fulfill the spirit of the 
Presidential Memorandum; that is, to ensure the protection of all 
patients' right to designate who may and may not visit the patient. 
Through this notice of proposed rulemaking, we are soliciting comments 
on the issue of patient visitation requirements with regard to these 
and other Medicare and Medicaid providers and suppliers.

II. Provisions of the Proposed Regulation

    The following provisions of this proposed rule would apply to all 
hospitals and CAHs participating in the Medicare and Medicaid programs. 
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 
the hospital's patients. Under this authority, the Secretary has 
established in the regulations at 42 CFR part 482 the requirements that 
a hospital must meet 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, Sec.  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 qualify for 
participation in Medicaid.
    We are proposing to incorporate the proposed visitation rights 
requirement for hospitals as a new standard within the patient rights 
CoP at Sec.  482.13. 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 proposed requirements, we are proposing to 
specify that 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 are further 
proposing 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 are 
specifically seeking public comments on the style and form that patient 
notices or disclosures would need to follow so that patients would be 
best informed of these rights.
    Consistent with the previously cited article's conclusions that a 
denial or restriction of visitation privileges can be inconsistent with 
the health and safety of patients where the denial is not justified by 
a medically appropriate reason, we are proposing that hospitals would 
not be permitted to restrict, limit, or otherwise deny visitation 
privileges on the basis of race, color, national origin, religion, sex, 
sexual orientation, gender identity, or disability. In addition, we are 
proposing 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.
    We are proposing to apply these same requirements to CAHs by 
revising the CoPs for CAHs. Because the CoPs for CAHs do not currently 
contain any patient rights provisions, we are proposing to add a new 
standard on patient visitation rights at Sec.  485.635(f) within the 
existing CoP on provision of services.
    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 conditions of participation 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

[[Page 36613]]

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 
representative 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 representative, 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.
    The requirement at Sec.  482.13(b)(2) is intended to ensure the 
patient's right to designate a representative. We are taking this 
opportunity to solicit 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, and 
consistently ensures the right to designate a representative for all 
patients in all Medicare- and Medicaid-participating hospitals. We 
intend 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.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):

A. ICRs Regarding Condition of Participation: Patient's Rights (Sec.  
482.13)

    Proposed Sec.  482.13(h) would require 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 
proposed Sec.  482.13(h)(1) through (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 
will be adding only a minimal amount of additional burden hours to 
comply with this requirement. Additionally, we believe that most 
hospitals include the visitation policies and procedures as part of 
their standard notice of patient rights. The burden associated with the 
notice of patient rights is currently approved under OMB control number 
0938-0328. We will be submitting a revision of the currently approved 
information collection request to account for the following burden.
    We estimate that 4,860 hospitals must comply with the 
aforementioned information collection requirements. We further estimate 
that it will take each hospital 0.25 hours to comply with the 
requirement in proposed Sec.  482.13(h). The total estimated annual 
burden associated with this requirement is 1,215 hours at a cost of 
$126,360.

B. ICRs Regarding Condition of Participation: Provision of Services 
(Sec.  485.635)

    Proposed Sec.  485.635(f) would require 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 
proposed Sec.  485.635(f)(1) through (4). The burden associated with 
this requirement is the time and effort necessary for a CAH to develop 
written policies and procedures with respect to visitation rights of 
patients and to distribute the information to the patients.
    We believe that most CAHs already have established policies and 
procedures regarding visitation rights of patients. These policies and 
procedures are most likely included as part of a CAH's patient care 
policies as required for CAHs under Sec.  485.635. Therefore, we will 
be adding only 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 proposed requirements in Sec.  485.635.
    We estimate that 1,314 CAHs must comply with the aforementioned 
information collection requirements. We further estimate that it will 
take each CAH 0.25 hours to comply with the requirement in proposed 
Sec.  482.13(h). The total estimated annual burden associated with this 
requirement is 329 hours at a cost of $34,216.
    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
[CMS-3228-P]; Fax: (202) 395-6974; or E-mail: OIRA_submission@omb.eop.gov.

IV. Response to Comments

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

V. 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)).

[[Page 36614]]

    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 economic threshold and thus is not considered a 
major rule.
    We believe that the benefits of the rule would amply justify its 
relatively small costs. Executive Order 12866 explicitly requires 
agencies to consider non-quantifiable benefits, including 
``distributive impacts'' and ``equity,'' and the benefits of the 
proposed rule, in these terms, would 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 the proposed 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 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 proposed changes would largely be 
limited to the one-time cost related to the revisions of hospital and 
CAH policies and procedures as they relate to the proposed requirements 
for patient visitation rights. There would also be the one-time cost of 
producing a printed page detailing the patient visitation rights that 
would 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 would 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 would be 
required by this proposed 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 would 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 would be performed by the hospital or CAH 
administrator at an hourly salary (including benefits) of $104 (our 
salary figures are from http:// www.salary.com/) and that this function 
would require approximately 15 minutes of an administrator's time to 
accomplish. Therefore, the total one-time cost for all hospitals and 
CAHs would be $104 x .25 hours x 6,174 total hospitals/CAHs = $160,524.
    The most recent CMS figures from 2008 also indicate that there were 
37,529,270 total hospital (and CAH) patient admissions in that year. 
Using that as an estimate, we then calculated the total cost for 
hospitals and CAHs to produce a one-page printed disclosure form 
detailing the patient visitation rights that would be provided to all 
patients upon admission. We estimated the cost of production to be 2 
cents per page. Therefore, the total estimated cost for all hospitals 
and CAHs to produce this one-page printed patient visitation rights 
disclosure form and provide it to all patients upon admission (based on 
the most recent hospital admission figures) would be 37,529,270 total 
hospital patient admissions x $0.02 = $750,585 for the first year. We 
would 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 we would 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 proposed patient visitation rights would be $0.9 million. 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 we have determined, and the Secretary 
certifies, that this proposed rule would 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 603 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) of the 
Act because we have determined, and the Secretary certifies, that this 
proposed rule would 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 proposed rule would have 
no consequential effect on State, local, or tribal governments or on 
the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Because this proposed regulation would 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 
proposed 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 proposes to amend 42 CFR chapter IV as set forth 
below:

[[Page 36615]]

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

    1. The authority citation for part 482 continues to read as 
follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)).

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


Sec.  482.13  Condition of participation: Patient's rights.

* * * * *
    (h) Standard: Patient visitation rights. A hospital must have 
written policies and procedures regarding the visitation rights of 
patients, including those setting forth any clinically necessary or 
reasonable restriction or limitation that the hospital may need to 
place on such rights and the reasons for the clinical restriction or 
limitation. A hospital must--
    (1) Inform each patient (or representative, 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 representative, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another 
family member, or a friend, and his or her right to withdraw or deny 
such consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, sexual 
orientation, gender identity, or disability.
    (4) 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.

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:


Sec.  485.635  Condition of participation: Provision of services.

* * * * *
    (f) Standard: Patient visitation rights. A CAH must have written 
policies and procedures regarding the visitation rights of patients, 
including those setting forth any clinically necessary or reasonable 
restriction or limitation that the CAH may need to place on such rights 
and the reasons for the clinical restriction or limitation. A CAH 
must--
    (1) Inform each patient (or representative, 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 representative, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another 
family member, or a friend, and his or her right to withdraw or deny 
such consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, sexual 
orientation, gender identity, or disability.
    (4) 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.

(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: June 18, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare 
& Medicaid Services.
    Approved: June 21, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-15568 Filed 6-23-10; 11:15 am]
BILLING CODE 4120-01-P