36610 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Proposed Rules 

incorporating by reference the State’s 

hazardous waste program as an 

immediate final rule. The EPA did not 

make a proposal prior to the immediate 

final rule because we believe these 

actions are not controversial and do not 

expect comments that oppose them. We 

have explained the reasons for this 

codification and incorporation by 

reference in the preamble to the 

immediate final rule. Unless we get 

written comments which oppose this 

incorporation by reference during the 

comment period, the immediate final 

rule will become effective on the date it 

establishes, and we will not take further 

action on this proposal. If we get 

comments that oppose these actions, we 

will withdraw the immediate final rule 

and it will not take effect. 

We will then respond to public 

comments in a later final rule based on 

this proposal. You may not have another 

opportunity for comment. If you want to 

comment on this action, you must do so 

at this time. 

DATES: Send written comments by 

July 28, 2010. 

ADDRESSES: Send written comments to 

Alima Patterson, Region 6 Regional 

Authorization Coordinator, OR Julia 

Banks, Codification Coordinator, State/ 

Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733, 

Phone numbers: (214) 665–8533 or (214) 

665–8178. You may also submit 

comments electronically or through 

hand delivery/courier; please follow the 

detailed instructions in the ADDRESSES

section of the immediate final rule 

which is located in the Rules section of 

this Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Alima Patterson, (214) 665–8533 or Julia 

Banks, (214) 665–8178. 

SUPPLEMENTARY INFORMATION: For 

additional information, please see the 

immediate final rule published in the 

‘‘Rules and Regulations’’ section of this 

Federal Register. 

Dated: April 30, 2010. 

Lawrence E. Starfield, 

Acting Regional Administrator, Region 6. 

[FR Doc. 2010–15329 Filed 6–25–10; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Proposed Rules 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/thepress-office/presidential-memorandumhospital-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 § 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 

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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
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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, § 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 § 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 

§ 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 § 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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Proposed Rules 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 § 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 (§ 482.13) 

Proposed § 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 

§ 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 § 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 

(§ 485.635) 

Proposed § 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 

§ 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 § 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 § 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 § 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)). 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
36614 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Proposed Rules 

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 patientdesignated 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 onetime cost for all hospitals and CAHs 

would be $104 × .25 hours × 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 × $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: 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Proposed Rules 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: 

§ 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: 

§ 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 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Part 192 

[Docket No. PHMSA–RSPA–2004–19854] 

Pipeline Safety: Information Collection 

Gas Distribution Annual Report Form 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Request for public comments 

and OMB approval of modifications to 

an existing information collection. 

SUMMARY: As required by the Paperwork 

Reduction Act of 1995 (PRA), the 

Pipeline and Hazardous Materials Safety 

Administration (PHMSA) published a 

notice in the Federal Register on 

December 4, 2009, under Docket No. 

PHMSA–2004–19854 of its intent to 

revise the agency’s Gas Distribution 

System Annual Report Form (PHMSA F 

7100.1–1). PHMSA F 7100.1–1 is 

covered under the PHMSA information 

collection titled: ‘‘Incident and Annual 

Reports for Gas Pipeline Operators,’’ 

with an OMB Control Number of 2137– 

0522. PHMSA is publishing this notice 

to respond to comments and announce 

that the revised information collection 

will be submitted to OMB for approval. 

This notice also informs operators of gas 

distribution systems that PHMSA is 

planning for the revised Annual Report 

Form, once approved, to be used for the 

2010 calendar year and submitted to 

PHMSA by March 15, 2011. The portion 

of the annual report relative to 

mechanical fitting (compression 

couplings) failures will be delayed by 

one year and will take effect starting 

with the 2011 calendar year. 

DATES: Submit comments to OMB on or 

before July 28, 2010. 

ADDRESSES: You may submit comments 

identified by the docket number 

‘‘PHMSA–2004–19854’’ and OMB 

Control Number ‘‘2137–0522’’ by any of 

the following methods: 

• Fax: 1–202–395–6566, ATTN: Desk 

Officer for Department of Transportation 

(DOT)/PHMSA. 

• Mail: Office of Information and 

Regulatory Affairs (OIRA), OMB, 726 

Jackson Place, NW., Washington, DC 

20503, ATTN: Desk Officer for DOT/ 

PHMSA. 

• E-mail: OIRA, Office of 

Management and Budget, at the 

following address: 

oira_submissions@omb.eop.gov (ATTN: 

Desk Officer for DOT/PHMSA). 

Requests for a copy of the information 

collection should be directed to 

Cameron Satterthwaite, 202–366–1319 

or by e-mail at 

Cameron.Satterthwaite@dot.gov, or by 

mail at DOT, PHMSA, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. 

FOR FURTHER INFORMATION CONTACT:

Technical Information: Mike Israni, 

202–366–4571 or by e-mail at 

Mike.Israni@dot.gov. 

Information Collection: Cameron 

Satterthwaite, 202–366–1319 or by email at Cameron.Satterthwaite@dot.gov. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS